Non-Small Cell Lung Cancer (NSCLC) - Market Insight, Epidemiology, and Market Forecast - 2036
Description
Non-Small Cell Lung Cancer (NSCLC) Insights and Trends
According to DelveInsight’s analysis, NSCLC market size was found to be ~33 billion in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
NSCLC is the most common type of lung cancer accounted for approximately 85% of all lung cancers. However, NSCLC metastasizes to other organs slower in comparison to small cell lung cancer, and microscopically, SCLC is composed of much smaller cells. NSCLC is mainly subcategorized into adenocarcinomas, squamous cell carcinomas, large cell carcinomas and several other types that occur less frequently include adenosquamous carcinomas, and sarcomatoid carcinomas.
The real-world treatment trend depicts a significant shift towards targeted and immunotherapies (from only systemic therapies in the past), which is expected to contribute the most now.
A majority of the population of NSCLC patients are not candidates for targeted therapy. PD-L1 therapies are mainly utilized in patients without genetic drivers. Merck’s KEYTRUDA is generally considered the ‘gold standard’ of care in 1L NSCLC when combined with platinum chemotherapy, regardless of PD-1 status.
Acquired resistance to anti-PD-1/L1 therapies is a key issue. Acquired resistance renders these therapies effectively useless in half of the patient population after this period where they fall back to chemotherapy approaches which are often ineffective and/or toxic. Given the high unmet need in this area, many companies are exploring novel molecules and combinations in second-line NSCLC post-IO.
From last few years, exon 20 insertions EGFR mutations have received the most attention and this space has become competitive. In EGFR NSCLC, uncommon/atypical EGFR mutations (G719X, S768I, as well as PACC mutations), represent another frontier in this segment.
At present, ALECENSA and ALUNBRIG are the preferred first-line ALK TKIs. ALECENSA is much more widely used compared to ALUNBRIG and dominate the ALK market. Prior to entry of ALECENSA and ALUNBRIG, XALKORI was the first-line treatment choice in ALK patients.
The most frequent KRAS variants in NSCLC is G12C. Since the majority of treatments for NSCLC now target the G12C variant, this variant type is likely to become crowded and competitive. Future opportunities in G12C may be found in R/R patient’s pool of approved KRAS drugs and in the first-line setting.
Due to rarity of some biomarkers in NSCLC and the lack of late-stage clinical studies, the treatment paradigm for rare NSCLC mutations is less clear. Rare biomarkers like ROS-1, HER2, RET fusion, and NTRK1/2/3 Gene fusion have seen a lot of progress in past few years.
Despite advances in precision medicine and immunotherapy, early-stage NSCLC (Stages I–III) remains a major unmet need. Standard treatment, surgery with adjuvant platinum-based chemotherapy, offers limited survival benefit, significant toxicity, and inconsistent patient benefit. Although immunotherapies such as PD-1/PD-L1 inhibitors and neoadjuvant chemo-immunotherapy show promising improvements in event-free survival and pathological response, their routine use in early-stage care is still evolving, unevenly accessible, and not yet widely personalized.
Non-Small Cell Lung Cancer (NSCLC) Market size and forecast in the 7MM
2025 NSCLC Market Size: ~USD 33 billion
2036 Projected NSCLC Market Size: ~USD 67 billion
NSCLC Growth Rate (2026–2036): 6.6% CAGR
DelveInsight's ‘Non-Small Cell Lung Cancer (NSCLC) – Market Insights, Epidemiology and Market Forecast – 2036’ report delivers an in-depth understanding of the NSCLC, historical and forecasted epidemiology, as well as the NSCLC market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The NSCLC market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, NSCLC patient burden trends, revenue & market share dynamics, peak patient share and therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022–2036) across global regions. The report highlights key unmet medical needs in NSCLC and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Geography Covered
North America: The United States ;
Europe: Germany, France, Italy, and Spain and the UK;
Asia-Pacific: Japan
Key Factors Driving the Non-Small Cell Lung Cancer (NSCLC) Market
Rising NSCLC Incidence
NSCLC incident cases in the US form a substantial yet gradually stabilizing disease burden, characterized by declining overall incidence driven by long-term tobacco control measures alongside rising early-stage detections from expanded low-dose CT screening programs and incidental imaging findings in routine care. In the US, in 2025, there were ~203,000 incident cases of NSCLC, which will further reach ~205,000 by 2036.
Rising Opportunities in EGFR NSCLC Therapies
In EGFR-mutated NSCLC, where TAGRISSO is the industry leader, J&J's RYBREVANT is gradually gaining ground. RYBREVANT from J&J has joined the broad first-line EGFR-mutated NSCLC market (RYBREVANT in combination with the oral EGFR-TKI LAZCLUZE). The company also intends to launch the SC version of RYBREVANT.
Emerging NSCLC Competitive Landscape
The most frequent KRAS variants in NSCLC is G12C. Since the majority of treatments for NSCLC now target the G12C variant, this variant type is likely to become crowded and competitive. Future opportunities in G12C may be found in R/R patient’s pool of approved KRAS drugs and in the first-line setting. Emerging key players in the pipeline include Eli Lilly, Genfleet Therapeutics/Merck, Merck/Otsuka Pharmaceutical, BioAtla, Taiho Pharmaceutical, Astex Pharmaceuticals, Revolution Medicines, Roche, Verastem Oncology, and others.
Non-Small Cell Lung Cancer (NSCLC) Understanding and Treatment Algorithm
NSCLC Overview and Diagnosis
Lung cancer primarily originates in the lungs and may spread to lymph nodes or distant organs such as the brain; this process is called metastasis. It is mainly classified into two types: small cell lung cancer (SCLC) and NSCLC. NSCLC is the most common type, accounting for about 85% of all lung cancers. Compared with NSCLC, SCLC is more aggressive, composed of smaller cells, spreads rapidly, and can become fatal within weeks if untreated. NSCLC refers to all epithelial lung cancers other than SCLC and is mainly classified into adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, with less common types including adenosquamous and sarcomatoid carcinomas. Although strongly associated with cigarette smoking, adenocarcinoma may also occur in never-smokers. NSCLC is generally less sensitive to chemotherapy and radiation therapy than SCLC.
NSCLC arises from epithelial cells along the respiratory tract, from central bronchi to terminal alveoli. Histological subtype often correlates with the site of origin: squamous cell carcinoma typically develops near central bronchi, whereas adenocarcinoma and bronchioloalveolar carcinoma usually arise in peripheral lung tissue. Common symptoms of both NSCLC and SCLC include persistent cough, chest pain, shortness of breath, wheezing, loss of appetite, weight loss, and fatigue.
Further details are provided in the report.
Current NSCLC Treatment Landscape
Treatment options for NSCLC vary depending on disease stage and patient condition. Surgery is a primary treatment for early-stage NSCLC and includes procedures such as wedge or segmental resection (removal of the tumor with a small margin of healthy tissue), lobectomy (removal of a lung lobe), pneumonectomy (removal of an entire lung), and sleeve resection (removal of part of the bronchus while preserving lung tissue). After surgery, some patients may receive adjuvant chemotherapy or radiation therapy to eliminate residual microscopic disease and reduce recurrence risk.
Radiation therapy uses high-energy radiation to destroy or inhibit cancer cell growth and can be delivered externally or internally. External radiation therapy directs radiation from outside the body, with advanced methods such as stereotactic body radiation therapy (SBRT) providing highly precise high-dose radiation to the tumor while minimizing damage to healthy tissue. Stereotactic radiosurgery is often used when lung cancer metastasizes to the brain. Internal radiation therapy involves placing radioactive materials directly into or near the tumor, sometimes through an endoscope for airway tumors. Chemotherapy involves drugs that kill cancer cells or prevent their division and is usually administered systemically through oral or intravenous routes. Common agents include carboplatin, cisplatin, docetaxel, doxorubicin, etoposide, gemcitabine, paclitaxel, pemetrexed, and vinorelbine. Chemotherapy may be used alone or in combination with other treatments such as radiation therapy or immunotherapy. Targeted therapy focuses on specific molecular abnormalities in cancer cells, and biomarker testing is often performed to identify suitable patients. Major targeted therapies include EGFR inhibitors (osimertinib, erlotinib, gefitinib), ALK inhibitors (alectinib, brigatinib, lorlatinib), KRAS inhibitors (sotorasib, adagrasib), and inhibitors targeting RET, MET, BRAF, and NTRK alterations (such as selpercatinib, capmatinib, dabrafenib, and larotrectinib). Angiogenesis inhibitors and monoclonal antibodies, including bevacizumab, ramucirumab, and cetuximab, are also used. Immunotherapy enhances the body’s immune response against cancer cells. Approved agents for NSCLC include atezolizumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and tremelimumab, which may be used alone or combined with chemotherapy or other immunotherapies.
Additional local treatments are sometimes used for airway tumors or symptom relief. Laser therapy uses focused light energy to destroy cancer cells and relieve airway obstruction. Photodynamic therapy (PDT) combines a photosensitizing drug with laser light to selectively destroy cancer cells, typically administered through an endoscope. Cryosurgery (cryotherapy) destroys abnormal tissue by freezing it and is useful for carcinoma in situ or airway tumors. Electrocautery uses an electrically heated probe to destroy abnormal tissue and is commonly performed endoscopically..
Further details related to country-based variations are provided in the report.
Non-Small Cell Lung Cancer (NSCLC) Unmet Needs
The section “unmet needs of NSCLC” outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
1. Antibiotic-associated ICI resistance in NSCLC
2. High cost of combination therapies
3. Reimbursement issues in Europe
4. Treatment gaps in molecularly driven NSCLC
and others…..
Note: Comprehensive unmet needs insights in NSCLC and their strategic implications are provided in the full report.
Non-Small Cell Lung Cancer (NSCLC) Epidemiology
Key Findings from NSCLC Epidemiological Analysis and Forecast
Based on DelveInsight's assessment in 2025, the 7MM had approximately 539,000 incident cases of NSCLC. These are expected to rise due to the growing incident population and advancements in diagnostic capabilities during the forecast period (2026-2036).
Among the 7MM, the US accounted for the highest incident cases of NSCLC in 2025. This was followed by Japan, whereas the least number of cases were accounted by Spain.
In 2025, Germany had the highest number (~57,000) of NSCLC cases among the EU4 and the UK, while Spain had the lowest number (~27,00).
NSCLC is slightly more common in men than in women. In addition, NSCLC has a substantially higher prevalence in individuals aged 65 years and older; alarmingly, however, the number of cases in persons younger than age 65 years has risen.
Most cases of NSCLC are diagnosed at advanced Stage IV, primarily due to delayed detection, limited access to screening in underserved populations, nonspecific early symptoms, and socioeconomic barriers to timely healthcare. However, diagnoses at early stages (Stage I) have been increasing, largely driven by the wider use of low-dose CT screening in high-risk individuals and the growing number of incidental findings during imaging performed for other medical conditions. In contrast, the incidence of Stage II–III disease has remained relatively stable.
The rising incidence of adenocarcinoma may partly reflect improved evaluation and reporting practices, along with underlying idiopathic trends. This increase is also likely influenced by a sustained rise in cigarette smoking, as adenocarcinoma shows a strong dose response relationship with tobacco exposure and a slower decline in risk after smoking cessation compared with squamous cell carcinoma. Consequently, increasing regional smoking prevalence has contributed to higher overall NSCLC incidence, including adenocarcinoma.
Non-Small Cell Lung Cancer (NSCLC) Drug Analysis & Competitive Landscape
The NSCLC drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I–III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships, upcoming key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the NSCLC treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the NSCLC market.
Approved Therapies for NSCLC
AUMSEQA (Aumolertinib): Jiangsu Hansoh Pharmaceutical
Aumolertinib is a third-generation EGFR-TKI for the treatment of locally advanced or metastatic NSCLC with activating EGFR mutations, including EGFR T790M-positive disease. In June 2025, the UK MHRA granted marketing authorization to aumolertinib mesilate tablets as monotherapy for these indications.
TEVIMBRA (Tislelizumab): BeiGene
EVIMBRA is a humanized IgG4 anti-PD-1 monoclonal antibody with high affinity and specificity for PD-1, designed to minimize Fc? receptor binding and enhance immune-mediated tumor recognition. In August 2025, the European Commission approved it in combination with platinum-based chemotherapy as neoadjuvant therapy followed by TEVIMBRA monotherapy as adjuvant treatment for adults with resectable NSCLC at high risk of recurrence.
HERNEXEOS (Zongertinib): Boehringer Ingelheim
Zongertinib (BI 1810631) is an investigational oral HER2-specific tyrosine kinase inhibitor being developed for HER2 (ERBB2)-mutant NSCLC. In September 2025, Boehringer Ingelheim received approval in Japan for HERNEXEOS, the first oral targeted therapy for previously treated HER2-mutant advanced NSCLC, and in November 2025 the FDA granted zongertinib a Commissioner’s National Priority Voucher (CNPV) recognizing its potential to address this rare and aggressive cancer.
Non-Small Cell Lung Cancer (NSCLC) Pipeline Analysis
Iza-bren (izalontamab brengitecan): SystImmune and Bristol Myers Squibb
Izalontamab brengitecan is a first-in-class bispecific EGFR×HER3 antibody–drug conjugate (ADC) developed by SystImmune and Bristol Myers Squibb that simultaneously blocks EGFR/HER3 signaling and delivers a cytotoxic payload to induce cancer cell death, showing potential as a monotherapy or in combination with osimertinib for EGFR-mutant NSCLC. Phase II results in metastatic or unresectable NSCLC and other solid tumors were presented at ESMO 2025.
Daraxonrasib (RMC-6236): Revolution Medicines
Daraxonrasib (RMC-6236) is an oral, multi-selective RAS(ON) inhibitor designed to block active RAS signaling and target multiple oncogenic RAS mutations (G12X, G13X, Q61X) across cancers such as NSCLC, PDAC, and CRC. In November 2025, Revolution Medicines announced plans to initiate a registrational trial in 2026 evaluating daraxonrasib with pembrolizumab and chemotherapy as first-line treatment for metastatic RAS-mutant NSCLC.
Non-Small Cell Lung Cancer (NSCLC) Key Players, Market Leaders and Emerging Companies
AstraZeneca
Boehringer Ingelheim
Pfizer
Takeda Pharmaceuticals
Johnson & Johnson
Eli Lilly
Bristol-Myers Squibb
Merck
AbbVie, and others
Non-Small Cell Lung Cancer (NSCLC) Drug Updates
Nuvalent anticipates the submission of NDA or neladalkib in TKI-pretreated ALK-positive NSCLC in 1H 2026.
Revolution Medicines plans to start a registrational trial in 2026 of daraxonrasib in 1L metastatic RAS-mutant NSCLC, combined with pembrolizumab and chemotherapy.
The IOV-LUN-202 trial is expected to complete enrollment in 2026, supporting a supplemental BLA for lifileucel in nonsquamous NSCLC, with a potential launch in H2 2027.
MK-1084’s KANDLELIT-004 study anticipates the data readout in Q1 2029.
Non-Small Cell Lung Cancer (NSCLC) Market Outlook
With more than 500,000 cases in the 7MM region, lung cancer is one of the leading causes of death worldwide. This condition is often diagnosed when the patient reaches the advanced, inoperable, or metastatic stage, adversely affecting their quality of life.
In April 2024, TEVIMBRA (tislelizumab) received approval in Europe across three indications in the first and second line for select patients with NSCLC. Then in July 2024 in the first-line setting, CEJEMLY (sugemalimab) plus chemotherapy received approved in Europe. Sugemalimab has not only become CStone's first independently developed product to receive overseas marketing authorization but it is also the world's first anti–PD-L1 monoclonal antibody to receive regulatory approval in Europe in combination with chemotherapy as first-line treatment for both squamous and nonsquamous NSCLC.
TROP-2-directed ADCs such as Dato-DXd, Sacituzumab Tirumotecan, and TRODELVY are being tested across various lines of therapy. In November, AstraZeneca and Daiichi pulled the US marketing application for Dato-DXd in NSCLC and instead sought the FDA’s accelerated approval for the product in EGFR-mutated NSCLC. AstraZeneca and Daiichi Sankyo are evaluating datopotamab deruxtecan alone and in novel combinations as treatment for patients with NSCLC in seven Phase III trials.
TAGRISSO is the first and only targeted therapy to demonstrate survival benefits across all stages of EGFR-mutated NSCLC. It is approved in more than 100 countries for both early-stage (adjuvant) and late-stage (metastatic) disease. Multiple landmark clinical trials, including AURA trial, FLAURA trial, ADAURA trial, LAURA trial, and FLAURA2 trial, have consistently demonstrated significant improvements in progression-free survival (PFS) and overall survival.
EXKIVITY received conditional approvals but was later withdrawn in the US, UK, and EU due to insufficient confirmatory data, leaving amivantamab as the only FDA-approved therapy for EGFR exon 20 insertions until recently.
Beyond ADCs, innovation is extending into gene therapy approaches such as Reqorsa in combination with osimertinib, as well as a new wave of next-generation TKIs like sutetinib, silevertinib (BDTX-1535), and JIN-A02, all targeting resistance pathways. The bispecific antibody pamvatamig (MCLA-129) with chemotherapy adds further diversity to the evolving treatment mix.
LUMAKRAS sales is seeing a lots of pressure on the other hand, KRAZATI is gaining ground. While LUMAKRAS was the first KRAS inhibitor approved in 2021, sales have faced pressure. Sales began to face pressure in 2023. Q3 2025 sales dipped by 2%, and previous reports indicated declines for consecutive quarters, such as a 5% dip in Q4 2022.
For patients with c-Met overexpressed NSCLC, no particular cancer treatments are currently licensed in the 7MM. Companies like AbbVie, Mythic Therapeutics, Regeneron Pharmaceuticals, and others are targeting c-met overexpressed NSCLC patients.
Despite advances in NSCLC treatment with EGFR/ALK TKIs, platinum-based combinations, and immune checkpoint inhibitors, significant unmet needs remain. Primary and acquired resistance limit durable disease control, while treatment gaps persist in molecularly driven NSCLC, including limited post-TKI options, challenges with exon 20 mutations, and restricted immunotherapy data. Additionally, late diagnosis, emerging resistance, and treatment-related toxicities continue to impact long-term survival and quality of life.
The total market size of EGFR-mutated NSCLC in the US was nearly USD 3.8 billion in 2025. EGFR is one of the profitable biomarker segments, with blockbuster therapies such as TAGRISSO. TAGRISSO is now the dominant EGFR inhibitor.
Several anti-PD-1/L1 therapies are expected to enter the NSCLC market. In 2025, the highest revenue was captured by KEYTRUDA. Merck’s KEYTRUDA is generally considered the ‘gold standard’ of care in first-line NSCLC when combined with platinum chemotherapy, regardless of PD-L1 status.
The total market size of ALK-mutated NSCLC in the US was nearly USD 1.28 billion in 2025. In the adjuvant setting, ALECENSA has become the first approved ALK inhibitor following surgical resection, expanding treatment duration and increasing the addressable early-stage population. In the 1L metastatic setting, next-generation ALK inhibitors including ALECENSA, LORBRENA/LORVIQUA, and ZYKADIA, ALUNBRIG dominate the standard of care due to superior progression-free survival and robust intracranial activity, which is critical given the high incidence of brain metastases in ALK-positive patients.
Further details will be provided in the report….
Drug Class/Insights into Leading Emerging and Marketed Therapies in NSCLC (2022–2036 Forecast)
The NSCLC market comprises monoclonal antibodies, small molecules, bispecific antibodies, and others, each targeting different aspects of tumor growth and progression.
Monoclonal antibody: Nivolumab (OPDIVO) is a human IgG4 monoclonal antibody that targets the PD-1 immune checkpoint receptor, enhancing T-cell–mediated antitumor activity. Pembrolizumab (KEYTRUDA) is a PD-1–blocking antibody used across multiple cancers, particularly advanced or PD-L1–positive tumors, and may also be used after surgery to reduce recurrence risk. Cemiplimab (LIBTAYO) is a fully human anti-PD-1 monoclonal antibody indicated for NSCLC, including use with platinum-based chemotherapy as first-line therapy in certain patients. Tislelizumab (TEVIMBRA) is a humanized IgG4 anti-PD-1 monoclonal antibody engineered to reduce Fc? receptor binding on macrophages, helping enhance immune recognition and destruction of tumors.
Small molecule: Dacomitinib is a small-molecule EGFR tyrosine kinase inhibitor used as first-line therapy for metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutations, blocking EGFR signaling to slow tumor growth. Afatinib maleate, developed by Boehringer Ingelheim, is an irreversible ErbB family TKI that inhibits EGFR, HER2, and HER4, suppressing downstream cancer signaling. Osimertinib is a third-generation, irreversible EGFR TKI used for EGFR-mutant NSCLC both as adjuvant therapy after tumor resection and as first-line treatment. Sunvozertinib is an oral irreversible kinase inhibitor indicated for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations after progression on platinum-based chemotherapy.
Non-Small Cell Lung Cancer (NSCLC) Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026–2036). The analysis covers the NSCLC drug’s uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.
Among the emerging first-line therapies are Zipalertinib (TAS6417) + CTx; Furmonertinib/Firmonertinib; Pamvatamig (MCLA-129) ± Osimertinib; Aumolertinib (AUMSEQA); Sunvozertinib (ZEGFROVY); Datopotamab deruxtecan (DATROWAY) ± Osimertinib (TAGRISSO); Telisotuzumab adizutecan (Temab-A) + TAGRISSO; Sutetinib; JMT101 + Osimertinib; and other investigational approaches, Firmonertinib, sunvozertinib, and JMT101 in combination with osimertinib are anticipated to be among the first to enter the market by 2027 and are expected to compete closely with established therapies such as RYBREVANT and TAGRISSO.
Detailed insights of emerging therapies' drug uptake is included in the report
NSCLC therapies Price Scenario & Trends
Pricing and analogue assessment of NSCLC therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
Pricing of NSCLC Approved Drugs
EXKIVITY dosing is 160mg (four 40mg capsules) taken by mouth once daily until disease progression or unacceptable toxicity occur. Capsules should be swallowed whole. Based on this, the estimated annual treatment cost is approximately USD 182,500.
Industry Experts and Physician Views for Non-Small Cell Lung Cancer (NSCLC)
To keep up with NSCLC market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the NSCLC emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in NSCLC, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight’s analysts connected with 10+ KOLs to gather insights at country level. Centers such as the University of Southern California, Ohio State University, Norris Comprehensive Cancer Center, Paris-Saclay University, and Germans Trias i Pujol Research Institute, etc. were contacted.Their opinion helps understand and validate current and emerging NSCLC therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in NSCLC.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of NSCLC, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial’s primary and secondary outcome measures are evaluated, whereas the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Scope of the Report
The report covers a segment of key events, an executive summary, a descriptive overview of NSCLC, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
A detailed review of the NSCLC market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM NSCLC market.
Report Insights
Non-Small Cell Lung Cancer (NSCLC) Patient Population Forecast
Non-Small Cell Lung Cancer (NSCLC) Therapeutics Market Size
Non-Small Cell Lung Cancer (NSCLC) Pipeline Analysis
Non-Small Cell Lung Cancer (NSCLC) Market Size and Trends
Report Key Strengths
Epidemiology-based (Epi-based) Bottom-up Forecasting
Artificial Intelligence (AI)-enabled Market Research Report
11-year Forecast
Non-Small Cell Lung Cancer (NSCLC) Market Outlook (North America, Europe, Asia-Pacific)
Patient Burden Trends (by geography)
Non-Small Cell Lung Cancer (NSCLC) Treatment Addressable Market (TAM)
Non-Small Cell Lung Cancer (NSCLC) Competitve Landscape
Non-Small Cell Lung Cancer (NSCLC) Major Companies Insights
Non-Small Cell Lung Cancer (NSCLC) Price Trends and Analogue Assessment
Non-Small Cell Lung Cancer (NSCLC) Therapies and Drug Adoption/Uptake
Non-Small Cell Lung Cancer (NSCLC) therapies Peak Patient Share Analysis
Report Assessment
Non-Small Cell Lung Cancer (NSCLC) Current Treatment Practices
Non-Small Cell Lung Cancer (NSCLC) Unmet Needs
Non-Small Cell Lung Cancer (NSCLC) Clinical Development Analysis
Non-Small Cell Lung Cancer (NSCLC) Emerging Drugs Product Profiles
Non-Small Cell Lung Cancer (NSCLC) Market Attractiveness
Non-Small Cell Lung Cancer (NSCLC) Qualitative Analysis (SWOT and Conjoint Analysis)
FAQs
Market Insights
What was the NSCLC market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
What can be the future treatment paradigm of NSCLC?
What are the disease risks, burdens, and unmet needs of NSCLC? What will be the growth opportunities across the 7MM concerning the patient population with NSCLC?
Who is the major future competitor in the market, and how will the competitors affect their market share?
What are the current options for the treatment of NSCLC? What are the current guidelines for treating NSCLC in the US, Europe, and Japan?
Reasons to Buy
The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the NSCLC market.
Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
According to DelveInsight’s analysis, NSCLC market size was found to be ~33 billion in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
NSCLC is the most common type of lung cancer accounted for approximately 85% of all lung cancers. However, NSCLC metastasizes to other organs slower in comparison to small cell lung cancer, and microscopically, SCLC is composed of much smaller cells. NSCLC is mainly subcategorized into adenocarcinomas, squamous cell carcinomas, large cell carcinomas and several other types that occur less frequently include adenosquamous carcinomas, and sarcomatoid carcinomas.
The real-world treatment trend depicts a significant shift towards targeted and immunotherapies (from only systemic therapies in the past), which is expected to contribute the most now.
A majority of the population of NSCLC patients are not candidates for targeted therapy. PD-L1 therapies are mainly utilized in patients without genetic drivers. Merck’s KEYTRUDA is generally considered the ‘gold standard’ of care in 1L NSCLC when combined with platinum chemotherapy, regardless of PD-1 status.
Acquired resistance to anti-PD-1/L1 therapies is a key issue. Acquired resistance renders these therapies effectively useless in half of the patient population after this period where they fall back to chemotherapy approaches which are often ineffective and/or toxic. Given the high unmet need in this area, many companies are exploring novel molecules and combinations in second-line NSCLC post-IO.
From last few years, exon 20 insertions EGFR mutations have received the most attention and this space has become competitive. In EGFR NSCLC, uncommon/atypical EGFR mutations (G719X, S768I, as well as PACC mutations), represent another frontier in this segment.
At present, ALECENSA and ALUNBRIG are the preferred first-line ALK TKIs. ALECENSA is much more widely used compared to ALUNBRIG and dominate the ALK market. Prior to entry of ALECENSA and ALUNBRIG, XALKORI was the first-line treatment choice in ALK patients.
The most frequent KRAS variants in NSCLC is G12C. Since the majority of treatments for NSCLC now target the G12C variant, this variant type is likely to become crowded and competitive. Future opportunities in G12C may be found in R/R patient’s pool of approved KRAS drugs and in the first-line setting.
Due to rarity of some biomarkers in NSCLC and the lack of late-stage clinical studies, the treatment paradigm for rare NSCLC mutations is less clear. Rare biomarkers like ROS-1, HER2, RET fusion, and NTRK1/2/3 Gene fusion have seen a lot of progress in past few years.
Despite advances in precision medicine and immunotherapy, early-stage NSCLC (Stages I–III) remains a major unmet need. Standard treatment, surgery with adjuvant platinum-based chemotherapy, offers limited survival benefit, significant toxicity, and inconsistent patient benefit. Although immunotherapies such as PD-1/PD-L1 inhibitors and neoadjuvant chemo-immunotherapy show promising improvements in event-free survival and pathological response, their routine use in early-stage care is still evolving, unevenly accessible, and not yet widely personalized.
Non-Small Cell Lung Cancer (NSCLC) Market size and forecast in the 7MM
2025 NSCLC Market Size: ~USD 33 billion
2036 Projected NSCLC Market Size: ~USD 67 billion
NSCLC Growth Rate (2026–2036): 6.6% CAGR
DelveInsight's ‘Non-Small Cell Lung Cancer (NSCLC) – Market Insights, Epidemiology and Market Forecast – 2036’ report delivers an in-depth understanding of the NSCLC, historical and forecasted epidemiology, as well as the NSCLC market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The NSCLC market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, NSCLC patient burden trends, revenue & market share dynamics, peak patient share and therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022–2036) across global regions. The report highlights key unmet medical needs in NSCLC and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Geography Covered
North America: The United States ;
Europe: Germany, France, Italy, and Spain and the UK;
Asia-Pacific: Japan
Key Factors Driving the Non-Small Cell Lung Cancer (NSCLC) Market
Rising NSCLC Incidence
NSCLC incident cases in the US form a substantial yet gradually stabilizing disease burden, characterized by declining overall incidence driven by long-term tobacco control measures alongside rising early-stage detections from expanded low-dose CT screening programs and incidental imaging findings in routine care. In the US, in 2025, there were ~203,000 incident cases of NSCLC, which will further reach ~205,000 by 2036.
Rising Opportunities in EGFR NSCLC Therapies
In EGFR-mutated NSCLC, where TAGRISSO is the industry leader, J&J's RYBREVANT is gradually gaining ground. RYBREVANT from J&J has joined the broad first-line EGFR-mutated NSCLC market (RYBREVANT in combination with the oral EGFR-TKI LAZCLUZE). The company also intends to launch the SC version of RYBREVANT.
Emerging NSCLC Competitive Landscape
The most frequent KRAS variants in NSCLC is G12C. Since the majority of treatments for NSCLC now target the G12C variant, this variant type is likely to become crowded and competitive. Future opportunities in G12C may be found in R/R patient’s pool of approved KRAS drugs and in the first-line setting. Emerging key players in the pipeline include Eli Lilly, Genfleet Therapeutics/Merck, Merck/Otsuka Pharmaceutical, BioAtla, Taiho Pharmaceutical, Astex Pharmaceuticals, Revolution Medicines, Roche, Verastem Oncology, and others.
Non-Small Cell Lung Cancer (NSCLC) Understanding and Treatment Algorithm
NSCLC Overview and Diagnosis
Lung cancer primarily originates in the lungs and may spread to lymph nodes or distant organs such as the brain; this process is called metastasis. It is mainly classified into two types: small cell lung cancer (SCLC) and NSCLC. NSCLC is the most common type, accounting for about 85% of all lung cancers. Compared with NSCLC, SCLC is more aggressive, composed of smaller cells, spreads rapidly, and can become fatal within weeks if untreated. NSCLC refers to all epithelial lung cancers other than SCLC and is mainly classified into adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, with less common types including adenosquamous and sarcomatoid carcinomas. Although strongly associated with cigarette smoking, adenocarcinoma may also occur in never-smokers. NSCLC is generally less sensitive to chemotherapy and radiation therapy than SCLC.
NSCLC arises from epithelial cells along the respiratory tract, from central bronchi to terminal alveoli. Histological subtype often correlates with the site of origin: squamous cell carcinoma typically develops near central bronchi, whereas adenocarcinoma and bronchioloalveolar carcinoma usually arise in peripheral lung tissue. Common symptoms of both NSCLC and SCLC include persistent cough, chest pain, shortness of breath, wheezing, loss of appetite, weight loss, and fatigue.
Further details are provided in the report.
Current NSCLC Treatment Landscape
Treatment options for NSCLC vary depending on disease stage and patient condition. Surgery is a primary treatment for early-stage NSCLC and includes procedures such as wedge or segmental resection (removal of the tumor with a small margin of healthy tissue), lobectomy (removal of a lung lobe), pneumonectomy (removal of an entire lung), and sleeve resection (removal of part of the bronchus while preserving lung tissue). After surgery, some patients may receive adjuvant chemotherapy or radiation therapy to eliminate residual microscopic disease and reduce recurrence risk.
Radiation therapy uses high-energy radiation to destroy or inhibit cancer cell growth and can be delivered externally or internally. External radiation therapy directs radiation from outside the body, with advanced methods such as stereotactic body radiation therapy (SBRT) providing highly precise high-dose radiation to the tumor while minimizing damage to healthy tissue. Stereotactic radiosurgery is often used when lung cancer metastasizes to the brain. Internal radiation therapy involves placing radioactive materials directly into or near the tumor, sometimes through an endoscope for airway tumors. Chemotherapy involves drugs that kill cancer cells or prevent their division and is usually administered systemically through oral or intravenous routes. Common agents include carboplatin, cisplatin, docetaxel, doxorubicin, etoposide, gemcitabine, paclitaxel, pemetrexed, and vinorelbine. Chemotherapy may be used alone or in combination with other treatments such as radiation therapy or immunotherapy. Targeted therapy focuses on specific molecular abnormalities in cancer cells, and biomarker testing is often performed to identify suitable patients. Major targeted therapies include EGFR inhibitors (osimertinib, erlotinib, gefitinib), ALK inhibitors (alectinib, brigatinib, lorlatinib), KRAS inhibitors (sotorasib, adagrasib), and inhibitors targeting RET, MET, BRAF, and NTRK alterations (such as selpercatinib, capmatinib, dabrafenib, and larotrectinib). Angiogenesis inhibitors and monoclonal antibodies, including bevacizumab, ramucirumab, and cetuximab, are also used. Immunotherapy enhances the body’s immune response against cancer cells. Approved agents for NSCLC include atezolizumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and tremelimumab, which may be used alone or combined with chemotherapy or other immunotherapies.
Additional local treatments are sometimes used for airway tumors or symptom relief. Laser therapy uses focused light energy to destroy cancer cells and relieve airway obstruction. Photodynamic therapy (PDT) combines a photosensitizing drug with laser light to selectively destroy cancer cells, typically administered through an endoscope. Cryosurgery (cryotherapy) destroys abnormal tissue by freezing it and is useful for carcinoma in situ or airway tumors. Electrocautery uses an electrically heated probe to destroy abnormal tissue and is commonly performed endoscopically..
Further details related to country-based variations are provided in the report.
Non-Small Cell Lung Cancer (NSCLC) Unmet Needs
The section “unmet needs of NSCLC” outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
1. Antibiotic-associated ICI resistance in NSCLC
2. High cost of combination therapies
3. Reimbursement issues in Europe
4. Treatment gaps in molecularly driven NSCLC
and others…..
Note: Comprehensive unmet needs insights in NSCLC and their strategic implications are provided in the full report.
Non-Small Cell Lung Cancer (NSCLC) Epidemiology
Key Findings from NSCLC Epidemiological Analysis and Forecast
Based on DelveInsight's assessment in 2025, the 7MM had approximately 539,000 incident cases of NSCLC. These are expected to rise due to the growing incident population and advancements in diagnostic capabilities during the forecast period (2026-2036).
Among the 7MM, the US accounted for the highest incident cases of NSCLC in 2025. This was followed by Japan, whereas the least number of cases were accounted by Spain.
In 2025, Germany had the highest number (~57,000) of NSCLC cases among the EU4 and the UK, while Spain had the lowest number (~27,00).
NSCLC is slightly more common in men than in women. In addition, NSCLC has a substantially higher prevalence in individuals aged 65 years and older; alarmingly, however, the number of cases in persons younger than age 65 years has risen.
Most cases of NSCLC are diagnosed at advanced Stage IV, primarily due to delayed detection, limited access to screening in underserved populations, nonspecific early symptoms, and socioeconomic barriers to timely healthcare. However, diagnoses at early stages (Stage I) have been increasing, largely driven by the wider use of low-dose CT screening in high-risk individuals and the growing number of incidental findings during imaging performed for other medical conditions. In contrast, the incidence of Stage II–III disease has remained relatively stable.
The rising incidence of adenocarcinoma may partly reflect improved evaluation and reporting practices, along with underlying idiopathic trends. This increase is also likely influenced by a sustained rise in cigarette smoking, as adenocarcinoma shows a strong dose response relationship with tobacco exposure and a slower decline in risk after smoking cessation compared with squamous cell carcinoma. Consequently, increasing regional smoking prevalence has contributed to higher overall NSCLC incidence, including adenocarcinoma.
Non-Small Cell Lung Cancer (NSCLC) Drug Analysis & Competitive Landscape
The NSCLC drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I–III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships, upcoming key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the NSCLC treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the NSCLC market.
Approved Therapies for NSCLC
AUMSEQA (Aumolertinib): Jiangsu Hansoh Pharmaceutical
Aumolertinib is a third-generation EGFR-TKI for the treatment of locally advanced or metastatic NSCLC with activating EGFR mutations, including EGFR T790M-positive disease. In June 2025, the UK MHRA granted marketing authorization to aumolertinib mesilate tablets as monotherapy for these indications.
TEVIMBRA (Tislelizumab): BeiGene
EVIMBRA is a humanized IgG4 anti-PD-1 monoclonal antibody with high affinity and specificity for PD-1, designed to minimize Fc? receptor binding and enhance immune-mediated tumor recognition. In August 2025, the European Commission approved it in combination with platinum-based chemotherapy as neoadjuvant therapy followed by TEVIMBRA monotherapy as adjuvant treatment for adults with resectable NSCLC at high risk of recurrence.
HERNEXEOS (Zongertinib): Boehringer Ingelheim
Zongertinib (BI 1810631) is an investigational oral HER2-specific tyrosine kinase inhibitor being developed for HER2 (ERBB2)-mutant NSCLC. In September 2025, Boehringer Ingelheim received approval in Japan for HERNEXEOS, the first oral targeted therapy for previously treated HER2-mutant advanced NSCLC, and in November 2025 the FDA granted zongertinib a Commissioner’s National Priority Voucher (CNPV) recognizing its potential to address this rare and aggressive cancer.
Non-Small Cell Lung Cancer (NSCLC) Pipeline Analysis
Iza-bren (izalontamab brengitecan): SystImmune and Bristol Myers Squibb
Izalontamab brengitecan is a first-in-class bispecific EGFR×HER3 antibody–drug conjugate (ADC) developed by SystImmune and Bristol Myers Squibb that simultaneously blocks EGFR/HER3 signaling and delivers a cytotoxic payload to induce cancer cell death, showing potential as a monotherapy or in combination with osimertinib for EGFR-mutant NSCLC. Phase II results in metastatic or unresectable NSCLC and other solid tumors were presented at ESMO 2025.
Daraxonrasib (RMC-6236): Revolution Medicines
Daraxonrasib (RMC-6236) is an oral, multi-selective RAS(ON) inhibitor designed to block active RAS signaling and target multiple oncogenic RAS mutations (G12X, G13X, Q61X) across cancers such as NSCLC, PDAC, and CRC. In November 2025, Revolution Medicines announced plans to initiate a registrational trial in 2026 evaluating daraxonrasib with pembrolizumab and chemotherapy as first-line treatment for metastatic RAS-mutant NSCLC.
Non-Small Cell Lung Cancer (NSCLC) Key Players, Market Leaders and Emerging Companies
AstraZeneca
Boehringer Ingelheim
Pfizer
Takeda Pharmaceuticals
Johnson & Johnson
Eli Lilly
Bristol-Myers Squibb
Merck
AbbVie, and others
Non-Small Cell Lung Cancer (NSCLC) Drug Updates
Nuvalent anticipates the submission of NDA or neladalkib in TKI-pretreated ALK-positive NSCLC in 1H 2026.
Revolution Medicines plans to start a registrational trial in 2026 of daraxonrasib in 1L metastatic RAS-mutant NSCLC, combined with pembrolizumab and chemotherapy.
The IOV-LUN-202 trial is expected to complete enrollment in 2026, supporting a supplemental BLA for lifileucel in nonsquamous NSCLC, with a potential launch in H2 2027.
MK-1084’s KANDLELIT-004 study anticipates the data readout in Q1 2029.
Non-Small Cell Lung Cancer (NSCLC) Market Outlook
With more than 500,000 cases in the 7MM region, lung cancer is one of the leading causes of death worldwide. This condition is often diagnosed when the patient reaches the advanced, inoperable, or metastatic stage, adversely affecting their quality of life.
In April 2024, TEVIMBRA (tislelizumab) received approval in Europe across three indications in the first and second line for select patients with NSCLC. Then in July 2024 in the first-line setting, CEJEMLY (sugemalimab) plus chemotherapy received approved in Europe. Sugemalimab has not only become CStone's first independently developed product to receive overseas marketing authorization but it is also the world's first anti–PD-L1 monoclonal antibody to receive regulatory approval in Europe in combination with chemotherapy as first-line treatment for both squamous and nonsquamous NSCLC.
TROP-2-directed ADCs such as Dato-DXd, Sacituzumab Tirumotecan, and TRODELVY are being tested across various lines of therapy. In November, AstraZeneca and Daiichi pulled the US marketing application for Dato-DXd in NSCLC and instead sought the FDA’s accelerated approval for the product in EGFR-mutated NSCLC. AstraZeneca and Daiichi Sankyo are evaluating datopotamab deruxtecan alone and in novel combinations as treatment for patients with NSCLC in seven Phase III trials.
TAGRISSO is the first and only targeted therapy to demonstrate survival benefits across all stages of EGFR-mutated NSCLC. It is approved in more than 100 countries for both early-stage (adjuvant) and late-stage (metastatic) disease. Multiple landmark clinical trials, including AURA trial, FLAURA trial, ADAURA trial, LAURA trial, and FLAURA2 trial, have consistently demonstrated significant improvements in progression-free survival (PFS) and overall survival.
EXKIVITY received conditional approvals but was later withdrawn in the US, UK, and EU due to insufficient confirmatory data, leaving amivantamab as the only FDA-approved therapy for EGFR exon 20 insertions until recently.
Beyond ADCs, innovation is extending into gene therapy approaches such as Reqorsa in combination with osimertinib, as well as a new wave of next-generation TKIs like sutetinib, silevertinib (BDTX-1535), and JIN-A02, all targeting resistance pathways. The bispecific antibody pamvatamig (MCLA-129) with chemotherapy adds further diversity to the evolving treatment mix.
LUMAKRAS sales is seeing a lots of pressure on the other hand, KRAZATI is gaining ground. While LUMAKRAS was the first KRAS inhibitor approved in 2021, sales have faced pressure. Sales began to face pressure in 2023. Q3 2025 sales dipped by 2%, and previous reports indicated declines for consecutive quarters, such as a 5% dip in Q4 2022.
For patients with c-Met overexpressed NSCLC, no particular cancer treatments are currently licensed in the 7MM. Companies like AbbVie, Mythic Therapeutics, Regeneron Pharmaceuticals, and others are targeting c-met overexpressed NSCLC patients.
Despite advances in NSCLC treatment with EGFR/ALK TKIs, platinum-based combinations, and immune checkpoint inhibitors, significant unmet needs remain. Primary and acquired resistance limit durable disease control, while treatment gaps persist in molecularly driven NSCLC, including limited post-TKI options, challenges with exon 20 mutations, and restricted immunotherapy data. Additionally, late diagnosis, emerging resistance, and treatment-related toxicities continue to impact long-term survival and quality of life.
The total market size of EGFR-mutated NSCLC in the US was nearly USD 3.8 billion in 2025. EGFR is one of the profitable biomarker segments, with blockbuster therapies such as TAGRISSO. TAGRISSO is now the dominant EGFR inhibitor.
Several anti-PD-1/L1 therapies are expected to enter the NSCLC market. In 2025, the highest revenue was captured by KEYTRUDA. Merck’s KEYTRUDA is generally considered the ‘gold standard’ of care in first-line NSCLC when combined with platinum chemotherapy, regardless of PD-L1 status.
The total market size of ALK-mutated NSCLC in the US was nearly USD 1.28 billion in 2025. In the adjuvant setting, ALECENSA has become the first approved ALK inhibitor following surgical resection, expanding treatment duration and increasing the addressable early-stage population. In the 1L metastatic setting, next-generation ALK inhibitors including ALECENSA, LORBRENA/LORVIQUA, and ZYKADIA, ALUNBRIG dominate the standard of care due to superior progression-free survival and robust intracranial activity, which is critical given the high incidence of brain metastases in ALK-positive patients.
Further details will be provided in the report….
Drug Class/Insights into Leading Emerging and Marketed Therapies in NSCLC (2022–2036 Forecast)
The NSCLC market comprises monoclonal antibodies, small molecules, bispecific antibodies, and others, each targeting different aspects of tumor growth and progression.
Monoclonal antibody: Nivolumab (OPDIVO) is a human IgG4 monoclonal antibody that targets the PD-1 immune checkpoint receptor, enhancing T-cell–mediated antitumor activity. Pembrolizumab (KEYTRUDA) is a PD-1–blocking antibody used across multiple cancers, particularly advanced or PD-L1–positive tumors, and may also be used after surgery to reduce recurrence risk. Cemiplimab (LIBTAYO) is a fully human anti-PD-1 monoclonal antibody indicated for NSCLC, including use with platinum-based chemotherapy as first-line therapy in certain patients. Tislelizumab (TEVIMBRA) is a humanized IgG4 anti-PD-1 monoclonal antibody engineered to reduce Fc? receptor binding on macrophages, helping enhance immune recognition and destruction of tumors.
Small molecule: Dacomitinib is a small-molecule EGFR tyrosine kinase inhibitor used as first-line therapy for metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutations, blocking EGFR signaling to slow tumor growth. Afatinib maleate, developed by Boehringer Ingelheim, is an irreversible ErbB family TKI that inhibits EGFR, HER2, and HER4, suppressing downstream cancer signaling. Osimertinib is a third-generation, irreversible EGFR TKI used for EGFR-mutant NSCLC both as adjuvant therapy after tumor resection and as first-line treatment. Sunvozertinib is an oral irreversible kinase inhibitor indicated for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations after progression on platinum-based chemotherapy.
Non-Small Cell Lung Cancer (NSCLC) Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026–2036). The analysis covers the NSCLC drug’s uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.
Among the emerging first-line therapies are Zipalertinib (TAS6417) + CTx; Furmonertinib/Firmonertinib; Pamvatamig (MCLA-129) ± Osimertinib; Aumolertinib (AUMSEQA); Sunvozertinib (ZEGFROVY); Datopotamab deruxtecan (DATROWAY) ± Osimertinib (TAGRISSO); Telisotuzumab adizutecan (Temab-A) + TAGRISSO; Sutetinib; JMT101 + Osimertinib; and other investigational approaches, Firmonertinib, sunvozertinib, and JMT101 in combination with osimertinib are anticipated to be among the first to enter the market by 2027 and are expected to compete closely with established therapies such as RYBREVANT and TAGRISSO.
Detailed insights of emerging therapies' drug uptake is included in the report
NSCLC therapies Price Scenario & Trends
Pricing and analogue assessment of NSCLC therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
Pricing of NSCLC Approved Drugs
EXKIVITY dosing is 160mg (four 40mg capsules) taken by mouth once daily until disease progression or unacceptable toxicity occur. Capsules should be swallowed whole. Based on this, the estimated annual treatment cost is approximately USD 182,500.
Industry Experts and Physician Views for Non-Small Cell Lung Cancer (NSCLC)
To keep up with NSCLC market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the NSCLC emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in NSCLC, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight’s analysts connected with 10+ KOLs to gather insights at country level. Centers such as the University of Southern California, Ohio State University, Norris Comprehensive Cancer Center, Paris-Saclay University, and Germans Trias i Pujol Research Institute, etc. were contacted.Their opinion helps understand and validate current and emerging NSCLC therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in NSCLC.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of NSCLC, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial’s primary and secondary outcome measures are evaluated, whereas the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Scope of the Report
The report covers a segment of key events, an executive summary, a descriptive overview of NSCLC, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
A detailed review of the NSCLC market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM NSCLC market.
Report Insights
Non-Small Cell Lung Cancer (NSCLC) Patient Population Forecast
Non-Small Cell Lung Cancer (NSCLC) Therapeutics Market Size
Non-Small Cell Lung Cancer (NSCLC) Pipeline Analysis
Non-Small Cell Lung Cancer (NSCLC) Market Size and Trends
Report Key Strengths
Epidemiology-based (Epi-based) Bottom-up Forecasting
Artificial Intelligence (AI)-enabled Market Research Report
11-year Forecast
Non-Small Cell Lung Cancer (NSCLC) Market Outlook (North America, Europe, Asia-Pacific)
Patient Burden Trends (by geography)
Non-Small Cell Lung Cancer (NSCLC) Treatment Addressable Market (TAM)
Non-Small Cell Lung Cancer (NSCLC) Competitve Landscape
Non-Small Cell Lung Cancer (NSCLC) Major Companies Insights
Non-Small Cell Lung Cancer (NSCLC) Price Trends and Analogue Assessment
Non-Small Cell Lung Cancer (NSCLC) Therapies and Drug Adoption/Uptake
Non-Small Cell Lung Cancer (NSCLC) therapies Peak Patient Share Analysis
Report Assessment
Non-Small Cell Lung Cancer (NSCLC) Current Treatment Practices
Non-Small Cell Lung Cancer (NSCLC) Unmet Needs
Non-Small Cell Lung Cancer (NSCLC) Clinical Development Analysis
Non-Small Cell Lung Cancer (NSCLC) Emerging Drugs Product Profiles
Non-Small Cell Lung Cancer (NSCLC) Market Attractiveness
Non-Small Cell Lung Cancer (NSCLC) Qualitative Analysis (SWOT and Conjoint Analysis)
FAQs
Market Insights
What was the NSCLC market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
What can be the future treatment paradigm of NSCLC?
What are the disease risks, burdens, and unmet needs of NSCLC? What will be the growth opportunities across the 7MM concerning the patient population with NSCLC?
Who is the major future competitor in the market, and how will the competitors affect their market share?
What are the current options for the treatment of NSCLC? What are the current guidelines for treating NSCLC in the US, Europe, and Japan?
Reasons to Buy
The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the NSCLC market.
Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
Table of Contents
981 Pages
- 1. Key Insights
- 2. Report Introduction
- 3. Key Highlights
- 4. Executive Summary
- 5. Key Events
- 5.1. Upcoming Key Catalysts
- 5.2. Key Conferences and Meetings
- 5.3. Key Transactions and Collaborations
- 5.4. News Flow
- 6. Epidemiology and Market Forecast Methodology of NSCLC
- 7. NSCLC Market Overview at a Glance
- 7.1. Emerging Landscape Analysis in the 7MM (by Phase)
- 7.2. Market Share of NSCLC by Biomarker (%) in the 7MM in 2025
- 7.3. Market Share of NSCLC by Biomarker (%) in the 7MM in 2036
- 8. Disease Background and Overview of NSCLC
- 8.1. Introduction
- 8.1.1. Cellular Classification of NSCLC
- 8.1.2. Risk Factors of Lung Cancer
- 8.1.3. Causes of NSCLC
- 8.1.4. Signs and Symptoms of NSCLC
- 8.2. Disease Biology: NSCLC
- 8.2.1. Disease Biology: NSCLC
- 8.2.1.1. Genomic Alterations
- 8.2.1.2. TME
- 8.2.1.3. TMB
- 8.2.1.4. Microsatellite Instability (MSI)
- 8.3. Diagnosis
- 8.3.1. Staging System
- 8.3.2. Stages of NSCLC
- 8.3.3. Diagnostic Guidelines
- 8.3.3.1. NCCN Diagnostic Guidelines for NSCLC (2026 Version)
- 8.3.3.2. European Society for Medical Oncology (ESMO) Clinical Practice Guidelines (2025)
- 8.3.3.3. The Japan Lung Cancer Society Diagnostic Guidelines (2025)
- 9. Current Treatment Practices: NSCLC
- 9.1. Treatment Algorithm
- 9.2. Treatment Guidelines and Recommendations for NSCLC
- 9.2.1. NCCN Guideline for NSCLC (2026 Version)
- 9.2.2. European Society for Medical Oncology (ESMO) Clinical Practice Guidelines (2025)
- 9.2.3. The Japan Lung Cancer Society Guidelines (2025)
- 9.2.4. Chinese Society of Clinical Oncology (CSCO) Clinical Practice Guidelines (2025)
- 9.2.5. Biomarkers Testing Recommendations
- 10. Epidemiology and Patient Population
- 10.1. Key Findings
- 10.2. Assumptions and Rationale
- 10.3. Total Incident Cases of NSCLC in the 7MM
- 10.4. United States
- 10.4.1. Total Incident Cases of NSCLC in the United States
- 10.4.2. Gender-specific Cases of NSCLC in the United States
- 10.4.3. Age-specific Cases of NSCLC in the United States
- 10.4.4. Total Incident Cases of NSCLC by Histology in the United States
- 10.4.5. Total Incident Cases of NSCLC by Stage in the United States
- 10.4.6. Total Cases of NSCLC by Genetic Mutations/Biomarkers in the United States
- 10.4.7. Patient Seeking Treatment for NSCLC in the United States
- 10.4.8. Line-wise Treated Cases of NSCLC in the United States
- 10.5. EU4 and the UK
- 10.5.1. Total Incident Cases of NSCLC in EU4 and the UK
- 10.5.2. Gender-specific Cases of NSCLC in EU4 and the UK
- 10.5.3. Age-specific Cases of NSCLC in EU4 and the UK
- 10.5.4. Total Incident Cases of NSCLC by Histology in EU4 and the UK
- 10.5.5. Total Incident Cases of NSCLC by Stage in EU4 and the UK
- 10.5.6. Total Cases of NSCLC by Genetic Mutations/Biomarkers in EU4 and the UK
- 10.5.7. Patient Seeking Treatment for NSCLC in EU4 and the UK
- 10.5.8. Line-wise Treated Cases of NSCLC in EU4 and the UK
- 10.6. Japan
- 10.6.1. Total Incident Cases of NSCLC in Japan
- 10.6.2. Gender-specific Cases of NSCLC in Japan
- 10.6.3. Age-specific Cases of NSCLC in Japan
- 10.6.4. Total Incident Cases of NSCLC by Histology in Japan
- 10.6.5. Total Incident Cases of NSCLC by Stage in Japan
- 10.6.6. Total Cases of NSCLC by Genetic Mutations/Biomarkers in Japan
- 10.6.7. Patient Seeking Treatment of NSCLC in Japan
- 10.6.8. Line-wise Treated Cases of NSCLC in Japan
- 11. Patient Journey
- 12. Key Endpoints in NSCLC
- 13. Marketed Therapies
- 13.1. Competitive Landscape
- 13.1.1. Regulatory Approval History Across the 7MM
- 13.2. EGFR Mutations
- 13.2.1. AUMSEQA (Aumolertinib): Jiangsu Hansoh Pharmaceutical
- 13.2.1.1. Product Description
- 13.2.1.2. Regulatory Milestones
- 13.2.1.3. Other Developmental Activity
- 13.2.1.4. Summary of Pivotal Clinical Trial
- 13.2.2. VIZIMPRO (Dacomitinib): Pfizer
- 13.2.2.1. Product Description
- 13.2.2.2. Regulatory Milestones
- 13.2.2.3. Other Developmental Activities
- 13.2.2.4. Summary of Pivotal Trials
- 13.2.2.5. Clinical Development
- 13.2.2.6. Safety and Efficacy
- 13.2.3. GILOTRIF/GIOTRIF (Afatinib maleate): Boehringer Ingelheim
- 13.2.3.1. Product Description
- 13.2.3.2. Regulatory Milestones
- 13.2.3.3. Other Developmental Activities
- 13.2.3.4. Summary of Pivotal Trials
- 13.2.3.5. Safety and Efficacy
- 13.2.4. TAGRISSO (Osimertinib): AstraZeneca
- 13.2.4.1. Product Description
- 13.2.4.2. Regulatory Milestones
- 13.2.4.3. Other Developmental Activities
- 13.2.4.4. Summary of Pivotal Trials
- 13.2.4.5. Clinical Development
- 13.2.4.6. Safety and Efficacy
- 13.2.5. PORTRAZZA (Necitumumab): Eli Lilly and Company
- 13.2.5.1. Product Description
- 13.2.5.2. Regulatory Milestones
- 13.2.5.3. Other Developmental Activities
- 13.2.5.4. Summary of Pivotal Trials
- 13.2.5.5. Safety and Efficacy
- 13.2.6. RYBREVANT (Amivantamab) ± LAZCLUZE (Lazertinib): Johnson & Johnson Innovative Medicine/Yuhan Corporation
- 13.2.6.1. Product Description
- 13.2.6.2. Regulatory Milestones
- 13.2.6.3. Other Developmental Activities
- 13.2.6.4. Summary of Pivotal Trials
- 13.2.6.5. Clinical Development
- 13.2.6.6. Safety and Efficacy
- 13.2.7. ZEGFROVY (Sunvozertinib) : Dizal Pharmaceutical
- 13.2.7.1. Product Description
- 13.2.7.2. Regulatory Milestones
- 13.2.7.3. Other Developmental Activities
- 13.2.7.4. Summary of Pivotal Trials
- 13.2.7.5. Clinical Development
- 13.2.7.6. Safety and Efficacy
- 13.2.8. DATROWAY (Datopotamab Deruxtecan): Daiichi Sankyo/AstraZeneca
- 13.2.8.1. Product Description
- 13.2.8.2. Regulatory Milestones
- 13.2.8.3. Other Developmental Activities
- 13.2.8.4. Summary of Pivotal Trials
- 13.2.8.5. Clinical Development
- 13.2.8.6. Safety and Efficacy
- 13.3. PD-1 Inhibitors
- 13.3.1. OPDIVO (Nivolumab): Bristol Myers Squibb/Ono Pharmaceutical
- 13.3.1.1. Product Description
- 13.3.1.2. Regulatory Milestones
- 13.3.1.3. Other Developmental Activities
- 13.3.1.4. Summary Pivotal Trials
- 13.3.1.5. Clinical Development
- 13.3.1.6. Safety and Efficacy
- 13.3.2. KEYTRUDA (Pembrolizumab): Merck
- 13.3.2.1. Product Description
- 13.3.2.2. Regulatory Milestones
- 13.3.2.3. Other Developmental Activities
- 13.3.2.4. Summary Pivotal Trials
- 13.3.2.5. Clinical Development
- 13.3.2.6. Safety and Efficacy
- 13.3.3. LIBTAYO (Cemiplimab): Regeneron/Sanofi
- 13.3.3.1. Product Description
- 13.3.3.2. Regulatory Milestones
- 13.3.3.3. Other Developmental Activities
- 13.3.3.4. Summary Pivotal Trials
- 13.3.3.5. Clinical Development
- 13.3.3.6. Safety and Efficacy
- 13.3.4. TEVIMBRA (Tislelizumab): BeiGene
- 13.3.4.1. Product Description
- 13.3.4.2. Regulatory Milestones
- 13.3.4.3. Other Developmental Activities
- 13.3.4.4. Summary Pivotal Trials
- 13.3.4.5. Clinical Development
- 13.3.4.6. Safety and Efficacy
- 13.3.5. IMFINZI (Durvalumab) + IMJUDO (Tremelimumab): AstraZeneca
- 13.3.5.1. Product Description
- 13.3.5.2. Regulatory Milestones
- 13.3.5.3. Other Developmental Activities
- 13.3.5.4. Summary Pivotal Trials
- 13.3.5.5. Clinical Development
- 13.3.5.6. Safety and Efficacy
- 13.3.6. CEJEMLY (Sugemalimab): CStone Pharmaceuticals
- 13.3.6.1. Product Description
- 13.3.6.2. Regulatory Milestone
- 13.3.6.3. Other Developmental Activities
- 13.3.6.4. Summary Pivotal Trials
- 13.3.6.5. Clinical Development
- 13.3.6.6. Safety and Efficacy
- 13.3.7. IMFINZI (Durvalumab): AstraZeneca
- 13.3.7.1. Product Description
- 13.3.7.2. Regulatory Milestones
- 13.3.7.3. Other Developmental Activities
- 13.3.7.4. Summary Pivotal Trials
- 13.3.7.5. Clinical Development
- 13.3.7.6. Safety and Efficacy
- 13.3.8. TECENTRIQ (Atezolizumab): Genentech/Roche
- 13.3.8.1. Product Description
- 13.3.8.2. Regulatory Milestones
- 13.3.8.3. Other Developmental Activities
- 13.3.8.4. Summary Pivotal Trials
- 13.3.8.5. Clinical Development
- 13.3.8.6. Safety and Efficacy
- 13.4. Other Mutations
- 13.4.1. LORBRENA/LORVIQUA (Lorlatinib): Pfizer
- 13.4.1.1. Product Description
- 13.4.1.2. Regulatory Milestones
- 13.4.1.3. Other Developmental Activities
- 13.4.1.4. Summary Pivotal Trials
- 13.4.1.5. Safety and Efficacy
- 13.4.2. ENSACOVE (Ensartinib): Betta Pharmaceuticals/Xcovery
- 13.4.2.1. Product Description
- 13.4.2.2. Regulatory Milestones
- 13.4.2.3. Other Development Activities
- 13.4.2.4. Summary of Pivotal Trials
- 13.4.3. ALUNBRIG (Brigatinib): Takeda Pharmaceuticals
- 13.4.3.1. Product Description
- 13.4.3.2. Regulatory Milestones
- 13.4.3.3. Other Developmental Activities
- 13.4.3.4. Summary of Pivotal Trials
- 13.4.3.5. Safety and Efficacy
- 13.4.4. AUGTYRO (Repotrectinib): BMS
- 13.4.4.1. Product Description
- 13.4.4.2. Regulatory Milestones
- 13.4.4.3. Other Developmental Activities
- 13.4.4.4. Summary Pivotal Trials
- 13.4.4.5. Clinical Development
- 13.4.4.6. Safety and Efficacy
- 13.4.5. ALECENSA (Alectinib): Roche/Chugai Pharmaceutical
- 13.4.5.1. Product Description
- 13.4.5.2. Regulatory Milestones
- 13.4.5.3. Other Development Activities
- 13.4.5.4. Summary of Pivotal Trials
- 13.4.6. ROZLYTREK (Entrectinib): Roche (Genentech)
- 13.4.6.1. Product Description
- 13.4.6.2. Regulatory Milestones
- 13.4.6.3. Other Developmental Activities
- 13.4.6.4. Pivotal Clinical Trials
- 13.4.6.5. Clinical Development
- 13.4.6.6. Safety and Efficacy
- 13.4.7. IBTROZI (Taletrectinib): Nuvation Bio
- 13.4.7.1. Drug Description
- 13.4.7.2. Regulatory Milestones
- 13.4.7.3. Other Developmental Activities
- 13.4.7.4. Summary of Pivotal Trials
- 13.4.7.5. Clinical Development
- 13.4.8. GAVRETO (Pralsetinib): Blueprint Medicines/Rigel Pharmaceuticals
- 13.4.8.1. Product Description
- 13.4.8.2. Regulatory Milestones
- 13.4.8.3. Other Developmental Activities
- 13.4.8.4. Pivotal Clinical Trial
- 13.4.8.5. Clinical Development
- 13.4.8.6. Safety and Efficacy
- 13.4.9. RETEVMO/RETSEVMO (Selpercatinib): Eli Lilly and Company
- 13.4.9.1. Product Description
- 13.4.9.2. Other Developmental Activities
- 13.4.9.3. Summary Pivotal Trials
- 13.4.9.4. Clinical Development
- 13.4.9.5. Safety and Efficacy
- 13.4.10. TEPMETKO (Tepotinib): EMD Serono (Merck KGaA)
- 13.4.10.1. Product Description
- 13.4.10.2. Regulatory Milestones
- 13.4.10.3. Other Developmental Activities
- 13.4.10.4. Summary Pivotal Trials
- 13.4.10.5. Clinical Development
- 13.4.10.6. Safety and Efficacy
- 13.4.11. HAIYITAN (Gumarontinib): Haihe Biopharma and Taiho Pharmaceutical
- 13.4.11.1. Product Description
- 13.4.11.2. Regulatory Milestones
- 13.4.11.3. Other Developmental Activities
- 13.4.11.4. Summary Pivotal Trials
- 13.4.11.5. Clinical Development
- 13.4.11.6. Safety and Efficacy
- 13.4.12. TABRECTA (Capmatinib): Novartis
- 13.4.12.1. Product Description
- 13.4.12.2. Regulatory Milestones
- 13.4.12.3. Other Developmental Activities
- 13.4.12.4. Summary Pivotal Trials
- 13.4.12.5. Clinical Development
- 13.4.12.6. Safety and Efficacy
- 13.4.13. LUMAKRAS/LUMYKRAS (Sotorasib): Amgen
- 13.4.13.1. Product Description
- 13.4.13.2. Regulatory Milestones
- 13.4.13.3. Other Developmental Activities
- 13.4.13.4. Summary Pivotal Trials
- 13.4.13.5. Clinical Development
- 13.4.13.6. Safety and Efficacy
- 13.4.14. KRAZATI (Adagrasib): BMS
- 13.4.14.1. Product Description
- 13.4.14.2. Regulatory Milestones
- 13.4.14.3. Other Developmental Activities
- 13.4.14.4. Summary Pivotal Trials
- 13.4.14.5. Clinical Development
- 13.4.14.6. Safety and Efficacy
- 13.4.15. ENHERTU (Trastuzumab deruxtecan): Daiichi Sankyo /AstraZeneca
- 13.4.15.1. Product Description
- 13.4.15.2. Regulatory Milestones
- 13.4.15.3. Other Developmental Activities
- 13.4.15.4. Pivotal Clinical Trials
- 13.4.15.6. Current Development
- 13.4.15.7. Safety and Efficacy
- 13.4.16. TAFINLAR (Dabrafenib) + MEKINIST (Trametinib): Novartis
- 13.4.16.1. Product Description
- 13.4.16.2. Regulatory Milestones
- 13.4.16.3. Other Developmental Activities
- 13.4.16.4. Summary Pivotal Trials
- 13.4.16.5. Safety and Efficacy
- 13.4.17. BRAFTOVI (Encorafenib) + MEKTOVI (Binimetinib): Pfizer/Pierre Fabre
- 13.4.17.1. Product Description
- 13.4.17.2. Regulatory Milestones
- 13.4.17.3. Other Developmental Activities
- 13.4.17.4. Summary Pivotal Trials
- 13.4.17.5. Clinical Development
- 13.4.17.6. Safety and Efficacy
- 13.4.18. VITRAKVI (Larotrectinib): Bayer
- 13.4.18.1. Product Description
- 13.4.18.2. Regulatory Milestones
- 13.4.18.3. Other Developmental Activities
- 13.4.18.4. Summary Pivotal Trials
- 13.4.18.5. Safety and Efficacy
- 13.4.19. EMRELIS (Telisotuzumab vedotin-tllv): AbbVie
- 13.4.19.1. Drug Description
- 13.4.19.2. Regulatory Milestones
- 13.4.19.3. Other Developmental Activities
- 13.4.19.4. Summary of Pivotal Trials
- 13.4.19.5. Clinical Development
- 13.4.20. BIZENGRI (Zenocutuzumab): Merus and Partner Therapeutics
- 13.4.20.1. Product Description
- 13.4.20.2. Regulatory Milestones
- 13.4.20.3. Other Developmental Activities
- 13.4.20.4. Pivotal Clinical Trials
- 13.4.20.5. Clinical Development
- 13.4.20.6. Safety and Efficacy
- 13.4.21. HYRNUO (Sevabertinib): Bayer
- 13.4.21.1. Drug Description
- 13.4.21.2. Regulatory Milestones
- 13.4.21.3. Other Developmental Activities
- 13.4.21.4. Summary of Pivotal Trials
- 13.4.21.5. Clinical Development
- 13.4.22. HERNEXEOS (Zongertinib): Boehringer Ingelheim
- 13.4.22.1. Drug Description
- 13.4.22.2. Regulatory Milestones
- 13.4.22.3. Other Developmental Activities
- 13.4.22.4. Summary of Pivotal Trials
- 13.4.22.5. Clinical Development
- 14. Emerging Therapies
- 14.1. Competitive Landscape
- 14.1.1. Emerging Therapies in the 7MM
- 14.2. Ateganosine: MAIA Biotechnology
- 14.2.1. Product Description
- 14.2.2. Other Developmental Activities
- 14.2.3. Clinical Development
- 14.2.3.1. Clinical Trials Information
- 14.2.4. Safety and Efficacy
- 14.3. BMS-986504 + Pembrolizumab: Bristol-Myers Squibb
- 14.3.1. Product Description
- 14.3.2. Other Developmental Activities
- 14.3.3. Clinical Development
- 14.3.3.1. Clinical Trials Information
- 14.3.4. Safety and Efficacy
- 14.4. Iza-bren (izalontamab brengitecan): SystImmune and Bristol Myers Squibb
- 14.4.1. Product Description
- 14.4.2. Other Developmental Activities
- 14.4.3. Clinical Development
- 14.4.3.1. Clinical Trials Information
- 14.4.4. Safety and Efficacy
- 14.5. Neladalkib (NVL-655): Nuvalent
- 14.5.1. Product Description
- 14.5.2. Other Developmental Activities
- 14.5.3. Clinical Development
- 14.5.3.1. Clinical Trials Information
- 14.5.4. Safety and Efficacy
- 14.6. PF-08046054 (SGN-PDL1V): Pfizer
- 14.6.1. Product Description
- 14.6.2. Other Developmental Activities
- 14.6.3. Clinical Development
- 14.6.3.1. Clinical Trials Information
- 14.6.4. Safety and Efficacy
- 14.7. Telisotuzumab adizutecan, Temab-A (ABBV-400): AbbVie
- 14.7.1. Product Description
- 14.7.2. Other Developmental Activities
- 14.7.3. Clinical Development
- 14.7.3.1. Clinical Trials Information
- 14.7.4. Safety and Efficacy
- 14.8. Daraxonrasib (RMC-6236): Revolution Medicines
- 14.8.1. Product Description
- 14.8.2. Other Developmental Activities
- 14.8.3. Clinical Development
- 14.8.3.1. Clinical Trials Information
- 14.8.4. Safety and Efficacy
- 14.9. ZEJULA (niraparib): GlaxoSmithKline
- 14.9.1. Product Description
- 14.9.2. Other Developmental Activities
- 14.9.3. Clinical Development
- 14.9.3.1. Clinical Trials Information
- 14.9.4. Safety and Efficacy
- 14.1. Rilvegostomig (AZD2936): AstraZeneca/Compugen
- 14.10.1. Product Description
- 14.10.2. Clinical Development
- 14.10.2.1. Clinical Trials Information
- 14.10.3. Safety and Efficacy
- 14.11. Pumitamig (BNT327/PM8002): BioNTech/Bristol Myers Squibb
- 14.11.1. Product Description
- 14.11.2. Other Developmental Activities
- 14.11.3. Clinical Development
- 14.11.3.1. Clinical Trials Information
- 14.11.4. Safety and Efficacy
- 14.12. CAN-2409 (aglatimagene besadenovec): Candel Therapeutics
- 14.12.1. Product Description
- 14.12.2. Other Developmental Activities
- 14.12.3. Clinical Development
- 14.12.3.1. Clinical Trials Information
- 14.12.4. Safety and Efficacy
- 14.13. Gotistobart (BNT316): OncoC4/BioNTech
- 14.13.1. Product Description
- 14.13.2. Other Developmental Activities
- 14.13.3. Clinical Development
- 14.13.3.1. Clinical Trials Information
- 14.13.4. Safety and Efficacy
- 14.14. ZYNYZ (retifanlimab-dlwr): Incyte/Macrogenics
- 14.14.1. Product Description
- 14.14.2. Other Developmental Activities
- 14.14.3. Clinical Development
- 14.14.3.1. Clinical Trials Information
- 14.14.4. Safety and Efficacy
- 14.15. LN-145: Iovance Biotherapeutics
- 14.15.1. Product Description
- 14.15.2. Other Developmental Activities
- 14.15.3. Clinical Development
- 14.15.3.1. Clinical Trials Information
- 14.15.4. Safety and Efficacy
- 14.16. Divarasib (GDC-6036): Hoffmann-La Roche/Genentech
- 14.16.1. Product Description
- 14.16.2. Other Developmental Activities
- 14.16.3. Clinical Development
- 14.16.3.1. Clinical Trials Information
- 14.16.4. Safety and Efficacy
- 14.17. Fianlimab (REGN3767): Regeneron Pharmaceuticals
- 14.17.1. Product Description
- 14.17.2. Other Developmental Activities
- 14.17.3. Clinical Development
- 14.17.3.1. Clinical Trials Information
- 14.18. Sacituzumab Tirumotecan (MK-2870): Merck and Kelun-Biotech
- 14.18.1. Product Description
- 14.18.2. Other Developmental Activities
- 14.18.3. Clinical Development
- 14.18.3.1. Clinical Trials Information
- 14.18.4. Safety and Efficacy
- 14.19. Eftilagimod alpha (Efti, IMP321): Immutep
- 14.19.1. Product Description
- 14.19.2. Other Developmental Activities
- 14.19.3. Clinical Development
- 14.19.3.1. Clinical Trials Information
- 14.19.4. Safety and Efficacy
- 14.2. Intismeran autogene (mRNA-4157/V940): Moderna Therapeutics and Merck Sharp & Dohme
- 14.20.1. Product Description
- 14.20.2. Other Developmental Activities
- 14.20.3. Clinical Development
- 14.20.3.1. Clinical Trials Information
- 14.20.4. Safety and Efficacy
- 14.21. Plinabulin: BeyondSpring
- 14.21.1. Product Description
- 14.21.2. Other Developmental Activities
- 14.21.3. Clinical Development
- 14.21.3.1. Clinical Trials Information
- 14.21.4. Safety and Efficacy
- 14.22. Zipalertinib (CLN-081): Cullinan Therapeutics and Taiho Pharma
- 14.22.1. Product Description
- 14.22.2. Other Developmental Activities
- 14.22.3. Clinical Development
- 14.22.3.1. Clinical Trials Information
- 14.22.4. Safety and Efficacy
- 14.24. Olomorasib (LY3537982): Eli Lilly and Company
- 14.24.1. Product Description
- 14.24.2. Other Developmental Activities
- 14.24.3. Clinical Development
- 14.24.3.1. Clinical Trials Information
- 14.24.4. Safety and Efficacy
- 14.25. Ceralasertib (AZD6738): AstraZeneca
- 14.25.1. Product Description
- 14.25.2. Other Developmental Activities
- 14.25.3. Clinical Development
- 14.25.3.1. Clinical Trials Information
- 14.25.4. Safety and Efficacy
- 14.26. TEDOPI (OSE2101): OSE Immunotherapeutics
- 14.26.1. Product Description
- 14.26.2. Other Developmental Activities
- 14.26.3. Clinical Development
- 14.26.3.1. Clinical Trial Information
- 14.26.4. Safety and Efficacy
- 14.27. Sigvotatug Vedotin (PF08046047, SGN-B6A): Pfizer
- 14.27.1. Product Description
- 14.27.2. Other Developmental Activities
- 14.27.3. Clinical Development
- 14.27.3.1. Clinical Trials Information
- 14.27.4. Safety and Efficacy
- 14.28. ANKTIVA (N-803, nogapendekin alfa inbakicept-pmln): ImmunityBio
- 14.28.1. Product Description
- 14.28.2. Other Developmental Activities
- 14.28.3. Clinical Development
- 14.28.3.1. Clinical Trials Information
- 14.28.4. Safety and Efficacy
- 14.29. Pyrotinib: Jiangsu HengRui Medicine
- 14.29.1. Product Description
- 14.29.2. Clinical Development
- 14.29.2.1. Clinical Trial Information
- 14.3. Volrustomig (MEDI5752): AstraZeneca
- 14.30.1. Product Description
- 14.30.2. Other Developmental Activities
- 14.30.3. Clinical Development
- 14.30.3.1. Clinical Trial Information
- 14.30.4. Safety and Efficacy
- 14.31. TRODELVY (sacituzumab govitecan): Gilead Sciences
- 14.31.1. Product Description
- 14.31.2. Other Developmental Activities
- 14.31.3. Clinical Development
- 14.31.3.1. Clinical Trial Information
- 14.31.4. Safety and Efficacy
- 14.32. Domvanalimab + Combination Therapies: Arcus Biosciences and Gilead Sciences
- 14.32.1. Product Description
- 14.32.2. Other Developmental Activities
- 14.32.3. Clinical Development
- 14.32.3.1. Clinical Trial Information
- 14.32.4. Safety and Efficacy
- 14.33. OPDUALAG (nivolumab and relatlimab): Bristol-Myers Squibb
- 14.33.1. Product Description
- 14.33.2. Other Developmental Activities
- 14.33.3. Clinical Development
- 14.33.3.1. Clinical Trial Information
- 14.33.4. Safety and Efficacy
- 14.34. Calderasib (MK-1084): Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals)
- 14.34.1. Product Description
- 14.34.2. Other Developmental Activities
- 14.34.3. Clinical Development
- 14.34.3.1. Clinical Trials Information
- 14.34.4. Safety and Efficacy
- 14.35. Firmonertinib: ArriVent BioPharma and Shanghai Allist Pharmaceuticals
- 14.35.1. Product Description
- 14.35.2. Other Developmental Activities
- 14.35.3. Clinical Development
- 14.35.3.1. Clinical Trials Information
- 14.35.4. Safety and Efficacy
- 14.36. Livmoniplimab (ARGX-115): AbbVie
- 14.36.1. Product Description
- 14.36.2. Other Developmental Activities
- 14.36.3. Clinical Development
- 14.36.3.1. Clinical Trials Information
- 14.36.4. Safety and Efficacy
- 14.37. IBI363: Innovent Biologics and Takeda Pharmaceutical
- 14.37.1. Product Description
- 14.37.2. Other Developmental Activities
- 14.37.3. Clinical Development
- 14.37.3.1. Clinical Trial Information
- 14.37.4. Safety and Efficacy
- 14.38. Ivonescimab (AK112): Akeso Bio and Summit Therapeutics
- 14.38.1. Product Description
- 14.38.2. Other Developmental Activity
- 14.38.3. Clinical Development
- 14.38.3.1. Clinical Trials Information
- 14.38.4. Safety and Efficacy
- 14.39. Vebreltinib (APL-101): Apollomics and Avistone Biotechnology
- 14.39.1. Product Description
- 14.39.2. Other Developmental Activities
- 14.39.3. Clinical Development
- 14.39.3.1. Clinical Trials Information
- 14.39.4. Safety and Efficacy
- 14.4. Zidesamtinib (NVL-520): Nuvalent
- 14.40.1. Product Description
- 14.40.2. Other Developmental Activities
- 14.40.3. Clinical Development
- 14.40.3.1. Clinical Trials Information
- 14.40.4. Safety and Efficacy
- 15. Phase II Emerging Drugs Under Development
- 16. NSCLC: 7MM Market Analysis
- 16.1. Key Findings
- 16.2. Total Market Size of NSCLC by Country in the 7MM
- 16.3. Total Market Size of NSCLC by Biomarker in the 7MM
- 16.4. Market Outlook of NSCLC
- 16.4.1. 7MM Market Dynamics Overview of NSCLC
- 16.4.1.1. PD-L1 Expression
- 16.4.1.2. EGFR Mutation
- 16.4.1.3. ALK Mutation
- 16.4.1.4. KRAS Mutation
- 16.4.1.5. BRAF Mutation
- 16.4.1.6. MET
- 16.4.1.7. Others Emerging Biomarkers
- 16.5. Key Market Forecast Assumptions
- 16.5.1. PD-L1 Expression
- 16.5.2. EGFR NSCLC
- 16.5.3. ALK NSCLC
- 16.5.4. KRAS NSCLC
- 16.5.5. ROS-1 NSCLC
- 16.5.6. HER2 NSCLC
- 16.5.7. BRAF NSCLC
- 16.5.8. C-Met NSCLC
- 16.5.9. RET NSCLC
- 16.5.10. NTRK NSCLC
- 16.5.11. NRG1 Fusion NSCLC
- 16.6. The United States
- 16.6.1. PD-L1 NSCLC
- 16.6.1.1. Total Market Size of PD-L1 NSCLC in the United States
- 16.6.1.2. Market Size of PD-L1 NSCLC by Therapies in the United States
- 16.6.2. EGFR NSCLC
- 16.6.2.1. Total Market Size of EGFR NSCLC in the United States
- 16.6.2.2. Market Size of EGFR NSCLC by Therapies in the United States
- 16.6.3. ALK NSCLC
- 16.6.3.1. Total Market Size of ALK NSCLC in the United States
- 16.6.3.2. Market Size of ALK NSCLC by Therapies in the United States
- 16.6.4. KRAS NSCLC
- 16.6.4.1. Total Market Size of KRAS NSCLC in the United States
- 16.6.4.2. Market Size of KRAS NSCLC by Therapies in the United States
- 16.6.5. ROS-1 NSCLC
- 16.6.5.1. Total Market Size of ROS-1 NSCLC in the United States
- 16.6.5.2. Market Size of ROS-1 NSCLC by Therapies in the United States
- 16.6.6. HER2 (mutation, amplification, and overexpression) NSCLC
- 16.6.6.1. Total Market Size of HER2 NSCLC in the United States
- 16.6.6.2. Market Size of HER2 NSCLC by Therapies in the United States
- 16.6.7. BRAF NSCLC
- 16.6.7.1. Total Market Size of BRAF NSCLC in the United States
- 16.6.7.2. Market Size of BRAF NSCLC by Therapies in the United States
- 16.6.8. C-Met NSCLC
- 16.6.8.1. Total Market Size of C-Met NSCLC in the United States
- 16.6.8.2. Market Size of C-Met NSCLC by Therapies in the United States
- 16.6.9. RET Fusion NSCLC
- 16.6.9.1. Total Market Size of RET Fusion NSCLC in the United States
- 16.6.9.2. Market Size of RET Fusion NSCLC by Therapies in the United States
- 16.6.10. NTRK1/2/3 Gene Fusion NSCLC
- 16.6.10.1. Total Market Size of NTRK1/2/3 Gene Fusion NSCLC in the United States
- 16.6.10.2. Market Size of NTRK1/2/3 Gene Fusion NSCLC by Therapies in the United States
- 16.6.11. NRG1 Fusion NSCLC
- 16.6.11.1. Total Market Size of NRG1 Fusion NSCLC in the United States
- 16.6.11.2. Market Size of NRG1 Fusion NSCLC by Therapies in the United States
- 16.7. EU4 and the UK
- 16.7.1. PD-L1 NSCLC
- 16.7.1.1. Total Market Size of PD-L1 NSCLC in EU4 and the UK
- 16.7.1.2. Market Size of PD-L1 NSCLC by Therapies in EU4 and the UK
- 16.7.2. EGFR NSCLC
- 16.7.2.1. Total Market Size of EGFR NSCLC in EU4 and the UK
- 16.7.2.2. Market Size of EGFR NSCLC by Therapies in EU4 and the UK
- 16.7.3. ALK NSCLC
- 16.7.3.1. Total Market Size of ALK NSCLC in EU4 and the UK
- 16.7.3.2. Market Size of ALK NSCLC by Therapies in EU4 and the UK
- 16.7.4. KRAS NSCLC
- 16.7.4.1. Total Market Size of KRAS NSCLC in EU4 and the UK
- 16.7.4.2. Market Size of KRAS NSCLC by Therapies in EU4 and the UK
- 16.7.5. ROS-1 NSCLC
- 16.7.5.1. Total Market Size of ROS-1 NSCLC in EU4 and the UK
- 16.7.5.2. Market Size of ROS-1 NSCLC by Therapies in EU4 and the UK
- 16.7.6. HER2 (mutation, amplification, and overexpression) NSCLC
- 16.7.6.1. Total Market Size of HER2 NSCLC in EU4 and the UK
- 16.7.6.2. Market Size of HER2 NSCLC by Therapies in EU4 and the UK
- 16.7.7. BRAF-mutated NSCLC
- 16.7.7.1. Total Market Size of BRAF NSCLC in EU4 and the UK
- 16.7.7.2. Market Size of BRAF NSCLC by Therapies in EU4 and the UK
- 16.7.8. C-Met-mutated NSCLC
- 16.7.8.1. Total Market Size of C-Met NSCLC in EU4 and the UK
- 16.7.8.2. Market Size of C-Met NSCLC by Therapies in EU4 and the UK
- 16.7.9. RET Fusion NSCLC
- 16.7.9.1. Total Market Size of RET Fusion NSCLC in EU4 and the UK
- 16.7.9.2. Market Size of RET Fusion NSCLC by Therapies in EU4 and the UK
- 16.7.10. NTRK1/2/3 Gene Fusion NSCLC
- 16.7.10.1. Total Market Size of NTRK1/2/3 Gene Fusion NSCLC in EU4 and the UK
- 16.7.10.2. Market Size of NTRK1/2/3 Gene Fusion NSCLC by Therapies in EU4 and the UK
- 16.7.11. NRG1 Fusion NSCLC
- 16.7.11.1. Total Market Size of NRG1 Fusion NSCLC in EU4 and the UK
- 16.7.11.2. Market Size of NRG1 fusion NSCLC by Therapies in EU4 and the UK
- 16.8. Japan
- 16.8.1. PD-L1 NSCLC
- 16.8.1.1. Total Market Size of PD-L1 NSCLC in Japan
- 16.8.1.2. Market Size of PD-L1 NSCLC by Therapies in Japan
- 16.8.2. EGFR NSCLC
- 16.8.2.1. Total Market Size of EGFR NSCLC in Japan
- 16.8.2.2. Market Size of EGFR NSCLC by Therapies in Japan
- 16.8.3. ALK NSCLC
- 16.8.3.1. Total Market Size of ALK NSCLC in Japan
- 16.8.3.2. Market Size of ALK NSCLC by Therapies in Japan
- 16.8.4. KRAS NSCLC
- 16.8.4.1. Total Market Size of KRAS NSCLC in Japan
- 16.8.4.2. Market Size of KRAS NSCLC by Therapies in Japan
- 16.8.5. ROS-1 NSCLC
- 16.8.5.1. Total Market Size of ROS-1 NSCLC in Japan
- 16.8.5.2. Market Size of ROS-1 NSCLC by Therapies in Japan
- 16.8.6. HER2 (mutation, amplification, and overexpression) NSCLC
- 16.8.6.1. Total Market Size of HER2 NSCLC in Japan
- 16.8.6.2. Market Size of HER2 NSCLC by Therapies in Japan
- 16.8.7. BRAF-mutated NSCLC
- 16.8.7.1. Total Market Size of BRAF NSCLC in Japan
- 16.8.7.2. Market Size of BRAF NSCLC by Therapies in Japan
- 16.8.8. C-Met NSCLC
- 16.8.8.1. Total Market Size of C-Met NSCLC in Japan
- 16.8.8.2. Market Size of C-Met NSCLC by Therapies in Japan
- 16.8.9. RET Fusion NSCLC
- 16.8.9.1. Total Market Size of RET Fusion NSCLC in Japan
- 16.8.9.2. Market Size of RET Fusion NSCLC by Therapies in Japan
- 16.8.10. NTRK1/2/3 Gene Fusion NSCLC
- 16.8.10.1. Total Market Size of NTRK1/2/3 Gene Fusion NSCLC in Japan
- 16.8.10.2. Market Size of NTRK1/2/3 Gene Fusion NSCLC by Therapies in Japan
- 16.8.11. NRG1 fusion NSCLC
- 16.8.11.1. Total Market Size of NRG1 fusion NSCLC in Japan
- 16.8.11.2. Market Size of NRG1 Fusion NSCLC by Therapies in Japan
- 17. Unmet Needs of NSCLC
- 18. SWOT Analysis of NSCLC
- 19. KOL Views of NSCLC
- 20. Market Access and Reimbursement of NSCLC
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