DelveInsight’s ‘Follicular Lymphoma – Market Insights, Epidemiology, and Market Forecast – 2030’ report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of Follicular Lymphoma in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The Follicular Lymphoma market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted Follicular Lymphoma market Size from 2018 to 2030, segmented by seven major markets. The report also covers the current Follicular Lymphoma treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.
Geographies Covered
The United States
EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Japan
Study Period: 2018–2030
Follicular Lymphoma: Disease Understanding and Treatment Algorithm
Follicular Lymphoma Overview
Follicular lymphoma (FL) is generally an indolent B cell lymphoproliferative disorder of transformed follicular center B cells. It is characterized by diffuse lymphadenopathy, bone marrow involvement, and splenomegaly. Extranodal involvement is less common. Cytopenias are relatively common, but constitutional symptoms of fever, night sweats, and weight loss are uncommon in the absence of transformation to diffuse large B cell lymphoma.
Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no apparent symptoms of the disease at diagnosis. Follicular lymphoma is usually not considered to be curable but more of a chronic disease. Besides, patients can live for many years with this form of lymphoma.
The World Health Organization (WHO) (2017) has a grading system (Grade 1, 2, or 3) for FL that depends on the percentage of centroblasts, and is as follows: grade 1 (follicular small cleaved): 0–5 centroblasts/HPF, grade 2 (follicular mixed): 6–15 centroblasts/HPF, grade 3 (follicular large cell): > 15 centroblasts/HPF (grade 3A - centrocytes present, grade 3B - solid sheets of centroblasts). It is clinically important to differentiate grades 1/2 vs. grade 3.
The diagnosis is based on histology from a biopsy of a lymph node or other affected tissue. Incisional biopsy is preferred over needle biopsies to give adequate tissue to assign grades and assess for transformation. Immunohistochemical staining is positive in virtually all cases for cell surface CD19, CD20, CD10, and monoclonal immunoglobulin, as well as cytoplasmic expression of bcl-2 protein. The overwhelming majority of cases have the characteristic t(14;18) translocation involving the IgH/bcl-2 genes.
The management of FL depends on the disease stage. Options available for the treatment of follicular lymphoma include radiation (RT), immunochemotherapy (Rituximab plus chemotherapy), Bendamustine with immunotherapy, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) plus obinutuzumabe or rituximab, CVP (cyclophosphamide, vincristine, prednisone) plus obinutuzumabe or rituximab, immunochemotherapy plus radiation therapy, single-agent rituximab, and observation until progression. The choice of regimen depends on the stage of the disease, physician preference, and patient preference.
With the recent approval of Yescarta for indolent follicular lymphoma, CAR T cells appear promising for follicular lymphoma. Kymirah (Novartis) and Breyanzi (BMS) are the key CART therapy that is currently in the pipeline for the treatment of patients with relapsed/refractory FL. There may be a specific group of follicular patients that may benefit most from this therapy.
The newer bispecific antibodies (Mosunetuzumab and Odronextamab) appear to be a promising asset, with less toxicity and just easier administration access for patients.
Follicular Lymphoma Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnosis available in the Follicular Lymphoma market to treat the condition. It also provides country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
The DelveInsight Follicular Lymphoma market report thoroughly understands Follicular Lymphoma by including disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides the treatment algorithms and treatment guidelines for Follicular Lymphoma in the US, Europe, and Japan.
Follicular Lymphoma Epidemiology
The Follicular Lymphoma epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool, trends, and assumptions.
Key Findings
The disease epidemiology covered in the report provides historical and forecasted Follicular Lymphoma epidemiology segmented as the Incident cases of Follicular Lymphoma, Grade-specific cases of Follicular Lymphoma, Age-specific cases of Follicular Lymphoma, and Stage-specific cases of Follicular Lymphoma. The report includes the prevalent scenario of Follicular Lymphoma in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.
Country-wise Follicular Lymphoma Epidemiology
The epidemiology segment also provides the Follicular Lymphoma epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The incident population of Follicular Lymphoma in the 7MM countries was estimated to be 35,737 cases in 2020.
Follicular Lymphoma Drug Chapters
The drug chapter segment of the Follicular Lymphoma report encloses the detailed analysis of Follicular Lymphoma marketed drugs and late stage (Phase-III, Phase-II/III, Phase-II, and Phase-I/II) pipeline drugs. It also helps understand the Follicular Lymphoma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
In stage 1 lymphomas, radiation therapy is preferred in grades 1, 2, and 3a lymphomas. In contrast, patients with grade 3b FL are treated with aggressive regimens (such as R-CHOP) used for other aggressive lymphomas (e.g., diffuse large B cell lymphoma).
Treatment of stage II-IV FL is mainly focused on the improvement of life, alleviation of symptoms, and reversal of cytopenias. Asymptomatic patients are mostly observed closely without any intervention. Anti-CD20 antibodies (obinutuzumab, rituximab) are combined with chemotherapy regimens for the treatment of symptomatic advanced follicular lymphomas.
Treatment of FL relapse or progression depends in part upon the duration of remission with previous treatments. For patients with relapse or progression on first-line treatment who have a longer duration of remission, options can include chemoimmunotherapy followed by rituximab maintenance.
The National Comprehensive Cancer Network guidelines mention multiple options for patients with follicular lymphoma in second-line and subsequent therapy, including lenalidomide plus rituximab, or lenalidomide plus obinutuzumab, or the EZH2 inhibitor, tazemetostat. There are also some chemotherapy options mentioned in the guidelines, like R-CVP [rituximab, cyclophosphamide, vincristine, prednisone], bendamustine plus rituximab or obinotuzumab, or R-CHOP [rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone].
Products detail in the report…
Follicular Lymphoma emerging drugs
Monjuvi/Tafasitamab (Incyte Corporation/MorphoSys) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibodies. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Tafasitamab is currently clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials (Phase III clinical trial is ongoing to treat FL). In January 2021, the US FDA granted orphan drug designation to tafasitamab for the treatment of FL.
Breyanzi/JCAR017 (Bristol Myers) is a CAR-T-cell therapy being developed by Juno Therapeutics, in collaboration with Celgene, to treat certain patients with aggressive B-cell NHL possibly. Juno’s CAR-T technology acts to reprogram T-cells to target cells that express a specific protein, called CD19, commonly found in cancerous B-cell NHL. It is currently being studied in several Phase (III, II, and I) clinical trials to treat FL.
Products detail in the report…
Follicular Lymphoma Market Outlook
The Follicular Lymphoma market outlook of the report builds a detailed comprehension of the historical, current, and forecasted Follicular Lymphoma market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.
This segment gives a thorough detail of Follicular Lymphoma market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to view the market at first sight clearly.
According to DelveInsight, the Follicular Lymphoma market in the 7MM is expected to change in the study period 2018–2030.
Tazemetostat is the first approved oral EZH2 inhibitor for relapsed/refractory follicular lymphoma after two or more lines of systemic therapy or for EZH2 wild type or unknown with relapsed/refractory disease in patients who do not have satisfactory alternative options. EZH2 is a histone methyltransferase that is abundant in the germinal center where FL originates. In about 20% of FL cases, EZH2 is mutated. Tazemetostat is known to inhibit this mutated form of EZH2. It is unique that tazemetostat can also inhibit the wild-type form, which is abundantly prevalent in the germinal center, as well as mutated EZH2. However, the response rates are higher in those with mutated EZH2.
In May 2019, a combination of lenalidomide (Revlimid) and rituximab (Rituxan; R2) was a treatment option for adult patients with grade 1–3A previously treated FL. It is a new type of targeted cancer therapy for people with previously treated FL. Nevertheless, with the approaching patent expiry, the generic version of lenalidomide will soon hit the market.
Chimeric antigen receptor (CAR) T-cell therapy has also emerged as an exciting alternative treatment for this patient population. Recently, Gilead subsidiary Kite’s Yescarta has been granted accelerated approval from the US Food and Drug Administration (FDA) for indolent FL, becoming the first CAR-T cell therapy approved in this indication.
Therapies targeting PI3K have also been important in the R/R setting based on the vital role of the p110δ isoform of PI3K in B-cell and T-cell development, B-cell receptor signaling, and the decreased B-cell number and function observed in mouse embryonic knockout of p110δ. The guidelines mention PI3 kinase inhibitors such as idelalisib, copanlisib, and duvelisib, for patients with FL who have previously received two lines of systemic therapy. In July 2014, the FDA granted accelerated approval to idelalisib (Zydelig tablets; Gilead Sciences, Inc.), a PI3 kinase delta inhibitor, to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma. However, it carries a boxed warning alerting patients and health care professionals about the potential for severe and fatal toxicities, including liver toxicity, diarrhea and colitis, pneumonitis, and intestinal perforation.
Key Findings
This section includes a glimpse of the Follicular Lymphoma market in the 7MM. The market size of Follicular Lymphoma in the seven major markets was USD 1,451 million in 2020.
The United States: Market Outlook
This section provides Follicular Lymphoma market size and market size by therapies of Follicular Lymphoma in the United States.
The United States accounts for the largest market size of Follicular Lymphoma compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
In September 2017, the US FDA granted accelerated approval to copanlisib (ALIQOPA, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. Furthermore, in September 2018, duvelisib, a PI3k delta inhibitor, received accelerated approval for adult patients with relapsed or refractory FL after at least two prior systemic therapies. Nevertheless, the prescribing information contains boxed warnings for fatal and/or serious infections, diarrhea or colitis, cutaneous reactions, pneumonitis, neutropenia, and hepatotoxicity warnings. A recent addition to the armamentarium in the PI3 kinase family is umbralisib that has also been FDA approved for patients with FL who have received at least three prior lines of therapy.
The armamentarium of treatment options is continually expanding, with numerous novel therapies attempting to exploit specific biological vulnerabilities of FL. Enrollment in clinical trials evaluating emerging therapies remains a high priority for patients with relapsed/refractory FL requiring treatment, especially those who are refractory to both rituximab and alkylating agents (double refractory).
EU-5 Countries: Market Outlook
The total Follicular Lymphoma market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.
Japan Market Outlook
The total Follicular Lymphoma market size and market size by therapies of Follicular Lymphoma in Japan are also mentioned.
Follicular Lymphoma Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2018–2030. The analysis covers Follicular Lymphoma market uptake by drugs, patient uptake by therapies, and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.
Follicular Lymphoma Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stage. It also analyses Follicular Lymphoma key players involved in developing targeted therapeutics.
Major players include Incyte Corporation, ADC Therapeutics, and others whose key products are expected to get launched in the US market by 20XX.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Follicular Lymphoma emerging therapies.
KOL Views
To keep up with current market trends, we take KOLs and SME’s opinions working in the Follicular Lymphoma domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or Follicular Lymphoma market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform a Competitive and Market Intelligence analysis of the Follicular Lymphoma market by using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
The report covers the descriptive overview of Follicular Lymphoma, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies
Comprehensive insight has been provided into the Follicular Lymphoma epidemiology and treatment in the 7MM
Additionally, an all-inclusive account of both the current and emerging therapies for Follicular Lymphoma is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
A detailed review of the Follicular Lymphoma market, historical and forecasted, is included in the report, covering drug outreach in the 7MM.
The report provides an edge while developing business strategies by understanding trends shaping and driving the global Follicular Lymphoma market.
Report Highlights
In the coming years, the Follicular Lymphoma market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
The companies and academics are working to assess challenges and seek opportunities that could influence Follicular Lymphoma R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
Major players are involved in developing therapies for Follicular Lymphoma. The launch of emerging therapies will significantly impact the Follicular Lymphoma market
A better understanding of disease pathogenesis will also contribute to developing novel therapeutics for Follicular Lymphoma.
Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competitor, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Follicular Lymphoma Report Insights
Patient Population
Therapeutic Approaches
Follicular Lymphoma Pipeline Analysis
Follicular Lymphoma Market Size and Trends
Market Opportunities
Impact of upcoming Therapies
Follicular Lymphoma Report Key Strengths
10-years Forecast
7MM Coverage
Follicular Lymphoma Epidemiology Segmentation
Key Competitors
Highly Analyzed Market
Drugs Uptake
Follicular Lymphoma Report Assessment
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
Market Drivers and Barriers
Key Questions
Market Insights:
What was the Follicular Lymphoma Market share (%) distribution in 2018, and how would it look like in 2030?
What would be the Follicular Lymphoma total market Size and market Size by therapies across the 7MM during the forecast period (2018–2030)?
What are the key findings pertaining to the market across 7MM, and which country will have the largest Follicular Lymphoma market Size during the forecast period (2018–2030)?
At what CAGR, the Follicular Lymphoma market is expected to grow in the 7MM during the forecast period (2018–2030)?
What would be the Follicular Lymphoma market outlook across the 7MM during the forecast period (2018–2030)?
What would be the Follicular Lymphoma market growth till 2030, and what will be the resultant market Size in the year 2030?
How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
What are the disease risk, burden, and unmet needs of Follicular Lymphoma?
What is the historical Follicular Lymphoma patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
What would be the forecasted patient pool of Follicular Lymphoma in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Follicular Lymphoma?
Out of all 7MM countries, which country would have the highest incidence of Follicular Lymphoma during the forecast period (2018–2030)?
At what CAGR is the population expected to grow in the 7MM during the forecast period (2018–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
What are the current options for the treatment of Follicular Lymphoma?
What are the current treatment guidelines for treating Follicular Lymphoma in the US, Europe, and Japan?
What are the Follicular Lymphoma marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
How many companies are developing therapies for the treatment of Follicular Lymphoma?
How many therapies are developed by each company for the treatment of Follicular Lymphoma?
How many emerging therapies are in the mid-stage and late stages of development to treat Follicular Lymphoma?
What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Follicular Lymphoma therapies?
What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
What are the clinical studies going on for Follicular Lymphoma and their status?
What are the key designations that have been granted for the emerging therapies for Follicular Lymphoma?
What are the global historical and forecasted markets for Follicular Lymphoma?
Reasons to buy
The report will help in developing business strategies by understanding trends shaping and driving the Follicular Lymphoma market
To understand the future market competition in the Follicular Lymphoma market and an Insightful review of the key market drivers and barriers.
Organize sales and marketing efforts by identifying the best opportunities for Follicular Lymphoma in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
Organize sales and marketing efforts by identifying the best opportunities for the Follicular Lymphoma market.
To understand the future market competition in the Follicular Lymphoma market.
Learn how to effectively navigate the market research process to help guide your organization on the journey to success.
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