Mantle Cell Lymphoma - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights

• Mantle cell lymphoma (MCL) is a rare B-cell non-Hodgkin lymphoma (NHL) that most often affects men over the age of 60. MCL represents about 5% of NHLs, and it often starts out as an indolent (slow-growing) disease but can become more aggressive (fast-growing) over time.
• MCL is diagnosed through a lymph node biopsy, blood tests, and imaging scans like CT or PET. Key markers include high levels of cyclin D1, the t (11; 14) translocation, and high levels of an abnormal p53 protein (due to a mutation in the TP53 gene) or loss of the TP53 gene. These tests help assess cancer aggressiveness and guide treatment.
• Major pharmaceutical companies like BeOne, Kite Pharma, Eli Lilly, Bristol Myers Squibb, and others have successfully gained approval for their drug candidates in treating MCL.
• There are various therapies approved for MCL, including BREYANZI (lisocabtagene maraleucel), JAYPIRCA (pirtobrutinib), TECARTUS (brexucabtagene autoleucel), BRUKINSA, and many more.
• The potential drugs that can mark a significant change in the forecast period include COLUMVI (glofitamab) by Roche, BGB-11417 (sonrotoclax) by BeOne, NVG-111 by NovalGen, and others.
• In June 2025, the FDA approved the tablet formulation of zanubrutinib for B-cell malignancies, including MCL, who have received at least 1 prior therapy.
• In January 2025, the US FDA granted traditional approval to acalabrutinib (CALQUENCE, AstraZeneca) with bendamustine and rituximab for adults with previously untreated MCL who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). The FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Acalabrutinib received external link disclaimer accelerated approval for this indication in 2017.

DelveInsight's “Mantle Cell Lymphoma– Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth analysis of mantle cell lymphoma epidemiology, market, and clinical development in Mantle Cell Lymphoma. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the mantle cell lymphoma market trends in the United States, EU4 (Germany, France, Italy, and Spain ), and the United Kingdom, and Japan.

The mantle cell lymphoma market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted MCL market size from 2020 to 2034 in 7MM. The report also covers current MCL treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Mantle Cell Lymphoma Understanding and Treatment Algorithm

Mantle Cell Lymphoma Overview and Diagnosis

MCL is an aggressive, rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone.” The mantle zone is the outer ring of small lymphocytes surrounding the center of a lymphatic nodule. MCL accounts for roughly six percent of all non-Hodgkin lymphoma cases in the United States. Frequently, MCL is diagnosed at a later stage of the disease and in most cases involves the gastrointestinal tract and bone marrow. Overproduction of a protein called cyclin D1 in the lymphoma cells is found in more than 90 percent of patients with MCL. Identification of excess cyclin D1 from a biopsy is considered a very sensitive tool for diagnosing MCL. Commonly seen complications from disease progression include low blood cell count and low numbers of platelets. Gastrointestinal, pulmonary, or central nervous system (CNS) complications are also seen as MCL is extranodal.

MCL is diagnosed based on detailed patient history, thorough clinical evaluation, and a variety of tests, including a biopsy of an affected lymph node or the bone marrow, blood tests, PET/CT scans, and imaging tests like CAT. There are 4 stages in MCL, and staging determines the extent of the disease, how much the cancer has spread, and where it is located. It helps doctors develop a prognosis and tailor treatment to individual patients and minimize the potential toxic effects of therapy.

The MCL report provides an overview of MCL pathophysiology and diagnostic approaches, along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report.

Mantle Cell Lymphoma Treatment

The treatment of MCL often involves a combination of chemotherapy, immunotherapy, and steroids. Common regimens include R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and dexamethasone), R-DHAP (rituximab, cytarabine, cisplatin, and dexamethasone), the Nordic protocol (rituximab, cyclophosphamide, doxorubicin, vincristine, cytarabine, prednisolone), and bendamustine with rituximab. Steroids like prednisolone and dexamethasone enhance chemotherapy effectiveness. Fit patients may undergo high-dose therapy followed by autologous stem cell transplantation using regimens like BEAM or LEAM. For less intensive treatment, options include targeted drugs like bortezomib, chemotherapy with chlorambucil, and ibrutinib.

Further details related to treatment are provided in the report.

Mantle Cell Lymphoma Epidemiology

The MCL epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total Incident cases of NHL, total Incident cases of MCL, gender-specific cases of MCL, stage-specific cases of MCL, age-specific cases of MCL, and total treatable cases of MCL in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• MCL is a relatively rare and aggressive form of B-cell NHL, with an estimated annual incidence of approximately one case per 200,000 individuals. Due to its rarity, it poses challenges in early diagnosis and clinical trial recruitment.
• MCL accounts for roughly 5% of all NHL cases, making it an uncommon subtype. Despite its low prevalence, it is clinically significant due to its often aggressive disease course and limited long-term treatment durability.
• The disease shows a strong male predominance, occurring about three times more frequently in men than in women. This gender disparity remains consistent across various geographic regions.
• The median age at diagnosis typically falls between 60 and 70 years, with most patients presenting in their late 60s. The disease is predominantly seen in older adults, and the age at diagnosis can influence treatment decisions and prognosis.

Mantle Cell Lymphoma Drug Chapters

The drug chapter segment of the MCL report encloses a detailed analysis of MCL marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the MCL's pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

BREYANZI (lisocabtagene maraleucel): Bristol Myers Squibb

BREYANZI is a prescription medicine used to treat four types of NHL, Large B-cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, and MCL when two or more kinds of treatment have not worked or stopped working, including a prior Bruton tyrosine kinase (BTK) inhibitor medicine. BREYANZI is different from other cancer medicines because it is made from white blood cells, which have been genetically modified to recognize and attack lymphoma cells. In May 2024, the US FDA approved Bristol Myers Squibb’s BREYANZI as a new CAR-T Cell therapy for relapsed or refractory MCL.

JAYPIRCA (pirtobrutinib): Eli Lilly

JAYPIRCA as monotherapy is indicated for the treatment of adult patients with relapsed or refractory MCL who have been previously treated with BTK inhibitors. It is approved under accelerated approval based on the response rate in a Phase I/II study, called the BRUIN trial. JAYPIRCA was designated an ‘orphan medicine’ in June 2021 by the European Commission. In April 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product pirtobrutinib (JAYPIRCA), intended for the treatment of relapsed or refractory MCL.

Emerging Drugs

Sonrotoclax: BeOne

Sonrotoclax is an investigational small-molecule B-cell lymphoma 2 (BCL2) inhibitor. It belongs to a class of BCL2 homology 3 (BH3) mimetics, and preclinical and IND-enabling studies have demonstrated potent activity and high selectivity of sonrotoclax against the antiapoptotic protein BCL2. Sonrotoclax is more potent and selective for BCL2 relative to BCLxL than venetoclax and shows the potential to overcome common BCL2 resistance mutations. At EHA 2025, BeOne presented updated Phase I data on sonrotoclax in combination with BRUKINSA, showing a 79% overall response rate in patients with relapsed/refractory MCL. The regimen demonstrated deep responses with no new safety signals, supporting advancement into pivotal studies.

COLUMVI (glofitamab): Roche

COLUMVI is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma that has relapsed or is refractory, and who have received 2 or more prior treatments for their cancer. It is a 2:1 format T cell-engaging bispecific antibody, designed to engage both CD20 on B cells and CD3 on T cells. By engaging both targets simultaneously, the antibody activates the T cells to attack and eliminate the B cells. Currently, the drug is under investigation in a Phase III trial (NCT06084936) as a single agent compared to the investigator’s choice in patients with relapsed/refractory MCL. The US FDA has also given Breakthrough Therapy Designation (BTD) to COLUMVI for R/R MCL. Roche anticipates submitting the filing for approval by 2027.

Mantle Cell Lymphoma Market Outlook

The current MCL treatment landscape is evolving rapidly, shaped by key regulatory approvals, innovative mechanisms, and advancing late-stage pipeline therapies. CAR T-cell therapies like BREYANZI (approved in May 2024) and TECARTUS continue to transform outcomes for heavily pretreated patients, while JAYPIRCA’s approval highlights the value of next-generation BTK inhibitors in BTK-pretreated settings. Acalabrutinib received full FDA approval in January 2025 for both first-line and relapsed MCL, reinforcing its role in combination and monotherapy settings. The recent approval of a tablet formulation of zanubrutinib (BRUKINSA) further expands patient convenience and access. Emerging therapies like sonrotoclax, a potent and selective BCL2 inhibitor now in Phase III, and COLUMVI, a bispecific antibody with BTD, signal continued innovation focused on resistance mechanisms and durable responses. Together, these developments indicate a dynamic and competitive MCL market, poised for further shifts as pivotal trial data and regulatory filings shape future standards of care.

Key players, such as BeOne, Roche, NovalGen, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of MCL.

• In 2024, the United States accounts for the largest market size of MCL, in comparison to EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Among the EU4 and the UK, Germany had the highest market size, while Spain had the smallest market size for MCL in 2024.

Mantle Cell Lymphoma Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies drug uptake in the report…

Mantle Cell Lymphoma Cancer Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for MCL emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Professors, and Others.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as UT Health San Antonio MD Anderson Cancer Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or MCL market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and 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.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the 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.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of MCL, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• 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 therapies, 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 MCL 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 MCL market.

Mantle Cell Lymphoma Report Insights

• Patient Population
• Therapeutic Approaches
• MCL Pipeline Analysis
• MCL Market Size and Trends
• Existing and future Market Opportunity

Mantle Cell Lymphoma Report Key Strengths

• 10-Year Forecast
• 7MM Coverage
• MCL Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Mantle Cell Lymphoma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the historical and forecasted MCL patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination treatment approaches will have a significant impact on the MCL drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of MCL?
• How many companies are developing therapies for the treatment of MCL?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the MCL market.
• Insights on patient burden/disease Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

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