Mantle Cell Lymphoma Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Diagnosis (Laboratory exams, Imaging Tests, Bone marrow Biopsy, Others), By Treatment (Diagnosis {Imaging Tests, Surgical Examination, Others}, Therapy{Chemotherapy, Targeted therapy, Immunotherapy, Stem Cell Transplantation, Others), By End User (Hospitals & Clinics, Ambulatory Care Centers, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.71 Billion
CAGR (2026-2031)	7.91%
Fastest Growing Segment	Surgical Examination
Largest Market	North America
Market Size (2031)	USD 4.28 Billion

Market Overview

The Global Mantle Cell Lymphoma Market will grow from USD 2.71 Billion in 2025 to USD 4.28 Billion by 2031 at a 7.91% CAGR. Mantle Cell Lymphoma is a rare and aggressive malignancy arising from B-cells within the mantle zone of lymph nodes and is clinically characterized by the overexpression of the cyclin D1 protein. The global market for these therapeutics is fundamentally supported by the increasing incidence of hematologic cancers among the aging global population and the expanded regulatory approval of targeted oral therapies and immunotherapies. These structural drivers provide a durable foundation for long-term industry expansion that is distinct from transient market trends or temporary shifts in prescribing patterns.

Despite these positive indicators, the sector faces a significant impediment regarding the high acquisition costs of novel treatment modalities which restricts widespread patient access and reimbursement coverage. This financial toxicity imposes severe pressure on healthcare systems and limits market penetration in cost-sensitive regions. Illustrating the scale of the target indication, according to the American Cancer Society, in 2025, approximately 80,350 new cases of non-Hodgkin lymphoma were estimated to occur in the United States, with Mantle Cell Lymphoma constituting a critical and aggressive subset of this total disease burden.

Key Market Drivers

The accelerated approvals of novel targeted therapies, specifically Bruton tyrosine kinase inhibitors, act as a primary catalyst for market growth by shifting the treatment paradigm away from traditional cytotoxic chemotherapy. This transition is fueled by clinical trials demonstrating superior progression-free survival and safety profiles in both frontline and relapsed settings. For instance, according to AstraZeneca, June 2024, in the 'CALQUENCE reduced the risk of disease progression or death by 27% versus standard of care in patients with untreated mantle cell lymphoma in ECHO trial' press release, the addition of acalabrutinib to standard chemoimmunotherapy resulted in a statistically significant improvement in patient outcomes. Such clinical advancements incentivize healthcare providers to adopt these premium-priced oral therapies earlier in the treatment continuum, thereby driving revenue expansion despite the rarity of the condition.

Simultaneously, the growing adoption of CAR-T cell therapies and immunotherapies is addressing high unmet medical needs for patients with refractory disease who have exhausted other options. These distinct biological treatments offer durable remission possibilities, sustaining market value through their high reimbursement potential. Highlighting the consistent demand for these specialized modalities, according to Gilead Sciences, November 2024, in the 'Gilead Sciences Announces Third Quarter 2024 Financial Results', sales of the cell therapy Tecartus totaled $98 million for the quarter. This adoption is significant given the niche patient population, as according to the Lymphoma Research Foundation, in 2024, Mantle Cell Lymphoma represented approximately 6% of all non-Hodgkin lymphoma cases. Consequently, the commercial viability of this market relies heavily on the high value of these complex biologic interventions rather than patient volume alone.

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Key Market Challenges

The primary challenge hampering the growth of the Global Mantle Cell Lymphoma Market is the prohibitive acquisition cost associated with novel therapeutic modalities. Advanced treatments, including CAR-T cell therapies and continuous oral kinase inhibitors, carry substantial price tags that frequently exceed the budgetary thresholds of public and private healthcare payers. This financial toxicity necessitates strict utilization management and rigorous reimbursement criteria, which directly restricts patient access to these potentially life-extending regimens. Consequently, the high economic burden creates a significant barrier to market penetration, particularly in cost-sensitive regions where healthcare systems cannot sustain the expenditure required for these premium agents, thereby dampening overall revenue expansion.

This economic friction is further exacerbated by the orphan nature of the disease, which compels manufacturers to maintain high per-patient pricing to recover development costs from a limited population. The constrained volume of the target market makes the industry highly sensitive to access limitations. Illustrating this niche demographic, according to the American Society of Hematology, in 2025, the annual incidence of Mantle Cell Lymphoma in the United States was projected to increase to approximately 3,589 cases. This relatively small patient pool, when coupled with high treatment costs, forces a selective approach to prescribing that limits the widespread adoption of innovative therapies and impedes the market's broader commercial trajectory.

Key Market Trends

The widespread adoption of non-covalent BTK inhibitors is systematically addressing the therapeutic void left by covalent resistance mechanisms, particularly for patients whose disease progresses on standard frontline agents. By utilizing a reversible binding mode, novel therapies such as pirtobrutinib effectively re-establish disease control in tumors harboring mutations that render traditional irreversible inhibitors ineffective, thereby extending the oral treatment duration before more intensive interventions are required. This clinical utility is driving substantial market traction; according to Eli Lilly, October 2024, in the 'Lilly reports Q3 2024 financial results' press release, the quarterly revenue for the non-covalent inhibitor Jaypirca reached $81 million, reflecting its rapid integration into treatment protocols for relapsed cases.

Concurrently, the emergence of bispecific antibodies acts as a disruptive force by providing immediate, off-the-shelf immunotherapeutic options that rival the efficacy of cell-based therapies. These agents bypass the manufacturing delays and logistical complexities of autologous CAR-T cells by engaging endogenous T-cells to directly target tumor antigens, making them highly suitable for patients with rapidly progressing disease who cannot wait for personalized manufacturing. Underscoring the high efficacy of this approach, according to OncLive, December 2024, in the 'Glofitamab Produces Durable Remissions in R/R Mantle Cell Lymphoma' article, study results presented at the 2024 ASH Annual Meeting demonstrated that glofitamab monotherapy elicited an overall response rate of 82% in the relapsed/refractory setting, positioning this class as a formidable competitor in the evolving landscape.

Segmental Insights

Within the Global Mantle Cell Lymphoma Market, the Surgical Examination segment is emerging as the fastest-growing category, driven by the critical necessity for definitive histopathological diagnosis. Unlike less invasive methods, surgical excisional biopsies provide the preserved lymph node architecture required to accurately differentiate mantle cell lymphoma from other B-cell malignancies. This procedure is essential for obtaining adequate tissue samples for advanced molecular profiling and genetic risk stratification. Leading institutions, such as the National Comprehensive Cancer Network, recommend these comprehensive surgical assessments to guide personalized treatment strategies, thereby sustaining the segment’s rapid expansion.

Regional Insights

North America commands the leading share of the Global Mantle Cell Lymphoma Market, primarily due to its highly developed healthcare infrastructure and substantial investment in oncology research. This dominance is reinforced by the proactive regulatory framework of the U.S. Food and Drug Administration (FDA), which expedites the approval and commercialization of novel therapeutics, including CAR T-cell therapies and BTK inhibitors. Furthermore, high healthcare expenditure and the presence of major pharmaceutical corporations facilitate widespread patient access to these targeted treatments, ensuring sustained regional market superiority.

Recent Developments

• In February 2025, BeiGene entered into a strategic collaboration with BostonGene to advance the discovery of biomarkers for mantle cell lymphoma. The partnership aims to leverage advanced AI-driven molecular and immune profiling technologies to identify tumor-specific biomarkers associated with therapeutic response and resistance in patients. By analyzing genomic and transcriptomic data from clinical trials, the companies intend to elucidate the molecular drivers of the disease and support the development of precision medicine approaches. This initiative seeks to improve patient outcomes by better understanding the underlying biology of this aggressive subtype of B-cell lymphoma.
• In January 2025, AstraZeneca received approval from the U.S. Food and Drug Administration (FDA) for its Bruton tyrosine kinase (BTK) inhibitor, acalabrutinib, to be used in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma. This regulatory decision marked the first approval of a BTK inhibitor in the first-line setting for this specific patient population. The approval was based on positive results from the Phase III ECHO trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to the standard-of-care chemoimmunotherapy regimen.
• In December 2024, Roche presented updated data from a Phase I/II study evaluating its bispecific antibody, glofitamab, in patients with heavily pretreated relapsed or refractory mantle cell lymphoma. Presented at the American Society of Hematology Annual Meeting, the findings highlighted that fixed-duration monotherapy with the drug induced high and durable complete response rates, even among patients with high-risk clinical features. The data indicated that most patients who achieved a complete response remained progression-free and alive eighteen months after completing treatment, suggesting the potential of this T-cell engaging therapy to provide lasting remission in advanced disease settings.
• In May 2024, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) granted approval to its CD19-directed chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. This regulatory milestone made the therapy available to patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. The approval was supported by results from the MCL cohort of the TRANSCEND NHL 001 trial, which demonstrated high rates of durable response in a difficult-to-treat patient population with limited remaining options.

Key Market Players

• Gilead Sciences, Inc.
• F. Hoffman La Roche Ltd
• Abbvie, Inc.
• Celgene Corporation
• Eli Lilly and Company
• Amgen, Inc.
• Takeda Pharmaceutical Co. Ltd
• AstraZeneca Plc
• Johnson and Johnson Services Inc.
• BeiGene GmBH

By Diagnosis	By Treatment	By End User	By Region
Laboratory exams Imaging Tests Bone marrow Biopsy Others	Diagnosis {Imaging Tests Surgical Examination Others} Therapy{Chemotherapy Targeted therapy Immunotherapy Stem Cell Transplantation Others	Hospitals & Clinics Ambulatory Care Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Mantle Cell Lymphoma Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Mantle Cell Lymphoma Market, By Diagnosis:

• Laboratory exams
• Imaging Tests
• Bone marrow Biopsy
• Others

• Mantle Cell Lymphoma Market, By Treatment:

• Diagnosis {Imaging Tests
• Surgical Examination
• Others}
• Therapy{Chemotherapy
• Targeted therapy
• Immunotherapy
• Stem Cell Transplantation
• Others

• Mantle Cell Lymphoma Market, By End User:

• Hospitals & Clinics
• Ambulatory Care Centers
• Others

• Mantle Cell Lymphoma Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE