The follicular lymphoma therapeutic market is experiencing robust growth, with projections indicating a 6% compound annual growth rate (CAGR) through 2034, according to DelveInsight's comprehensive market analysis. This expansion is primarily driven by increased disease awareness leading to higher numbers of treated cases and a surge in clinical trials focused on this indolent form of non-Hodgkin lymphoma.
Market Size and Geographic Distribution
The global follicular lymphoma market was valued at approximately $1.082 billion in 2024, with the United States representing the dominant market. Among European markets, Germany held the largest market share at around $108 million, while Spain represented the smallest at approximately $61 million. Japan and other major markets contribute to the overall seven-market (7MM) landscape that forms the basis of current market assessments.
In 2024, approximately 35,000 cases of follicular lymphoma were diagnosed across the 7MM, with the United States accounting for roughly 17,000 cases. The disease predominantly affects older adults, with the 60-80 age group representing the highest incidence at around 9,000 cases, followed by the 40-59 age group with approximately 4,000 cases. Stage IV follicular lymphoma cases accounted for approximately 34% of all diagnosed cases in 2024.
Recent Regulatory Milestones
The therapeutic landscape has witnessed significant regulatory progress in recent months. In February 2025, Japan's Ministry of Health, Labour and Welfare approved EPKINLY (epcoritamab) for treating patients with relapsed or refractory follicular lymphoma who have undergone two or more prior treatments. This approval establishes EPKINLY as the first and only subcutaneously administered T-cell engaging bispecific antibody approved in Japan for both relapsed or refractory follicular lymphoma and large B-cell lymphomas.
The FDA granted approval to tafasitamab-cxix (Monjuvi) in combination with lenalidomide and rituximab for treating patients with relapsed or refractory follicular lymphoma in June 2025. This approval was based on findings from the phase 3 inMIND trial, a double-blind, placebo-controlled study involving 548 patients with relapsed or refractory follicular lymphoma.
Additionally, the European Commission approved lisocabtagene maraleucel (liso-cel; Breyanzi), a CD19-targeting CAR T-cell therapy, for adult patients with relapsed or refractory follicular lymphoma who have undergone at least two prior lines of systemic treatment in March 2025.
Pipeline Development and Innovation
The follicular lymphoma pipeline demonstrates remarkable depth, with over 45 companies developing more than 50 therapeutic candidates across various stages of clinical development. Key companies driving innovation include Regeneron Pharmaceuticals, which resubmitted its Biologics License Application for odronextamab in February 2025, with an FDA decision expected in the second half of 2025.
AstraZeneca presented interim results for AZD0486, an innovative bispecific T-cell engager, at the 2024 American Society of Hematology Annual Meeting, demonstrating the continued focus on novel mechanisms of action. CRISPR Therapeutics announced plans to collaborate with regulatory authorities regarding CTX112 in B-cell malignancies, with updates anticipated by mid-2025.
Therapeutic Landscape and Key Players
The current therapeutic arsenal includes established treatments such as LUNSUMIO (mosunetuzumab) from Roche, BRUKINSA (zanubrutinib) from BeiGene, and YESCARTA from Kite Pharma. Emerging therapies span multiple mechanism classes, including monoclonal antibodies, CAR-T cell treatments, and targeted small molecules.
Major pharmaceutical companies actively developing follicular lymphoma treatments include Roche, BeiGene, Kite Pharma, Incyte Corporation, AstraZeneca, Novartis, Innovent Biologics, Regeneron, Genentech, Eli Lilly and Company, ADC Therapeutics, and AbbVie, among others.
Disease Characteristics and Treatment Approach
Follicular lymphoma is characterized as a slow-growing type of non-Hodgkin lymphoma that arises from B-lymphocytes, typically originating in lymph nodes but potentially affecting bone marrow and spleen. The disease presents with painless swelling, fatigue, night sweats, and unexplained weight loss, most commonly affecting adults over age 60.
Current treatment approaches vary based on disease stage and symptoms, ranging from active surveillance in early stages to targeted therapies, immunotherapy, chemotherapy, and radiation therapy in more advanced cases. While generally considered incurable, follicular lymphoma is highly treatable, with many patients achieving extended survival with proper disease management.
Market Drivers and Future Outlook
The market expansion is supported by several key factors, including the aging global population, increased disease awareness, and continuous advancement in targeted therapies. The rising number of clinical trials focused on follicular lymphoma represents a significant driver of market growth, with ongoing research exploring novel therapeutic approaches aimed at improving outcomes and extending progression-free survival.
The anticipated launch of emerging therapies is expected to transform the market landscape significantly. As these cutting-edge treatments continue to mature and gain regulatory approval, they are positioned to reshape treatment standards and create new opportunities for medical innovation and economic growth in the follicular lymphoma therapeutic space.
