EPKINLY Market Summary

Key Factors Driving EPKINLY Growth

1. Expansion into follicular lymphoma (FL) has significantly broadened the addressable market:

EPKINLY was initially approved for adults with relapsed/refractory (R/R) DLBCL after ≥2 systemic therapies, but its label has expanded substantially. In November 2025, the FDA granted traditional approval for EPKINLY monotherapy in R/R FL after ≥2 lines of systemic therapy and approved EPKINLY in combination with lenalidomide and rituximab (R²) for R/R FL. The EPCORE FL-1 study enrolled 488 patients and demonstrated a PFS hazard ratio of 0.21, with median PFS not reached for EPKINLY + R² versus 11.2 months for R² alone; ORR was 89% vs. 74%. This expansion into FL provides an important additional commercial opportunity.

2. Strong commercial growth in DLBCL and FL is already translating into higher sales:

Global EPKINLY/TEPKINLY sales reached $468 million in 2025, compared with $281 million in 2024, representing a 67% increase. Genmab attributed this growth to strong demand in 3L+ DLBCL and expansion into 3L+ FL. In the first half of 2026, global EPKINLY/TEPKINLY sales increased another 48% year over year to $312 million, compared with $211 million in H1 2025. This provides strong evidence that the additional FL indication is contributing to the franchise's commercial momentum.

3. Earlier-line DLBCL expansion could substantially increase patient access:

EPKINLY is being developed beyond its current later-line DLBCL positioning. In January 2026, AbbVie and Genmab announced positive topline results from the Phase III EPCORE DLBCL-1 study in R/R DLBCL, comparing epcoritamab with investigator's-choice chemoimmunotherapy. The trial demonstrated improved PFS, with a hazard ratio of 0.74 (95% CI 0.60–0.92), alongside improvements in complete response rate, duration of response and time to next treatment. The companies stated that they would engage global regulators regarding next steps. A successful earlier-line expansion could materially increase the number of patients eligible for EPKINLY.

4. Subcutaneous administration provides a practical advantage for a bispecific antibody:

EPKINLY is a CD3×CD20 T-cell-engaging bispecific antibody administered subcutaneously, rather than requiring intravenous administration. The approved FL R² regimen uses a step-up schedule followed by subcutaneous dosing, transitioning to every-four-week administration from Cycle 4 through Cycle 12. This route and maintenance schedule may facilitate outpatient administration and reduce infusion-related treatment burden compared with some intravenously administered immunotherapies. The subcutaneous formulation is an important component of EPKINLY's differentiation within the rapidly developing bispecific-antibody class.

EPKINLY Recent Developments

In June 2026, The EC granted marketing authorization for TEPKINLY (the EU brand name) in combination with lenalidomide and rituximab (R²) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) in the second-line setting. This major milestone was backed by data from the Phase III EPCORE® FL-1 trial. This regimen showed a statistically significant improvement in progression-free survival (PFS) over standard R² therapy.

“EPKINLY Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of EPKINLY for approved indication like Diffuse large B cell lymphoma and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Chronic lymphocytic leukaemia, Haematological malignancies, and Richter’s syndrome in the 7MM. A detailed picture of EPKINLY’s existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the EPKINLY for approved and potential indications. The EPKINLY market report provides insights about EPKINLY’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current EPKINLY performance, future market assessments inclusive of the EPKINLY market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of EPKINLY sales forecasts, along with factors driving its market.

EPKINLY Drug Summary

EPKINLY is a subcutaneous bispecific T-cell engager (BiTE®-like) antibody developed by AbbVie and Genmab for the treatment of certain B-cell malignancies. It is designed to simultaneously bind to CD3 on T cells and CD20 on malignant B cells, bringing the patient's immune cells into close proximity to cancer cells and promoting T-cell-mediated cytotoxicity. By facilitating the formation of an immune synapse, epcoritamab activates T cells, leading to the release of cytotoxic molecules that induce the destruction of CD20-expressing B cells. Unlike conventional intravenous monoclonal antibody therapies, EPKINLY is administered through subcutaneous injection, using a step-up dosing schedule to reduce the risk and severity of cytokine release syndrome (CRS). The report provides EPKINLY’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the EPKINLY Market Report

The report provides insights into:

• A comprehensive product overview including the EPKINLY MoA, description, dosage and administration, research and development activities in approved indications like Diffuse large B cell lymphoma and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Chronic lymphocytic leukaemia, Haematological malignancies, and Richter’s syndrome.
• Elaborated details on EPKINLY regulatory milestones and other development activities have been provided in EPKINLY market report.
• The report also highlights EPKINLY‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The EPKINLY market report also covers the patents information, generic entry and impact on cost cut.
• The EPKINLY market report contains current and forecasted EPKINLY sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The EPKINLY market report also features the SWOT analysis with analyst views for EPKINLY in approved and potential indications.

Methodology

The EPKINLY market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

EPKINLY Analytical Perspective by DelveInsight

• In-depth EPKINLY Market Assessment

This EPKINLY sales market forecast report provides a detailed market assessment of EPKINLY for approved indication like Diffuse large B cell lymphoma and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Chronic lymphocytic leukaemia, Haematological malignancies, and Richter’s syndrome in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted EPKINLY sales data uptil 2034.

• EPKINLY Clinical Assessment

The EPKINLY market report provides the clinical trials information of EPKINLY for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

EPKINLY Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

EPKINLY Market Potential & Revenue Forecast

• Projected market size for the EPKINLY and its key indications
• Estimated EPKINLY sales potential (EPKINLY peak sales forecasts)
• EPKINLY Pricing strategies and reimbursement landscape

EPKINLY Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• EPKINLY Market positioning compared to existing treatments
• EPKINLY Strengths & weaknesses relative to competitors

EPKINLY Regulatory & Commercial Milestones

• EPKINLY Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

EPKINLY Clinical Differentiation

• EPKINLY Efficacy & safety advantages over existing drugs
• EPKINLY Unique selling points

EPKINLY Market Report Highlights

• In the coming years, the EPKINLY market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The EPKINLY companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence EPKINLY’s dominance.
• Other emerging products for Diffuse large B cell lymphoma and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Chronic lymphocytic leukaemia, Haematological malignancies, and Richter’s syndrome are expected to give tough market competition to EPKINLY and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of EPKINLY in approved and potential indications.
• Analyse EPKINLY cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted EPKINLY sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of EPKINLY in approved and potential indications.

Key Questions

• What is the class of therapy, route of administration and mechanism of action of EPKINLY? How strong is EPKINLY’s clinical and commercial performance?
• What is EPKINLY’s clinical trial status in each individual indications such as Diffuse large B cell lymphoma and Follicular lymphoma; as well as potential indication like Non-Hodgkin’s lymphoma, B-cell lymphoma, Chronic lymphocytic leukaemia, Haematological malignancies, and Richter’s syndrome and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the EPKINLY Manufacturers?
• What are the key designations that have been granted to EPKINLY for approved and potential indications? How are they going to impact EPKINLY’s penetration in various geographies?
• What is the current and forecasted EPKINLY market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of EPKINLY in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to EPKINLY for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is EPKINLY? What is the duration of therapy and what are the geographical variations in cost per patient?