Assessing the Investment Potential of Outpatient Bispecific Antibody Therapy in Hematology

The emergence of outpatient bispecific antibody therapies marks a transformative shift in hematology, offering both clinical and economic advantages. Among these, Genmab and AbbVie’s Epcoritamab (Epkinly) stands out as a paradigm-shifting treatment for B-cell malignancies. Its subcutaneous administration, coupled with robust efficacy and manageable safety profiles, positions it to redefine standards of care while unlocking significant financial potential for its developers.

Clinical Feasibility and Therapeutic Outcomes

Epcoritamab’s outpatient viability has been rigorously validated. In the Phase 2 EPCORE NHL-6 trial, 92% of patients received the first full dose of epcoritamab monotherapy in an outpatient setting, with adverse events such as cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) resolving rapidly—40.2% of patients experienced CRS, predominantly low-grade, resolving within two days [1]. This contrasts sharply with intravenous bispecifics or CAR-T therapies, which often require inpatient monitoring due to higher toxicity risks.

Long-term data further underscore its durability. A 3-year follow-up of the EPCORE NHL-3 trial in Japanese patients revealed a 56% overall response rate (ORR) and 47% complete response rate (CR), with 53% of complete responders remaining in remission at three years [2]. Similarly, the EPCORE NHL-1 trial demonstrated that 96% of patients achieving complete remission at two years maintained their response at three years, with median overall survival (OS) and progression-free survival (PFS) not yet reached [3]. These outcomes highlight epcoritamab’s potential to deliver sustained remission, a critical factor for market adoption.

Competitive Positioning and Market Dynamics

The bispecific antibody market is expanding rapidly, driven by innovations in outpatient administration. By 2030, the global market is projected to grow at a compound annual growth rate (CAGR) of 17.8%, reaching $22.44 billion [4]. Epcoritamab’s subcutaneous delivery model aligns with this trend, offering logistical advantages over competitors like Roche’s Columvi (glofitamab) and Lunsumio. For instance, Columvi, while effective, is associated with a higher CRS rate (64.3% vs. epcoritamab’s 40.2%) and requires intravenous administration [5]. Epcoritamab’s fixed-dose subcutaneous route not only reduces healthcare costs but also enhances patient compliance, a key differentiator in a crowded therapeutic landscape.

Genmab and AbbVie’s strategic label expansions further strengthen their competitive edge. The recent approval of epcoritamab in combination with R2 (rituximab and lenalidomide) for follicular lymphoma reduced the risk of disease progression by 79% compared to R2 alone [6]. Analysts project this indication alone could generate $1.2–$1.5 billion in annual sales by 2030, assuming 30–40% market penetration [7]. With ongoing trials in earlier lines of therapy and first-line diffuse large B-cell lymphoma (DLBCL), epcoritamab’s label is poised for broadening, potentially capturing a larger share of the $2.5 billion relapsed/refractory follicular lymphoma (R/R FL) market [8].

Financial Projections and Investment Implications

The financial potential of epcoritamab is underscored by its rapid revenue growth and market penetration. In the first half of 2025, Epkinly generated $211 million in sales, a 74% year-over-year increase, contributing to Genmab’s total revenue of $1.64 billion for the period [9]. Analysts project annual sales of $3.94 billion by 2031, driven by label expansions and combination therapies [10]. This trajectory reflects not only clinical success but also Genmab and AbbVie’s ability to navigate regulatory and commercial challenges.

The partnership between Genmab and AbbVie is a critical enabler of this growth. By combining Genmab’s bispecific antibody expertise with AbbVie’s commercial infrastructure, the duo has accelerated epcoritamab’s development across multiple indications. This collaboration also mitigates risks associated with single-product dependency, as both firms have a pipeline of bispecific candidates in development [11].

Conclusion

Epcoritamab’s outpatient feasibility, supported by compelling clinical data and a favorable safety profile, positions it as a cornerstone of next-generation hematology care. For investors, the drug represents a confluence of unmet medical need, technological innovation, and scalable commercial potential. As Genmab and AbbVie continue to expand epcoritamab’s indications and optimize its combination regimens, the investment case strengthens further. In a market projected to grow exponentially, the ability to deliver effective, convenient, and cost-efficient therapies will define leaders—and epcoritamab is well on its way to becoming one.

Source:
[1] AbbVie Announces Updated Results From Phase 2 EPCORE® NHL-6 Study [https://news.abbvie.com/2025-09-03-AbbVie-Announces-Updated-Results-From-Phase-2-EPCORE-R-NHL-6-Study-Evaluating-the-Potential-for-Outpatient-Monitoring-of-Epcoritamab-in-Patients-With-Relapsed-Refractory-R-R-Diffuse-Large-B-Cell-Lymphoma-DLBCL]
[2] Efficacy and safety of epcoritamab in Japanese patients [https://pubmed.ncbi.nlm.nih.gov/40434509/]
[3] Epcoritamab Maintains Responses at 3 Years in Relapsed/Refractory LBCL [https://www.onclive.com/view/epcoritamab-maintains-responses-at-3-years-in-relapsed-refractory-lbcl]
[4] Bispecific Antibodies Market Size & Share Analysis [https://www.mordorintelligence.com/industry-reports/bispecific-antibodies-market]
[5] Epkinly (epcoritamab-bysp) vs Columvi (glofitamab-gxbm) [https://everyone.org/explore/compare?id1=556&id2=568]
[6] Trial results set up AbbVie, Genmab's Epkinly for key expansion [https://www.fiercepharma.com/pharma/new-results-set-abbvie-genmabs-epkinly-key-expansion-follicular-lymphoma]
[7] Genmab's EPCORE® FL-1 Trial: A Strategic Leap in [https://www.ainvest.com/news/genmab-epcore-fl-1-trial-strategic-leap-bispecific-antibody-market-lymphoma-treatment-2508/]
[8] Bispecific Antibody Market Opportunity, Drug Dosage [https://www.globenewswire.com/news-release/2025/03/12/3041385/28124/en/Bispecific-Antibody-Market-Opportunity-Drug-Dosage-Patent-Price-Sales-Clinical-Trials-Insight-2030-New-Report-Highlights-600-Bispecific-Antibodies-in-Clinical-Trials-Worldwide.html]
[9] Genmab Announces Financial Results for the First Half of [https://ir.genmab.com/news-releases/news-release-details/genmab-announces-financial-results-first-half-2025]
[10] EHA 2025: Genmab and AbbVie's Epkinly outpaces BiTE [https://www.clinicaltrialsarena.com/analyst-comment/eha-2025-genmab-abbvie-epkinly-dlbcl/]
[11] Genmab and AbbVie Announce Broad Oncology [https://ir.genmab.com/news-releases/news-release-details/genmab-and-abbvie-announce-broad-oncology-collaboration]