CD137 Antibody Market By Type (Monoclonal Antibodies, Bispecific Antibodies, Fc-Engineered Variants); By Application (Solid Tumors, Hematologic Malignancies, Combination Immunotherapy); By Development Stage (Preclinical, Phase I, Phase II, Phase III); By End User (Academic Cancer Centers, Biopharma Companies, CROs, Specialty Oncology Clinics); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global CD137 Antibody Market is expected to grow steadily at a CAGR of 10.6%, valued at USD 782 million in 2024, and projected to reach around USD 1.43 billion by 2030, according to Strategic Market Research.

 

CD137, also known as 4-1BB or TNFRSF9, is an immune checkpoint receptor expressed primarily on activated T cells. CD137-targeted antibodies are being developed as next-generation immunotherapies to stimulate T-cell activation, proliferation, and memory responses — a mechanism that complements or enhances the effects of PD-1, PD-L1, and CTLA-4 inhibitors. As cancer treatment continues its shift toward precision immunotherapy, CD137 agonists are emerging as a promising class of agents capable of enhancing anti- tumor immunity without broadly suppressing the immune system.

 

Between 2024 and 2030, the market’s relevance is increasing due to a combination of expanding oncology pipelines, increasing R&D collaborations, and more nuanced understanding of co-stimulatory checkpoint biology. Unlike early-stage immune checkpoint inhibitors that blunt suppression, CD137 agonists actively promote immune activation — an approach that’s gaining favor in refractory and solid tumor settings.

 

Pharma and biotech firms are pivoting to combination strategies, where CD137 antibodies are being trialed alongside PD-1 inhibitors, radiotherapy, and tumor vaccines. These combinations are being explored in hard-to-treat cancers like hepatocellular carcinoma, triple-negative breast cancer, and advanced head and neck squamous cell carcinoma — all of which have shown limited response to first-line monotherapies.

 

On the regulatory front, agencies like the FDA and EMA are expanding their guidance frameworks for novel immune-oncology agents, making room for conditional approvals and biomarker-linked submissions. In Asia-Pacific, countries like China and South Korea are fast-tracking CD137-related trials, especially through regional partnerships between academic hospitals and emerging biotech firms.

 

From a stakeholder standpoint, this market is drawing interest from original biologics developers, CDMO platforms, immuno-oncology research institutes, and venture capital firms seeking to place early bets on tumor -specific co-stimulatory modulators. In 2024, there are at least six active clinical candidates in Phase I or II, with multiple preclinical programs in stealth or incubator mode — a signal that investor attention is intensifying, despite the biological complexities involved.

 

Market Segmentation And Forecast Scope

The CD137 antibody market cuts across multiple strategic dimensions, each reflecting how companies and institutions are positioning this immunotherapy class within the broader oncology treatment paradigm. The segmentation logic revolves around mechanism of action, therapeutic application, development stage, and clinical setting — offering both scientific and commercial visibility.

By Type of Antibody

• Monoclonal Antibodies (Agonistic mAbs): The foundational segment, monoclonal CD137 agonists were the first to enter trials. These agents directly stimulate T cells via CD137 but have struggled with systemic toxicity in earlier generations (e.g., urelumab).

• Bispecific Antibodies (e.g., CD137 x PD-L1, CD137 x HER2): Designed to activate CD137 only in the presence of tumor antigens, reducing off-target effects and systemic immune activation. This format is gaining significant traction due to improved selectivity and safety.

• Fc-Engineered or Conditional Antibodies: These are antibodies with modified Fc regions or tumor microenvironment (TME)-responsive switches, enabling localized immune stimulation. Often paired with cytokine modulation or receptor clustering strategies.

As of 2024, monoclonal antibodies dominate preclinical and early-phase trials, but bispecific constructs are projected to be the fastest-growing segment through 2030 as clinical safety concerns drive innovation in format design.

 

By Application

• Solid Tumors: The leading application, particularly in hepatocellular carcinoma (HCC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC). These tumors often resist first-line checkpoint inhibitors, creating a role for CD137 agonists in combination regimens.

• Hematologic Malignancies: While less common than solid tumors, CD137 antibodies are also under investigation for lymphomas and leukemias, often as part of bispecific or trispecific platforms in early-phase trials.

• Combination Immunotherapy: An increasingly important segment where CD137 antibodies are paired with PD-1/PD-L1, CTLA-4 inhibitors, tumor vaccines, or radiotherapy. This strategy is favored in checkpoint-resistant settings or cold tumor microenvironments.

In 2024, over 68% of development activity is focused on solid tumors, but combination immunotherapy is driving the highest pipeline growth rate, especially for co-formulations with approved checkpoint inhibitors.

 

By Development Stage

• Preclinical: Most active segment, featuring experimental agonists and novel formats (e.g., conditional or Fc-engineered variants). Biotech innovation and AI-guided design dominate here.

• Phase I: Early clinical testing focused on dose escalation, safety profiling, and early efficacy signals — especially in tumor-selective designs.

• Phase II: Translational stage where agents are tested for efficacy in selected cancer types or in combination regimens. A handful of candidates are progressing into Phase II as of 2025.

• Phase III: No current CD137 antibodies have reached full Phase III trials, reflecting the nascent stage of the market.

The pipeline is heavily skewed toward preclinical and Phase I, but accelerated pathways (e.g., FDA Fast Track) could push select agents into pivotal trials by 2026–2027.

 

By End User

• Academic Cancer Centers: The primary drivers of early CD137 research. These centers conduct first-in-human trials and manage immune-related toxicities using real-time biomarker tracking.

• Biopharma Developers: Mid-sized biotechs and innovation-driven pharma are leading preclinical discovery and early development, often in partnership with academic or AI discovery platforms.

• Contract Research Organizations (CROs): Handle outsourced clinical execution, especially in Asia, Eastern Europe, and early safety monitoring trials. Growing influence as trial designs become more complex.

• Specialty Oncology Clinics: Expected to play a greater role post-approval, especially for combination use cases and outpatient immunotherapy regimens. Still in the observation phase today.

Academic institutions and CROs account for the majority of current CD137 end-use, but as combination therapies mature, specialty clinics will become critical access points.

 

By Region

• North America: Dominates in trial activity, with the U.S. leading in IND approvals, trial networks, and translational immuno-oncology programs. FDA fast-track mechanisms are a key accelerant here.

• Europe: Active but cautious. Countries like Germany, UK, and Netherlands are involved in Phase I trials via EU partnerships. The EMA is monitoring CD137 innovation but maintains strict safety protocols post-urelumab.

• Asia Pacific: Fastest-growing region. China and South Korea are investing heavily in domestic CD137 R&D, especially in tumor types prevalent in Asia (HCC, gastric cancer). Japan and Singapore are emerging players in adaptive trial execution.

• Latin America & Middle East & Africa (LAMEA): Currently low activity, with limited trial access and slower regulatory pathways. Some participation in preclinical research and CRO work, but broader adoption is years away.

North America remains the clinical engine, while Asia Pacific is the scale-up region — driven by government funding, disease burden, and trial speed.

 

Market Trends And Innovation Landscape

The CD137 antibody market is shifting from academic exploration to early-stage translational acceleration. The innovation landscape here is defined less by scale and more by scientific specificity — with a steady stream of refinements aimed at solving one major problem: how to safely unlock CD137’s powerful co-stimulatory signal without triggering systemic toxicity.

One of the most notable trends is the move toward tumor -selective activation. Early CD137 monoclonal antibodies like urelumab showed strong T-cell activation but also came with dose-limiting hepatotoxicity. In response, developers are now designing conditionally active antibodies — such as bispecifics that only activate in the presence of a tumor marker or localized cytokine environment. These next-gen molecules aim to narrow the therapeutic window in a way that’s safer, especially for solid tumors like liver and pancreatic cancer.

 

A second trend is the rise of bispecific and multi-specific antibodies. Several biopharma startups are developing fusion formats that link CD137 to tumor -associated antigens or other checkpoint targets. These formats — including CD137 × PD-L1, CD137 × HER2, and even trispecific antibodies — are designed to reduce off-target activation and provide synergistic immune stimulation. For example, one pipeline candidate pairs CD137 activation with HER2-targeting in HER2+ breast cancer, aiming to turn “cold” tumors hot.

 

There’s also momentum around Fc engineering and receptor clustering techniques. New CD137 constructs are being engineered to activate only when crosslinked within the tumor microenvironment — a strategy that leverages innate immune cells to cluster antibody- receptor complexes and avoid systemic engagement. These innovations are still mostly in preclinical stages but could represent a safer pathway forward.

 

On the tech partnership front, there’s a growing number of collaborations between CD137 developers and AI-enabled discovery platforms. Machine learning is being used to model receptor binding kinetics, predict immune activation thresholds, and simulate cytokine release scenarios before animal testing begins. These predictive models are reducing development cycles and improving candidate selection.

 

Another emerging area is the integration of CD137 antibodies into personalized immunotherapy pipelines. In some early trials, CD137 agonists are being layered on top of tumor vaccines or neoantigen therapies to enhance memory T-cell formation. This could open a path toward more durable responses, especially in cancers that show initial checkpoint resistance.

 

In terms of clinical design, the market is seeing more basket trials and adaptive trial structures. Given the diversity of tumor types under investigation, sponsors are opting for platform trials that can simultaneously test a CD137 agent across multiple cohorts — including combination arms with PD-1, CTLA-4, and even radiation therapy.

 

According to one principal investigator involved in a U.S.-based Phase I trial, “CD137 is no longer just a curiosity — it's becoming a tool. The challenge is controlling the volume without shutting off the music.”

 

Competitive Intelligence And Benchmarking

The CD137 antibody market may still be in its clinical infancy, but the competitive landscape is already taking shape — and it’s not dominated by pharma giants. Instead, this space is led by a mix of mid-sized biotechs, early-stage immuno-oncology platforms, and select global pharma firms willing to experiment at the edge of immune activation.

Pfizer

Pfizer is one of the few large-cap players with a direct CD137 program. While early efforts with urelumab faced toxicity hurdles, the company has since re-entered the space with combination trials and alternative dosing strategies. Its broad immuno-oncology network and co-development alliances give it an edge when navigating combination regimens across PD-1 and CTLA-4 backbones.

 

Aurigene Oncology and Enumeral Biomedical

Aurigene Oncology and Enumeral Biomedical were among the earliest biotechs exploring CD137, but the more recent innovation leadership has shifted toward companies like Apexigen, Sotio Biotech, and iTeos Therapeutics. These firms are developing CD137 constructs with Fc engineering, tumor -localized activation, or bispecific frameworks — often in parallel with internal PD-1/PD-L1 programs.

 

Genmab

Genmab, known for its strong bispecific antibody platform, is collaborating with BioNTech on an agonistic CD137 bispecific candidate that engages both 4-1BB and tumor -associated antigens. The strategy is to limit systemic activation and deliver targeted co-stimulation where it's most needed — inside the tumor bed.

 

Bristol Myers Squibb

Bristol Myers Squibb, despite pulling back on earlier CD137 efforts due to toxicity concerns, continues to monitor the space and may re-enter with next-gen formats once safety profiles improve. Their broader checkpoint portfolio gives them a potential springboard for CD137 inclusion, especially in tumor types that respond poorly to PD-1 monotherapy.

 

Leap Therapeutics

Leap Therapeutics is positioning itself around DKN-01 (an anti-DKK1 antibody) but has also expressed interest in co-stimulatory combinations. The company is reportedly exploring CD137 agonists as part of its long-term development roadmap.

 

Xilio Therapeutics

Xilio Therapeutics is developing tumor -activated cytokines and antibodies, including a tumor -activated anti-CD137 agent designed to minimize systemic exposure. Their pipeline is tightly focused on achieving local activity while avoiding the liver toxicity seen in first-generation agonists.

 

From a strategic perspective, most of these players are not betting on CD137 as a standalone drug. Instead, they see it as a key amplifier within combination immunotherapy, particularly for patients who’ve failed first-line checkpoint inhibitors. Companies are increasingly using CD137 antibodies as a way to reactivate exhausted T cells or deepen responses in otherwise low-infiltrated tumors.

 

What differentiates the top competitors isn’t just molecule design — it’s trial strategy. The most credible players are those running adaptive early-phase studies, using translational biomarkers, and co-developing with PD-1 or vaccine platforms to mitigate risk and demonstrate synergy.

 

Regional Landscape And Adoption Outlook

The adoption trajectory for CD137 antibodies varies significantly by region, largely because of differences in clinical trial infrastructure, regulatory pathways, and investment appetite for early immuno-oncology assets. This isn’t a market where commercial rollouts are the current focus — it’s still a development-stage race. But even at this stage, regional patterns are starting to emerge.

North America

North America remains the epicenter of CD137 clinical activity. The United States accounts for the highest number of active early-phase trials, driven by a deep network of academic cancer centers, immuno-oncology consortiums, and venture-backed biotechs. Institutions like MD Anderson, Memorial Sloan Kettering, and Dana-Farber are running or supporting Phase I/II trials, often in combination with PD-1 inhibitors or tumor vaccines. The FDA, while cautious, has created regulatory pathways — including Fast Track and Breakthrough Therapy designations — that may apply to certain CD137-based therapies, especially those targeting high-unmet-need solid tumors.

 

Europe

In Europe, adoption is more cautious but still growing. Countries like Germany, the UK, and the Netherlands are participating in multicenter trials, typically through EU-funded consortia or biotech-pharma collaborations. The EMA has not yet approved any CD137-specific agents, but it is actively reviewing immuno-stimulatory checkpoint pathways under broader oncology frameworks. One challenge here is the region’s strict safety thresholds — early CD137 candidates with liver toxicity profiles had difficulty advancing in European trials. That said, next-gen bispecifics and conditional activators are rekindling institutional interest.

 

Asia Pacific

Asia Pacific is emerging as the fastest-growing region in this space. China, in particular, has ramped up its CD137 research footprint. Biotechs based in Shanghai, Shenzhen, and Hong Kong are conducting preclinical work on tumor -selective 4-1BB antibodies — often in collaboration with local academic centers. Regulatory agencies like China’s NMPA are showing increasing flexibility, particularly for assets targeting underserved cancers or backed by dual-mechanism rationales. South Korea and Singapore are also supporting early-stage trials through public-private hospital networks, while Japan is beginning to explore CD137 as part of broader combination immunotherapy programs.

One regional distinction in Asia is the emphasis on local tumor types. For instance, CD137 antibodies are being explored in hepatocellular carcinoma (HCC), nasopharyngeal carcinoma, and certain gastric cancers — areas where standard checkpoint inhibitors have shown only limited results. These regional disease burdens are driving demand for more aggressive immune activation strategies.

 

Latin America and the Middle East & Africa (MEA)

Latin America and the Middle East & Africa (MEA) currently play a minimal role in the CD137 development pipeline. A few Phase I trials have involved patient cohorts in Brazil or South Africa, but these are exceptions. Most sponsors in these regions are focused on traditional checkpoint pathways like PD-1 and CTLA-4, given their broader commercial viability and regulatory familiarity. That said, regional CROs and university labs are increasingly being tapped for preclinical studies, especially in low-cost animal models or biomarker validation work.

 

From a forward-looking standpoint, North America will remain the clinical engine, but Asia Pacific is where scale and diversification are building fastest. Europe will continue to serve as a high-bar regulatory environment, pushing companies to refine their safety and selectivity strategies.

 

End-User Dynamics And Use Case

Unlike mature therapeutic classes, where adoption is driven by broad prescribing behaviors, the CD137 antibody market is still deeply rooted in specialist-driven ecosystems — mainly oncology research hubs, academic trial centers, and early-phase biopharma collaborators. Here, “end-user” doesn’t necessarily mean the prescribing clinician — it means the trial operator, translational scientist, or immunotherapy decision-maker.

The most engaged users today are academic cancer centers, particularly those with immuno-oncology trial units and translational research programs. These institutions are critical not only for running Phase I studies, but also for generating mechanistic insights through tissue biopsies, cytokine monitoring, and T-cell profiling. Centers like Dana-Farber, City of Hope, and Gustave Roussy are deeply involved in evaluating how CD137 antibodies interact with the tumor microenvironment — and how they can be safely layered with other therapies.

 

Specialty oncology clinics will eventually play a role, but only once CD137 agents clear Phase II and start approaching conditional approvals. These clinics will be especially relevant for combination regimens, where familiarity with complex immune-related adverse event management is key. Until then, most remain outside the immediate adoption curve.

 

Biopharma R&D divisions and clinical-stage biotech companies are also core users — not of the therapies themselves, but of the CD137 antibody platform as a development tool. They’re the ones designing fusion constructs, running mouse models, and partnering with contract development and manufacturing organizations (CDMOs) to scale the production of investigational batches. For many of these companies, CD137 is part of a multi-pronged immunotherapy strategy — not a standalone bet, but a key cog in a wider co-stimulation roadmap.

 

Contract research organizations (CROs) have also become a quiet but crucial part of the CD137 end-user picture. As more companies outsource Phase I/II trials to CROs with immuno-oncology expertise, these vendors are gaining a deeper understanding of the operational and safety complexities involved. Their influence may grow further as CD137 trials expand into Asia and Eastern Europe.

 

Use Case Highlight

A leading cancer research hospital in South Korea recently initiated a multi-arm trial testing a tumor -targeted CD137 bispecific antibody in advanced hepatocellular carcinoma (HCC). These patients had already failed sorafenib and showed limited response to PD-1 inhibitors. The trial used an adaptive protocol — escalating doses only in patients whose tumors expressed both the CD137 activation ligand and a local T-cell infiltration signature. Preliminary results showed that tumor -localized activation reduced systemic cytokine spikes, and at least two patients demonstrated partial response within six weeks. The hospital is now considering expansion cohorts for gastric and biliary tract cancers, both of which are prevalent in the region.

 

This use case illustrates the real-world complexity of CD137 antibody deployment: It’s not just about the drug. It’s about biomarkers, dose modulation, and patient selection — all of which must be tightly controlled in early-stage settings.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• Xilio Therapeutics initiated a first-in-human trial in 2023 for its tumor -activated anti-CD137 monoclonal antibody, designed to activate only in the tumor microenvironment to minimize systemic toxicity.

• Genmab and BioNTech announced a joint development program in 2024 for a bispecific antibody targeting CD137 and a tumor -associated antigen, aimed at improving T-cell activation specifically within solid tumors.

• Pfizer resumed exploratory clinical work on CD137 in 2023 after shelving urelumab due to safety concerns; its new program focuses on low-dose combinations with PD-1 inhibitors in resistant tumor types.

• iTeos Therapeutics expanded its CD137 preclinical program by acquiring a proprietary Fc-engineering platform that allows conditional immune activation, targeting hepatocellular and head and neck cancers.

• Sotio Biotech received clearance for a Phase I trial in the EU for its CD137-FAP bispecific antibody candidate, intended for use in fibroblast-rich tumors like pancreatic and colorectal cancer.

 

Opportunities

• Tumor -Selective Activation Platforms:
  The rise of conditionally active or tumor -restricted CD137 constructs is opening new doors in previously inaccessible tumor types where systemic activation was unsafe.

• Combination Therapy Expansion:
  CD137 agonists are gaining traction as synergistic agents in dual and triple checkpoint blockade regimens, especially for checkpoint-resistant tumors.

• Emerging Market R&D:
  Countries like China and South Korea are heavily investing in domestic CD137 programs, offering licensing and joint development opportunities for Western biotechs.

 

Restraints

• Dose-Limiting Toxicity Risk:
  Despite engineering advances, hepatotoxicity and cytokine release remain major hurdles in full agonist CD137 programs, especially at higher doses or in poorly selected patient groups.

• Lack of Predictive Biomarkers:
  The absence of validated biomarkers for patient stratification complicates trial design and slows down enrollment, particularly in basket or combination studies.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 782 Million
Revenue Forecast in 2030	USD 1.43 Billion
Overall Growth Rate	CAGR of 10.6% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Type, Application, Development Stage, End User, Geography
By Type	Monoclonal Antibodies, Bispecific Antibodies, Fc-Engineered Variants
By Application	Solid Tumors, Hematologic Malignancies, Combination Immunotherapy
By Development Stage	Preclinical, Phase I, Phase II, Phase III
By End User	Academic Cancer Centers, Biopharma Companies, CROs, Specialty Oncology Clinics
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Germany, U.K., China, Japan, South Korea, Brazil
Market Drivers	• Rising demand for co-stimulatory immune checkpoint pathways • Expansion of combination immunotherapy trials • Technological advancements in bispecific antibody platforms
Customization Option	Available upon request