Report Description Table of Contents Introduction And Strategic Context The Global CD137 Antibody Market is valued at USD 782 million in 2024 and is projected to reach USD 1.43 billion by 2030, expanding at a strong 10.6% CAGR, driven by advances in immuno-oncology, bispecific antibodies, tumor-selective immune activation, and combination checkpoint therapies, 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. Comprehensive Market Snapshot 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. The USA CD137 Antibody Market, accounting for 31% of the global market, was valued at approximately USD 242.4 million in 2024 and is projected to expand at a healthy 9.3% CAGR, reaching around USD 412.9 million by 2030. The Europe CD137 Antibody Market, representing 24% of the global share, stood at nearly USD 187.7 million in 2024 and is expected to grow at an 8.4% CAGR, reaching approximately USD 304.5 million by 2030. The APAC CD137 Antibody Market, holding 15% of the global market, was valued at about USD 117.3 million in 2024 and is forecast to grow at the fastest regional pace of 11.5% CAGR, reaching roughly USD 225.4 million by 2030. Market Segmentation Insights By Type of Antibody Monoclonal Antibodies (Agonistic mAbs) held the largest market share of approximately 49% in 2024, reflecting their first-mover advantage in early clinical development, with an estimated market value of around USD 383 million. Bispecific Antibodies (e.g., CD137 x PD-L1, CD137 x HER2) accounted for about 33% share in 2024, translating to an estimated value of approximately USD 258 million, and are projected to grow at the fastest CAGR during 2024–2030, driven by tumor-selective immune activation strategies and improved safety profiles. Fc-Engineered or Conditional Antibodies represented roughly 18% of the global market in 2024, valued at approximately USD 141 million, supported by innovation in receptor clustering, TME-responsive switches, and Fc-optimization approaches. By Application Solid Tumors represented the highest application share of approximately 68% in 2024, supported by active clinical programs in HCC, NSCLC, TNBC, and HNSCC, corresponding to a market value of around USD 532 million. Hematologic Malignancies accounted for about 18% of the market in 2024, translating to an estimated value of approximately USD 141 million, primarily driven by early-phase bispecific and trispecific platform exploration. Combination Immunotherapy captured around 14% share in 2024, with a market value of about USD 109 million, and is expected to grow at the strongest CAGR through 2030 due to increasing co-formulation strategies with PD-1/PD-L1 and CTLA-4 inhibitors. By Development Stage Preclinical Programs dominated the pipeline with approximately 46% share in 2024, reflecting experimental agonists and next-generation conditional designs, equivalent to about USD 360 million in development-stage allocation. Phase I Trials accounted for nearly 34% of the market in 2024, translating to an estimated value of approximately USD 266 million, supported by dose-escalation and safety validation studies. Phase II Trials represented about 20% share in 2024, valued at approximately USD 156 million, and are projected to expand at a notable CAGR as select tumor-targeted programs advance. Phase III Trials currently hold 0% share in 2024, reflecting the early-stage nature of the CD137 therapeutic landscape. By End User Academic Cancer Centers represented the largest end-user segment with approximately 42% share in 2024, reflecting their leadership in first-in-human trials and immune-related toxicity management, corresponding to about USD 328 million. Biopharma Developers accounted for around 31% share in 2024, valued at approximately USD 242 million, driven by preclinical innovation and translational oncology partnerships. Contract Research Organizations (CROs) held roughly 17% of the market in 2024, translating to an estimated value of approximately USD 133 million, supported by outsourced clinical execution and biomarker monitoring services. Specialty Oncology Clinics represented about 10% share in 2024, valued at approximately USD 78 million, and are expected to witness accelerated growth through 2024–2030 as combination regimens move closer to commercialization. Strategic Questions Driving the Next Phase of the Global CD137 Antibody Market What therapeutic formats, molecular designs, and clinical indications are explicitly included within the CD137 Antibody Market, and which immune-stimulatory platforms fall outside its defined scope? How does the CD137 Antibody Market differ structurally from adjacent immuno-oncology segments such as PD-1/PD-L1 inhibitors, CTLA-4 inhibitors, and other co-stimulatory checkpoint targets (e.g., OX40, GITR)? What is the current and forecasted size of the Global CD137 Antibody Market, and how is value distributed across antibody formats and development stages? How is investment and pipeline value allocated between monoclonal agonists, bispecific constructs, and Fc-engineered or conditional antibodies, and how is this mix expected to evolve through 2030? Which therapeutic areas (e.g., solid tumors, hematologic malignancies, combination immunotherapy settings) represent the largest and fastest-growing opportunity pools? Which CD137 platforms contribute disproportionately to long-term value creation based on safety optimization, tumor selectivity, and combination compatibility rather than sheer trial volume? How does clinical demand differ between checkpoint-resistant tumors, immune-cold microenvironments, and earlier-line therapy settings, and how does this influence CD137 positioning? How are CD137 antibodies being integrated into first-line, second-line, and salvage immunotherapy regimens within evolving oncology treatment pathways? What role do combination durability, response depth, and immune-related adverse event management play in long-term commercial viability? How are cancer prevalence trends, biomarker-driven patient selection, and access to advanced oncology centers shaping demand across geographies? What clinical, safety, or regulatory hurdles — particularly hepatotoxicity concerns from earlier-generation agonists — continue to limit broader advancement? How do pricing expectations, reimbursement readiness, and value-based oncology frameworks influence potential revenue realization once approvals occur? How robust is the global CD137 development pipeline, and which emerging mechanisms (e.g., tumor-conditional activation, receptor clustering strategies, dual-target bispecifics) are most likely to define the next wave of innovation? To what extent will next-generation CD137 platforms expand the treated population versus compete within already crowded immunotherapy regimens? How are advances in antibody engineering, Fc-modification, and tumor microenvironment-responsive switches improving therapeutic index and safety margins? How might intellectual property positioning and platform patents influence competitive dynamics across monoclonal and bispecific segments? What role could future biosimilar or follow-on biologic pathways play once first-generation CD137 agents reach commercialization? How are leading biopharma companies structuring partnerships, co-development agreements, and regional trial strategies to accelerate CD137 programs? Which geographic regions — including North America, Europe, and Asia Pacific — are expected to drive pipeline acceleration, trial enrollment, and eventual commercialization leadership? How should biotech innovators and investors prioritize specific antibody formats, combination strategies, and regional development hubs to maximize long-term clinical and financial returns in the CD137 Antibody Market? Segment-Level Insights and Market Structure - CD137 Antibody Market The CD137 Antibody Market is organized around antibody engineering formats, therapeutic application areas, clinical development stages, and institutional end users. Unlike fully commercialized oncology drug markets, CD137 remains largely pipeline-driven, meaning segment dynamics are shaped more by trial design, safety optimization, and platform innovation than by prescription volume. Each segment reflects a different strategic approach to activating the CD137 (4-1BB) co-stimulatory pathway while balancing efficacy and immune-related toxicity risk. Type of Antibody Insights Monoclonal Agonistic Antibodies Monoclonal CD137 agonists represent the earliest generation of this therapeutic class. These antibodies directly stimulate T-cell activation through systemic CD137 engagement. Their development established proof-of-concept for immune amplification but also highlighted safety constraints, particularly dose-limiting liver toxicity in earlier programs. From a structural perspective, this segment anchors the scientific foundation of the market and continues to inform next-generation design improvements. Although innovation has shifted toward more selective formats, monoclonal agonists remain relevant in early-phase trials and mechanistic exploration. Bispecific Antibodies Bispecific CD137 antibodies are engineered to engage CD137 alongside a tumor-associated antigen or checkpoint pathway, such as PD-L1 or HER2. This design restricts immune activation to the tumor microenvironment, improving selectivity and reducing systemic immune stimulation. Strategically, bispecific constructs represent the fastest-evolving segment of the market. They align closely with combination immunotherapy paradigms and are increasingly favored in development pipelines seeking a better therapeutic index. As safety optimization becomes central to clinical advancement, bispecific formats are positioned to capture growing strategic value. Fc-Engineered or Conditional Antibodies This segment includes antibodies modified at the Fc region or designed with tumor microenvironment-responsive activation mechanisms. These constructs may rely on receptor clustering, cytokine co-modulation, or conditional activation switches that become active only under specific biological conditions. From a development standpoint, Fc-engineered and conditional antibodies represent the innovation frontier of CD137 targeting. They aim to preserve immune activation potency while minimizing off-target effects, making them critical to the long-term viability of this therapeutic class. Application Insights Solid Tumors Solid tumors represent the primary therapeutic focus within the CD137 Antibody Market. Indications such as hepatocellular carcinoma, non-small cell lung cancer, triple-negative breast cancer, and head and neck cancers are common targets due to suboptimal response rates to standalone checkpoint inhibitors. CD137 agonism is frequently explored in these settings as a strategy to amplify T-cell activation in immune-resistant tumor environments. As a result, this segment accounts for the majority of development activity and shapes overall market direction. Hematologic Malignancies CD137 antibodies are also being investigated in lymphomas and leukemias, particularly in combination with bispecific or trispecific immune-engaging platforms. While smaller in pipeline volume compared to solid tumors, this segment offers a biologically favorable environment for immune modulation due to the accessibility of malignant cells within circulation or lymphatic tissue. Hematologic applications are strategically important for validating mechanistic efficacy in controlled immune contexts. Combination Immunotherapy Combination therapy represents a cross-cutting segment rather than a single indication. CD137 antibodies are frequently paired with PD-1/PD-L1 inhibitors, CTLA-4 blockers, tumor vaccines, or radiotherapy. This strategy addresses checkpoint resistance and immune-cold tumor microenvironments. Over time, combination regimens are expected to become the dominant clinical positioning strategy for CD137 agents, particularly as standalone systemic activation approaches prove limited by safety thresholds. Development Stage Insights Preclinical Programs The preclinical segment reflects the research-intensive nature of the CD137 market. Biotech firms and academic laboratories are actively designing tumor-selective agonists, Fc-modified antibodies, and multi-specific constructs. Innovation at this stage is driven by computational antibody modeling, biomarker discovery, and receptor clustering research. The preclinical segment shapes long-term market potential by determining which formats can overcome historical toxicity challenges. Phase I Trials Phase I programs focus primarily on dose-escalation, safety profiling, and preliminary efficacy signals. Given the pathway’s immune-activating mechanism, safety remains the principal gating factor. Tumor-selective and bispecific formats dominate early clinical trials, reflecting the shift toward localized immune stimulation strategies. Phase II Trials Phase II development emphasizes proof-of-efficacy within specific tumor types or combination regimens. Although relatively limited in number, Phase II programs are critical for validating whether next-generation constructs can achieve meaningful clinical benefit without replicating earlier toxicity concerns. Phase III Trials No CD137 antibody has yet reached late-stage Phase III validation, underscoring the developmental nature of this market. The absence of pivotal-stage assets reflects both scientific opportunity and regulatory caution, positioning this segment as a future inflection point. Segment Evolution Perspective The CD137 Antibody Market is transitioning from proof-of-concept systemic agonism toward precision-engineered, tumor-selective immune activation platforms. Early monoclonal constructs established biological feasibility but revealed safety boundaries that now guide innovation. Bispecific and conditional formats are redefining how CD137 stimulation is delivered, emphasizing localization and controlled activation. At the same time, application focus is consolidating around combination immunotherapy in resistant solid tumors, while development-stage concentration remains skewed toward preclinical and early-phase trials. As regulatory pathways evolve and safety optimization advances, value distribution across segments is expected to shift from foundational monoclonal approaches toward next-generation engineered platforms. 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. 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 Frequently Asked Question About This Report Q1: How big is the CD137 antibody market? A1: The global CD137 antibody market is valued at USD 782 million in 2024. Q2: What is the CAGR for the CD137 antibody market during the forecast period? A2: The market is projected to grow at a CAGR of 10.6% between 2024 and 2030. Q3: Who are the major players in the CD137 antibody market? A3: Key players include Pfizer, Genmab, Xilio Therapeutics, BioNTech, iTeos Therapeutics, and Sotio Biotech. Q4: Which region leads the CD137 antibody market in terms of clinical activity? A4: North America, particularly the U.S., leads due to its strong immuno-oncology research ecosystem and regulatory flexibility. Q5: What’s driving interest in CD137 antibodies? A5: Growth is fueled by rising demand for co-stimulatory immunotherapies, emerging combination treatment strategies, and advancements in bispecific antibody engineering. Table of Contents – Global CD137 Antibody Market Report (2024–2030) Executive Summary Market Overview Market Attractiveness by Type of Antibody, Application, Development Stage, End User, and Region Strategic Insights from Key Executives (CXO Perspective) Historical Market Size and Future Projections (2019–2030) Summary of Market Segmentation by Type of Antibody, Application, Development Stage, End User, and Region Market Share Analysis Leading Players by Revenue and Market Share Market Share Analysis by Type of Antibody, Application, and Development Stage Investment Opportunities in the CD137 Antibody Market Key Developments and Innovations Mergers, Acquisitions, and Strategic Partnerships High-Growth Segments for Investment Market Introduction Definition and Scope of the Study Market Structure and Key Findings Overview of Top Investment Pockets Research Methodology Research Process Overview Primary and Secondary Research Approaches Market Size Estimation and Forecasting Techniques Market Dynamics Key Market Drivers Challenges and Restraints Impacting Growth Emerging Opportunities for Stakeholders Impact of Regulatory and Technological Factors Biomarker Development and Clinical Validation Barriers Global CD137 Antibody Market Analysis Historical Market Size and Volume (2019–2023) Market Size and Volume Forecasts (2024–2030) Market Analysis by Type of Antibody: Monoclonal Antibodies (Agonistic mAbs) Bispecific Antibodies (CD137 x PD-L1, CD137 x HER2, Others) Fc-Engineered or Conditional Antibodies Market Analysis by Application: Solid Tumors Hematologic Malignancies Combination Immunotherapy Market Analysis by Development Stage: Preclinical Phase I Phase II Phase III Market Analysis by End User: Academic Cancer Centers Biopharma Developers Contract Research Organizations (CROs) Specialty Oncology Clinics Market Analysis by Region: North America Europe Asia Pacific Latin America Middle East & Africa Regional Market Analysis North America CD137 Antibody Market Analysis Historical Market Size and Volume (2019–2023) Market Size and Volume Forecasts (2024–2030) Market Analysis by Type of Antibody, Application, Development Stage, and End User Country-Level Breakdown United States Canada Mexico Europe CD137 Antibody Market Analysis Historical Market Size and Volume (2019–2023) Market Size and Volume Forecasts (2024–2030) Market Analysis by Type of Antibody, Application, Development Stage, and End User Country-Level Breakdown Germany United Kingdom France Italy Spain Rest of Europe Asia Pacific CD137 Antibody Market Analysis Historical Market Size and Volume (2019–2023) Market Size and Volume Forecasts (2024–2030) Market Analysis by Type of Antibody, Application, Development Stage, and End User Country-Level Breakdown China Japan South Korea India Rest of Asia Pacific Latin America CD137 Antibody Market Analysis Historical Market Size and Volume (2019–2023) Market Size and Volume Forecasts (2024–2030) Market Analysis by Type of Antibody, Application, Development Stage, and End User Country-Level Breakdown Brazil Argentina Rest of Latin America Middle East & Africa CD137 Antibody Market Analysis Historical Market Size and Volume (2019–2023) Market Size and Volume Forecasts (2024–2030) Market Analysis by Type of Antibody, Application, Development Stage, and End User Country-Level Breakdown GCC Countries South Africa Rest of Middle East & Africa Competitive Intelligence and Benchmarking Leading Key Players: Pfizer Genmab BioNTech Xilio Therapeutics Sotio Biotech iTeos Therapeutics Apexigen Aurigene Oncology Competitive Landscape and Strategic Insights Benchmarking Based on Antibody Format, Safety Profile, and Combination Strategy Appendix Abbreviations and Terminologies Used in the Report References and Sources List of Tables Market Size by Type of Antibody, Application, Development Stage, End User, and Region (2024–2030) Regional Market Breakdown by Segment Type (2024–2030) List of Figures Market Drivers, Challenges, and Opportunities Regional Market Snapshot Competitive Landscape by Market Share Growth Strategies Adopt by Key Players Market Share by Type of Antibody and Application (2024 vs 2030)