Immuno-oncology Market
By Treatment Type;
Immune Checkpoint Inhibitors, Immune System Modulators, Cancer Vaccines, Oncolytic Virus, and OthersBy Disease Type;
Melanoma, Lung Cancer, Blood Cancers, Renal Cell Carcinoma, Prostate Cancer, Bladder Cancer, and OthersBy End User;
Hospitals, Clinics and Ambulatory Surgical CentersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Immuno-Oncology Market Overview
Immuno-Oncology Market (USD Million)
Immuno-Oncology Market was valued at USD 61,378.77 million in the year 2024. The size of this market is expected to increase to USD 131,587.58 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 11.5%.
Immuno-oncology Market
*Market size in USD million
CAGR 11.5 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 11.5 % |
Market Size (2024) | USD 61,378.77 Million |
Market Size (2031) | USD 131,587.58 Million |
Market Concentration | Low |
Report Pages | 315 |
Major Players
- Bristol Myers Squibb (US)
- Novartis (Switzerland)
- F. Hoffmann-La Roche Ltd (Switzerland)
- Merck & Co., Inc. (US)
- GSK (UK)
- Eli Lilly and Company (US)
- Fresenius Kabi Schweiz (Germany)
- Pfizer (US)
- AbbVie . (US)
- Genentech (US)
- Sanofi (France)
- AstraZeneca (UK)
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Immuno-oncology Market
Fragmented - Highly competitive market without dominant players
The Immuno-Oncology Market is redefining how cancer is treated by enhancing the immune system’s ability to recognize and destroy malignant cells. Over 60% of cancer-related research is now focused on immunotherapy, showcasing its rapid integration into mainstream oncology. Techniques such as immune checkpoint inhibitors and cancer vaccines are reshaping therapeutic approaches.
Marked Improvement in Patient Outcomes
The effectiveness of immuno-oncology therapies continues to improve, with response rates reaching as high as 45% for certain hard-to-treat cancers. These outcomes are leading to broader adoption across treatment centers, supported by growing trust among healthcare providers in immune-targeted interventions.
Intensifying R&D Activity
With more than 55% of biopharma R&D spending dedicated to immuno-oncology, the market is witnessing a surge in innovation. A substantial number of new candidates, particularly combination therapies and biologics, are advancing through the clinical pipeline, supported by an increasing number of early-phase trials.
Strengthening Market Reach Across Cancer Types
Immuno-oncology is now widely used in both hematologic and solid tumors, with penetration in solid tumor therapies rising above 40%. Its growing role in treatment regimens highlights a shift toward immune-based, precision therapies that are rapidly replacing conventional methods.
Immuno-Oncology Market Recent Developments
-
In September 2022, the U.S. FDA approved Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selecting patients. This approval focused on individuals with RET,fusion positive locally advanced or metastatic non,small cell lung cancer (NSCLC), RET,fusion positive advanced or metastatic thyroid cancer, and RET,mutation positive advanced or metastatic medullary thyroid cancer (MTC), who may be eligible for treatment with Lilly's Retevmo (selpercatinib).
-
In June 2022, Agilent Technologies Inc. received approval from the South Korea Ministry of Food and Drug Safety (MFDS) for its PD,L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non,small cell lung cancer (NSCLC). This diagnostic was deemed suitable for first,line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform.
Immuno-oncology Market Segment Analysis
In this report, the Immuno-oncology Market has been segmented by Treatment Type, Disease Type, End User, and Geography.
Immuno-oncology Market, Segmentation by Treatment Type
The Immuno-oncology Market has been segmented by Treatment Type into Immune Checkpoint Inhibitors, Immune System Modulators, Cancer Vaccines, Oncolytic Virus, and Others.
Immune Checkpoint Inhibitors
Immune checkpoint inhibitors are among the most advanced and effective treatments in oncology, enabling the immune system to recognize and attack tumors. Drugs targeting PD-1, PD-L1, and CTLA-4 have gained FDA approval and market traction. Their success in treating various cancers like melanoma and lung cancer drives rapid adoption. Increased clinical trials and regulatory approvals are accelerating market expansion.
Immune System Modulators
Immune system modulators adjust immune responses to enhance anti-tumor activity. These include cytokines, interleukins, and toll-like receptor agonists. Their use is expanding in combination with checkpoint therapies. As research continues, new modulators are emerging that improve tumor microenvironment targeting and reduce immune escape. This segment benefits from increased funding in immunotherapy R&D.
Cancer Vaccines
Cancer vaccines are designed to trigger an immune response against tumor-specific antigens. While historically slower to commercialize, newer platforms such as mRNA-based and peptide-based vaccines are gaining attention. Personalized vaccines are also emerging for individual tumor profiles. Collaborations between biotech firms and academic centers are supporting innovation in this space.
Oncolytic Virus
Oncolytic viruses selectively infect and destroy cancer cells while stimulating systemic immune response. FDA-approved therapies like T-VEC have validated this approach. The segment is growing due to advancements in viral engineering and intratumoral delivery. Research is increasingly focused on combining oncolytic viruses with other immunotherapies for synergistic effects.
Others
This category includes next-generation therapies such as adoptive T-cell transfer, bispecific antibodies, and immune agonists. These approaches offer novel mechanisms of action and are often tailored to specific cancer types. Continued breakthroughs in cell-based immunotherapy are expected to transform the landscape of cancer treatment. Investments in biotech startups are fueling growth in this frontier segment.
Immuno-oncology Market, Segmentation by Disease Type
The Immuno-oncology Market has been segmented by Disease Type into Melanoma, Lung Cancer, Blood Cancers, Renal Cell Carcinoma, Prostate Cancer, Bladder Cancer, and Others.
Melanoma
Melanoma was the first cancer to demonstrate remarkable results with checkpoint inhibitors. Treatments targeting PD-1 and CTLA-4 have become standard of care. Early-stage and metastatic melanoma cases are now widely treated using immunotherapy. Ongoing research into resistance mechanisms and adjuvant therapy supports growth in this segment.
Lung Cancer
Lung cancer, particularly non-small cell lung cancer (NSCLC), has shown significant improvement with immunotherapy. Combination regimens with chemotherapy or targeted drugs enhance survival outcomes. Expanding screening programs and biomarker-based selection are propelling market demand. Clinical adoption is robust across both first-line and second-line treatments.
Blood Cancers
Blood cancers such as leukemia, lymphoma, and multiple myeloma benefit from cell therapies and monoclonal antibodies. CAR-T therapy has revolutionized treatment for relapsed cases. The segment is bolstered by clinical trial momentum and promising pipeline candidates. Advances in immune profiling are enabling more precise therapy choices.
Renal Cell Carcinoma
Immuno-oncology has reshaped the management of renal cell carcinoma, with checkpoint inhibitors replacing older targeted agents. Combination strategies with VEGF inhibitors and immunotherapies have shown superior efficacy. Regulatory approvals and improved response rates contribute to steady market expansion. Patients increasingly benefit from longer survival and manageable side effects.
Prostate Cancer
While prostate cancer has been less responsive to immunotherapy, innovative combinations are being explored. Therapeutic cancer vaccines and androgen-targeted approaches show promise. Biomarker-driven trials and tumor microenvironment research are gaining traction. This segment holds long-term potential as immune-based options evolve.
Bladder Cancer
Checkpoint inhibitors are gaining acceptance as first-line and second-line treatments for advanced bladder cancer. PD-L1 expression plays a key role in therapy selection. Clinical trials are expanding into non-muscle-invasive cases. Enhanced survival outcomes and favorable safety profiles are increasing physician confidence in immunotherapy for bladder cancer.
Others
This segment encompasses cancers like head and neck, cervical, gastric, and pancreatic cancers. While immunotherapy efficacy varies, trials show encouraging results in specific subtypes. Broader access to biomarker testing and combination regimens could unlock market potential. Continued drug innovation aims to improve outcomes across these diverse indications.
Immuno-oncology Market, Segmentation by End User
The Immuno-oncology Market has been segmented by End User into Hospitals, Clinics, and Ambulatory Surgical Centers.
Hospitals
Hospitals represent the largest end-user segment due to their capacity to handle complex immuno-oncology therapies. These institutions offer multidisciplinary care, inpatient monitoring, and specialized facilities. Integration of diagnostics and treatment under one roof ensures better patient management. High-volume centers often serve as sites for clinical trials and early adoption of new therapies.
Clinics
Oncology clinics provide outpatient care and are key points for immunotherapy administration. They focus on chemotherapy, infusion services, and biologic treatment regimens. Clinics enable personalized care and frequent follow-ups. As therapies become more targeted and tolerable, clinic-based delivery is expanding, especially in developed healthcare systems.
Ambulatory Surgical Centers
Ambulatory centers are emerging as cost-effective sites for day-care immunotherapy treatments. These facilities offer reduced hospital stays and improved patient convenience. Growth is driven by healthcare cost-containment policies and patient preference for decentralized care. Technological advancements in infusion devices further support adoption in this setting.
Immuno-oncology Market, Segmentation by Geography
In this report, the Immuno-oncology Market has been segmented by Geography into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
Regions and Countries Analyzed in this Report
Immuno-oncology Market Share (%), by Geographical Region
North America
North America holds the largest share of the immuno-oncology market, accounting for approximately 42%. The U.S. leads in innovation, drug approvals, and clinical trials. Strong healthcare infrastructure and high awareness drive widespread adoption of immunotherapies. Reimbursement support and early access programs further stimulate growth in this region.
Europe
Europe contributes nearly 29% to the market, with countries like Germany, France, and the UK at the forefront. Government support for precision medicine and oncology research strengthens the region. Harmonized regulatory pathways and centralized reimbursement policies streamline therapy availability. The region is also seeing rising participation in global cancer trials.
Asia Pacific
The Asia Pacific region represents around 18% of the market and shows the highest growth rate. Rising cancer incidence, improving healthcare infrastructure, and increased clinical trial activity contribute to expansion. Countries such as China, Japan, and South Korea are actively adopting novel cancer therapies. Strategic alliances with global pharma players further enhance access.
Middle East & Africa
This region accounts for about 6% of the market. Countries like UAE, Saudi Arabia, and South Africa are leading adoption of advanced oncology treatments. Growth is driven by government investments in specialty hospitals and medical tourism. However, access disparities and cost barriers persist in some low-income nations.
Latin America
Latin America holds roughly 5% of the market share. Brazil and Mexico are at the forefront, with improving diagnostic capabilities and public-private collaborations. Reimbursement for immunotherapy is gradually expanding. Educational campaigns and physician training programs are helping accelerate adoption across the region.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Immuno-Oncology Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Immunotherapy Advancements
- Rising Cancer Incidence
-
Increased Awareness : Increased awareness of the global immuno-oncology market is driving transformative changes in cancer care, patient advocacy, and healthcare policymaking. With the rising prevalence of cancer worldwide and the growing recognition of immunotherapy's potential to revolutionize cancer treatment, there has been a concerted effort to educate healthcare providers, patients, and the public about the benefits and limitations of immuno-oncology therapies. Healthcare professionals are increasingly integrating immuno-oncology into their clinical practice, staying abreast of the latest research findings, treatment guidelines, and emerging immunotherapy agents. Medical societies, professional organizations, and advocacy groups play a crucial role in disseminating information, organizing educational events, and promoting best practices in immuno-oncology across various cancer types and clinical settings.
Increased awareness of immuno-oncology has empowered patients to become more informed and proactive participants in their cancer care journey. Patients are increasingly seeking information about immunotherapy treatments, clinical trials, and supportive care resources to make well-informed treatment decisions in collaboration with their healthcare providers. Patient advocacy organizations and online support communities provide valuable resources, support networks, and educational materials to help patients navigate their cancer diagnosis, treatment options, and survivorship. By advocating for improved access to immunotherapy treatments, equitable healthcare policies, and patient-centered care models, advocacy groups play a pivotal role in amplifying patient voices and driving positive change in the immuno-oncology landscape.
Increased awareness of immuno-oncology is influencing healthcare policymaking and regulatory decision-making processes globally. Regulatory agencies are adapting their review and approval processes to accommodate the unique challenges and opportunities associated with immunotherapy, ensuring timely access to safe and effective treatments for cancer patients. Policymakers are also recognizing the importance of investing in cancer research, infrastructure, and healthcare workforce development to support the widespread adoption of immuno-oncology and address disparities in cancer care. By fostering collaboration among stakeholders, fostering innovation, and prioritizing patient-centered care, policymakers can contribute to the continued advancement and accessibility of immuno-oncology therapies, ultimately improving outcomes for cancer patients worldwide.
Restraints
- Regulatory hurdles
- Toxicity concerns
-
Resistance mechanisms : Resistance mechanisms represent a significant challenge in the Global Immuno-Oncology Market, impacting the effectiveness of immunotherapy treatments. Despite the remarkable success of immune checkpoint inhibitors and other immunotherapies in some cancer patients, a subset of patients either fail to respond to treatment initially or develop resistance over time. One of the primary resistance mechanisms involves alterations in the tumor microenvironment, such as the upregulation of alternative immune checkpoint pathways, recruitment of immunosuppressive cells (e.g., regulatory T cells, myeloid-derived suppressor cells), and secretion of inhibitory cytokines. These changes create an immunosuppressive milieu that impairs immune cell function and promotes tumor immune evasion, limiting the efficacy of immunotherapy.
Tumor heterogeneity poses another challenge to immuno-oncology treatments, contributing to resistance mechanisms. Within a single tumor or across metastatic lesions, there can be diverse subclones with distinct immunogenic profiles and genetic alterations. Some tumor cells may lack expression of target antigens or major histocompatibility complex molecules, rendering them invisible to the immune system and resistant to immune-mediated destruction. Intratumoral genetic and epigenetic changes can modulate immune recognition and response, leading to immune evasion and treatment resistance. Understanding and overcoming tumor heterogeneity through comprehensive profiling and combination therapies targeting multiple pathways are essential strategies to mitigate resistance in immuno-oncology.
Adaptive resistance mechanisms driven by tumor evolution and immune selection pressure contribute to treatment failure in immuno-oncology. Tumor cells can undergo genetic mutations, epigenetic changes, and clonal evolution in response to immunotherapy, leading to the emergence of resistant clones that evade immune surveillance and continue to proliferate. Dynamic interactions between tumor cells, immune cells, and the tumor microenvironment contribute to the development of acquired resistance. Strategies to overcome adaptive resistance include combination therapies targeting complementary pathways, adaptive treatment strategies based on biomarker monitoring, and the development of next-generation immunotherapies designed to circumvent resistance mechanisms. By unraveling the complex interplay between cancer biology and the immune system, researchers aim to enhance the durability and effectiveness of immuno-oncology treatments and overcome resistance in the quest for improved outcomes for cancer patients.
Opportunities
- Biomarker Discovery
- Combination Therapies
-
Personalized Medicine : Personalized medicine represents a paradigm shift in the approach to cancer treatment, particularly within the global immuno-oncology market. By tailoring treatment strategies to individual patients based on their unique genetic, molecular, and immune profiles, personalized medicine aims to maximize treatment efficacy while minimizing adverse effects. Within immuno-oncology, personalized medicine approaches involve the identification of predictive biomarkers that can help stratify patients based on their likelihood of responding to specific immunotherapy agents. For example, the expression of immune checkpoint proteins such as PD-L1 on tumor cells has been established as a predictive biomarker for response to PD-1/PD-L1 inhibitors in certain cancer types. Molecular profiling techniques such as next-generation sequencing (NGS) are used to identify genetic mutations and other molecular alterations that may influence response to immunotherapy.
The integration of personalized medicine into the global immuno-oncology market has led to the development of companion diagnostic tests designed to identify biomarker-defined patient populations who are most likely to benefit from specific immunotherapy treatments. Companion diagnostics play a critical role in guiding treatment decisions, optimizing therapy selection, and improving patient outcomes by ensuring that the right treatment is delivered to the right patient at the right time. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) play a crucial role in evaluating and approving companion diagnostics for use in conjunction with immunotherapy agents, ensuring their analytical and clinical validity.
The advancement of personalized medicine in immuno-oncology is driving the development of combination therapy approaches aimed at enhancing treatment efficacy and overcoming resistance mechanisms. By combining different immunotherapy agents or combining immunotherapy with other cancer treatments such as chemotherapy, targeted therapy, or radiation therapy, researchers and clinicians aim to leverage synergistic effects and improve patient outcomes. Personalized combination therapies are tailored to the specific characteristics of each patient's tumor and immune microenvironment, allowing for a more precise and comprehensive approach to cancer treatment. As personalized medicine continues to evolve, it holds the potential to revolutionize cancer care by offering more effective and individualized treatment options for patients across a wide range of cancer types.
Competitive Landscape Analysis
Key players in Global Immuno-Oncology Market include:
- Bristol Myers Squibb (US)
- Novartis (Switzerland)
- F. Hoffmann-La Roche Ltd (Switzerland)
- Merck & Co., Inc. (US)
- GSK (UK)
- Eli Lilly and Company (US)
- Fresenius Kabi Schweiz (Germany)
- Pfizer (US)
- AbbVie . (US)
- Genentech (US)
- Sanofi (France)
- AstraZeneca (UK)
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Treatment Type
- Market Snapshot, By Disease Type
- Market Snapshot, By End User
- Market Snapshot, By Region
- Immuno-Oncology Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Immunotherapy Advancements
- Rising Cancer Incidence
- Increased Awareness
- Restraints
- Regulatory hurdles
- Toxicity concerns
- Resistance mechanisms
- Opportunities
- Biomarker Discovery
- Combination Therapies
- Personalized Medicine
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Immuno-Oncology Market, By Treatment Type, 2021 - 2031 (USD Million)
- Immune Checkpoint Inhibitors
- Immune System Modulators
- Cancer Vaccines
- Oncolytic Virus]
- Others
- Immuno-Oncology Market, By Disease Type, 2021 - 2031 (USD Million)
- Melanoma
- Lung Cancer
- Blood Cancers
- Renal Cell Carcinoma
- Prostate Cancer
- Bladder Cancer
- Others
- Immuno-Oncology Market, By End User, 2021 - 2031 (USD Million)
- Hospitals
- Clinics
- Ambulatory Surgical Centers
- Immuno-Oncology Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Immuno-Oncology Market, By Treatment Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Bristol Myers Squibb (US)
- Novartis (Switzerland)
- F. Hoffmann-La Roche Ltd (Switzerland)
- Merck & Co., Inc. (US)
- GSK (UK)
- Eli Lilly and Company (US)
- Fresenius Kabi Schweiz (Germany)
- Pfizer (US)
- AbbVie . (US)
- Genentech (US)
- Sanofi (France)
- AstraZeneca (UK)
- Company Profiles
- Analyst Views
- Future Outlook of the Market