Table of Contents
Overview
New York, NY – June 09, 2025 – Global Immuno-Oncology Market was valued at US$ 47.3 Billion in 2024 and is expected to grow at a CAGR of 22.7% from 2025 to 2034. In 2024, North America led the market, achieving over 52.1% share with a revenue of US$ 24.6 Billion.
Immuno-oncology is revolutionizing cancer care by leveraging the body’s immune system to detect, target, and eliminate cancer cells. Unlike traditional therapies, immuno-oncology focuses on stimulating a patient’s immune response, offering new hope in the fight against difficult-to-treat tumors. It represents a paradigm shift in oncology, moving away from direct tumor destruction to immune-mediated tumor control.
Checkpoint inhibitors, cancer vaccines, T-cell therapies (such as CAR-T), and monoclonal antibodies are central components of this approach. These therapies enhance immune recognition of tumor cells and disrupt mechanisms cancer uses to evade immune detection. The development of PD-1/PD-L1 and CTLA-4 inhibitors has shown durable responses in cancers like melanoma, lung, and renal cell carcinoma.
Global healthcare systems are increasingly adopting immuno-oncology therapies due to their clinical efficacy and long-term survival benefits. Major regulatory bodies such as the FDA and EMA continue to approve new indications, accelerating their market availability.
Ongoing research focuses on combination therapies, biomarkers for patient selection, and reducing immune-related adverse events. Advances in precision medicine and genomics further support the growth of personalized immuno-oncology approaches. With robust clinical pipelines and growing investments, immuno-oncology is positioned as a cornerstone in modern cancer therapy. Its future lies in expanding access, improving outcomes, and transforming survival expectations across oncology disciplines.
Key Takeaways
- Market Size: Valued at USD 47.3 billion in 2024 projected to reach USD 366.3 billion by 2034.
- Growth Rate: Expected to grow at a strong CAGR of 22.7% during 2025–2034.
- Leading Therapy: CAR T-cell therapy dominated in 2024 with 40.8% of global revenue share.
- Regional Dominance: North America led the global market with over 52.1% revenue share in 2024.
- Market Drivers: Rising cancer incidence, advancements in cellular therapies, and growing regulatory approvals.
- Future Focus: Emphasis on combination therapies, personalized treatment, and expanded access in emerging markets.
Segmentation Analysis
Treatment Type Analysis
The immuno-oncology market is segmented by treatment type into immune checkpoint inhibitors, CAR T-cell therapy, monoclonal antibodies (mAbs), cancer vaccines, and oncolytic virus therapy. Among these, the immune checkpoint inhibitors segment held the largest market share, accounting for 40.8% of the global revenue in 2024.
The dominance of this segment can be attributed to its significant impact on modern cancer therapy. Immune checkpoint inhibitors, including drugs like pembrolizumab (Keytruda) and nivolumab (Opdivo), function by targeting immune checkpoint proteins such as PD-1, PD-L1, and CTLA-4. These proteins are commonly used by cancer cells to avoid detection by the immune system.
By blocking these checkpoints, the therapy reactivates the immune response, allowing T-cells to identify and destroy cancer cells. Their clinical success across multiple cancer types, such as melanoma, lung cancer, and bladder cancer, has reinforced their position as a cornerstone in immuno-oncology treatments.
Market Segments
- Immune Checkpoint Inhibitors
- PD-1/PD-L1 Inhibitors
- Pembrolizumab (Keytruda)
- Nivolumab (Opdivo)
- Dostarlimab (Jemperli)
- CTLA-4 Inhibitors (Ipilimumab (Yervoy))
- Combination (PD-1/PD-L1+CTLA-4)
- CAR T-cell Therapy
- mAbs
- Cancer Vaccines
- Oncolytic Virus Therapy
Regional Analysis
North America held a dominant position in the global immuno-oncology market in 2024, capturing a 52.1% share of total revenue. The high regional share is driven by a rising cancer burden and growing demand for advanced, targeted therapies. The increasing prevalence of cancers such as colorectal, endometrial, breast, and lung cancer continues to fuel the adoption of immuno-oncology treatments.
Strong regulatory support from the U.S. Food and Drug Administration (FDA) has contributed to market expansion. Multiple immunotherapies, including checkpoint inhibitors like pembrolizumab and nivolumab, have received approval for a variety of cancer types, enhancing treatment accessibility and patient outcomes.
According to the American Cancer Society (ACS), an estimated 1.9 million new cancer cases are expected to be diagnosed in the United States in 2024, with approximately 609,000 deaths projected in the same year. Among these, breast cancer is anticipated to represent nearly 20% of all new cases, making it one of the most common cancer types. The high incidence rates and continuous innovation in immunotherapy platforms position North America as a leading region in the global immuno-oncology landscape.
Emerging Trends
- Biomarker-Driven Drug Approvals: A growing share of new cancer drugs is approved based on specific molecular markers rather than tumor location. Between January and March 2021, 33% of FDA novel drug approvals were tied to biomarkers such as PD-L1 or MSI status.
- Expansion of TIL Therapy into Common Solid Tumors: Tumor-infiltrating lymphocyte (TIL) therapies are now effective beyond melanoma. In a phase 2 trial for metastatic gastrointestinal cancers, 23.5% of patients receiving selected TILs plus pembrolizumab had their tumors shrink, compared with 7.7% without pembrolizumab.
- Combination Checkpoint Inhibitor Regimens by Genetic Subtype: Checkpoint inhibitor combinations are increasingly matched to genetic profiles. On April 8, 2025, the FDA approved nivolumab plus ipilimumab for unresectable or metastatic MSI-high colorectal cancer in patients 12 years and older.
- Personalized Cell-Based Immunotherapies: Autologous T cell therapies tailored to each patient’s tumor are advancing. In February 2024, lifileucel (Amtagvi) became the first tumor-derived T cell immunotherapy approved for metastatic melanoma.
- AI Tools to Predict Immunotherapy Response: Artificial intelligence models are being tested to guide treatment. The SCORPIO tool, for example, more accurately forecasts which patients will benefit from checkpoint inhibitors and estimates survival times.
Use Cases
- Lifileucel in Metastatic Melanoma: In a global trial of 73 patients, lifileucel achieved an objective response rate of 31.5% (4.1% complete, 27.4% partial). Of responders, 56.5% remained progression-free at six months.
- Dostarlimab for dMMR Rectal Cancer: A phase 2 study treated 12 patients with mismatch repair–deficient, locally advanced rectal adenocarcinoma using single-agent dostarlimab. All 12 (100%) had a complete clinical response without needing chemoradiation or surgery at a median 12-month follow-up.
- Selected TIL Therapy Plus Pembrolizumab: In 34 heavily pretreated patients with metastatic gastrointestinal tumors, 8 (23.5%) experienced tumor shrinkage of ≥30% when pembrolizumab was given before selected TIL infusion. By contrast, only 3 of 39 patients (7.7%) responded to TIL therapy without pembrolizumab.
- Nivolumab + Ipilimumab in MSI-High Colorectal Cancer: For patients aged ≥12 with unresectable or metastatic MSI-high/dMMR colorectal cancer, this combination was approved on April 8, 2025. MSI-high tumors account for about 2–3% of metastatic CRC cases.
Conclusion
The global immuno-oncology market is undergoing rapid transformation, driven by rising cancer prevalence, regulatory approvals, and breakthrough therapies. With a projected CAGR of 22.7% from 2025 to 2034, the market is expected to reach USD 366.3 billion by 2034. Innovations such as immune checkpoint inhibitors, CAR T-cell therapies, and biomarker-driven approaches are redefining cancer treatment.
North America remains the leading region, supported by a strong clinical and regulatory environment. Advancements in personalized immunotherapies, AI integration, and combination regimens continue to enhance clinical outcomes, positioning immuno-oncology as a critical pillar of modern oncology across global healthcare systems.
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