United States Cancer Immunotherapy Market is expected to reach US$ 261.74 billion by 2033 | Major key players - AstraZeneca, Pfizer Inc., Novartis AG

Market Size and Growth:

The Cancer Immunotherapy Market size reached US$ 137.70 billion in 2024 and is expected to reach US$ 261.74 billion by 2033, growing at a CAGR of 7.9% during the forecast period 2025-2033. The Market is growing due to increasing cancer prevalence, advancements in immunotherapy treatments, and rising investment in research and development.

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The Cancer Immunotherapy Market involves therapies that stimulate or restore the body's immune system to identify and attack cancer cells. It includes immune checkpoint inhibitors, CAR-T cell therapy, cancer vaccines, and monoclonal antibodies. Driven by rising cancer prevalence, technological advancements, and personalized medicine, this market focuses on enhancing treatment efficacy, reducing side effects, and improving patient survival rates globally.

Industry Recent Developments:

United States:

✅ In August 2025, there was rapid productivity gain in R&D through AI-enhanced biomarker analytics and automated cell-therapy production, leading to faster clinical development cycles and enabling more novel assets to enter pivotal studies. Notable approvals included Merck and Moderna's FDA Breakthrough Therapy Designation for personalized vaccines in melanoma.

✅ Increasing cancer prevalence in the U.S., with 2 million new cases estimated in 2025, is driving demand for immunotherapies that offer personalized treatment options beyond chemotherapy, expanding market adoption significantly. (August 2025)

✅ The U.S. market is supported by strong R&D and biopharmaceutical innovation, including advances in immune checkpoint inhibitors, CAR-T therapies, and monoclonal antibodies, coupled with favorable FDA approvals and expanding healthcare infrastructure expanding patient access. (August 2025)

Japan:

✅ Japan's cancer immunotherapy market is forecasted to grow driven by rising incidence of cancers such as lung, breast, and hematological cancers, supported by government initiatives including reimbursement and regulatory fast-tracks enabling faster market entry of new therapies. (October 2025)

✅ Technological advancements in CAR-T therapies, checkpoint inhibitors, and vaccines, along with the integration of AI and biomarker-based precision medicine, are enhancing personalized immunotherapy delivery and expanding treatment options in Japan. (October 2025)

✅ Japan's well-developed R&D ecosystem, including academic-industry collaborations and government oncology initiatives, is accelerating the commercialization of next-generation immunotherapies, supported by supportive reimbursement policies enhancing access and affordability. (October 2025)

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FDA Approvals in Cancer Immunotherapy (2025):

✅ Key Approvals:

Pembrolizumab (Keytruda Qlex, Merck): Approved for subcutaneous injection in adults and pediatric patients aged 12 and older with solid tumor indications previously approved for the intravenous formulation.

Nivolumab (Opdivo) with Ipilimumab (Yervoy, Bristol Myers Squibb): Approved for first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

Retifanlimab-dlwr (Zynyz, Incyte Corporation): Approved in combination with carboplatin and paclitaxel for first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.

Datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.): Granted accelerated approval for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.

✅ New Combination Therapies:

Lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.): Approved in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy.

Mergers & Acquisitions in Cancer Immunotherapy (2025):

💰 Notable Deals:

Sun Pharmaceutical: Acquired Checkpoint Therapeutics for up to $416 million, following the FDA approval of Checkpoint's cancer immunotherapy drug, Unloxcyt.

Shuttle Pharmaceuticals: Entered the AI-driven drug discovery space through a $10 million acquisition of Molecule.ai.

Merck KGaA: Set its sights on acquiring SpringWorks Therapeutics, the maker of Ogsiveo, a treatment for neurofibromatosis type 2.

📈 Industry Trends:

Increased M&A Activity: The biopharmaceutical industry experienced a 101% surge in total deal value in Q1 2025, from $18.8 billion in Q4 2024 to $37.7 billion.

Regulatory Landscape:

Accelerated Approvals: The FDA granted accelerated approval to several therapies, including zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.) for HER2-mutated non-small cell lung cancer.

Combination Therapy Approvals: Lurbinectedin's approval in combination with atezolizumab and hyaluronidase-tqjs reflects a growing trend towards combination therapies in cancer treatment.

Major Key Players:

Merck & Co., Inc.
Johnson & Johnson Services, Inc.
Bristol-Myers Squibb Company
AstraZeneca
Pfizer Inc.
F. Hoffmann-La Roche Ltd
Novartis AG
Kite Pharma, Inc.
Dendreon Pharmaceuticals LLC.
Amgen Inc.

Segments Covered in the Cancer Immunotherapy Market:

By Type: Immune Checkpoint Inhibitors, Cytokines, Cancer Vaccines, Adoptive Cell Therapy, Other Immunotherapies.

By Indication: Non-Small Cell Lung Cancer (NSCLC), Melanoma, Colorectal Cancer, Renal Cell Carcinoma, Breast Cancer, Bladder Cancer, Others.

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Cancer Immunotherapy market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Cancer Immunotherapy Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The Global Cancer Immunotherapy market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Cancer Immunotherapy Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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