United States Cancer Immunotherapy Market is expected to reach US$ 109.47 billion by 2033 | Top Companies - Merck & Co., Inc., Johnson & Johnson Services, Inc., Bristol-Myers Squibb Company.

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 worldwide and advancements in targeted immunotherapies improving treatment outcomes. According to DataM Intelligence Report.

Get a Free Sample Research PDF: https://datamintelligence.com/download-sample/cancer-immunotherapy-market?sz

The Cancer Immunotherapy Market encompasses therapies that stimulate or restore the immune system's ability to detect and destroy cancer cells. It includes treatments like checkpoint inhibitors, CAR-T cell therapy, cancer vaccines, and monoclonal antibodies. Driven by innovation, rising cancer prevalence, and personalized medicine trends, this market focuses on enhancing patient survival, reducing side effects, and improving overall quality of life.

Industry Recent Developments: United States

✅ September 2025: FDA granted breakthrough therapy designation to olomorasib combined with pembrolizumab (Keytruda) for cancer treatment, marking progress in combination immunotherapy approaches.

✅ October 2025: Multiple FDA approvals and designations were issued, enhancing treatment options with immune checkpoint inhibitors, CAR-T cell therapies, and monoclonal antibodies.

✅ November 2025: The U.S. cancer immunotherapy drug market size is estimated to be expanding rapidly, supported by strong R&D pipelines, expediting innovations in immunomodulators and cancer vaccines. Focus on lung cancer immunotherapy remains critical with ongoing clinical trials and combination regimens.

Industry Recent Developments: Japan

✅ September 2025: Noile-Immune participated in BioJapan 2025, highlighting advancements and collaborations in cancer immunotherapy including novel vaccine candidates and cell therapies.

✅ October 2025: Regulatory adaptations and corporate collaborations enhanced clinical progress in cancer immunotherapy tailored to meet Japan's healthcare policies and patient needs.

✅ November 2025: The Japanese cancer immunotherapy market is forecasted to grow steadily due to government support, reimbursement policies, fast-track approvals, and technological advancements including CAR-T and checkpoint inhibitors, with strong research and development ecosystems.

Get Customization in the report as per your requirements: https://datamintelligence.com/customize/cancer-immunotherapy-market?sz

Major FDA Approvals in 2025:

Nivolumab + Ipilimumab for MSI‐High / dMMR Colorectal Cancer:

✅ On April 8, 2025, the FDA approved the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for adult and pediatric patients (>= 12 years) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

✅ The approval is based on the CHECKMATE-8HW Phase III trial; the combination showed very strong progression-free survival (PFS) vs chemotherapy (HR 0.21).

✅ Additionally, FDA converted the prior accelerated approval of nivolumab monotherapy in MSI-H/dMMR CRC into a regular (full) approval.

Penpulimab‐kcqx for Nasopharyngeal Carcinoma (NPC):

✅ On April 23, 2025, FDA approved penpulimab-kcqx, a PD‐1-blocking antibody (from Akeso Biopharma), in two regimens:

✅ First-line with cisplatin (or carboplatin) + gemcitabine for recurrent or metastatic non-keratinizing NPC.

✅ As a single-agent for metastatic disease after progression on prior platinum-based chemo + at least one other line.

✅ In the pivotal trial (AK105-304), median PFS was 9.6 months in the penpulimab arm vs ~7.0 months in control.

The therapy was granted fast-track, breakthrough, and orphan designations.

Cosibelimab-ipdl (Unloxcyt) for Cutaneous Squamous Cell Carcinoma (cSCC):

✅ FDA had earlier (Dec 13, 2024) approved cosibelimab-ipdl (brand name Unloxcyt) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients not eligible for curative surgery/radiation.

✅ Though this approval came at end-2024, it is clinically relevant for 2025 market dynamics (especially in immunotherapy M&A). Also, the approval package (label, safety) is publicly available.

Mergers & Acquisitions in 2025:

Sun Pharma → Checkpoint Therapeutics:

✅ Sun Pharmaceutical (India) is acquiring Checkpoint Therapeutics (US) for US$ 355 million.

✅ Rationale: Checkpoint's lead asset is cosibelimab (Unloxcyt), a PD-L1 immunotherapy (approved by FDA) for cSCC.

✅ For Sun Pharma, this is a strategic push to build a stronger oncology / immuno-oncology franchise.

AstraZeneca → EsoBiotec (Cell Therapy):

✅ AstraZeneca is acquiring EsoBiotec, a biotech focused on cell therapies, for up to US$ 1 billion (US$ 425 mn upfront + contingent payments).

✅ This strengthens AZ's presence in cell therapy (which includes immune-based therapies) for cancer.

BioNTech - Bristol Myers Squibb (BMS) big collaboration

✅ BMS is collaborating with BioNTech to co-develop / co-market BNT-327, a bispecific antibody targeting PD-L1 and VEGF-A.

✅ Financials: $1.5 Bn upfront, up to $2 Bn in fixed payments, and up to $7.6 Bn in milestones.

✅ Clinical plan: Phase III trials for lung cancer (small-cell, non-small-cell), and potential expansion into triple-negative breast cancer.

Broader Oncology M&A Trends (H1 2025):

✅ According to DealForma, H1 2025 saw ~19 cancer M&A deals totaling US$ 22 billion, exceeding 2024's pace.

✅ Average upfront payment per deal has also more than doubled vs 2024, indicating bigger bets / more conviction: ~US$ 1.5 bn average upfront.

✅ One of the top deals was Sanofi acquiring Blueprint Medicines for US$ 9.5 bn - though Blueprint is more broadly oncology than purely immunotherapy.

Regulatory & Market Trends in (2025):

Cancer Research Institute (CRI) "Insights + Impact" Report:

✅ CRI published its inaugural 2025 Cancer Immunotherapy Insights + Impact report.

✅ Key datapoints: Over 150 distinct FDA immunotherapy approvals (since 2011) across modalities (checkpoint inhibitors, cell therapies, bispecifics, etc.).

✅ In particular, ICIs (immune checkpoint inhibitors) still dominate (~81% of FDA-approved immunotherapies), but other modalities-like adoptive cell therapy, bispecifics, next-generation agonists-are gaining momentum.

✅ Also, they highlight a shift in administration: subcutaneous formulations (e.g., for some ICIs) are being approved to improve patient access / convenience.

Accelerating Regulatory Momentum:

✅ According to a PR‐Newswire industry commentary, the "cancer immunotherapy surge" is driving strong market growth, with regulatory momentum accelerating newer modalities.

✅ The same piece projects very large market expansion in coming years, driven by next-gen platforms.

Clinical / Regulatory Developments beyond Approvals:

✅ The FDA cleared an IND (Investigational New Drug) application in March 2025 for EVM14, which is a tumor-associated antigen vaccine for cancers such as non-small cell lung cancer and head & neck cancer.

✅ FDA also aligned on a Phase 3 design for IMNN-001 in advanced ovarian cancer (neoadjuvant + chemotherapy) in March 2025.

Major Key Players:

1. Merck & Co., Inc. - A leading global biopharmaceutical company, Merck focuses on innovative therapies across oncology, vaccines, and infectious diseases.

2. Johnson & Johnson Services, Inc. - A diversified healthcare giant, J&J develops pharmaceuticals, medical devices, and consumer health products worldwide.

3. Bristol-Myers Squibb Company - Specializes in biopharmaceuticals for oncology, immunology, cardiovascular, and fibrosis treatments, emphasizing innovative therapies.

4. AstraZeneca - Global biopharma company known for oncology, cardiovascular, and respiratory treatments, with strong R&D in innovative medicines.

5. Pfizer Inc. - A multinational pharmaceutical leader focusing on vaccines, oncology, rare diseases, and innovative therapies with a broad global presence.

6. F. Hoffmann-La Roche Ltd - Swiss pharma giant renowned for oncology and diagnostics, leading in targeted therapies and personalized medicine solutions.

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 for Cancer Immunotherapy Market:

⇥ 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)

Buy Now & Get 30% OFF - Grab 50% OFF on 2+ reports: https://www.datamintelligence.com/buy-now-page?report=cancer-immunotherapy-market

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.

Unlimited Insights. One Subscription: https://www.datamintelligence.com/reports-subscription

Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Cancer Immunotherapy market?

➠ Who are the global key manufacturers of the Cancer Immunotherapy Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Cancer Immunotherapy market opportunities and threats faced by the vendors in the global Cancer Immunotherapy Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Cancer Immunotherapy market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

Contact Us -
Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us -
DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.
Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.

This release was published on openPR.