Immunotherapy Market By Type of Therapy (Monoclonal Antibodies, Checkpoint Inhibitors, Cancer Vaccines, Adoptive Cell Transfer, Cytokines & Interleukins and Oncolytic Virus Therapy), By Application (Cancer, Autoimmune Disease, Infectious Diseases, Allergies, and Others), By Route of Administration (Intravenous, Subcutaneous, Intramuscular, Oral and Intratumoral), By End-user (Hospitals, Research Laboratories, Clinics, and Pharmaceutical Companies), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Immunotherapy market accounted for USD 164.3 Billion in 2024 and is expected to reach USD 432.6 Billion by 2035, growing at a CAGR of around 9.2% between 2025 and 2035. The immunotherapy market is focuses on treatments utilizing the body's immune system to fight against diseases, especially cancer. This helps improve the immunity response to tumors or altered immune cells to better and more aggressively recognize and destroy the cancerous cells. Important types of immunotherapy drugs include checkpoint inhibitors, CAR T-cell therapies, and monoclonal antibodies. Immunotherapy markets have grown fast due to the advancement of research in this field and the high prevalence of cancers and its increasing trend over time along with the paradigm shift to personalized medicine. Companies invest a lot in the development of new therapies, and as a result, a large pipeline of innovative treatment is developed. Immunotherapy does appear to be a truly promising frontier in oncology as well as other applications.

Report Scope:

Market Dynamics

Surging Cancer Incidence Fuels Demand for Innovative Immunotherapy Solutions

The rising diagnosis of cancer across the globe is one of the significant growth promoters for the immunotherapy market. In 2022, approximately 20 million new cases of cancer and around 9.7 million deaths were due to cancer across the globe. In addition, one in five people will be afflicted with cancer at some point during their lives, meaning cancer is also as common as any other disease. In the United States, alone, the American Cancer Society estimated that about 1.9 million new cases of cancer were diagnosed in 2021.

Immunotherapeutic agents have been in focus for their potential results in the treatment of hard-to-cure cancers. Governments as well as healthcare systems worldwide are investing heavily in research and development work. This is driving the growth in demand for immunotherapeutic drugs. As the rate of cancer increases, so will the market for immunotherapy, driven by demand for targeted and personalized treatment options.

Rise of Genetic Testing Enhances Precision in Immunotherapy for Cancer Treatment

The increasing application of genetic testing is significantly changing the immunotherapy market through identification of candidates for specific treatments. The National Cancer Institute has reported that as of 2021, close to 30% of patients suffering from cancer are liable to be benefited by such targeted therapies based on genetic profiles. Genetic testing also enables identification of mutations and biomarkers that can point out the response of the patient to a particular form of immunotherapy.

Genomics testing services have been improving in terms of availability and are reducing in cost. With clinical practice adopting more genetic tests on the part of healthcare professionals, the market for immunotherapy is going to broaden because of a more holistic and personalized cancer treatment opportunity.

Clinical Trial Recruitment Challenges Hinder Diversity and Progress in Immunotherapy Development

Recruitment of diversified patients is one of the greatest challenges for immunotherapy to overcome in clinical trial processes. Most of these clinical trials have been a real challenge to recruit diversely profiled patients that skew the results and do not get generalized. The FDA stated that diversity should characterize these clinical trials. This regulatory body noted that particular races and ethnic minorities always make up the minority segment within the population.

Additional challenges to the recruitment process are logistical, including location and accessibility. Mitigating the recruitment difficulties for the diversification of participants will therefore be very crucial for the future development and effectiveness of the market for immunotherapy. Not increasing participation may limit very much the further development of individualized therapies and influence patient response.

Expanding Immunotherapy Applications Offer New Growth Avenues beyond Cancer Treatment

Expanding application areas of immunotherapy toward other treatments aside from cancer will provide huge growth potential. Over the last couple of years, scientists have discussed the notion of immunotherapies applied in the treatment of various non-oncological conditions, including autoimmune diseases, such as rheumatoid arthritis, lupus, and multiple sclerosis.

As more health care systems discover the possibility of immunotherapy in greater applications, the door for pharmaceutical companies to diversify their portfolios is now open.  As such, through this paradigm shift, millions of patients who have non-cancer diseases will see treatment possibilities they previously never had, and as immunotherapy will expand and penetrate more profoundly into healthcare delivery systems.

Innovations in CAR-T and Cell Therapies Open New Horizons in Immunotherapy

Advances in cell therapy, especially CAR-T (chimeric antigen receptor T-cell) therapy, promise new entries into the immunotherapy market. The FDA has already approved several CAR-T therapies for specific hematologic malignancies: Kymriah and Yescarta, with an excellent potential to improve patient outcomes. The research field is also working on extending CAR-T applications beyond hematologic malignancies and into solid tumors and other diseases. National Cancer Institute, stresses the fact that cell therapies involving CAR T is a primary area of research and at present various other clinical trials have also been planned to develop it safely and effectively.

It has proved that with new inventions and developments in progress this will only grow much greater because its growth will not be limited by the advancement of advanced technology and vast investments made in the areas of R and D. This evolution brings forth a critically important opportunity to advance treatment modalities for challenging cancers as well as other diseases for broader impacts on immunotherapy.

Industry Experts Opinion

“We are grateful to be able to offer this first-in-class immunotherapy to qualified bladder cancer patients less than two months after the therapeutic was approved by the FDA.”

• Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

“By integrating Ki67 staining into the ADC development process, researchers are ensuring their research is built on a solid foundation of validated, high-quality biospecimens.”

• Cathie Miller, PhD, Senior Director of Product Management at BioIVT

Segment Analysis

Based on the type of therapy, the market of Immunotherapy has been classified into monoclonal antibodies, checkpoint inhibitors, cancer vaccines, adoptive cell transfer, cytokines & interleukins and oncolytic virus therapy. The Monoclonal antibodies are the leaders in the immunotherapy market, as they have established efficacies by targeting specific cancer cells with utmost precision, thus considerably improving patient outcomes. They have been approved for use in a wide range of cancers including breast, lung, and melanoma.

Based on the application, the market of Immunotherapy has been classified into cancer, autoimmune disease, infectious diseases, allergies and others. Cancer is the leading segment in the market due to the rising global incidence of the disease, which creates an urgent demand for effective treatments. Improving survival opportunities are to be given more preference of immunotherapies, particularly relating to cancer with available medicines such as monoclonal antibodies and checkpoint inhibitors.

Regional Analysis

The immunotherapy market shares are highest in North America and the United States in particular. Factors for this reason are well-developed infrastructure for healthcare, massive research and development spending, and a few of the top pharmaceutical companies being based here. In the United States alone, there are thousands of clinical studies and some innovative therapies that get approved by the FDA with most of these new agents of immunotherapy. High prevalence of cancer and increased patient awareness of immunotherapy options also go into making this market. Added support of regulatory environment and strong technological capabilities enable North America to top the list of the world's immunotherapy markets.

The Asia-Pacific region is the fastest-growing segment of the immunotherapy market, driven by increasing rates of cancer and rising health care expenditures. Countries like China, Japan, and India are experiencing rapid development in medical technology and increased investment in biopharmaceutical research. The growing middle class and better access to healthcare are driving demand for innovative treatments. Moreover, regulatory bodies in the region are becoming increasingly supportive of new therapies, which is allowing for quicker approvals. Increased interest in personalized medicine and innovative targeted therapies drive growth opportunities for immunotherapy in Asia-Pacific.

Competitive Landscape

The competitive landscape of the immunotherapy market is dominated by major players such as Bristol-Myers Squibb, Merck & Co., Roche, and Novartis. These companies dominate the sector with their vast portfolios of approved therapies. Recent developments highlight ongoing innovation and competition among these companies. Gilead Sciences and Amgen are also investing in CAR-T cell therapies and other advanced treatments, thereby showing the trend toward personalized medicine. The biotech firms with its rising partnerships for R and D further increase competition to the firms as they pursue developing new therapies for its patients. This dynamic market creates rapid progress in immune-based therapeutic options that come across to meet the strong growing demand for cancer medicine treatments.

Immunotherapy Market, Company Shares Analysis, 2024

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Recent Developments:

• In October 2024, BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, has announced that it has sponsored the 8th Annual Biomarker & Precision Medicine U.S. Congress. The company also participated in The Society for Immunotherapy of Cancer's 39th Annual Meeting where it showcased its recently launched Ki67 tissue staining service to support antibody-drug conjugate (ADC) development.
• In June 2024, ImmunityBio, Inc. reported today that its first treatment of multiple patients in the United States under its recently approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ has been initiated with ANKTIVA®.

Report Coverage:

By Type of Therapy

• Monoclonal Antibodies
• Checkpoint Inhibitors
• Cancer Vaccines
• Adoptive Cell Transfer
• Cytokines and Interleukins
• Oncolytic Virus Therapy

By Application

• Cancer
• Autoimmune Disease
• Infectious Diseases
• Allergies
• Others

By Route of Administration

• Intravenous
• Subcutaneous
• Intramuscular
• Oral
• Intratumoral

End-user  

• Hospitals
• Research Laboratories
• Clinics
• Pharmaceutical Companies

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Bristol-Myers Squibb (BMS)
• Merck & Co.
• Roche
• Amgen
• Novartis
• Gilead Sciences
• AstraZeneca
• Pfizer
• Eli Lilly
• Sanofi
• Johnson & Johnson
• Regeneron Pharmaceuticals
• Bayer
• Celgene (part of Bristol-Myers Squibb)
• Blueprint Medicines

Frequently Asked Questions (FAQs)