U.S. Immunotherapy Drugs Market Size to Surpass USD 464.06 Bn by 2034

According to latest report, the U.S. immunotherapy drugs market size was USD 87.03 billion in 2024, calculated at USD 102.89 billion in 2025 and is expected to reach around USD 464.06 billion by 2034, expanding at a CAGR of 18.22% from 2025 to 2034.

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U.S. Immunotherapy Drugs Market Report Highlights

•   By drug type, the monoclonal antibodies segment dominated the market, accounting for the largest share in 2024.

•  By drug type, the vaccines segment is projected to expand rapidly in the market in the coming years.

•   By therapeutic area, the cancer segment led the market with the highest revenue share in 2024.

•   By therapeutic area, the autoimmune & inflammatory diseases segment is predicted to witness significant growth in the market over the forecast period.

The market is driven by the increasing collaborations and acquisitions among biotechnological sectors and pharmaceutical companies to serve unmet medical needs, sustainability initiatives backed by various governments, ongoing clinical trials, and improved patient outcomes with technological advancements.

The U.S. immunotherapy market is expanding due to various reasons: the rising number of chronic diseases such as cancer and the inclination towards therapies to support the immune system's ability to combat illness. Immunotherapy offers significant solutions as compared to conventional therapies. Immunotherapy targets particular cells that hold the potential to affect the human system in an adverse way. Several types of immunotherapy drugs are monoclonal antibodies with immune checkpoint inhibitors. This has become prominently accepted in clinical therapies as the most effective treatment. With the evolution in the market, continued research and development efforts are anticipated to generate more innovative therapies, help improve patients' results, and expand treatment options for patients suffering from chronic illness. Progress is expected to increase the overall effectiveness of immunotherapy, which will further strengthen its role in modern medicine.

Immunotherapies have listed one of the therapies used for cancer treatment, which is mainly used to strengthen the immune system of the patient, which is able to attack tumors. Hence, it's becoming the fifth pillar of cancer treatment. The immune system boosts the efficiency of the drug and makes it work better, even eradicating the tumors completely in some cases, and these treatments can last for many years. Another form of immunotherapy is called CAR-T cell therapy. Its most popular treatment in recent years among oncologists and researchers is majorly used as an immune checkpoint inhibitor.

Artificial Intelligence (AI) integration in immunotherapy is revolutionizing as it majorly focuses on the use of AI to predict immunogenic tumor antigens at a faster rate and with high precision, minimizing experimental screening and validation, which was a major challenge in detecting tumors. More space for improvement includes AI-enhanced antibodies that have the potential to treat cancer patients with a higher success rate. Scientists are developing various AI tools that use routine clinical information to detect cancer patients responding more to immunotherapy drugs known as checkpoint inhibitors. It has greatly impacted cancer treatment in a positive manner. There are two biomarkers that have been accepted by the U.S. FDA to detect that patients have more possibility to benefit from these types of drugs. One is tumor mutational burden, which is a number of mutations in cancer cells. Another is a predictive test, which is entirely dependent on molecular data of tumors, is high in cost and is not used in routine check-ups.

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Immunotherapy Drugs Market Report Scope

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U.S. Immunotherapy Drugs Market Trends:

•  Growing demand for advanced cancer treatment:

The immunotherapy drugs market is rapidly expanding owing to the increasing cases of cancers and growing demand for cancer treatment, with advanced treatments having fewer side effects. Immunotherapy works by changing the body’s immune system, with significant effects in fighting cancer cells. This option has become more promising as a cancer treatment as it targets cancer cells only and does not damage other healthy cells in the body, making it suitable for everyone looking for effective treatment for cancer. According to the cancer facts and figures, in January 2023, nearly 1.9 million cancer cases had been diagnosed in the U.S., which highlights its severity and need for effective treatment. Chemotherapy is a conventional method to treat cancer, but it has side effects as well. Immunotherapy exhibits fewer side effects, making it more useful and popular as compared to traditional chemotherapy, which has been used for decades to treat cancer. Hence, many patients opt for immunotherapy these days, augmenting the U.S. immunotherapy market. Factors like growing research collaborations, the rising number of research laboratories, and increasing direct and indirect investments in research and development by pharmaceutical and biotechnology companies are other driving factors for the market.

•  Continued research and development:

Another driving factor for the U.S. immunotherapy market is ongoing research and development in the immunotherapy drug sector. Many leading pharmaceutical companies are hugely investing to work on immunotherapy and find innovative solutions to treat various types of cancers and other life-threatening diseases. This has led to the approval of many immune checkpoint inhibitors and other significant therapies that have shown higher success rates. Hence. The increasing approval from the FDA, along with a growing number of clinical trials, are augmenting the market's growth on a wider scale. For instance, in May 2023, the FDA granted approval for an investigational new drug application introduced by Precigen, Inc., highlighting the commencement of a phase II study.

•  Access to immunotherapy:

Another crucial factor for the market’s growth is increased awareness about the numerous benefits offered by immunotherapy and growing access to immunotherapy treatments across the globe. These factors positively impacted the market's growth. As many people access immunotherapy treatment, the demand for such innovation is on the rise. One case study was done by a research team from the National Cancer Institute, set to create predictive tools based on readily available biomarkers. Assessment has been done on 20 various clinical, pathologic, and genomic features. The patient results are examined in terms of response and survival rate. They used machine learning techniques to detect which feature combination would be better to diagnose patients' responses to innovative treatments like immune checkpoint inhibitors. Its results have been published in Nature Cancer on 3rd June 2024.

U.S. Immunotherapy Drugs Market Segment Insights

By drug type

By drug type, the monoclonal antibodies segment accounted for the largest market share in 2024, thus dominating the U.S. immunotherapy drugs market. The growth of this segment can be attributed to the increasing research and development in therapeutic monoclonal antibodies, which is backed by the government. For instance, in May 2022, the supplemental biologics License application for priority review for dupilumab was accepted by the U.S. FDA. It is primarily used to treat prurigo nodularis.

By drug type, the vaccine segment is anticipated to witness the fastest growth rate during the upcoming period. The segment is expanding due to increasing strategic collaborations and partnerships between leading industry players along with growing clinical trials targeted for innovative drug discovery and vaccine development. For instance, in March 2022, a phase I trial was launched by national institutes of health for three investigational HIV vaccines with the foundation of mRNA technology.

By Therapeutic Area

By therapeutic area, the cancer segment accounted for the largest market share in 2024 and hence dominated the U.S. immunotherapy drugs market. The segment is driven by the increasing prevalence of various types of cancer around the world, and to combat this, leading players are investing heavily to launch innovative and efficient cancer immunotherapies, according to recent data. Breast cancer and lung cancer are the most diagnosed cancers, having prevalence rates of nearly 11.7% and 11.4% each. The data showcase the significant effect of these cancers on individual health. Breast cancer is the most prevalent cancer found in women, surpassing lung cancer. For instance, in May 2024, Amgen introduced the US FDA-approved drug IMDELLTRA, which was curated for the treatment of extensive stage small cell lung cancer. IMDELLTRA grants approval quickly due to its effectiveness.

By therapeutic area, the infectious diseases segment is registered as the fastest-growing segment in the U.S. immunotherapy market. The segment is proliferating due to the increasing demand for preventive and effective healthcare measures by the masses to prevent infectious diseases. Diseases like dengue, fever, and influenza, specifically in low and middle-income countries, are creating lucrative market opportunities to expand the segment.

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Related reports

U.S. Immunotherapy Drugs Market Top Key Companies:

•  Merck & Co.

•  Bristol Myers Squibb

•  F. Hoffmann-La Roche Ltd.

•  AstraZeneca

•  Pfizer Inc.

•  GlaxoSmithKline plc

•  Novartis AG

•  AbbVie Inc.

•  Amgen Inc.

U.S. Immunotherapy Drugs Market Recent Developments:

•  In February 2024, ImmunoGen was acquired by ABB Vie to enhance its oncology profile. Immunogen is working on a project called ELAHERE. It specifically targets folate receptor-alpha-positive-ovarian cancer. This strategic collaboration between two leading players helps to strengthen their roots in the U.S. immunotherapy market.

•  In March 2023, the Food and Drug Administration approved a grant for a drug known as abemaciclib. This approval highlights its efficient use in combination with endocrine therapy.

•  In February 2024, AbbVie acquired ImmunoGen, significantly enhancing its oncology portfolio. ImmunoGen's lead product, ELAHERE, specifically targets folate receptor-alpha-positive ovarian cancers. This strategic acquisition aligned with AbbVie's focus on expanding its capabilities in immunotherapy and oncology.

•  In December 2023, F. Hoffmann-La Roche completed the acquisition of Telavant Holdings, Inc., owned by Roivant Sciences and Pfizer. This deal was expected to allow Roche to develop a new therapy-RVT-3101-to treat inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. The acquisition was a part of Roche's strategy to strengthen its focus on gastrointestinal health and to bring innovative treatments to patients with these conditions.

U.S. Immunotherapy Drugs Market Report Segmentation

This report forecasts revenue growth at regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the global U.S. Immunotherapy Drugs Market

U.S. Immunotherapy Drugs Market Segmentation:

By Drug Type

•  Monoclonal Antibodies

•  Vaccines

•  Interleukins

•  Interferons Alpha & Beta

•  Others

By Therapeutic Area

•  Cancer

•  Infectious Diseases

•  Autoimmune & Inflammatory Diseases

•  Others

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