Immunotherapy Drugs Market Size, Share & Trends Analysis Report By Type (Monoclonal Antibodies, Vaccines, Immunomodulators), By Therapeutic Area (Cancer, Autoimmune and Inflammatory Diseases, Infectious Diseases, Others), By End-User (Hospital, Clinic) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global immunotherapy drugs market size was valued at USD 202.4 billion in 2022. It is projected to reach USD 425.3 billion by 2031, growing with a CAGR of 8.6% during the forecast period (2023–2031).

Immunotherapy is a biological therapy used to fight against cancer and infectious diseases. It inhibits or slows the growth of cancer cells, prevents cancer from spreading to other parts of the body, and strengthens the immune system. Rising cases of chronic diseases, increasing adoption of targeted therapy over traditional therapy, and growing demand for monoclonal antibodies contribute to market growth.

Immunotherapy is widely used in cancer treatment. Cell-based immunotherapies are useful for some types of cancers. Therapies, including granulocyte colony-stimulating factor (G-CSF), imiquimod, interferons, and parts of cellular membranes from bacteria, are approved for medical use. In addition, immunotherapies are used to treat allergies, reduce the rejection of transplanted organs, and dampen autoimmunity. The increasing awareness of various therapies, such as targeted therapy, monoclonal antibodies, and biosimilars, fuels the demand for immunotherapy drugs. Increasing investments by biopharmaceutical companies in the research and development of immunotherapy drugs positively affect market expansion.

Market Dynamics

What are the factors driving the market growth?

Rising prevalence of cancer and autoimmune diseases

The increasing cases of chronic diseases, such as cancer, kidney failure, and heart disease, are surging the demand for immunotherapy. In these disease treatments, immunotherapy drugs emerge as an evolving and promising treatment that works by accelerating the immune system. Immunotherapy drugs include checkpoint inhibitors and CAR T-cell therapy. As per the World Health Organization (WHO), cancer is the second leading cause of death worldwide. It was responsible for about 9.6 million death in 2018, which is about one in every six deaths. The American Cancer Society, on the other hand, estimated that more than 1.7 million new cancer cases were diagnosed in North America in 2019. As per the British Society for Immunology, the incidence of autoimmune conditions is increasing at a rapid rate year-on-year. This includes a 7.0% increase yearly in rheumatic diseases and a 6.3% increase in endocrinological conditions.

Emergence of biosimilars

Unlike generic drugs with active pharmaceutical ingredients, such as original drugs, biosimilars are nearly identical to their creator biological compounds. They are less expensive than biologics, further raising their adoption across the end-users. Companies in the biosimilars market are tapping into opportunities in orphan biosimilars. Because of the high prevalence of rare diseases, companies have a renewed purpose to steer innovation in biosimilars. Thus, manufacturers are increasing efforts to fulfill the unmet needs of patients with rare diseases by increasing the availability of low-cost biosimilars.

Regional Analysis

The global market for immunotherapy drugs is divided into four regions: North America, Europe, Asia Pacific, and LAMEA.

North America dominates the immunotherapy drugs market. According to the National Cancer Institute, there were approximately 16.9 million cancer cases in the United States as of January 2019. It also stated that cancer cases are anticipated to reach 22.2 million by 2030. The rise in the adoption of advanced cancer treatment and the growing cancer prevalence has surged the demand for advanced solutions. The introduction and regulatory approval of new immunotherapy medications and favorable reimbursement policies would be anticipated to contribute to the region’s expansion. In addition, the growing government funding and support to boost R&D, technological advancement in next-generation sequencing and personalized medicine, and a robust healthcare research framework positively influence regional market growth. 

Asia-Pacific is expected to show the highest growth in the immunotherapy drugs market because of the introduction of advanced immunotherapy drugs in China and Japan. These countries have numerous ongoing clinical trials and FDA approvals for new drug molecules and combination therapies. These approvals of new drugs contribute to the adoption of immunotherapy for cancer treatment. Japan is anticipated to experience a substantial CAGR over the predicted period. The rising incidence of cancer in Japan, the rising geriatric population, the rising investments in medical research, and the well-developed healthcare infrastructure are among the primary drivers driving the region's expansion. Moreover, growing investments from the key market players, such as AstraZeneca, Merck & Co., Inc., and Pfizer, Inc., accelerate the regional market growth. According to research, more than 600 locations have participated in the clinical development of immunotherapy medications, and hundreds more have conducted clinical studies using immunotherapies for both monotherapy and combination therapies. 

The European market is expected to maintain a significant share during the forecast period. The growth is attributable to the increasing demand for safer cancer therapies, the availability of innovative technology, and the introduction of favorable reimbursement policies. Major nations such as Germany, the United Kingdom, and France contribute significantly to regional market expansion. Increasing rates of cancer, infectious, and autoimmune diseases are driving the immunotherapy drugs market in Europe. Findings have revealed that the number of new cancer cases in the EU and European Free Trade Association (EFTA) countries is predicted to increase by 21.4%, from 2.8 million in 2020 to 3.4 million in 2040. From 2020 to 2040, the number of cancer deaths is projected to increase by 32.2%, from 1.3 million to 1.7 million. In addition, the increasing preference for immunotherapy drugs over conventional treatment regimens is anticipated to propel market expansion. In addition, the rising demand for monoclonal biosimilars and accelerated regulatory approvals are anticipated to positively influence market growth.

The LAMEA region is anticipated to show significant growth over the forecast period. Obesity, lifestyle changes, smoking, and eating habits contribute to the rise in cancer cases in Latin America. As immunotherapy drugs have been shown to have fewer side effects than other treatments, this is likely to drive the growth of the Latin American immunotherapy drugs market over the next few years. Additionally, it has been observed that the risk of liver cancer increases dramatically as body mass index rises (BMI). According to the OECD Health Authorities, Latin American countries have particularly high rates of obesity. In Mexico, for instance, 33% of men aged 15 and older are obese, and it is predicted that by 2035, nearly 41% of the population will be obese. Due to the factors mentioned earlier, market growth is anticipated in the near future.

Segmental Analysis

The global market for immunotherapy drugs market is segmented based on therapeutic areas, type, and end-users.

Based on therapeutic areas, the market is segmented into cancer, autoimmune and inflammatory diseases, infectious diseases, and others.

The cancer segment has the highest revenue share due to rising cancer prevalence and cancer immunotherapy launches. A major driver driving the revenue growth of this category is the increasing incidence of cancer around the world, as well as the substitution of chemotherapy with an alternative due to its negative effects. Immunotherapy is a type of cancer treatment that uses substances produced by the body or in a lab to boost the immune system and assist the body in finding and killing cancer cells. Due to the prevalence of cancer, there is a greater demand for effective medicines, such as immunotherapy medications.

The segment of autoimmune illnesses is predicted to develop at the quickest rate throughout the projection period. This segment's rise can be due to the global increase in autoimmune illnesses and regional approvals of immunotherapy medications. According to NCBI research, an estimated 0.46 percent of the global population has rheumatoid arthritis.

Based on type, the market is segmented into monoclonal antibodies, vaccines, and immunomodulators.

The segment of monoclonal antibodies held the biggest market share due to increased research and development in therapeutic monoclonal antibodies and government initiatives. Using immunotherapy mediated by monoclonal antibodies, clinicians can treat cancer without damaging healthy cells. It typically has fewer side effects than other cancer treatments and boosts the immune system's fight against malignancy. Certain monoclonal antibodies mark cancer cells to assist the immune system in identifying and eliminating them more efficiently. Other monoclonal antibodies attract T cells to cancer cells so the immune system can eliminate them. The FDA has approved multiple monoclonal antibodies for cancer treatment. 

The vaccines section is anticipated to have the highest CAGR. This segment's rise is attributable to strategic partnerships between major businesses and increased clinical trials for vaccine development.

Based on end users, the global market for immunotherapy drugs is segmented into hospitals and clinics. 

Hospitals account for the biggest market share worldwide. This segment will also expand at the greatest CAGR during the forecast period. The segment's substantial share can be ascribed to hospitals' increasing spending on immunotherapies and the desire for innovative treatments that are now only available in hospitals.

Recent Developments

• March 2022- The Food and Drug Administration of the United States has approved a novel treatment for patients with metastatic or inoperable melanoma, an aggressive form of skin cancer. Based on breakthrough research conducted at the Johns Hopkins Kimmel Cancer Center, the treatment consists of two immunotherapy agents, relatlimab (anti-LAG-3) and nivolumab (anti-PD-1), significantly slowing the progression of cancer in a global, multicenter clinical trial.
• January 2022- Palleon Pharmaceuticals, a pioneer in glyco-immunology for the treatment of cancer and inflammatory diseases, announced that the U.S. Food and Drug Administration approved the company's investigational new drug (IND) application for its lead candidate. This clearance paves the way for the clinical testing of Palleon's first-in-class cancer immunotherapy, which targets immunosuppressive sialoglycans.
• August 2021- Pfizer Inc. and Trillium Therapeutics Inc. announced that they have entered into a definitive agreement whereby Pfizer will acquire Trillium, a clinical-stage immuno-oncology company developing innovative cancer treatments.