The size of global Immunotherapy Drugs Market in terms of revenue was estimated to be worth $285.3 billion in 2024 and is poised to reach $580.6 billion by 2029, growing at a CAGR of 15.3% from 2024 to 2029. The comprehensive research encompasses an exhaustive examination of industry trends, meticulous pricing analysis, patent scrutiny, insights derived from conferences and webinars, identification of key stakeholders, and a nuanced understanding of market purchasing dynamics.
This growth is driven by technological advancements in antibody engineering, increasing demand for antibody therapies in clinical cancer treatment, and a growing preference for personalized medicines and targeted therapies. Immunotherapy drugs are designed to enhance the immune response or modulate the immune system’s regulatory mechanisms, thereby enabling the body to effectively target and eliminate disease-causing agents or cells. However, the market faces challenges such as the complexities involved in developing antibody therapeutics. Key drivers of the market growth include technological advancements in antibody engineering, the rising demand for antibody therapies in clinical cancer treatment, and the increasing need for personalized medicines and targeted therapies.
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Key Market Players
The immunotherapy drugs market is a competitive market, with Merck & Co., Inc. (US), Johnson & Johnson Services, Inc. (US), F. Hoffman-La Roche Ltd. (Switzerland) emerging as top three players in the market. While Pfizer Inc. (US), AstraZeneca (UK), Novartis AG (Switzerland), Amgen Inc. (US), Gilead Sciences, Inc. (UK), Bristol-Myers Squibb Company (US), Eli Lilly and Company (US), Sanofi (France), Takeda Pharmaceutical Company Limited (Japan), Teva Pharmaceutical Industries Ltd (Israel), GSK PLC (US), and Abbvie Inc. (US) are some of the other prominent players in the market.
DRIVER: Technological advancements in antibody engineering
Advancements in antibody engineering are significantly driving the growth of the immunotherapy drugs market by leveraging molecular biology techniques to enhance antibodies for therapeutic and diagnostic purposes, the development of highly targeted and effective treatments is facilitated. Technologies such as recombinant DNA enable the customization of antibodies for specific therapeutic applications, increasing their clinical efficacy. Platforms like Wacker’s ESETEC and Ligand Pharmaceuticals’ Pelican Expression Technology optimize the production and secretion of antibody fragments, further propelling market growth. These innovations are crucial in meeting the rising demand for personalized medicines and targeted therapies, thereby expanding the market for immunotherapy drugs.
RESTRAINT: Stringent regulatory approval process for immunotherapy drugs
Developing and commercializing immunotherapy drugs faces rigorous evaluation and compliance with complex regulatory frameworks. The US FDA and European Medicines Agency (EMA) impose stringent guidelines, resulting in prolonged approval timelines and significant financial investments. Smaller companies face challenges due to these exhaustive requirements. Guidelines from the EMA and WHO cover development, production, and evaluation of antibody therapeutics. Regulatory rejections, such as those experienced by Y-mAbs Therapeutics and Eli Lilly, highlight the challenges. Market players must diligently adhere to these regulations to navigate the approval process and succeed in the competitive landscape of antibody therapeutics.
OPPORTUNITY: Increasing collaborations among pharmaceutical companies, CROs, CDMOs, and academic institutions
A collaborative approach fosters a synergistic environment, driving advancements in R&D and commercialization of Immunotherapy Drugs. Academic institutions contribute cutting-edge research, while pharmaceutical companies offer formulation expertise and market knowledge. CROs ensure robust scientific validation and regulatory compliance. Notable collaborations include AstraZeneca and the University Health Network’s phase II study on AZD2936 for LA-HNSCC, and Salipro Biotech’s multi-target antibody research agreement with Icosagen. This collaborative strategy promotes innovation, accelerates drug development, reduces costs, and enhances global market penetration, positioning antibody fragment-based therapies for substantial market growth and clinical impact.
CHALLENGE: Complexities in development of antibody therapeutics
The production of antibody therapeutics is intricate and time-consuming, involving cell line development, bioreactor cultivation, and purification, leading to high production costs and affecting market competitiveness. Compliance with stringent regulatory guidelines further increases costs and causes delays. Manufacturing involves complex operations and rigorous quality assurance, making antibody therapies more expensive than small-molecule medicines. Limited specialized manufacturing facilities force companies to outsource production, adding to costs and posing a challenge to market growth. The use of expression systems for antibody fragments through recombinant DNA technology is critical but resource-intensive.
The Antibody drugs segment maintains major market share of the immunotherapy drugs industry in the forecast period.
Based on type, the immunotherapy drugs market is divided into antibody drugs, inhibitor drugs, interferons & interleukins, cancer vaccines, and other immunotherapy drugs, which include oncolytic virus therapy and t-cell therapy. Antibody drugs hold the major market share in 2023. Rising cancer rates along with the growing adoption of biological therapies, increased spending on R&D by both governments and Immunotherapy Drug Companies coupled with favorable government policies are driving this market.
The Cancer segment is anticipated to dominate immunotherapy drugs industry through 2023-2029.
Based on applications, the immunotherapy drugs market is divided into cancer, autoimmune & inflammatory diseases, hematology, osteology, neurology, and other applications, including ophthalmology, dermatology, and cardiovascular diseases. Cancer commanded the largest market share in 2023 due to the projected growth in burden of cancer cases throughout the world along with rising product approvals for cancer application, and increased R&D Spending.
The Intravenous Route segment of the immunotherapy drugs industry is anticipated to grow at the fastest pace throughout the forecast period.
Based on the route of administration, the immunotherapy drugs market is broadly segmented into intravenous, subcutaneous, and other routes of administration (intravitreal and intramuscular). In 2023, the intravenous route of administration segment accounted for the largest share of the immunotherapy drugs market. This segment is also expected to grow at the highest CAGR during the forecast period. The large share and high growth rate are attributed to the growing preference for intravenous routes owing to its direct delivery into the bloodstream, ensuring rapid and consistent therapeutic effects for several conditions, including cancer and autoimmune diseases.
Hospitals segment of the immunotherapy drugs industry generated the highest revenue in 2024 in the market.
Based on end users, the immunotherapy drugs market is broadly segmented into hospitals, long-term care facilities, and other end users (specialty care centers). In 2023, the hospitals segment commanded the largest share of the immunotherapy drugs market. Hospitals extensively use mAbs for their targeted therapy, rapid diagnostic applications, and efficacy in treating several disease indications, including cancer, autoimmune disorders, and infectious diseases.
The North America immunotherapy drugs industry is expected to dominate the market.
The immunotherapy drugs market has been segmented into six major regions: North America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa. In 2023, North America accounted for the largest share of the global immunotherapy drugs market. The growth in the North American market can be attributed to rising immunotherapy research, the expansion of the healthcare sector, growing cancer prevalence, and the increasing approval and adoption of immunotherapy drugs for treating cancer and other chronic diseases.
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Recent Developments:
- In May 2024, Merck acquired EyeBio (UK), a privately held ophthalmology-focused biotechnology company. Merck gained rights to EyeBio’s pipeline candidate—Restoret (EYE103) through this acquisition. This is an investigational tri-specific antibody that acts as an agonist of the wingless-related integration site (WNT) signaling pathway.
- In December 2023, F. Hoffman-La Roche acquired Telavant Holdings, Inc. (owned by Roivant Sciences Ltd. and Pfizer Inc.) to develop advanced therapies targeted toward gastrointestinal health.
- In May 2023, Janssen Global Services, LLC (a subsidiary company of J&J) collaborated with Cellular Biomedicine Group Inc. (CBMG) to develop and commercialize advanced chimeric antigen receptor (CAR) T-cell therapies to treat B-cell malignancies.