세계의 면역치료제 시장 : 약제 유형별, 적응증별, 투여 경로별, 최종사용자별, 지역별, 기회 및 예측(2018-2032년)

Global immunotherapy drugs market is projected to witness a CAGR of 11.11% during the forecast period 2025-2032, growing from USD 251.30 billion in 2024 to USD 583.74 billion in 2032. The global immunotherapy drug market is expanding rapidly, driven by the increasing need to prevent and cure autoimmune diseases. The market's growth is fueled by rising cases of cancer, strong government immunization programs, and increasing public awareness. Governments and organizations like WHO, Gavi, and UNICEF are actively funding and supporting large-scale vaccination campaigns, especially in developing countries. Biotechnology giants are coming together to be able to produce big results. Additionally, advancements in vaccine technology, such as mRNA and recombinant vaccines, are accelerating development and production. Increased R&D investments from pharmaceutical companies and biotech firms are leading to innovative immunotherapy drugs for diseases such as HIV, and cancer. Favorable regulatory policies and growing healthcare expenditures further support market expansion. The increasing geriatric population, rising healthcare infrastructure in emerging economies, and expanding global vaccination coverage are expected to sustain the market's long-term growth. For instance, in May 2023, Precigen, Inc. announced the launch of a Phase 2 research after the FDA approved an investigatory new drug (IND) application. The first-in-class PRGN-2009 Off-the-Shelf (OTS) AdenoVerse immunotherapy will be assessed in this study in conjunction with pembrolizumab. Patients with metastatic or recurring cervical cancer are of main focus.

Strategic Collaborations and Mergers Boosts Market Demand

The immunotherapy market is witnessing an increasing number of strategic collaborations, partnerships, and mergers as pharmaceutical companies aim to strengthen their product pipelines and accelerate drug development. Leading companies are forming alliances with biotech firms, research institutions, and healthcare organizations to leverage expertise, share resources, and gain access to innovative technologies. For example, to develop a novel late-stage clinical immuno-oncology pipeline of treatments to overcome cancer immunotherapy resistance, CohBar, Inc. and Morphogenesis, Inc. signed a definitive merger agreement in May 2023. Similarly, MediLink Therapeutics and BioNTech announced a multi-target TMALIN ADC technology platform license deal in May 2024, strengthening their strategic alliance on a global scale. Such collaborations facilitate the rapid development and commercialization of novel immunotherapies by combining expertise in different therapeutic areas. Licensing agreements and joint ventures also play a crucial role in overcoming regulatory challenges and market entry barriers. Moreover, partnerships with universities and research labs enable firms to stay ahead in emerging fields like personalized cancer immunotherapy. These strategic moves are significantly shaping the competitive landscape of the immunotherapy market.

Advancements in Biotechnological Sector Supports Market Expansion

Immunotherapy is being revolutionized by biotechnology, which makes it possible to create more individualized, accurate, and efficient treatments. Recent developments in cell-based therapy, genetic engineering, and the creation of monoclonal antibodies have greatly enhanced patient outcomes. CAR-T cell therapy, which includes altering a patient's immune cells to identify and combat cancer cells, is among the most revolutionary developments. Additionally, by stopping tumor cells from eluding immune responses, checkpoint inhibitors such as PD-1 and CTLA-4 blockers have demonstrated impressive efficacy in treating a variety of malignancies. Furthermore, the creation of next-generation immunotherapies is accelerated by bioinformatics and AI-driven drug discovery developments. Additionally, scientists are developing bispecific antibodies that can target several cancer pathways at once, improving the effectiveness of treatment. The administration of immunotherapy is being further optimized by the incorporation of nanotechnology into medication delivery devices. These continuous technological breakthroughs are expanding the potential of immunotherapy, making it one of the fastest-growing segments in the pharmaceutical industry. For instance, A Phase I/II trial (NCT03665285) to assess the safety and tolerability of NC318 as a possible treatment for advanced or metastatic solid cancers was announced by NextCure, Inc. in September 2023. Evaluations for diseases such as ovarian cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma are part of the experiment.

Cancer Accounting for a Significant Share of the Market

One of the main factors propelling the market for immunotherapy medications is the rising incidence of autoimmune disorders and cancer worldwide. For example, according to a report by the American Cancer Society published in 2025, new cancer cases are expected in the United States are 2,041,910, which is an alarmingly high figure and should be addressed. The most common cancers are breast, lung, colon and rectum, and prostate cancers. In more advanced cases, traditional treatments like radiation and chemotherapy can have little efficacy and serious adverse effects. A promising substitute is immunotherapy, which uses the body's immune system to combat illnesses. In a similar vein, environmental influences, lifestyle modifications, and genetic predispositions are contributing to an increase in autoimmune disorders like psoriasis, multiple sclerosis, and rheumatoid arthritis. Monoclonal antibodies, checkpoint inhibitors, and cytokine-based therapies are examples of immunotherapies that offer focused and durable relief. The increasing patient pool and advancements in diagnostic techniques drive the demand for immunotherapy drugs, making them an essential component of modern treatment strategies.

North America Holds Major Market Share in the Market

North America holds the greatest market share in the global market for immunotherapy drugs because of its strong healthcare system, cutting-edge medical research, and high patient awareness. Many pharmaceutical and biotechnology firms specializing in cancer vaccine research and development are based in the United States. Significant public and corporate investments in the area support steady advancements in vaccine development. Furthermore, North America has a well-established healthcare system and a comparatively quicker clearance process for new medications, which makes advanced treatments and vaccinations more widely available to the populace. Additionally, the existence of cancer vaccine reimbursement programs guarantees that patients can afford their therapies. Furthermore, the market in North America is being supported by rising healthcare costs and growing awareness of the benefits of vaccinations for cancer prevention. Leading pharmaceutical firms like Merck and GlaxoSmithKline help propel product research and commercialization, which in turn helps the market expansion for drugs and vaccines. For instance, the presentation of first comprehensive results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck & Co. Inc.'s anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) was made by Moderna, Inc., a biotechnology company that is at the forefront of messenger RNA (mRNA) therapeutics and vaccines. Adjuvant treatment with mRNA-4157 (V940) in conjunction with KEYTRUDA improved recurrence-free survival (RFS) in the entire intention-to-treat population in a statistically significant and clinically meaningful way. It also decreased the risk of recurrence or death by 44% when compared to KEYTRUDA alone. North America maintains its position as the leading area in the worldwide market due to its comprehensive healthcare regulations and emphasis on cancer prevention.

Future Market Scenario (2025-2032F)

One of the main factors contributing to the anticipated growth of the immunotherapy drugs market is the increasing demand for treatment options to ensure patient safety by delivering the right quality of drug or any other such chemical product. Not only that, but the rising population and cases of cancer are also a factor that will always propel market growth in the future. Given that technology is advancing, we can expect cutting-edge technology in the area also. Players in this market are expanding at an un-paralleled rate, introducing cost-effective and efficient technologies. For instance, OncoC4, Inc., a clinical-stage biopharmaceutical firm committed to the discovery and development of innovative biologicals for cancer therapy among patients, partnered with BioNTech SE in March 2023.

Key Players Landscape and Outlook

The key players in the market are significantly investing in the development of immunotherapy drugs and are utilizing strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing large-cap industry players to increase their presence and, therefore, find new opportunities in this market.

For example, in December 2023, F. Hoffmann-La Roche completed the acquisition of Telavant Holdings, Inc., which is owned by Roivant Sciences and Pfizer. It was anticipated that this agreement will enable Roche to create RVT-3101, a novel treatment for inflammatory bowel conditions like Crohn's disease and ulcerative colitis. The acquisition was a part of Roche's plan to increase its emphasis on gastrointestinal health and provide patients with these disorders with cutting-edge therapies.

Also, in April 2024, Boehringer Ingelheim and 3T Biosciences entered into a second partnership to develop next-generation cancer immunotherapies.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Immunotherapy Drugs Market Outlook, 2018-2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Drug Type
    • 4.2.1.1. Monoclonal Antibodies
    • 4.2.1.2. Vaccines
    • 4.2.1.3. Immunomodulators
  • 4.2.2. By Indication
    • 4.2.2.1. Cancer
    • 4.2.2.2. Infectious Diseases
    • 4.2.2.3. Autoimmune Diseases
    • 4.2.2.4. Neurological Disorder
    • 4.2.2.5. Others
  • 4.2.3. By Route of Administration
    • 4.2.3.1. Intravenous
    • 4.2.3.2. Intramuscular
    • 4.2.3.3. Oral
    • 4.2.3.4. Subcutaneous
    • 4.2.3.5. Other
  • 4.2.4. By Distribution Channel
    • 4.2.4.1. Hospital Pharmacies
    • 4.2.4.2. Retail Pharmacies
    • 4.2.4.3. Online Pharmacies
    • 4.2.4.4. Others
  • 4.2.5. By Region
    • 4.2.5.1. North America
    • 4.2.5.2. Europe
    • 4.2.5.3. Asia-Pacific
    • 4.2.5.4. South America
    • 4.2.5.5. Middle East and Africa
  • 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Drug Type
  • 4.3.2. By Indication
  • 4.3.3. By Route of Administration
  • 4.3.4. By End-user
  • 4.3.5. By Region

5. North America Immunotherapy Drugs Market Outlook, 2018-2032F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Drug Type
    • 5.2.1.1. Monoclonal Antibodies
    • 5.2.1.2. Vaccines
    • 5.2.1.3. Immunomodulators
  • 5.2.2. By Indication
    • 5.2.2.1. Cancer
    • 5.2.2.2. Infectious Diseases
    • 5.2.2.3. Autoimmune Diseases
    • 5.2.2.4. Neurological Disorder
    • 5.2.2.5. Others
  • 5.2.3. By Route of Administration
    • 5.2.3.1. Intravenous
    • 5.2.3.2. Intramuscular
    • 5.2.3.3. Oral
    • 5.2.3.4. Subcutaneous
    • 5.2.3.5. Other
  • 5.2.4. By Distribution Channel
    • 5.2.4.1. Hospital Pharmacies
    • 5.2.4.2. Retail Pharmacies
    • 5.2.4.3. Online Pharmacies
    • 5.2.4.4. Others
  • 5.2.5. By Country Share
    • 5.2.5.1. United States
    • 5.2.5.2. Canada
    • 5.2.5.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Immunotherapy Drugs Market Outlook, 2018-2032F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Drug Type
        • 5.3.1.2.1.1. Monoclonal Antibodies
        • 5.3.1.2.1.2. Vaccines
        • 5.3.1.2.1.3. Immunomodulators
      • 5.3.1.2.2. By Indication
        • 5.3.1.2.2.1. Cancer
        • 5.3.1.2.2.2. Infectious Diseases
        • 5.3.1.2.2.3. Autoimmune Diseases
        • 5.3.1.2.2.4. Neurological Disorder
        • 5.3.1.2.2.5. Others
      • 5.3.1.2.3. By Route of Administration
        • 5.3.1.2.3.1. Intravenous
        • 5.3.1.2.3.2. Intramuscular
        • 5.3.1.2.3.3. Oral
        • 5.3.1.2.3.4. Subcutaneous
        • 5.3.1.2.3.5. Other
      • 5.3.1.2.4. By Distribution Channel
        • 5.3.1.2.4.1. Hospital Pharmacies
        • 5.3.1.2.4.2. Retail Pharmacies
        • 5.3.1.2.4.3. Online Pharmacies
        • 5.3.1.2.4.4. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Immunotherapy Drugs Market Outlook, 2018-2032F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific Immunotherapy Drugs Market Outlook, 2018-2032F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Immunotherapy Drugs Market Outlook, 2018-2032F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Immunotherapy Drugs Market Outlook, 2018-2032F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa
• 9.4. Israel

10. Demand Supply Analysis

11. Value Chain Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Market Trends and Developments

17. Regulatory Framework and Innovation

• 17.1. Regulatory Approvals
• 17.2. Clinical Trials

18. Patent Landscape

19. Case Studies

20. Competitive Landscape

• 20.1. Competition Matrix of Top 5 Market Leaders
• 20.2. SWOT Analysis for Top 5 Players
• 20.3. Key Players Landscape for Top 10 Market Players
  • 20.3.1. Merck & Co., Inc.
    • 20.3.1.1. Company Details
    • 20.3.1.2. Key Management Personnel
    • 20.3.1.3. Products and Services
    • 20.3.1.4. Financials (As Reported)
    • 20.3.1.5. Key Market Focus and Geographical Presence
    • 20.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 20.3.2. GlaxoSmithKline plc
  • 20.3.3. F. Hoffmann-La Roche Ltd
  • 20.3.4. AbbVie Inc.
  • 20.3.5. Amgen Inc.
  • 20.3.6. Bristol-Myers Squibb Company
  • 20.3.7. Novartis AG
  • 20.3.8. Eli Lilly and Company
  • 20.3.9. Johnson & Johnson Services, Inc.
  • 20.3.10. AstraZeneca plc

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

21. Strategic Recommendations

22. About Us and Disclaimer