Immunotherapy Drugs Market

Market Definition

Immunotherapy drugs are pharmaceutical agents designed to modulate the body’s immune system to treat conditions such as cancer, autoimmune disorders, and infectious diseases. These drugs function by either enhancing immune activity to identify and destroy harmful cells or downregulating immune responses when excessive activation contributes to disease progression.

Immunotherapy Drugs Market Overview

The global immunotherapy drugs market size was valued at USD 260.12 billion in 2024 and is projected to grow from USD 273.59 billion in 2025 to USD 409.89 billion by 2032, exhibiting a CAGR of 5.95% during the forecast period.

Market growth is attributed to the rising adoption of immunotherapy drugs in treating rare and hard-to-treat cancers driven by their targeted mechanisms and reduced side effects compared to traditional therapies. The market is further progressing due to increasing regulatory approvals for multi-indication use in solid tumors and hematologic malignancies, reinforcing confidence in immune-based oncology treatments.

Key Highlights:

1. The immunotherapy drugs industry size was recorded at USD 260.12 billion in 2024.
2. The market is projected to grow at a CAGR of 5.95% from 2025 to 2032.
3. North America held a market share of 42.02% in 2024, with a valuation of USD 109.30 billion.
4. The monoclonal antibodies segment garnered USD 114.45 billion in revenue in 2024.
5. The cancer segment is expected to reach USD 235.78 billion by 2032.
6. The oral segment is anticipated to grow at a CAGR of 7.07% over the forecast period.
7. The hospitals & clinics segment held a market share of 54.88% in 2024.
8. Asia Pacific is anticipated to grow at a CAGR of 6.35% through the projection period.

Major companies operating in the market are Bristol-Myers Squibb Company, Adaptimmune, BioNTech SE, Cellectis SA, Merck & Co., Inc., Novartis AG, Pfizer Inc., Actym Therapeutics, Inc., Autolus Therapeutics, BPS Bioscience, Inc., Gilead Sciences, Inc., Crown Bioscience, Lilly, GenScript and ImmunityBio, Inc.

Additionally, rising R&D investments are fueling significant advancements in immunotherapy by enabling the development of targeted and personalized treatment approaches. Increased funding is allowing researchers to explore novel immune pathways to improve therapeutic efficacy and reduce side effects.

These investments are supporting clinical trials and the rapid translation of scientific discoveries into approved therapies. In response, pharmaceutical companies are accelerating innovation in cancer and autoimmune disease treatments which are contributing to the steady growth of the immunotherapy drugs market.

• According to the National Center for Science and Engineering Statistics, U.S. R&D spending reached USD 940 billion in 2023, with USD 292 billion allocated to research, reflecting a robust commitment to biomedical innovation. This surge in funding is significantly driving the market by enabling the development of advanced immune-based treatments for cancer and chronic diseases.

Market Driver

Increasing Incidence of Cancer

The increasing incidence of cancer is significantly driving the immunotherapy drugs market as rising global cancer cases are creating a greater need for effective and targeted treatment options. Immunotherapies are gaining preference due to their ability to harness the body’s immune system to selectively attack cancer cells while minimizing damage to healthy tissue. 

Limitations associated with conventional treatments, such as limited efficacy and severe side effects, are accelerating the adoption of immunotherapeutic approaches to improve clinical outcomes.

• According to the Surveillance, Epidemiology, and End Results (SEER) Cancer Stat Facts, an estimated 2,041,910 new cancer cases are projected in the U.S. in 2025. This rising disease burden highlights the growing need for advanced treatment approaches, including immunotherapy, to improve patient outcomes and address gaps in conventional care.

Market Challenge

Limited Efficacy in All Patients

A key challenge in the immunotherapy drugs market is the limited and inconsistent efficacy across diverse patient populations. Many patients show significant clinical improvement, but a large proportion do not respond effectively due to factors such as tumor heterogeneity, immune resistance mechanisms, and genetic differences.  These inconsistencies hinder the ability to standardize treatment protocols and predict outcomes effectively.

To address this challenge, companies are increasingly investing in biomarker discovery and precision medicine initiatives to enhance patient selection and maximize the therapeutic efficacy of immunotherapy treatments.

Companies are also developing combination therapies that enhance immune response and overcome resistance mechanisms. Additionally, advanced genomic and transcriptomic profiling tools are being integrated into clinical trials to better understand patient variability and tailor immunotherapy treatments more effectively.

Market Trend

Advancing RNA-Based Therapeutics with Self-Amplifying RNA Platforms

The development of self-amplifying RNA (saRNA) platforms is accelerating progress in RNA-based therapeutics by enabling higher protein expression from smaller RNA doses.

This efficiency supports lower manufacturing costs and enhances the effectiveness of applications such as cancer immunotherapy, vaccines, and gene therapies. The adoption of saRNA platforms is steadily transforming RNA-driven therapeutic innovation to meet the rising demand for effective and scalable solutions in advancing next-generation therapies targeting complex diseases such as cancer and genetic disorders.

• In May 2024, GenScript Biotech Corporation launched its self-amplifying RNA (saRNA) synthesis service to support vaccine, cancer immunotherapy, and gene therapy development. This next-generation RNA platform enables robust protein expression at lower dosages, potentially reducing production costs and improving therapeutic efficacy.

Immunotherapy Drugs Market Report Snapshot

Segmentation	Details
By Drug Type	Monoclonal Antibodies (Naked Monoclonal Antibodies, Conjugated Monoclonal Antibodies, Bispecific Monoclonal Antibodies), Immune Checkpoint Inhibitors,(PD-1/PD-L1 Inhibitors, CTLA-4 Inhibitors), Interferons & Interleukins,(Interferons (Alpha, Beta), Interleukins (IL-2, IL-12, etc.), Vaccines (Cancer Vaccines, Preventive Vaccines), Others (CAR-T Therapies, Cytokines)
By Therapy Area	Cancer (Lung Cancer, Breast Cancer, Melanoma, Prostate Cancer, Others), Autoimmune & Inflammatory Diseases (Rheumatoid Arthritis, Multiple Sclerosis, Crohn’s Disease), Infectious Diseases (Hepatitis B, Hepatitis C, HIV, HPV), Others
By Route of Administration	Intravenous, Subcutaneous, Oral
By End-User Industry	Hospitals & Clinics, Research Institutes, Others
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific
	Middle East & Africa: Turkey, U.A.E., Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

 Market Segmentation:

• By Drug Type (Monoclonal Antibodies, Immune Checkpoint Inhibitors, Interferons & Interleukins, Vaccines, and Others): The monoclonal antibodies segment earned USD 114.45 billion in 2024 due to their high specificity, clinical efficacy, and widespread adoption in oncology and chronic disease treatment.
• By Therapy Area (Cancer, Autoimmune & Inflammatory Diseases, Infectious Diseases, and Others): The cancer segment held 64.00% of the market in 2024, due to strong pipeline activity, high disease prevalence, and growing acceptance of immuno-oncology therapies.
• By Route of Administration (Intravenous, Subcutaneous, and Oral): The intravenous segment is projected to reach USD 231.69 billion by 2032, owing to its rapid bioavailability and preference for hospital-based delivery of complex biologics.
• By End-User Industry (Hospitals & Clinics, Research Institutes, and Others): The hospitals & clinics segment is anticipated to grow at a CAGR of 5.88% over the forecast period, propelled by rising patient inflow, improved immunotherapy access, and increasing institutional spending on oncology care.

Immunotherapy Drugs Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

North America immunotherapy drugs market accounted for a share of around 42.02% in 2024, with a valuation of USD 109.30 billion. This dominance is attributed to the strong presence of advanced research infrastructure, rising cancer incidence, and the early adoption of innovative treatment platforms in the region.

The market is witnessing increasing strategic acquisitions that are extending the application of immunotherapy across a wide range of cancer types. Moreover, the market is further driven by sustained investment by biotechnology companies aiming to enhance treatment efficacy and improve long-term patient outcomes. Players in the region are integrating pre-clinical and clinical assets to build diverse oncology pipelines, thereby driving market growth across North America.

• In April 2025, OS Therapies completed the acquisition of Advaxis Immunotherapies’ clinical, from Ayala Pharmaceuticals. It supports three clinical-stage and eight pre-clinical immunotherapy candidates targeting over 30 cancers, expanding OS Therapies’ pipeline and strengthening its position in the oncology immunotherapy market with long-term IP protection through 2040.

The Asia Pacific immunotherapy drugs industry is set to grow at a robust CAGR of 6.35% over the forecast period. This growth is attributed to the rising prevalence of cancer and expanding investments by pharmaceutical companies across the Asia Pacific.

The region is witnessing increased regulatory approvals and clinical trial activity which is accelerating the availability of advanced immunotherapy drugs in the region. The market is also benefitting from increased efforts to boost local manufacturing  and improved access to novel treatments in countries such as China and India.

Moreover, the presence of cost-effective manufacturing infrastructure and a large patient pool is encouraging global and domestic players to scale their operations within the region. Market players in the region are focusing on collaborations with research institutions to enhance drug development capabilities, thereby fueling regional market growth.

• In May 2025, Sun Pharma acquired Checkpoint Therapeutics to gain access to UNLOXCYT, the only FDA-approved anti-PD-L1 therapy for advanced cutaneous squamous cell carcinoma. Through this acquisition, the company aims to expand its presence in immunotherapy and oncology, with a focus on innovative treatments in the onco-dermatology segment.

Regulatory Frameworks

• In the U.S., the Food and Drug Administration (FDA) regulates immunotherapy drugs through its Center for Biologics Evaluation and Research (CBER), overseeing product approval, clinical trial design, safety evaluations, and post-marketing surveillance. It ensures compliance with manufacturing standards, evaluates risk-benefit profiles, and monitors adverse events to uphold public safety and therapeutic efficacy in biologics and cell-based therapies.
• In China, the National Medical Products Administration (NMPA) regulates the approval, production, and distribution of immunotherapy drugs in China. It evaluates clinical trial data, manufacturing practices, and quality control processes.
• In India, the Central Drugs Standard Control Organization (CDSCO) regulates immunotherapy drugs by approving clinical trials, issuing manufacturing licenses, and evaluating safety and efficacy data. Under the Ministry of Health, it ensures compliance with the Drugs and Cosmetics Act, oversees pharmacovigilance programs, and monitors ethical conduct in trials, ensuring that biologics meet national regulatory and quality standards.
• In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) oversees immunotherapy drug regulation by evaluating clinical data, issuing marketing authorizations, and conducting post-market safety monitoring. It ensures that cell and gene therapies meet UK-specific manufacturing, labeling, and distribution standards.

Competitive Landscape

Major players in the immunotherapy drugs industry are expanding their pipelines through the acquisition of clinical-stage assets targeting rare and pediatric cancers. They are increasingly focusing on highly differentiated therapies to serve small, high-need patient populations. 

Integrating late-stage novel candidates is helping companies strengthen their position in niche oncology segments through targeted innovation and strategic portfolio growth. This approach is enhancing long-term development capabilities while addressing gaps in current treatment options.

• In April 2024, Essential Pharma acquired Renaissance Pharma to add Hu14.18K322A, a Phase II clinical-stage immunotherapy for high-risk neuroblastoma, to its portfolio. It aims to  focus on clinically differentiated treatments for small patient populations. The acquisition expands the company’s role in pediatric oncology and immunotherapy.

List of Key Companies in Immunotherapy Drugs Market:

• Bristol-Myers Squibb Company
• Adaptimmune
• BioNTech SE
• Cellectis SA
• Merck & Co., Inc
• Novartis AG
• Pfizer Inc
• Actym Therapeutics, Inc
• Autolus Therapeutics
• BPS Bioscience, Inc.
• Gilead Sciences, Inc.
• Crown Bioscience
• Lilly
• GenScript
• ImmunityBio, Inc.

Recent Developments (M&A)

• In February 2024, AbbVie acquired ImmunoGen, to gain access to ELAHERE, a FDA-approved antibody-drug conjugate (ADC) for folate receptor-alpha positive platinum-resistant ovarian cancer. This acquisition aims to strengthen AbbVie’s oncology pipeline with next-generation ADCs targeting solid tumors and rare hematologic cancers.
• In June 2024, Merck secured its 40th FDA approval for Keytruda (pembrolizumab) in combination with chemotherapy for treating advanced or recurrent endometrial cancer in adults. The approval is based on Phase 3 NRG-GY018 trial results, which showed a 70% reduction in disease progression.