Global Immunomodulators Market Size, Share, and COVID-19 Impact Analysis, By Product (Immunostimulants, Immunoadjuvants, and Immunosuppressants), By Application (Human Immunodeficiency Virus (HIV), Respiratory Diseases, and Oncology), By End-User (Specialty Clinics, Hospitals, Homecare, and Others), By Distribution Channel (Retail Pharmacy, Online Pharmacy, Hospital Pharmacy, and Others), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2023 - 2033

Global Immunomodulators Market Insights Forecasts to 2033

• The Global Immunomodulators Market Size Was Estimated at USD 211.27 Million in 2023
• The Market Size is Expected to Grow at a CAGR of around 6.11% from 2023 to 2033
• The Worldwide Immunomodulators Market Size is Expected to Reach USD 382.21 Million by 2033
• Asia Pacific is predicted to grow at the fastest CAGR throughout the projection period

The Global Immunomodulators Market Size is Predicted to Exceed USD 382.21 Million by 2033, Growing at a CAGR of 6.11% from 2023 to 2033. The market growth is driven by the rising prevalence of inflammatory diseases and immune-related diseases, government and private programs that increase the awareness of autoimmune diseases and their treatment, innovations in biotechnological and pharmaceutical research, upsurge in the geriatric population, and growth in healthcare expenditure.

Market Overview

The immunomodulators market aims to develop, produce, and distribute the immunomodulator drugs that are used in the management of several autoimmune diseases. Immunomodulators are therapeutic or prophylactic agents that function by stimulating or suppressing natural and adaptive immune mechanism that supports the human body in tackling various medical conditions. According to the clinical perspective, immunomodulators are classified into three categories: immunoadjuvants, immunostimulants, and immunosuppressants. Immunoadjuvants such as Bacillus Calmette-Guerin (BCG), Freund’s adjuvant, etc., serve as an immune enhancer of antigenic components of vaccines and are utilized in vaccine development for the generation of greater immune responses. Immunostimulants, including cytokines (interleukins (IL-2), interferons, etc.), microbial toxins, venom, herb, etc., stimulate either cellular or humoral immune responses and are widely used in cases of allergy, immunodeficiency, autoimmunity, and cancer. Immunosuppressants such as corticosteroids, adalimumab, tacrolimus, cyclosporine, etc., suppress the activation of the immune system and are used in the treatment of myasthenia gravis, rheumatoid arthritis, and Grave’s disease.

The rising prevalence of autoimmune diseases drives the need for immunomodulators for its management. For instance, the data provided by the National Library of Medicine reveals that annually, the overall worldwide incidence and prevalence of autoimmune diseases are 19.1% and 12.5%, respectively.

The Indian Council of Medical Research (ICMR) and the Department of Science and Technology (DST) are actively funding and supporting research on immunomodulators in India. The ICMR provides financial assistance for immunomodulator-focused projects, while the DST funds projects at institutions like AIIMS to explore their use in cancer treatment. The growing awareness and the expansion of the biotechnology and pharmaceutical sectors accelerate the growth of the immunomodulators market.

Report Coverage

This research report categorizes the global immunomodulators market based on various segments and regions, forecasts revenue growth, and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the global immunomodulators market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the global immunomodulators market.

Driving Factors:

The immunomodulator market is experiencing growth due to the increasing incidence of chronic diseases such as asthma, allergic conditions, cancer, and multiple sclerosis. Factors contributing to this growth include organ transplantation cases, early immunomodulator therapy for Crohn's disease treatment, awareness of inflammatory bowel diseases, growing autoimmune diseases, and drug resistance. The growing geriatric population worldwide is expected to favor immunomodulators due to their higher proneness to developing diseases. The number of people above 65 years is projected to double in the coming years, causing a demand for immunomodulator cases globally.

A growing awareness of monoclonal therapy in immunomodulation is also contributing to market growth. Monoclonal antibodies are being adopted for various diseases, such as multiple sclerosis, Crohn's disease, rheumatoid arthritis, and non-Hodgkin's Lymphoma. Immunomodulators, particularly immune checkpoint inhibitors like PD-1 and PD-L1 inhibitors, have demonstrated efficacy across various cancer types, instigating a paradigm shift toward immunotherapy.

Continuous research in oncology uncovers new targets and mechanisms for immunomodulation within the tumor microenvironment. This ongoing exploration leads to the development of innovative immunomodulators and synergistic therapeutic combinations, further expanding the market. As the oncology community embraces immunotherapy as a standard of care, the immunomodulators market is poised for sustained expansion.

Restraining Factors

Rising infection risk, occurrence of progressive multifocal leukoencephalopathy, and high doses of immunomodulator drugs may lead to adverse effects such as alopecia, fatigue, skin disorders, and gastrointestinal disorders, and stringent clinical study regulations may impede market growth.

Market Segmentation

The global immunomodulators market share is classified into product, application, end-user, and distribution channel.

• The immunostimulants segment dominated the market with 46.84% of the share in 2023 and is anticipated to grow at a significant CAGR throughout the forecast period.

Based on the product, the global immunomodulators market is categorized into immunostimulants, immunoadjuvants, and immunosuppressants. Among these, the immunostimulants segment dominated the market with 46.84% of the share in 2023 and is anticipated to grow at a significant CAGR throughout the forecast period. The segment growth is attributed to an increased geriatric population, targeted therapy of immunostimulants gives a better outcome, improved immunological response, personalized medicines, fewer side effects, provides better protection against infectious disease, growing use of herbal immunostimulants such as genistein, curcumin, and aloevera, and rising cases of cancer. For instance, the International Agency for Research on Cancer (IARC) reported that in 2022, globally, 20 million new cancer cases were identified, and 9.7 million deaths were estimated.

• The oncology segment accounted for the largest market share of 57.18% in 2023 and is anticipated to grow at a significant CAGR throughout the projected timeframe.

Based on the application, the global immunomodulators market is categorized into human immunodeficiency virus (HIV), respiratory diseases, and oncology. Among these, the oncology segment accounted for the largest market share of 57.18% in 2023 and is anticipated to grow at a significant CAGR throughout the projected timeframe. The segmental expansion is owing to growing awareness of cancer through various government programs, rising cases of cancer patients, and widespread use of immunomodulators in cancer treatment. Immunomodulators, including cytokines and immune check inhibitors, are intended to enhance the immune system of the body.

• The hospitals segment held the largest share in 2023 and is expected to grow at a significant CAGR throughout the projected timeframe.

Based on the end-user, the global immunomodulators market is categorized into specialty clinics, hospitals, homecare, and others. Among these, the hospitals segment held the largest share in 2023 and is expected to grow at a significant CAGR throughout the projected timeframe. This segment growth is ascribed to frequent medical attention to patients with chronic diseases, specialized healthcare services, availability of healthcare insurance, provision of advanced and innovative medical devices, facility of preventive healthcare services such as wellness programs, regular checkups of the hematological profile and vaccinations, physical and rehabilitation centers for the patients with immune-mediated diseases.

• The hospital pharmacy segment accounted for the largest share in 2023 and is predicted to grow at a substantial CAGR throughout the projected timeframe.

Based on the distribution channel, the global immunomodulators market is categorized into retail pharmacy, online pharmacy, hospital pharmacy, and others. Among these, the hospital pharmacy segment accounted for the largest share in 2023 and is predicted to grow at a substantial CAGR throughout the projected timeframe. The growth of this segment is accompanied by the collaborations of the hospital pharmacies with the doctors and healthcare professionals, ensuring better outcomes for the patient's health, compounding medication, availability of large stocks of immunomodulator medications, provision of cost-effective medication management strategies, and better coordination of hospital pharmacists with hospital staff and doctors reduces the risk of medication errors.

Regional Segment Analysis of the Global Immunomodulators Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

North America is anticipated to hold the largest share of the global immunomodulators market over the predicted timeframe.

North America is anticipated to hold the largest share of the global immunomodulators market over the predicted timeframe.A rise in chronic illnesses, an aging population, and an inclination for immunomodulatory medications are the drivers extending North America's market dominance. The rapid adoption of new treatments is considered conceivable by the region's sophisticated healthcare system, and regulatory bodies such as the FDA enforce stringent safety and effectiveness requirements for newer immunomodulators. In North America, the United States (U.S.) has the highest market share owing to its strong healthcare spending, advantageous reimbursement rules, emphasis on research and development, and awareness of early disease detection.

Asia Pacific is anticipated to grow at the fastest CAGR throughout the projected timeframe. The increasing prevalence of infectious diseases, cancers, and autoimmune disorders, in conjunction with the aging population's increased susceptibility to immune-related ailments, is driving the immunomodulators market in the Asia-Pacific area. Accessibility to immunomodulatory therapy is being improved by the region's superior healthcare infrastructure and growing investments. Research and development are being encouraged by collaborations with international pharmaceutical companies which is producing new immunomodulatory drugs. In Asia Pacific, Japan is predicted to grow at the fastest pace, attributed to the rising proportion of the geriatric population, increasing prevalence of chronic diseases, and high investments in the research and development sector.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the global immunomodulators market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Merck and Co., Inc.
• Atox Bio
• Horizon Therapeutics plc
• Pfizer Inc.
• Squarex
• Novartis AG
• Amgen Inc.
• Reso Ther Pharma
• Takeda Pharmaceutical Company Limited
• BioRap Technologies Ltd.
• Johnson & Johnson Services, Inc.
• GlaxoSmithKline plc.
• ZERIA Pharmaceutical Co., Ltd.
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Recent Developments

• In February 2025, ImmunityBio, Inc., a leading immunotherapy company, disclosed that the U.S. Food and Drug Administration (FDA) has authorized an expanded access program (EAP) to provide a vital alternative source of BCG, a standard-of-care medicine in the management of bladder cancer, to patients in the United States.

• In February 2025, Nexus Pharmaceuticals, LLC announced the U.S. Food and Drug Administration (FDA) approval of Tacrolimus Injection (5mg/ml). Tacrolimus injection is developed as an immunosuppressive drug that is used in various diseases, enhances the quality of life, and reduces the risk of organ rejection. It is available in the vial form.

• In January 2025, Charles River Laboratories International Inc. incorporated Akron Bio’s Closed System Solutions (CSS) liquid cytokines into its Cell Therapy Flex Platform for Process Development, enhancing closed-system processing, streamlining operations, minimizing risk, and improving process robustness.

• In July 2024, Hanmi Pharmaceutical Co., Ltd., announced the initiation of a phase-I clinical trial under the Food and Drug Administration (FDA) approval of the phase-I Investigational New Drug Application (IND) for its next-generation immunomodulatory anticancer drug (HM16390). These trials assessed the safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics of HM16390 in patients with advanced solid tumors. HM16390 is a novel IL-2 variant and key regulator for immune function.

Market Segment

This study forecasts revenue at global, regional, and country levels from 2023 to 2033. Spherical Insights has segmented the global immunomodulators market based on the below-mentioned segments:

Global Immunomodulators Market, By Product

• Immunostimulants
• Immunoadjuvants
• Immunosuppressants

Global Immunomodulators Market, By Application

• Human Immunodeficiency Virus (HIV)
• Respiratory Diseases
• Oncology

Global Immunomodulators Market, By End-User

• Specialty Clinics
• Hospitals
• Homecare
• Others

Global Immunomodulators Market, By Distribution Channel

• Retail Pharmacy
• Online Pharmacy
• Hospital Pharmacy
• Others

Global Immunomodulators Market, By Regional

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa