Global Immunomodulators 2026-2031 - Rising Prevalence of Autoimmune Diseases Drives Market Growth
Dublin, Aug. 20, 2026 (GLOBE NEWSWIRE) -- "Immunomodulators - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.
Global Immunomodulators Market to Reach USD 349.78 Billion by 2031 as Precision Immunotherapy Adoption Accelerates
The global immunomodulators market is estimated to reach USD 260.03 billion in 2026, rising from USD 245.08 billion in 2025. The market is projected to expand at a compound annual growth rate of 6.11% from 2026 to 2031, reaching USD 349.78 billion by the end of the forecast period. Growth is being supported by the increasing burden of cancer and autoimmune diseases, wider adoption of targeted immunotherapies, and continued advances in biomarker-guided treatment.
Rising Cancer and Autoimmune Disease Burden Drives Demand
The growing prevalence of cancer and autoimmune disorders is expanding the patient population eligible for immunomodulator therapies. The International Agency for Research on Cancer projects that annual global cancer incidence will reach 35 million new cases by 2050, representing a 77% increase from 2022. In the United States alone, approximately 50 million people are living with autoimmune disorders, according to the National Institutes of Health.
Aging populations in developed economies, combined with improving diagnostic capabilities in emerging markets, are expected to reinforce demand for immune-focused treatments. Precision medicines targeting specific molecular pathways are gaining attention as healthcare providers seek alternatives to conventional therapies that may offer lower tolerability or limited effectiveness for certain patient groups.
Targeted Immunotherapy Gains Ground Over Conventional Treatment
Targeted immunotherapy is becoming increasingly important across oncology and autoimmune disease care. Checkpoint inhibitors, cytokine modulators, cell therapies, and combination regimens are demonstrating the potential to improve treatment outcomes while supporting more individualized patient management.
Recent clinical developments illustrate this shift. In the Phase III IMforte study, Roche's Tecentriq combined with lurbinectedin reduced the risk of disease progression or death by 46% in extensive-stage small-cell lung cancer while maintaining a manageable safety profile. Subcutaneous formulations such as Tecentriq Hybreza can also reduce administration time to approximately seven minutes, helping improve clinical efficiency and patient convenience.
Research involving dostarlimab in mismatch repair-deficient rectal cancer has further highlighted the potential of biomarker-selected immunotherapy. These advances are encouraging healthcare systems to incorporate precision immune treatments earlier in care pathways where supporting clinical evidence is available.
Companion Diagnostics Support Precision Dosing
Healthcare systems with established laboratory infrastructure are increasingly using companion diagnostics and biomarkers to guide immunomodulator selection and dosing. PD-L1 expression testing supports checkpoint inhibitor decisions, while molecular assays measuring cytokine activity may help refine the use of interleukin blockers and other targeted therapies.
More accurate patient stratification can improve response rates, reduce unnecessary toxicity, and strengthen the economic case for premium treatments. Biomarker-guided care may also support outcomes-based reimbursement agreements as payers place greater emphasis on measurable clinical value.
Immunostimulants Expected to Record Strong Growth
Immunosuppressants accounted for 50.62% of global immunomodulators market revenue in 2025. Calcineurin inhibitors, mTOR inhibitors, corticosteroids, antiproliferative agents, and monoclonal antibodies remain central to transplant medicine and chronic autoimmune disease treatment. Although biosimilar competition is placing pressure on prices, greater affordability is helping sustain treatment volumes and broaden patient access.
Immunostimulants are forecast to grow at a faster CAGR of 9.74% through 2031. Innovation involving CAR-T therapies, checkpoint agonists, vaccine adjuvants, Toll-like receptor agonists, bispecific engagers, and interleukin-based treatments is expanding the category's clinical potential. The approval of ImmunityBio's ANKTIVA, an IL-15 agonist, underscores the momentum behind therapies designed to activate immune responses against cancer.
Cell-surface receptor blockade represented 41.88% of market revenue in 2025, supported by established clinical experience with targets such as PD-1, CTLA-4, and IL-6. Epigenetic modulation is expected to post a 9.21% CAGR through 2031 as developers investigate therapies capable of resetting immune-cell gene expression. These treatments may offer durable disease control, oral administration, and broader tissue penetration, although long-term safety and efficacy data will remain critical to adoption.
Regional Immunomodulators Market Outlook
North America generated 38.02% of global market revenue in 2025, supported by extensive research and development pipelines, established reimbursement systems, advanced manufacturing capacity, and accelerated regulatory review programs. The region maintains a strong position in checkpoint inhibitors and CAR-T therapies. Growing biosimilar penetration is creating pricing pressure but is also expanding access to established biologic treatments.
Asia-Pacific is projected to be the fastest-growing regional market, advancing at a CAGR of 7.48%. China and India are expanding biologics manufacturing capacity through public incentives, while Japan continues to invest in mRNA and cell therapy infrastructure. Regulatory alignment with international standards is also helping streamline product reviews across the region. Rising household incomes and broader healthcare coverage are expected to support the adoption of innovative immunomodulators.
Europe continues to benefit from centralized regulatory procedures and policies encouraging biosimilar adoption. The region's development pipeline includes treatments focused on immune tolerance and targeted pathway modulation. Meanwhile, investment in oncology facilities and advanced therapies is supporting market development in the Middle East and Africa, particularly in Saudi Arabia and the United Arab Emirates.
Looking ahead, artificial intelligence-enabled drug discovery, precision biomarkers, novel delivery methods, and next-generation immune therapies are expected to create new opportunities across the immunomodulators market. However, high treatment costs, complex safety monitoring requirements, and biosimilar-driven price erosion will remain important considerations for manufacturers, healthcare providers, and payers through 2031.
Key Topics Covered:
1 Introduction
1.1 Study Assumptions & Market Definition
1.2 Scope of the Study
2 Research Methodology
3 Executive Summary
4 Market Landscape
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Burden of Cancer & Autoimmune Diseases
4.2.2 Growing Investment in Biologics R&D
4.2.3 Adoption of Targeted Immunotherapy Over Conventional Care
4.2.4 AI-Enabled Discovery of Next-Gen Immunomodulators
4.2.5 Uptake of Companion-Diagnostic Biomarkers for Precision Dosing
4.2.6 Post-COVID Fast-Track Pathways for Antiviral Immunomodulators
4.3 Market Restraints
4.3.1 Stringent Regulatory Guidelines
4.3.2 High Cost of Treatment
4.3.3 Biosimilar Price Erosion Pressure
4.3.4 Immunotoxicity-Driven Label Warnings
4.4 Regulatory Landscape
4.5 Porter's Five Forces Analysis
4.5.1 Threat of New Entrants
4.5.2 Bargaining Power of Buyers
4.5.3 Bargaining Power of Suppliers
4.5.4 Threat of Substitutes
4.5.5 Intensity of Competitive Rivalry
5 Market Size & Growth Forecasts (Value, USD)
5.1 By Product Type
5.1.1 Immunosuppressants
5.1.1.1 Corticosteroids
5.1.1.2 Calcineurin Inhibitors
5.1.1.3 mTOR Inhibitors
5.1.1.4 Anti-proliferative Agents
5.1.1.5 Monoclonal Antibodies
5.1.2 Immunostimulants
5.1.2.1 Cytokines & Interleukins
5.1.2.2 Checkpoint Agonists
5.1.2.3 Vaccine Adjuvants
5.1.2.4 Toll-like Receptor Agonists
5.1.2.5 Small-molecule Modulators
5.2 By Mechanism of Action
5.2.1 Cytokine Modulation
5.2.2 Cell-surface Receptor Blockade
5.2.3 Signal-transduction Inhibition
5.2.4 Epigenetic Modulation
5.3 By Application
5.3.1 Oncology
5.3.2 Autoimmune Disorders
5.3.2.1 Rheumatoid Arthritis
5.3.2.2 Multiple Sclerosis
5.3.2.3 Inflammatory Bowel Disease
5.3.2.4 Systemic Lupus Erythematosus
5.3.3 Respiratory
5.3.4 HIV
5.3.5 Other Applications
5.4 By End-User
5.4.1 Hospitals
5.4.2 Specialty Clinics
5.4.3 Home-care Settings
5.4.4 Other End-Users
5.5 By Route of Administration
5.5.1 Parenteral
5.5.2 Oral
5.5.3 Topical
5.6 Geography
5.6.1 North America
5.6.1.1 United States
5.6.1.2 Canada
5.6.1.3 Mexico
5.6.2 Europe
5.6.2.1 Germany
5.6.2.2 United Kingdom
5.6.2.3 France
5.6.2.4 Italy
5.6.2.5 Spain
5.6.2.6 Rest of Europe
5.6.3 Asia-Pacific
5.6.3.1 China
5.6.3.2 Japan
5.6.3.3 India
5.6.3.4 Australia
5.6.3.5 South Korea
5.6.3.6 Rest of Asia-Pacific
5.6.4 Middle East & Africa
5.6.4.1 GCC
5.6.4.2 South Africa
5.6.4.3 Rest of Middle East & Africa
5.6.5 South America
5.6.5.1 Brazil
5.6.5.2 Argentina
5.6.5.3 Rest of South America
5.6.5.3.1 Rest of Africa
6 Competitive Landscape
6.1 Market Concentration
6.2 Market Share Analysis
6.3 Company Profiles (includes Global-level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
6.3.1 F. Hoffmann-La Roche Ltd
6.3.2 Bristol-Myers Squibb Co.
6.3.3 Novartis AG
6.3.4 Merck & Co., Inc.
6.3.5 Amgen Inc.
6.3.6 Pfizer Inc.
6.3.7 Eli Lilly and Co.
6.3.8 Biogen Inc.
6.3.9 AstraZeneca plc
6.3.10 Gilead Sciences Inc.
6.3.11 AbbVie Inc.
6.3.12 Astellas Pharma Inc.
6.3.13 Horizon Therapeutics
6.3.14 Biocon Ltd.
6.3.15 CSL Behring
6.3.16 Sanofi SA
6.3.17 Takeda Pharmaceutical Co.
6.3.18 Regeneron Pharmaceuticals
6.3.19 Seagen Inc.
6.3.20 Acrotech Biopharma
6.3.21 Step-Pharma
7 Market Opportunities & Future Outlook
7.1 White-space & Unmet-Need Assessment
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