Immunomodulator Therapeutics Market, Global, 2024-2030

Mechanism-targeted Approaches are Driving Transformational Growth by Enabling Innovation in Autoimmune, Oncology, and Inflammatory Therapies

This research service offers a comprehensive analysis of the global immunomodulator therapeutics market, specifically targeting inflammatory disorders in the immunology, gastrointestinal (GI), and dermatology segments. The report defines this market through products designed to modify and regulate pathological immune responses, either by inhibiting or suppressing them. It categorizes the market by modality and key indications, providing a 6-year revenue forecast for global immunomodulator prescription drugs, alongside an analysis of key industry participants. The geographic scope encompasses North America, Europe, Asia-Pacific (APAC), the Middle East and Africa (MEA), and Latin America (LATAM), with regional revenue share estimates presented on a best-effort basis. The report also discusses prevalent and emerging business models, analyzes trends in market access and reimbursement for immunomodulator therapies, and offers competitive assessments and revenue share analyses. It examines the factors driving and restraining growth in this space, offering insights into drug development trends, partnerships, and the investment landscape. The report highlights key companies pioneering disruptive virtual care technologies and adjunctive therapies for effective disease management. Based on clinical needs, technological advancements, business models, and competitive dynamics, the report identifies the growth opportunities emerging from this space for market players and stakeholders to leverage. The base year is 2024, and the forecast period is from 2025 to 2030.

Revenue Forecast

Revenue estimate for the base year 2024 is $93 billion with a CAGR of 9.0% for the study period 2024-2030.

Scope of Analysis

• This research service provides a detailed overview of the global immunomodulator therapeutics market for immunology, gastrointestinal (GI), and dermatology inflammatory disorders.
• The report defines the market by products designed to treat diseases by modifying (inhibiting or suppressing) and regulating a pre-existing, pathological immune response. The market is further broken down by modality and key indications.
• It forecasts the potential revenue of global immunomodulator prescription drugs and provides a 6-year revenue forecast, including an analysis of industry participants.
• The research provides regional revenue share estimates of the overall market on a best-effort basis. The geographic scope includes North America, Europe, Asia-Pacific (APAC), the Middle East and Africa (MEA) and Latin America (LATAM).
• It discusses the most prevalent and emerging business models, market access, and reimbursement trends for immunomodulator therapies. It also covers revenue share analysis and competitive assessments and identifies key market trends.
• The report highlights the primary market drivers and restraints, drug development trends, partnerships, and investment and consolidation activities that affect market growth.
• It provides brief insights into game-changing companies developing disruptive virtual care technologies and adjunctive therapies for disease management.
• It identifies emerging growth opportunities for industry players based on clinical needs, technology trends, business models, and competitive outlooks.

The Impact of the Top 3 Strategic Imperatives on the Immunomodulator Therapeutics Industry

Disruptive Technologies

• Why: There is an increasing incidence of autoimmune diseases, particularly impacting women. Limitations in existing therapies demand more targeted applications.
• Frost Perspective: A new wave of drug classes (JAK1, IL, calcineurin, TNF?, TYK2, PDE4), across small molecules, biologics, and cell and gene therapies, will emerge, offering enhanced efficacy and safety profiles for treating autoimmune and inflammatory conditions. There will be a growing trend towards combination therapies that utilize multiple mechanisms of action to achieve better clinical outcomes.

Internal Challenges

• Why: The industry is moving toward an extended patent cliff, with several revenue-generating blockbuster drugs like Humira and Stelara losing their exclusivity, leading to revenue losses and increased biosimilar competition, creating an urgent need for pipeline growth, and driving increased research and development (R&D). Resource demands for R&D can strain budgets, especially for smaller biotech firms.
• Frost Perspective: Companies may increasingly seek strategic partnerships to share costs and risks, fostering innovation through collaborative R&D efforts. Companies that emphasize unique value propositions in these strategic alliances will be better positioned to access markets/fair pricing with drugs like JAK inhibitors and women-specific therapies. Payers will scrutinize clinical costs and patient outcomes to ensure balance and sustainable reimbursement models that reflect indication-specific needs and improve affordability.

Transformative Megatrends

• Why: Healthcare systems are under pressure to contain current and future spending. Healthcare plan sponsors are considering their next moves as governments contemplate the impact of the Inflation Reduction Act (IRA) 2022, and associated price cuts in the United States.
• Frost Perspective: Firms will invest in adaptive trial designs for evidence generation to expedite approvals for novel MoA-based targeted therapies, advancing precision medicine going forward. Pharma companies will utilize diagnostic delivery services to improve patient access by partnering with telehealth/AI-enabled symptom monitoring platforms (e.g., Ada Health) and focus on an emerging market-expansion strategy. Focus on predictive convergence of drugs and digital therapeutics will likely personalize medicine and improve experiences and outcomes.

Key Competitors

• ABBVIE
• J&J
• ELI LILLY
• ASTRAZENECA
• MERCK & CO
• SANOFI
• NOVARTIS
• AMGEN
• PFIZER
• GSK
• UCB
• BRISTOL MYERS SQUIBB
• ROCHE
• BOEHRINGER INGELHEIM
• ARGENX
• REGENERON PHARMACEUTICALS
• NOVO NORDISK
• BRISTOL MYERS SQUIBB
• REPERTOIRE IMMUNE MEDICINES
• ELI LILLY
• PFIZER
• ASTRAZENECA
• ROCHE
• BOEHRINGER INGELHEIM
• MERCK & CO
• SANOFI
• ARGENX
• UCB
• INCYTE
• MALLINCKRODT PHARMACEUTICALS
• ASAHI KASEI
• AFIBBIDY
• SWEDISH ORPHAN BIovitrum
• ANH PHARMACEUTICALS
• VERA THERAPEUTICS
• RIGEL PHARMACEUTICALS
• ASTELLAS PHARMA
• TAKEDA
• CHUGAI PHARMA
• MITSUBISHI CHEMICAL
• SUN PHARMACEUTICAL INDUSTRIES
• SHANGHAI PHARMACEUTICALS HOLDING
• ZAI LAB
• INNOVENT BIOLOGICS
• KISSEI PHARMACEUTICAL
• BIOCON
• OTSUKA PHARMA
• SUMITOMO PHARMA
• CELLTRION
• 3BIO
• TEVA PHARMA
• KYOWA KIRIN
• DR REDDY'S LAB
• JIANGSHENG HENGHUI PHARMACEUTICALS
• EVA PHARMA
• ROCHE
• TEVA
• ASTELLAS PHARMA
• HIKMA PHARMACEUTICALS ALS
• BOEHRINGER INGELHEIM
• SANOFI
• INTAS PHARMACEUTICALS LTD
• BIOCON
• NOVARTIS
• LABORATORIO ELEA PHOENIX S.A.
• IMMUNICORE HOLDINGS PLC
• CELLTRION
• SUNSHINE GUOJIAN PHARMACEUTICAL

Growth Drivers

Rising Prevalence of Autoimmune and Inflammatory Diseases

Increasing prevalence of diseases like lupus, RA, Crohn's disease, and psoriasis is driving demand for immunomodulators like tumor necrosis factor (TNF) inhibitors (e.g., Humira, Remicade) and JAK inhibitors (e.g., Xeljanz). The rapidly aging global population is more susceptible to chronic autoimmune conditions. It is further bolstering demand for treatments tailored to older adults, such as more tolerable biologics.

Biotech Advancements

Innovations in biotech platforms and advanced modalities such as CGT, bispecific antibodies, and RNA therapies are enhancing the efficacy and safety profiles of immunomodulators and driving the development of next-gen targeted therapies. Carisma Therapeutics Inc. and Moderna, Inc. have collaborated to use Carisma's proprietary CAR-M technology and Moderna's mRNA/lipid nanoparticles (LNP) platform to develop a macrophage engineering approach for autoimmune diseases.

Growing Investment in R&D

Increased funding from both public and private sectors is accelerating R&D efforts for discovering new therapies and improving existing ones. The NIH allocates significant funding for research on immunomodulatory therapies, fostering innovation. An increasing number of M&A deals demonstrate a growing focus on immunology by big pharma.

Success in Oncology and Expanding Applications

The success of immunotherapies in oncology has raised awareness and acceptance of similar approaches in treating autoimmune and inflammatory diseases. For example, Roche's Gazyva/Gazyvaro (obinutuzumab), approved in 100 nations for several lymphoma types, is being investigated in the Phase III REGISTRY trial for lupus nephritis.

Growth Restraints

Immunomodulator Therapeutics: Growth Restraints, Global, 2025-2030

Stringent Regulatory Processes: Stringent regulatory processes for immunomodulatory treatment approval or the development of novel mechanisms of action, globally, can cause delays in market access and raise development expenses for pharmaceutical companies. Moreover, inadequate reimbursement/insurance coverage globally may deter wide-scale adoption, especially in public health systems or regions with limited healthcare resources. Inadequate coverage of high-cost new drugs would increase the expenses of managing long-term conditions, impacting patient compliance and market growth.

Potential Adverse Effects and Safety Concerns: Immunomodulators may have serious adverse effects, such as an elevated risk of infections and autoimmune responses. For example, checkpoint inhibitor use in autoimmune disease is linked to immune-related side effects that need to be carefully managed. Adverse outcomes and safety risks may lead to regulatory actions such as market recalls, limited prescriptions, and reduced patient confidence, challenging market uptake.

Patent Expiry: Expiry of blockbuster drug patents is leading to the introduction of biosimilars and generic versions, intensifying market competition, resulting in price erosions, and leading to a loss of sales revenue for branded products. For example, AbbVie's blockbuster Humira, approved for several autoimmune conditions like RA, psoriasis, Crohn's disease, and ankylosing spondylitis, started facing biosimilar competition in 2023.

Patient Inconvenience: Biotech advancements have facilitated the development of effective biologic therapies; however, therapy administration requires frequent injections or infusions, making it challenging for patients to adhere to their treatment regimens. It may affect overall patient satisfaction and treatment discontinuation.