Global immunomodulators market is projected to reach USD 155.66 billion by 2033, at a CAGR of 6.3% from 2024 to 2033. Global immunomodulators market is witnessing a considerable growth owing to increasing incidences of autoimmune diseases across the globe. The increasing incidence of multiple sclerosis creates fresh biological response modifiers, leading to a significant surge in the immunomodulators industry. This can be attributed to an escalating count of ongoing clinical trials aimed at developing innovative immunotherapeutic agents like ponesimod, ozanimod and laquinimod for treating multiple sclerosis. As a result, notable growth is anticipated in this sector in the upcoming years. Moreover, the existence of significant unfulfilled medical requirements in addressing immune-related conditions like rheumatoid arthritis is driving the growth of this sector. Immunotherapies are projected to see increased demand due to their lower risk of negative effects relative to other currently available medications. Nevertheless, strict regulatory processes for approving immunomodulator antibodies may create entry barriers for small-scale producers and manufacturers.

Market Overview:

Immunomodulators are the agents that stimulate the response of immune system by modulating immune response. They help normalize or regulate the immune system by either stimulating or suppressing the immune system. Immunostimulants, such as interferons and vaccines, enhance the body's resistance against infections. Immunomodulators generally classified into two categories: immunostimulants and immunosuppressants. There are several types of medications and therapy are available in each category, with unique mechanisms of action, indications (both labelled and unlabeled), and with novel immune targets. The number of drugs used to manage autoimmune disorders has increased dramatically in recent years. The immunomodulators have resulted in improvements in patient outcomes by slowing of disease progression. Each type of immunomodulator medication contains a particular kind of active ingredient which works by altering the way of immune system carries out its functions in a specific person's body. These drugs work by weakening or suppressing the immune system or by modifying the way it works in different ways. Immunosuppressant drugs are used to reduce the immune response by modifying the function or production of cytokines and immune cells.

Immunomodulators are widely used in chronic illness and recommended for people with autoimmune diseases, as they help to restore immune system health in people who have been on lengthy courses of antibiotics or anti-viral therapies. There are ongoing trends of immunomodulation to combat a vast range of animal and human diseases, including incurable diseases like cancers, autoimmune diseases, viral diseases, and inflammatory conditions. Immunomodulators drugs are most commonly used to treat autoimmune disorders that are severe or moderate. The majority of new immunomodulators are in development, which is likely to provide more growth opportunities in the market. Major players such as GSK and Pfizer are focusing on the development of new drugs.

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Market Dynamics:

Drivers

• Rising incidences of multiple sclerosis propelling the market growth

In multiple sclerosis (MS), the immune system attacks nerve cells, causing symptoms that can include weakness, poor coordination, muscle spasms, pain, and blindness. It is one of the most common disorder and poses a significant personal and socioeconomic burden. For instance, as per the study by National Society of MS, currently, an estimated 2.3 million people live with multiple sclerosis worldwide. Immunomodulators are used for the treatment of various forms of multiple sclerosis. Thus, rising incidences of multiple sclerosis are propelling the market growth.

• Increasing adoption of immunomodulator therapy for the treatment of Crohn's disease

Immunomodulator is an effective treatment for people with Crohn's disease. It can be used either single in pair with other medications. These drugs help to modify or weaken the immune system to reduce inflammation caused by Crohn's disease, which can help to reduce symptoms and keep the patients in remission. Thus, increasing adoption of immunomodulator therapy for the treatment of Crohn's disease, driving the growth of the market. 

Restraints:

• Adverse side effects of immunomodulator drugs

There is a greater risk of infection, including both primary infection and reactivation of latent infections. These infections include hepatitis B and hepatitis C viruses, tuberculosis (TB), fungal infections, and HIV. There is also a high risk of progressive multifocal leukoencephalopathy (PML). Thus, before the initiation of immunomodulator treatment, patients must be screened for these threats or historical exposure to the viruses associated with these diseases.

Opportunities:

• Increasing R&D activities will provide future growth opportunities

The increasing interest in immunomodulators leads to the discovery and development of a diverse array of new drugs and treatment for the various autoimmune disorders. Many key vendors are investing heavily in the research and development activities and focusing on the launching the new drugs cater to the demand of a large number of customers. A number of disorders such as autoimmune disease, immunodeficiency state, cancer and viral infection can be treated with immunostimulants drugs. Thus, with the widening scope of immunomodulators to manage a large number of diseases, offering potential opportunities for the major vendors in the market.

Challenges:

• Stringent government regulations for the approval and launch of the drug

Stringent government regulations for the approval and launch of the immunomodulators drug is one of the critical challenges for the vendors.  For the approval of the drugs, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to the respective regulatory institutes to verify the safety and efficacy of the drug. The approval of the drug procedure consumes a lot of time and requires substantial capital investment. Thus, these factors are anticipated to hinder the market growth over the forecast period.

Segmentation Analysis:

The global immunomodulators market has been segmented based on type, route of administration, application, and regions.

• The type segment is divided into immunosuppressants and immunostimulants. The immunosuppressants segment further classified into calcineurin inhibitors, antimetabolites, glucocorticoids, and others. Immunostimulants further divided into vaccines, antibodies, others. Immunosuppressants segment led the immunomodulators market with the highest market share of 38.2% in 2023. This is mainly attributed to the presence of an extensive product range in this segment with the ability to treat the variety of autoimmune diseases. These drugs suppress or reduce, the strength of the body's immune system. These drugs are given for autoimmune disorders such as multiple sclerosis (MS), Rheumatoid arthritis, alopecia areata, and lupus, to decrease the undesirable immune response of the body.
• The route of administration segment includes oral, injectable, and intravenous. The oral route of administration is estimated to grow at the highest CAGR of 6.9% over the forecast period, as it is one of the most convenient and usually the safest and least expensive route of administration. After oral administration, these drugs quickly absorbed and approximately 30% circulates in the blood bound to plasma proteins. Drugs, in the form of liquids, capsules, tablets, or chewable tablets, can be taken orally.
• The application segment includes respiratory, human immunodeficiency virus (HIV), oncology, and others. Other segment includes disease such as multiple sclerosis, Crohn's disease, rheumatoid arthritis, etc. Other segment accounted for the major market share of 45.8% in 2023. This is mainly due to the widely used of immunomodulators for the treatment of these diseases. These drugs have been used for over two decades to treat relapsing these diseases. Immunomodulators help to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations.

Regional segmentation analysis:

The regions analysed for the market include North America, Europe, South America, Asia Pacific, and the Middle East and Africa. The North America region emerged as the largest market for the immunomodulators market, with a 39.2% share of the market revenue in 2023.

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• This is because North America has the highest number of populations suffering from autoimmune diseases. In addition to this, the presence of a large number of companies in the region, positively impacting the growth of the market. For instance, as per the study of the National Institute of Environmental Science, autoimmune diseases affect over than 24 million people in the United States. In addition to this, as per the National Multiple Sclerosis Society, Canada is the country, which has the highest prevalence of multiple sclerosis in the world. Thus, the rising incidence of these diseases in the countries such as U.S. and Canada, driving the growth of the market.
• The Asia Pacific region is anticipated to hold the considerable market share in the global immunomodulators market, owing to rising awareness about various immune disorders, In addition to this, favourable government regulations and increasing healthcare expenditure in the countries such as India and China, further propelling the growth of the market in the Asia Pacific region. 

Competitive Analysis:

The key players are now concentrating on implementing strategies such as adopting new technology, product innovations, mergers & acquisitions, joint venture, alliances and partnerships to improve their market position in the global immunomodulators industry.

In October 2019, Pandion Therapeutics, Inc. and Astellas Pharma Inc. announced the partnership for the development and market launch of immunomodulator drugs for pancreas autoimmune disease.

In January 2020, KYORIN Holdings, Inc. today announced that its wholly-owned subsidiary KYORIN Pharmaceutical Co., Ltd has entered into a partnership and license agreement with aTyrPharma, Inc. for Japan with regard to ATYR1923, aTyr's novel immunomodulator to develop and commercialize ATYR1923 for interstitial lung diseases in Japan.

List of Key Market Players:

• Hoffmann-La Roche Ltd.
• Amgen Inc.
• Abbott Laboratories
• Johnson & Johnson
• Novartis AG
• Bristol-Myers Squibb Company
• Merck & Co.
• Eli Lilly and Company
• Pfizer Inc.
• Biogen Inc.
• Teva Pharmaceuticals
• Pandion Therapeutics, Inc.
• aTyrPharma, Inc.

Key Target Audience

• Healthcare Institutes
• Drug Manufacturers
• Pharmaceutical Companies
• Government Authorities and R&D Institutions
• World Health Organization
• Food and Drug Administration
• Consulting And Research Firms

Report Description:

• Global Immunomodulators Market, Industry Analysis, Trends, Analysis and Forecast, 2024 to 2033 is a forthcoming/imminent research report which is to be published by The Brainy Insights.
• 2023 is considered as the base year of the report. 2020, 2021 and 2022 are considered as the historic years and 2024 to 2033 are the forecast years. The global immunomodulators market is based on revenue (USD Million/Billion). The report incorporates the market study on the basis of revenue. The study covers the market share revenue/market share for each of the segments, regions and countries catering to global immunomodulators market. The regions analyzed for the market are Europe, Asia Pacific, North America, South America and Middle East & Africa. Furthermore, the regions are further analyzed at the country level.
• The report encompasses with the relative data & information, which have been validated by the leading industry professionals and experts all across the globe. The research report also delivers an outline of the attractiveness of immunomodulators and regions which are deduced and formulated on the basis of their growth rate (CAGR), market size, and attractiveness by analyzing the present and future prospects to market growth and development in future.
• The report illustrates the detailed (both quantitative and qualitative) analysis of historical data, revenues, key developments, along with the crucial strategies adopted by key organizations catering to global immunomodulators market. This offers vital and in depth insights in order to depict the overall market scenario.
• The report offers the detailed study for the company profiles of key organizations operating in the global immunomodulators market and a comparative assessment based on their product offering, business overviews, geographic presence, business strategies, segment market share, product development & innovations, recent developments, joint venture, partnerships, mergers & acquisitions, strategic alliances, SWOT analysis, and key financial information. This helps in evaluating the overall competition present in the market scenario. 
• The report provides an elaborative assessment of the porter’s five forces analysis coupled with SWOT analysis so as to provide business related data and information’s. Porter’s five forces model is analyzed to understand the overall competitive scenario that is prevailing in the market. Additionally, the SWOT analysis identifies both the positive and negative attributes of the market development which influences the company growth and development in order to sustain and survive in the long run.
• Along with that, the report also focuses on the market related driving factors, growth limitations (restraints), potential industry opportunities, significant trends and development which act as a key potential for the investors. 
• Potential growth prospects along with the penetration rate analysis of the products (market related i.e., global immunomodulators market is covered in order to comprehend the adoption rate and evaluate the market size.