The global immunomodulators market accounted for USD 131.7 billion in 2015 and is expected to grow at a CAGR of over 5.8% during the forecast period. The increasing incidence of chronic diseases including asthma, cancer, allergic conditions, and multiple sclerosis is presumed to be the key contributing factor providing a fillip to this vertical.
In addition, increasing adoption of early immunomodulator therapy for the treatment of Crohn's disease is anticipated to drive the market growth. Fewer incidents of organ rejection and higher remission rate associated with immunomodulatory therapy render it a promising alternative.
U.S. immunomodulators market, by product, 2014 - 2025 (USD Billion)
Rising incidence of multiple sclerosis is boosting the generation of new biological response modifiers. As a result, the immunomodulators market is predicted to witness significant growth owing to the rising number of ongoing clinical trials for the development of immunotherapeutic agents, such as ponesimod, ozanimod, and laquinimod, in the treatment of multiple sclerosis.
Furthermore, the presence of high unmet clinical needs with regard to treatment for immune disorders, such as rheumatoid arthritis, is the factor propelling the expansion of this vertical. These immunotherapies are expected to gain popularity in the coming years as these present a lower risk of adverse effects compared to other existing drugs. However, stringent regulations involved in the approval process for immunomodulator antibodies are anticipated to pose entry hurdles for the small scale manufacturers.
On the other hand, the growing demand for treatment alternatives for rheumatoid arthritis due to the availability of few options, limited to TNF-inhibitors, is expected to provide this sector with lucrative growth opportunities. In addition, the adverse effects associated with TNF-inhibitors and the high therapy cost involved per year coupled with insufficient insurance coverage access is engendering significant activity in the development of immunotherapeutic agents. The aforementioned factors are anticipated to drive the market growth in the foreseeable future.
The immunosuppressant segment held the largest share of over 50.0% in 2015. The high sales figure is attributable to a wide range of available therapeutics, such as azathioprine, cyclosporine, corticosteroids, and monoclonal antibodies, in this segment. These drugs are used to suppress the immune response to preclude rejection of transplanted organs such as kidney, heart, and liver transplants.
In addition to the presence of a wide product range in this segment, the high applicability of immunosuppressant drugs in the treatment of various autoimmune diseases, such as psoriasis, alopecia areata, lupus, among others, is serving this segment with broader growth prospects. With the surging occurrence of these diseases, the demand likewise, for immunosuppressant drugs, is expected to escalate in the next eight years.
According to statistics published by the National Kidney Foundation in the U.S., 4,761 patients died during the wait for kidney transplants in 2014. This heightened the need for organ transplantation procedures in the U.S., which consequently is boosting the demand for immunosuppressants to lower the incidence of organ transplant rejections.
The other applications segment, including multiple sclerosis, Crohn's disease, rheumatoid arthritis, etc., held a dominant share in 2015 owing to the wide usage of immunomodulators for treatment purposes. Significant untapped opportunities coupled with new drug development initiatives in response to unmet needs and projected product launches for several indications are creating future growth opportunities.
The expected launch of immunomodulatory therapies for the treatment of multiple sclerosis is primarily anticipated to drive the segment growth. For instance, Plegridy & Daclizumab by Biogen, Ocrelizumab by Roche, and Receptos' RPC-1063 & Nerventra by Teva Pharmaceuticals are expected to be made commercially available during the forecast period. These immunomodulators are expected to capture a significant market share in the coming years.
In 2015, North America dominated the global immunomodulators industry with a share of 38.0%. This dominance can be attributed to the presence of a large diseased population in this region. For instance, in June 2014, according to statistics published by Cleveland Clinic, multiple sclerosis, which constitutes the larger share of the other applications segment, affected approximately 400,000 people in the U.S. alone. The high prevalence level is expected to surge the demand for immunomodulatory therapy in this region.
Global immunomodulators market share, by application, 2015
Hence, increasing demand from end-users for immunomodulator-based treatment and the high therapy cost associated with treating multiple sclerosis using these immunotherapeutic agents are anticipated to drive revenue growth in this segment. The presence of supportive government initiatives and higher awareness levels among end-users are further leading to high demand for immunomodulatory drugs.
This industry is predicted to witness intense competition in the near future due to the rising adoption of disruptive strategies amongst market players to sustain themselves in the competition. The strategies include extensive product development activities, distribution channel enhancement, and regional expansion efforts, mergers & acquisitions, and collaborative agreements for drug development.
Furthermore, patent expiration of branded therapies of corticosteroids, B/T cell suppressive agents, and antihistamines is anticipated to provide a lucrative growth platform for new market entrants in this vertical. For instance, the patent for Nasonex, a nasal corticosteroid used in the treatment of allergic rhinitis expired in 2014, thus presenting opportunities for the development of immunomodulatory therapies.
In June 2023, Merck announced the acquisition of Prometheus Biosciences, Inc. to strengthen its presence in immunology and other related treatments delivering high patient value.
In June 2023, Eli Lilly and Company announced the acquisition of DICE Therapeutics, Inc. This acquisition will further accelerate innovation in the treatment of autoimmune diseases.
Base year for estimation
Actual estimates/Historic data
2014 - 2015
2016 - 2025
Revenue in USD Billion & CAGR from 2016 to 2025
North America, Europe, Asia-Pacific, Latin America & MEA
U.S., Canada, U.K., Germany, Japan, China, Brazil, Mexico, South Africa
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the immunomodulators market on the basis of product, application, and region:
Product Outlook (Revenue, USD Billion, 2014 - 2025)
Application Outlook (Revenue, USD Billion, 2014 - 2025)
Regional Outlook (Revenue, USD Billion, 2014 - 2025)
The Middle East and Africa
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