Global Immunosuppressive Drugs Market is expected to cross USD 1.39 Billion by 2025 at a CAGR of 4.63%. Immunosuppressants are generally used post organ transplants and for the treatment of autoimmune diseases such as multiple sclerosis, rheumatoid arthritis, and psoriasis. According to the World Health Organization (WHO) and the Spanish Transplant Organization, Organización Nacional de Trasplantes (ONT), in 2018, organ transplants increased by 7.25% from the previous year to reach approximately 138,000, including 40.4% living kidney transplants and 19.8% living liver transplants.
Immunosuppressive drugs find utility post organ transplants when the receiver’s immunity must be suppressed for the body to accept the newly attached organ.
This market is growing due to the increasing number of organ transplants and advances in tissue engineering and organ transplant techniques.
Increase in the number of organ transplants and rising prevalence of autoimmune diseases globally would directly fuel market growth.
- Growing number of organ transplantation procedures. The increasing number of organ transplants for lungs, kidneys, liver, and pancreas, among other organs, is one of the major drivers for market growth. As per the WHO and ONT, in 2018, there were 91,800 kidney transplantation procedures globally, a 6.5% increase from 2017; 6,200 lung transplantation procedures, a 7.2% increase; and 30,800 liver transplantation procedures, a 5.5 % increase. Due to the increase in the number of organ transplantation procedures worldwide, major companies in the market are focusing on strengthening their position and expanding business operations through strategic initiatives and product launches.
- Imperative for the success of organ transplants
- Increasing prevalence of autoimmune disease due to changing lifestyles
- Stringent regulatory and approvals processes
- Immunosuppressive drugs usually do not offer any complementary treatment
By Drug Type
- Calcineurin Inhibitors: A very high success rate makes this the preferred type of immunosuppressant. Very successful for kidney transplants where the post-op survivability has increased to 90% for the first year and 75% for 5 years, according to the US National Center for Biotechnology Information.
- Corticosteroids: Beneficial in the treatment of autoimmune disorders, they are also used to suppress the immune response after organ transplants. However, a plethora of side effects limits their use.
- Antiproliferative Agents: Widely used for chronic renal transplant dysfunction and certain autoimmune diseases. Used for conditions that require sustained drug release.
- mTOR Inhibitors: Useful in cancer therapy, these drugs find limited applicability in treatment post organ transplants and for autoimmune disorders due to possible acute side effects.
- IMDH Inhibitors: The use of IMDH inhibitors reduces the risk of the patients developing Parkinson’s disease due to the intake of immunosuppressants.
- Others: This segment covers drugs such as biologics and monoclonal antibodies, as well as experimental drugs.
By Route of Administration
- Intravenous: Used when oral administration is not possible and for certain specific organ transplants with a high failure rate, such as cardiac transplants. Intravenous immunosuppressants have stronger action and side effects.
- Oral: The usual route of administration for most immunosuppressants.
- Others: Includes immunosuppressants administered nasally, rectally, and vaginally. These are usually for very specific disorders and constitute a niche segment of the market.
- Autoimmune Disease: The largest segment of the market due to the increasing incidence of autoimmune diseases, especially in developed nations. The segment is slated to grow as autoimmune diseases usually require lifelong medication.
- Organ Transplant: A fast-growing segment, organ transplants are becoming increasingly common and offer consistently better survival rates. Immunosuppressant drugs are critical to the success of organ transplants.
- Kidney Transplant: The most transplanted organ accounting is the kidney. A well-developed immunosuppressive drug market exclusively for kidney transplants serves the growth of the segment.
- Liver Transplant: North America and Europe are seeing an increasing number of liver transplants, directly driving the growth of the segment.
- Heart Transplant: Requiring strong immunosuppressants with specific action, heart transplants are very expensive and difficult procedures, which is driving the innovation of immunosuppressants.
- Others: Covering various transplants such as intestines, skin, tissue, and fluids that require specific immunosuppressant drugs.
- Others: Immunosuppressants are used for the treatment of many allergies and non-autoimmune inflammatory diseases. This is a small segment but shows high growth potential with the discovery of new application areas for immunosuppressant drugs.
By End User
- Hospitals and Clinics: A very large segment that continues to grow, hospitals and clinics are the primary centers for the diagnosis and treatment of diseases and conditions that require immunosuppressant medication.
- Organ Transplant Centers: With the facilitation of organ transplant procedures due to the increasing number of donors and technological advances, the segment is expected to register high growth.
- Others: The segment covers the management of certain chronic diseases and life-long medication required after most transplants at homes, rehabilitation centers, and old age homes.
- Americas: Leading the global immunosuppressive drug market with the maximum number of organ transplants annually and rising prevalence of autoimmune diseases, the regional market growth can be also be attributed to technological advancements and large-scale investments in R&D. According to the US National Kidney Foundation, as of December 2016, there were 121,678 people registered for organ transplantation, including 100,791 people for kidney transplantation.
- Europe: An increase in the number of transplants and the rising prevalence of autoimmune diseases in Western Europe would ensure market growth in the region.
- Asia-Pacific: Though there are fewer people suffering from autoimmune diseases as compared to the Americas and Europe, the high population in the region is expected to drive market growth. A well-established healthcare industry is also seeing a rise in medical tourism in Asia-Pacific, furthering the demand for immunosuppressive drugs.
- Middle East & Africa: Currently the smallest regional market due to the low prevalence of autoimmune diseases and an underdeveloped organ transplant market.
- Accord Healthcare (UK): Researching a wide variety of immunosuppressants drugs to cater to rising demand in its domestic market.
- Astella Pharma (Japan): Currently commercializing immunosuppressants with a narrow therapeutic index such as tacrolimus under the name Prograf.
- Bristol-Myers Squibb Company (US): The company’s Belatacept brand name of immunosuppressants help manage renal transplant rejection with ongoing testing for use in lung transplant rejection.
- Genzyme Co. (Switzerland): Researching drugs to primarily treat autoimmune diseases and allergic reactions, the company’s Dupixent, for example, which shows much promise in treating atopic dermatitis in adolescents.
- Hoffmann-La Roche AG (US): Focused on the development of drugs to treat atypical autoimmune diseases, the latest drug MabThera was approved by EU legislation for the treatment of pemphigus vulgaris.
- GlaxoSmithKline PLC (UK): With a dedicated R&D wing for immune-inflammation therapy, the pharmaceutical giant has launched numerous immunosuppressants. In April 2019, it launched Benlysta, a drug to be used to treat systemic lupus erythematosus.
- Glenmark Pharmaceuticals, Inc. (India): A growing company with a large market share in the US and India, it has two immunosuppressants ready to hit the market pending approval.
- Mylan Laboratories Inc. (US): Investing in drugs to cater to the global organ transplant market, clinical trials have been successfully carried out for Mycophenolate Mofetil for the prophylaxis of kidney and liver transplant failure; the drug is currently pending approval.
- Pfizer Inc. (US): Using its vast resources, Pfizer has invested in the creation of immunosuppressive drugs for a wide range of conditions. The novel drug CP-690550 has been shown to be an effective immunosuppressant for the treatment of rheumatoid arthritis, transplant rejection, psoriasis, and other autoimmune diseases. It is currently in the development phase. The company has also developed a range of other immunosuppressants with specific applications.
- Novartis AG (Switzerland): Novartis AG offers the immunosuppressant cyclosporine that is used post liver, kidney, and heart transplant procedures. Cyclosporine works by weakening the immune system to help the patient’s body accept the new organ.
- Actavis, Inc.: Produces a wide range of immunosuppressive drugs for use in combating various autoimmune diseases.
- Zydus Cadila (India): Zydus caters to the Indian organ transplant market, often using in-licensing agreements with other companies. Its highly successful immunosuppressant Grafalon was licensed from Neovii Pharmaceuticals AG, a Swiss company.
2025: 1.39 Billion 2027: Significant value
Value (USD Billion)
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
By Drug Type, By Route of Administration, By Application and By End User
North America, Europe, Asia-Pacific, and Rest of the World (RoW)
Accord Healthcare (UK), Astella Pharma (Japan), Bristol-Myers Squibb Company (US), Genzyme Co. (Switzerland), Hoffmann-La Roche AG (US), GlaxoSmithKline PLC (UK), Glenmark Pharmaceuticals, Inc. (India), Mylan Laboratories Inc. (US), Pfizer Inc. (US), Novartis AG (Switzerland), Actavis, Inc., Zydus Cadila (India)
Key Market Opportunities
Stringent regulatory and approvals processes\r\nImmunosuppressive drugs usually do not offer any complementary treatment
Key Market Drivers
Growing number of organ transplantation procedures.Imperative for the success of organ transplants. Increasing prevalence of autoimmune disease due to changing lifestyles
Frequently Asked Questions (FAQ) :
The immunosuppressive drugs market is projected to grow at a 4.63% CAGR between 2019-2025.
The Americas are predicted to have the largest share in the immunosuppressive drugs market.
The immunosuppressive drugs market is predicted to touch USD 1.39 billion by 2025.
Rising prevalence of autoimmune diseases and rising number of organ transplantation procedures are boosting market growth.
Strict regulatory and approval processes may limit market growth.
This table of content is tentative and subject to change as the research progresses.
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