Immunosuppressants Market Size, Share & Trends Analysis Report By Drug Class (Corticosteroids, Monoclonal Antibodies, Calcineurin Inhibitors, mTOR Inhibitors, Antiproliferative Agents, Others), By Indication (Organ Transplantation, Autoimmune Disorders, Non-Autoimmune Inflammatory Diseases), By Distribution Channels (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global immunosuppressants market size was valued at USD 23.47 billion in 2022. It is estimated to reach USD 77.54 billion by 2031, growing at a CAGR of 14.2% during the forecast period (2023–2031). The surge in autoimmune disorders and the increase in demand for organ transplantation promotes market growth.

Immunosuppressive medications prevent the immune system from attacking healthy cells and tissues. These medications are used to prevent transplant rejection in people who have had organ transplants or stem cell transplants. The medications also alleviate the symptoms of autoimmune diseases. Immunosuppressants are potent medications that must be carefully monitored to avoid side effects. Immunosuppressants are drugs that serve to suppress the immunological response or agents. During organ transplantation from a donor to a recipient, the recipient's immune system is stimulated, producing an immunological response similar to that produced in reaction to other foreign substances. This immune reaction severely harms the transplanted or grafted organ. It is commonly referred to as rejection and can be acute or chronic.

Immunosuppressive medicines, which block the immune response and safeguard the new organ and its function, are used to prevent organ rejection. They are mostly used to prevent autoimmune illnesses such as myasthenia gravis, arthritis, lupus, rheumatoid arthritis, Crohn's disease, and organ transplant rejections such as kidney, liver, and heart transplants. Clinical immunosuppression is divided into three stages: induction therapy, maintenance therapy, and treatment of an established acute rejection response.

Market Dynamics

Global immunosuppressants market drivers

Surge in autoimmune disorders

Over the past few years, autoimmune illnesses have become increasingly common worldwide. For instance, autoimmune illnesses, which affect more than 23.5 million Americans, are among the most common diseases in the U.S., according to the National Institute of Environmental Health Sciences (NIH). In addition, the American Autoimmune Related Diseases Association, Inc. estimates that almost 50 million Americans suffer from an autoimmune disorder. Thus, one of the key factors driving the market expansion for immunosuppressants is the rise in autoimmune illnesses.

Increase in demand for organ transplantation

When any organ in a person ceases working, organ transplantation is the only option remaining. Transplants of several organs, including the kidney, liver, and heart, are now often carried out worldwide. Additionally, immunosuppressive medications are frequently utilized to treat the recipient's immune system's hyper-response following organ transplant surgery. As a result, the market for immunosuppressants is growing due to increased demand for organ transplantation procedures.

The market for immunosuppressant medications is expanding due to increased organ failure cases and the need for organ transplants. ONT- WHO Global Observatory On Donation and Transplantation data show that about 119,873 organs were transplanted globally in 2014, an increase of 1.8% from 2013. The market for immunosuppressant medications is expanding due to developments in tissue engineering and transplantation techniques. One of the key factors driving the market for immunosuppressant medications is the rise in the prevalence of autoimmune illnesses. The American Autoimmune Related Disease Association (AARDA) estimated that 50 million persons in the U.S. had an autoimmune disease in 2016. Anti-immunosuppressive medications have successfully treated autoimmune disorders.

Global immunosuppressants market restraint

Lack of awareness toward organ transplantation

Despite the rising demand for organ transplants, little awareness of the procedure has been reported. People are unaware of organ donation and developed and developing nations exhibit this lack of knowledge. For instance, the American Transplant Foundation estimates that over 114,000 Americans are waiting for a life-saving organ transplant. Additionally, 20 people lose their lives each day on average due to a shortage of organs for transplant. Therefore, it is projected that this lack of knowledge and the lack of available organs may hinder market growth in the future.

Global immunosuppressants market opportunities

Growth opportunities in emerging economies

The expanding economies of Asia-Pacific and LAMEA provide the immunosuppressant market with excellent growth opportunities due to their enhanced healthcare infrastructure and growing need for better healthcare. The prevalence of numerous autoimmune conditions and the need for research to develop new drugs to cure illnesses contribute to the increased demand for immunosuppressants. Additionally, the swiftly expanding healthcare reforms in developing nations will open profitable market expansion potential.

The immunosuppressant market is also growing due to increased healthcare and R&D costs in developing countries like Brazil, China, and India. The Indian government announced its intention to raise healthcare spending from 1.04% of GDP to 2.5% by 2020 in 2015. G.E. Healthcare announced in 2016 that it would triple all of its operating segments' investments in India, including those in the pharmaceutical and life sciences sectors. Collaboration and acquisition are also projected to lead to an increase in the creation of new medications, technological improvements, and continuous changes in the immunosuppressant market in emerging nations. This trend is anticipated to last for the duration of the forecast period.

Regional Analysis

Based on region, the global immunosuppressants market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North america dominates the global market

North America is the most significant global immunosuppressants market shareholder and is estimated to exhibit a CAGR of 13.2% over the forecast period. The major players have consistently concentrated on medication class approvals and new drug class launches to continue to dominate the immunosuppressant industry. Increased government funding for the research and development of innovative immunosuppressants and an increase in the prevalence of auto-immune illnesses, including irritable bowel syndrome and Crohn's disease, are some of the reasons driving the overall growth of the North American immunosuppressants market share. Additionally, the market for immunosuppressants is growing due to the rise in organ transplant demand brought on by the region's increased occurrences of heart, kidney, and liver failure.

Europe is anticipated to exhibit a CAGR of 14.1% over the forecast period. Increased government focus on autoimmune disease treatment in Europe, the presence of established healthcare systems, and a growth in healthcare spending. During the projected period, a significant increase in R&D activities for medication development and ongoing launches of new drug classes are anticipated to open up new potential for market expansion. Key European businesses are using partnerships as their primary method for developing and introducing novel immunosuppressants. These alliances should give these businesses a competitive advantage over rivals. Additionally, the pharmaceutical industry's increased demand for immunosuppressants and the European Union's increased investment in R&D in the healthcare industry support the expansion of the immunosuppressant market in Europe.

Asia-Pacific accounted emerged as one of the fastest-growing regions in the global market. India and China are the most populous nations in this densely populated region. The demand for medical infrastructure is rising; there are more hospitals in developing nations, more healthcare reforms are being implemented, and medical technology improvements contribute to this growth. Due to their massive population bases, a sharp increase in the demand for rapid diagnosis of autoimmune disorders, and an increase in R&D activities in the pharma sector, India and China are predicted to develop at the quickest CAGR over the forecast period.

Additionally, the increase in per capita income in many nations, the rise in government initiatives to improve the healthcare sector, and the increased focus of top manufacturers on expanding their geographic presence in developing Asia-Pacific nations to seize high growth opportunities in the market are the main factors boosting the immunosuppressant market in the region. Leading immunosuppressant producers are gradually focusing on this region to introduce immunosuppressive medications. Additionally, the market expansion in this region is fueled by an increase in the demand for organ translation and an increase in autoimmune illnesses, including arthritis and irritable bowel syndrome.

In LAMEA, there is a shift in emphasis in this area toward biotech and pharmaceutical research. Additionally, rising R&D efforts to improve novel immunosuppressive medications and the rising prevalence of autoimmune disorders considerably expand the market. By 2025, Latin America's senior population, which is now growing quickly, should total 100.5 million people. This demographic has a higher risk of developing chronic conditions like irritable bowel syndrome, which raises the prevalence of chronic illnesses and fuels demand for fecal management devices. Additionally, throughout the forecast period, the market will benefit from increased demand for speedy and innovative treatment approaches in the healthcare sector.

Segmental Analysis

The global immunosuppressants market is bifurcated into drug class, indication, and distribution channels.

Based on the drug class, the global market is bifurcated into corticosteroids, monoclonal antibodies, calcineurin inhibitors, mTOR inhibitors, antiproliferative agents, and others.

The calcineurin inhibitors segment dominates the global market and is projected to exhibit a CAGR of 15.7% over the forecast period. Calcineurin inhibitors are a subclass of medications that block the activity of calcineurin. The enzyme calcineurin stimulates the immune system's T-cells. Calcineurin inhibitors are known as immunosuppressants because they suppress the immune system. Tacrolimus and pimecrolimus are examples of calcineurin inhibitors utilized to initiate and maintain postoperative immunosuppression. Tacrolimus and cyclosporine are the two calcineurin inhibitors that are most frequently administered. This segment will grow quickly among drug classes during the projected period.

Based on indication, the global market is segmented into organ transplantation, autoimmune disorders, and non-autoimmune inflammatory diseases. 

Autoimmune disorders dominate the global market and are predicted to exhibit a CAGR of 13.6% during the forecast period. "Autoimmune disorders" refers to conditions where the body begins manufacturing antibodies independently. It occurs when the immune system attacks and destroys healthy body tissues because it recognizes such tissues as antigens. There are over 80 forms of autoimmune diseases, including rheumatoid arthritis, reactive arthritis, multiple sclerosis, myasthenia gravis, pernicious anemia, and Sjogren syndrome. Drugs that inhibit the immune system are widely used to treat autoimmune illnesses. They aid in reducing the body's immune system's overactive immunological response. The market is expanding due to continuing research into creating immunosuppressant medications that suppress the immune system.

Based on distribution channels, the global market is bifurcated into hospital pharmacies, retail pharmacies, and online pharmacies.

The hospital pharmacies segment owns the highest market share and is predicted to exhibit a CAGR of 13.2% over the forecast period. Hospital pharmacies can usually be found on the hospital's grounds. Hospital pharmacies are not retail businesses; they primarily offer pharmaceuticals to hospitalized patients. Hospital pharmacies connect Doctors and patients. Doctors advise patients to maximize the medications' expected effects and reduce undesirable or adverse consequences. In addition, hospitals house many patients with acute and chronic illnesses, which supports the expansion of the market.

Recent Developments

• April 2023- The Ministry of Food and Drug Safety (MFDS) has issued a recall order for the water for injection (WFI) co-packaged with Novartis' immunosuppressant, Simulect Inj., due to the possibility of glass particles. During an internal investigation of the WFI, it discovered unexpected particles in a storage sample.
• November 2022- Lupin has launched generic immunosuppressant Tacrolimus capsules in the U.S. market after its alliance partner Concord Biotech got approval from the U.S. Food and Drug Administration.