Global Organ Transplant Immunosuppressant Drugs Market Size, Share, and COVID-19 Impact Analysis, By Drug Class (Calcineurin Inhibitors, Antiproliferative Agents, mTOR Inhibitor, Steroids, and Other Drug Classes), By Transplant Type (Kidney, Liver, Heart, Lung, Pancreas, and Other Transplant Types), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2025 - 2035

Global Organ Transplant Immunosuppressant Drugs Market Insights Forecasts to 2035

• The Global Organ Transplant Immunosuppressant Drugs Market Size Was Estimated at USD 5.25 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of around 4.53% from 2025 to 2035
• The Worldwide Organ Transplant Immunosuppressant Drugs Market Size is Expected to Reach USD 8.55 Billion by 2035
• Asia Pacific is expected to grow the fastest during the forecast period.

The Global Organ Transplant Immunosuppressant Drugs Market Size was worth around USD 5.25 Billion in 2024 and is Predicted to Grow to around USD 8.55 Billion by 2035 with a Compound Annual Growth Rate (CAGR) of 4.53% from 2025 to 2035. An increasing number of organ transplants, owing to the chronic diseases and an aging population, is driving the organ transplant immunosuppressant drugs market globally.

Market Overview

The organ transplant immunosuppressant drugs market refers to the industry encompassing the medications that suppress the immune system in transplant recipients, preventing rejection of the transplanted organ. Organ transplant immunosuppressant drugs are the anti-rejection medications playing a crucial role in organ transplantation for preventing the body from rejecting the transplanted organ. The rising prevalence of autoimmune diseases like arthritis, multiple sclerosis, and alopecia, as well as the prevalence of organ failure, is driving in number of organ transplant treatments, leading to market demand. The integration of AI and ML for optimizing immunosuppression protocols in organ transplants, particularly in kidney transplantation, is creating new market opportunities. Further, the development of personalized therapy for managing the immune response as per the individual patient characteristics, including genetics, immune profile, and medication response, is offering market growth opportunities.

Report Coverage

This research report categorizes the organ transplant immunosuppressant drugs market based on various segments and regions, forecasts revenue growth, and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the organ transplant immunosuppressant drugs market. Recent market developments and competitive strategies such as expansion, type launch, development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the organ transplant immunosuppressant drugs market.

Driving Factors

An increasing number of organ transplants is responsible for driving market demand as these immunosuppressant drugs aid in preventing the recipient’s immune system from attacking the transplanted organ. According to a Statista report, in the year 2023, there were a total of 172,397 organ transplants worldwide. Kidney transplantation is found to be most prevalent worldwide, followed by liver and heart transplantation. Further, the prevalence of chronic diseases such as kidney failure, cirrhosis, heart failure, and lung diseases such as cystic fibrosis is driving the market demand. The growing aging population and advancements in medical care are contributing to promoting the market growth.  

Restraining Factors

The increased cost and side effects associated with the administration of these drugs are hampering the organ transplant immunosuppressant drugs market. Further, the donor organ shortage and challenges with patient compliance are negatively influencing the market demand.

Market Segmentation

The organ transplant immunosuppressant drugs market share is classified into drug class and transplant type.

• The calcineurin inhibitors segment dominated the market with the largest share of 41.5% in 2024 and is projected to grow at the fastest CAGR during the forecast period.

Based on the drug class, the organ transplant immunosuppressant drugs market is divided into calcineurin inhibitors, antiproliferative agents, mTOR inhibitor, steroids, and other drug classes. Among these, the calcineurin inhibitors segment dominated the market with the largest share of 41.5% in 2024 and is projected to grow at the fastest CAGR during the forecast period. Calcineurin inhibitors, including cyclosporine and tacrolimus, used as organ transplant immunosuppressants for preventing rejection, work by blocking the specific enzyme, calcineurin, in the T-cell activation. The use of the calcineurin inhibitors drug class for reducing the inflammation and preventing body rejection of transplanted tissues is driving the market in the calcineurin inhibitors segment. 

• The kidney segment accounted for the largest market share of 49.1% in 2024 and is anticipated to grow at a significant CAGR during the forecast period.

Based on the transplant type, the organ transplant immunosuppressant drugs market is divided into kidney, liver, heart, lung, pancreas, and other transplant types. Among these, the kidney segment accounted for the largest market share of 49.1% in 2024 and is anticipated to grow at a significant CAGR during the forecast period. Triple therapy includes a calcineurin inhibitor, an antiproliferative/antimetabolite agent, and corticosteroids, is used for kidney transplant immunosuppression. The growing incidence of kidney diseases and kidney transplants, as well as advancements in immunosuppressive therapies, is anticipated to drive the market growth.

Regional Segment Analysis of the Organ Transplant Immunosuppressant Drugs Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

North America is anticipated to hold the largest share of the organ transplant immunosuppressant drugs market over the predicted timeframe.

North America is anticipated to hold the largest share of the organ transplant immunosuppressant drugs market over the predicted timeframe. An increasing number of organ transplants, as well as the need for immunosuppression for preventing graft rejection, is contributing to propel the market demand. An increasing prevalence of chronic diseases is likely to drive the market demand for organ transplant immunosuppressant drugs. For instance, as per the data from Statistics Canada, approximately 45.1% of Canadians lived with at least one major chronic disease in 2021.

Asia Pacific is expected to grow at a rapid CAGR in the organ transplant immunosuppressant drugs market during the forecast period. An increasing awareness of organ donation, especially in countries like China and India, is promoting the organ transplant immunosuppressant drugs market. Prevalence of chronic diseases, number of organ transplants, and initiatives for creating awareness about organ donations and advancements are contributing to propel the market in the region.

Europe is anticipated to hold a significant share of the organ transplant immunosuppressant drugs market during the predicted timeframe. The presence of well-established healthcare infrastructure, an increasing number of organ transplants, and supportive government policies are all responsible for driving the market of organ transplant immunosuppressant drugs. The presence of key market players, including Astellas Pharma, Sanofi, Novartis, and Dr. Reddy’s Laboratories, significantly contributes to market growth.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the organ transplant immunosuppressant drugs market, along with a comparative evaluation primarily based on their type of offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes type development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Astellas Pharma d.o.o.
• Sanofi
• Accord Healthcare
• Novartis AG
• Viatris Inc.
• F. Hoffmann-La Roche Ltd
• GlaxoSmithKline plc.
• Veloxis Pharmaceuticals, Inc.
• Bristol-Myers Squibb Company
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting And Research Firm
• Venture capitalists
• Value-Added Resellers (VARs) 

Recent Development

• In April 2024, United Therapeutics Corporation, a public benefit corporation, announced the world’s first successful transplant of a UThymoKidney, which the company produced, into a living person.
• In June 2023, Dr. Reddy’s Laboratories Ltd. announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study.
• In February 2022, Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, announced that VEL-101, a novel investigational maintenance immunosuppressive agent being developed for prophylaxis of renal allograft rejection in patients receiving a kidney transplant, was granted fast-track designation by the US FDA.

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the organ transplant immunosuppressant drugs market based on the below-mentioned segments: 

Global Organ Transplant Immunosuppressant Drugs Market, By Drug Class

• Calcineurin Inhibitors
• Antiproliferative Agents
• mTOR Inhibitor
• Steroids
• Other Drug Classes

Global Organ Transplant Immunosuppressant Drugs Market, By Transplant Type

• Kidney
• Liver
• Heart
• Lung
• Pancreas
• Other Transplant Types

Global Organ Transplant Immunosuppressant Drugs Market, By Regional Analysis

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa

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