Immunosuppressants Global Market Report 2024

The immunosuppressants market size has grown rapidly in recent years. It will grow from $25.94 billion in 2023 to $29.72 billion in 2024 at a compound annual growth rate (CAGR) of 14.6%. The growth observed in the historic period can be attributed to advancements in transplant medicine, continuous drug development and innovation, regulatory approvals, an increase in transplant surgeries, and the emphasis on clinical efficacy and safety measures.

The immunosuppressants market size is expected to see rapid growth in the next few years. It will grow to $48.88 billion in 2028 at a compound annual growth rate (CAGR) of 13.2%. Forecasted growth relies on targeted therapies, precision medicine, biologics and biosimilars progress, immunotherapy combinations, gene therapy, and innovative drug delivery. Anticipated trends include expanded therapy indications, heightened focus on regulatory and safety concerns, precision medicine adoption, telehealth utilization, and biosimilars/generics prominence.

The growth of the immunosuppressant market is primarily attributed to the increasing prevalence of organ transplant procedures, particularly kidney and liver transplants, driven by the rising incidences of organ failure. Notably, the American Kidney Fund reported in June 2022 that the national transplant waiting list in the US would exceed 106,000 individuals, with 87% of them awaiting kidney transplants. This surge in organ transplantation cases is expected to be a key driver for the growth of the immunosuppressant market.

The immunosuppressant market is poised for growth due to the escalating instances of autoimmune diseases. Autoimmune diseases, characterized by abnormal immune responses attacking healthy cells, tissues, and organs, are on the rise. Immunosuppressant medications prove beneficial in managing autoimmune conditions such as rheumatoid arthritis, offering relief from symptoms and slowing down disease progression. A significant example is the data from the Centers for Disease Control and Prevention in June 2023, indicating that 54.4 million adults in the US were diagnosed with arthritis, a figure expected to reach 78 million by 2040. Moreover, the United Nations' World Population Prospect data in November 2022 projected a rise in the share of the global population aged 65 and above from 10% in 2022 to 16% in 2050. This increasing prevalence of autoimmune diseases, particularly in the aging population, is anticipated to drive the demand for immunosuppressants in the market.

The anticipated hindrance to the growth of the immunosuppressants market stems from stringent government regulations imposed during the drug approval process by regulatory bodies such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). These regulatory authorities, committed to ensuring public safety, subject immunosuppressant drugs to rigorous evaluation regarding their safety and efficacy for patients with defined clinical conditions. Sponsors seeking approval must provide satisfactory evidence, and any immunotoxicology evaluation information becomes subject to review by the Center for Drug Evaluation and Research (CDER). The European Union (EU) has also adopted various guidelines, encompassing general, quality, and non-clinical and clinical aspects. Consequently, the stringent regulatory and approval procedures pose challenges to the overall growth of the immunosuppressants market.

The emergence of Phenotypic Personalized Medicine (PPM), employing a hybrid of artificial intelligence and physician intervention, presents a novel approach. Tacrolimus, a widely used immunosuppressant for organ transplant patients, requires frequent monitoring and adjustments during hospitalization. The PPM approach utilizes a computational platform, considering factors such as the patient's historical drug response, concurrent medications, and current liver and kidney data. This approach empowers physicians to identify optimal drug and dose combinations from a range of possibilities, enhancing personalization and effectiveness in drug dosing. Artificial intelligence, through PPM, not only facilitates more personalized drug dosing but also enriches physicians' decision-making capabilities by providing clinical data rather than predicted responses.

Major companies operating in the immunosuppressant market are focusing on developing innovative drugs such as prograf to prevent organ rejection in adult and pediatric patients receiving lung transplantation. Prograf is a calcineurin inhibitor, which is a type of immunosuppressant drug. It works by blocking the calcineurin pathway, which is involved in the immune response. This helps to suppress the immune system and prevent the body from rejecting the transplanted organ or treating eczema as a threat. For instance, in July 2021, Astellas Pharma Inc., a Japan-based pharma company, received approval for Prograf (tacrolimus) from the U.S. Food and Drug Administration (FDA) for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation. Prograf marks the first approval of an immunosuppressant drug to prevent rejection in adults and pediatric patients receiving lung transplants, making it the only approved immunosuppressant drug product on the market.


Prominent companies in the immunosuppressant market are directing their efforts towards the development of innovative drugs, exemplified by Prograf, designed to prevent organ rejection in both adult and pediatric patients undergoing lung transplantation. Prograf, classified as a calcineurin inhibitor, operates as a type of immunosuppressant drug. Its mechanism involves blocking the calcineurin pathway, a crucial component in the immune response, leading to immune system suppression. This action is instrumental in averting the rejection of transplanted organs and treating conditions such as eczema perceived as a threat by the immune system. A notable example is Astellas Pharma Inc., a Japan-based pharmaceutical company, which achieved approval for Prograf (tacrolimus) from the U.S. Food and Drug Administration (FDA) in July 2021. The approval pertained to Prograf's use in combination with other immunosuppressant drugs for preventing organ rejection in both adult and pediatric patients undergoing lung transplantation. This marked a significant milestone as Prograf became the first immunosuppressant drug approved for preventing rejection in adults and pediatric patients undergoing lung transplants. Consequently, Prograf stands as the sole approved immunosuppressant drug product in the market, reflecting the pioneering efforts of major companies in advancing therapeutic solutions in the field.

In October 2022, Amgen Inc., a U.S.-based biopharmaceutical and biotechnology company, successfully acquired ChemoCentryx Inc. for $3.7 billion. This strategic acquisition significantly augments Amgen's portfolio of drugs focused on inflammation and nephrology. Additionally, the acquisition brings three therapeutic candidates in the early stages that target chemoattractant receptors, address additional inflammatory conditions, and explore an oral cancer checkpoint. ChemoCentryx, Inc., the acquired company, is a U.S.-based biopharmaceutical firm specializing in the development and commercialization of novel drugs for cancer, autoimmune disorders, and inflammatory illnesses. Major companies operating in the immunosuppressants market report are Pfizer Inc.; Johnson & Johnson Services Inc.; BASF SE; F Hoffmann La Roche Ltd.; AbbVie Inc.; Allergan plc; Novartis AG; Sanofi SA; Bristol-Myers Squibb Co.; GlaxoSmithKline plc; Covestro AG; Mylan Laboratories Inc.; Teva Pharmaceuticals USA Inc.; Astellas Pharma Inc.; Sandoz Inc.; Aurobindo Pharma Limited; Hikma Pharmaceuticals plc; Intas Pharmaceuticals Ltd.; Zydus Lifesciences Limited; Glenmark Pharmaceuticals Ltd.; Fresenius Kabi USA; Lupin Pharmaceuticals Inc.; Strides Pharma Inc.; Accord Healthcare Ltd.; RPG Life Sciences Limited; Genzyme Transgenics Corp.; Akriti Pharmaceuticals Pvt. Ltd.; SEBELA PHARMACEUTICALS Inc.; Healthy Life Pharma Private Limited; Apotex Inc.

Key classes of drugs in this market include corticosteroids, monoclonal antibodies (MABs), calcineurin inhibitors, mTOR inhibitors, anti-proliferative agents, among others. Monoclonal antibodies are produced by cloning a single white blood cell and are traceable back to that parent cell. These medications are indicated for organ transplantation, autoimmune disorders, and non-autoimmune inflammatory diseases. They are distributed through hospital pharmacies, retail pharmacies, and online channels.

The immunosuppressants market research report is one of a series of new reports that provides immunosuppressants market statistics, including the immunosuppressants industry's global market size, regional shares, competitors with an immunosuppressants market share, detailed immunosuppressants market segments, market trends and opportunities, and any further data you may need to thrive in the immunosuppressants industry. This immunosuppressants market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

North America was the largest region in the immunosuppressants market in 2023. The regions covered in the immunosuppressants market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the immunosuppressants market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The immunosuppressants market consists of sales of induction drugs, maintenance drugs, corticosteroids, and calcineurin inhibitors. Values in this market are "factory gate values," that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.