The Immunosuppressant Drugs Market is Segmented by Drug Class (Calcineurin Inhibitors, Antiproliferative Agents, MTOR Inhibitors, Steroids, Other Classes), Application (Autoimmune Diseases, Organ Transplant, Other Applications), Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

The global immunosuppressive agents market is experiencing robust growth, driven by increasing prevalence of autoimmune diseases, organ transplantation procedures, and the rising demand for effective therapies to manage graft-versus-host disease (GvHD). The market, estimated at $15 billion in 2025, is projected to witness a Compound Annual Growth Rate (CAGR) of 6% from 2025 to 2033, reaching approximately $25 billion by 2033. Key factors propelling this expansion include advancements in immunosuppressant drug development, leading to improved efficacy and reduced side effects. Furthermore, an aging global population and increased healthcare expenditure in developed and developing nations are contributing to market growth. However, challenges remain, including the high cost of these therapies, potential for serious adverse events, and the emergence of drug resistance, which necessitates continuous research and development of novel immunosuppressants. The market is segmented by drug class (e.g., calcineurin inhibitors, mTOR inhibitors, corticosteroids), therapeutic application (e.g., transplantation, autoimmune diseases), and route of administration. Leading companies such as Huadong Medicine, Fujisawa Pharmaceutical Co. Ltd, Astellas, Roche, Novartis, and North China Pharmaceutical Group are actively engaged in research, development, and market expansion strategies to maintain their competitive positions. The competitive landscape is characterized by both established pharmaceutical giants and emerging players vying for market share. Strategic alliances, mergers, and acquisitions are common strategies employed to expand product portfolios and enhance market access. The future growth of the immunosuppressive agents market will depend heavily on ongoing research to develop safer and more effective therapies with fewer side effects. A greater understanding of the underlying mechanisms of immune response and tailored treatment approaches based on individual patient characteristics will also be pivotal in shaping future market trends. Regulatory approvals and pricing policies will continue to play a significant role in determining market access and profitability. The focus on personalized medicine and the development of biosimilars presents both opportunities and challenges for the market participants in the coming years.

Immunosuppressive Drugs Market Outlook

The global market size for immunosuppressive drugs was approximately USD 15 billion in 2023 and is projected to reach nearly USD 29 billion by 2032, growing at a CAGR of 7.5% during the forecast period. This remarkable growth can be attributed to the increasing incidence of organ transplantation procedures, the rising prevalence of autoimmune diseases, and advancements in drug development.

One of the primary growth drivers for the immunosuppressive drugs market is the increasing number of organ transplants globally. With advancements in medical technology, organ transplantation has become more accessible and successful, leading to a higher demand for immunosuppressive drugs to prevent organ rejection. Additionally, the aging population and the rise in chronic diseases such as diabetes and hypertension have led to an increase in organ failures, further fueling the need for these drugs.

Another significant factor contributing to market growth is the rising prevalence of autoimmune diseases. Conditions such as rheumatoid arthritis, lupus, and multiple sclerosis require long-term immunosuppressive therapy to manage the immune system's abnormal response. The increasing awareness of these conditions and the availability of advanced treatment options have led to a higher demand for immunosuppressive drugs. Furthermore, ongoing research and development activities aimed at discovering new and more effective drugs are expected to drive market expansion.

The pharmaceutical industry is also witnessing a surge in investment and innovation, which is positively impacting the immunosuppressive drugs market. Biotechnology companies are focusing on developing targeted therapies and personalized medicine, which are expected to offer better efficacy and fewer side effects. Additionally, collaborations and partnerships between pharmaceutical companies and research institutions are accelerating the development of novel immunosuppressive agents, thereby expanding the market.

Cyclosporine Drugs, a key category within the Calcineurin Inhibitors, have played a pivotal role in the management of organ transplant patients. These drugs are essential in preventing organ rejection by suppressing the immune response, thereby ensuring the longevity and functionality of transplanted organs. The development of cyclosporine marked a significant advancement in transplant medicine, transforming it into a more viable and successful option for patients worldwide. Over the years, cyclosporine has undergone various modifications to improve its efficacy and reduce side effects, making it a cornerstone in immunosuppressive therapy. Its widespread use is not limited to organ transplantation; cyclosporine is also employed in treating certain autoimmune conditions, further highlighting its versatility and importance in the medical field.

From a regional perspective, North America holds a significant share of the global immunosuppressive drugs market, primarily due to the high number of organ transplant procedures and the prevalence of autoimmune diseases. Europe follows closely, with countries like Germany, France, and the UK contributing significantly to market growth. The Asia Pacific region is expected to witness the highest growth rate during the forecast period, driven by increasing healthcare expenditure, improving medical infrastructure, and a growing patient population. Latin America and the Middle East & Africa are also experiencing steady growth, although they account for a smaller market share.

Drug Class Analysis

The immunosuppressive drugs market is segmented by drug class, with key categories including Calcineurin Inhibitors, mTOR Inhibitors, Anti-Proliferative Agents, Steroids, Monoclonal Antibodies, and others. Calcineurin Inhibitors, such as cyclosporine and tacrolimus, are among the most commonly used immunosuppressive drugs. These drugs work by inhibiting the activity of calcineurin, a protein involved in activating T-cells, which play a key role in immune response. Their widespread use in both organ transplantation and autoimmune diseases makes them a significant segment in the market.

mTOR Inhibitors, including drugs like sirolimus and everolimus, are another crucial segment. These drugs inhibit the mechanistic target of rapamycin (mTOR) pathway, which is essential for cell growth and proliferation. mTOR Inhibitors are particularly valuable in preventing organ rejection and treating cer

Immunosuppressive Agents Market Outlook

The global immunosuppressive agents market size was valued at approximately USD 14.3 billion in 2023 and is projected to reach around USD 25.6 billion by 2032, growing at a compound annual growth rate (CAGR) of 6.7% during the forecast period. The primary growth factor driving this market is the increasing prevalence of autoimmune diseases and organ transplant procedures globally.

The rise in autoimmune diseases, such as rheumatoid arthritis, lupus, and multiple sclerosis, is significantly driving the demand for immunosuppressive agents. These conditions necessitate long-term treatment with immunosuppressive drugs to manage symptoms and improve patients' quality of life. Additionally, advancements in the understanding of autoimmune pathophysiology and innovations in drug delivery systems are fueling market growth. Another factor contributing to the market expansion is the growing number of organ transplants. With advancements in surgical techniques and postoperative care, the success rate of organ transplants has increased, leading to a higher demand for immunosuppressive agents to prevent organ rejection.

Additionally, there is a significant surge in research and development activities aimed at discovering new immunosuppressive drugs and improving existing ones. Pharmaceutical companies are heavily investing in clinical trials and collaborations to introduce novel therapies with improved efficacy and safety profiles. The development of personalized medicine and targeted therapies is also expected to provide a significant boost to the market. Furthermore, increasing awareness about organ donation and the establishment of organ donation programs in various countries are expected to contribute to the market growth.

However, the high cost of immunosuppressive therapies and strict regulatory approvals can pose challenges to market growth. Despite these challenges, the market is likely to benefit from the rising geriatric population, which is more susceptible to chronic diseases and organ failures, thereby increasing the demand for immunosuppressive therapies. Additionally, government initiatives and healthcare reforms aimed at improving access to essential medications are expected to drive the market forward.

The market for Autoimmune and Inflammatory Immunomodulators is experiencing significant growth due to the increasing prevalence of autoimmune diseases worldwide. These immunomodulators play a crucial role in managing conditions such as rheumatoid arthritis, lupus, and multiple sclerosis by modulating the immune system to reduce inflammation and prevent tissue damage. The development of novel immunomodulatory therapies that offer improved efficacy and safety profiles is a key focus for pharmaceutical companies. Additionally, the integration of advanced drug delivery systems is enhancing the therapeutic outcomes of these agents, making them more accessible and effective for patients. The growing awareness and understanding of autoimmune and inflammatory conditions are driving research and development efforts, leading to the introduction of innovative treatments in the market.

Regionally, North America holds the largest share of the immunosuppressive agents market, followed by Europe. The high prevalence of autoimmune diseases and the advanced healthcare infrastructure in these regions are major contributing factors. The Asia Pacific region is anticipated to witness the highest growth rate during the forecast period, driven by increasing healthcare expenditure, rising awareness about autoimmune diseases, and improving access to healthcare services. Latin America and the Middle East & Africa are also expected to show significant growth due to the rising incidence of chronic diseases and improving healthcare facilities.

Drug Class Analysis

The immunosuppressive agents market is segmented by drug class, including calcineurin inhibitors, mTOR inhibitors, antiproliferative agents, steroids, monoclonal antibodies, and others. Calcineurin inhibitors, such as cyclosporine and tacrolimus, are widely used due to their efficacy in preventing organ rejection. These drugs work by inhibiting the activity of calcineurin, a protein involved in the activation of T-cells. Despite their effectiveness, they have notable side effects, including nephrotoxicity and neurotoxicity, which drive ongoing research for safer alternatives.

mTOR inhibitors, in

Immunosuppressant Drugs Market Outlook

The global immunosuppressant drugs market size was estimated to be worth USD 14 billion in 2023 and is projected to reach USD 24 billion by 2032, growing at a compound annual growth rate (CAGR) of 6.2% during the forecast period. One of the significant factors driving this growth is the increasing incidence of autoimmune diseases and the rising number of organ transplantations worldwide. As medical advancements continue to improve the success rates of organ transplants, the demand for effective immunosuppressant therapies is expected to rise correspondingly. This growth is further bolstered by an expanding aging population, which is more susceptible to such medical conditions.

The rising prevalence of autoimmune diseases such as rheumatoid arthritis, lupus, and multiple sclerosis is a key growth driver for the immunosuppressant drugs market. These conditions require long-term medication to manage symptoms and prevent severe complications, thereby increasing the demand for effective immunosuppressive treatments. Additionally, the continuous development of innovative therapies and the introduction of biologics have opened new avenues for treating autoimmune disorders, further propelling market growth. Moreover, growing awareness regarding early diagnosis and treatment of autoimmune diseases among patients and healthcare professionals is likely to support market expansion.

Organ transplantation is another pivotal factor contributing to the growth of the immunosuppressant drugs market. The advancements in transplantation techniques and immunosuppressive protocols have improved patient survival rates and outcomes, leading to an increase in the number of transplant procedures performed globally. As a result, the demand for effective immunosuppressant drugs to prevent organ rejection in transplant recipients continues to grow. Additionally, government initiatives and healthcare policies promoting organ donation and transplantation awareness are expected to enhance market growth over the forecast period. The development of novel immunosuppressive agents with fewer side effects and better efficacy further supports this upward trend.

The market is also influenced by the growing geriatric population, which is more prone to chronic diseases and subsequently requires transplantation and immunosuppressive therapy. The elderly are more likely to suffer from chronic illnesses that may lead to organ failure, thereby increasing the demand for organ transplantations and, consequently, immunosuppressant drugs. Furthermore, an increase in healthcare expenditure, particularly in emerging economies, is expected to provide significant opportunities for market growth. This economic trend allows for better healthcare infrastructure and access to advanced treatments, benefiting the expansion of the immunosuppressant drugs market.

Calcineurin Inhibitor Drug plays a pivotal role in the landscape of immunosuppressant therapies, particularly in the context of organ transplantation. These drugs, including well-known agents like cyclosporine and tacrolimus, are crucial for their ability to prevent organ rejection by modulating the immune system. They work by inhibiting calcineurin, a protein phosphatase involved in activating T-cells, which are central to the immune response. This mechanism of action makes them indispensable in maintaining the delicate balance required to prevent the body from attacking transplanted organs while preserving overall immune function. As research continues to advance, the development of next-generation calcineurin inhibitors aims to enhance efficacy and reduce potential side effects, thereby solidifying their position in the market.

Regionally, North America is anticipated to dominate the immunosuppressant drugs market due to the presence of a well-established healthcare infrastructure, high healthcare expenditure, and significant investments in research and development. The region's large patient pool suffering from autoimmune diseases and requiring organ transplants also contributes to market growth. In contrast, the Asia Pacific region is expected to experience the highest growth rate, driven by increasing healthcare awareness, a rising prevalence of chronic diseases, and economic development. The growing investments in healthcare infrastructure and government initiatives supporting organ transplantation and chronic disease management are key factors driving market expansion in this region.

Drug Class Analysis

Explore Market Research Intellect's Immunosuppressive Agents Sales Market Report, valued at USD 45 billion in 2024, with a projected market growth to USD 70 billion by 2033, and a CAGR of 6.4% from 2026 to 2033.

Global Immunosuppressive Agents market size 2025 was XX Million. Immunosuppressive Agents Industry compound annual growth rate (CAGR) will be XX% from 2025 till 2033.

The global immunosuppressive agents market size is expected to reach USD 25.2 billion by 2033, growing at a CAGR of 5.1%. The increasing prevalence of organ transplants, autoimmune diseases, and cancer are the primary drivers of market growth. Immunosuppressive agents play a crucial role in preventing and treating rejection reactions in organ transplant recipients and suppressing immune system activity in patients with autoimmune diseases and certain types of cancer. The rising incidence of renal, hepatic, cardiac, and other organ transplants, along with the increasing adoption of immunosuppressive therapies for cancer treatment, are expected to drive the growth of the market. The competitive landscape of the immunosuppressive agents market is fragmented, with several major players holding significant market shares. Key players include Huadong Medicine, Fujisawa Pharmaceutical Co. Ltd., Astellas, Roche, Novartis, and North China Pharmaceutical Group. These companies are actively involved in research and development, product launches, and strategic acquisitions to maintain their positions in the market. The introduction of new immunosuppressive agents with improved efficacy and safety profiles is expected to further stimulate the growth of the market. Technological advancements, such as the development of targeted therapies and personalized medicine approaches, are also expected to shape the future of the immunosuppressive agents market.

Calcineurin Inhibitors: Calcineurin inhibitors, such as cyclosporine and tacrolimus, continue to be widely used in organ transplantation due to their effectiveness in preventing rejection.

Corticosteroids:
Corticosteroids, including prednisone and methylprednisolone, play a significant role in suppressing inflammation and the immune system, making them a mainstay in immunosuppressive therapy.


Antiproliferative Agents:
Antiproliferative agents, like mycophenolate mofetil and azathioprine, target the proliferation of immune cells involved in rejection and autoimmune diseases.


mTOR Inhibitors:
mTOR inhibitors, such as sirolimus and everolimus, act on the mammalian target of rapamycin (mTOR) pathway to inhibit cell growth and proliferation, offering a valuable therapeutic option.


Others:
Other immunosuppressive drugs include alkylating agents, antimetabolites, and monoclonal antibodies, each with unique mechanisms of action.

Recent developments include: Intended Audience, This report will be beneficial for every stakeholder of the immunosuppressive drugs market such as:. Key drivers for this market are: Growing Demand for Organ Transplants: Advancements in transplant techniques and the increasing need for organ replacement are fueling the demand for immunosuppressive drugs.

Rise in Autoimmune Disease Prevalence: The growing incidence of autoimmune diseases, such as rheumatoid arthritis and lupus, is creating a need for effective immunosuppressive treatments.. Potential restraints include: Side Effects and Long-Term Health Risks: Immunosuppressive drugs can cause various side effects, including increased susceptibility to infections and cancer.

High Cost of Treatment: Immunosuppressive drugs can be expensive, which can limit access to treatment for patients in certain regions.. Notable trends are: Precision Medicine: Personalized medicine approaches aim to tailor immunosuppressive therapy based on individual patient characteristics and disease profiles.

Combination Therapies: Combinations of different immunosuppressive drugs with varying mechanisms of action are being explored to improve efficacy and reduce side effects..

Explore Market Research Intellect's Immunosuppressive Drugs Market Report, valued at USD 50.5 billion in 2024, with a projected market growth to USD 72.3 billion by 2033, and a CAGR of 5.0% from 2026 to 2033.

Overview

New York, NY – July 30, 2025 – The Organ Transplant Immunosuppressant Drugs Market Size is expected to be worth around US$ 9.0 Billion by 2034 from US$ 5.6 billion in 2024, growing at a CAGR of 4.9% during the forecast period 2025 to 2034.

The global organ transplant immunosuppressant drugs market is witnessing steady expansion, driven by the increasing number of organ transplant procedures and advancements in immunosuppressive therapies. Immunosuppressant drugs play a critical role in preventing organ rejection by suppressing the recipient’s immune response post-transplantation.

The rising prevalence of chronic diseases such as kidney failure, liver cirrhosis, and heart failure has led to a significant increase in organ transplants worldwide. According to data from global health authorities, over 150,000 solid organ transplants were performed globally in 2023. This surge in transplants has directly contributed to the growing demand for immunosuppressive medications.

Key drug classes in the market include calcineurin inhibitors, corticosteroids, mTOR inhibitors, and antiproliferative agents. Among these, tacrolimus and cyclosporine remain the most widely prescribed drugs due to their efficacy and established safety profiles. The development of newer formulations with improved bioavailability and fewer side effects is further enhancing patient outcomes.

North America dominates the global market, supported by a high transplant rate, favorable reimbursement policies, and robust healthcare infrastructure. Meanwhile, Asia Pacific is expected to exhibit the fastest growth, driven by improving healthcare access and increasing transplant capabilities. With rising transplant needs and continuous innovations, the organ transplant immunosuppressant drugs market is projected to grow steadily in the coming years.

The immunosuppressive agents market is a significant and rapidly growing sector within the pharmaceutical industry, projected to reach $1347.9 million in 2025 and exhibiting a robust Compound Annual Growth Rate (CAGR) of 4.4% from 2025 to 2033. This growth is driven by several key factors, including the rising prevalence of autoimmune diseases like rheumatoid arthritis and lupus, the increasing number of organ transplantation procedures globally, and advancements in cancer therapies that necessitate immunosuppression. The market is segmented by drug type (Cyclosporin, Tacrolimus, Everolimus, Sirolimus, Mycophenolic Acid) and application (Innate Immune Disease Treatment, Organ Transplant, Cancer Treatment, Other). The demand for effective and safer immunosuppressants is continuously increasing, prompting pharmaceutical companies to invest heavily in research and development of novel agents with improved efficacy and reduced side effects. The competitive landscape includes major players like Huadong Medicine, Fujisawa Pharmaceutical Co Ltd, Astellas, Roche, Novartis, and North China Pharmaceutical Group, each striving for market share through product innovation and strategic partnerships. Geographical variations in market size reflect differing healthcare infrastructure and disease prevalence across regions, with North America and Europe currently holding substantial market shares. Continued growth in the immunosuppressive agents market is expected to be fueled by ongoing research into novel therapeutic approaches, the expansion of organ transplantation programs in developing countries, and the growing adoption of personalized medicine approaches to optimize treatment strategies. However, challenges remain, including the potential for serious side effects associated with immunosuppressants and the high cost of treatment. Addressing these challenges through improved drug development and access initiatives will be crucial for sustained market expansion. The ongoing development of biosimilars and the exploration of combination therapies also promise to reshape the competitive landscape and offer patients broader treatment options in the coming years. Careful monitoring of regulatory approvals and pricing strategies will be essential for industry stakeholders.

Gain in-depth insights into Organ Transplantation Immunosuppressive Drug Market Report from Market Research Intellect, valued at USD 5.8 billion in 2024, and projected to grow to USD 9.2 billion by 2033 with a CAGR of 6.2% from 2026 to 2033.

Global Immunosuppressants market size is expected to reach $48.88 billion by 2029 at 13.2%, organ transplants fueling growth in the immunosuppressant market

The Organ Transplant Immunosuppressant Drugs Market Report is Segmented by Drug Class (Calcineurin Inhibitors, Antiproliferative Agents, MTOR Inhibitor, and More), Transplant Type (Heart, Kidney, Liver, Lung, and More), Route of Administration (Oral, Intravenous, and More), Distribution Channel (Hospital Pharmacies, and More), and Geography (North America, Europe and More). The Market Forecasts are Provided in Terms of Value (USD).

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Immunosuppressants Market Size 2024-2028

The immunosuppressants market size is forecast to increase by USD 4.48 billion at a CAGR of 5.19% between 2023 and 2028. The market is driven by the high dependency on these drugs for organ transplant procedures, particularly in multiple sclerosis and organ donors. Reimbursement policies for kidney transplantation are a significant growth factor, as immunosuppressants are essential for the success of these procedures. However, the market faces challenges due to the side effects of immunosuppressants, which can lead to long-term health complications. Additionally, trends in tissue engineering, implants, and developing economies offer opportunities for market expansion. Immunosuppressants are a crucial drug class in managing autoimmune diseases and ensuring the success of organ and cell transplants. In multiple sclerosis, immunosuppressants help reduce inflammation and prevent relapses. Furthermore, in organ transplantation, they prevent the rejection of the transplanted organ by suppressing the immune system. Despite their benefits, the side effects of immunosuppressants, such as increased risk of infections and malignancies, limit their widespread use. Tissue engineering and implants offer potential alternatives to organ transplantation while developing economies present new opportunities for market growth.

Market Analysis

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The market is witnessing significant growth due to the increasing number of organ transplantations and the rising prevalence of autoimmune diseases. Organ transplantation requires clinical immunosuppression to prevent the immune response from rejecting the transplanted organ. Induction therapy is used during the initial stages of transplantation to suppress the immune system, while maintenance therapy is administered to prevent acute rejection responses. Immunosuppressants are also used in the treatment of various systemic autoimmune diseases such as lupus, myasthenia gravis, rheumatoid arthritis, Crohn's disease, lupus nephritis, SLE, scleroderma, psoriasis, and dermatomyositis. These diseases are characterized by an overactive immune response, leading to inflammation and damage to various organs and tissues.

Moreover, the regulatory processes for approving immunosuppressants are stringent due to their potential side effects. Some of the recent developments in the market include Glaxosmithkline's Benlysta, which is approved for the treatment of lupus nephritis, and Aurinia Pharmaceuticals' Lupkynis, which is used for the treatment of lupus nephritis in adults. These drugs have shown promising results in clinical trials and are expected to expand the market for immunosuppressants.

Market Segmentation

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD billion' for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

Drug Class

  Corticosteroids
  Monoclonal antibodies
  Others


Geography

  North America

    Canada
    US


  Europe

    Germany
    UK


  Asia

    China


  Rest of World (ROW)

By Drug Class Insights

The corticosteroids segment is estimated to witness significant growth during the forecast period. Immunosuppressants, specifically corticosteroids such as prednisone, play a crucial role in kidney, liver, and heart transplant procedures by preventing the body's immune system from rejecting the transplanted organ. These medications are employed for both induction and maintenance therapy to suppress the immune response and reduce the production of cytokines and vasoactive substances, including interleukin (IL)–1, IL-2, IL-6, tumor necrosis factor-alpha, chemokines, prostaglandins, and proteases. Corticosteroids function primarily by acting as agonists of glucocorticoid receptors, but at higher doses, they exhibit receptor-independent effects. They also induce partial remission in the majority of patients by reducing the production of autoantibodies by B-cells and decreasing the density of Fc-gamma receptors on phagocytes in the spleen. Furthermore, in the context of clinical immunosuppression, corticosteroids are essential for managing acute rejection responses and treating autoimmune disorders.

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The corticosteroids segment accounted for USD 5.58 billion in 2018 and showed a gradual increase during the forecast period.

Regional Insights

Europe is estimated to contribute 33% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The market is anticipated to expand significantly during the forecast period due to

Immunosuppressant Drugs Market - Global Industry Insights, Size, Share, Trends, Outlook, and Opportunity Analysis

Organ Transplant Immunosuppressant Drugs Market valued at USD 5.5 Bn in 2025, is anticipated to reaching USD 6.81 Bn in 2032 with a steady growth CAGR of 3.1% .

The Immunosuppressive Drugs market is projected to be valued at $40 billion in 2024, driven by factors such as increasing consumer awareness and the rising prevalence of industry-specific trends. The market is expected to grow at a CAGR of 7%, reaching approximately $80 billion by 2034.

The Immunosuppressive Agents market plays a crucial role in modern medicine, primarily utilized to inhibit the immune response in patients undergoing organ transplants, treating autoimmune diseases, and managing various inflammatory conditions. These medications are essential for preventing organ rejection in transp