Tacrolimus Market Size

Tacrolimus Market size was valued at USD 6.6 billion in 2023 and is expected to expand at a CAGR of 5.6% between 2024 and 2032. The rising number of organ transplant procedures and the increasing prevalence of autoimmune diseases are anticipated to be key drivers fueling the growth of the market.

The significant increase in the number of organ transplant procedures is attributed to various factors such as the increasing prevalence of end-stage organ failure, heightened awareness about organ donation, and advancements in procedural technology, among others. Conditions such as chronic kidney disease, liver cirrhosis, and heart failure, driven by aging populations and lifestyle-related diseases, have spurred the demand for transplantation as a life-saving measure.

For instance, according to the United Network for Organ Sharing (UNOS), the U.S. recorded a record-breaking 42,887 organ transplant procedures in 2022, with over 14,000 deceased organ donors contributing to more than 36,400 transplants. These statistics underscore the global efforts and advancements in organ donation and transplantation, indicating a promising trajectory for the tacrolimus market.

Tacrolimus is a medication belonging to the class of drugs known as calcineurin inhibitors. It is primarily used in organ transplant recipients to prevent rejection of the transplanted organ by suppressing the immune system.

Tacrolimus Market Trends

The increasing prevalence of autoimmune disorders, coupled with surging research and development activities aimed at developing more effective and promising drugs, is anticipated to emerge as the key contributors propelling the growth trajectory of the market.

• The surge in research and development activities in immunosuppression is primarily driven by the increasing incidence of autoimmune diseases. For instance, autoimmune diseases affect up to 8% of the U.S. population, making them among the most prevalent disorders in the country. To address the anticipated population affected due to autoimmune disease diagnostics, there's a growing demand for advanced solutions in immunosuppression.
  
• Additionally, in response to this need, new immunosuppressive agents like the JAK inhibitor tofacitinib and mTOR inhibitor everolimus have been developed, showing promising therapeutic effects in clinical use compared to existing drugs. These new agents are designed to be more selective and have fewer side effects, driving the demand for technological advancements in immunosuppression. This rising prevalence of autoimmune diseases underscores the necessity for such developments, leading to an expanding market in this field.    
  

Tacrolimus Market Analysis

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Based on application, the tacrolimus market is segmented into dermatitis, immunosuppression, and other applications. The immunosuppression segment is poised to cross USD 6.4 billion by 2032.

• Organ transplantation has become more common and successful due to advancements in surgical techniques, organ preservation solutions, and post-transplant care, which ultimately increases the need for immunosuppressive drugs, hence may result in the segmental growth.  
  
• Additionally, advances in biotechnology have enabled the development of biologic immunosuppressive agents, such as monoclonal antibodies and fusion proteins. These biologics offer targeted approaches to immune modulation and have revolutionized the treatment of autoimmune diseases and transplantation, contributing to the growth of the immunosuppression segment.
  

Based on product type, the market is segmented into injections, tablets and capsules, ointments, and granules. The injections segment is expected to reach USD 4.1 billion by 2032.

• Immediately after transplantation surgery, patients often require high doses of immunosuppressive medications to prevent organ rejection. Tacrolimus injections are frequently used during this critical post-operative period to ensure timely and effective immunosuppression, particularly in patients that are unable to tolerate oral medications, hence anticipated to its increasing demand. 
  
• Moreover, injections allow for precise control over the dosage administered, which is especially important in critical care settings. Healthcare providers can titrate the dose of tacrolimus based on individual patient factors and clinical response, ensuring therapeutic efficacy while minimizing the risk of adverse effects to the above-mentioned features are projected to fuel the segmental growth over the forecast period.
  

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The tacrolimus market by end-use is categorized into hospitals, specialty clinics, and other end-use. The hospital segment dominated around USD 3.3 billion revenue in 2023.

• Hospitals are equipped to handle medical emergencies, including cases of acute rejection or complications related to tacrolimus therapy. In such situations, rapid access to medical expertise, supportive care, and alternative treatment options is essential for patient management, which may increase the demand for tacrolimus in hospital settings.   
  
• Moreover, hospitals often participate in research and clinical trials aimed at advancing the understanding and treatment of autoimmune diseases and organ transplantation. Tacrolimus can be substantially used in these research settings to evaluate its efficacy, safety, and optimal dosing strategies.
  

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North America tacrolimus market accounted for USD 2.7 billion revenue in 2023 and is predicted to witness substantial growth over the analysis timeline.

• North America boasts advanced healthcare infrastructure, including specialized transplant centers, hospitals, and clinics equipped to perform organ transplant surgeries, manage complex medical conditions, and provide organ transplant rejection medication. Due to this infrastructure advancement the market is anticipated to record growth over the forecast period.
  
• Furthermore, majority of the patients in North America have access to health insurance coverage, that may facilitate access to medications including tacrolimus. Insurance coverage for tacrolimus prescriptions helps ensure affordability and accessibility for patients, which is anticipated to further boost the demand for the drug in the region.
  

Tacrolimus Market Share

The tacrolimus industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products based on different formulations is among a key market strategy. Some of the leading industry players including Abbott Laboratories, Astellas Pharma Inc., Novartis AG, Biocon Ltd., and Glenmark Pharmaceuticals Ltd. among others have a notable presence in the market.

Tacrolimus Market Companies

Some of the eminent market participants operating in the tacrolimus industry include:

• Abbott Laboratories
• Astellas Pharma Inc.
• Biocon Ltd.
• F. Hoffmann-La Roche Ltd
• Glenmark Pharmaceuticals Ltd.
• GSK plc
• Lupin Pharmaceuticals Ltd
• Novartis
• Pfizer Inc.
• Takeda Pharmaceutical Company Limited
• Viatris Inc.
  

Tacrolimus Industry News

• In August 2023, Glenmark Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) for its Tacrolimus ointment, 0.03%, which is the generic version of Leo Pharma's Protopic Ointment, 0.03%. This approval is expected to improve the company’s revenue generation, reputation, and brand awareness.
  
• In December 2020, Biocon expanded its generic formulations portfolio with the launch of Tacrolimus capsules in the U.S. This portfolio expansion enabled the company to enter the lucrative U.S. market, expanding its reach and potential customer base.
  

The tacrolimus market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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Market, By Product Type

• Injections
• Tablets and capsules
• Ointments
• Granules

Market, By Application

• Dermatitis
• Immunosuppression
• Other applications

Market, By End-use

• Hospitals
• Specialty clinics
• Other end-users

The above information has been provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa