According to a recent report by Coherent Market Insights, the global tacrolimus market is projected to be valued at USD 6,485.3 million in 2022 and is expected to soar to approximately USD 9,380.2 million by 2030, growing at a remarkable CAGR of 4.7% from 2022 to 2030.
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Global Tacrolimus Market Key Takeaways
• The global tacrolimus market size is projected to grow at a CAGR of 4.7% during the forecast period, totaling US$ 9,380.2 million by 2030.
• By product type, tacrolimus segment is anticipated to retain its dominance during the assessment period. It accounted for about 38.8% of the global tacrolimus market share in 2022.
• Based on application, immunosuppression segment accounted for a 55.8% share of the tacrolimus market in 2022.
• North America is expected to remain at the top of the ladder in the global tacrolimus market owing to increasing organ transplant surgeries, strong presence of key players, and continuous new product launches and approvals.
• As per Coherent Market Insights’ latest tacrolimus market analysis, Asia Pacific, spearheaded by China and India, will likely experience fastest growth. This is attributable to increasing prevalence of autoimmune and cardiovascular diseases, growing health awareness, and favorable government support.
Increasing Chronic Kidney Disease (CKD) Burden Propelling Growth
A new report by Coherent Market Insights outlines significant tacrolimus market trends. One such trend expected to propel growth of tacrolimus industry is the increasing cases of chronic kidney disease (CKD) globally.
There is a sharp rise in the cases of CKD globally. According to a report published in The Lancet, chronic kidney disease affects around 9.1% to 13.4% of the global population. This increasing CKD prevalence is anticipated to drive tacrolimus market demand.
Tacrolimus is widely used as an immunosuppressant to prevent organ transplant rejection, especially during kidney transplants. Thus, rise in kidney transplants due to CKD, especially in end-stage renal disease (ESRD) patients, will directly boost tacrolimus market growth during the forecast period.
More CKD Cases → More Kidney Transplants→ Higher Tacrolimus Demand
Similarly, rise in liver and heart transplants will play a key role in improving the global tacrolimus market value through 2030.
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Adverse Side Effects and Availability of Alternative Therapies Limited Growth
Tacrolimus is associated with serious side effects, including infection, hypertension, nephrotoxicity, diabetes mellitus, hyperglycemia, and neurotoxicity. These adverse side effects often lead to treatment discontinuation, thereby limiting tacrolimus market growth.
Availability of other alternative therapies is also limiting growth of the tacrolimus market. Many physicians and patients opt for cyclosporine, mofetil, sirolimus, and newer biologics that offer immunosuppressant benefits with minimal side effects.
Expanding Applications in Autoimmune Disorders Creating Growth Avenues
Tacrolimus is increasingly being explored for the treatment of autoimmune conditions like rheumatoid arthritis, atopic dermatitis, psoriasis, and lupus. This is due to the tendency of this immunosuppressant to manage chronic inflammation and prevent immune-mediated tissue damage in these conditions. Thus, increasing incidence of these autoimmune diseases will likely create new growth opportunities for tacrolimus manufacturers during the forecast period.
Emerging Tacrolimus Market Trends
Companies are also looking to offer personalized immunosuppressive therapies tailored to individual patient needs. This will further boost growth of the tacrolimus market during the assessment period.
Patent expirations for original tacrolimus products are making a clear road for generic and biosimilar versions. This can increase affordability and accessibility of tacrolimus products, especially in developing nations like India and China.
Analyst’s View
“The future of tacrolimus market looks bright and promising, considering the increasing number of organ transplant procedures performed globally and expanding applications in autoimmune diseases,” said senior analyst Ghanshyam Shrivastava. “Innovations in drug formulations are opening new frontiers, while generics and biosimilars are paving way for broader accessibility.”
Competitor Insights
Key companies in tacrolimus market report:
- Novartis AG
- Mylan N.V.
- Astellas Pharma Inc.
- Dr. Reddy's Laboratories Ltd.
- Pfizer Inc.
- Abbott
- Senju Pharmaceutical Co. Ltd.
- Glenmark Pharmaceuticals Ltd.
- Lupin Limited
- Vibcare Pharma Pvt. Ltd.
Key Developments
• In February 2025, Nexus Pharmaceuticals received U.S. FDA approval for its Tacrolimus Injection 5 mg/mL. This approval marks the introduction of the first and only single-dose vial of Tacrolimus Injection. It will offer a new ray of hope for patients requiring immunosuppressive therapy, such as those undergoing organ transplants.
• In January 2025, China’s National Medical Products Administration (NMPA) approved Biocon Pharma Limited’s Tacrolimus capsules in 0.5mg, 5mg, and 1mg strengths for use in organ transplant patients.
• In April 2024, Biocon Limited received approval for Tacrolimus capsules from the South African Health Products Regulatory Authority. This marks the company’s first approval in the nation.
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Detailed Segmentation:
Global Tacrolimus Market, By Product Type:
- Tacrolimus Capsules and Tablets
- Tacrolimus Ointment
- Tacrolimus Injection
- Tacrolimus Granules
Global Tacrolimus Market, By Application:
- Immunosuppression
- Dermatitis
- Others
Global Tacrolimus Market, By End User:
- Organ Transplant Centers
- Hospitals
- Clinics
- Others
Global Tacrolimus Market, By Region:
- North America
- U.S.
- Canada
- Latin America
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Germany
- U.K.
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- South Africa
- North Africa
- Central Africa
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