| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 8.67 Billion |
| Market Size (2030) | USD 13.64 Billion |
| CAGR (2025 - 2030) | 9.50 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
Calcineurin Inhibitors Market Analysis
The Calcineurin Inhibitors Market size is estimated at USD 8.67 billion in 2025, and is expected to reach USD 13.64 billion by 2030, at a CAGR of 9.5% during the forecast period (2025-2030).
Calcineurin inhibitors (CNIs), a key class of immunosuppressive agents, are pivotal in treating autoimmune disorders, managing atopic dermatitis, and ensuring the success of solid organ transplants. The rise in organ transplantation procedures significantly propels market expansion as cyclosporine and tacrolimus are crucial in preventing organ rejection post-transplant. Data published in January 2024 by the Organ Procurement and Transplantation Network (OPTN) reveals that in 2023, the U.S. witnessed 46,632 organ transplants sourced from both living and deceased donors. Notably, 6,953 of these were made possible through living organ donors. The increasing number of organ transplantation procedures underscores the growing demand for effective immunosuppressive therapies, thus driving the market development over the forecasted period.
The rising incidence of diseases such as dry eye disease, coupled with the growing need for effective treatment is fueling progress in the calcineurin inhibitors market. Additionally, regulatory approvals for indications, including dry eye disease, are anticipated to further accelerate market expansion. For instance, in June 2023, Novaliq GmbH announced that the U.S. Food and Drug Administration (FDA) has approved VEVYE (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye disease. This approval makes VEVYE the first and only cyclosporine solution specifically indicated for this condition. This approval underscores the continuous advancements in the field, paving the way for improved treatment options and driving market growth in the coming years.
Moreover, the increasing focus on clinical research and the development of advanced ophthalmic solutions are propelling the growth of the calcineurin inhibitors market. These efforts aim to improve patient outcomes and tackle the rising prevalence of dry eye disease (DED) worldwide.. For instance, in October 2023, Sun Pharmaceutical Industries Limited has presented Phase 4 clinical data showing that CEQUA (cyclosporine ophthalmic solution) 0.09% offers sustained improvement in the signs and symptoms of dry eye disease (DED). Consequently, ongoing regulatory approvals and continuous research efforts are anticipated to drive market growth in the coming years.
However, the market growth is hindered by the high cost of drugs, the availability of alternative treatment options, and limited accessibility in low-income countries.
Calcineurin Inhibitors Market Trends
The Voclosporin Segment is Expected to Witness Significant Growth Over the Forecast Period
Voclosporin, sold under the brand name Lupkynis, is a novel calcineurin inhibitor approved in 2021 for treating adults with lupus nephritis. It works by suppressing the immune system to reduce inflammation and other symptoms. Furthermore, the increasing prevalence of lupus nephritis and the launch of Voclosporin in new markets are some of the major factors expected to drive the segment's growth over the forecasted period.
According to the American Kidney Fund annual report published in January 2024, around 9 in 10 people with lupus are women, and it is more common in Black women. Of the total cases reported of Lupus, 50% of adults with lupus will develop lupus nephritis once in their lifetime with people aged 20-40 years being more prone to get diagnosed with Lupus nephritis. Thus, the growing patient pool and susceptibility of younger adults to developing lupus nephritis are expected to strengthen the segment growth during the projected period.
It should be written as - As the number of individuals with lupus nephritis continues to rise, the demand for alternative treatment options is increasing. Consequently, regulatory approvals for new formulations are expected to further bolster the segment's growth throughout the forecast period. For instance, in September 2024, Otsuka Pharmaceutical Co., Ltd. secured regulatory approval for Lupkynis (voclosporin) in Japan. Following this, in November 2024, the company rolled out Lupkynis, targeting the treatment of lupus nephritis in the Japanese populace. This launch represents a crucial advancement in meeting the unmet medical needs of lupus nephritis patients in Japan, thereby fostering the development of this segment.
Additionally, in May 2023, Aurinia Pharmaceuticals Inc. announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization for Lupkynis (voclosporin) in combination with background immunosuppressive therapy for the treatment of adults with active class III, IV, and V lupus nephritis, including mixed classes III/V and IV/V. Additionally, the company has received Orphan Drug designation in Switzerland, providing 15 years of market exclusivity in conjunction with the approval.
Hence, due to the abovementioned factors, the voclosporin segment is expected to witness significant growth in the upcoming years.
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North America is Expected to Dominate the Calcineurin Inhibitors Market
North America is expected to dominate the market owing to factors such as increasing prevalence of autoimmune diseases, the presence of prominent market players, and the launch of new products. Moreover, the market in this region is also driven by factors such as increasing geriatric population which are more susceptible to autoimmune diseases such as lupus nephritis and psoriasis.
The growing prevalence of dry eye disease coupled with an increase in the number of hospital visits is expected to support market development during the projected period. According to data published in January, 2025, by the American Academy of Ophthalmology, dry eye disease (DED) is a common reason for ophthalmological visits in the United States, ranking third after refractive errors and cataracts. According to the data published by Johnson & Johnson, in July 2024, nearly 16 million individuals in the United States were affected by dry eye disease (DED). The risk of DED increases with age, with prevalence rates ranging from 2.7% among individuals aged 18 to 34 to 18.6% among those aged 75 and older. Thus, the growing aging population is expected to create further demand for calcineurin inhibitors to treat symptoms of dry eye disease.
Furthermore, awareness campaigns play a pivotal role in educating the public about health conditions, fostering better understanding, and encouraging proactive management. Leveraging social media platforms has become an effective strategy adopted by market players to reach wider audiences and address critical health issues. For instance, in July 2023, Bausch + Lomb launched a new social media campaign aimed at enhancing awareness and understanding of dry eye disease among the American population. Such campaigns are anticipated to increase the adoption rate of novel treatment options, such as calcineurin inhibitors available on the market, thereby driving market development. With the growing demand for effective immunosuppressive therapies, the calcineurin inhibitors market is expected to continue its upward trajectory during the forecast period. Strategic collaborations and ongoing research and development activities are likely to further enhance market opportunities, ensuring better treatment options for patients.
Additionally, several prominent players in the North American region are focused on developing novel treatment formulations, thereby supporting market development during the projected period. For instance, on February 13, 2025, Nexus Pharmaceuticals, LLC secured FDA approval for its Tacrolimus Injection, marking it as the first and only product of its kind on the market. The newly approved Tacrolimus Injection, presented in a 5 mg/mL concentration, will be available as a single-dose vial and packaged in a convenient 10-pack configuration. The launch of this new product is expected to drive growth in the North American market.
Therefore, owing to the factors mentioned above, the growth of the studied market is expected in the North American region.
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Calcineurin Inhibitors Industry Overview
The calcineurin inhibitors market is fragmented in nature due to the presence of several companies operating globally as well as regionally. The competitive landscape includes an analysis of a few international as well as local companies that hold significant market share and are well known, including Otsuka Pharmaceuticals, Nexus Pharmaceuticals, LLC, Bausch + Lomb, Aurinia Pharmaceuticals Inc., Novaliq GmbH, Novartis AG, Teva Pharmaceuticals Inc., Glenmark Pharmaceuticals Ltd., Viatris Inc., Biocon, Dr. Reddy’s Laboratories Ltd., Astellas Pharma Inc., Intas Pharmaceutical Ltd., Alkem, Lupin, and Strides Pharma Science Limited, among others.
Calcineurin Inhibitors Market Leaders
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Novartis AG
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Astellas Pharma Inc.
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Aurinia Pharmaceuticals Inc.
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Novaliq GmbH
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Otsuka Pharmaceuticals
- *Disclaimer: Major Players sorted in no particular order
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Calcineurin Inhibitors Market News
- April 2024: Biocon received approval from the South African Health Products Regulatory Authority (SAHPRA) for its vertically integrated, complex drug product, Tacrolimus capsules, in 0.5 mg, 1 mg, and 5 mg strengths, for the South African market. This development highlights the growing opportunities in the calcineurin inhibitors market, driven by regulatory advancements and expanding regional access.
- November 2023: Aurinia Pharmaceuticals Inc. Collaborated with Otsuka Pharmaceutical Ltd., has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour, and Welfare for the manufacture and commercialization of voclosporin for the treatment of lupus nephritis (LN) in Japan.
Calcineurin Inhibitors Industry Segmentation
Calcineurin inhibitors (CNIs) exert their immunosuppressive effects by binding to cytoplasmic immunophilins, forming complexes that inhibit calcineurin activity. This inhibition prevents the transcription of proteins in response to interleukin-2 (IL-2), thereby suppressing cellular proliferation.
The calcineurin inhibitors market is segmented into drug type, route of administration, application, distribution channel, and geography. By drug type, the market is segmented into tacrolimus, cyclosporine, pimecrolimus, and voclosporin. By route of administration, the market is segmented into oral, topical, and intravenous. By application, the market is segmented into organ transplantation, autoimmune disorders, atopic dermatitis, and other applications. By distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. By geography, the market is segmented into North America, Europe, Asia-Pacific, South America, and Middle East and Africa. The report also offers the market size and forecasts for 17 countries across the region. For each segment, the market sizing and forecasts have been done on the basis of revenue (USD).
| By Drug Type | Tacrolimus | ||
| Cyclosporine | |||
| Pimecrolimus | |||
| Voclosporin | |||
| By Route of Administration | Oral | ||
| Topical | |||
| Intravenous | |||
| By Application | Organ Transplantation | ||
| Autoimmune Disorders | |||
| Atopic Dermatitis | |||
| Other Applications | |||
| By Distribution Channel | Hospital Pharmacies | ||
| Retial Pharmacies | |||
| Online Pharmacies | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Calcineurin Inhibitors Market Research FAQs
How big is the Calcineurin Inhibitors Market?
The Calcineurin Inhibitors Market size is expected to reach USD 8.67 billion in 2025 and grow at a CAGR of 9.5% to reach USD 13.64 billion by 2030.
What is the current Calcineurin Inhibitors Market size?
In 2025, the Calcineurin Inhibitors Market size is expected to reach USD 8.67 billion.
Who are the key players in Calcineurin Inhibitors Market?
Novartis AG, Astellas Pharma Inc., Aurinia Pharmaceuticals Inc., Novaliq GmbH and Otsuka Pharmaceuticals are the major companies operating in the Calcineurin Inhibitors Market.
Which is the fastest growing region in Calcineurin Inhibitors Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Calcineurin Inhibitors Market?
In 2025, the North America accounts for the largest market share in Calcineurin Inhibitors Market.
What years does this Calcineurin Inhibitors Market cover, and what was the market size in 2024?
In 2024, the Calcineurin Inhibitors Market size was estimated at USD 7.85 billion. The report covers the Calcineurin Inhibitors Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Calcineurin Inhibitors Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
Calcineurin Inhibitors Industry Report
Statistics for the 2025 Calcineurin Inhibitors market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Calcineurin Inhibitors analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
