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  • Published In : Nov 2023
  • Code : CMI5848
  • Pages :130
  • Formats :
      Excel and PDF
  • Industry : Pharmaceutical

Global calcineurin inhibitor market size is expected to be valued at US$ 10.07 Bn in 2023, and is expected to reach US$ 20.64 Bn by 2030, exhibiting a CAGR of 10.8% during the forecast period of 2023 to 2030.

Global calcineurin inhibitors market growth is driven by rising incidence of organ transplant, increasing prevalence of autoimmune diseases, and growing geriatric population.

  • Organ Transplantation: Calcineurin inhibitors are used to suppress the immune system in organ allotransplant recipients, in order to prevent rejection of the donated tissue. Rising number of organ transplant surgeries is expected to drive growth of the global calcineurin inhibitor market.
  • Autoimmune Diseases: Calcineurin inhibitors are used to treat a variety of autoimmune diseases such as psoriasis, atopic dermatitis, and rheumatoid arthritis. Increasing prevalence of these diseases is expected to drive growth of the global calcineurin inhibitor market.
  • Growing Geriatric Population: Aging population is more susceptible to developing autoimmune diseases and other chronic conditions. Growing geriatric population is expected to drive the growth of the global calcineurin inhibitor market.

Global Calcineurin Inhibitor Market- Regional Insights

  • North America: North America is expected to dominate the calcineurin inhibitor market during the forecast period. The high prevalence of autoimmune diseases, such as psoriasis, atopic dermatitis, and ulcerative colitis, in the region is driving growth of the market. Rising number of organ transplants in the region is also contributing to the growth of the market. It holds 36.2 % market share.
  • Europe: Europe is expected to be the second-largest market for calcineurin inhibitor during the forecast period. The high prevalence of autoimmune diseases and organ transplants in the region is driving the growth of the market. Increasing focus on research and development in the region is also contributing to the growth of the market. It holds 18% market share.
  • Asia Pacific: Asia Pacific is expected to be the fastest-growing market for calcineurin inhibitor during the forecast period. Rising awareness about autoimmune diseases and organ transplants in the region is driving the growth of the market. Growing geriatric population in the region is also contributing to the growth of the market. It holds 27.2% market share.

Figure 1. Global Calcineurin Inhibitor Market Share (%), By Region, 2023


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Analyst View

  • Global calcineurin inhibitor market is expected to witness growth due to increasing uptake in immunosuppressive therapies post-organ transplant surgeries. The high recurrence of organ transplant rejections boosts demand for long-term immunosuppressive drugs like calcineurin inhibitors. Asia Pacific region is expected to witness growth, owing to growing transplantation and rising healthcare spending in countries like China and India.
  • However, concerns about drug toxicity and the possibility of side effects from long-term calcineurin inhibitor use may limit the market's potential. This may encourage transplant physicians to consider minimizing dosage and explore alternate options wherever possible. Emergence of biosimilars may also create downward pricing pressures. Stringent regulations surrounding the development and approval of transplant drugs remains a challenge as well.
  • Regarding prospects, the market is expected to expand as a result of the growing amount of research being done on novel drug delivery strategies meant to improve the effectiveness and lower toxicity of calcineurin inhibitors. Due to low organ donation rates and an underrepresented patient pool in need of transplantation, developing countries continue to provide headroom. The market participants profit from the recent approval of tacrolimus for various non-transplant indications, such as atopic dermatitis.
  • While long-term usage remains a concern, advances in delivery systems and newer applications can retain calcineurin inhibitors

Global Calcineurin Inhibitor Market- Drivers

  • Organ Transplantation: Calcineurin inhibitors such as cyclosporine and tacrolimus are widely used in organ transplantation to prevent organ rejection. As the number of organ transplant procedures continues to increase worldwide, the demand for calcineurin inhibitors is also expected to grow. The efficacy of these inhibitors in suppressing the immune response and reducing the risk of rejection has made them a vital component of post-transplant immunosuppressive regimens.
  • Rising Prevalence of Autoimmune Diseases: Calcineurin inhibitors have shown effectiveness in the treatment of various autoimmune diseases including rheumatoid arthritis, psoriasis, atopic dermatitis, and systemic lupus erythematous. Increasing prevalence of these diseases, coupled with the growing demand for effective treatment options is expected to boost demand for calcineurin inhibitors.
  • Continuous Advancements in Drug Delivery: Innovations in drug delivery systems have improved the bioavailability, efficacy, and patient compliance of calcineurin inhibitors. For instance, the development of extended-release formulations and novel delivery methods, such as topical creams and ointments, has expanded the application of calcineurin inhibitors beyond systemic administration. These advancements have positively influenced the market by offering convenient and efficient treatment options.
  • Patent Expirations and Generic Competition: The expiration of patents for branded calcineurin inhibitors has led to the entry of generic versions into the market. Generic competition has resulted in price reductions, making these medications more affordable and accessible to a larger patient population. This increased affordability has contributed to the expansion of the calcineurin inhibitor market.

Calcineurin Inhibitor Market Report Coverage

Report Coverage Details
Base Year: 2022 Market Size in 2023: US$ 10.07 Bn
Historical Data for: 2018 to 2022 Forecast Period: 2023 - 2030
Forecast Period 2023 to 2030 CAGR: 10.8% 2030 Value Projection: US$ 20.64 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East & Africa:  GCC Countries, Israel,  South Africa, North Africa, and Central Africa and Rest of Middle East
Segments covered:
  • By Drug Type: Cyclosporine, Tacrolimus, Pimecrolimus, Voclosporin, and Others
  • By Route of Administration: Oral, Topical, and Intravenous
  • By Indication: Organ Transplant Rejection Prevention, Autoimmune Diseases, Ophthalmic Diseases (Dry Eye Syndrome, Uvei, Other Dermatological Conditions
  • By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
  • By End User: Hospitals, Specialty Clinics, Dermatology Centers, Transplant Centers
Companies covered:

Novartis AG, Amgen, F. Hoffmann-La Roche Ltd, Pfizer Inc., Incyte Corporation, Chiesi Farmaceutici S.p.A., Astellas Pharma Inc., Sanofi SA, Bristol Myers Squibb Company, Mylan N.V., Dr. Reddy's Laboratories Ltd., Senju Pharmaceutical Co. Ltd, Abbott, Lupin Limited, and Vibcare Pharma Pvt. Ltd.

Growth Drivers:
  • Organ Transplantation
  • Rising Prevalence of Autoimmune Diseases
  • Continuous Advancements in Drug Delivery
  • Patent Expirations and Generic Competition
Restraints & Challenges:
  • Adverse Effects and Toxicity
  • Availability of Alternative Therapies
  • Cost of Treatment
  • Complex Dosing and Monitoring

Global Calcineurin Inhibitor Market- Opportunities

  • Expansion into New Indications: While calcineurin inhibitors are primarily used in organ transplantation and autoimmune diseases, there is growing interest in exploring their potential in other therapeutic areas. Researchers are investigating the use of calcineurin inhibitors in conditions like neurodegenerative disorders, asthma, and inflammatory bowel disease. Positive outcomes from clinical studies may pave new paths and boost calcineurin inhibitors' potential market share.
  • Development of Improved Formulations: There is an opportunity for the development of improved formulations of calcineurin inhibitors. Efforts to enhance drug delivery systems such as sustained-release formulations, topical preparations, and novel routes of administration can improve patient compliance, convenience, and efficacy. The development of such formulations could lead to new product launches and expansion of the market.
  • Personalized Medicine and Precision Therapeutics: As the understanding of individual patient variations in drug response increases, there is an opportunity for personalized medicine approaches in the field of calcineurin inhibitors. Tailoring the dosage and treatment regimens to individual patients based on genetic factors, biomarkers, and pharmacogenomics can optimize therapeutic outcomes and minimize adverse effects. This approach can lead to the development of targeted therapies and increase the demand for calcineurin inhibitors.
  • Emerging Markets: The demand for calcineurin inhibitors is growing in emerging markets due to various factors such as improving healthcare infrastructure, increasing awareness about organ transplantation, and rising prevalence of autoimmune diseases. As these markets continue to develop, there is an opportunity for pharmaceutical companies to expand their presence and tap into the growing demand for calcineurin inhibitors.

Global Calcineurin Inhibitor Market- Trends

  • Shift towards Targeted Therapies: There is a growing trend towards targeted therapies in the calcineurin inhibitor market. Researchers and pharmaceutical companies are focusing on developing drugs that selectively inhibit calcineurin activity, minimizing off-target effects and reducing the risk of adverse reactions. Targeted therapies have the potential to enhance the efficacy and safety profile of calcineurin inhibitors.
  • Development of Novel Calcineurin Inhibitors: Increasing initiative to develop novel calcineurin inhibitors with improved pharmacokinetic and pharmacodynamics properties is a major trend. These include next-generation calcineurin inhibitors that have enhanced potency, reduced toxicity, and improved bioavailability. Novel calcineurin inhibitors can address limitations associated with existing drugs, providing new treatment options with improved therapeutic outcomes.
  • Combination Therapies: Combination therapies involving calcineurin inhibitors are gaining traction in the market. Researchers are exploring the synergistic effects of calcineurin inhibitors with other immunosuppressive agents such as mTOR inhibitors, corticosteroids, and biologics. Combination therapies aim to enhance efficacy while minimizing the doses and associated side effects of individual drugs. The development of effective combination regimens is expected to improve patient outcomes and drive the market growth.

Global Calcineurin Inhibitor Market- Restraints

  • Adverse Effects and Toxicity: Calcineurin inhibitors are associated with a range of adverse effects including nephrotoxicity, neurotoxicity, hepatotoxicity, and increased risk of infections and malignancies. These side effects can limit their long-term use and affect patient compliance. The potential for adverse effects and toxicity poses a significant restraint on the calcineurin inhibitor market.
  • Availability of Alternative Therapies: While calcineurin inhibitors are widely used in organ transplantation and autoimmune diseases, alternative therapies are available. Newer immunosuppressive agents, such as mTOR inhibitors, biologics, and small molecules, offer alternative treatment options with potentially improved safety and efficacy profiles. The availability of these alternatives can impact the demand for calcineurin inhibitors and pose a challenge to market growth.
  • Cost of Treatment: Calcineurin inhibitors can be costly, especially for patients who require long-term therapy. The high cost of these medications can limit patient access, particularly in regions with limited healthcare resources or inadequate insurance coverage. Affordability issues can hinder the market growth and restrict the use of calcineurin inhibitors.
  • Complex Dosing and Monitoring: Calcineurin inhibitors require individualized dosing and therapeutic drug monitoring to maintain therapeutic efficacy while minimizing toxicity. Therapeutic drug monitoring involves measuring drug levels in the blood and adjusting the dosage accordingly. The complexity of dosing and monitoring can pose challenges in clinical practice and affect patient adherence to treatment regimens.

Figure 2. Global Calcineurin Inhibitor Market Share (%), By Drug Type, 2023


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Global Calcineurin Inhibitor Market- Recent Developments

New Product Launches

  • In June 2020, Sandoz, a Novartis division and a global leader in generic pharmaceuticals and biosimilars, announced the launch of once-daily generic tacrolimus capsules known as Dailiport in Germany, the U.K., The Netherlands, Finland, Sweden, Estonia, Latvia, and Slovakia, and as Conferoport in Italy and Spain
  • In November 2020, Glenmark Pharmaceuticals Ltd. (GPL), a global research-led pharmaceutical company, had been granted final approval by the U.S. Food and Drug Administration (U.S. FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharma US, Inc.
  • On November 25, 2020, Lupin Limited, a pharmaceutical company, announced the launch of Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, after Lupin’s alliance partner Concord Biotech Limited, a Biotechnology company, received an approval for its Abbreviated New Drug Application from the U.S. FDA

Acquisition and Agreement

  • In January 2022, Aequus Pharmaceuticals Inc., a growing specialty pharmaceutical company, announced that it had agreed to an extension of terms for its promotional service agreement with Sandoz, a global leader in generic pharmaceuticals and biosimilars, on Tacrolimus immediate-release to December 31, 2022. Aequus began Canadian promotional efforts in 2016 for Sandoz’s generic Tacrolimus. Through targeted awareness, valued added services, and customized support for both provincial and transplant center stakeholders, Aequus had achieved a 4-Year CAGR of almost 20% for the Sandoz Tacrolimus brand.
  • On March 11, 2022, Pfizer Inc., a pharmaceutical and biotechnology company has announced the complete acquisition of Arena Pharmaceuticals, a clinical-stage company developing innovative potential therapies for the treatments for therapeutic areas such as gastroenterology, dermatology, and cardiology, and immunology

Top companies in Global Calcineurin Inhibitor Market

  • Novartis AG
  • Amgen
  • F. Hoffmann-La Roche Ltd 
  • Pfizer Inc.
  • Incyte Corporation
  • Chiesi Farmaceutici S.p.A.
  • Astellas Pharma Inc.
  • Sanofi SA
  • Bristol Myers Squibb Company
  • Mylan N.V.
  • Dr. Reddy's Laboratories Ltd.
  • Senju Pharmaceutical Co. Ltd
  • Abbott
  • Lupin Limited
  • Vibcare Pharma Pvt. Ltd.

*Definition: Calcineurin inhibitor market refers to the pharmaceutical market that focuses on drugs that inhibit the activity of the calcineurin enzyme. Calcineurin Inhibitors are primarily used as immunosuppressive agents in organ transplantation procedures to prevent rejection of transplanted organs. These work by suppressing the immune response, specifically targeting T-cell activation. Calcineurin inhibitors are also used in the treatment of certain autoimmune diseases such as rheumatoid arthritis, psoriasis, and atopic dermatitis.

Frequently Asked Questions

Adverse effects and toxicity, availability of alternative therapies, cost of treatment, and complex dosing and monitoring are expected to hamper the market growth.

Increasing transplant procedures, growing incidence of autoimmune diseases, expanding applications in dermatology, advancements in drug delivery systems, increasing research and development, favorable reimbursement policies are expected to drive the market growth.

The leading drug type segment in the market is Cyclosporine.

Novartis AG, Amgen, F. Hoffmann-La Roche Ltd, Pfizer Inc., Incyte Corporation, Chiesi Farmaceutici S.p.A., Astellas Pharma Inc., Sanofi SA, Bristol Myers Squibb Company, Mylan N.V., Dr. Reddy's Laboratories Ltd., Senju Pharmaceutical Co. Ltd, Abbott, Lupin Limited, and Vibcare Pharma Pvt. Ltd.

In September 2021, North America lead the market. The region's leading position was attributed to factors such as the high prevalence of organ transplant procedures, a significant number of autoimmune diseases, well-established healthcare infrastructure, and favorable reimbursement policies.

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