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CYCLOSPORINE DRUG MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2025-2032)

Cyclosporine Drug Market, By Application (Organ Transplant Rejection Prophylaxis (Kidney Transplant, Liver Transplant, Heart Transplant, Lung Transplant), Autoimmune Disorders (Rheumatoid Arthritis, Psoriasis, Ophthalmic Disorders, Dermatological Disorders, and Other Uses), By Formulation (Capsules, Tablets, Oral Solution, Intravenous Solution, Topical Solution, and Eye Drops), By Type (Brand and Generic), By Gender (Male and Female), By Age Group (Pediatric, Adult, and Geriatric), By End User (Hospitals, Specialty Clinics, Ambulatory Surgical Centers or Transplant Centers, Homecare Settings, Academic & Research Institutions, and Others), By Geography (North America, Latin America, Europe, Asia Pacific, Middle East & Africa)

  • Published In : Jul 2025
  • Code : CMI8195
  • Pages :156
  • Formats :
      Excel and PDF
  • Industry : Pharmaceutical

Global Cyclosporine Drug Market Size and Forecast – 2025 to 2032

The Global Cyclosporine Drug Market is estimated to be valued at USD 4.37 billion in 2025 and is expected to reach USD 6.33 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 5.4% from 2025 to 2032. This steady growth reflects increasing demand for effective immunosuppressive therapies, especially in organ transplant patients, alongside expanding applications in autoimmune diseases and dermatology.

Key Takeaways of the Global Cyclosporine Drug Market:

  • The organ transplant rejection prophylaxis segment remains the dominant application in the global cyclosporine drug market, accounting for an estimated 40.1% of the market share in 2025.
  • The eye drops segment leads the formulation segment and is expected to hold 42% of the market share in 2025 due to rising demand for dry eye treatments.
  • The brand segment also maintains a strong presence, commanding an estimated 53.2% of the market share in 2025, driven by the high trust placed in branded drugs by both healthcare professionals and patients.
  • North America is expected to lead the market, holding a share of 38.3% in 2025. Asia Pacific is anticipated to be the fastest-growing region, with a market share of 28.2% in 2025.

Market Overview:

Market trends indicate a rising focus on novel drug delivery systems and formulation improvements to enhance cyclosporine’s bioavailability and reduce side effects. Additionally, growing investments in research and development, coupled with an aging global population and higher incidences of chronic diseases, are driving market expansion. Emerging markets with improving healthcare infrastructure also contribute significantly to the increasing adoption of cyclosporine-based treatments.

Currents Events and Its Impact

Current Events

Description and its impact

Expansion of Generic and Biosimilar Options

  • Description: The introduction of generic and biosimilar cyclosporine products has increased market competition and affordability.
  • Impact: This shift has led to a more competitive market landscape, potentially reducing treatment costs and expanding patient access.

Rising Incidence of Autoimmune Diseases

  • Description: The cyclosporine drug market is growing due to the rising prevalence of inflammatory and autoimmune diseases, a robust pipeline of treatments, and government support for disease awareness. A May 2022 report by JAMA Network states that 3% of Americans and 125 million people globally suffer from psoriasis, with adults being more frequently affected. Cyclosporine is commonly used to treat psoriasis due to its ability to provide rapid symptom relief. As the burden of diseases like psoriasis increases, the demand for cyclosporine is expected to boost market growth
  • Impact: Cyclosporine's role in managing these conditions has contributed to its market growth, with projections indicating significant expansion through 2034.

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Segmental Analysis

Cyclosporine Drug Market By Application

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Cyclosporine Drug Market Insights, By Application - Organ Transplant Rejection Prophylaxis is Driving Demand in the Cyclosporine Drug Market as it Prevents Rejection of Transplanted Organs

In terms of application, the organ transplant rejection prophylaxis segment is expected to hold a predominant position within the global cyclosporine drug market with a share of 40.1% in 2025. This is largely due to the critical role cyclosporine plays in preventing the rejection of transplanted organs such as kidneys, livers, hearts, and lungs. Organ transplant remains one of the most effective treatments for end-stage organ failure; however, the recipient’s immune system naturally perceives the transplanted organ as a foreign body, triggering an immune response that can lead to rejection. Cyclosporine, as a potent immunosuppressive agent, selectively inhibits T-cell activation, which is central to the rejection process, thereby significantly enhancing graft survival rates.

The rising prevalence of chronic diseases leading to organ failure, coupled with advances in surgical techniques, has increased the number of transplant procedures worldwide.

In March 2025, according to a study by UCLA Health, chronic disease prevalence has risen to nearly 30% over the past 20 years, affecting approximately 25 million young people aged 5 to 25. Conditions like ADHD, autism, asthma, prediabetes, and depression are key contributors to this rise. The prevalence has grown from 23% in 1999 to over 30% in children aged 5-17, and from 18.5% to 29% in young adults aged 18-25. Socioeconomic factors such as lower income and lack of education increase the likelihood of chronic conditions. The study emphasizes the need for improved healthcare access to support these youth throughout their lives, especially in transitioning from pediatric to adult care.

This, in turn, drives the demand for effective immunosuppressive drugs. Among the various transplanted organs, kidney transplants constitute a major segment benefiting from cyclosporine treatment due to their relatively higher frequency. Moreover, the drug’s established efficacy in reducing acute rejection episodes in liver, heart, and lung transplants further strengthens its application in this area.

Cyclosporine Drug Market Insights, By Formulation - Eye Drops Dominate Cyclosporine Market Due to Rising Prevalence of Dry Eye Disease

Eye drops emerged as the leading formulation segment in the global cyclosporine drug market, capturing an estimated 42% share in 2025. This dominance is largely attributed to the rising prevalence of chronic dry eye disease, which has become one of the most common ophthalmic conditions worldwide. The launch of innovative cyclosporine-based eye drops, including preservative-free and water-free formulations, has expanded treatment options and improved patient adherence. Regulatory approvals across key markets in North America, Europe, and Asia Pacific have further accelerated product adoption.

The segment’s growth is also supported by increasing awareness among both physicians and patients about early diagnosis and proactive management of ocular surface disorders. Companies have invested in patient education campaigns and advanced drug delivery technologies to enhance the bioavailability and tolerability of topical cyclosporine. As a result, eye drops are expected to maintain their dominant position in the market, driven by sustained demand, continuous product innovation, and the expanding pool of patients seeking effective long-term relief from dry eye symptoms.

In January 2022, Sun Pharmaceutical Industries Ltd, a global leader in specialty pharmaceuticals, launched PrCEQUA (cyclosporine ophthalmic solution 0.09%) in Canada, the first dry eye treatment using nanomicellar (NCELL) technology. This innovative technology enhances the bioavailability and stability of cyclosporine, improving its ocular tissue penetration for more effective treatment.

Cyclosporine Drug Market Insights, By Type - Brand Cyclosporine Dominates on Account of Trustworthiness and Proven Clinical Efficacy

The brand segment maintains a dominant share in the global cyclosporine drug market with an estimated 53.2% in 2025, primarily driven by the trust placed in branded drugs among healthcare professionals and patients alike. Brand-name cyclosporine products have a long-standing reputation backed by extensive clinical trials demonstrating their safety and effectiveness, which influences prescribing habits toward branded formulations.

Physicians typically favor brands due to their consistent quality, reliable manufacturing practices, and established pharmacokinetic profiles. This assurance becomes critical in sensitive clinical scenarios such as transplant rejection prophylaxis or management of severe autoimmune disorders, where drug variability can have serious implications. Brand drugs undergo rigorous regulatory scrutiny and quality control, reducing risks of substandard batches that may affect treatment outcomes.

Regional Insights:

Cyclosporine Drug Market Regional Insights

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North America Cyclosporine Drug Market Analysis and Trends

In North America, the dominance in the global cyclosporine drug market with an estimated share of 38.3% in 2025 is driven by a well-established pharmaceutical ecosystem combined with favorable government policies that support biopharmaceutical innovation and stringent regulatory frameworks, ensuring drug quality and safety. The presence of leading pharmaceutical giants such as Novartis (Sandoz), Pfizer, and Mylan has strengthened the market by facilitating extensive R&D and continuous production of advanced cyclosporine formulations. Novartis, via its generics division Sandoz, is a major player in the cyclosporine market, providing formulations such as Sandimmune and Neoral, which are commonly used in organ transplants and the treatment of autoimmune diseases.

Additionally, North America benefits from a robust healthcare infrastructure and high patient awareness, which boosts demand for immunosuppressive therapies including cyclosporine. Trade dynamics in the region favor access to cutting-edge technology and global collaborations, reinforcing its position as a market leader.

Asia Pacific Cyclosporine Drug Market Analysis and Trends

Meanwhile, the Asia Pacific region is expected to exhibit the fastest growth in the cyclosporine market with a share of 28.2% in 2025 due to expanding healthcare infrastructure, increasing prevalence of chronic diseases like autoimmune disorders, and greater accessibility to advanced therapies. Government initiatives encouraging pharmaceutical manufacturing and foreign investments, particularly in countries like India and China, have accelerated market penetration.

Moreover, cost advantages, coupled with technological advancements and the growing presence of multinational pharmaceutical companies such as Sun Pharmaceutical Industries, Lupin, and Zhejiang Huahai Pharmaceutical, have fueled rapid market expansion. Increased healthcare spending and rising awareness of transplant-related treatments also underpin this growth trajectory. For example, another major Indian pharmaceutical company, Lupin is well-known for its generic cyclosporine products. The company's commitment to affordable medicines has made it a key player in the immunosuppressive drug market, especially in developing countries.

Global Cyclosporine Drug Market Outlook for Key Countries:

U.S. Cyclosporine Drug Market Trends

The U.S. cyclosporine drug market is characterized by extensive clinical research activities and early adoption of innovative cyclosporine products. The growing incidence of target diseases such as psoriasis and rheumatoid arthritis in the region is a key factor contributing to the market growth. According to the Global Psoriasis Atlas 2022, psoriasis is relatively common in U.S, affecting 2-3% of the population. However, in the province of Newfoundland and Labrador, its prevalence is estimated to be 5 to 10 times higher than in other Caucasian populations. Additionally, the Arthritis Foundation's October 2021 report on rheumatoid arthritis states that approximately 1.5 million people in the U.S. are affected, with women being three times more likely to be impacted than men.

Japan Cyclosporine Drug Market Trends

Japan cyclosporine drug market is characterized by its maturity, driven by a robust healthcare infrastructure and a high prevalence of conditions such as dry eye disease, autoimmune disorders, and organ transplantations. The aging population further contributes to the demand for immunosuppressive therapies. Key trends include the adoption of advanced drug delivery systems and the development of preservative-free formulations to enhance patient compliance. Notably, Santen Pharmaceutical, a leading Japanese ophthalmic company, has been instrumental in advancing cyclosporine-based treatments, particularly for dry eye disease.

In June 2021, Santen Pharmaceutical Co., Ltd., a Japan-based global ophthalmology company, announced U.S. FDA approval of Verkazia (cyclosporine ophthalmic emulsion 0.1%) for treating vernal keratoconjunctivitis (VKC) in children and adults. VKC is a rare, severe allergic eye disease causing intense itching, pain, and light sensitivity that can impair daily life and lead to vision loss. Santen plans to leverage its U.S. Eyevance platform to quickly bring this treatment to patients and improve quality of life for those affected.

China Cyclosporine Drug Market

China’s rapid cyclosporine drug market expansion is underpinned by growing healthcare investments and supportive policies aimed at local pharmaceutical development. Key domestic players, including Zhejiang Huahai Pharmaceutical and Hansoh Pharmaceutical, collaborate with global companies to enhance manufacturing capabilities and introduce affordable cyclosporine alternatives. Rising disease prevalence, improving healthcare access, and increasing export potential also contribute significantly. Government initiatives targeting chronic disease management and transplant programs create a conducive environment for market growth.

In May 2023, Zambon, a pharmaceutical company, completed enrollment in two pivotal Phase 3 studies (BOSTON-1 and BOSTON-2) to evaluate Liposomal Cyclosporine A for Inhalation (L-CsA-i) in treating Bronchiolitis Obliterans Syndrome (BOS) in lung transplant patients. BOS is a rapidly progressive disease that affects lung transplant recipients, often leading to respiratory failure. With no approved treatments for BOS, these trials aim to assess the safety and efficacy of L-CsA-i. Zambon plans to report top-line results in 2024.

India Cyclosporine Drug Market

India cyclosporine drug market reflects vigorous growth fueled by an increasing patient population and a cost-sensitive healthcare system. Leading pharmaceutical companies such as Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, and Lupin focus on producing generic cyclosporine drugs, making treatment more accessible and affordable. Government policies encouraging pharmaceutical exports and simplified regulatory frameworks help position India as a vital manufacturing hub. Furthermore, expanding healthcare infrastructure and growing awareness drive increased demand for immunosuppressive medications.

In August 2022, Strides Pharma Science Limited, an India-based pharmaceutical company specializing in niche and complex generics, received U.S. FDA approval for Cyclosporine Softgel Capsules USP (Modified) in 25 mg, 50 mg, and 100 mg strengths. The product is used for preventing organ rejection in kidney, liver, and heart transplants, as well as treating severe rheumatoid arthritis and psoriasis.

Germany Cyclosporine Drug Market

Germany continues to lead the European cyclosporine drug market with robust healthcare infrastructure and strong governmental support for pharmaceutical innovation. Companies like Bayer and Sandoz significantly impact the market by investing in R&D and ensuring broad availability of cyclosporine formulations. The nation’s emphasis on high-quality medical care and extensive insurance coverage facilitates wide adoption of immunosuppressant therapies. Additionally, Germany’s strategic location enables favorable trade routes within Europe, aiding efficient distribution.

End User Feedback and Unmet Needs in the Global Cyclosporine Drug Market

  • End user feedback from key application sectors, including healthcare providers, pharmaceutical companies, and patients, highlights both positive experiences and recurring challenges with cyclosporine treatments. A positive user experience often revolves around the drug’s rapid efficacy in treating conditions like psoriasis and rheumatoid arthritis. For instance, many healthcare providers report high satisfaction with the drug's ability to provide quick symptom relief for patients with autoimmune disorders, with one notable example being the use of cyclosporine in psoriatic disease management. Physicians appreciate its effectiveness in reducing inflammation and preventing flare-ups, allowing patients to experience significant improvements in quality of life. However, a frequently cited concern among users is the high cost of cyclosporine treatments, especially for patients in lower-income regions or those without adequate insurance coverage. Despite its clinical efficacy, the affordability and accessibility of cyclosporine remain significant barriers to widespread use, with many patients struggling to access the medication consistently.
  • The unmet needs in the cyclosporine drug market primarily focus on technological gaps, affordability, and accessibility. A lack of customization in treatment options and delivery forms also limits the market’s growth potential. For example, while cyclosporine is effective for treating dry eye disease (DED), its current formulations often require frequent application, which can be burdensome for patients. There is an increasing demand for more patient-friendly drug delivery systems, such as extended-release formulations or topical applications that reduce treatment frequency. Additionally, affordability remains a critical issue, particularly in emerging markets where cost-effective alternatives are needed. Addressing these gaps by investing in novel drug delivery technologies, offering more flexible dosing regimens, and reducing the cost of production could drive market growth, enhance customer retention, and foster innovation in both product development and patient care solutions. By focusing on these unmet needs, pharmaceutical companies can improve their competitive edge and deliver more effective and accessible solutions to a broader patient base.

Market Players, Key Developments, and Competitive Intelligence:

Cyclosporine Drug Market Concentration By Players

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Top Strategies Followed by Global Cyclosporine Drug Market Players

  • Established pharmaceutical companies dominate this space by heavily investing in research and development (R&D) to innovate high-performance cyclosporine products that cater to evolving patient needs and regulatory standards. Industry leaders in the cyclosporine market are focusing on developing formulations with better bioavailability, enhanced safety profiles, and targeted delivery systems. Along with their innovation efforts, these companies strategically form partnerships and alliances with other major players and original equipment manufacturers (OEMs) to optimize production efficiencies and strengthen their market presence.
    • In February 2022, Mylan Pharmaceuticals Inc., a part of Viatris Inc., a global healthcare company focused on generics and biosimilars, gained U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Cyclosporine Ophthalmic Emulsion 0.05%. This is the first generic version of Restasis, indicated to increase tear production in patients with dry eye disease (keratoconjunctivitis sicca).
  • Mid-level market participants adopt a more balanced approach by concentrating on cost-effective cyclosporine drug solutions that strike an equilibrium between quality and affordability. Key players in the cyclosporine market often form strategic collaborations with contract manufacturing organizations, technology providers, and regional distributors to boost their production capabilities and expand market reach while minimizing costs.
    • In March 2023, Amman Pharmaceutical Industries, a leading pharmaceutical company in Jordan, launched its new cyclosporine-based product, ClasGen, for treating Dry Eye Syndrome. The formulation, which is the only U.S. FDA-approved treatment for this condition, was introduced during a ceremony attended by ophthalmologists. The event included a scientific lecture by Dr. Khaled Ayesh and a speech by Dr. Fadi Al-Atrash, CEO of Amman Pharmaceutical Industries. ClasGen joins the company's portfolio of 170 registered preparations, marking a significant milestone in the company's growth, including expanding into the U.S.
  • Small-scale players in the cyclosporine drug market typically carve out their own specialized niches by focusing on unique product features or innovation-driven offerings that distinguish them from larger competitors. These companies frequently adopt cutting-edge technologies such as novel drug delivery platforms and biosimilars development to stay competitive in a market dominated by giants.
    • A global biopharmaceutical company, Biocon focuses on biosimilars and has developed biosimilar versions of cyclosporine. By leveraging its expertise in biologics and biosimilars, Biocon provides affordable alternatives to branded cyclosporine products, catering to price-sensitive markets, especially in emerging economies.

Key Developments:

  • In April 2025, Zhaoke Ophthalmology Limited, a China-based specialty eye care company, enrolled the first patient in its Phase 3 trial of cyclosporine A (CsA) ophthalmic gel for treating moderate to severe dry eye disease. The randomized, placebo-controlled study will involve 360 patients across 25 centers. This innovative hydrogel formulation improves CsA’s ocular exposure and aims to deliver enhanced efficacy compared to existing treatments like Restasis.
  • In March 2025, Harrow Health, a U.S.-based ophthalmic pharmaceutical company, launched the VEVYE Access for All program in partnership with PhilRx, a national mail-order pharmacy. The initiative aims to simplify access to VEVYE (cyclosporine ophthalmic solution 0.1%) for dry eye disease by removing prior authorization requirements and offering flat-rate refills at USD 59 per bottle. Eligible commercially insured patients may pay as little as USD 0 for their first prescription.
  • In July 2024, Lupin Limited, a leading Indian pharmaceutical company, partnered with Huons Co Ltd, a South Korean firm with six decades of experience in prescription drugs, to launch Cyclosporine Ophthalmic Nanoemulsion in Mexico. The preservative-free nanoemulsion, already approved in South Korea and other markets, is used to treat dry eye syndrome and corneal ulcers by boosting tear production through advanced nanoparticle technology.
  • In February 2022, Viatris Inc., a global healthcare company committed to expanding access to affordable medicines, has become the first to receive U.S. FDA approval for the generic version of Restasis (cyclosporine ophthalmic emulsion 0.05%) to treat dry eye disease. Developed over nearly a decade by Viatris’ subsidiary Mylan Pharmaceuticals, the product faced numerous legal and regulatory hurdles, all of which have now been cleared.

Market Report Scope

Cyclosporine Drug Market Report Coverage

Report Coverage Details
Base Year: 2024 Market Size in 2025: USD 4.37 Bn
Historical Data for: 2020 To 2024 Forecast Period: 2025 To 2032
Forecast Period 2025 to 2032 CAGR: 5.4% 2032 Value Projection: USD 6.33 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: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Application: Organ Transplant Rejection Prophylaxis (Kidney Transplant, Liver Transplant, Heart Transplant, Lung Transplant), Autoimmune Disorders (Rheumatoid Arthritis, Psoriasis, Ophthalmic Disorders, Dermatological Disorders, and Other Uses
  • By Formulation: Capsules, Tablets, Oral Solution, Intravenous Solution, Topical Solution, and Eye Drops
  • By Type: Brand and Generic
  • By Gender: Male and Female
  • By Age Group: Pediatric, Adult, and Geriatric
  • By End User: Hospitals, Specialty Clinics, Ambulatory Surgical Centers or Transplant Centers, Homecare Settings, Academic & Research Institutions, and Others (Specialty Pharmacies) 
Companies covered:

Novartis AG, Teva Pharmaceutical, Sun Pharmaceuticals, Mylan (Viatris), Hikma Pharmaceuticals, Glenmark Pharmaceuticals, Zydus Lifesciences, Lupin Limited, Cipla Ltd, Santen Pharmaceutical, Amneal Pharmaceuticals, Endo International, Strides Pharma, Panacea Biotec

Growth Drivers:
  • Rising global organ transplantation rates
  • Increasing autoimmune disease prevalence
Restraints & Challenges:
  • Risk of nephrotoxicity and other serious side‑effects
  • Intense pricing pressure from generics

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Cyclosporine Drug Market Dynamics

Cyclosporine Drug Market Key Factors

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Cyclosporine Drug Market Driver - Rising Global Organ Transplantation Rates

The increasing prevalence of organ transplantation procedures worldwide is a significant factor propelling the demand for cyclosporine drugs. As advancements in medical technology and transplant techniques improve patient survival rates, more individuals are undergoing kidney, liver, heart, and lung transplants, all of which require effective immunosuppressive therapy to prevent organ rejection. Cyclosporine, being one of the cornerstone immunosuppressive agents, plays a critical role in maintaining the transplanted organ’s viability by modulating the immune response. Moreover, the growing incidence of chronic diseases such as end-stage renal disease and liver cirrhosis, coupled with the rising awareness around organ transplantation as a treatment option, has expanded the patient pool that depends on cyclosporine. Healthcare infrastructure improvements in emerging markets and increased accessibility to transplant surgeries further contribute to the surge in organ transplantation rates, reinforcing the necessity for cyclosporine drugs in post-transplant care regimens globally.

For instance, in November 2024, a new edition of Newsletter Transplant, published with support from Spain’s Organización Nacional de Transplants and the Council of Europe’s EDQM, reveals global organ transplantation rose by 9% in 2023 across 89 countries. Over 42,500 transplants were performed, mainly kidneys and livers, thanks to nearly 22,000 donors. Notably, donation after circulatory death accounted for 25% of deceased donors. Despite progress, 56,000 patients joined waiting lists, and over 7,000 died waiting. EDQM Director Petra Doerr praised the dedication of healthcare teams and donors, underscoring the need for continued efforts to expand ethical, safe organ donation worldwide.

Cyclosporine Drug Market Opportunity - Development of Novel Delivery Systems for Cyclosporine Drugs

The global cyclosporine drug market presents significant growth potential through the development of novel delivery systems, aimed at enhancing drug efficacy, patient compliance, and safety profiles. Traditional cyclosporine formulations are often associated with challenges such as poor bioavailability, variable absorption, and systemic side effects, which limit their therapeutic effectiveness. Innovations in drug delivery, including nano-formulations, sustained-release implants, and targeted delivery mechanisms, offer promising solutions to these issues.

For example, lipid-based nanoparticles and liposomal carriers can improve cyclosporine’s solubility and stability, leading to more consistent plasma concentrations and reduced toxicity The integration of advanced biomaterials and controlled-release technologies also supports more precise dosing regimens, further optimizing therapeutic outcomes. Pharmaceutical companies and research institutions are investing heavily in these advanced delivery platforms, driven by growing demand for safer and more effective immunosuppressive therapies.

In October 2024, Novaliq, a biopharma company specializing in novel eye treatments using its proprietary EyeSol water-free technology, and Laboratoires Théa, Europe’s largest independent eye care group, announced that the European Commission has approved Vevizye (ciclosporin 0.1% eye drops) for use in Europe. Under their new partnership, Théa will commercialize Vevizye across Europe and selected MENA countries.

Analyst Opinion (Expert Opinion)

  • The global cyclosporine drug market is experiencing steady growth driven by increasing prevalence of chronic eye conditions such as dry eye disease and keratoconjunctivitis sicca, along with organ transplant procedures requiring immunosuppressive therapy. Regulatory support, including recent U.S. FDA and EMA approvals for novel formulations like Novaliq’s Vevizye and Viatris’ generic Restasis, is accelerating product availability and affordability. Technological advancements in drug delivery—especially water-free and nanoemulsion platforms, are expanding therapeutic options. However, market players face challenges such as stringent manufacturing requirements, pricing pressures from generics, and patient adherence issues, which may temper growth momentum. Emerging opportunities lie in expanding treatment access across emerging economies and developing next-generation cyclosporine-based combination therapies.
  • Recent conferences such as the European Society of Cataract and Refractive Surgeons (ESCRS) Annual Congress, American Academy of Ophthalmology (AAO) Annual Meeting, and World Cornea Congress have significantly contributed to knowledge-sharing and clinical updates on cyclosporine treatments. Notable market-related initiatives include Viatris’ immediate launch of the first generic Restasis in the U.S., Novaliq and Laboratoires Théa’s partnership to commercialize Vevizye across Europe and MENA, and pilot projects exploring sustained-release cyclosporine delivery systems—efforts expected to enhance market adoption and improve patient outcomes globally.

Market Segmentation

  •  Application Insights (Revenue, USD Bn, 2020 - 2032)
    • Organ Transplant Rejection Prophylaxis
      • Kidney Transplant
      • Liver Transplant
      • Heart Transplant
      • Lung Transplant
    • Autoimmune Disorders
      • Rheumatoid Arthritis
      • Psoriasis
      • Myasthenia Gravis
      • Crohn’s Disease
      • Nephrotic Syndrome
    • Ophthalmic Disorders
      • Dry Eye Disease
      • Vernal Keratoconjunctivitis
    • Dermatological Disorders
      • Severe Atopic Dermatitis
      • Other Severe Inflammatory Skin Conditions
    • Other Uses
  •  Formulation Insights (Revenue, USD Bn, 2020 - 2032)
    • Capsules
    • Tablets
    • Oral Solution
    • Intravenous Solution
    • Topical Solution
    • Eye Drops
  •  Type Insights (Revenue, USD Bn, 2020 - 2032)
    • Brand
    • Generic
  •  Gender Insights (Revenue, USD Bn, 2020 - 2032)
    • Male
    • Female
  •  Age Group Insights (Revenue, USD Bn, 2020 - 2032)
    • Pediatric
    • Adult
    • Geriatric
  •  End User Insights (Revenue, USD Bn, 2020 - 2032)
    • Hospitals
    • Specialty Clinics
    • Ambulatory Surgical Centers or Transplant Centers
    • Homecare Settings
    • Academic & Research Institutions
    • Others (Specialty Pharmacies)
  • Regional Insights (Revenue, USD Bn, 2020 - 2032)
    • 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
  • Key Players Insights
    • Novartis AG
    • Teva Pharmaceutical
    • Sun Pharmaceuticals
    • Mylan (Viatris)
    • Hikma Pharmaceuticals
    • Glenmark Pharmaceuticals
    • Zydus Lifesciences
    • Lupin Limited
    • Cipla Ltd
    • Santen Pharmaceutical
    • Amneal Pharmaceuticals
    • Endo International
    • Strides Pharma
    • Panacea Biotec

Sources

Primary Research Interviews

  • Practicing Ophthalmologists
  • Transplant Surgeons
  • Hospital Pharmacy Directors
  • Regulatory Affairs Specialists
  • Senior Executives in Biopharmaceutical Manufacturing

Government and International Databases

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Central Drugs Standard Control Organisation (CDSCO), India
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • World Health Organization (WHO)
  • Pan American Health Organization (PAHO)
  • European Directorate for the Quality of Medicines & Healthcare (EDQM)
  • European Clinical Trials Database (EudraCT)

Trade Publications

  • Pharmaceutical Executive
  • BioPharm International
  • The Pharma Letter
  • Drug Development & Delivery
  • PharmaTimes

Academic Journals

  • The Lancet
  • New England Journal of Medicine
  • British Journal of Ophthalmology
  • Journal of Ocular Pharmacology and Therapeutics
  • Transplantation Proceedings
  • American Journal of Transplantation
  • Clinical Therapeutics

Reputable Newspapers

  • The Wall Street Journal
  • Financial Times
  • The New York Times
  • The Guardian
  • The Economic Times

Industry Associations

  • International Society of Ocular Pharmacology
  • International Society for Eye Research
  • American Academy of Ophthalmology
  • International Society for Heart and Lung Transplantation
  • European Society of Organ Transplantation

Public Domain Resources

  • WHO Global Health Observatory
  • Eurostat
  • OECD Health Data

Proprietary Elements:

  • CMI Data Analytics Tool: Proprietary analytics tool to analyze real-time market trends, consumer behavior, and technology adoption in market
  • Proprietary CMI Existing Repository of Information for Last 8 Years

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About Author

Ghanshyam Shrivastava - With over 20 years of experience in the management consulting and research, Ghanshyam Shrivastava serves as a Principal Consultant, bringing extensive expertise in biologics and biosimilars. His primary expertise lies in areas such as market entry and expansion strategy, competitive intelligence, and strategic transformation across diversified portfolio of various drugs used for different therapeutic category and APIs. He excels at identifying key challenges faced by clients and providing robust solutions to enhance their strategic decision-making capabilities. His comprehensive understanding of the market ensures valuable contributions to research reports and business decisions.

Ghanshyam is a sought-after speaker at industry conferences and contributes to various publications on pharma industry.

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Frequently Asked Questions

The Global Cyclosporine Drug Market is estimated to be valued at USD 4.37 Bn in 2025 and is expected to reach USD 6.33 Bn by 2032.

The CAGR of the global cyclosporine drug market is projected to be 5.4% from 2025 to 2032.

Rising global organ transplantation rates and increasing autoimmune disease prevalence are the major factors driving the growth of the global cyclosporine drug market.

Risk of nephrotoxicity and other serious side‑effects and intense pricing pressure from generics are the major factors hampering the growth of the global cyclosporine drug market.

In terms of application, the organ transplant rejection prophylaxis segment is estimated to dominate the market revenue share in 2025.

Novartis AG, Teva Pharmaceutical, Sun Pharmaceuticals, Mylan (Viatris), Hikma Pharmaceuticals, Glenmark Pharmaceuticals, Zydus Lifesciences, Lupin Limited, Cipla Ltd, Santen Pharmaceutical, Amneal Pharmaceuticals, Endo International, Strides Pharma, and Panacea Biotec are the major players.

North America is expected to lead the global cyclosporine drug market in 2025.
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