Global Bullous Keratopathy Market Poised for Growth, Expected to Reach USD 650 Million by 2033

The global bullous keratopathy market is forecasted to grow at a compounded annual growth rate (CAGR) of 4.3% from 2023 to 2033, is anticipated, with an anticipated closing value of USD 650 Million by 2033. With a valuation of USD 427.54 Million in 2023, as per a new report from Future Market Insights (FMI). The increasing prevalence of ophthalmic diseases and advancements in treatment options are the key factors driving this growth.

Rising Incidence of Ophthalmic Diseases Fuels Market Demand

Bullous keratopathy, a degenerative disease of the cornea, is becoming increasingly prevalent as a consequence of various ophthalmic conditions. Keratoconus, Fuchs dystrophy, and infectious keratitis are some of the leading causes contributing to the growth of the bullous keratopathy market. Notably, keratoconus, a condition in which the cornea thins and bulges into a cone shape, affects a significant portion of the population, with 10-15% of diagnosed individuals requiring corneal implant procedures at some stage in their lives. According to data from the National Center for Biotechnology Information (NCBI), corneal blindness is the third leading cause of blindness worldwide, after cataract and glaucoma, impacting an estimated 10 million people globally.

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Surgical Complications and the Growing Need for Treatment

The damage caused to the corneal endothelium layer, typically from eye surgeries such as cataract removal, is one of the most common causes of bullous keratopathy. Although bullous keratopathy occurs in a relatively small percentage of patients undergoing cataract surgery (approximately 1-2%), the sheer volume of cataract surgeries performed worldwide (around 10 million annually) means that a significant number of individuals may suffer from the condition.

The increasing demand for effective treatment options has spurred the growth of the bullous keratopathy market, particularly for collagen-based bio-engineered artificial corneas. These artificial corneas are increasingly being preferred due to their low cost, biocompatibility, and improved safety and effectiveness when compared to traditional treatments. As manufacturers focus on product innovation, two products are currently undergoing clinical trials, which are expected to drive further growth in the market.

Innovations in Treatment and Product Development

One of the most promising advancements in the bullous keratopathy treatment landscape is the development of artificial corneas. A notable example is Corneat Vision’s CorNeat KPro, an artificial cornea that is currently undergoing clinical trials. Expected to receive marketing approval in 2024, this product is anticipated to play a significant role in expanding the bullous keratopathy market. Corneal transplantation remains the definitive treatment for bullous keratopathy, as it restores the normal structure and function of endothelial cells. Various types of corneal transplantation procedures, including penetrating keratoplasty (PK), Descemet membrane endothelial keratoplasty (DMEK), and Descemet stripping automated endothelial keratoplasty (DSAEK), continue to dominate the treatment landscape.

A national survey in Japan conducted by the Japan Cornea Society found that bullous keratopathy accounted for 24.2% of all keratoplasty surgeries performed between 1999 and 2001. This indicates the significant volume of patients affected by the condition and the continuing demand for surgical solutions.

Key Market Insights

• The global bullous keratopathy market is expected to reach USD 650 million by 2033, driven by growing prevalence, technological advancements, and enhanced treatment options.
• North America is expected to hold the largest market share during the forecast period due to a well-established healthcare infrastructure, high treatment awareness, and significant investment in ophthalmic research.
• Europe’s bullous keratopathy market accounted for 19.1% of the total business share in 2022, driven by high patient awareness and the availability of advanced treatment options in the region.
• The amniotic membrane transplantation method has emerged as an effective treatment for bullous keratopathy. It enhances corneal healing and improves visual acuity, making it a valuable addition to the range of treatment options.
• Hospitals lead the market in terms of end-user revenue, accounting for USD 150 million in 2023. This is due to their role in providing specialized care and advanced surgical treatments for bullous keratopathy patients.

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Treatment Options and Emerging Therapies

The bullous keratopathy market offers a range of therapeutic approaches, including medical management with lubricants, steroids, hyperosmotic agents, and antibiotics. In addition, innovative surgical treatments such as amniotic membrane grafting (AMG), annular keratotomy, and anterior stromal puncture are gaining popularity due to their ability to improve corneal healing and visual outcomes.

Amniotic membrane transplantation (AMT) has shown a significant impact on improving the healing process and reducing symptoms for patients suffering from bullous keratopathy. This method is becoming increasingly important as a cost-effective alternative to full corneal transplants. Moreover, regenerative therapies, such as cell-based treatments, are also being explored for their potential to restore corneal function and improve outcomes for patients with severe disease.

Competitive Landscape and Key Players

The bullous keratopathy market is highly competitive, with key players investing in R&D and strategic partnerships to expand their market presence. Prominent companies in the market include Hoffmann-La Roche Ltd, Regeneron Pharmaceuticals Inc., Pfizer Inc., Bayer AG, Cellusion, CRST Europe, Barraquer Eye Hospital, Planchard Eye & Laser Center, and Medscape.

Recent developments in the market include:

• Celregen and Cellusion Inc. signed an exclusive license agreement for corneal endothelial cell regenerative therapy in Greater China in September 2022.
• Carl Zeiss Meditec partnered with Precise Bio in July 2022 to develop and commercialize tissue-based implants for ophthalmology.

These partnerships are indicative of the growing interest in regenerative treatments and tissue engineering for corneal diseases like bullous keratopathy.

Key Segments Profiled in the Bullous Keratopathy Market Industry Survey

Bullous Keratopathy Market by Therapies:

• Emmecell
  • Drug Description
  • Regulatory Milestones
  • Safety and Efficiency
  • Product Profile
• Cellusion
  • Drug Description
  • Other Development Activities
  • Clinical Development
  • Safety and Efficiency
  • Product Profile

Bullous Keratopathy Market by End User:

• Hospitals
• Surgical Centers

Bullous Keratopathy Market by Treatment:

• Medical Management
  • Lubricants
  • Steroids
  • Hyperosmotic agents
  • Anti- Glaucoma drugs
  • Antibiotics
  • Amniotic Membrane Grafting (AMG)
  • Annular Keratotomy
  • Anterior Stromal Puncture

Bullous Keratopathy Market by Region:

• North America
• Latin America
• Europe
• South Asia & Pacific
• East Asia
• Middle East & Africa

Conclusion

The bullous keratopathy market is poised for significant growth, driven by advancements in surgical techniques, regenerative therapies, and the increasing prevalence of ophthalmic diseases. As the industry continues to evolve, the focus on developing more effective and affordable treatments will shape the future of the market, offering hope to millions of patients worldwide suffering from corneal blindness. With the market expected to reach USD 650 million by 2033, stakeholders, including healthcare providers, researchers, and manufacturers, must continue to innovate and collaborate to address the growing need for specialized care in this field.