Bullous Keratopathy Market Snapshot (2023 to 2033)

The global bullous keratopathy market was valued at USD 410 Million in 2022. By 2023, the market is forecast to reach a valuation of USD 427.54 Million. During the 2023 to 2033 assessment period, a CAGR of 4.3% is anticipated, with an anticipated closing value of USD 650 Million.

Bullous keratopathies are much less common than they used to be as surgery techniques and implants have enhanced. Complications from cataract surgery used to be the most common cause of bullous keratopathy. Currently, the most common cause of bullous keratopathy is complications due to glaucoma surgery.

Occasionally, bullous keratopathy may be caused by corneal dystrophy. Corneal dystrophies are a group of genetic conditions that result in abnormal material accumulating within the cornea. Rarely, a few other eye conditions or blunt-force trauma to the eye can result in bullous keratopathy.

The ultimate method of curing bullous keratopathy is a corneal transplant. A corneal transplant replaces the affected cornea with a donor. This may include transplant techniques such as a penetrating keratoplasty to replace the entire cornea, a Descemet Stripping Endothelial Keratoplasty (DSEK), Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), or Descemet Membrane Endothelial Keratoplasty (DMEK) to replace the just the Descemet membrane.

Bullous keratopathy has many treatment options including both medicinal and surgical. Medical management options for bullous keratopathy include lubricants, steroids, hyperosmotic agents in the form of sodium chloride drops and ointment, anti-glaucoma drugs, and antibiotics. Other surgical management options for bullous keratopathy include Amniotic membrane grafting (AMG), annular keratotomy, anterior stromal puncture, and basement membrane polishing, among others.

EO2002, a first-in-class, non-surgical, magnetic cell-based therapy with the ability to modify disease, was developed by Emmecell through its exclusive Magnetic Cell Delivery (MCD) nanoparticle platform. It provides easier access to treatment before the disease becomes disabling and painful, and has the potential to prevent or delay the onset of more serious and invasive surgical procedures, including corneal transplantation. EO2002 is being evaluated in Phase I, a prospective, multicenter, open-label, dose-escalation study (EMME-01″) designed to assess the safety and tolerability of EO2002 with and without endothelial brushing (EB) or Descemet stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualifies for surgery involving full-thickness corneal transplantation or endothelial keratoplasty.

Report Attribute Details
Market Value in 2022 USD 410 Million
Expected Market Value (2023) USD 427.54 Million
Anticipated Forecast Value (2033) USD 650 Million
Projected Growth Rate (2023 to 2033) CAGR 4.3%

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2017 to 2022 Bullous Keratopathy Demand Analysis vs. Forecast 2023 to 2033

The bullous keratopathy market was valued at USD 410 Million in 2022 and expanded with a CAGR of 4.2% between 2018 and 2022. Rising cases of cataract surgeries and the advent of advanced technologies in corneal transplant and implant surgeries are proving to be game changers in market expansion. Considering these factors, the bullous Keratopathy market is expected to possess a valuation of USD 650 Million, growing with a CAGR of 4.3%.

Which are Some Prominent Drivers of the Bullous Keratopathy market?

Complications from Cataract Surgeries augmenting Market Growth

Rising complications from cataract surgeries and glaucoma surgeries and the growing prevalence of eye disorders are driving the market of bullous keratopathy. Furthermore, the adoption of surgical management options for bullous keratopathy including Amniotic membrane grafting (AMG), annular keratotomy, anterior stromal puncture, basement membrane polishing, etc. is boosting the growth of this market. Cataract surgery remained the leading cause of endothelial dysfunction/bullous keratopathy (39.9%), followed by combined surgery (23.0%) and FED (11.1%). FED, Fuchs’ endothelial dystrophy.

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What are the Challenges Projected to be Faced by the Market?

Increased risk factors of the surgery

Most people do well with bullous Keratopathy surgery. But complications can happen. Possible complications are Keratitis, perforation of the eye, extrusion of your ring, eye swelling, movement of your ring, night halos or glare, chronic eye pain, infections, etc. are expected to hamper the growth of the market during the forecast period. Furthermore, the high cost of ophthalmology devices and surgical procedures is anticipated to restrain the growth of this market during the forecast period.

Increase in risk of surgery failure

There is a risk that surgery might not correct the vision as much as expected. It might cause another vision problem like Astigmatism, where the curvature of the cornea becomes irregular. Some people who have corneal ring implantation may need an adjustment surgery to get a better outcome which will restrict the market growth.

Region-Wise Insights

What are the growth avenues for Bullous Keratopathy in North America?

Favorable Reimbursement policies driving the market

North America dominated the industry in 2021 and accounted for the largest share of around 59% of the overall revenue. Domicile of major market players, efficient reimbursement policies, and increasing Research and Development activities related to bullous Keratopathy are the factors expected to drive the region’s growth further.

North America's bullous keratopathy market was worth over USD 190 Million in 2021. This is credited to the rising geriatric population base and the greater susceptibility of aging people to several chronic ailments, such as diabetes. Diabetic people are more prone to develop eye diseases that lead to vision loss. National Eye Institute estimates suggest that over 30,000 Americans undergo corneal transplants to replace injured and diseased corneas, creating numerous growth opportunities for the bullous Keratopathy market.

Surgical Incidences of Eye diseases to spur bullous keratopathy demand in Europe

Europe's bullous keratopathy market held over 19.1% business share in 2022 and is slated to record an appreciable target valuation by 2033. The regional industry is fuelled by the growing number of eye surgeries led by the prevalence of several eye disorders in Europe.

The increasing Research and Development investments and practices focused on developing advanced corneal implants will create favorable regional market statistics for the expansion of the bullous keratopathy market.

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Category-Wise Insights

The hospital segment dominates the market with a revenue share of 58%

The hospital segment dominated the industry in 2021. The segment accounted for the largest revenue share of more than 58% with a revenue generation of USD 150 Million in 2022 and is expected to register a lucrative CAGR over the forecast period.

The presence of highly skilled surgeons, the rising number of patients, and access to transnational eye banks are the factors anticipated to drive the segment growth.

Amniotic Membrane Grafting dominating in terms of Surgical Procedures

Amniotic membrane grafting segment accounts for the highest revenue share in the market. In this technique, first, the loose epithelium is removed with the help of a sponge or a blade. This results in a large epithelial defect, usually sparing the limbus. A required amniotic membrane is cut and placed over the cornea with the stromal side towards the cornea, which is sticky compared to the basement membrane. The AMG is then attached to the cornea with the help of interrupted stay sutures. If needed, a BCL can also be placed. Amniotic membrane transplantation is a successful adjunctive method in achieving corneal epithelization which will propel the growth of this segment during the forecast period.

Anti-Glaucoma Drugs lead the market for the postoperative period

These drugs are the most prevalent in primary medical management procedures. The drugs commonly employed are beta-blockers and alpha agonists-these work by reducing intraocular pressure, which reduces corneal edema and thickness in the postoperative period. Miotics and prostaglandins are avoided because they usually aggravate inflammation. Carbonic anhydrase inhibitors are also avoided as they are epitheliotoxic.

Start-ups in Bullous Keratopathy Market

  • Founded in 2015, Cellusion is a Japan-based Developer of iPS cell-based regenerative technology for bullous keratopathy. The regenerative material is developed by using iPS cell-derived cell transplantation for corneal endothelium replacement. The iPS cells are injected into the cornea for treating bullous keratopathy. It received funding of USD 14.7 million from Toyo Seikan Kaisha, UTEC, and 5 more.
  • Founded in 2016, Allotex is a Zurich, Switzerland-based company that is developing therapeutic solutions for the treatment of presbyopia, hyperopia, myopia, and astigmatism. The therapy is based on tissue addition technology that utilizes precisely-shaped human corneal allografts to create contact lenses or lens inserts. The corneal allografts can be placed on top of or just under Bowman’s (no need to place them deep in the cornea). It can be made in any shape, diameter, and thickness.

Market Competition

Key players in the Bullous Keratopathy market are- Hoffmann-La Roche Ltd, Regeneron, Pharmaceuticals, Inc., Pfizer, Inc., Bayer AG, Cellusion, CRSTEurope, Barraquer Eye Hospital, Planchard Eye & Laser Center, and Medscape. Some recent developments in the bullous keratopathy market are:

  • In September 2022: Celregen and Cellusion Inc. signed an exclusive license agreement for corneal endothelial cell regenerative therapy in Greater China.
  • In July 2022: Carl Zeiss Meditec and Precise Bio announced a partnership in the development and commercialization of tissue-based implants for ophthalmology.

Report Scope

Report Attribute Details
Market Value in 2023 USD 427.54 Million
Market Value in 2033 USD 650 Million
Growth Rate CAGR of 4.3% from 2023 to 2033
Base Year for Estimation 2022
Historical Data 2018 to 2022
Forecast Period 2023 to 2033
Quantitative Units Revenue in USD Million and CAGR from 2023 to 2033
Report Coverage Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis
Segments Covered Therapies, Treatment, End Users, Region
Regions Covered North America; Latin America; Europe; South Asia & Pacific; East Asia; Middle East & Africa
Key Countries Profiled USA, Canada, Brazil, Mexico, Mexico, Germany, UK, France, Spain, Italy, India, Malaysia, Singapore, Thailand, China, Japan, South Korea, Australia, New Zealand, GCC countries, South Africa, Israel
Key Companies Profiled Hoffmann-La Roche Ltd; Regeneron Pharmaceuticals; Pfizer Inc.; Bayer AG; Cellusion; CRSTEurope; Barraquer Eye Hospital; Planchard Eye & Laser Center; Medscape
Customization Available Upon Request

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

Frequently Asked Questions

What is the anticipated growth of the Bullous Keratopathy market until 2033?

FMI projects the global Bullous Keratopathy market to expand at a 4.3% value CAGR by 2033.

What is the estimated market value of the Bullous Keratopathy market expected in 2022?

The global Bullous Keratopathy market is estimated at a market value of USD 410 Million in 2022.

What is the estimated market value of the Bullous Keratopathy market expected in 2033?

The global Bullous Keratopathy market is expected to garner a market value of USD 650 Million by 2033.

Which region is forecast to be the most lucrative for Bullous Keratopathy market growth?

FMI has projected North America to be one of the most profitable regions for the Bullous Keratopathy market.

Table of Content
	1. Executive Summary | Bullous Keratopathy Market
	2. Market Overview
	3. Market Background
	4. Global Analysis 2018 to 2022 and Forecast, 2023 to 2033
	5. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By Treatment
		5.1. Medical Management
			5.1.1. Lubricants
			5.1.2. Steroids
			5.1.3. Hyperosmotic Agents
			5.1.4. Anti-Glaucoma Drugs
			5.1.5. Antibiotics
		5.2. Surgical Management
			5.2.1. Amniotic Membrane Grafting (AMG)
			5.2.2. Annular Keratotomy
			5.2.3. Anterior Stromal Puncture
	6. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By Therapies
		6.1. Emmecell
			6.1.1. Drug Description
			6.1.2. Regulatory Milestones
			6.1.3. Safety and Efficacy
			6.1.4. Product Profile
		6.2. Cellusion
			6.2.1. Drug Description
			6.2.2. Clinical Development
			6.2.3. Other Development Activities
			6.2.4. Safety and Efficacy
			6.2.5. Product Profile
	7. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By End Users
		7.1. Hospitals
		7.2. Surgical Centers
	8. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region
		8.1. North America
		8.2. Latin America
		8.3. Europe
		8.4. South Asia & Pacific
		8.5. East Asia
		8.6. Middle East and Africa (MEA)
	9. North America Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	10. Latin America Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	11. Europe Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	12. South Asia & Pacific Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	13. East Asia Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	14. MEA Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
	15. Key Countries Analysis
	16. Market Structure Analysis
	17. Competition Analysis
		17.1. Hoffmann-La Roche Ltd.
		17.2. Regeneron
		17.3. Pfizer, Inc.
		17.4. Bayer AG
		17.5. Cellusion
		17.6. CRSTEurope
		17.7. Barraquer Eye Hospital
		17.8. Planchard Eye & Laser Center
		17.9. Medscape
		17.10. Eyewiki
	18. Assumptions & Acronyms Used
	19. Research Methodology
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