US Ophthalmology Amniotic Membrane Market - 2025-2033

May 2025 | 126 pages | ID: U04B71D155FCEN
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Overview

The US ophthalmology amniotic membrane market reached US$ 3.13 billion in 2024 and is expected to reach US$ 7.35 billion by 2033, growing at a CAGR of 9.4% during the forecast period 2025-2033.

The amniotic membrane, or amnion, is the innermost layer of the placenta, which consists of a thick basement membrane and an avascular stromal matrix. Amniotic membrane transplantation (AMT) has been used as a graft or as a dressing in different surgical subspecialties. In ophthalmology, it is used broadly to reconstruct the ocular surface after various procedures, as a graft for ocular surface melts, and as a bandage to promote healing in cases of persistent epithelial defects or ocular surface inflammation. All of these indications use the amniotic membrane's ability to promote healing.

Market Dynamics: Drivers & Restraints

Increasing Incidence of Ocular Surface Disorders

The prevalence of ocular surface conditions, such as chemical burns, corneal ulcers, and dry eye syndrome, is rising. The effectiveness of amniotic membrane grafts in treating these disorders has increased the demand for these treatments. According to the American Academy of Ophthalmology (2024, the prevalence of dry eye syndrome increases with age. An estimated 3.2 million women age 50 and over and 1.68 million men age 50 and over are affected by dry eye syndrome.

A multifactorial chronic illness of the ocular surface known as dry eye disease (DED) causes sensations of discomfort and anguish. DED is characterized by increased tear evaporation, decreased tear output, and poor tear quality. The most common symptoms of those who are affected include photophobia, weariness, itching, and burning sensations in their eyes. A major public health issue is DED. It is among the most prevalent eye conditions seen in an ophthalmology office. The prevalence of DED ranges from 7.4% to 33.7% worldwide.

According to the Journal of BMC Ophthalmology, in 2023, global surveys indicate that the prevalence of DED ranges from 5 to 50%, with Asia having a higher frequency than Europe and the United States. Geographical location, population, and various diagnostic criteria are the key determinants of the diversity in DED prevalence. Numerous epidemiological studies have revealed that characteristics that increase the likelihood of developing dry eyes include female sex, advanced age, dry and harsh climates, and elderly age.

High Cost of Amniotic Membrane

The high cost of amniotic membranes is a significant restraint in the US ophthalmology market, limiting widespread adoption despite their proven therapeutic benefits. These costs originate at multiple points in the supply chain. First, the procurement of amniotic membranes is inherently expensive due to strict donor screening protocols, ethical sourcing limitations, and the requirement that membranes be harvested exclusively from placentas during elective cesarean sections.

Processing adds further financial strain, especially in the case of cryopreserved membranes, which must be stored and transported at ultra-low temperatures, significantly increasing logistical costs. Even dehydrated membranes, which offer more stability, involve advanced drying and sterilization processes that drive up prices.

On average, the cost of a single amniotic membrane graft ranges from $200 to $1,000, depending on its type and size. These material costs are compounded by the clinical and surgical expenses associated with implantation, including specialized ophthalmic tools and skilled personnel, bringing the total procedure cost to $2,000–$4,000 per case. Furthermore, insurance reimbursement policies are inconsistent, with Medicare and private insurers often reluctant to cover or fully reimburse for such treatments, especially when used in outpatient or non-emergency scenarios.

Segment Analysis

The US ophthalmology amniotic membrane market is segmented based on product type, application, and end-user.

Product Type:

The cryopreserved amniotic membrane segment in the product type is expected to dominate the US ophthalmology amniotic membrane market share

CAM is particularly effective for promoting the healing of corneal and ocular surface wounds due to its anti-inflammatory, anti-scarring, and anti-angiogenic properties. These characteristics are attributed to its composition, which includes heavy-chain hyaluronic acid and pentraxin 3, both of which are preserved during the cryopreservation process. CAM is used to treat conditions such as mechanical dry eye, conjunctival defects, and infectious corneal ulcers. For instance, in cases of severe corneal ulcers, CAM has demonstrated faster epithelialization compared to standard treatments, with significant healing outcomes observed within weeks.

Major players in the country's innovative launches and key developments that would help to drive this segment growth. For instance, in December 2023, Damon Dierker, OD, FAAO, discusses the groundbreaking potential of sutureless cryopreserved amniotic membrane therapy for moderate to severe dry eye.

Also, in March 2021, Bio-Tissue, Inc., announced today that its parent company TissueTech had received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase 2 study using morselized Cryopreserved Amniotic Membrane (CAM) and Cryopreserved Umbilical Cord (CUC) Investigational New Drug (IND) TTBT01. This clearance represents another milestone as the company works to achieve FDA approval for its graft and morselized human birth tissue products as biologics for important clinical indications.

Competitive Landscape

The major players in the US ophthalmology amniotic membrane market include MiMedx Group, Inc., Corza Ophthalmology (Katena Products, Inc.), Skye Bioscience, Inc., INTEGRA LIFESCIENCES HOLDINGS CORPORATION, Amnio Technology, LLC, Human Regenerative Technologies, LLC, Surgenex, BioTissue, VIVEX Biologics, Inc., and Merakris Therapeutics, Inc., among others.

Key Developments
  • In June 2024, BioTissue announced the unveiling of its CAM360 AmnioGraft (CAM360 AG), which is a new, hydrated, shelf-stable cryopreserved amniotic membrane (CAM) solution that has been developed for the treatment of ocular surface disease and disorders. The solution is ideal for patients with mild to moderate dry eye disease (DED) and other ocular surface conditions, working to optimize their comfort.
  • In November 2022, Vers?a launched several products in the ophthalmic space. The company is rolling out the Biovance 3L ocular tri-layer human amniotic membrane.
Why Purchase the Report?
  • Pipeline & Innovations: Reviews ongoing clinical trials and Product Type pipelines and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Type Performance & Market Positioning: Analyze Product Type performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into Product Type development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: This covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyze competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient Product Type delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance Product Type safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.
The US ophthalmology amniotic membrane market report delivers a detailed analysis with 39 key tables, more than 27 visually impactful figures, and 126 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024
  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Application & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.
1. MARKET INTRODUCTION AND SCOPE

1.1. Objectives of the Report
1.2. Report Coverage & Definitions
1.3. Report Scope

2. EXECUTIVE INSIGHTS AND KEY TAKEAWAYS

2.1. Market Highlights and Strategic Takeaways
2.2. Key Trends and Future Projections
2.3. Snippet by Product Type
2.4. Snippet by Application
2.5. Snippet by End-User

3. DYNAMICS

3.1. Impacting Factors
  3.1.1. Drivers
    3.1.1.1. Increasing Incidence of Ocular Surface Disorders
    3.1.1.2. Innovations in Surgical Techniques
    3.1.1.3. XX
  3.1.2. Restraints
    3.1.2.1. High Cost of Amniotic Membrane
    3.1.2.2. Competition from Alternative Therapies
    3.1.2.3. XX
  3.1.3. Opportunity
    3.1.3.1. Advancements in Regenerative Medicine
    3.1.3.2. XX
  3.1.4. Impact Analysis

4. STRATEGIC INSIGHTS AND INDUSTRY OUTLOOK

4.1. Market Leaders and Pioneers
  4.1.1. Emerging Pioneers and Prominent Players
  4.1.2. Established leaders with the largest-selling Brand
  4.1.3. Market leaders with established Product Type
4.2. Latest Developments and Breakthroughs
4.3. Regulatory and Reimbursement Landscape
4.4. Porter’s Five Forces Analysis
4.5. Supply Chain Analysis
4.6. SWOT Analysis
4.7. Unmet Needs and Gaps
4.8. Recommended Strategies for Market Entry and Expansion
4.9. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
4.10. Pricing Analysis and Price Dynamics

5. US OPHTHALMOLOGY AMNIOTIC MEMBRANE MARKET, BY PRODUCT TYPE

5.1. Introduction
  5.1.1. Analysis and Y-o-Y Growth Analysis (%), By Product Type
  5.1.2. Market Attractiveness Index, By Product Type
5.2. Cryopreserved Amniotic Membrane*
  5.2.1. Introduction
  5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
5.3. Lyophilization Amniotic Membrane
5.4. Dehydrated Amniotic Membrane

6. US OPHTHALMOLOGY AMNIOTIC MEMBRANE MARKET, BY APPLICATION

6.1. Introduction
  6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  6.1.2. Market Attractiveness Index, By Application
6.2. Ophthalmology*
  6.2.1. Introduction
  6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Surgical Wounds
6.4. Others

7. US OPHTHALMOLOGY AMNIOTIC MEMBRANE MARKET, BY END-USER

7.1. Introduction
  7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  7.1.2. Market Attractiveness Index, By End-User
7.2. Hospitals*
  7.2.1. Introduction
  7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Ambulatory Surgical Centers (ASCs)
7.4. Specialty Clinics
7.5. Others

8. COMPETITIVE LANDSCAPE AND MARKET POSITIONING

8.1. Competitive Overview and Key Market Players
8.2. Market Share Analysis and Positioning Matrix
8.3. Strategic Partnerships, Mergers & Acquisitions
8.4. Key Developments in Product Type Portfolios and Innovations
8.5. Company Benchmarking

9. COMPANY PROFILES

9.1. MiMedx Group, Inc.
  9.1.1. Company Overview
  9.1.2. Product Type Portfolio
    9.1.2.1. Product Type Description
    9.1.2.2. Product Type Key Performance Indicators (KPIs)
    9.1.2.3. Historic and Forecasted Product Type Sales
    9.1.2.4. Product Type Sales Volume
  9.1.3. Financial Overview
    9.1.3.1. Company Revenue
    9.1.3.2. Geographical Revenue Shares
    9.1.3.3. Revenue Forecasts
  9.1.4. Key Developments
    9.1.4.1. Mergers & Acquisitions
    9.1.4.2. Key Product Type Development Activities
    9.1.4.3. Regulatory Approvals, etc.
  9.1.5. SWOT Analysis
9.2. Corza Ophthalmology (Katena Products, Inc.)
9.3. Skye Bioscience, Inc.
9.4. INTEGRA LIFESCIENCES HOLDINGS CORPORATION
9.5. Amnio Technology, LLC
9.6. Human Regenerative Technologies, LLC
9.7. Surgenex
9.8. BioTissue
9.9. VIVEX Biologics, Inc.
9.10. Merakris Therapeutics, Inc.
LIST NOT EXHAUSTIVE

10. ASSUMPTIONS AND RESEARCH METHODOLOGY

10.1. Data Collection Methods
10.2. Data Triangulation
10.3. Forecasting Techniques
10.4. Data Verification and Validation

11. APPENDIX

11.1. About Us and Services
11.2. Contact Us

LIST OF TABLES

Table 1 US Ophthalmology Amniotic Membrane Market Value, By Product Type, 2025, 2029 & 2033 (US$ Billion)
Table 2 US Ophthalmology Amniotic Membrane Market Value, By Application, 2025, 2029 & 2033 (US$ Billion)
Table 3 US Ophthalmology Amniotic Membrane Market Value, By End-User, 2025, 2029 & 2033 (US$ Billion)
Table 4 US Ophthalmology Amniotic Membrane Market Value, By Product Type, 2025, 2029 & 2033 (US$ Billion)
Table 5 US Ophthalmology Amniotic Membrane Market Value, By Product Type, 2022-2033 (US$ Billion)
Table 6 US Ophthalmology Amniotic Membrane Market Value, By Application, 2025, 2029 & 2033 (US$ Billion)
Table 7 US Ophthalmology Amniotic Membrane Market Value, By Application, 2022-2033 (US$ Billion)
Table 8 US Ophthalmology Amniotic Membrane Market Value, By End-User, 2025, 2029 & 2033 (US$ Billion)
Table 9 US Ophthalmology Amniotic Membrane Market Value, By End-User, 2022-2033 (US$ Billion)
Table 10 MiMedx Group, Inc.: Overview
Table 11 MiMedx Group, Inc.: Product Type Portfolio
Table 12 MiMedx Group, Inc.: Key Developments
Table 13 Corza Ophthalmology (Katena Product Types, Inc.): Overview
Table 14 Corza Ophthalmology (Katena Product Types, Inc.): Product Type Portfolio
Table 15 Corza Ophthalmology (Katena Product Types, Inc.): Key Developments
Table 16 Skye Bioscience, Inc.: Overview
Table 17 Skye Bioscience, Inc.: Product Type Portfolio
Table 18 Skye Bioscience, Inc.: Key Developments
Table 19 INTEGRA LIFESCIENCES HOLDINGS CORPORATION: Overview
Table 20 INTEGRA LIFESCIENCES HOLDINGS CORPORATION: Product Type Portfolio
Table 21 INTEGRA LIFESCIENCES HOLDINGS CORPORATION: Key Developments
Table 22 Amnio Technology, LLC: Overview
Table 23 Amnio Technology, LLC: Product Type Portfolio
Table 24 Amnio Technology, LLC: Key Developments
Table 25 Human Regenerative Technologies, LLC: Overview
Table 26 Human Regenerative Technologies, LLC: Product Type Portfolio
Table 27 Human Regenerative Technologies, LLC: Key Developments
Table 28 Surgenex: Overview
Table 29 Surgenex: Product Type Portfolio
Table 30 Surgenex: Key Developments
Table 31 BioTissue: Overview
Table 32 BioTissue: Product Type Portfolio
Table 33 BioTissue: Key Developments
Table 34 VIVEX Biologics, Inc.: Overview
Table 35 VIVEX Biologics, Inc.: Product Type Portfolio
Table 36 VIVEX Biologics, Inc.: Key Developments
Table 37 Merakris Therapeutics, Inc.: Overview
Table 38 Merakris Therapeutics, Inc.: Product Type Portfolio
Table 39 Merakris Therapeutics, Inc.: Key Developments

LIST OF FIGURES

Figure 1 US Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 2 US Ophthalmology Amniotic Membrane Market Share, By Product Type, 2024 & 2033 (%)
Figure 3 US Ophthalmology Amniotic Membrane Market Share, By Application, 2024 & 2033 (%)
Figure 4 US Ophthalmology Amniotic Membrane Market Share, By End-User, 2024 & 2033 (%)
Figure 5 US Ophthalmology Amniotic Membrane Market Y-o-Y Growth, By Product Type, 2023-2033 (%)
Figure 6 Cryopreserved Amniotic Membrane Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 7 Lyophilization Amniotic Membrane Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 8 Dehydrated Amniotic Membrane Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 9 US Ophthalmology Amniotic Membrane Market Y-o-Y Growth, By Application, 2023-2033 (%)
Figure 10 Ophthalmology Application in US Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 11 Surgical Wounds Application in US Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 12 Other Applications in US Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 13 US Ophthalmology Amniotic Membrane Market Y-o-Y Growth, By End-User, 2023-2033 (%)
Figure 14 Hospitals End-User in US Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 15 Ambulatory Surgical Centers (ASCs) End-User in US Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 16 Specialty Clinics End-User in US Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 17 Other End-Users in US Ophthalmology Amniotic Membrane Market Value, 2022-2033 (US$ Billion)
Figure 18 MiMedx Group, Inc.: Financials
Figure 19 Corza Ophthalmology (Katena Product Types, Inc.): Financials
Figure 20 Skye Bioscience, Inc.: Financials
Figure 21 INTEGRA LIFESCIENCES HOLDINGS CORPORATION: Financials
Figure 22 Amnio Technology, LLC: Financials
Figure 23 Human Regenerative Technologies, LLC: Financials
Figure 24 Surgenex: Financials
Figure 25 BioTissue: Financials
Figure 26 VIVEX Biologics, Inc.: Financials
Figure 27 Merakris Therapeutics, Inc.: Financials


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