From USD 810 million in 2022 to USD 1.8 billion by 2031, the worldwide ophthalmology amnionic membrane market is expected to rise at a CAGR of 10.2%. Over the projection period, North America is expected to control the market.
Rising elderly population, growing incidence of ocular diseases, and developments in tissue engineering methods are driving notable expansion of the ophthalmology amniotic membrane market. Promoting wound healing and lowering inflammation, amniotic membrane transplantation has been a successful therapy choice for certain ocular surface conditions. Further boosting market growth is growing knowledge among ophthalmologists and patients on the advantages of amniotic membrane grafts.
Market Trend: Increasing acceptance of amniotic membrane transplants free of suture
Adoption of sutureless amniotic membrane grafts is clearly trending in the ophthalmology amniotic membrane market. Many times involving suturing, traditional amniotic membrane transplantation methods can be time-consuming and cause patient discomfort. Conversely, sutureless grafts have many benefits including less surgical time, simpler application, and more patient comfort. Usually self-adherent, these grafts can be laid on the ocular surface with ease without sutures needed. Particularly for treating corneal epithelial abnormalities, pterygium, and other ocular surface diseases, the ease and efficiency of sutureless grafts have made them more and more common among ophthalmologists. Furthermore compared to conventional sutured grafts, sutureless grafts have shown either similar or even better results in terms of wound healing and visual acuity enhancement. Many producers are so concentrating on creating creative sutureless amniotic membrane products to meet this rising demand. The sutureless graft trend is likely to keep pushing market expansion and influencing product development plans in the next years.
Market Driver: growing frequency of ocular surface conditions
The ophthalmology amniotic membrane market is much driven by the increasing frequency of ocular surface diseases. Conditions ranging from dry eye syndrome to corneal ulcers to pterygium to Stevens-Johnson syndrome affect the cornea, conjunctiva, and eyelids in ocular surface disorders. These diseases can seriously affect vision and quality of life, which fuels increasing demand for sensible treatment choices. Because of its special qualities, amniotic membrane transplantation has become a useful therapeutic method for controlling several ocular surface diseases. Perfect biological dressing for the ocular surface, the amniotic membrane has anti-inflammatory, anti-scarring, and wound-healing characteristics. It lowers inflammation, encourages epithelialization, and offers a surface on which cells could proliferate and differentiate. The incidence of ocular surface diseases is predicted to rise even more as the world population ages and environmental elements causing them get more prevalent. Demand for amniotic membrane products in ophthalmology offices all around is being driven by this development. Furthermore expanding their uses in both surgical and office-based environments are developments in preservation methods and the creation of simple-to-use amniotic membrane products. The increasing amount of clinical data confirming the effectiveness of amniotic membrane transplantation in treating ocular surface diseases is also motivating more ophthalmologists to use this therapeutic method, therefore promoting market expansion.
Market Restraint: High expenses and meager return policy
The ophthalmology amniotic membrane market development is greatly hampered by the great cost connected with amniotic membrane products and limited reimbursement choices. Because of the difficult processing and preservation methods used in their manufacture, amniotic membrane grafts—especially cryopreserved varieties—can be costly. For ocular surface diseases, the cost of these biological materials is sometimes more than that of synthetic substitutes or conventional therapy approaches. Particularly in underdeveloped nations or healthcare environments with limited resources, this great expense can restrict the general acceptance of amniotic membrane products. Furthermore different areas and healthcare systems have varying amniotic membrane transplantation reimbursement policies. Some nations have limited or nonexistent insurance coverage for certain operations, therefore burdening patients or healthcare providers financially. Adoption of amniotic membrane goods in some areas can also be hampered by the absence of consistent refund policies and codes. If these products are not sufficiently reimbursed, healthcare professionals could be reluctant to apply them, therefore restricting patient access to this advantageous therapy choice. Moreover, the great expense and reimbursement issues could deter some ophthalmologists from using amniotic membrane transplantation in their work and instead choose more reasonably priced options. Efforts to overcome this constraint should focus on cost-effectiveness, production process simplification, and advocacy of better reimbursement policies to guarantee more general availability of amniotic membrane products in ophthalmology.
Amniotic membrane frozen in cryopreservation rules the market.
With the highest market share, cryopreserved amniotic membrane takes front stage in the ophthalmology amniotic membrane industry. Several elements contribute to the popularity of this segment among ophthalmologists using cryopreserved amniotic membrane for different ocular surface operations. Preserving the amniotic membrane with structural integrity and biological characteristics—including growth factors and cytokines necessary for wound healing and inflammation reduction—is accomplished by cryopreservation. Usually about -80°C, the cryopreservation procedure entails freezing the tissue at ultra-low temperatures, therefore enabling long-term storage without appreciable membrane breakdown of medicinal efficacy. This preservation technique precisely replics the natural thickness, elasticity, and biological activity of the amniotic membrane by ensuring that it keeps these qualities. Consequently, compared to alternative preservation techniques, cryopreserved amniotic membranes are regarded to be more efficient in supporting epithelial development, lowering scarring, and controlling inflammation. Various ophthalmic operations, including corneal ulcer therapy, pterygium surgery, and ocular surface reconstruction, have embraced cryopreserved amniotic membranes thanks in great part to their improved clinical outcomes. Further driving their appeal among doctors are cryopreserved amniotic membranes, which provide extended shelf life and simpler handling during surgical operations. Driven by the increasing body of clinical data confirming the effectiveness of cryopreserved amniotic membranes in ophthalmology, many practitioners now turn to them first option, therefore influencing the segment's main market share.
Ophthalmology amniotic membrane market is led by North America.
Currently leading in the worldwide ophthalmology amniotic membrane market is North America; this dominance is projected to last the whole forecast period. Strong market presence of the area may be ascribed to a number of important elements that have generated an environment suitable for the acceptance and expansion of amniotic membrane products in ophthalmology. First of all, North America enjoys a developed healthcare system with high concentration of qualified ophthalmologists and excellent medical facilities. This infrastructure helps to widely use creative ophthalmic procedures including amniotic membrane transplantation. Furthermore, ocular surface diseases are becoming more common in the area, partly because of an aging population and more screen time, which fuels need for sensible treatment solutions. Major market companies and research facilities found in North America have also helped to drive fast commercialization and development of sophisticated amniotic membrane products. These firms have made large R&D investments that have resulted in new preservation procedures and application approaches that have increased the use of amniotic membranes in ophthalmology. Furthermore, North America gains from quite favorable payment rules for amniotic membrane operations when compared to other areas, which has helped them to be adopted in clinical practice. Strong emphasis on evidence-based medicine by the area has produced many clinical research proving the effectiveness of amniotic membrane transplantation, hence increasing its acceptance among patients and healthcare professionals. Finally, North America's well-developed regulatory system—especially in the United States—has clearly offered a route for the approval and marketing of amniotic membrane products, therefore promoting market expansion and innovation.
Growing numbers of new competitors and fierce competition among few important players define the ophthalmology amniotic membrane market. Using this knowledge, established companies heavily involved in the fields of tissue engineering and regenerative medicine have created creative amniotic membrane products for ophthalmic uses. To advance preservation methods, raise product efficacy, and increase clinical applications, these market leaders have extensively committed themselves in research and development Common tactics used by businesses to improve their market position and increase their product ranges have been mergers, acquisitions, and strategic alliances. Regional businesses who have acquired notable market share in particular geographical areas by emphasizing local needs and regulatory constraints also help to define the competitive scene. Companies concentrating on product differentiation, clinical evidence generation, and widening their distribution networks to acquire a competitive edge should drive increasing intensity of rivalry as the market grows.
MiMedx Group, Inc.
Alliqua BioMedical, Inc.
Amnio Technology, LLC
Applied Biologics LLC
Human Regenerative Technologies, LLC
Skye Biologics Inc.
Amniox Medical, Inc.
Katena Products, Inc.
BioTissue, Inc.
NuVision Biotherapies Limited
Surgenex, LLC
Tissue-Tech, Inc.
In 2023, MiMedx Group, Inc. launched a new cryopreserved amniotic membrane product specifically designed for ophthalmic applications, featuring improved handling characteristics and extended shelf life.
In 2022, BioTissue, Inc. received FDA clearance for its novel sutureless amniotic membrane graft, expanding its product offerings in the ophthalmology market.
1. INTRODUCTION
1.1. Market Definition
1.2. Study Scope
1.3. Currency Conversion
1.4. Study Period (2022- 2031)
1.5. Regional Coverage
2. RESEARCH METHODOLOGY
2.1. Primary Research
2.2. Secondary Research
2.3. Company Share Analysis
2.4. Data Triangulation
3. EXECUTIVE SUMMARY
3.1. Global Ophthalmology Amniotic Membrane Market (2018 – 2022)
3.2. Global Ophthalmology Amniotic Membrane Market (2023 – 2031)
3.2.1. Market Segment By Type (2023 – 2031)
3.2.2. Market Segment By Application (2023 – 2031)
3.2.3. Market Segment By End User (2023 – 2031)
3.2.4. Market Segment By Region (2023 – 2031)
4. MARKET DYNAMICS
4.1. Market Trends
4.1.1. Rising adoption of sutureless amniotic membrane grafts
4.1.2. Increasing use of amniotic membrane in regenerative medicine
4.1.3. Growing popularity of office-based amniotic membrane procedures
4.2. Market Drivers
4.2.1. Increasing prevalence of ocular surface disorders
4.2.2. Advancements in tissue preservation techniques
4.2.3. Rising geriatric population susceptible to eye disorders
4.3. Market Restraints
4.3.1. High cost and limited reimbursement
4.3.2. Stringent regulatory requirements
4.4. Porter's Five Forces Analysis
4.4.1. Threat of New Entrants
4.4.2. Bargaining Power of Buyers/Consumers
4.4.3. Bargaining Power of Suppliers
4.4.4. Threat of Substitute Products
4.4.5. Intensity of Competitive Rivalry
4.5. Supply Chain Analysis
4.6. Pricing Analysis
4.7. Regulatory Analysis
4.8. Pipeline Analysis
5. BY TYPE (MARKET VALUE (US$ MILLION) – 2022-2031*)
5.1. Cryopreserved Amniotic Membrane
5.2. Dehydrated Amniotic Membrane
6. BY APPLICATION
6.1. Surgical Wounds
6.2. Ophthalmology
6.3. Others
7. BY END USER
7.1. Hospitals
7.2. Ambulatory Surgical Centers
7.3. Specialty Clinics
7.4. Research Institutes
8. GEOGRAPHY
8.1. North America
8.1.1. United States
8.1.2. Canada
8.1.3. Mexico
8.2. South America
8.2.1. Brazil
8.2.2. Argentina
8.2.3. Rest of South America
8.3. Europe
8.3.1. Germany
8.3.2. United Kingdom
8.3.3. France
8.3.4. Italy
8.3.5. Spain
8.3.6. Russia
8.3.7. Rest of Europe
8.4. Asia-Pacific
8.4.1. China
8.4.2. Japan
8.4.3. India
8.4.4. Australia
8.4.5. South Korea
8.4.6. Rest of Asia-Pacific
8.5. Middle-East
8.5.1. UAE
8.5.2. Saudi Arabia
8.5.3. Turkey
8.5.4. Rest of Middle East
8.6. Africa
8.6.1. South Africa
8.6.2. Egypt
8.6.3. Rest of Africa
9. COMPETITIVE LANDSCAPE
9.1. Key Developments
9.2. Company Market Share Analysis
9.3. Product Benchmarking
10. SWOT ANALYSIS
11. COMPANY PROFILES
11.1. MiMedx Group, Inc.
11.2. Alliqua BioMedical, Inc.
11.3. Amnio Technology, LLC
11.4. Applied Biologics LLC
11.5. Human Regenerative Technologies, LLC
11.6. Skye Biologics Inc.
11.7. Amniox Medical, Inc.
11.8. Katena Products, Inc.
11.9. BioTissue, Inc.
11.10. NuVision Biotherapies Limited
11.11. Surgenex, LLC
11.12. Tissue-Tech, Inc.
12. MARKET OPPORTUNITIES
Cryopreserved Amniotic Membrane
Dehydrated Amniotic Membrane
By Application:
Surgical Wounds
Ophthalmology
Others
By End User:
Hospitals
Ambulatory Surgical Centers
Specialty Clinics
Research Institutes
By Region:
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
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