Amniotic Membrane Market Information By Product (Cryopreserved and Dehydrated), By Application (Surgical Wounds, Ophthalmology, and others), By End-User (Hospitals, Ambulatory Surgical Centers (ASCs), Specialty Clinics, and Research & Academic Institutes), and By Region (North America, Europe, Asia-Pacific, and the Rest of the World)—Forecast till 2030

Global Amniotic Membrane Market Research (MRFR Insights)

The amniotic membrane market size is projected to reach approximately USD 1.69 Billion by 2030, at a CAGR of 4.3% from 2022 to 2030. The placenta's innermost layer, known as the amniotic membrane (AM), comprises tissue and cells that serve as a wound-healing mechanism for soft tissue regeneration. Biologically active cells are present in the epithelial and stromal layers of the amniotic membrane and release growth factors and cytokines with anti-inflammatory, anti-immunogenic, and anti-fibrotic properties. Amniotic membrane eye treatment is also growing in the market. As per the amniotic membrane market report, tissue-based goods have recently increased due to rising transplant rates brought on by increased awareness. The sector is growing as a consequence of more donations coming in as a result of more awareness. Amniotic membranes are typically utilized for purposes such as limbal stem cell deficiency, regenerative medicine, pterygium excisions, surgical wounds, corneal ulcers, and pressure and venous leg ulcers, among others. Undoubtedly, the industry will expand steadily and quickly. The research and study are also going on the amniotic membrane transplantation technique to implement in the future and the development of amniotic membrane in the field of amniotic membrane ophthalmology.

COVID-19 Impact Analysis

The COVID-19 pandemic harmed the market. Elective procedures were being refused (cancelled/postponed) to reserve or reallocate the limited capacities and resources (such as patient care specialists and hospital beds) toward COVID-19 patient care. Additionally, many nations have implemented curfews and lockdowns to reduce the rising number of COVID-19 instances. Due to these lockdowns, patients could not visit clinics, hospitals, or OPDs. This temporary restriction of non-emergent healthcare services limited the market's growth for amniotic membranes. But in the upcoming years, it's anticipated that demand for amniotic products will increase.

Amniotic Membrane Market Dynamics

Due to their thin, lightweight, elastic, and transparent qualities, amniotic membrane works as biological bandages, ideal for use on the eye's surface. So, it is becoming increasingly popular in surgical operations. These membranes are applied during surgical procedures involving removing eye tissue to treat chemical burns, corneal ulcers, and conditions causing ulcerations. Numerous items made from amniotic membranes used in ophthalmology dominate the market. For instance, Next Biosciences' Dehydrated AmnioMatrix is a dry amniotic membrane that has had the cells in the epithelial layer removed. Once applied to the wound, it serves as a scaffold for new cells to develop. Over the anticipated time, there has been a growth in the amniotic membrane market research and development activity for creating ophthalmic amniotic membranes and amniotic membrane injection. New patent applications for the ophthalmology amniotic membrane are now being filed, affecting the market.

Market Drivers

• An increasing number of burn injuries

Due to the rising occurrence of burn wounds, the need for biologics used in wound care, such as amniotic membranes, has dramatically grown. According to the WHO, nearly two-thirds of burn cases occur in the African and Southeast Asian regions, with the majority occurring in low and middle-income countries. For instance, 1 million Indians each year suffer from light to severe burns (Source: WHO). Significant burn incidence rates can also be seen in Southeast Asian countries like Bangladesh and Nepal. Every year, 173,000 children in Bangladesh suffer mild to severe burns. In Nepal, burns account for 5% of all injuries and are the second most common type of disability.

• Increasing the amount spent on research and development in the fields of stem cells and regenerative medicine


• Rise in the number of treatments being performed and the patient population

Market Restraints 

• Amniotic membrane use is filled with drawbacks and restrictions

Amniotic membranes should not be used haphazardly because complications might arise. The patient or the receiver of an might transfer bacterial, viral, or fungal illnesses if the donors were not thoroughly screened for infectious diseases. There may be additional risks for the patient or receiver if the membrane is not treated sterilely or preserved correctly. Post-amniotic membrane transplantation incidence rates range from 1.6% to 8.0%, with gram-positive isolates being the most common. A concern in and of itself is the potential for early amniotic membrane degeneration and cheese wiring to lead to recurrent transplants.

• Amniotic membrane stem cell therapies come with high costs and are not very cost-effective

Market Opportunities 

• Putting the 21st Century Cures Act (US) into practice 

In December 2016, the US ratified the 21st Century Cures Act, among other things. This new law was established to support regenerative medicine research and medical innovation. The act has several provisions that may impact how many products are created and approved in the years to come. A fast-track regulatory pathway and a new "Regenerative Medicine Advanced Therapy" designation have both been established by this act for cutting-edge treatments and goods for regenerative medicine. When this act is implemented, the US government could approve new regenerative medicine therapies and goods in addition to fostering R&D in this field.

• Paradigm shift in the worldwide market trends is expected due to technological advancements to create affordable treatments

Product Insights

The amniotic membrane market segmentation, based on product, is segmented into cryopreserved amniotic membrane, and dehydrated amniotic membrane. Due to their extensive use in eye procedures to repair or replace eye tissue and their capacity to retain fresh tissue's histological and morphological characteristics, cryopreserved amniotic membranes hold the largest market share. The cryopreserved amniotic membrane is frozen at -80°C using DMEM/glycerol preservation medium in slow-rate freezing preservation techniques. The extracellular matrix components, including heavy-chain hyaluronic acids, amniotic membrane market growth factors, fibronectin, and collagen, which all support anti-inflammatory effects and healing, are well preserved with this slow-rate freezing preservation strategy. For instance, in June 2021, The MIMEDX Group, Inc. was granted permission by the Japanese Ministry of Health, Labor, and Welfare (JMHLW) to market and distribute Epifix in Japan. As a platform for regenerative medicine, amniotic tissue is used most frequently by MIMEDX, a market leader.

Application Insights

The amniotic membrane market segmentation, based on application, is segmented into surgical wounds, ophthalmology, and others. In 2021, the surgical wound category dominated the amniotic membrane market and was expected to do so throughout the forecast period. Due to the membrane's ability to reduce scar tissue formation and its anti-inflammatory effects, this segment is anticipated to increase rapidly. For instance, AmnioFix is a dehydrated amniotic membrane made by MiMedx Group Inc. is used exclusively for surgical wounds because it acts as a barrier membrane and reduces scar tissue formation.

End-User Insights

Based on end-user, the amniotic membrane market is classified into hospitals, ambulatory surgical centers (ASCS), specialty clinics, and research & academic institutes. Hospitals currently dominate the market as the end user, which is projected to continue, attributed to an increase in the number of amniotic membrane transplants performed in hospitals over the projected period. Growing government measures to upgrade the healthcare system and the rise of the middle class in emerging countries will lead to increased demand for high-quality medical services provided by hospitals, supporting segment growth.

Global Amniotic Membrane Market Share by Region, 2021 (%)

Amniotic Membrane Market Overview, by region

By region, the amniotic membrane market has been divided into North America, Europe, Asia-Pacific, and the Rest of the World. North America accounted for the most extensive market share. Europe is projected to exhibit the highest CAGR during the review period.

North America

North America led the amniotic membrane market with the largest revenue share in 2021. The main drivers of regional market growth in North America are top industry competitors and well-established healthcare facilities. This region is expected to emphasize alternative technologies and embrace sophisticated technologies during the projected period. The high frequency of the target illnesses, expanding geriatric population, the growing knowledge of cutting-edge treatment alternatives, and the substantial presence of leading market players in the area can all be credited for the significant share of the North American market.

Europe

The Europe region dominates the market share over the amniotic membrane market forecast period, which is anticipated to expand at a consistent CAGR. The demand for the product has increased because the European region's healthcare system is publicly supported, and several nations have implemented universal healthcare systems. Medical practitioners' use of amniotic membranes is anticipated to increase as the number of patients with chronic conditions rises. Because of the surge in pterygium, conjunctival surface reconstructions, and ocular reconstruction procedures, the market in Europe is predicted to expand significantly. The largest contributor to the European market is Germany. As a whole, there aren't many shares held in other regions of the world. Almost everywhere in the world, a rapid increase in the amniotic membrane market is projected.

Amniotic Membrane Market Competitive Landscape

Most market participants have been implementing laws and regulations according to stringent norms. They have been making sure that they work for both their businesses and the improvement of the market as a whole. Numerous alliances, purchases, and mergers among themselves have helped the industry develop dramatically. Additionally, they have served as an idol for newcomers. The tactics they have been doing are what have brought them to this situation. They have also been attempting to expand the market and introduce new technology to boost the amniotic membrane market growth. The major players in the market are employing various methods to keep their dominant positions in the industry. Players are concentrating on growing and commercializing their product portfolios. By a study on the industry's prospects, such initiatives are anticipated to lead to the industry's rapid rise in the years to come. For instance, in 2021, ReNu, an amniotic suspension, was introduced by Organogenesis Inc. (US). The firm also got FDA clearance by receiving the regenerative medicine advanced therapy designation for treating knee osteoarthritis. Furthermore, in 2021, Integra LifeSciences (US) bought ACell, Inc. (US) to increase the company's offering of advanced wound care.

Prominent amniotic membrane market players include Alliqua BioMedical Inc.; Amnio Technology, LLC; Skye Biologics, Inc., Applied Biologics LLC; MiMedx Group Inc., DermaSciences, Human Regenerative Technologies, LLC; Katena Products, Inc.; Amniox Medical Inc.; Organogensis, Inc.

Scope of the Amniotic Membrane Market Report

Product Outlook

• Cryopreserved


• Dehydrated

Application Outlook

• Surgical Wounds


• Ophthalmology


• Others

End-User Outlook

• Hospitals


• Ambulatory Surgical Centers (ASCs)


• Specialty Clinics


• Research and Academic Institutes

Region Outlook

• 
  North America
  
  
  
  • US
  
  
  • Canada
  
  
  • Mexico
  
  
  
  


• 
  Europe
  
  
  
  • UK
  
  
  • Germany
  
  
  • France
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• 
  Asia-Pacific
  
  
  
  • China
  
  
  • India
  
  
  • Japan
  
  
  • Australia and New Zealand
  
  
  • Rest of Asia-Pacific
  
  
  
  


• 
  Rest of the World
  
  
  
  • South America
  
  
  • Middle East
  
  
  • Africa
  
  
  
  

Objectives of the Study

The objectives of the study are summarized in 5 stages. They are as mentioned below:

Amniotic Membrane Market Forecast & Size:

To identify and estimate the amniotic membrane market size for the  market segmented by product, application, and end-users by value (in US dollars). Also, to understand the consumption/ demand created by consumers of amniotic membranes between 2022 and 2030

Market Landscape and Trends:

To identify and infer the drivers, restraints, opportunities, and challenges for the  amniotic membrane market

Market Influencing Factors:

To find out the factors which are affecting the sales of amniotic membranes among consumers

Impact of COVID-19:

To identify and understand the various factors involved in the  market affected by the pandemic

Company Profiling:

To provide a detailed insight into the major companies operating in the market. The profiling will include the financial health of the company in the past 2-3 years with segmental and regional revenue breakup, product offering, recent developments, SWOT analysis, and key strategies.