The global amniotic membrane market size was valued at USD 2.87 billion in 2021 and is projected to reach USD 9.42 billion by 2030 at a CAGR of 14.12% from 2022 to 2030. These tissue-based products may be more widely used in surgical wounds and ophthalmology as a result of the amniotic membrane's ability to lessen pain. The amnion membrane is mostly employed for wound healing due to its bacteriostatic and analgesic qualities.
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Demand for wound care biologics, especially amniotic membranes, has increased significantly as a result of the increasing prevalence of burn wounds. The bulk of burn cases, according to the WHO, occur in low- and middle-income nations, with roughly two-thirds of those instances occurring in the WHO regions of Africa and Southeast Asia. One million people in India, for instance, experience moderate to severe burns each year (Source: WHO). In other Southeast Asian nations like Bangladesh and Nepal, burn incidents are also common. Every year, moderate to severe burns affects an estimated 173,000 children in Bangladesh. 5% of all disabilities in Nepal are caused by burns, which are the second most frequent injury.
Over the course of the projection period, it is expected that initiatives such as escalating investments, a spike in partnerships and collaborations, and creative product development techniques would boost market expansion. As a surgical graft or a biological bandage for maintaining and treating wounds, amniotic membranes are commonly employed in one of two ways. By serving as a scaffold when utilized as a graft, these membranes help in re-epithelialization. In addition, rising consumer awareness of these advantages is predicted to fuel market expansion. Additionally, they are frequently employed in the treatment of conditions affecting the eye's surface, including bacterial keratitis, corneal ulcers, cataract, glaucoma, bullous keratopathy, corneal degeneration, and ocular dystrophy, eyelid reconstruction, and a number of others. Substantial demand for these tissue-based products has been generated by the increase in the elderly population around the world, which has increased the number of ophthalmology surgeries.
Since there is little chance of difficulties, amniotic membranes shouldn't be handled carelessly. If the donors are not sufficiently screened for communicable diseases, the patient or the recipient of an amniotic membrane may transmit bacterial, viral, or fungal infections. If the membrane is processed outside of sterile settings or is kept in an unsuitable environment for storage, there may be additional dangers for the patient or recipient. Post amniotic membrane transplantation, incidence rates of 1.6% to 8.0% have been documented, with gram-positive isolates being the most often observed. Furthermore, repeated and repetitive transplantations may result in early amniotic membrane deterioration and cheese wiring, which is a concern in and of itself.
The market is anticipated to grow as a result of a variety of factors, including a rise in the number of surgeries performed globally, significant R&D investments, and expanding stem cell and regenerative medicine research. Additionally, in December 2016, the US government approved The 21st Century Cures Act, making it a law. This new law was passed, among other things, to advance medical innovation and research into regenerative medicine. The Act contains a number of provisions that could affect the creation and approval of several products in the upcoming years. A fast-track approval procedure for innovative regenerative medicine products and therapies has also been established under this Act, along with a new "Regenerative Medicine Advanced Therapy" designation. The passage of this Act may pave the way for the US Food and Drug Administration to approve fresh regenerative medicine treatments and goods. It may also encourage further research and development in the area.
This amniotic membrane market share can be segmented on the basis of Products, Applications, End-uses, Regions and Competitors. Dehydrated and cryopreserved amniotic membranes are the two categories into which the market is divided based on the product. Due to its widespread use and great efficacy, cryopreserved amniotic membrane maintained the largest revenue share of more than 58.5% in 2021. This type of cryopreserved membrane is typically kept at -80 °C in a cell culture medium that contains 50% glycerol. Cryopreserved amniotic membranes include the histological and biological characteristics of the amniotic membrane in good condition. Cryopreserved membranes are thus frequently utilized in vision procedures to help with healing and minimize inflammation of the eye. As a result, it is projected that over the forecast period, this market will expand at a profitable rate.
Surgical wounds, ophthalmology, and other applications make up the market's application-based segments. The highest revenue share of more than 36% was accounted for in 2021 by the surgical wounds segment. The number of surgeries performed globally has increased, increasing the market potential as a result of the rise in chronic and infectious diseases. The most frequent application of these drugs is during ophthalmic procedures to promote a quicker healing process and lower inflammation. In order to speed up healing and lessen scarring, these membranes are also utilized during reconstructive procedures. In 2017, around 17.5 million surgical cosmetic procedures were carried out nationwide, according to the American Society of Plastic Surgeons. These statistics show that more and more people are having surgery to improve their appearance.
Hospitals, Ambulatory Surgical Centers (ASCs), specialized clinics, and academic and research institutions make up the different end-use market segments. More than 38% of the market was accounted for by the hospital sector in 2021. As hospitals are the primary care environments that facilitate simple treatment for a wide range of ailments, this is primarily owing to frequent visits by patients. Another element that should accelerate market expansion is the increasing use of amniotic membranes in ASCs. The usage of these items is simple and efficient, and it also helps the wound heal without the need for frequent trips to clinics or hospitals. This encourages sector expansion.
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With a revenue share of more than 31% in 2021, North America controlled the majority of the market. The main drivers of regional market expansion in North America are the existence of well-established healthcare facilities and prominent market players. During the projection period, it is anticipated that this region's increased emphasis on alternative technologies and adoption of cutting-edge technologies would further accelerate market expansion. The second-highest revenue share was accounted for by the Europe region, and it is anticipated that between 2022 and 2030, it will expand at a consistent CAGR. Europe has a publicly funded healthcare system, and some nations have universal coverage policies, which has increased demand for the products. Healthcare practitioners should embrace amniotic membranes more widely as there are more patients with chronic disorders.
According to the WHO, non-communicable diseases like cancer, chronic respiratory illnesses, cardiovascular diseases, and diabetes collectively cause over 86% of fatalities and account for 77% of the disease burden in Europe. As a result, it is projected that a high frequency of chronic diseases and an increase in surgical treatments will hasten market expansion. Over the course of the prediction, Asia Pacific is anticipated to increase significantly. Economic development is occurring in the majority of the countries in this region, and disposable income is rising gradually.
Both local and international firms are prevalent in the sector. To assure placental donations, the bulk of the market's companies work closely with hospitals and tissue banks. The main responsibilities of the major players include creating and advertising membranes that are only intended for usage in particular fields. AmnioFix, for instance, is a dehydrated amniotic membrane created by MiMedx Group Inc. that is used specifically for surgical incisions because it functions as a barrier membrane and lessens the production of scar tissue. Applied Biologics LLC, Human Regenerative Technologies, LLC, DermaSciences, Katena Products, Inc., MiMedx Group Inc., Skye Biologics, Inc., Amniox Medical Inc., and Organogensis, Inc. are a few of the major companies competing in the global amniotic membrane market.