Amniotic Products Market Research Report and Outlook by 2028

The amniotic products market is projected to expand from US$ 1,164.32 million in 2022 to US$ 1,889.07 million by 2028, reflecting a compound annual growth rate (CAGR) of 8.4% during this period.

Amniotic products encompass various tissues and components derived from the amniotic sac, which are utilized to protect and support damaged tissues and other bodily areas. Among these products, the amniotic membrane and amniotic suspension are notable for their therapeutic applications. The amniotic membrane, which is the innermost layer of the placenta, plays a crucial role in nourishing and sustaining a developing fetus. Meanwhile, amniotic fluid serves as a protective liquid surrounding the baby until birth.

The rising incidence of burn injuries has significantly increased the demand for wound care biologics, particularly amniotic membranes. According to the World Health Organization (WHO), a substantial number of burn injuries occur in low- and middle-income nations, with approximately two-thirds to three-quarters of these cases reported in the African and Southeast Asian regions. In India alone, around one million individuals experience mild to severe burns annually (Source: WHO). Other countries in Southeast Asia, such as Bangladesh and Nepal, also report high burn injury rates, with an estimated 173,000 children in Bangladesh suffering from moderate to severe burns each year. In Nepal, burns rank as the second most common cause of injury, contributing to 5% of disability cases.

The amniotic products market can be categorized based on product type into two main segments: amniotic membranes and amniotic suspensions. The amniotic membranes segment is anticipated to dominate the market share in 2022. This growth can be attributed to increased research in stem cell and regenerative medicine, substantial investments in research and development, and a rise in the number of surgical procedures performed globally. Amniotic membranes are frequently utilized in treating various ocular conditions, including bacterial keratitis, corneal ulcers, cataracts, glaucoma, bullous keratopathy, corneal degeneration, ocular dystrophy, eyelid reconstruction, and other eye surface disorders. The growing elderly population worldwide is leading to an uptick in ophthalmic surgeries, thereby escalating the demand for tissue-based products.

Several commercially available dehydrated amniotic membranes, such as PalinGen, Fl?Graft, AmbioDisk, and AmnioFix, are widely used in clinical settings. These membranes are particularly effective in managing surgical wounds and incisions due to their unique properties, which include the ability to maintain a watertight seal, reduce inflammatory responses, and prevent the transmission of infections. Consequently, these factors are propelling the growth of the amniotic membranes segment.

In December 2016, the United States enacted the 21st Century Cures Act, aimed at promoting advancements in regenerative medicine research and medical innovation. This legislation introduced several provisions that could significantly influence the development and approval processes for various medical products in the future. Notably, it established a new classification for "Regenerative Medicine Advanced Therapy" and introduced a fast-track approval pathway for innovative regenerative medicine products and therapies. The implications of this Act are expected to facilitate the approval of new regenerative medicine products in the U.S. and enhance research and development efforts in this field. The Act was designed to improve patient access to electronic health information, foster innovation, and combat information blocking practices. By streamlining medication development and approval processes, the 21st Century Cures Act aims to ensure that new medical advancements reach patients more swiftly and efficiently. These initiatives are anticipated to enhance interoperability and promote the access, exchange, and utilization of electronic health information.

In preparing the report on the amniotic products market, several key primary and secondary sources were consulted, including the World Health Organization (WHO), the Centers for Disease Control and Prevention, and the National Programme for Prevention, Management, and Rehabilitation of Burn Injuries.