Amniotic Products Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global amniotic products market, valued at US$846 million in 2022, is forecasted to grow at a robust CAGR of 7.4%, reaching US$900 million in 2023 and an impressive US$1289 million by 2028. The growth of this market is majorly driven by Growth in the target patient population and Rising incidence of burn injuries and increasing number of traumatic wounds. However, Complications and limitations associated with the use of amniotic membranes may restrain the growth of this market.

Amniotic Products Market Trends

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Amniotic Products Market Dynamics

DRIVER: Growth in the target patient population

Physical health conditions, such as chronic diseases, have a negative effect on the wound healing process. For instance, diabetes and obesity can result in an increased incidence of ulcerations, such as leg or foot ulcers, which would require wound treatment and incur exorbitant medical expenses.

As per the IDF 2021, 537 million adults (20-79 years) are living with diabetes (1 in 10). This number is estimated to rise to 643 million by 2030 and 783 million by 2045. Diabetic foot ulcers occur because of major complications of diabetes. Nearly 15% of the total diabetic population suffers from diabetic foot ulcers (Source: Cellular and Molecular Basis of Wound Healing in Diabetes by Brem H., Journal of Clinical Investigation). An article published in the Journal of Foot and Ankle Research estimates that more than 10% of people with type 2 diabetes mellitus are highly prone to foot ulcers, with a lifetime risk of 15%. Thus, the increasing incidence of diabetes will correspondingly drive the demand for wound care products. As the wound healing process is slower in diabetes, advanced wound care products such as amniotic membranes are required for treatment.

Amniotic membranes are also useful in the management of many ocular conditions. Amniotic membranes are widely used for eye surgeries and the treatment of an increasing number of ocular surface pathologies such as ulcers of the cornea or conjunctiva, or in other cases, severe dry eyes.

According to the American Academy of Ophthalmology, the annual incidence of corneal ulcers in the US ranges between 30,000 and 75,000.

According to the National Eye Institute, by 2050, the number of people with cataracts in the US is estimated to double from 24.4 million to about 50 million.

The growth of the target patient population and the subsequent increase in the number of target medical procedures is expected to play a key role in the increased adoption of amniotic products.

Obesity leads to various critical conditions, wounds, and infections, which lead to surgeries and infectious wounds. Such conditions, along with comorbidities like diabetes, lead to non-healing/long-term chronic wounds. Such wounds are highly susceptible to developing infections more than once and need wound care treatments and devices for enhanced wound healing and successful recovery.

Obesity is now termed a worldwide epidemic; approximately 57.8% of all adults will be obese by 2030 (Source: WHO, 2020). Similarly, more than 1 billion people worldwide are obese 650 million adults, 340 million adolescents and 39 million children. This number is still increasing. WHO estimates that by 2025, approximately 167 million people adults and children will become less healthy because they are overweight or obese. (Source: WHO, 2022).

As per the World Obesity Atlas 2022, estimation, one billion people globally, including 1 in 5 women and 1 in 7 men, will be living with obesity by 2030. Moreover, according to the WHO, as of 2019, an estimated 38.2 million children under the age of five years were reportedly overweight/obese. Obesity is an epidemic in low- and middle-income countries as well. In 2019, the prevalence of childhood obesity in Africa increased by approximately 24% since 2000. Considering this constantly increasing trend of obesity across all age groups and genders, it is anticipated that the associated wounds, infections, and critical illnesses/surgeries will also increase. This will result in the increasing demand for amniotic products during the forecast period.

OPPORTUNITY: Emerging economies

Emerging countries such as China, India, South Korea, Brazil, and Mexico offer significant growth opportunities to major players functioning in the amniotic products industry. This can be attributed to low regulatory barriers, improvements in healthcare infrastructure, growing patient population, and rising healthcare expenditure. Moreover, regulatory policies in the Asia Pacific region are more adaptive and business-friendly in comparison to those of developed countries. This factor, in addition to the increasing competition in mature markets, has drawn key players in the market to focus on the emerging economies.

China is a prominent market for amniotic products, owing to its recent infrastructural improvements, rapid economic growth, rising domestic demand, and public-private initiatives to support healthcare research. Similarly, the Indian market reported an increasing prevalence of target diseases and a fast-growing healthcare industry, coupled with a shift towards advanced treatment options.

• In China, the population suffering from diabetes is projected to reach 140.5 million by 2030 from 116.4 million in 2019.
• Diabetes prevalence in % of the population ages 20 to 79 in China was 10.6% in 2021 (Source: The World Bank).
• The China' healthcare expenditure per capita was increased from USD 539.62 in 2019 to USD 583.43 in 2020 (Source: The World Bank).
• The India' healthcare expenditure per capita was increased from USD 44.9 in 2010 to USD 56.63 in 2020 (Source: The World Bank).
• To capitalize on the growth opportunities offered, prominent players in the market are focusing on enhancing their presence in emerging countries.
• In January 2020, LifeCell International Pvt. Ltd. (India) received accreditation from the American Association of Tissue Banks (AATB) for its birth tissue products. The company plans to launch Amchoplast in India. Amchoplast is a minimally manipulated and aseptically processed dehydrated human amnion-chorion tissue allograft used for wound healing applications as it enhances the healing mechanism, reduces scar tissue formation, and modulates inflammation of the wound.
• Compared to Europe and North America, the Asia Pacific and Latin America are relatively untapped markets for amniotic products and have huge growth potential. Owing to this, various players are focusing on increasing their presence in these regions.

CHALLENGE: High cost of amniotic membrane products

The high cost of amniotic products and their associated treatments can be a significant concern for patients, healthcare providers, and healthcare systems.  As per the article published by American Optometric Association, Amniotic membranes can cost from USD 300 to USD 900 per device which can be a significant problem for patients. Similarly, purchase price for the physician can range from USD 125 to USD 900 (Source: Modern Optometry 2021). Likewise, the average 1 year per patient medical cost of DFUs is estimated at USD 28,000 where amniotic membranes are being used to improve healing rates in diabetic foot ulcers. Some of the other factors contribute to the high cost which are listed below.

Processing and Manufacturing: Amniotic products require specialized processing and manufacturing techniques to preserve their biological properties and ensure safety. These processes involve extensive quality control, testing, and regulatory compliance, which can increase the overall cost of production.

Donor Screening and Testing: Donor screening and testing are essential to ensure the safety and quality of amniotic products. Extensive testing for infectious diseases and genetic abnormalities adds to the cost of processing and manufacturing.

Storage and Logistics: Proper storage and transportation of amniotic products require specific conditions, such as controlled temperatures and specialized packaging. These requirements increase the cost of storage, distribution, and logistics.

Research and Development: The development of amniotic products involves significant research and development efforts, including preclinical studies and clinical trials. The costs associated with research, obtaining regulatory approvals, and ensuring compliance with applicable regulations contribute to the overall cost.

Limited Supply: The availability of amniotic products is often limited due to the challenges associated with donor tissue procurement and processing. Limited supply and high demand can drive up the cost of these products.

Regulatory Compliance: Compliance with regulatory requirements and quality standards adds to the cost of manufacturing and distribution. Meeting the necessary regulatory standards and maintaining ongoing compliance require dedicated resources and infrastructure.

Reimbursement Challenges: Reimbursement for amniotic products and their associated treatments can be challenging. Insurance coverage and reimbursement policies may vary, and obtaining adequate reimbursement for these products can be complex, potentially increasing the cost burden for patients and healthcare providers.

US accounted for the largest share of the North American amniotic products industry

Based on the region, the North American amniotic products market is segmented into US and Canada. In 2022, the US accounted for the largest share of the North American market. Growth in this market can be attributed to presence of stringent regulatory standard, rising healthcare expenditure, the increasing number of surgical procedures performed in the US, the rising geriatric population, the high prevalence of chronic wounds and diabetes, and the strong presence of amniotic product manufacturers.

Japan registered the highest growth rate in Asia Pacific amniotic products industry.

The APAC amniotic products market is segmented into Japan, China, India, and Rest of Apac. In 2022, China accounted for the highest growth rate of the Asian market. The high growth rate of Japan can be attributed to the presence of a well-established healthcare sector and the rapidly increasing geriatric population. An increase in the number of elderly people gives rise to various orthopedic and ophthalmological diseases which is highly susceptible to several diseases and disorders. Therefore, growth in this population segment will directly drive the demand for effective and efficient wound care biologics, including amniotic products.

The UK in European amniotic products industry to witness the growth rate during the forecast period.

The Europe amniotic products market is segmented into Germany, France, the UK, and the Rest of Europe. Germany is registered the highest growth rate during the forecast period. The major factors contributing to the growth of this market are the high prevalence of diabetes and venous ulcers, rising in ophthalmic, orthopedic & wound cases in the UK, increasing R&D activities, strategic developments by key players, and the growing geriatric population.

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Some of the major players operating in this market are mimedx (US), Organogenesis Inc. (US), Smith+Nephew (UK), Integra LifeSciences (US). In 2022, mimedx (US), held the leading position in the market. The company’s large share can be attributed to its broad range of amniotic-based products. Smith+Nephew (UK), held the second position in the amniotic products market in 2022.

Amniotic Products Market Report Scope

This research report categorizes the amniotic products market to forecast revenue and analyze trends in each of the following submarkets:

By Type

• Cryopreserved Amniotic Membrane
• Dehydrated Amniotic Membrane

By Application

• Wound Care
• Orthopedics
• Ophthalmology
• Other Applications

By End User

• Hospitals, & Ambulatory Surgical Centers
• Other End Users

By Region

• North America
• Europe
• Apac
• Latin America
• Middle East & Africa

Recent Developments of Amniotic Products Market

• In 2021, The company VIVEX Biologics (US) launched Cygnus Matrix Disks with the latest configuration of the Cygnus family of amniotic tissue allografts.
• In 2021, MiMedx (US) received approval from the Japanese Ministry of Health, Labour, and Welfare for the commercialization of EPIFIX in Japan.
• In 2021, The company Celularity Inc. (US) entered into an exclusive distribution agreement for the commercial distribution rights for orthopedic surgery and sports medicine products with Arthrex, Inc. (US).

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