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市場調查報告書
商品編碼
1832087
2025 年至 2033 年羊膜市場規模、佔有率、趨勢及預測(按產品、應用、最終用戶和地區)Amniotic Membrane Market Size, Share, Trends and Forecast by Product, Application, End User, and Region, 2025-2033 |
2024 年全球羊膜市場規模為 16.6 億美元。展望未來, IMARC Group估計,到 2033 年,市場規模將達到 33.3 億美元,2025-2033 年期間的複合年成長率為 7.63%。北美目前佔據市場主導地位,2024 年將佔據約 37.6% 的顯著市場。由於羊膜具有抗發炎、抗疤痕和癒合特性,其在再生醫學、眼科和傷口護理領域的應用日益增多,從而推動了羊膜市場的發展。眼部疾病、燒傷和糖尿病足潰瘍病例的增加,加上臨床醫生對羊膜移植臨床益處的認知不斷提高,正在刺激需求。此外,組織保存技術的進步、醫療基礎設施的擴大以及羊膜產品在外科手術中的應用日益增多,都在增加羊膜的市場佔有率。
由於再生醫學應用範圍的不斷擴大以及羊膜衍生產品在美容手術中的應用,市場正在顯著擴張。此外,人們日益認知到冷凍保存和冷凍乾燥膜對傷口癒合的益處,這也刺激了需求。此外,生物製藥公司和組織庫之間的策略合作正在支持產品創新和更廣泛的臨床應用。向門診和流動護理的轉變極大地促進了羊膜產品的需求。隨著外科手術擴大轉向非醫院環境,對高效、生物相容性傷口癒合解決方案的需求也在增加。產業報告預測,2017年至2027年期間,美國門診手術中心 (ASC) 市場的年成長率將達到4%。這一擴張與羊膜在眼科手術、皮膚科干預和軟組織修復等手術中的更廣泛應用相一致,這些手術優先考慮快速恢復和減少併發症。羊膜移植的便利性和有效性使其非常適合整合到 ASC 治療方案中。
在美國,市場受益於門診和專科診所穩步採用先進的傷口管理解決方案。此外,臨床上對用於治療糖尿病足潰瘍和眼表疾病的生物敷料的興趣日益濃厚,這也支撐了需求的成長。羊膜市場的一個重要新興趨勢是充足的科學研究資金和高度結構化的監管環境,這正在加速新應用的臨床應用。例如,全球最大的生物醫學研究公共資助機構是美國聯邦機構美國國立衛生研究院 (NIH)。 NIH 將其約 480 億美元的資金大部分用於醫學研究,旨在提高生活品質並降低疾病和殘疾的盛行率。專注於胎盤組織處理的生物技術新創公司的激增正在引入創新的交付模式。業內人士加強臨床醫生培訓和進行宣傳活動也有助於擴大羊膜療法在全國範圍內的應用。
再生醫學需求不斷成長
糖尿病和類風濕性關節炎等多種慢性疾病的發生率不斷上升,導致慢性傷口和潰瘍,對有效治療方法的需求也日益增加。世界衛生組織 (WHO) 報告稱,糖尿病患者人數從 1990 年的 2 億增加到 2022 年的 8.3 億。羊膜提供了一種創新的解決方案,可以促進癒合過程。除此之外,全球老年人口的成長極易受到各種健康狀況的影響,這推動了對促進更快癒合和組織再生的治療的需求。此外,羊膜在骨科和牙科等各種醫學專業中的應用日益廣泛,這對羊膜市場前景產生了積極影響。此外,羊膜促進細胞生長和減少發炎的能力也推動了其在其他再生治療中的應用。
醫療程序的技術進步
先進技術的融合推動了羊膜的開發,使其效率和功效得到提升。現代技術確保維持必需的生長因子和癒合特性,從而增強其在各個醫療領域的適用性。羊膜與幹細胞療法和3D (3D) 生物列印等尖端療法的兼容性,為其帶來了良好的市場前景。尤其是幹細胞療法,由於強力的臨床證據支持其有效性,其應用範圍正在擴大。例如,在多發性硬化症患者中,接受自體造血幹細胞移植的患者五年內殘疾狀況改善了 19%,而單純接受藥物治療的患者僅改善了 4%。這些技術融合使得治療更加個人化和有效,並提高了患者護理品質。此外,改進的保存方法可以延長保存期限並擴大銷售範圍,從而增加了其在不同地區和醫療系統中的應用。這反過來又促進了羊膜市場的成長。
支持性監管環境
各國監管機構正逐漸認知到羊膜的治療價值,並針對羊膜的提取、加工、保存和應用制定了清晰明確的指導方針。這些指導方針確保了操作的一致性,並維護了產品品質。此外,監管機構也積極監測市場,以確保其符合所有相關規則和標準。定期檢查、審計和報告要求有助於維護行業的信任和誠信。此外,監管機構還提供扶持性政策,包括撥款、激勵措施和公私合作,以鼓勵該領域的研發。例如,MTF Biologics 在 2025 年為同種異體移植轉化研究提供了超過 100 萬美元的資助。值得關注的獲獎者包括:Derrick Wan 博士,他正在探索臍帶羊膜和絨毛膜同種異體移植用於傷口癒合;以及 Sameer Shakir 博士,他正在研究羊膜在唇顎裂治療中的應用。與研究機構的合作可以推動創新,並將新產品和療法推向市場。
The global amniotic membrane market size was valued at USD 1.66 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 3.33 Billion by 2033, exhibiting a CAGR of 7.63% during 2025-2033. North America currently dominates the market, holding a significant market share of around 37.6% in 2024. The market is driven by increasing applications in regenerative medicine, ophthalmology, and wound care due to its anti-inflammatory, anti-scarring, and healing properties. Rising cases of ocular disorders, burns, and diabetic foot ulcers, coupled with growing awareness among clinicians about the clinical benefits of amniotic grafts, are boosting demand. Additionally, advancements in tissue preservation techniques, expanding healthcare infrastructure, and rising adoption of amniotic products in surgical procedures are augmenting the amniotic membrane market share.
The market is experiencing notable expansion due to the widening scope of regenerative medicine applications and the incorporation of amniotic-derived products in aesthetic procedures. Additionally, the increasing awareness regarding the wound-healing benefits of cryopreserved and lyophilized membranes is also encouraging demand. Moreover, strategic collaborations between biopharmaceutical firms and tissue banks are supporting product innovations and wider clinical access. The shift toward outpatient and ambulatory care is contributing significantly to the demand for amniotic membrane products. As surgical procedures increasingly transition to non-hospital settings, the need for efficient, biologically compatible wound-healing solutions has risen. Industry reports project a 4% annual growth rate in the ambulatory surgery center (ASC) market between 2017 and 2027 in the United States. This expansion aligns with the broader adoption of amniotic membranes in procedures such as ophthalmic surgeries, dermatological interventions, and soft tissue repair, where rapid recovery and reduced complications are prioritized. The convenience and efficacy of amniotic-based grafts make them well-suited for integration within ASC treatment protocols.
In the United States, the market is benefiting from the steady adoption of advanced wound management solutions across outpatient and specialty care clinics. Furthermore, heightened clinical interest in biologic dressings for managing diabetic foot ulcers and ocular surface disorders is supporting demand growth. One of the significant emerging amniotic membrane market trends is robust research funding and a highly structured regulatory environment, which are accelerating the clinical adoption of novel applications. For instance, the biggest public funder of biomedical research worldwide is the National Institutes of Health, which is a United States federal agency. The NIH spends the majority of its around USD 48 Billion funding on medical research with the goal of enhancing quality of life and reducing the prevalence of illness and disability. The proliferation of biotechnology startups specializing in placental tissue processing is introducing innovative delivery formats. Enhanced clinician training and awareness campaigns by industry players are also contributing to the expanding utilization of amniotic membrane therapies nationwide.
Increasing Demand for Regenerative Medicine
The rising prevalence of several chronic conditions like diabetes and rheumatoid arthritis, leading to chronic wounds and ulcers is increasing the need for effective treatment methods. The World Health Organization (WHO) reported that the number of people living with diabetes increased from 200 million in 1990 to 830 million in 2022. Amniotic membranes offer an innovative solution and stimulate the healing process. Apart from this, the growing global geriatric population, which is highly susceptible to various health conditions is driving the need for treatments that promote faster healing and tissue regeneration. Furthermore, the increasing adoption of amniotic membranes in various medical specialties like orthopedics and dental medicine is positively impacting the amniotic membrane market outlook. Moreover, the ability of the amniotic membrane to facilitate cellular growth and decrease inflammation is driving its adoption in other regenerative treatments.
Technological Advancements in Medical Procedures
The integration of advanced technologies is resulting in the development of amniotic membranes with increased efficiency and efficacy. Modern techniques ensure that essential growth factors and healing properties are maintained, enhancing their applicability in various medical domains. The compatibility of the amniotic membrane with cutting-edge treatments, such as stem cell therapies and three-dimensional (3D) bioprinting, is offering a favorable market outlook. Stem cell treatments, in particular, are seeing increased adoption due to strong clinical evidence supporting their effectiveness. For instance, in multiple sclerosis, patients who received autologous hematopoietic stem cell transplants experienced a 19% improvement in disability over five years, compared to just a 4% improvement in those receiving medication alone. These integrations allow for more personalized and effective treatments and enhance the quality of patient care. Apart from this, improved preservation methods allow for longer shelf life and wider distribution, which is increasing its adoption across various regions and healthcare systems. This, in turn, is contributing to amniotic membrane market growth.
Supportive regulatory environment
Regulatory bodies of various countries are recognizing the therapeutic value of the amniotic membrane and implementing clear and well-defined guidelines for the extraction, processing, preservation, and application of amniotic membranes. These guidelines ensure uniformity in practices and uphold the quality of products. Apart from this, regulatory authorities are actively monitoring the market to ensure compliance with all relevant rules and standards. Regular inspections, audits, and reporting requirements help maintain trust and integrity in the industry. Furthermore, they are offering supportive policies, which include grants, incentives, and public-private partnerships that encourage research and development in the field. As such, in 2025, MTF Biologics awarded over USD 1 Million in grants for allograft translational research. Notable recipients include Dr. Derrick Wan, exploring umbilical cord amnion and chorion allografts for wound healing, and Dr. Sameer Shakir, studying amniotic membrane in cleft lip/palate treatments. Collaborative efforts with research institutions can drive innovation and bring novel products and therapies to market.
Cryopreserved amniotic membrane leads the market with around 64.5% of market share in 2024. It has a long shelf life, and it allows hospitals and clinics to maintain an inventory without the risk of degradation. It also offers ease of storage, simplifies logistics, and reduces waste. Additionally, it aids in maintaining the biological integrity of the amniotic membrane and enhancing the therapeutic effectiveness of the membrane. This ability to retain the natural healing properties is attracting healthcare providers. Apart from this, regulatory bodies are recognizing the benefits of cryopreservation and are actively providing supportive guidelines and approvals. This support from regulatory authorities is promoting the adoption of cryopreserved amniotic membranes across different regions.
Surgical wounds lead the market with around 45.3% of market share in 2024. Increasing road accidents and major sports injuries are leading to a rise in elective and emergency surgeries across various medical disciplines, which is catalyzing the need for effective wound care. Additionally, technological advancements in surgical procedures are allowing for more complex and numerous surgeries to be performed with optimal efficiency. Apart from this, the rising focus on minimizing post-operative infections and complications is driving the demand for high-quality wound care products. The growing awareness about the importance of infection prevention and control is encouraging healthcare providers and patients to opt for optimal wound care solutions. Furthermore, rising preferences for effective healing without significant scarring is leading to innovations in wound care products specifically designed for surgical wounds.
Hospitals lead the market with around 55% of market share in 2024. Hospitals have specialized medical professionals and skilled staff trained to deal with various medical conditions. They can offer enhanced diagnostic and therapeutic procedures as they are equipped with technologically advanced medical equipment. Apart from this, they provide emergency medical services and handle urgent and life-threatening situations, which is offering a favorable market outlook. Furthermore, many hospitals have established relationships with insurance providers, facilitating easier and more comprehensive coverage for patients, which makes hospital-based care more accessible for many individuals. Moreover, hospitals in various regions receive government funding and support, which ensures the availability of essential healthcare services to the wider population.
In 2024, North America accounted for the largest market share of over 37.6%. The region is home to leading research institutions and biotechnology companies that actively invest in the research and development (R&D) activities of regenerative medicine, including amniotic membranes. Additionally, the region has a highly developed healthcare system with state-of-the-art facilities and technology, which drives innovation and facilitates the adoption of advanced medical products, such as amniotic membranes. Apart from this, supportive regulatory guidelines for the development, approval, and use of amniotic membrane products in North America is encouraging manufacturers to expand their market reach. Furthermore, collaborations between hospitals, research institutions, and biotechnology companies is enhancing innovation and market penetration in the region.
United States Amniotic Membrane Market Analysis
In 2024, the United States holds a substantial share of around 89.65% of the market share in North America. The market is primarily driven by the increasing demand for advanced wound care solutions due to rising incidences of chronic wounds and burn injuries. According to NCBI, chronic wounds affect approximately 2.5% of the U.S. population, placing significant burdens on both patients and healthcare systems. In line with this, the growing adoption of minimally invasive surgical procedures enhancing the use of amniotic membranes in tissue regeneration, is propelling market growth. Similarly, continual advancements in stem cell therapies and their integration with amniotic membrane applications are contributing to the market's expansion. The increasing prevalence of eye-related conditions such as dry eye disease and corneal injuries is supporting demand for amniotic membrane-based treatments in the market. Industry research indicates that nearly 16 million people in the country are living with dry eye disease (DED). Furthermore, stringent regulatory approvals and the growing recognition of amniotic membranes' therapeutic benefits by healthcare authorities are encouraging wider product usage. The expanding healthcare infrastructure and rising healthcare expenditures in the U.S. are providing a favorable environment for market development. Moreover, the emerging trend of personalized medicine is also augmenting the market progress.
Europe Amniotic Membrane Market Analysis
The market in Europe is experiencing growth due to the increasing prevalence of ophthalmic disorders, such as corneal damage and dry eye disease. In accordance with this, the growing elderly population in Europe, which is more susceptible to chronic wounds and degenerative conditions, is propelling market growth. The continual advancements in regenerative medicine, including stem cell therapy, enhancing the use of amniotic membranes in tissue repair and regeneration, are strengthening market demand. Furthermore, the rising number of surgical procedures, particularly in orthopedics and plastic surgery, is encouraging the adoption of amniotic membranes for post-surgical recovery. In 2024, the UK saw a 5% increase in cosmetic surgery, with 27,462 procedures performed. Popular surgeries included breast augmentations (up 6%), liposuction (up 8%), and tr(up 8%), according to the British Association of Aesthetic Plastic Surgeons (BAAPS). The favorable regulatory environment within the European Union, along with approvals for innovative therapies, is fostering market expansion. Similarly, greater awareness of the therapeutic potential of amniotic membranes among healthcare professionals is accelerating market accessibility. Moreover, increasing investments in healthcare infrastructure and research and development (R&D) are expanding the market reach.
Asia Pacific Amniotic Membrane Market Analysis
The Asia Pacific market is advancing attributed to the rising prevalence of chronic conditions, such as diabetic foot ulcers and corneal diseases. An industry research study estimates that the pooled prevalence of diabetic foot ulcers (DFUs) in India is 6.2%. Subgroup analysis showed a higher prevalence in males (14.5%) compared to females (7.7%). In addition to this, increasing healthcare infrastructure investments in emerging economies are contributing to market expansion. Furthermore, the growing acceptance of regenerative medicine and tissue engineering stimulating the use of amniotic membranes in various medical applications, is impelling the market. Similarly, ongoing advancements in medical technologies and surgical techniques improving the efficacy of amniotic membrane products are supporting amniotic membrane market demand. The growing government support through regulatory frameworks and funding encouraging innovation in the field is bolstering market development. Besides this, the increasing focus on wound care, particularly in aging populations, is providing an impetus to the market.
Latin America Amniotic Membrane Market Analysis
In Latin America, the market is progressing propelled by the increasing burden of chronic diseases, such as diabetes and cardiovascular conditions. The International Diabetes Federation (IDF) reported that by 2021, approximately 341 million adults aged 20 to 79 in South and Central America were living with diabetes. The five countries with the highest number of diabetic individuals were Brazil, Colombia, Venezuela, Argentina, and Chile. Similarly, growing healthcare awareness among the population is contributing to greater adoption of regenerative therapies in the market. Additionally, the expansion of medical tourism in countries like Mexico and Brazil augmenting the demand for high-quality medical treatments, is impelling the market. Moreover, the region's shifting regulatory environment supporting the introduction of innovative amniotic membrane products, is further driving market growth.
Middle East and Africa Amniotic Membrane Market Analysis
The market in the Middle East and Africa is experiencing growth due to the rising prevalence of traumatic injuries and burns. NCBI reported that in 2021, over 42 million people in sub-Saharan Africa were affected by injuries. Nigeria accounted for 16% of this total. Southern sub-Saharan Africa recorded 104 deaths per 100,000 from injuries, twice as high as the rate in western sub-Saharan Africa. Furthermore, the growing adoption of regenerative medicine in the region accelerating the use of amniotic membranes, is fostering market expansion. Additionally, increasing healthcare investments and infrastructure development are enhancing the availability and accessibility in the market. Apart from this, the region's expanding medical tourism industry promoting the use of cutting-edge treatments, including amniotic membrane-based products, is positively influencing the market.
The competitive landscape of the market is characterized by ongoing innovations, product segmentation, and increased spending on clinical studies. Players are working to enhance sophisticated preservation technologies and build uses in surgical practices, wound care, and ophthalmic practices. Regulation permits and quality approval remain instrumental for determining credibility as well as attaining market penetration. Hospital, research center, and surgery center partnerships are emerging as new ways of expanding customer bases. Competition also exists on the basis of the type of membrane (cryopreserved or dehydrated), with companies seeking to enhance shelf-life and therapeutic effectiveness. The barriers to entry are moderate, with manufacturing expertise and adherence to safety regulations being the key. According to the amniotic membrane market forecast, competition is expected to intensify as more companies enter the space and existing players broaden their offerings, driven by rising demand for biologics-based therapies and expanding use of amniotic membranes in regenerative medicine.