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市场调查报告书
商品编码
1832087
2025 年至 2033 年羊膜市场规模、份额、趋势及预测(按产品、应用、最终用户和地区)Amniotic Membrane Market Size, Share, Trends and Forecast by Product, Application, End User, and Region, 2025-2033 |
2024 年全球羊膜市场规模为 16.6 亿美元。展望未来, IMARC Group估计,到 2033 年,市场规模将达到 33.3 亿美元,2025-2033 年期间的复合年增长率为 7.63%。北美目前占据市场主导地位,2024 年将占据约 37.6% 的显着市场。由于羊膜具有抗发炎、抗疤痕和癒合特性,其在再生医学、眼科和伤口护理领域的应用日益增多,从而推动了羊膜市场的发展。眼部疾病、烧伤和糖尿病足溃疡病例的增加,加上临床医生对羊膜移植临床益处的认识不断提高,正在刺激需求。此外,组织保存技术的进步、医疗基础设施的扩大以及羊膜产品在外科手术中的应用日益增多,都在增加羊膜的市场份额。
由于再生医学应用范围的不断扩大以及羊膜衍生产品在美容手术中的应用,市场正在显着扩张。此外,人们日益认识到冷冻保存和冷冻干燥膜对伤口癒合的益处,这也刺激了需求。此外,生物製药公司和组织库之间的策略合作正在支持产品创新和更广泛的临床应用。向门诊和流动护理的转变极大地促进了羊膜产品的需求。随着外科手术越来越多地转向非医院环境,对高效、生物相容性伤口癒合解决方案的需求也在增加。产业报告预测,2017年至2027年期间,美国门诊手术中心 (ASC) 市场的年增长率将达到4%。这一扩张与羊膜在眼科手术、皮肤科干预和软组织修復等手术中的更广泛应用相一致,这些手术优先考虑快速恢復和减少併发症。羊膜移植的便利性和有效性使其非常适合整合到 ASC 治疗方案中。
在美国,市场受益于门诊和专科诊所稳步采用先进的伤口管理解决方案。此外,临床上对用于治疗糖尿病足溃疡和眼表疾病的生物敷料的兴趣日益浓厚,这也支撑了需求的增长。羊膜市场的一个重要新兴趋势是充足的科学研究资金和高度结构化的监管环境,这正在加速新应用的临床应用。例如,全球最大的生物医学研究公共资助机构是美国联邦机构美国国立卫生研究院 (NIH)。 NIH 将其约 480 亿美元的资金大部分用于医学研究,旨在提高生活品质并降低疾病和残疾的盛行率。专注于胎盘组织处理的生物技术新创公司的激增正在引入创新的交付模式。业内人士加强临床医生培训和进行宣传活动也有助于扩大羊膜疗法在全国范围内的应用。
再生医学需求不断成长
糖尿病和类风湿性关节炎等多种慢性疾病的发生率不断上升,导致慢性伤口和溃疡,对有效治疗方法的需求也日益增加。世界卫生组织 (WHO) 报告称,糖尿病患者人数从 1990 年的 2 亿增加到 2022 年的 8.3 亿。羊膜提供了一种创新的解决方案,可以促进癒合过程。除此之外,全球老年人口的成长极易受到各种健康状况的影响,这推动了对促进更快癒合和组织再生的治疗的需求。此外,羊膜在骨科和牙科等各种医学专业中的应用日益广泛,这对羊膜市场前景产生了积极影响。此外,羊膜促进细胞生长和减少发炎的能力也推动了其在其他再生治疗中的应用。
医疗程序的技术进步
先进技术的融合推动了羊膜的开发,使其效率和功效得到提升。现代技术确保维持必需的生长因子和癒合特性,从而增强其在各个医疗领域的适用性。羊膜与干细胞疗法和三维 (3D) 生物列印等尖端疗法的兼容性,为其带来了良好的市场前景。尤其是干细胞疗法,由于强有力的临床证据支持其有效性,其应用范围正在扩大。例如,在多发性硬化症患者中,接受自体造血干细胞移植的患者五年内残疾状况改善了 19%,而单纯接受药物治疗的患者仅改善了 4%。这些技术融合使得治疗更加个人化和有效,并提高了患者护理品质。此外,改进的保存方法可以延长保质期并扩大销售范围,从而增加了其在不同地区和医疗系统中的应用。这反过来又促进了羊膜市场的成长。
支持性监管环境
各国监管机构正逐渐认识到羊膜的治疗价值,并针对羊膜的提取、加工、保存和应用制定了清晰明确的指导方针。这些指导方针确保了操作的一致性,并维护了产品品质。此外,监管机构也积极监测市场,以确保其符合所有相关规则和标准。定期检查、审计和报告要求有助于维护行业的信任和诚信。此外,监管机构还提供扶持性政策,包括拨款、激励措施和公私合作,以鼓励该领域的研发。例如,MTF Biologics 在 2025 年为同种异体移植转化研究提供了超过 100 万美元的资助。值得关注的获奖者包括:Derrick Wan 博士,他正在探索脐带羊膜和绒毛膜同种异体移植用于伤口癒合;以及 Sameer Shakir 博士,他正在研究羊膜在唇颚裂治疗中的应用。与研究机构的合作可以推动创新,并将新产品和疗法推向市场。
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.