Amniotic Membrane Market Size:

The Amniotic Membrane Market size was worth USD 3.65 billion in 2023 and is predicted to be worth USD 10.18 billion by 2032, growing at a CAGR of 12.10% Over the Forecast Period of 2024 and 2032. The amniotic membrane market is witnessing significant growth due to increasing awareness about the benefits of amniotic membrane treatments in wound healing, surgical procedures, and regenerative medicine. Amniotic membranes, which are rich in growth factors and anti-inflammatory properties, are used to treat chronic wounds, surgical wounds, and ophthalmic disorders. Their usage has expanded across multiple healthcare domains due to their ability to reduce healing time, minimize scarring, and promote tissue regeneration. Amniotic membranes are widely used to treat a variety of eye surface conditions, such as corneal ulcers, bacterial keratitis, cataracts, glaucoma, and ocular dystrophy. A key driver behind the significant rise in amniotic membrane usage in the global ophthalmology market is the rapidly growing elderly population.

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The World Health Organization has projected, by 2050, the global population consisting of the elderly, aged 60 and older, is estimated to rise to 2.1 billion. Thereby, the increased demand for remedies for age-related eye diseases, such as cataracts and macular degeneration, will increase manifold. Furthermore, the American Academy of Ophthalmology reported that 91% of cataract surgeries in the U.S. are performed on those aged over 65, clearly suggesting the highly proportional age factor for increased ophthalmology treatment demand.

The technological shift has influenced market growth with an increased demand for cryopreserved and dehydrated amniotic membranes. Their clinical study success ranges over 85% for treating various images of corneal surface disorders. Furthermore, amniotic membranes will be increasingly used for orthopaedic and plastic surgeries, as, according to the American Academy of Orthopaedic Surgeons, they have regenerative characteristics vital for quick recovery from trauma and sports injuries.

Amniotic Membrane Market Dynamics

Drivers

• Improvements in surgical methods and technologies have enhanced the effectiveness of amniotic membrane applications in various medical fields.

• There is a growing trend towards using biologically derived products in surgical procedures, which boosts the demand for amniotic membranes.

• The focus on regenerative medicine and tissue engineering is leading to greater interest and investment in amniotic membrane applications.

A significant effect on the amniotic membrane market is caused by the increasing attention to regenerative medicine and tissue engineering. These disciplines focus on using the organism’s capabilities for natural healing, which highlights amniotic membranes, enriched with growth factors and extracellular matrix components as indispensable resources for wound healing and functional tissue and organ construction. This tendency has caused its increased popularity among healthcare industry specialists and investors due to continually emerging cutting-edge applications. Innovations in cryopreserved and dehydrated amniotic membrane preparation significantly improved their treatment outcomes and efficiency. Nowadays they are effectively used in ophthalmology, orthopedics, plastic surgery, and other clinical fields. The improved quality of these products has increased their effectiveness and, subsequently, the success rate of products and companies working in the market. Thus, the analysts claim that regenerative medicine’s trend on the increasing usage and applications of amniotic membranes attracts significant attention and investments from the biotech startups and various research organizations. This fact underlines the optimistic prognosis for the microeconomic growth of the market. As it is known from the current clinical trials and research, amniotic membranes are effective in treating a wide variety of different conditions including corneal and ocular surface disorders.

Increased realization and taking on tissue-based therapies reflect a growing recognition of their potential benefits in medical treatments. These therapies, which make use of biological tissues like amniotic membranes, are gaining traction due to their effectiveness in promoting healing and tissue regeneration. As patients and healthcare providers gain more knowledge about these advanced treatments, there is an increasing tendency to include them in standard medical practices. This shift is leading to improved outcomes and encouraging advancements in regenerative medicine.

Restraints

• The approval process for medical products, including amniotic membranes, can be lengthy and complex, potentially delaying market entry and increasing costs.

• Differences in the quality and efficacy of amniotic membrane products from various suppliers can affect clinician trust and patient outcomes.

• The manufacturing and processing of amniotic membranes can be expensive, limiting accessibility for smaller healthcare providers and potentially affecting pricing strategies.

Amniotic membranes provide a wide range of benefits, making them a popular choice in numerous medical applications. However, this product’s manufacturing and processing costs are extremely high; it poses a severe challenge in the market, including for smaller healthcare providers. To guarantee safety and quality, the product must undergo complicated and unique production methods, including cleaning and gamma irradiation. While these measures ensure the tissue’s sterility, they also require a significant investment from the producer, raising operational costs and, consequently, product costs. This factor makes it challenging for smaller healthcare providers to incorporate the product into their treatment options, thereby limiting the number of patients with access to these cutting-edge treatments. At the same time, the dynamic implies that larger companies control the pricing landscape. These corporations see significant benefits from economies of scale and have much higher leverage when negotiating with their suppliers than smaller companies, making their pricing offers much more appealing. In conclusion, the product’s high costs in the production stage pose a significant risk to the overall potential of the market.

Variabilities regarding the quality and efficacy of products among the different suppliers considerably affect the confidence of the clinicians. When healthcare providers observe variations in the quality of amnions among products, it becomes challenging for them to trust these mixtures. In such cases, where there are mistrusts in the products, the clinicians may have doubts about recommending the same to the patients, and the patients may consider the application of the same as a waste of time due to poor results. Research shows that the integrity and effectiveness of such amalgams play a fundamental role, not only in treating corneal ulcers but other ocular surface diseases as well. Therefore, it is evident that maintaining uniform quality among various suppliers builds confidence among clinicians, thereby enhancing the care of the patients in an amniotic membrane market.

Amniotic Membrane Market Segmentation Analysis

By Product

The cryopreserved amniotic membrane segment led the market with a substantial share of 58.7% in 2023 and is projected to experience the highest CAGR throughout the forecast period. Cryopreserved amniotic membrane is a form of biologically active tissue that is preserved using cryogenic freezing to keep its cellular structure as well the structure of extracellular matrix. The procedure is also known as cryopreservation amniotic membrane and usually involves the use of liquid nitrogen for storage and subsequent procedures of freezing and storing at low temperatures. Among the most valuable properties of cryopreservation are the preservation of important therapeutic factors, including growth factors, cytokines, and matrix components, due to the involvement of liquid nitrogen and other similar substances.

CAM is actively used in various medical areas. For example, in ophthalmology, it is used to cover corneal defects, such as persistent epithelial defects, ulcers, or chemical burns, to promote healing, faster recovery, and less scarring. In wound care, it is recommended to treat chronic wounds, such as diabetic foot ulcers and those due to venous leg ulcers and pressure sores, because of the advantages of biological scaffolds to provide tissue repair and stimulate cell growth, as well as reduce inflammation and infections.

By Application

In 2023, the others (Burn Treatment, Chronic Wound Care, Gynecology) segment dominated the market and represented over 42.3% of revenue share. Multiple applications characterize the amniotic membrane market as it is used in dermatology for treating burns, chronic ulcers, and at the wound sites of the skin grafts. Applications in dentistry involve assistance in periodontal surgery and the regeneration of oral tissues, which helps reduce recovery time and inflammation. In gynecology, the product is applied for managing vaginal atrophy and serving as a biological barrier in various surgeries of the pelvis. In the above applications, the anti-inflammatory, antimicrobial, and tissue-repair features of amniotic membranes are utilized, making them pivotal in various aspects of the medical industry.

The ophthalmology segment is anticipated to achieve the fastest CAGR during the forecast period, primarily due to the effectiveness of amniotic membranes in treating ocular surface conditions like corneal ulcers and persistent epithelial defects.This product also helps in the reduction of pain and scarring and increases the rate at which the skin heals, which reduces the probability of infection characteristic of open wounds. It is also used in pterygium surgery and reconstructions of the conjunctiva. The demand for the product in ophthalmology is increasing because of the positive patient outcomes, which ensure that the patients receive better health outcomes, such as improved vision and reduction in eye complications, rendering the product a vital asset in advanced eye care.

By End Use

The hospital & clinics segment dominated the market represented over 39.1% of revenue share in 2023. Hospitals use the regenerative, anti-inflammatory, and scar-reducing benefits of amniotic membranes to address chronic wounds, corneal defects, and reconstructive surgeries. More importantly, hospitals employ the use there to improve healing rates and better patient outcomes to cope with the increasing demand for advanced treatment options in the modern healthcare setting.

The ambulatory surgical centers (ASCs) segment is projected to grow at the fastest CAGR throughout the forecast period.. The ambulatory surgical centers or outpatient surgery centers employ amniotic membranes to deal with their minimal invasive regenerative and anti-inflammatory abilities for a relatively quick healing and low complication outcomes. The regenerative skins are used in ophthalmic surgeries such as pterygium excision, and provide faster healing rates and reduce postoperative scarring. They are also commonly employed in cleaning and minor wound care procedures. Given their efficiency, cost-effectiveness and relatively quick treatment turnover, the ambulatory surgical centers are the ideal option to deal with the growing demand for advanced, minimally invasive treatment options that improve patient outcomes and reduce hospital stay through shorter surgical and recovery times.

Amniotic Membrane Market Reginal Insights

In 2023, North America led the market, accounting for more than 32.1% of total revenue, thanks to its well-established healthcare facilities and the presence of major industry players. Additionally, the increased concentration on alternative technologies and the implementation of advanced technologies in the region are anticipated to drive further market growth in the forecast period. The demand for regenerative medicine, including amniotic membrane treatments for various medical conditions, is driven by advanced healthcare infrastructure and cutting-edge technology. The region's robust regulatory agencies, like the FDA in the United States and Health Canada in Canada, ensure product safety and effectiveness. This regulatory framework provides reassurance to healthcare providers and patients about using amniotic membrane products.

APAC region maintained the fastest growth in the market. Contributing to such a prediction is the economic advancement of numerous APAC countries as the surplus income gradually grows. Numerous multinational establishments are investing in this region. At the same time, there is a vast amount of unfulfilled healthcare needs, and the healthcare infrastructure in many countries, including Japan and India, continues to evolve.

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Key Players

The major key players are

• Amniox Medical, Inc. - (AmnioGraft, AmnioBand)

• NovoSorb - (NovoSorb BTM)

• MediVerbs - (MediVerbs Amniotic Membrane Allograft)

• Tissue Regenix - (dCell® Dermal Matrix)

• Integra LifeSciences - (AmnioExcel, AmnioMatrix)

• AlloSource - (AlloPatch, AlloDerm)

• SBiC - (AmnioMatrix, AmnioWrap)

• MiMedx - (EpiFix, AmnioFix)

• Organogenesis - (Apligraf, Dermagraft)

• Skye Biologics - (Amniotic Membrane Tissue)

• Surgenex - (Amniotic Membrane Allograft)

• Eyre Bio - (Eyre Amniotic Membrane)

• Cure Medical - (Amniotic Membrane Allograft)

• Acelity - (TAPESTRY, CellerateRx)

• Vericel Corporation - (Epicel)

• Athersys, Inc. - (MultiStem)

• TissueTech, Inc. - (AmnioGuard, AmnioFix)

• Celltex Therapeutics - (Amniotic Membrane Tissue)

• Tissue Sciences Corporation - (Amniotic Membrane Allograft)

• Regenesis Biomedical - (Amniotic Membrane)

Recent Developments

• In February 2024, Verséa launched a point-of-care platform for amniotic membrane grafting. This innovative solution enables swift and efficient testing, improving patient care in ophthalmology by delivering immediate diagnostic results and treatment options.

• In December 2023, NovaBay Pharmaceuticals collaborated with Woo University to provide education for eye care professionals on the use of amniotic membranes.