An amniotic membrane (AM), the innermost layer of the placenta, encompasses a combination of cells and tissues that promote epithelialization while minimizing scarring, neovascularization, and inflammation. As per Inkwood Research, the global amniotic membrane market is set to reach a revenue of $2891.80 million by 2032, projecting a CAGR of 7.27% during the forecast period, 2023-2032.
The amniotic membrane is elastic, lightweight, thin, and almost transparent, making it viable for use on the eye surface. Accordingly, it is used in the surgical management of varied ophthalmic conditions.
Amniotic Membrane’s Thriving Utility in Ophthalmology
According to the World Health Organization (WHO), around 2.2 million people globally have near or distant vision impairment. Amniotic membrane transplantation (AMT) is used in varied ways to treat several ophthalmic conditions. The membrane may serve either as a temporary patch, permanent graft, or a combination of both. As a graft, the amniotic membrane is placed at the site of a conjunctival or corneal tissue defect caused by surgery or disease. The graft placed epithelial side up facilitates a basement membrane and stroma wherein normal epithelium can grow. It helps minimize scarring & inflammation and eventually integrates into the host tissue.
As a patch, AM is placed with the epithelial side down. The patch suppresses acute inflammation and covers the epithelial defect to enable the healing of underneath tissues. The membrane is then reabsorbed, removed, or falls off. The amniotic membrane, with regard to ocular applications, integrates itself into the host cornea in different patterns based on the particular surgical technique or ocular surface disorder.
Limbal Stem Cell Deficiency (LSCD)
Limbal Stem Cell Deficiency (LSCD) entails loss of vision, recurring episodes of pain, photophobia, and tearing. LSCD, though congenitally acquired, more commonly occurs after thermal & chemical burns, cicatricial pemphigoid, and inflammatory conditions like Stevens-Johnson Syndrome (SJS). The disruption of limbal stem cells residing at the corneoscleral limbus results in visual impairment by vascularization and conjunctivalization with subsequent loss of corneal transparency. The amniotic membrane is frequently used to treat partial or total LSCD.
The amniotic membrane enables the limbal stem cells to grow in vivo alongside expanding limbal stem cells ex vivo before transplant. With regard to the treatment of SJS or toxic epidermal necrolysis, amniotic membrane transplant (AMT) has shown promising results during the acute phase to prevent the cicatricial changes associated with chronic disease.
Bullous Keratopathy
Amniotic membrane transplantation (AMT) is considered an alternative to conjunctival flaps in alleviating pain, preserving cosmetic appearance, and promoting epithelial healing in patients with poor visual prognosis and symptomatic bullous keratopathy. Bullous keratopathy is characterized by corneal stromal edema with or without epithelial bullae or blisters. It is caused by corneal endothelial decompensation, surgical procedures including cataract extraction, uncontrolled glaucoma, Fuchs endothelial dystrophy, and nonsurgical trauma.
Corneal Epithelial Defects and Ulcers
Persistent epithelial defects (PEDs) are corneal wounds wherein corneal epithelium ceases to regenerate normally. They occur due to poor wound healing from exposure or neurotrophic keratopathy, inflammation, or dry eye. Conventionally, PEDs are treated through frequent lubrication with autologous or artificial tears and punctual occlusion.
Further, corneal infection or infectious keratitis (IK) is the most common cause of corneal blindness globally, particularly in developing countries. As per a review article, the IK incidence was estimated at 2.5-799 per 100,000 population/year. It is a potentially blinding ocular emergency requiring hospital admission for intensive medical or surgical treatment. Amniotic membrane transplantation (AMT) is usually a second-line therapy in infectious keratitis (IK) to promote cornea healing in non-healing ulcers after the sterilization phase.
Accordingly, amniotic membrane transplantation (AMT) has been administered to treat neurotrophic keratopathy, radiation keratopathy, chemical eye injury, bullous keratopathy, and several other ophthalmic conditions. The vast availability of AM donor tissues, enhanced storage methods, and lack of rejection have raised the popularity of amniotic membrane transplantation (AMT) for treating such ocular surface diseases.
Pterygium and Conjunctival Reconstruction
Pterygium is the benign growth of the conjunctiva considered to be the result of ultraviolet light exposure. The growth can be associated with dry-eye symptoms since they result in irregular wetting of the ocular surface. It can lead to visual changes due to induced astigmatism and result in an unpleasant cosmetic appearance. Several surgical techniques are deployed to treat pterygia to prevent and eliminate recurrence. Amniotic membrane is often used as an alternative for the same. Once the pterygium is eliminated, the amniotic membrane graft is sutured to the bare sclera.
Our analysis of the global amniotic membrane market by product includes cryopreserved amniotic membrane and lyophilized amniotic membrane. Cryopreserved amniotic membrane is projected to garner a revenue of $2081.94 million by 2032.
Future of Amniotic Membrane Products
The hallmark of a chronic non-healing wound is extended inflammation, which disrupts the healing cycle. This results in decreased proliferation of growth factors and an imbalance in protective v/s degradative enzymes, facilitating extracellular matrix destruction. The amniotic membrane enables wound healing by inducing necessary growth factors that adhere to the extracellular matrix to improve tissue healing and growth.
Further, several preservation methods have helped overcome the perception that amniotic membrane tissue was impractical for outpatient or office use due to severe disease transmission risks and limited shelf life. Moreover, commercially available amniotic products adopted either dehydration preservation or cryopreservation methods.
As per a feature article on PodiatryToday, over 80 commercial placenta membrane products are available in the market, and dehydrated amniotic membranes are the most common. Similarly, market players are launching products that comply with regulations. For instance, in 2021, MiMedx Group Inc announced the Japanese Ministry of Health, Labour and Welfare (JMHLW)’s regulatory approval of EPIFIX in Japan. Such developments foster steady growth opportunities for the global amniotic membrane market.
By Akhil Nair
FAQs:
Which is the dominant application in the global amniotic membrane market?
According to Inkwood Research, surgical wounds are the dominant application in the global amniotic membrane market, with a revenue share of 55.64% in 2022.
Which are the key players in the global amniotic membrane market?
Celularity, Integra LifeSciences, Stryker Corporation, and MiMedx Group Inc are among the key players in the global amniotic membrane market.