The global opthalmology amniotic membrane market size was worth $ 315.5 million in 2018 and is forecasted to reach $ 662.9 million by 2026, at a CAGR of 9.8% during the forecast period.
Increasing cell and tissue research is driving the growth of the opthalmology amniotic membrane market. Ease of FDA approval for novel and innovative amniotic membrane allografts coupled with adoption of amniotic membrane for varied applications would boost the revenue growth in Germany & the US market. Significant investment in the development of the amniotic membrane based products including allografts and suspensions in North America and European countries would further bring a bundle of opportunities for amniotic membrane product manufacturers to open their manufacturing base. Manufacturers are focusing on production of high grade amniotic membranes due to its high demand from end users.
Market Dynamics
Drivers
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Increasing Focus on Tissue-Cell and Stem Cell Research
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Financial Investments for Development of Innovative Amniotic Membrane
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Rise in Number of Amniotic Membrane Transplants
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Unmet Clinical Needs Fueling Demand for Regenerative Therapies (Amniotic Membrane Based)
Restraints
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Lack of Skilled/Experienced Professionals
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High Gestation Period and Time-to-Market due to Lengthy Clinical Trials
Market Segmentation
The cryopreserved amniotic membrane market is valued at USD 274.1 Mn in 2018 and is estimated to grow at a CAGR of 10.0% over the forecast period to reach a USD 585.3 Mn by 2026.
The cryopreserved amniotic membrane systems segment holds 86.9% of the market share in 2018, and is expected to be 88.3% by 2026, for global ophthalmology amniotic membrane market.
The amniotic membrane was first used on its own in ophthalmology in 1940, when De Rotth suggested it for the use in the treatment of an ocular burn wound. The treatment was successful, but the use of amniotic membrane then went out of favour until the early 1990’s, when improved processing and storage techniques were developed. Cryopreserved amniotic membrane (CAM) has been used as a temporary biologic bandage for the cornea to restore the health of the ocular surface in a wide range of disorders.
The success of amniotic membrane for the treatment of ocular surface disease has been attributed to its anti-inflammatory, antifibrotic, and antiangiogenic properties in addition to its ability to enhance epithelial healing. Initially, grafting of amniotic membranes was performed exclusively using sutures, but the emergence of sutureless, self-retaining CAM has facilitated the use of amniotic membrane for the treatment of ocular surface disease.
Geographical Analysis
The North America segment of opthalmology amniotic membrane Market is valued at US$ 98.4Million in 2018 and is estimated to grow at a CAGR of 10.6% over the forecast period to reach US$ 220.2 Million by 2026. North America holds 31.2% of market share in 2018, and is expected to be 33.2% by 2026, for the opthalmology amniotic membrane Market. The U.S holds 71.1% of market share in 2018, and is expected to increase to 74.2% by 2026, for North America opthalmology amniotic membrane Market.
The collective revenue of opthalmology amniotic membrane market by North America is expected to generate USD 1,043.5 Mn from 2019-2026. North America is dominating the global opthalmology amniotic membrane market in 2018 and estimated to hold significant market size over the forecast period (2020-2027) owing to the increased funding for research and development. Researchers are working on the development of new clinical infrastructures in placenta-derived amniotic membrane product field, which is still in an initial stages of development with a failure rate of 80% in the initiation phases. There is an increasing penetration of tissue banks in North America.
In these tissue banks, amniotic membrane has been observed as a particularly good target for amniotic transplantation. Simultaneously, improvements in tissue processing and storage is being promoted by bigger hospitals. These institutions encourage use of accredited tissue banks with stringent criteria for donor screening and graft processing measures. Legislation for amniotic transplantation is more supportive in Canada than in the U.S. Presently, the Biologics and Genetic Therapy Directorate (BGTD) of the Health Products and Food Branch of Health Canada is reviewing the guidelines written in 2000 for safety of cells, tissue, and organs for transplantation. Legislative support and regulatory harmonization is expected to fuel the smoothness of the clinical trial infrastructure in the region.
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