The global Retinal Implant Market size was valued at USD 14.01 million in 2015. Retinal implants are widely used for the treatment of vision loss in elderly patients having age above 65 years. Retinal implants are also known as a bionic eye. Researchers and healthcare professionals are continuously involved in the development of retinal prosthesis which can restore vision and assist blind patients suffering from age-related macular degeneration (AMD) and retinitis pigmentosa (RP).
Rising prevalence of target diseases (RP and AMD) is primarily boosting the demand for advanced treatment options. AMD is the third leading cause of visual impairment with a prevalence rate of 8.7% globally. According to the National Eye Institute statistics, in 2000, 1.8 million people were affected by AMD with the loss of one or both eyes in the U.S. alone.
Retinal Implant Market, By Region, 2012-2022 (USD Million)
In addition, 7.3 million people are at high risk of vision loss owing to AMD. Rapidly aging population in the U.S. is expected to double the number of patients suffering from AMD by the end of 2050. In addition, no treatment is available for end-stage AMD which leads to irreversible vision loss. However, innovative products, such as Argus II and Implantable Miniature Telescope (IMT), have shown the potential of restoring vision. Taking into account increasing the prevalence of AMD coupled with the potential of commercially available products, demand for a bionic eye is anticipated to grow swiftly during the forecast period.
On the other hand, presently available products are costly and surgeons require training to implant the device successfully. In addition, limited data availability regarding the safety and efficacy of the products is impeding adoption of the product in the market.
Presently, very few products such as Argus II, Implantable Miniature Telescope (IMT), and Alpha IMS are approved for commercialization. Argus II is the first retinal implant to receive approval in the world. The device received CE mark in 2011 and was approved by the U.S. FDA in 2013 for the treatment of retinitis pigmentosa (RP).
Second Sight Medical Products, Inc. manufactures and markets Argus II in the U.S., Austria, Canada, Germany, France, Netherlands, Italy, Saudi Arabia, Switzerland, Turkey, Spain, and the UK. The company is actively involved in protecting the technology and product through intellectual property rights.
As of March 2015, the company had 220 granted patents in the U.S., 96 pending patent applications in the U.S., and 88 foreign granted patents. Moreover, the company is progressively trying to expand the reimbursement coverage for the product, since the high cost of the product is challenging its adoption. Considering approved and granted a patent, anticipated expansion of reimbursement coverage is expected to push the adoption of Argus II during the forecast period.
Implantable Miniature Telescope (IMT) and Alpha IMS are commonly used to restore vision in end-stage macular degeneration (AMD). The implantable miniature telescope is available in the U.S. and Europe market. However, Alpha IMS is available only in Germany.
Though, the target patient population for these products is more as compared to RP, revenue generated by these devices together is lesser owing to low average cost (USD 15,000) of the product. As a result, others market segment including cumulative market analysis of IMT and Alpha IMS accounted for a market share of around 47% in 2014.
Presently, the global market is concentrated in North America and Europe (together accounting for more than 90% of the global market) owing to launch of advanced products in the region coupled with the availability of well-defined regulatory framework and skilled healthcare professionals.
North America accounted for the largest market share of around 51% in 2014. Availability of the product, reimbursement coverage, and high cost of the product are some of the factors resulting in the dominance of this region in the world. Moreover, the presence of skilled healthcare professionals to perform implant procedures coupled with higher adoption rate for advanced healthcare treatments and products is supporting the growth of retinal implants in North America.
Australia and Japan are anticipated to show significant growth during the forecast period with the entry of innovative products from domestic players from the respective country. In addition, many other companies/organizations are in the process of developing innovative products to treat AMD and retinitis pigmentosa. With the successful completion of R&D of these organizations/companies coupled with rising awareness about the availability of the products is anticipated to boost market growth during the forecast period.
The retinal implant market is a niche space with very few players competing with each other. Several players are involved in the development of advanced and innovative products to cater to untapped opportunities in the field of bionic eyes. Commercial availability of very few products compared to multiple products in the pipeline is threatening the market growth of the existing players. As a result, companies are actively seeking patent protection through intellectual property rights across geographies. Key players contributing to the global Retinal Implant Market include Second Sight Medical Products, Inc., Retina Implant AG, and VisionCare Ophthalmic Technologies, Inc. However, projects such as Boston Retinal Implant Project (BRIP) by Bionic Eye Technologies, Inc. and Visus Technology, Inc. and companies such as Bionic Vision Australia have products in the pipeline.
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