Retinal gene therapy is performed for inherited retinal diseases. Gene therapy can improve the vision impairment caused by mutation in RPE65 gene. The recently launched retinal gene therapy, Luxturna, is being used for patient with Leber congenital amaurosis type 2, it is a form of inherited disease which causes impaired vision at birth leading to a more progressive degeneration. There are many retinal gene therapy clinical trials present at the moment using recombinant viruses.
Retinal Gene Therapy Market: Drivers and Restraints
Retinal gene therapy is projected to grow at an enormous rate. Retina is a desirable target for gene therapy, it is growing because of it being an irreplaceable part of human body. Retinal gene therapy market is expected to experience new entrants, with promising candidates in clinical phases of drug approval.
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The market is expanding exponentially over the last year, with many drugs in ongoing clinical trials. Currently, retinal gene therapy market have only one FDA approved product, Luxturna from Spark Therapeutics. The product received FDA approval in year 2017, starting an era of possible retinal gene therapy. Recently it was announced that Roche is interested in purchasing the company for approximately US$ 4.8 Bn, the interests from leading pharmaceutical manufacturers highlight the potential within this retinal gene therapy market.
The market is influenced with a high prevalence of Stargardt disease, a common type of inherited retinal dystrophies, prevalence of around 1 in 12,000. Accurate and early diagnosis can lead to a better market structure, with patients willing to enroll in the clinical trials process. More number of approved products can lead to a more convenient reach for patients. The availability of the approved therapy is also minimal in emerging economies, if available, emerging countries can be the most attractive segments in terms of value addition. Qualified surgeons and standard infrastructure is required for retinal gene therapy procedures, it involves a surgical and delivery plan with great precision. Socio-economic condition can lead to the late entry of such modality in emerging countries. But, if treatment is present for a previously stated incurable disorder, it should reach out to as many as possible. Cost associated with the retinal gene therapy is considerably high as observed in other gene therapy procedures. The cost of retinal gene therapy is estimated to be around US$ 450,000 to US$ 850,000 in the US
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Retinal Gene Therapy Market: Overview
The global market for retinal gene therapy would expand with the emergence of new manufacturers and better technological advances. Retinal gene therapy is favored to become the standard treatment, given the advantages with eye it has been at the forefront of translation research of gene therapy. The research initiatives for retinal gene therapy date back to the mid-1990s. The success of the very first retinal gene therapy will be replicated by other entrants, it just require a planned clinical trial platform for human testing to observe the level of expression achieved.
Retinal Gene Therapy Market: Regional Wise Outlook
Geographically, the retinal gene therapy market is segmented into seven regions viz. South Asia, East Asia, North America, Latin America, Oceania, Europe, and Middle East and Africa. The North America retinal gene therapy market is the leader in the concerned global retinal gene therapy market. The only product approved is from a US based manufacturer, which reflects to the current market share for North America. The retinal gene therapy is also available in Europe from Spark Therapeutics. The deal is such that Novartis has exclusive rights to commercialize and distribute “Luxturna” in Europe and in all other countries outside the US, when regularized for use. So, clearly the current market for retinal gene therapy is consolidated in these two region.
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The only player involved in this market of retinal gene therapy is Spark Therapeutics, Inc. The present market structure of retinal gene therapy is expected to change with efforts and research present in clinical phase.