Cell and Gene Therapies in Ophthalmology – Disease Overview, Treatment Options and Future Market Assessment

Cell and Gene Therapies in Ophthalmology Market Report Overview

The Cell and Gene Therapies (CGT) in ophthalmology market was $46 million in 2023. The market will experience moderate growth during the forecast period with gene therapies targeting Leber congenital amaurosis (LCA) and retinitis likely to be the primary drivers of the CGT market in the ophthalmology space.

The CGT in ophthalmology market research report will aid clients in gaining insight into the competitive landscape of leading CGT agents in ophthalmology including launch date projections, key clinical trial analysis, analyst consensus forecasts, likelihood of approval analysis, and commentary on current and future players. The report also includes an outlook of pricing and reimbursement assessment. Additionally, the report includes regulations of CGTs in 8MM, FDA guidance, and future market assessment.

Cell and Gene Therapies (CGT) in Ophthalmology Market Dynamics

Various factors could impact the CGT in ophthalmology such as continued improvement of precision medicine, funding for clinical trials, access barriers, and others.

Funding for clinical trials: There is a need to measure the effects of a product more rapidly. KOLs noted that trials currently require many patients, over a relatively large duration to measure an impact on outcome with confidence. Industry trends indicate that there are initiatives poised to meet this need, with an increasing number of companies, especially big pharma companies who are investing in CGTs in ophthalmology.

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Cell and Gene Therapies (CGT) in Ophthalmology – Current Treatment Options

Marketing activity is heavily focused on the US audience, with most approved therapies prioritizing marketing materials for patients/healthcare professionals (HCPs) in this geography. On the other hand, Holostem’s Holoclar, the only therapy that is marketed exclusively in the EU, does not have a marketing strategy.

There is no publicly available ongoing commercial activity for the approved cell therapies Vyznova, Nepic, Ocural, and Sakracy in Japan, and ReliNethra and ReliNethra C in India. Thus, patient assistance programs specifically focusing on treatment journey navigation are offered mainly for Luxturna because the primary focus of commercial activities is due to the complicated route to diagnosis, treatment, and access pathways associated with CGTs.

Cell and Gene Therapies (CGT) in Ophthalmology – Future Market Assessment

• Ophthalmology indications with the highest number of CGTs in the pipeline include a range of high-profile and rare indications. Gene therapies are in development to target rare genetic ophthalmology indications including LCA and juvenile macular degeneration (Stargardt disease).
• Looking at the top five ophthalmology indications with the most CGT pipeline assets, the pipeline is concentrated towards the early stages of drug development, particularly the preclinical stage. AMD has one Phase III product in development, and retinitis has two Phase III products in development.

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Cell and Gene Therapies (CGT) in Ophthalmology – Competitive Landscape

The key players in the CGT in the ophthalmology market are Luxturna (voretigene neparvovec), Holoclar, Vyznova, Nepic, Ocural, and Sakracy among others.

Spark Therapeutics’s Luxturna was the first CGT asset to receive traditional approval in the ophthalmology market in 2017. Moreover, the current marketed landscape for gene therapies only comprises Luxturna, which targets retinitis pigmentosa (retinitis) and LCA, particularly the confirmed biallelic RPE65 mutation-associated retinal dystrophy. This product has been granted orphan drug designation by the FDA and EMA and is of significant benefit to patients.

Key CGT in Ophthalmology Players

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Scope

Overview of cell and gene therapies (CGT) in ophthalmology. The report focuses on the marketed CGT assets addressing ophthalmology indications as well as the top five ophthalmology indications with the most CGT pipeline assets. Clients will gain insight into the competitive landscape of leading CGT agents in ophthalmology including launch date projections, analyst consensus forecasts, likelihood of approval analysis, and commentary on current and future players. The report also includes outlook from three key opinion leaders in the 5EU, and US, and analyses key challenges and opportunities in the application of CGTs in ophthalmology. Additionally, the report includes commentary on the regulatory landscape of CGTs and on the reimbursement environment.

Key Highlights

Report deliverable includes a PowerPoint report.

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

• Develop business strategies by understanding the trends shaping and driving the CGT in ophthalmology market.

• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the opthalmology CGT therapeutics market in the future.

• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

• Identify emerging players with potentially strong product portfolios and create effective counterstrategies to gain a competitive advantage.

• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.