Market Growth and Uptake of EYLEA Drug Industry

Regeneron Pharmaceuticals' EYLEA has dominated the wet age-related macular degeneration (wet AMD) treatment market since its approval in 2011. EYLEA is an injectable vascular endothelial growth factor (VEGF) inhibitor that is administered directly into the eye every 4-8 weeks to help prevent further vision loss from wet AMD. Within a few years of launching, EYLEA captured over 50% of the global wet AMD drug market and has maintained that leading market share position.

EYLEA has experienced rapid uptake and adoption among retina specialists globally due to its efficacy and safety profile demonstrated in clinical trials. Real-world evidence has also shown EYLEA to achieve good outcomes with stable or improved vision for many wet AMD patients when dosed according to the approved treatment regimen. Retina specialists have appreciated EYLEA's ability to provide long-lasting effects with fewer injections needed compared to alternative anti-VEGF drugs like Roche/Novartis' Lucentis.

Revenue Growth Driven By Expansion To More Indications

Regeneron has been able to significantly grow EYLEA Drug revenue over the past decade by gaining approvals for additional ophthalmic indications beyond wet AMD. EYLEA is now also approved for the treatment of diabetic macular edema, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

As EYLEA penetrates these expanded markets, global sales have increased substantially each year. In 2020, EYLEA brought in over $7.1 billion in worldwide revenue for Regeneron, up 12% from the previous year. EYLEA now accounts for the vast majority of Regeneron's total product sales. Revenue is projected to continue growing impressively over the next several years as uptake continues in both wet AMD and newly approved indications.

 Fierce Competition from Biosimilar Entrants

Despite EYLEA's dominance of the ophthalmic disease treatment landscape thus far, the drug is facing a major competitive threat from biosimilar entrants in the next couple years. Drugmakers like Samsung Bioepis, Novartis, and Pfizer all have biosimilar versions of aflibercept in various stages of clinical development and regulatory review.

These biosimilars could gain FDA and EMA approval as early as 2023 based on current timelines. Their market entry would offer retina specialists and healthcare payers significant price discounts compared to the originator EYLEA drug. Regeneron anticipates EYLEA biosimilars capturing up to 30-40% of the total anti-VEGF market within a few years of availability.

Regeneron is Fighting to Protect EYLEA Drug Industry Franchise

To defend its monopoly on the EYLEA franchise, Regeneron has waged an aggressive global legal strategy against biosimilar competitors. The company has sued biosimilar drugmakers claiming patent infringement related to the manufacturing process. Regeneron also lobbied the US Congress to pass legislation extending EYLEA's pharmaceutical data and market exclusivities.

While Regeneron's legal maneuvers aim to delay biosimilar approvals, most experts anticipate biosimilars will ultimately gain approval and market entry. This represents the biggest near-term threat to Regeneron continuing to achieve double-digit revenue growth from EYLEA. The company is pursuing new indications, formulations, and drug-device combination products to bolster future sales once biosimilar competition significantly impacts the market.

Global EYLEA Launch and Adoption Patterns

EYLEA was first approved and launched in key global pharmaceutical markets like the US, Europe, and Japan. These regions represent the largest markets for anti-VEGF drugs used to treat ophthalmic diseases prevalent in aging populations. Unsurprisingly, EYLEA uptake was strongest initially in the US, Europe, and Japan where healthcare reimbursement was favorable.

More recently, Regeneron has aggressively pursued launching EYLEA in emerging pharmaceutical markets across Latin America, Asia, Middle East, and Africa. These less developed markets have been growing rapidly as their populations also age and prevalence of diseases like wet AMD increases. Launching EYLEA in emerging markets earlier allows Regeneron to establish brand recognition with retina specialists before biosimilar competition arises globally.

In Summary, countries where launch and adoption have lagged include China, India, Russia, and Brazil. These large, price-sensitive markets have posed marketing and reimbursement challenges for EYLEA. However, Regeneron is investing heavily to educate physicians on EYLEA's benefits and also pursuing local manufacturing partnerships to potentially offer more affordable EYLEA in the future. Securing broader uptake in emerging markets will be key to sustaining overall revenue growth once biosimilars impact developed markets.

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