Alarm bells are ringing loud and clear as diabetes has grown to epidemic proportions worldwide, triggering intensive ophthalmic research into vision-compromising comorbidities. The Centers for Disease Control and Prevention predicts that diabetic retinopathy will triple from 5.5 million in 2005 to 16.0 million in 2050. As diabetes is the leading cause of blindness in working age people, improved treatments are urgently needed. The presence of novel biopharmaceuticals as well as advancements in formulation technology has boosted the outlook for the U.S. retinal therapeutics market.
New analysis from Frost & Sullivan’s (pharma.frost.com) U.S. Retinal Therapeutics Market research estimates revenues in the age-related macular degeneration (AMD) segment of the market to reach $2.26 billion by 2016. Revenues in the diabetic macular edema (DME) segment are expected to reach $455.2 million by 2016.
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“While the cannibalization of Roche/Genentech profits (i.e., Avastin and Lucentis) may sound like a market challenge for that company versus a driver for the market, the very availability of these two highly effective, novel medications is expected to continue to drive this previously underserved market,” said a Frost & Sullivan research analyst. “Moreover, the absence of laws and regulations permitting the manufacture of generic equivalents of biologics ensures that these therapies will remain under patent protection until 2019.”
Developing therapies to treat diseases of the back of the eye is complex and, as a result, there is strong market opportunity for wet AMD drugs. The scope for wet AMD drugs such as Lucentis and Avastin is being further expanded by penetration into other back-of-the-eye conditions such as DME and retinal vein occlusion.
Another factor uplifting market prospects is the aging baby boomer population in the United States, which will create a demand upsurge for ophthalmics that improve, restore and preserve sight. Ease of use of therapy is also expected to be of considerable importance among this growing elderly patient base. This has opened up new avenues of opportunity for pharmaceutical and drug delivery companies, enabling a boost in their revenues.
Established treatment alternatives impede the success of new DME therapies. Although Lucentis may achieve its primary endpoint in its trials for DME, it is unlikely to achieve the same level of commercial success it did with wet AMD due to the cost and relative effectiveness of existing treatment options. Lucentis must demonstrate significant clinical efficacy to justify the costly monthly injections required to sustain visual acuity gains in the DME patient population.
Long, drawn out and costly clinical trials will deter new market entrants. In addition, difficulties in finding patients willing to participate in clinical trials and the lack of funds for costly and lengthy trials limit drug companies' abilities to introduce new products into the market. Several pharmaceutical and drug delivery companies are ramping up research efforts to improve the delivery of drugs to the back of the eye.
“Trends indicate that Avastin will remain the most-utilized pharmacologic therapy for the treatment of retinal vascular disease,” said the research analyst. “By 2016, Regeneron is expected to supplant Roche/Genentech as the largest revenue contributor to the market.”
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U.S. Retinal Therapeutics Market / N85D