Diabetic Macular Edema Market Trends

Market Driver - Growing Prevalence of Diabetes and Diabetic Retinopathy Drives the Need for Novel Treatment.

As the prevalence of diabetes continues to grow unabated across the world, so too does the burden of diabetic retinopathy. According to estimates from the International Diabetes Federation, approximately 463 million adults were living with diabetes in 2019 worldwide, and this number is expected to rise to over 700 million by 2045. The alarming increase in the diabetes population is the growing epidemic of obesity and physical inactivity are significant risk factors for the development of type 2 diabetes. Unfortunately, diabetic retinopathy often manifests as a complication of poorly controlled diabetes, with nearly all patients with type 1 diabetes and over 60% of those with type 2 diabetes expected to develop some form of the eye disease over their lifetime.

Diabetic retinopathy occurs when high blood glucose levels damage the tiny blood vessels inside the light-sensitive tissue (retina) at the back of the eye over a period of time. The disease can progress from mild non-proliferative retinopathy involving only microaneurysms and hemorrhages to more advanced proliferative stages marked by the growth of new abnormal blood vessels which can rapidly lead to severe vision loss or blindness if left untreated. It is estimated that approximately one-third of diabetics already have some form of retinopathy at the time of diagnosis of their diabetes. Furthermore, the risk and severity of retinopathy is directly linked to how long a person has had diabetes and the levels of control over their blood glucose, blood pressure, and cholesterol.

As such, the rising tide of diabetes ensures a steady population susceptible to developing diabetic eye diseases such as diabetic macular edema (DME). DME occurs when the retinal blood vessels leak fluid and lipids into the macula - the sensitive central area of the light-sensitive tissue at the back of the eye responsible for sharp, straight-ahead vision. This swelling can distort vision and eventually cause blindness if not urgently treated. Given the overwhelming evidence that diabetic retinopathy and DME risk increases progressively with duration of poorly controlled diabetes, the continued growth in the global diabetes epidemic presents an alarming driver that can fuel the expansion of the diabetic macular edema therapeutics market in the years to come.

Market Driver- Advancements in anti-VEGF Therapies and Novel Treatment Approaches.

Significant progress has been made in recent decades towards developing more effective treatment options for diabetic macular edema. Currently, the standard of care involves the use of intraocular injections of anti-VEGF drugs that inhibit vascular endothelial growth factor - a protein that promotes endothelial cell proliferation and vascular permeability. By blocking VEGF, anti-VEGF therapies help reduce fluid leakage and lessen edema in DME patients. Notably, drugs such as ranibizumab and aflibercept have revolutionized DME treatment since their approval, providing marked vision improvements for many patients.

However, anti-VEGF therapies still have limitations such as the need for frequent eye injections and incomplete response in some individuals. This has intensified research efforts into alternate pharmacological approaches and novel drug delivery technologies. Some promising new strategies under investigation include sustained-release drug delivery systems aimed at extending dosing intervals, corticosteroid therapies targeting different pathways, and molecularly targeted therapies designed to block key mediators of vascular permeability besides VEGF. In the pipeline are also gene therapies employing gene silencing techniques, as well as stem cell therapies employing differentiated retinal pigment epithelial cells.

Forward-thinking pharmaceutical companies have rapidly advanced multiple candidates through clinical trials in pursuit of safer, simpler, and more effective DME therapies. This robust R&D activity reflects the urgent clinical needs as well as commercial opportunities in the expanding DME market. Successful approvals of superior therapies with enhanced safety, efficacy and convenience profiles have the potential to readily displace older anti-VEGF drugs and even expand the addressable patient population.

Market Challenge - High Costs of Advanced Therapies Limits the Market Growth.

One of the major challenges faced in the diabetic macular edema market is the high costs of advanced therapy options. Newer treatment options like intravitreal injections of anti-VEGF drugs have significantly improved visual outcomes for patients compared to older laser photocoagulation therapies. However, these biologic drugs that block vascular endothelial growth factor are also very expensive, with average annual treatment costs estimated to be over USD10,000 per patient. The high drug costs and need for frequent office visits place a heavy financial burden both on patients as well as third-party payers. While these advanced therapies may seem cost-effective from a health outcomes perspective, their pricing remains a barrier for broader adoption and access. Unless alternatives are developed that deliver comparable efficacy but at lower price points, a sizeable portion of those affected by diabetic macular edema may not be able to access or afford regular treatment.

Market Opportunity: Development of long-term therapies like KSI-301.

One promising area of opportunity in the diabetic macular edema market is the development of novel long-acting therapies that can potentially reduce treatment burden. KSI-301, an investigational drug being developed by Kodiak Sciences, represents a potential breakthrough in this regard. If approved, KSI-301 will offer the first long-duration treatment option, with the ability to remain active in the eye for multiple months with just one or two annual injections. This has the potential to significantly improve patient compliance and experience by reducing the need for frequent office visits that currently plague anti-VEGF drugs. From the perspective of the healthcare system and payers as well, long-acting therapies like KSI-301 that allow fewer number of administrations can lower overall costs of care. Their pricing is also expected to be more affordable in comparison to existing drugs. With a favorable safety profile demonstrated so far in clinical trials, KSI-301 has the capability to transform treatment landscape for diabetic macular edema worldwide.