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Diabetic retinopathy (DR) is a sight-threatening, prevalent complication of type 1 and 2 diabetes which is characterized by damage to the small blood vessels in the retina. As the most common microvascular complication of diabetes, more than 60% of patients will experience DR within 20 years of developing diabetes. DR the principal cause of preventable vision loss in working-age adults around the world. There are two major clinical stages of diabetic retinopathy: a less severe subtype known as non-proliferative diabetic retinopathy (NPDR), and a vision-threatening subtype known as proliferative diabetic retinopathy (PDR). Signs of mild, moderate, and severe NPDR include microaneurysms, swollen blood vessels, retinal hemorrhages, vascular occlusion, and the accumulation of hard exudates in the choroid layer.
PDR is characterized by the growth of abnormal, new, fragile blood vessels in the retina. These vessels can leak, causing sudden and severe vision loss. Furthermore, abnormal new blood vessels formed in PDR can press on retinal veins, blocking blood flow, causing a condition known as retinal vein occlusion (RVO). Diabetic macular edema (DME) is a potential complication of DR that involves the macula, which is the small, oval-shaped part of the retina that is responsible for high acuity vision. DME is a condition where fluid accumulates within the macular area, causing swelling and retinal thickening. This can lead to sudden vision loss, resulting from the deterioration of the blood-retinal barrier.
Currently, only severe forms of diabetic retinopathy such as PDR and severe NPDR are managed with pharmacotherapy. The standard of care for DME and RVO are anti-angiogenic agents which inhibit vascular endothelial growth factor (VEGF). The most frequently used anti-VEGF drugs are Roche/Genentech’s humanized antibodies Lucentis (ranibizumab) and Avastin (bevacizumab), and Bayer/Regeneron’s fusion protein Eylea (aflibercept). Angiotensin converting enzyme (ACE) inhibitors can be used to treat patients with comorbid hypertension and diabetic retinopathy, while corticosteroids Alimera’s Iluvien (fluocinolone acetonide), Allergan’s Ozurdex (dexamethasone), and MaQaid (triamcinolone acetonide) can be used to treat people with RVO.
There are nine pharmaceutical markets covered in this report and forecast model (US, France, Germany, Italy, Spain, UK, Japan, China, and Australia). GlobalData estimates that drug sales for DR in 2019 were approximately $3.6B across the nine major markets. Over the 10-year forecast period, the market is expected to grow to $8.6B at a CAGR of 9.1%. This growth will be driven by the launch of longer-acting anti-angiogenic products, topical, and oral drug candidates, which are expected to increase patient compliance, addressing some of the key clinical unmet needs for this indication.
- The DR market is expected to grow at a CAGR of 9.1% from 2029 to 2029, reaching a global value of $8.6B.
- GlobalData projects that the marketed for DR, DME, and RVO will experience growth driven by the launch of long-acting anti-angiogenic products, topical, and oral drug candidates.
- Drug developers are also focusing on producing non-steroidal ocular implants and oral DME products that increase patients’ compliance. These products will reduce the need for patients to attend frequent hospital appointments in order to receive treatment.
- Despite the clear signs of innovation in the DR pipeline, growth will be limited by the loss of market exclusivity for the major brands of anti-VEGFs: Lucentis, Eylea, and Avastin. The emergence of biosimilars will also negatively impact sales by taking critical patient share away from branded products over the forecast window.
- DME is the most sight-threatening complication of DR and this indication is the focus of most drug developers in this therapy area.
- The top selling drug for non-proliferative diabetic retinopathy in 2029 will be Boehringer Ingelheim’s BI-1467335 because the oral therapy is expected to be well received by patients who will appreciate the convenience of being table to self-administer the drug. Furthermore, BI-1467335 is expected to launch in the US, 5EU, Japan, and Australia by the end of the forecast window.
- The top selling drug for proliferative diabetic retinopathy in 2029 will be Novartis’ brolucizumab because of its established efficacy profile and lower frequency of administration, compared to Roche’s Lucentis (ranibizumab) and Bayer/Regeneron’s Eylea (aflibercept).
- As well as Novartis’ brolucizumab, other drugs that are specifically in development for retinal vein occlusion are Graybug Vision’s sunitinib malate CR, Addmedica’s hydroxyurea, and Chengdu Kanghong’s conbercept.
- Brolucizumab is expected to be the top selling drug in this cohort with conbercept taking the second position with estimated sales of $295.2M in 2029. Both brolucizumab and conbercept are marketed for age-related macular degeneration, have well understood safety and efficacy profiles, and are injected less frequently than Lucentis, Eylea, and Avastin.
- Products focusing on inhibiting neovascularization will generate $6.8B in sales in 2029, followed by anti-neoplastic agents and erythropoietin modulators generating $431.6M and $421.7M in the final year of the forecast window, respectively.
- Some unmet needs such as the need for a more manageable frequency of administration for intravitreal agents will be better addressed in markets such as the US and 5EU, where drugs such as Adverum
- Biotechnologies’ gene therapy ADVM-022 and Novartis’ LKA-651 will launch.
- The presence of first-in-class products in the pipeline is evidence of breakthroughs in research allowing more diverse therapeutic targets to be identified and explored in R&D strategies.
Key Questions Answered
- What were the key DR treatments in 2019?
- When will the late stage pipeline products launch in each of the 9MM?
- What are the major clinical and environmental unmet needs in the DR market?
- What are the key opportunities for pharmaceutical companies developing drug candidates for DR, RVO, and DME?
- Overview of DR, RVO, and DME including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized DR, RVO, and DME therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments (severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, diabetic retinopathy and retinal vein occlusion, and diabetic retinopathy and diabetic macular edema) forecast from 2019 to 2029.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the DR, RVO, and DME markets.
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for DR, RVO, and DME therapy. The most promising candidates in Phase II and Phase III stages of development are profiled.
- Analysis of the current and future market competition in the global DR, RVO, and DME therapeutics market. Insightful review of the key market drivers, opportunities, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons To Buy
The report will enable you to -
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- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies 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.