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Diabetic Retinopathy - Global Drug Forecast and Market Analysis to 2029

  • ID: 5142167
  • Report
  • August 2020
  • Region: Global
  • 260 Pages
  • GlobalData

FEATURED COMPANIES

  • 3SBio
  • Alphapharm
  • Chugai
  • Hanmi Pharmaceuticals
  • Novartis
  • Quark Pharma
  • MORE
1h Free Analyst Time

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Summary

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). The publisher 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.

Key Highlights
  • The DR market is expected to grow at a CAGR of 9.1% from 2029 to 2029, reaching a global value of $8.6B.
  • The publisher 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?
Scope
  • 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 -
  • 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 global DR therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global DR therapeutics market in the future.
  • 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.
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • 3SBio
  • Alphapharm
  • Chugai
  • Hanmi Pharmaceuticals
  • Novartis
  • Quark Pharma
  • MORE
1 Table of Contents

2 Diabetic Retinopathy: Executive Summary
2.1 Consistent Growth Will See the DR Market More than Double in Size from 2019-2029
2.2 Novel Mechanisms of Action and Non-Invasive Routes of Administration Are Being Investigated in Clinical Trials
2.3 Lack of Specific Therapies for Early-Stage DR is a Significant Unmet Need
2.4 Reducing the Burden of Frequent Anti-VEGF Injections Is a Key Priority for Drug Developers
2.5 Sales of Neovascularization Inhibitors Will Exceed $6B in 2029
2.6 What Do Physicians Think?

3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports

4 Disease Overview
4.1 Etiology and Pathophysiology
4.2 Classification or Staging Systems

5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.5 Epidemiological Forecast for Diabetic Retinopathy (2019-2029)
5.6 Discussion

6 Disease Management
6.1 Diagnosis Overview
6.2 Treatment Overview
6.3 Pharmacotherapeutic Interventions for DR, RVO, and DME
6.4 Non-Pharmacotherapeutic Treatment Options for Diabetic Retinopathy
6.5 US
6.6 5EU
6.7 Asia-Pacific

7 Competitive Assessment

8 Unmet Needs and Opportunity Assessment

9 Pipeline Assessment

10 Current and Future Players

11 Market Outlook

12 Appendix

List of Tables
Table 1: Diabetic Retinopathy: Key Metrics in the 9MM
Table 2: Stages of DR
Table 3: Risk Factors and Comorbidities for Diabetic Retinopathy
Table 4: National and International Treatment Guidelines for DR
Table 5: DR Disease Management - US
Table 6: DR Disease Management - 5EU
Table 7: DR Disease Management - Asia-Pacific:
Table 8: Marketed Drugs for DR in the 9MM, 2020
Table 9: Comparison of Therapeutic Classes in the DR, RVO, and DME Pipelines, 2019-2029
Table 10: Phase I Pipeline Products in Development for DR, RVO, and DME
Table 11: Roche/Genentech/Chugai’s DR Portfolio Assessment, 2020
Table 12: Bayer’s DR Portfolio Assessment, 2020
Table 13: Regeneron’s DR Portfolio Assessment, 2020
Table 14: Alimera’s DR Portfolio Assessment, 2020
Table 15: Allergan’s DR Portfolio Assessment, 2020
Table 16: Novartis’ DR Portfolio Assessment, 2020
Table 17: Allegro’s DR Portfolio Assessment, 2020
Table 18: Gene Signal International’s DR Portfolio Assessment, 2020
Table 19: Boehringer Ingelheim’s DR Portfolio Assessment, 2020
Table 20: Oculis’ DR Portfolio Assessment, 2020
Table 21: Araim Pharma’s DR Portfolio Assessment, 2020
Table 22: Opthea’s DR Portfolio Assessment, 2020
Table 23: Pfizer’s DR Portfolio Assessment, 2020
Table 24: Clearside BioMedical’s DR Portfolio Assessment, 2020
Table 25: EyeGene’s DR Portfolio Assessment, 2020
Table 26: Kubota Vision’s DR Portfolio Assessment, 2020
Table 27: Oxurion’s Vision’s DR Portfolio Assessment, 2020
Table 28: Outlook Therapeutics’ DR Portfolio Assessment, 2020
Table 29: Kodiak Sciences’ DR Portfolio Assessment, 2020
Table 30: DR Market - Global Drivers and Barriers, 2019-2029
Table 31: Key Events Impacting Sales for DR in the US, 2019-2029
Table 32: DR Market - Drivers and Barriers in the US, 2019-2029
Table 33: Key Events Impacting Sales for DR in the 5EU, 2019-2029
Table 34: DR Market - Drivers and Barriers in the 5EU, 2019-2029
Table 35: Key Events Impacting Sales for DR in Japan, 2019-2029
Table 36: DR Market - Global Drivers and Barriers in Japan, 2019-2029
Table 37: Key Events Impacting Sales for DR in China, 2019-2029
Table 38: DR Market - Global Drivers and Barriers in China, 2019-2029
Table 39: Key Events Impacting Sales for DR in Australia, 2019-2029
Table 40: DR Market - Global Drivers and Barriers in Australia, 2019-2029

List of Figures
Figure 1: Global Sales Forecast by Country for DR in 2019 and 2029
Figure 2: Analysis of the Company Portfolio Gap in DR During the Forecast Period
Figure 3: Competitive Assessment of the Ten Top-Selling Late-Stage Pipeline Agents for the Treatment of DR, RVO, and DME During the Forecast Period
Figure 4: Pathogenic Processes in DR, RVO and DME
Figure 5: 9MM, Diagnosed Prevalence of Diabetic Retinopathy Among the Diagnosed Diabetics Population, Both Sexes, %, Ages ≥20 Years, 2019
Figure 6: 9MM, Diagnosed Prevalence of RVO in the General Population, Both Sexes, %, Ages ≥20 Years, 2019
Figure 7: 9MM, Sources Used and Not Used, Diagnosed Prevalent Cases of Diabetic Retinopathy
Figure 8: 9MM, Sources Used and Not Used, Diagnosed Prevalent Cases of RVO
Figure 9: 9MM, Sources Used and Not Used, Diagnosed Prevalent Cases of Diabetic Retinopathy by Severity
Figure 10: 9MM, Sources Used and Not Used, Diagnosed Prevalent Cases of Diabetic Macular Edema
Figure 11: 9MM, Sources Used, Diagnosed Prevalent Cases of Macular Edema Following BRVO
Figure 12: 9MM, Sources Used, Diagnosed Prevalent Cases of Macular Edema Following CRVO
Figure 13: 9MM, Sources Used, Diagnosed Prevalent Cases of CSME
Figure 14: 9MM, Diagnosed Prevalent Cases of Diabetic Retinopathy, N, Both Sexes, Ages ≥20 Years, 2019
Figure 15: 9MM, Age-Specific Diagnosed Prevalent Cases of Diabetic Retinopathy, N, Both Sexes, 2019
Figure 16: 9MM, Diagnosed Prevalent Cases of Diabetic Retinopathy by Sex, N, Ages ≥20 Years, 2019
Figure 17: 9MM, Diagnosed Prevalent Cases of Diabetic Retinopathy by Severity, N, Ages ≥20 Years, 2019
Figure 18: 9MM, Diagnosed Prevalent Cases of RVO, Both Sexes, N, Ages ≥20 Years, 2019
Figure 19: 9MM, Diagnosed Prevalent Cases of RVO by Age, N, Both Sexes, 2019
Figure 20: 9MM, Diagnosed Prevalent Cases of RVO by Sex, N, Ages ≥20 Years, 2019
Figure 21: 9MM, Diagnosed Prevalent Cases of DME in the Diabetic Retinopathy Population, N, Ages ≥20 Years, Both Sexes, 2019
Figure 22: 9MM, Diagnosed Prevalent Cases of Macular Edema Following BRVO, Both Sexes, N, Ages ≥20 Years, 2019
Figure 23: 9MM, Diagnosed Prevalent Cases of Macular Edema Following CRVO, Both Sexes, N, Ages ≥20 Years, 2019
Figure 24: 9MM, Diagnosed Prevalent Cases of CSME in the DME Population, N, Both Sexes, Ages ≥20 Years, 2019
Figure 25: Unmet Needs and Opportunities in DR
Figure 26: ETDRS Chart Used to Measure Visual Acuity
Figure 27: Overview of the Development Pipeline in DR
Figure 28: Ongoing Phase II/III Trials for Anti-VEGF Pipeline Agents in Development for DR in the 9MM
Figure 29: Ongoing Trials for Pipeline Agents in Development for DR in the 9MM
Figure 30: Competitive Assessment of the Therapeutic Classes in the Late-Stage pipeline that the Publisher Expects to be Licensed for the Treatment of DR During the Forecast Period
Figure 31: Company Portfolio Gap Analysis in DR, 2019-2029
Figure 32: Values of Co-development Deals in the 9MM, 2010-Q2 2020
Figure 33: Global (9MM) Sales Forecast by Country for DR in 2019 and 2029
Figure 34: Sales Forecast by Therapeutic Class for DR in the 9MM, 2019 and 2029
Figure 35: DR Sales Forecast in the 9MM by Drug, 2019 and 2029
Figure 36: Sales Forecast by Drug for DR in the US in 2019 and 2029
Figure 37: Sales Forecast by Drug for DR in the 5EU in 2019 and 2029
Figure 38: Sales Forecast by Drug for DR in Japan in 2019 and 2029
Figure 39: Sales Forecast by Drug for DR in China in 2019 and 2029
Figure 40: Sales Forecast by Drug for DR in Australia in 2019 and 2029
Note: Product cover images may vary from those shown
  • Roche
  • Novartis
  • Genentech
  • Addmedica
  • Chengdu Kanghong Pharma
  • Kowa
  • Wakamoto
  • CSL Behring
  • AstraZeneca
  • Adverum Biotechnologies
  • Bayer
  • Regeneron
  • Allergan
  • Alimera
  • BMS
  • Merck
  • Pfizer
  • Sanofi
  • Addmedica
  • Gene Signal International
  • YD Life Science
  • Boehringer Ingelheim
  • Xbrane Biopharma
  • Oculis
  • Clearside BioMedical
  • Araim Pharmaceuticals
  • Chugai
  • Aerie Pharma
  • Allegro Ophthalmics
  • Hanmi Pharmaceuticals
  • Opthea
  • Kuur Therapeutcs
  • SciFluor Life Sciences
  • Graybug Vision
  • Kalvista Pharmaceuticals
  • Adverum Biotechnologies
  • Ocuphire Pharma
  • Ampio Pharmaceuticals
  • EyeGene
  • Kubota Vision
  • AbbVie
  • Mylan
  • Esteve
  • Alphapharm
  • Arrow Pharma
  • Horus Pharma
  • Daaichi Sankyo
  • Brill Pharma
  • Santen
  • Silence Therapeutics
  • Quark Pharma
  • Molecular Partners
  • Oxurion
  • OcuNexus Therapeutics
  • OccuRx
  • Generium
  • Kato Pharmaceuticals
  • Reven Pharmaceuticals
  • Senju Pharmaceutical
  • Kodiak Sciences
  • Qilu Pharmaceutical
  • Aciont
  • Glycadia
  • 3SBio
  • Panoptes Pharma
  • RemeGen
  • Ocular Therapeutix
  • Bio-Thera Solutions
  • Targeted Therapy Technologies
Note: Product cover images may vary from those shown
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