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市場調查報告書

糖尿病性視網膜病:全球治療藥物預測和市場分析(-2029年)

Diabetic Retinopathy - Global Drug Forecast and Market Analysis to 2029

出版商 GlobalData 商品編碼 956057
出版日期 內容資訊 英文
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糖尿病性視網膜病:全球治療藥物預測和市場分析(-2029年) Diabetic Retinopathy - Global Drug Forecast and Market Analysis to 2029
出版日期: 2020年08月31日內容資訊: 英文
簡介

2019年,糖尿病視網膜病(DR)藥物在九個主要全球市場(美國,法國,德國,意大利,西班牙,英國,日本,中國,澳大利亞)的銷售額將約為36億美元。預計在10年的預測期內市場規模將保持9.1%的複合年增長率,到2029年將達到86億美元。這種增長將受到長效抗血管生成產品,局部和口服候選藥物的推出的推動,這些產品有望解決DR的主要臨床未滿足需求並改善患者依從性。

該報告調查了全球糖尿病視網膜病變(DR)藥物市場,包括DR,RVO(視網膜靜脈阻塞),包括流行病學,病因,病理生理,症狀,診斷和疾病管理。以及DME(糖尿病性乳酸菌)概述,DR,RVO,DME治療的年度市場收入,每位患者的治療費用以及四個患者細分市場(嚴重的非增殖性糖尿病視網膜)的治療模式使用模式提供了疾病,增生性糖尿病視網膜病變,糖尿病性視網膜病變和視網膜靜脈阻塞,糖尿病性視網膜病變和糖尿病性黃體水腫的預測。

目錄

第1章目錄

第2章糖尿病性視網膜病變:執行摘要

  • 在2019年至2029年期間,持續增長將是災難恢復市場規模的兩倍以上
  • 通過臨床試驗研究新的作用機理和非侵入性給藥途徑
  • 缺乏針對早期DR的特殊治療是未滿足的主要需求
  • 減輕頻繁的抗VEGF注射負擔是藥物開發人員的重要任務
  • 血管生成抑製劑的銷售額到2029年將超過60億美元
  • 醫生的看法是什麼?

第3章簡介

  • 催化劑
  • 相關報告
  • 未來相關報告

第4章疾病概述

  • 病因與病理生理
  • 分類或分期系統

第5章流行病學

  • 疾病背景
  • 危險因素和合併症
  • 世界趨勢和歷史趨勢
  • 預測調查方法
  • 糖尿病視網膜病變的流行病學預測
  • 討論

第6章疾病管理

  • 診斷概述
  • 治療大綱
  • DR,RVO和DME的藥物治療干預措施
  • 糖尿病視網膜病變的非藥物治療選擇
  • 美國
  • 歐盟5個國家
  • 亞太地區

第7章競爭力評估

第8章未滿足的需求和機會的評估

第9章管道評估

第10章,當前和將來的公司

第11章市場前景

第12章附錄

目錄
Product Code: GDHC199PIDR

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.

Key Highlights

  • The DR market is expected to grow at a CAGR of 9.1% from 2019 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?

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.

Table of Contents

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 GlobalData 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