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Diabetic Macular Edema (DME)- Market Insight, Epidemiology and Market Forecast -2030

Diabetic Macular Edema (DME)- Market Insight, Epidemiology and Market Forecast -2030

  • May 2021
  • 250 pages
  • ID: 6071720
  • Format: PDF
  • Delve Insight


Table of Contents

‘Diabetic macular edema (DME)- Market Insights, Epidemiology, and Market Forecast—2030’ report delivers an in-depth understanding of the DME , historical and forecasted epidemiology as well as the DME market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.
The DME market report provides current treatment practices, emerging drugs, DME market share of the individual therapies, current and forecasted DME market size from 2018 to 2030 segmented by seven major markets. The Report also covers current DME treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

DME Disease Understanding and Treatment Algorithm

DME Overview
DME is triggered by diabetic retinopathy (DR), a well-known complication of diabetes. DR is the most prevalent diabetic eye disease and the leading cause of irreversible blindness in people in their working years in the developed and other developing countries. DR is caused by long-term damage to the retina’s small blood vessels. The leakage of fluid into the retina may lead to swelling of the surrounding tissue, including the macula. If left untreated, fluid can leak into the macula’s center, called the fovea, the part of the eye where sharp, straight-ahead vision occurs. The fluid makes the macula swell, blurring vision. This condition is called DME. The definition of clinically significant macular edema (CSME) is the most significant outcome of the Early Treatment Diabetic Retinopathy Study (ETDRS); it established a method for classifying and diagnosing DME and determining when treatment is required. Previously, DME was defined as CSME or not, and focal laser treatment was initiated only for CSME. Then, DME was subcategorized into two main categories: focal diabetic macular edema (fDME) and diffuse diabetic macular edema (dDME).
DME Diagnosis
For the diagnosis of CSME, one of the following characteristics must be present on clinical examination: Any retinal thickening within 500 ?m of the center of the macula. Hard exudates within 500 ?m of the center of the macula with adjacent retinal thickening. Retinal thickening at least 1 disc area in size, any part of which is within 1 disc diameter of the macula’s center. DME diagnosis is clinically performed by fundoscopy; when the center of the macula (fovea centralis) is thickened or swollen, this is referred to as a clinically significant central-involved macular edema (CI-CSME). It is referred to as a clinically significant non-central-involved macular edema (NCI-CSME) when it is unaffected. Apart from this, tests that help in the diagnosis of DME are visual acuity, refractive error examination, fluorescein angiography (FA), optical coherence tomography (OCT) scan, pupil examination, slit-lamp examination, and retinal examination. However, if the diagnosis is delayed or the condition is left untreated, complications can arise and may even permanently impair the vision.

DME Treatment
Treatment for DME mainly involves the usage of anti-VEGF Drugs, corticosteroids, and Laser photocoagulation. The current standard of care for DME is intravitreal injection. Nonsteroidal anti-inflammatory drugs (NSAIDs), in the form of eye drops, are sometimes used either before or after cataract surgery to prevent the development of macular edema. Currently, intravitreal anti-VEGF agents are the preferred first-line treatment for DME. The three most used anti-VEGF drugs are Avastin (off-label), Eylea, and Lucentis. Corticosteroids are mostly a second-line treatment option. These anti-inflammatory drugs are usually administered via eye drops, pills, or injections of sustained-release corticosteroids into or around the eye. The US FDA approved sustained-release corticosteroid implants for more serious or longer-lasting conditions are Ozurdex, and Iluvien.

DME Epidemiology

Key Findings
In 2020, the overall prevalent cases of DME accessed to be around 1,862,529 in the 7MM, which are expected to grow during the forecast period, i.e., 2021–2030.
The disease epidemiology covered in the report provides historical as well as forecasted DME epidemiology [segmented as Total Prevalent Cases of DME, Total Diagnosed Prevalent cases of DME, Gender-specific Diagnosed Prevalent Cases of DME, Age-specific Diagnosed Prevalent Cases of DME, Subgroups-Specific Diagnosed Prevalent Cases of DME and Treated cases of DME] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2021 to 2030.

Country Wise- DME Epidemiology
• In the United States, the total number of prevalent cases of DME were 1,026,346 in 2020 which are expected to increase during the forecast period, i.e., 2021–2030.
• In 2020, the total prevalent cases of DME were 641,864 in EU-5, which are projected to increased during the forecast period, i.e., 2021–2030.
• In Japan, the total number of prevalent cases of DME were 194,319 in 2020 which are expected to grow during the forecast period, i.e., 2021–2030.
• Findings from various secondary studies suggest that DME affects more males as compared to females, and is more prevalent in elderly population. In the 7MM, the gender-specific diagnosed cases of DME were 486,120 for males and 352,018 for females, in 2020. In the 7MM, the age-specific diagnosed prevalent cases of DME were 120,436, 363,767 and 353,935 for the age-groups 18-44, 45-64 and ?75 year, in 2020
• In 2020, 193,979 non-central involved cases of DME and 267,876 central-involved DME cases were observed in the United States

DME Drug Chapters
Drug chapter segment of the DME report encloses the detailed analysis of DME developmental stage pipeline drugs. It also helps to understand the DME clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
DME Marketed Therapies
Lucentis (Ranibizumab): Genentech/Novartis
Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with DME. It binds to the receptor-binding site of active VEGF-A forms, including the biologically active, cleaved form of this molecule, VEGF110. In January 2011, the European Medicines Agency (EMA) approved Lucentis in patients with visual impairment due to DME. Whereas, in August 2012, Lucentis (ranibizumab injection) was approved by the US FDA for treatment of DME. Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the US, and Novartis has exclusive commercial rights for the rest of the world. Outside the US, Lucentis is approved in more than 110 countries to treat patients with DME.
Eylea (Aflibercept): Bayer/Regeneron Pharmaceuticals/Santen
Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. In July 2014, the US FDA approved Eylea (aflibercept) injection for the treatment of DME. Later on, in the same year Eylea received approval from European Commission followed by Japan’s Ministry of Health, Labour and Welfare (MHLW) to treat DME patients. Eylea solution for injection into the eye has been approved in approximately 100 countries (ex-US) for five different indications for adults. It was co-developed and co-marketed as Eylea by Regeneron and Bayer (also marketed by Santen in Japan).
Note: Full and detailed list of emerging therapies will be provided in the final report.

DME Emerging Drugs
Faricimab (RG 7716): Roche
Faricimab, also known as RG 7716, is the first investigational bispecific antibody designed for the eye with CrossMab technology. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive several retinal conditions. Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation. By simultaneously blocking both pathways involving Ang-2 and VEGF-A, faricimab is designed to stabilize blood vessels, potentially improving vision outcomes for longer for people living with retinal conditions. Three distinct Phase III trials, NCT04432831, NCT03622593, and NCT03622580, are currently ongoing for DME and are anticipated to be completed by 2023, 2023 and 2021, respectively.

Beovu (RTH258; brolucizumab): Novartis
Beovu, formerly known as RTH258, is one of the lead product of Novartis. The drug is the most clinically advanced, humanized single-chain antibody fragment (scFv) in development explicitly designed for the eye. Single-chain antibody fragments are highly sought after in drug development due to properties like small size, enhanced tissue penetration, rapid clearance from systemic circulation, and drug delivery characteristics. In preclinical studies, brolucizumab inhibited activation of VEGF receptors through the prevention of the ligand-receptor interaction.
ADVM-022: Adverum Biotechnologies
ADVM-0022 is an investigational gene therapy being developed by Adverum for the treatment of wet-AMD and DME. It utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. ADVM-022 is administered as a one-time intravitreal injection (IVT), designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance and improve vision outcomes for patients with wet AMD and DME. Adverum is currently evaluating ADVM-022 in the INFINITY Phase II (NCT04418427) trial in patients with DME. This ongoing trial is a multicenter, randomized, double-masked, active comparator-controlled trial designed to assess a single IVT injection of ADVM-022 in patients with DME. The company is looking forward to sharing the data from this trial in the second half of 2021.
THR-149: Oxurion
THR-149, is a plasma kallikrein (PKal) inhibitor for the treatment of DME. Its mechanism of action includes the inhibition of the plasma kallikrein-kinin (PKaI-kinin) system through which THR-149 prevents the induction of retinal vascular permeability, inflammation, and angiogenesis. It has been shown that DME patients have raised levels of PKal and that the vitreous level of PKal varies less compared to VEGF, making it a potentially more effective target for treating DME. Currently, this drug is in Phase II (KALAHARI: NCT04527107) clinical study which is a randomized, prospective, multicenter study assessing multiple (3) injections of THR-149 in two parts (part A and part B). The company expected the Part A data by mid-2021 and topline results from Part B are expected in the first half of 2023.
LKA651: Novartis
LKA651, an investigational drug also known as NOV-9, is an erythropoietin inhibitor being developed by Novartis to treat patients with DME. The company is currently conducting Phase II (NCT03927690) randomized, active-controlled, patient and investigator-masked, multiple-dose, proof-of-concept study of intravitreal LKA651 in patients with DME. This study, which estimates to involve 90 patients, is expected to be completed by November 2021.
Note: Full and detailed list of emerging therapies will be provided in the final report.

DME Market Outlook

Key Findings
The DME market size in the 7MM is expected to change during the study period 2018–2030, at a CAGR of 3.2%. In 2020, according to The’s estimates, the highest market size of DME is accessed in the United States followed by Germany, and Japan.

The United States Market Outlook
In United States, the total market size of DME therapies is expected to increase at a CAGR of 5.5% during the study period (2018–2030).

DME Pipeline Development Activities
The drugs which are in pipeline include:
1. ADVM-022: Adverum Biotechnologies
2. GB-102: Graybug Vision
3. Faricimab (RG 7716): Roche
4. Beovu (RTH258; brolucizumab): Novartis
5. KVD001: KalVista Pharmaceuticals
6. APX3330: Ocuphire Pharma
7. THR-149: Oxurion
8. YD-312: YD Life Science
9. LKA651: Novartis
10. Abicipar: Allergan (AbbVie)/Molecular Partners
11. Luminate (ALG-1001, Risuteganib): Allergo Opthalmics/ Bausch Health
12. KSI-301: Kodiak Sciences
13. Xipere (CLS-TA): Clearside Biomedical
Note: Detailed emerging therapies assessment will be provided in the final report.

DME Drugs Uptake
Analysts Insight
At present, market is currently dominated by anti-VEGFs. Secondary findings suggest that about half of the US ophthalmologists still prescribe off-label bevacizumab as first-line DME therapy. The pharmaceutical competitive landscape of DME is quite robust as several companies are involved in the development of emerging novel thrapies. Upcoming drug therapies are based on unique mechanisms which targets distinct pathways. In addition, the patent expiration of both the marketed anti-VEGF drugs in coming years will open huge window of opportunities for the drugs in pipeline. It is projected that the future of DME care is going to trend toward prolonged ocular half-life therapies with less average injections per year, as well as more innovative approaches which possess better safety and efficacy profile. If such therapies at decent price are eventually successfully commercialized, will change the current standard of care for DME patients.
Access and Reimbursement Scenario in DME Therapies
Anti-VEGFs (Eylea and Luentis) are the first line defense treatment for DME but due to their high cost, off label drugs like Avastin (bevacizumab) comes into the picture. Avastin is not approved for DME but it has proved to be beneficial and effective for a large patient population. In order to make Eylea and Luentis more accessible to patients and reimbursing them for financial assistance, there are certain Patient assistance programs (PAPs) which are of great use for the patients. Both the approved anti-VEGFs have specific Co-pay Programs. Apart from this, in France, Eylea and dexamethasone have been reimbursed by the healthcare system since September and October of 2015, respectively, while Ranibizumab has been reimbursed since 2012.
To keep up with current market trends, we take KOLs and SME’s opinion working in the DME domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or DME market trend. This will support the clients in potential upcoming novel treatment by identifying the over DME scenario of the market and the unmet needs.

Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the DME Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report
• The report covers the descriptive overview of DME, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
• Comprehensive insight has been provided into the DME epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for DME is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of DME market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global DME market.

Report Highlights
• In the coming years, DME market is set to change due to the rising patient pool of diabetes and increasing changes in lifestyle across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence DME R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for DME .
• Our in-depth analysis of the pipeline assets across different stages of development different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the over DME scenario of the research and development activities.

DME Report Insights
• Patient Population
• Therapeutic Approaches
• DME Pipeline Analysis
• DME Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

DME Report Key Strengths
• 10 Years Forecast
• 7MM Coverage
• DME Epidemiology Segmentation
• Highly Analyzed Market

• Drugs Uptake

DME Report Assessment
• SWOT Analysis
• Conjoint Analysis
• Current Treatment Practices
• Unmet Needs
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:
• What was the DME Market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the DME total market size as well as market size by therapies across the 7MM during the study period (2018–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest DME market size during the study period (2018–2030)?
• At what CAGR, the DME market is expected to grow in the 7MM during the study period (2018–2030)?
• What would be the DME market outlook across the 7MM during the study period (2018–2030)?
• What would be the DME market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and a subsequent analysis of the associated trends?
• DME patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
• How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies on the basis of their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the DME market?

Epidemiology Insights:
• What is the disease risk, burden and unmet needs of the DME ?
• What is the historical DME patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What would be the forecasted patient pool of DME in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to DME?
• Out of DME the 7MM countries, which country would have the highest prevalent population of DME during the study period (2018–2030)?
• At what CAGR the population is expected to grow in the 7MM during the study period (2018–2030)?
• What are the various recent and upcoming events which are expected to improve the diagnosis of DME?

Current Treatment Scenario and Emerging Therapies:
• What are the current options for the treatment of DME?
• What are the current treatment guidelines for the treatment of DME in the US, Europe and Japan?
• How many companies are developing therapies for the treatment of DME?
• How many therapies are developed by each company for the treatment of DME?
• How many emerging therapies are in mid stage, and late stage of development for the treatment of DME?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the DME therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for DME and their status?
• What are the key designations that have been granted for the emerging therapies for DME?
• What is the global historical and forecasted market of DME?

Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the DME market.
• To understand the future market competition in the DME market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for DME in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
• Identification of strong upcoming players in market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for DME market.
• To understand the future market competition in the DME market.

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