Global Diabetic Macular Edema Market - 2024-2031

Report Overview

The Global Diabetic Macular Edema Market reached US$ 3.27 billion in 2023 and is expected to reach US$ 4.55 billion by 2031 growing with a CAGR of 4.2% during the forecast period 2024-2031.

Diabetic macular edema (DME) is a serious eye condition that affects individuals with diabetes, whether type 1 or type 2. The term "macular" refers to the macula, the central part of the retina responsible for sharp central vision. "edema" indicates swelling caused by fluid accumulation.

DME occurs when damaged blood vessels leak fluid, leading to swelling that blurs vision. If diabetic retinopathy progresses, the eye may develop new, abnormal blood vessels over the retina, which can break easily and bleed, resulting in severe vision loss or even blindness. DME can manifest at any stage of diabetic retinopathy, but its likelihood increases as the disease advances.

Diabetic macular edema (DME) can be broadly classified into two main anatomical categories: Focal and Diffuse. Focal DME is characterized by distinct areas of leakage within the macula, where there is adequate blood flow to the macula. Diffuse DME occurs when there is leakage from the entire capillary network surrounding the macula, resulting from a breakdown of the inner blood-retina barrier.

In addition to these anatomical classifications, DME is also categorized based on clinical examination findings into clinically significant macular edema (CSME), non-CSME, and CSME with central involvement (CSME-CI), which specifically affects the fovea.

Market Dynamics: Drivers

Rising prevalence of diabetes and advancements in treatments

The demand for the global diabetic macular edema market is driven by multiple factors. One of the primary factors is the rising prevalence of diabetes and advancements in treatments. The increasing prevalence of diabetes, especially type 2 diabetes, is a significant factor driving the DME market. As more individuals are diagnosed with diabetes, the occurrence of related complications, including diabetic macular edema (DME), is anticipated to rise correspondingly.

According to an NCBI research publication in July 2022, around 5.5% of individuals with diabetes have diabetic macular edema (DME), with a prevalence that is statistically nonsignificantly lower in high-income countries compared to low- to middle-income countries. Similarly, JAMA publications in March 2022, the increase in the prevalence of proliferative diabetic retinopathy (PDR) from 2.1% to 3.8% and the rise in diabetic macular edema (DME) from 0.4% to 2.1% reflect a growing concern regarding the complications associated with diabetes.

Furthermore, technological advancements have been made in the treatment options for diabetic macular edema (DME), particularly with the development of anti-VEGF therapies like Ranibizumab (Lucentis) and Aflibercept (Eylea). These therapies have transformed the management of DME by enhancing vision outcomes compared to traditional treatments such as laser photocoagulation.

Moreover, key players in the market more focus on the treatment for DME, the rising number of clinical trials, major player's innovative product launches & approvals, and key developments that would drive this market growth. For instance, in July 2024, Genentech, part of the Roche Group, announced two-year findings from the Phase III Pagoda and Pavilion studies assessing Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema (DME) and diabetic retinopathy (DR), which are the primary causes of vision loss in adults with diabetes. Susvimo is notable as the first and only refillable eye implant that delivers a continuous supply of a specially formulated ranibizumab through the Port Delivery Platform.

Also, in October 2023, Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Vabysmo (faricimab-svoa) for treating macular edema resulting from retinal vein occlusion (RVO). This marks the third indication for Vabysmo, which is already approved for wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Collectively, these three retinal conditions impact approximately 3 million individuals in the U.S. and are among the leading causes of vision loss.

Restraints

Factors such as high treatment costs, limited awareness & diagnosis among individuals, complications associated with the drugs, and reimbursement challenges, are expected to hamper the market.

Market Segment Analysis

The global diabetic macular edema market is segmented based on type, treatment, form, end-user, and region.

The anti-vascular endothelial growth factor (VEGF) medications segment accounted for approximately 54.4% of the global diabetic macular edema market share.

The anti-vascular endothelial growth factor (VEGF) medications segment is expected to hold the largest market share over the forecast period. Anti-VEGF therapies, including Ranibizumab (Lucentis) and Aflibercept (Eylea), have transformed the treatment approach for diabetic macular edema (DME). These medications target vascular endothelial growth factor (VEGF), a protein that stimulates the growth of abnormal blood vessels and increases vascular permeability in the retina. By inhibiting VEGF, these therapies reduce fluid leakage, alleviate inflammation, and prevent the formation of new, potentially damaging blood vessels in the eye.

Ranibizumab is a humanized monoclonal antibody fragment that specifically binds to and inhibits all isoforms of vascular endothelial growth factor A (VEGF-A). This action prevents VEGF-A from attaching to its receptors, VEGFR-1 and VEGFR-2, thereby blocking the signaling pathways that promote the growth of abnormal blood vessels and increase vascular permeability in the retina.

Aflibercept, in contrast, is a recombinant fusion protein that functions as a soluble decoy receptor. It binds to VEGF-A with a higher affinity than its natural receptors, effectively inhibiting VEGF signaling. Both Ranibizumab and Aflibercept have demonstrated efficacy in maintaining or improving visual acuity and reducing the risk of severe vision loss in patients with ocular vascular disorders, including diabetic macular edema (DME).

Moreover, key players in the industry product launches and approvals that would drive this market growth. For instance, in May 2024, Biocon Biologics Ltd (BBL), announced that the U.S. Food and Drug Administration (FDA) has approved its first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable biosimilar of aflibercept.

Yesafili is a vascular endothelial growth factor (VEGF) inhibitor designed to treat various ophthalmic conditions, including neovascular age-related macular degeneration, visual impairment from macular edema due to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. This approval signifies Biocon's entry into the ophthalmology market in the U.S.

Similarly, in January 2024, Santen Pharmaceutical Co., Ltd. and Bayer Yakuhin, Ltd. announced that they received regulatory approval from the Ministry of Health, Labour, and Welfare (MHLW) for "Eylea 8mg Intravitreal Injection 114.3 mg/mL" (aflibercept [recombinant] intravitreal injection). This ophthalmic vascular endothelial growth factor (VEGF) inhibitor is approved for treating neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

In addition, key player strategies such as partnerships and collaborations would propel this segment's growth in the market. For instance, in November 2023, Lupin Limited announced a partnership with Amman Pharmaceuticals Industries, a prominent pharmaceutical manufacturer operating in the MENA region and beyond. This collaboration focuses on the exclusive marketing and commercialization of Ranibizumab, a biosimilar of Lucentis, in the Middle East, including specific territories such as Jordan, Saudi Arabia, the UAE, Iraq, Lebanon, and other GCC countries. Both companies share a commitment to delivering innovative and high-quality healthcare solutions to patients in the MENA region.

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that specifically binds to and inhibits vascular endothelial growth factor A (VEGF-A). It is indicated for the treatment of various conditions, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).

Market Geographical Share

North America accounted for approximately 44.2% of the global diabetic macular edema market share

North America region is expected to hold the largest market share over the forecast period owing to the high prevalence of diabetes in the region, combined with the presence of a well-developed healthcare infrastructure driving this market growth in this region. According to CDC news in 2021, approximately 38.4 million individuals in the United States, representing 11.6% of the total population, were living with diabetes. Among these, about 38.1 million adults aged 18 and older, or 14.7% of the adult population, had diabetes.

Similarly, in Genentech Inc., news in 2024, around 34.2 million individuals in the U.S. are living with diabetes. People with diabetes face a heightened risk of developing eye issues. This increased risk is partly due to diabetes and its complications damaging the blood vessels in the retina, a condition known as diabetic retinopathy, which can ultimately progress to a more severe vision-threatening condition called diabetic macular edema (DME).

In this region, major players in research & development, and rising awareness among people help to drive this market growth. Moreover, in this region, a major number of key players' presence, a well-advanced healthcare system, product launches & approvals would drive this market growth. For instance, in August 2023, Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved EYLEA HD (aflibercept) Injection at a dosage of 8 mg for treating patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR).

The recommended administration schedule for EYLEA HD involves an initial dose of 8 mg (0.07 mL of a 114.3 mg/mL solution) every four weeks for the first three months across all conditions. After this initial period, the dosing frequency changes to 8 mg every 8 to 16 weeks (2 to 4 months) for wAMD and DME, and every 8 to 12 weeks (2 to 3 months) for DR.

Also, in April 2024, Eluminex Biosciences announced that the U.S. Food and Drug Administration (FDA) accepted their Investigational New Drug (IND) application for EB-105. It is a novel tri-specific fusion antibody designed to target VEGF-A (and its isomers), VEGF-B, placental growth factor (PlGF), angiopoietin-2 (Ang-2), and the interleukin-6 receptor (IL-6R) for treating diabetic macular edema (DME).

Market Segmentation

By Type

• Focal Diabetic Macular Edema
• Diffuse Diabetic Macular Edema
• Others

By Treatment

• Anti- Vascular Endothelial Growth Factor (VEGF) Medications
  • Ranibizumab
  • Aflibercept
  • Brolucizumab
  • Faricimab
• Corticosteroid Therapies
  • Dexamethasone Intravitreal Implant
  • Fluocinolone Acetonide
  • Intravitreal Triamcinolone Acetonide (IVTA)
• Laser Photocoagulation
• Others

By Form

• Intravitreal Injections
• Intravitreal Implants

By End-User

• Hospitals
• Specialty Clinics
• Home Care
• Others

By Region

• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • The rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Market Competitive Landscape

The major global players in the diabetic macular edema market include Novartis AG, Regeneron Pharmaceuticals, Inc., Genentech, Inc., Eluminex Biosciences, Biocon, Formycon AG, Lupin, Bayer AG, Santen Pharmaceutical Co., Ltd., and F. Hoffmann-La Roche Ltd among others.

Key Developments

• In March 2024, Formycon AG and MS Pharma announced that FYB201, a biosimilar of Lucentis (Ranibizumab), has received marketing authorization from the Saudi Food & Drug Authority. The biosimilar, marketed as Ravegza, is approved in Saudi Arabia for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious eye conditions, including diabetic retinopathies.

Why Purchase the Report?

• To visualize the global diabetic macular edema market segmentation based on type, treatment, form, end-user, and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of the diabetic macular edema market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in Excel consisting of key products of all the major players.

The global diabetic macular edema market report would provide approximately 70 tables, 63 figures, and 183 pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies