Market Overview
The global diabetic macular edema (DME) market reached US$ 4.70 billion in 2023 and is expected to reach US$ 6.77 billion by 2031, growing at a CAGR of 4.7% 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. 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.
For instance, according to WHO, around 2.2 billion people worldwide have near or distance vision impairment, with 1 billion of these being preventable or unaddressed. The leading causes are refractive errors and cataracts. Only 36% of people with distance vision impairment due to refractive error and 17% of those with cataract impairment have access to appropriate intervention. Vision impairment is a significant global financial burden, costing US$ 411 billion annually. Most people with vision impairment and blindness are over 50 years old.
Market Dynamics: Drivers & Restraints
Rise in the Prevalence of Diabetes
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. DME is a consequence of microvascular changes in diabetes, which cause vessel incompetence and edema.
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.
Additionally, the International Diabetes Federation estimated that the total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045. With increased diabetes prevalence, there is more focus on screening and early detection of complications such as DME. This promotes early detection and raises the demand for therapeutic solutions.
Thus, the above factors are expected to drive the market growth during the forecast period.
High cost of treatment
The global market for diabetic macular edema (DME) has been affected significantly by the treatment cost especially the advanced pharmacological treatment options such as anti-VEGF injections and corticosteroids. The injections and other medications are costly and require repeated treatment which can prove a burden to patients who do not enjoy adequate coverage.
These also include diagnostic tools such as optical coherence tomography (OCT) which are also expensive and put more strain on both the patients and the healthcare system because of these high cost barriers, twenty-three percent of those patients cannot afford treatment and therefore cannot access the market, which in turn makes the growth potential of the market low, particularly among the low or underinsurance population. For instance, for DME, the estimated average cost is $35,344.96 and $26,305.16 for faricimab and aflibercept 8 mg, respectively.
For more details on this report – Request for Sample
Market Segment Analysis
The global diabetic macular edema (DME) market is segmented based on type, treatment type, form, end-user, and region.
Treatment Type:
Anti-Vascular Endothelial Growth Factors (VEGF) segment is expected to dominate the Diabetic Macular Edema (DME) market share
The Anti-Vascular Endothelial Growth Factors (VEGF) segment holds a major portion of the Diabetic Macular Edema (DME) market share. 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.
Moreover, product launches and approvals of the market players would drive this segment’s 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.
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. These strategies and partnerships are expected to increase the supply and distribution of drugs across various regions which is expected to contribute to the segment’s growth.
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.
Corticosteroid therapies segment is the fastest-growing segment in the Diabetic Macular Edema (DME) market share
The Corticosteroid therapies segment is the fastest-growing segment in the Diabetic Macular Edema (DME) market share and is expected to hold the market share over the forecast period.
Corticosteroids have a crucial role in the management of DME based on their mechanism of action against proinflammatory mediators and inhibition of VEGF production. They inhibit the production of thromboxanes, leukotrienes and prostaglandins by blocking the arachidonic acid pathway. This results in improved perfusion of the retina, increased density and functioning of the tight junctions of the retinal capillary endothelium and better oxygen delivery to the retina.
Also, DME may disrupt Müller cells which are important for the maintenance of the retina homeostasis, leading to the accumulation of intracellular edema and active toxic agents. Such cells might become apoptotic with the advancement of the disease. Corticosteroids can also enhance tissue repair mechanisms in vivo animal experiments conducted before clinical trials. An evidence based use of corticosteroids for DME management is to ameliorate these inflammatory episodes and avoid changes in the retinal glia.
Type:
Focal DME segment is expected to dominate the Diabetic Macular Edema (DME) market share
The Focal DME segment holds a major portion of the Diabetic Macular Edema (DME) market share and is expected to continue to hold a significant portion of the Diabetic Macular Edema (DME) market share during the forecast period.
Focal diabetic macular edema (DME) is a specific type of DME that presents with swelling restricted to the macula, the center of the retina that provides high acuity vision. It occurs when certain regions of the retina suffer from vascular damage leading to fluid leaking into the macula at focal points.
Central vision, which is affected by focal DME, usually becomes blurry or distorted hampering the completion of activities, such as reading and facial identification, that require vision acuity of a certain level. The management of focal DME very often includes procedures like laser treatment where the aim is to eliminate the sources of leaking blood vessels in an attempt to prevent fluid accumulation, and intravitreal anti-VEGF therapy to restrict neovascularization. While these interventions may help improve or stabilize vision, the subsequent constant care and attention to the patients tend to be an economic strain to the patients and the health system’s budgets especially considering the rising cases of diabetes around the world.
Diffuse DME segment is the fastest-growing segment in the Diabetic Macular Edema (DME) market share
The Diffuse DME segment is the fastest-growing segment in the Diabetic Macular Edema (DME) market share and is expected to hold the market share over the forecast period. Diffuse diabetic macular edema (DME) is a subtype of DME characterized by the diffuse or sizeable swelling of the macula, which is the central region of the retina responsible for sharp vision. In contrast to focal DME that results from a thin area of fluid leaking from blood vessels, diffuse DME is caused when the blood vessels leak throughout the entire retina. This results in the accumulation of liquid and swelling of the macula, which leads to severe and progressive loss of vision.
Diffuse DME causes a significant loss of vision to the patients and it affects their day to day functioning. This type of DME is difficult to treat and usually requires a combination of anti-VEGF injections and corticosteroid injections; in some cases, laser photocoagulation is still necessary. These treatments are generally aimed at reducing the edema and the consequent risk of vision loss; however, because of the extensive fluid leaks, diffuse DME tends to have a more aggressive treatment and maintenance plan, which has further healthcare and economic implications to the treatment of this condition.
Market Geographical Share
North America is expected to hold a significant position in the Diabetic Macular Edema (DME) market share
North America holds a substantial position in the Diabetic Macular Edema (DME) market and is expected to hold most of the market share due to high prevalence of diabetes in the region, combined with the presence of a well-developed healthcare infrastructure.
For instance, 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).
The research and developmental activities conducted by the major players and the growing awareness among individuals are expected to contribute to the market growth in the region.
Moreover, the presence of a large number of market players, 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.
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). driving this market growth in this region.
Europe is growing at the fastest pace in the Diabetic Macular Edema (DME) market
Europe holds the fastest pace in the Diabetic Macular Edema (DME) market and is expected to hold most of the market share due to the high rate of diabetes, especially among the older population in the region, has corresponded with an increase in the incidence of diabetic retinopathy, and as a result, DME.
Moreover, developed countries in Europe provide modern healthcare systems, which enables patients to receive advanced imaging techniques such as optical coherence tomography (OCT) and intravitreal anti-VEGF injections, ingredients essential for the treatment of DME. Also, there is a lot of government and institutional support for diabetes and eye health programs in Europe that encourage people of all ages to know why they should have their eyes checked regularly and the need to prevent conditions like DME from occurring. Further, the market benefits also from a growing trend of diagnosing and treating patients at an earlier stage of the disease, which will help to control many patients with the early forms of the disease.
For instance, in September 2024, MSD and EyeBio have initiated the Phase IIb/III clinical trials of Restoret (MK-3000) for diabetic macular edema (DME) treatment BRUNELLO. The trial will evaluate the efficacy and safety of two dose levels of Restoret against a control of ranibizumab. During the course of the study, subjects will be randomized to receive treatment with either Restoret low dose or Restoret high dose every four weeks. A personalized treatment interval algorithm will be applied in the second year to adjust the treatment frequency. The primary endpoints for the trial will be safety and the mean change in best-corrected visual acuity.
Market Competitive Landscape
The major global players in the Diabetic Macular Edema (DME) market include Novartis, Regeneron Pharmaceuticals, Inc, F. Hoffmann-La Roche AG, Formycon AG, Bayer AG, Santen Pharmaceutical Co., Ltd, AbbVie Inc, Teva Pharmaceutical Industries Ltd., Alimera Sciences, Knight Therapeutics Inc among others.
Emerging Players
The emerging players in the Diabetic Macular Edema (DME) market include Kubota Vision Inc, Ocuphire Pharma Inc, Graybug Vision Inc, Kodiak Sciences Inc and among others.
Metrics | Details | |
CAGR | XX% | |
Market Size Available for Years | 2022-2031 | |
Estimation Forecast Period | 2024-2031 | |
Revenue Units | Value (US$ Mn) | |
Segments Covered | Type | Focal DME, Diffuse DME |
Treatment | Anti-Vascular Endothelial Growth Factors (VEGF), Corticosteroid Therapies, Laser Photocoagulation, Others | |
Form | Intravitreal Injections, Intravitreal Implants | |
End-User | Hospitals, Speciality Clinics, Home Care, Others | |
Regions Covered | North America, Europe, Asia-Pacific, South America, and Middle East & Africa | |
Key Developments
- In October 2024, Oculis Holding a global biopharmaceutical company purposefully driven to save sight and improve eye care, has announced an upcoming presentation of an update on the DIAMOND Phase 3 program with OCS-01, an OPTIREACH formulation of high concentration dexamethasone eye drops for the treatment of diabetic macular edema (DME), by David Eichenbaum, M.D. at Innovate Retina.
- In March 2024, Roche Pharma India, the global pharmaceutical company, made its foray into ophthalmology with the introduction of Vabysmo (faricimab) in the Indian market. The drug caters to age-related macular degeneration (nAMD) and diabetic macular edema (DME), both of which rank among the highest causes of vision impairment worldwide.
Why Purchase the Report?
- To visualize the global diabetic macular edema (DME) market segmentation based on type, , treatment type, 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 (DME) 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 (DME) market report would provide approximately 70 tables, 63 figures, and 184 pages.
Target Audience 2024
- Manufacturers/ Buyers
- Industry Investors/Investment Bankers
- Research Professionals
- Emerging Companies
