Macular Edema and Macular Degeneration Market to Set $22.51 Bn by 2034

Macular Edema and Macular Degeneration Market Size, Shares and Companies

The global macular edema and macular degeneration market was evaluated at US$ 10.33 billion in 2023 and is expected to attain around US$ 22.51 billion by 2034, growing at a CAGR of 7.34% from 2024 to 2034. The macular edema and macular degeneration market is growing based on different treatment options for the underlying pathology, which may include vascular endothelial growth factor therapy, corticosteroids, nonsteroidal anti-inflammatory drugs, or surgical intervention.

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Market Overview

The macular edema and macular degeneration market is growing rapidly because macular edema is the leading cause of vision loss in diabetic retinopathy among workers worldwide. In population studies, the prevalence ranges from 4.2% to 7.9% in patients with type 1 diabetes and 1.4% to 12.8% in patients with type 2 diabetes. Most cases of diabetic retinopathy (DR) and diabetic macular edema (DME) are very severe and high in the latter patients. Macular edema is defined as an abnormality of the macula associated with fluid in the accessory and sometimes intracellular portions of the plexiform layer and inner nuclear. It causes blindness by altering the interaction between cells in the retina and stimulating the repair response. Vitreous traction-related macular edema represents a tissue-specific condition due to changes in the retina. Treatment of macular edema depends on the pathophysiological mechanism of the outcome and can be performed alone or in combination with medical therapy. Researchers have estimated that age-related macular degeneration affects approximately 20 million people in the United States and 196 million people worldwide.

For Instance,

• In August 2023, Regeneron Pharmaceuticals, Inc. announced, the U.S. Food and Drug Administration (FDA) that has approved EYLEA HD (aflibercept) injection 8 mg for the treatment of patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR).

Market Trends

• In November 2024, a neonatologist and researcher at the University of Oklahoma earned a five-year, $2.3 million grant from the National Institutes of Health to further investigate retinopathy of prematurity, a serious eye disease that can affect premature babies and lead to lifelong problems including blindness, which is responsible for the development of macular edema and macular degeneration market.
• Gene therapy for nAMD, such as intravitreal anti-VEGF agents, is on the verge of transforming treatment and outcomes. Gene therapy offers the real possibility of “and done manner. The approval of gene therapy for RPE65-associated retinal dystrophy by the U.S. Food and Drug Administration and the European Medicines Agency paves the way for a new era of retinal gene therapy products, which lead to the development of macular edema and delayed macular degeneration market.
• The Academy's EyeSmart public education program is dedicated to educating the public about the importance of eye health and encouraging healthy vision by providing the most helpful information and treatment for eye diseases, pain, and injuries. This leads to macular edema. And macular degeneration market growth.
• In October 2023, the OrCam MyEye is a wearable device that uses artificial intelligence and computer vision to help blind people with everyday tasks. It features a lighted camera unit that can be attached to the frame of regular glasses or sunglasses.

AI Integration

AI to the management and assessment of macular edema and macular degeneration. It involves deep learning (DL), which can be used effectively to diagnose AMD, predict the risk of hospitalization in the short term, and the need for injections in the next 2 years. In addition, deep learning methods can adjust anti-VEGF treatment options with higher accuracy than human experts. In addition, the use of ML models can provide patients with accurate predictions of VA response to treatment, which can increase patient compliance with treatment under appropriate conditions. The development and use of intelligent tools have the potential to increase the efficiency of DME management and provide patients with the most appropriate treatment, thereby reducing the cost of treating diseases for retinal doctors and providing significant cost savings to patients through better care will help support the growth of the macular edema and macular degeneration market.

Market Dynamics

Driver

The Growing Impact of Age-Related Macular Degeneration (AMD) on Healthcare and Market Demand

Age-related macular degeneration (AMD) is increasingly recognized as a leading cause of vision loss in the elderly, especially those over the age of 60. This disease has serious effects on individuals and society, causing higher rates of falls, depression, and poor quality of life. As the global population ages, the prevalence of AMD has increased significantly in recent years, leading to an increased need for treatment and interventions. Given the important role of communication and collaboration in early diagnosis, doctors agree that it is important for people over the age of 50 to undergo an evaluation. This surge in AMD cases has also driven growth in the macular edema and macular degeneration market, spurring investment in both innovative therapies and diagnostic technologies aimed at addressing the rising healthcare needs of this patient demographic.

For Instance,

• In May 2023, Alimera Sciences, Inc. announcement of successful enrollment in the NEW DAY clinical trial, a randomized, controlled, multicenter study designed to establish a trial of 0.19 mg fluocinolone acetonide intravitreal implant (ILUVIEN) as treatment in patients with macular edema (DME).

Opportunity

Advancements in Anti-VEGF and Gene Therapy

The introduction of anti-VEGF agents has revolutionized the field of diabetic macular edema (DME) treatment and set a new gold standard by offering superior clinical and anatomical outcomes compared to laser treatments. This change not only improves patient care but also opens up a large market for pharmaceutical companies targeting retinal diseases. Additionally, the emergence of retinal gene therapy as a promising treatment for age-related macular degeneration (AMD) has further expanded the macular edema and macular degeneration market. Gene therapy, which uses adeno-associated virus (AAV) vectors to deliver anti-VEGF directly to the retina, offers an alternative to monthly ocular injections, providing long-term benefits to people’s pain and reducing treatment. These breakthroughs in anti-VEGF therapy and gene therapy are expected to fuel growth in the macular edema and macular degeneration market and drive innovation and investment in ophthalmology.

For Instance,

• In June 2024, ANI Pharmaceuticals, Inc. and Alimera Sciences, Inc. announced that they have entered into a definitive agreement under which ANI will acquire Alimera for $5.50 per share in cash at closing, exempt from the Securities Exchange Act. (CVR) represents the right to receive up to $0.50 per share if certain revenue targets are achieved.

Restraint

Diagnostic and Therapeutic Challenges

The macular edema and macular degeneration market is hampered by several major issues, including the inability to identify the pathological process, the lack of reliable biomarkers, and drug under-efficacy. These factors complicate drug selection and treatment improvement, highlighting the need for improved diagnostic tools and further research into better treatments. Additionally, existing treatments have similar safety issues, including blindness, eye pain, vitreous floaters, conjunctival hemorrhage, and vitreous detachment, as with intravitreal injection attempts. These safety and regulatory issues, along with regulatory restrictions surrounding the use of existing drugs, pose major barriers to accessing healthcare and economic growth. These conditions, therefore, limit the expansion of the macular edema and macular degeneration market and highlight the need for continued innovation in drug development and treatment modalities.

Regional Insights

Rising DME Prevalence and AI Advancements in North America

The North American market dominates the macular edema and macular degeneration market due to the increasing prevalence of diabetic macular edema in the North American population. Approximately 745,000 Americans have DME, more than half of whom are undiagnosed. Approximately one-third of people with diabetes develop diabetes-related macular edema. There are currently more than 37 million adults with diabetes in the United States. The US Food and Drug Administration (FDA) has approved two artificial intelligence systems that can detect DR without human supervision. The IDx-DR system is an FDA-cleared AI point-of-care screening system with 87% sensitivity, 90% specificity, and 96% imageability for more than mild DR (mtmDR), this causes the growth of macular edema and macular degeneration market.

For Instance,

• In May 2024, Merck and Eyebiotech Limited (EyeBio), a privately held biotechnology company focused on healthcare, announced that the companies had agreed. Under the agreement, Merck will acquire EyeBio from its subsidiaries.

Rising DME Prevalence and Aging Population in Europe

Macular edema and macular degeneration market forecast is expected to have the highest growth in Europe as the prevalence of DME is 3.7% in Europe and the average annual incidence tested in patients with type 2 diabetes is 0.4%. Diabetic eye disease currently affects 6.4 million people in Europe and is estimated to affect 8.6 million people by 2050. The prevalence of age-related macular degeneration (AMD) and diabetic macular edema (DME) is increasing as the population ages and the number of people with diabetes increases. The EU has an important role to play in facilitating access to healthcare and treatment for high-risk and vulnerable groups, especially those with emerging diseases. The European Commission is working to create a strong European Health Alliance where all EU countries can jointly prepare and respond to the health crisis that has led to the development of the macular edema and macular degeneration market.

Segmental Insights

By Treatment Type

By type, the drug therapy segment accounted for the majority of the market share in the global market, as drugs inhibit cyclooxygenase, reducing the production of prostaglandins. Most studies show that medical therapy is effective in treating intraocular cystoid macular edema. Treatment of macular edema caused by retinal vein occlusion shows improvement for at least five years, although most patients require ongoing treatment. Whereas laser treatment is the fastest-growing segment in the market as a laser treatment focused on the retina, it can treat swelling in the center of the retina, also known as macular edema. There are different treatments for patients with macular edema, including photocoagulation treatment with focal or grid laser, which is still the gold standard of treatment.

By Application

In terms of application, the macular degeneration segment holds the majority of the market share and is expected to remain so throughout the forecast period as the number of macular degeneration (MD) patients is expected to increase over the next 20 years. Macular degeneration is usually seen in the elderly and is caused by damage to the macula of the retina. Diabetic macular edema (DME) is the fastest-growing segment, resulting from inadequate treatment of diabetes (DM) and often progressing to diabetic retinopathy, which causes visual impairment in DM patients. Development of diabetic macular edema, an eye disease associated with diabetes.

By End User

By end users, the hospital segment accounted for the maximum market because the hospital has improved its treatment for macular edema many times, and vision can be improved even immediately after an injection. Treatment options vary depending on the underlying disease and may include vascular endothelial growth factor therapy, corticosteroids, nonsteroidal anti-inflammatory drugs, or surgical intervention.

Recent Announcement of Key Players

• In October 2024, Kubota Vision Inc., a clinical-stage specialty ophthalmology company and a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd., announced that a private clinical trial conducted at Shinshu University Hospital has advanced to the next phase of testing eyeMO*1. It is a portable, low-cost, home, remote, and in-office ophthalmology device for monitoring eye disease.
• In June 2024, Faricimab for the treatment of neovascular age-related macular degeneration and diabetic macular edema: from preclinical studies to phase 3 results.
• In November 2023, REGENXBIO Inc. announced additional positive data from the ongoing Phase II ALTITUDE trial of ABBV-RGX-314 for the treatment of diabetic retinopathy (DR) center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery.

Recent Developments

• In July 2024, Genentech, a member of the Roche Group, announced the reactivation of Susvimo, 100 mg/mL, for the intravitreal treatment of U.S. patients with wet eye disease due to implantation following spontaneous resolution or neovascularization. Age-related macular degeneration (AMD) conditions (U.S.).
• In May 2024, Biocon Biologics Ltd (BBL), an integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the U.S. Food and Drug Administration (FDA) approved the initial submission of Yesafili, the company's biosimilar replacement for aflibercept.
• In March 2022, Novartis announced that the European Commission (EC) had approved Beovu (brolucizumab) 6 mg for the treatment of blindness due to diabetic macular edema (DME).
• In September 2022, Coherus BioSciences, Inc. announced the launch of CIMERLI™ (ranibizumab-eqrn), a biosimilar product, injectable solution for all approved indications. CÄ°MERLÄ° is an anti-VEGF drug from the class of biologics that has revolutionized the ability to help retinal patients maintain or improve vision.
• On January 22, 2024, Sandoz, a global leader in generics and biosimilars, signed an agreement to acquire U.S. biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) Coherus BioSciences, Inc. for $170 million upfront.
• In July 2024, Clearside Biomedical, Inc., a biopharmaceutical company revolutionizing the delivery of treatments to the back of the eye via the suprachoroidal space, announced in partnership with Arctic Vision that ARCATUS has reported positive results from a Phase 3 clinical trial in China for the treatment of Uveitic macular edema (UME).

Top Companies in the Macular Edema and Macular Degeneration Market

• Kubota Pharmaceutical Holdings Co. Ltd
• Alimera Sciences Inc
• Abbvie Inc
• Novartis AG
• F. Hoffmann-La Roche Ltd
• Regeneron Pharmaceuticals Inc.
• Regen X Bio Inc.
• GlaxoSmithKline Plc
• Bayer AG
• Bausch Health Companies Inc.

Segments Covered in the Macular Edema and Macular Degeneration Market

By Treatment Type

• Drug Therapy
• Laser Treatment

By Application

• Macular Edema
• Diabetic Macular Edema (DME)
• Cystoid Macular Edema (CME)
• Macular Degeneration
• Dry age-related macular degeneration
• Wet age-related macular degeneration

By End User

• Hospitals
• Clinics
• Others

By Geography

• North America
• Europe
• Asia Pacific
• Middle East & Africa
• Latin America