Anti-VEGF Therapeutics Market

Market Overview

The global anti-VEGF therapeutics market size was valued at USD 12.3 billion in 2022. It is estimated to reach USD 13.7 billion by 2031, growing at a CAGR of 0.6% during the forecast period (2023–2031).

The human body naturally produces VEGF, also known as vascular endothelial growth factor, responsible for maintaining and growing new blood vessels. It creates abnormal blood vessels under abnormal circumstances, such as diabetic retinopathy, blood vessel obstruction, or age-related macular degeneration, which can bleed, leak, and ultimately cause scar formation and vision loss.

Vascular endothelial growth factor activity is inhibited by medications known as anti-vascular endothelial growth factor treatments or anti-VEGF medicines. Among other disorders, this class of drugs is used to treat cancer and ophthalmic conditions such as diabetic retinopathies, age-related macular edema, and retinal vein occlusion. When anti-VEGF drugs are used under the right conditions, they work at the molecular level to block VEGF's function, ultimately decreasing morbidity.

Highlights

• Eylea dominates the product segment
• Age-related macular degeneration dominates the disease segment
• North America is the highest shareholder in the global market

Market Dynamics

Market Drivers

Rising Incidence of Diseases and Growing Geriatric Population

The rising incidence of ophthalmic conditions such as macular edema, retinal vein occlusion, diabetic retinopathy, and age-related macular degeneration are expected to contribute to market growth. AMD is an eye disease affecting the elderly with progressive loss of central vision. According to the WHO, AMD affects approximately 196 million persons worldwide, including over 10.4 million moderate to severe vision impairment cases.

In addition, the incidence of ocular disorders is anticipated to rise as the elderly population grows. The United Nations Department of Economic and Social Affairs data, the global elderly population (60 years and above) was around 703 million in 2019. In 2016, 6% of the population was 65 or older, rising to 9% in 2019. Hence, the increase in the geriatric population is anticipated to propel the number of AMD cases. The rising cases of AMD propel the market growth over the forecast period.

Robust Product Pipeline

The anti-VEGF therapeutics market is expected to grow as multiple market players focus on R&D to develop innovative treatments. Market players are involved in extensive R&D to develop novel drugs for treating eye disorders and gain a higher market share. In addition, there is a growing need for novel therapies and treatments due to the disease's rapidly increasing prevalence. Hospitals and healthcare institutes are working closely with pharmaceutical companies to conduct clinical trials while ensuring the safety of patients. The current class of anti-VEGF medications is effective but not long-lasting. Hence, players' focus on developing therapeutics with longer action duration increases.

Market Restraints

Patent Expiry of Products

The patent cliff is one of the most significant issues in the pharmaceutical industry, as blockbuster drugs typically account for a significant portion of company revenues. Several key blockbuster drugs have lost their patent exclusivity in recent years, and many more are expected to lose theirs over the coming years. For instance, Lucentis (F. Hoffmann-La Roche Ltd.) lost its patent in June 2020 in the United States.

In addition, the patent of Avastin (F. Hoffmann La Roche Ltd.), used as an off-label medication for treating RVO and AMD, expired in the U.S. in July 2019. Loss of patent protection will likely harm a company's performance, leading big pharma companies to consider new revenue streams. However, this is creating an emerging market for biosimilar drug producers in the region. This rising competition is anticipated to impede market growth. However, the launch of novel products with a competitive advantage is anticipated to lower the impact of the restraint during the forecast period.

Market Opportunities

Increasing Adoption of Treatment Due to Therapeutic Advancements

Many players are involved in developing new treatments for various conditions, such as dry and wet AMD and DR, as current treatments are known to provide temporary symptomatic relief. Longer-acting VEGF drugs and treatments are becoming more popular among market participants for these ailments. Short-acting anti-VEGF products, such as Lucentis (Ranibizumab), are required once every month, which accounts for USD 24,000 per patient annually. Similarly, Eylea accounts for an annual cost of USD 22,200 to USD 13,875. However, the high cost of these products decreases their adoption.

Additionally, the new release of brolucizumab by Novartis in 2019 has heightened rivalry between already available medications. Beovu (brolucizumab), a longer-acting VEGF medicine, was introduced. After an initial loading phase of three monthly doses, maintenance dosing occurs every 8-12 weeks. The annual cost of the product is USD 7,400 and USD 11,100 for 12- and 8-week regimens, respectively.

Similarly, firms are creating a range of formulations and drug delivery technologies that might broaden the use of these treatments. For instance, F. Hoffmann La Roche Ltd. is creating the port delivery system for RG6321 (Ranibizumab), undergoing a phase 3 clinical trial. An eye implant can be refilled and constantly administers ranibizumab in a specialized formulation for several months. Thus, such factors create opportunities for market growth.

Regional Analysis

Based on region, the global anti-VEGF therapeutics market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global anti-VEGF therapeutics market shareholder and is estimated to exhibit a CAGR of 0.2% during the forecast period. The growth of North America's anti-VEGF therapeutics market can be attributed to various factors, such as the high burden of disease and the increase in favorable government initiatives. Funding for research is high in the region. Moreover, increasing product launches and demand for medicines will positively impact the regional market's growth. In addition, technological advancements in medications may fuel market growth. For instance, in May 2020, F. Hoffmann-La Roche Ltd. announced the topline phase 3 clinical trial results for formulation advancement of ranibizumab with the Port Delivery System.

Furthermore, technology improvements and delivery methods might give the business a competitive edge in the market. An article suggests that direct healthcare costs of visual impairment due to AMD accounted for USD 98 billion in the WHO subregion, which covers the U.S., Canada, and Cuba. The presence of leading products, such as Avastin, Eylea, and Lucentis, among others, is also expected to improve the availability of treatment in the region.

Europe is estimated to exhibit a CAGR of 0.4% over the forecast period. The growing disease burden of ophthalmic diseases in the region and surging investments in the development of treatment options are expected to drive the anti-VEGF therapeutics market in the region. Prevalence and incidence of indications, such as AMD and diabetic retinopathies, are reported to be high in the region, which can support market growth. In Europe, AMD is estimated to have a prevalence of 34 million patients, of which 22 million patients belong to EU-5 countries. In addition, this number is estimated to increase by 25% in 2050. For Diabetic Eye Disease (DED), around 25% of the diabetic population, or around 4 million patients, is present in the region.

Additionally, European healthcare is universal, with coverage available for all approved uses. On the contrary, reimbursement for off-label drug use differs across Europe by legislation permitting off-label use. While certain countries discourage it and deny coverage, there are certain others, such as France with a Temporary Recommendation for Use (RTU) and Italy legally permitting unapproved drug use, which is reimbursable.

Asia-Pacific is estimated to exhibit a significant CAGR over the forecast period because of increasing market opportunities and growing healthcare expenditure. Licensing agreements between companies and increasing demand for anti-VEGF products can support market growth over the coming years. Furthermore, an increase in initiatives undertaken by governments to improve the health of the population is expected to spur market growth throughout the forecast period. Improving access to anti-VEGF drugs through favorable reimbursement policies in high-income countries of Asia-Pacific can fuel the market by boosting adoption. In Australia, including anti-VEGF products in PBS can support market growth. However, the presence of generic players in the market can limit market growth.

Latin America's anti-VEGF therapeutics market is anticipated to witness significant growth over the projection period, owing to the growing prevalence of related diseases and the increasing trend of prescribing generic products for treatment. Furthermore, increasing government initiatives, such as patient awareness campaigns, investments in the healthcare sector for advancing infrastructure, and clinical studies for developing novel treatments, may contribute to regional market growth.

In the Middle East and Africa, a considerable increase in the prevalence of AMD due to low living standards, unhealthy diets, and an increasing geriatric population has increased the need for novel and advanced treatments. Major opportunities and improvements in healthcare facilities over the recent past in the Middle East and Africa's underdeveloped economies are expected to fuel the region's market. In addition, the high cost of treatments is typically not affordable for most of the African population because many people are below the poverty line. Hence, an increase in demand for affordable substitutes and increasing penetration of generic products is anticipated to drive the market.

Segmental Analysis

The global anti-VEGF therapeutics market is segmented by product and disease.

Based on products, the global anti-VEGF therapeutics market is bifurcated into Eylea, Lucentis, and Beovu. 

The Eylea segment dominates the global market and is projected to exhibit a CAGR of 0.4% over the forecast period. Eylea (aflibercept) is an anti-VEGF targeted therapy approved for a range of ophthalmic diseases, including Diabetic Retinopathy (DR), Diabetic Macular Edema (DME), and Wet Age-related Macular Degeneration (WAMD). The recommended dosage of Eylea is every four weeks for the first three months, followed by once every two months. Aflibercept is an injectable co-developed by Bayer AG and Regeneron Pharmaceuticals, Inc. and is available in the U.S. Eylea intravitreal solution of 0.05ml is priced at USD 1,940.90. As per the agreement between the companies, Regeneron Pharmaceuticals, Inc. holds exclusive commercial rights in the U.S. along with net sales in Japan.

In addition, Bayer AG holds the marketing rights outside the U.S., wherein profits from future product sales are to be equally shared with Regeneron Pharmaceuticals, Inc. Due to improvements in formulation and the creation of cutting-edge drug delivery methods, the product is predicted to increase dramatically. Further, the introduction of prefilled Eylea injection syringes to the EU market, legal in all 27 EU member states, was announced by Bayer AG in April 2020. This new formulation may increase adoption by ophthalmologists due to ease of administration.

Lucentis (Ranibizumab) is a VEGF inhibitor medication used for patients with diabetic retinopathy and WAMD. The product is developed by F. Hoffmann La Roche Ltd. and Novartis AG and holds the marketing rights of the product in Europe. The recommended dose for treating AMD patients is once a month for the first three months, followed by once in 3 months. The cost of 0.5 mg vials of the intravitreal injection in the U.S. is USD 2,000, and around 12% of the patients are treated using this drug in the U.S. The company focuses on label expansion to increase sales and strengthen its market position. Similarly, in July 2019, Novartis AG received a positive CHMP opinion on Lucentis for treating preterm infants with Retinopathy of Prematurity (ROP). However, the patent expiry of the product and the current biosimilar competition in the market may slow the growth of this segment.

Based on disease, the global anti-VEGF therapeutics market is segmented into macular edema, diabetic retinopathy, retinal vein occlusion, and age-related macular degeneration. 

The age-related macular degeneration segment owns the highest market share and is estimated to exhibit a CAGR of 0.51% during the forecast period. Age-related Macular Degeneration (AMD) is common in the geriatric population, and the disease is progressive and chronic and leads to blurring of vision, eventually resulting in blindness. As per the American Macular Degeneration Foundation, AMD leads to vision loss in more Americans compared to cataract and glaucoma combined. In addition, there are two categories of AMD, wet and dry. Dry-type accounts for 85% to 90% of cases, while 10% to 15% were wet-type. As of 2020, wet AMD impacts over 1.75 million people in America, which creates a wide target population for anti-VEGF drugs. Globally, it is the third largest cause of vision loss, impacting over 170 million people. All the major anti-VEGF products are indicated for AMD, including Eylea and Lucentis. Off-label drugs, such as Avastin, are also used in treating the condition. Hence, the high prevalence of AMD is expected to drive the demand for anti-VEGF products.

The term ""diabetic retinopathy"" refers to damage to the retinal blood vessels, which can give rise to blurred or even lost vision. The alarmingly rising prevalence of diabetes globally is a key market driver. The annual incidence of diabetic retinopathy in 2018 varied between 12.7% and 2.2%, according to the Lancet Journal. In addition, the increasing number of treatment approvals for diabetic retinopathy is further aiding the market growth. For instance, the FDA granted Regeneron Pharmaceuticals permission to treat diabetic retinopathy in all stages in May 2019. Moreover, 56% of cases of visual impairment worldwide are caused by retinopathy, which affects one-fifth of the diabetic population. However, this illness's low screening and diagnostic rates harm market expansion in underdeveloped countries. Another issue limiting market growth is the significant likelihood of intraocular damage associated with anti-VEGF therapy.

Recent Developments

• March 2023- EyePoint Pharmaceuticals, Inc. announced that enrollment in Phase 2, ""Durasert® and Vorolanib in Ophthalmology 2"" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration has been completed (wet AMD). Patients were randomly assigned to one of two doses of EYP-1901 or an aflibercept on-label control after receiving standard anti-VEGF therapy.
• December 2022- Mirati Therapeutics, Inc. announced that the FDA had granted BTD to adagrasib in combination with cetuximab for patients with KRASG12C-mutated, advanced CRC whose cancer has progressed based on prior chemotherapy and anti-VEGF therapy.