Advances in treating various types of retinal diseases, mostly those affecting an area in the eye called macula like age-related macular degeneration (AMD) and diabetic macular edema (DME), are driving major trends in the market for retinal biologics. One of these is an increasing visibility of biologic therapies aimed at hitting specific pathways involved in the development of retinal disorders. Usually given as intravitreal injections, these biologics aim at addressing causes thus working more precisely than conventional treatments.
The rise of anti-vascular endothelial growth factor (anti-VEGF) biologics has been a game changer in the pharmaceutical retinal market. Ranibizumab and aflibercept are now becoming standard therapies for neovascular AMD and DME respectively among other anti-VEGF agents. Such drugs help suppress abnormal blood vessel growth and leakages that improve patients’ vision drastically. Another important trend is the continuous development of new anti-VEGF drugs with longer half-lives that reduce frequency of intravitreal injections thereby providing convenience to patients.
The pharmaceutical industry’s retina biologics business has started to shift towards personalized healthcare. Researchers have been looking into genetic or molecular markers that could identify different types of retinal conditions and predict responses from individuals when using certain biological treatments. This tendency is consistent with overall trend of healthcare toward precision medicine where unique attributes are considered before formulating treatment options leading to enhanced results and reduced side effects.
Innovation in the field of retinal biologics coming from collaborations among drug companies and research centers helps drive progressiveness. The complexity associated with diseases linked to retina calls for multidisciplinary approach thereby making partnerships essential for discovering new therapeutic approaches to them. Such partnerships make it faster to convert scientific findings into useful clinical products such as biologicals which spurs a dynamic market response.
Patient-centered factors are shaping the pharmaceutical market for retinal biologics by focusing on optimizing patient outcomes and experiences. This implies that technological advancement is not just about making biologics with longer action duration but also avoiding frequent intravitreal injections which are a burden to patients. Moreover, the trend towards non-invasive techniques of administration including sustained-release implants is more friendly to patients as compared to the traditional injection-based therapies.
The retinal biologics market has been influenced by innovations in drug delivery technologies. Among several other trends, one can highlight the development of devices or implants for continuous release of drugs into the eye. These techniques help reducing treatment frequency providing relief to sufferers from repeated injections. Thus, it is anticipated that upcoming generations of these innovative systems will foster growth and diversification in the field of retinal therapeutics.
Some challenges in the pharmaceutical retinal biologics market include long-term safety assessment requirements, cost elements and access concerns for example. For instance, since retinal diseases are chronic conditions requiring extended treatment periods, it becomes important having long-term safety data for retinal biologicals. The high costs associated with biologic therapies such as research and development expenses may limit their accessibility even if they could be beneficial to certain groups of patients. Meeting this objective while balancing between innovation, lower costs and broadening patient reach remains a struggle for pharmaceutical players operating in this industry.
Retinal Biologics Market Size was valued at USD 6.5 Billion in 2022. The Retinal Biologics market Drug Class is projected to grow from USD 7.4 Billion in 2023 to USD 19.8 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 13.20% during the forecast period (2023 - 2032). Retinal vein occlusion (RVO) and age-related macular degeneration are becoming more common, and there are a rising number of cases of ophthalmic conditions causing chronic retinal diseases worldwide, are the key market drivers enhancing the market growth.
Source Secondary Research, Primary Research, MRFR Database and Analyst Review
In March 2024, Sandoz, a major player in generic and bio-similar medications, announced that it had finished buying the American biosimilar for ranibizumab-earn (Cimerli) from Coherus Biosciences, Inc. before the planned time frame. The purchase, according to the company statement, is an extension of Sandoz’s leadership position in US ophthalmology and lays an even stronger foundation for future product launches. CIMERLI treats certain retinal diseases that, if not treated, could lead to blindness and ranks among the top 10 causes of disability in the United States. It falls under the anti-VEGF therapy class of biologics designed to help maintain or increase vision among patients with multiple retinal conditions. On January 1st, 2024, a deal was made between Sandoz AbbVie, wherein Sandoz agreed to buy all CIMERLI business for an upfront cash price of $170 million.
In May 2024, GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985 PEA-PME eligible), a biopharma Company specialized in developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announces resumption of trading in shares following the success of its Offering (as defined below) through (i) capital increase reserved to specialized investors and (ii) concurrent capital increase by way of private placement by the issuance of new shares with warrants attached at total gross amount of EUR 9-28251580 (excludes any future net proceeds related with exercising warrants). Offering Price per one ABSA equals €0.395 (“Offering Price”). The offering Price is the same as the Offering Price for two simultaneous capital increases.
In September 2023, Ocugen Inc. (OCGN) announced a clinical study update for Retinitis Pigmentosa (RP) Participants Treated in the Phase 1/2 Trial to Assess the Safety and Efficacy of OCU400 for RP Associated with NR2E3 and Rhodopsin (RHO) Mutations and Leber Congenital Amaurosis (LCA) With Mutation(s) in the CEP290 Gene. This announcement is an expansion of the earlier results from April 14th, 2023, on a high-dose cohort by Ocugen. The Company believes that OCU400—Ocugen’s therapeutic approach, utilizing a proprietary modifier gene therapy platform—has the potential to be a gene-agnostic therapeutic for RP AND LCA patients WITH inherited retinal degeneration.
The main reason fueling the market's expansion is the rising incidence of ocular problems that lead to chronic retinal diseases in different parts of the world. The World Health Organisation estimates that over 2.2 billion individuals worldwide have a vision issue. The enormous patient base experiencing eye problems is what fuels market expansion. Age-related macular degeneration (AMD) and retinal vein occlusion (RVO) are becoming more common. RVO is the second most prevalent retinal vascular condition and a major contributor to vision loss. There are around 11 million Americans who suffer from some sort of age-related macular degeneration. By 2050, this figure is projected to rise to around 22 million. The market expansion for retinal biologics is supported over the forecast period by expanding R&D efforts and new launches.
The market would be propelled by a high emphasis on research and development (R&D) related to retinal gene treatments carried out by various institutes, biologics companies, and innovative product releases by key industry participants in the form of biologics and implants. The market will grow faster if efforts are made to provide complementary therapeutic interventions. Concern over diabetic retinopathy has increased as more type I and type II adult diabetes individuals experience visual loss as a result of the condition. The effects of diabetic retinopathy, which cause the macula to swell, also result in diabetic macular edoema. Another factor driving the demand for retinal medicines and biologics is the rising prevalence of other retinal illnesses such uveitis and orbital inflammation. Retinal gene therapy is a therapeutic strategy in which DNA or RNA is used to treat inherited faulty genes. Because there is minimal contamination and the viral vector can fit easily into the eyes, retinal gene therapy is seen as a key strategy.
Age-related macular degeneration (AMD) and other disorders associated with an ageing population will be a driving force behind this market's expansion. There are about 15 million AMD sufferers in the United States, according to studies by the American Academy of Ophthalmology. In some persons, especially the elderly, the condition may result in a loss of central visual acuity in either one or both eyes. Age-related progression of AMD disease puts the older population at higher risk. Additionally, increased alcohol and smoking use opens the door for a number of illnesses, including hypertension and hypercholesterolemia, which will benefit the retinal biologics business. The development of retinal biologics will benefit from significant investments in R&D as well as strategic alliances amongst market participants. As diabetes causes diabetic retinopathy and diabetic macula edoema, two of the most prevalent retinal illnesses, it will also have an impact on the growth of the retinal biologics market. Thus, driving the Retinal Biologics market revenue.
The Retinal Biologics market segmentation, based on Drug Class, includes TNF-a inhibitor and VEGF-A antagonist. VEGF-A antagonist segment dominated the market in 2022. This biologic is used to treat age-related macular degeneration with neovascularization. Businesses are concentrating on creating and introducing VEGF for the treatment of eye issues. For instance, Lucentis (ranibizumab injectable) for the treatment of diabetic retinopathy was approved by the US FDA in March 2018 and was manufactured by F. Hoffmann-La Roche Ltd. The segmented retinal biologics market is expanding as a result of rising product approvals and the introduction of new treatments.
The Retinal Biologics market segmentation, based on Indication, includes macular degeneration, diabetic retinopathy, uveitis, and others. Macular degeneration segment dominated the market in 2022. One of the main causes of the incidence of DR is the rapidly growing diabetic population. By 2045, the International Diabetes Federation (IDF) predicts that 783 million adults would be living with diabetes. As a result, it could raise the risk of DR, which is one of the most prevalent reasons for visual loss in people with diabetes. These elements are anticipated to hasten the market development for retinal biologics.
The Retinal Biologics market segmentation, based on Distribution Channel, includes hospitals and clinics, pharmacies, and others. Hospitals and clinics segment dominated the Retinal Biologics market in 2022. Hospitals have access to a wide variety of cutting-edge treatments that can significantly improve a patient's surgical success. Retinal biologic treatments have been made available by numerous prestigious hospital networks to successfully treat a range of eye conditions. As an illustration, the Max Hospital in South Delhi, India opened its Max Institute Eye Care (MIEC), a cutting-edge eye care facility, to provide cutting-edge technologies and treatments for various eye illnesses. Such advancements are enhancing the market outlook by enticing more patients to visit hospitals for routine eye exams.
Figure 1 Retinal Biologics Market, by Distribution Channel, 2022 & 2032 (USD Billion)
Source Secondary Research, Primary Research, MRFR Database and Analyst Review
Retinal Biologics Regional Insights
By region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. The North America Retinal Biologics Market dominated this market in 2022 (45.80%). Eye illnesses are regarded as one of the ongoing issues for the US and other nations. Due to the increasing incidences of macular degeneration, diabetic retinopathy, uveitis, and other eye diseases, America accounted for the largest market. Macular degeneration affects about 196 million individuals ly today, and that number is predicted to rise to 288 million by 2040. The need for retinal biologics products is rising in this region as there are more and more new cases of eye ailments. Further, the U.S. Retinal Biologics market held the largest market share, and the Canada Retinal Biologics market was the fastest growing market in the North America region.
Further, the major countries studied in the market report are The US, Canada, German, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 2 RETINAL BIOLOGICS MARKET SHARE BY REGION 2022 (USD Billion)
Source Secondary Research, Primary Research, MRFR Database and Analyst Review
Europe Retinal Biologics market accounted for the healthy market share in 2022. Growing healthcare innovation, increased emphasis on creating new retinal biologics, and the presence of numerous healthcare businesses in this area all contribute to the expansion of the European market. In the European Union (EU) and its five most populous nations—Germany, France, the United Kingdom, Italy, and Spain—almost 22 million individuals had age-related macular degeneration (AMD) as of 2017. Further, the German Retinal Biologics market held the largest market share, and the U.K Retinal Biologics market was the fastest growing market in the European region
The Asia Pacific Retinal Biologics market is expected to register significant growth from 2023 to 2032. Due to increased research into the creation of retinal biologics and the rising incidence of eye illnesses, this region has been experiencing an increase in market growth. Additionally, the market for retinal biologics is supported by the growing elderly population. Moreover, China’s Retinal Biologics market held the largest market share, and the Indian Retinal Biologics market was the fastest growing market in the Asia-Pacific region.
Retinal Biologics Key Market Players & Competitive Insights
Leading market players are investing heavily in research and development in order to expand their product lines, which will help the Retinal Biologics market, grow even more. Market participants are also undertaking a variety of strategic activities to expand their footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, Retinal Biologics Industry must offer cost-effective items.
Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the Retinal Biologics Industry to benefit clients and increase the market sector. In recent years, the Retinal Biologics Industry has offered some of the most significant advantages to medicine. Major players in the Retinal Biologics market, including Amgen, Inc., AbbVie Inc., MeiraGTX Limited, Regeneron Pharmaceuticals Inc, Ocular Therapeutixc., Spark Therapeutics, F. Hoffmann-La, Roche Ltd., Genentech, and Johnson & Johnson, are attempting to increase market demand by investing in research and development operations.
A biotechnology corporation called F. Hoffmann-La Roche Ltd. (Roche) creates medications and diagnostic tools to combat serious illnesses. It offers medications for the treatment of respiratory illnesses, cancer, various auto-immune diseases, neurological disorders, ophthalmological disorders, and central nervous system problems. The business also provides diabetes management programmes, tissue-based cancer diagnostics, and in vitro diagnostics. Roche carries out research to find cutting-edge ways to treat, diagnose, and prevent illnesses. Hospitals, healthcare professionals, commercial laboratories, researchers, and chemists are among the groups that the business serves with its goods and services. In order to increase SemaThera's portfolio of innovative biologics for the treatment of ischemic retinal diseases such diabetic retinopathy, Roche and SemaThera Inc. launched a multi-year research and licencing collaboration in 2021.
The creation, manufacture, and marketing of prescription and over-the-counter medications, as well as items for eye care, are the specialties of a healthcare company by the name of Novartis AG (Novartis). It provides medications for treating solid tumours, immune system problems, infections, cardiovascular disease, dermatological problems, neurological problems, ophthalmic and respiratory illnesses, cancer, and neurological abnormalities, among other conditions. The company sells biosimilars and generic drugs through Sandoz. Novartis conducts research in several disease-related sectors through the Novartis Institutes for BioMedical Research (NIBR). Novartis' supplementary biologic licence application (sBLA) for Beovu (brolucizumab) 6 mg for the treatment of diabetic macular edoema (DME) was approved by the US Food and Drug Administration (FDA) in October 2021.
Key Companies in the Retinal Biologics market include
Retinal Biologics Industry Developments
July 2021 The Biologics Licence Application (BLA) for faricimab by Genentech to treat wet, or neovascular, diabetic macular edoema (DME), age-related macular degeneration (AMD), and diabetic retinopathy has been authorised by the US Food and Drug Administration (FDA). Genentech is a part of the Roche Group.
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