Report ID: PMRREP34570
Number of Pages: 219
Format: PPT*, PDF, EXCEL
Industry: Healthcare
Published Date: June-2024
The global retinal biologics market is estimated to value at US$42.9 Bn by the end of 2031 from US$24.9 Bn in 2024. The market is expected to secure a CAGR of 8.1% during the forecast period from 2024 to 2031.
Key Highlights of the Market
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Market Attributes |
Key Insights |
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Market Size (2024E) |
US$24.9 Bn |
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Projected Market Value (2031F) |
US$42.9 Bn |
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Global Market Growth Rate (CAGR 2024 to 2033) |
8.1% |
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Historical Market Growth Rate (CAGR 2019 to 2023) |
7.5% |
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Retinal biologics are bioengineered substances administered into the eyes to address persistent retinal disorders. These biologics are typically derived from living organisms like microbes, animal cells, or plant cells.
Prime examples of retinal biologics used in treating such conditions include Eylea, Lucentis, Humira, and Macugen. The rising incidence of retinal disorders like age-related macular degeneration globally is fueling market expansion.
According to statistics from the World Health Organization (WHO), nearly 2.2 billion people worldwide experience near or distance visual impairment. With the increasing prevalence of vision issues, there is a corresponding surge in demand for effective treatment options, such as retinal biologics.
Noteworthy market developments include innovations in ocular drug delivery to the retina, such as the introduction of intravitreal medications. Macroeconomic and industry factors, along with stringent regulatory criteria and biologic approval processes, also impact the retinal biologics market.
The decline in BPS values is attributed to the scarcity of retinal biologics, their significant side effects, stringent regulatory criteria for approval, and the high cost of effective medications, and biologics.
Despite these challenges, the market is projected to experience favorable growth due to increased research efforts focusing on developing innovative biologics for novel disease therapies.
Development of new biologics to specifically target the molecular pathways involved in retinal diseases is marked as one of the important trends shaping the market in the upcoming years.
These treatments offer targeted action, minimizing systemic side effects and potentially improving visual outcomes. For instance, drugs like Vabysmo target both VEGF-A, and Ang-2 pathways?.
The prevalence of VEGF-A antagonists, and TNF-A inhibitors is also perceived as an influential market trend. The former, including ranibizumab, aflibercept, and the recently approved faricimab-svoa (Vabysmo), have shown particularly successful in treating wet age-related macular degeneration, and diabetic macular edema.
These medications target specific molecular pathways to manage and treat retinal disorders, resulting in better patient outcomes and significant market growth.
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Get a Customized VersionMarket research suggests a significant rise in the retinal biologics market between 2019 and 2023. The growth is likely driven by factors like the increasing prevalence of retinal diseases like age-related macular degeneration (AMD), and diabetic retinopathy.
The growing geriatric population, more susceptible to these diseases, and the rising adoption of novel retinal biologics for treatment.
The growth outlook of the market for the upcoming years looks promising, majorly driven by continued advancements in gene therapies for retinal diseases, sustained demand for effective treatments due to the growing prevalence of retinal conditions, and rising healthcare expenditure globally.
As this is responsible for raising the accessibility of these treatments, the market expansion is likely to pick pace in the years to come.
Increasing Prevalence of Retinal Diseases
Growing global elderly population presents significant challenges for society today and in the foreseeable future. Over the past two centuries, average human life expectancy has doubled in many developed nations.
Projections indicate that the global population is estimated to reach 8.5 billion by 2030, 9.7 billion by 2050, and 10.9 billion by 2100.
Currently, around 9% of the world's population is aged 65 or older, with estimates suggesting this is going to rise to nearly 12% by 2030, 16% by 2050, and 23% by 2100.
The rate of growth is notably faster for individuals over 80 years old. For instance,
Diabetes presents a significant risk factor for retinal diseases like diabetic retinopathy, and diabetic macular edema (DME).
The global rise in diabetes prevalence directly correlates with an increase in these retinal conditions. Managing these conditions effectively often requires advanced biologic therapies, leading to the growth of the retinal biologics market.
Lifestyle factors such as poor diet, sedentary habits, and prolonged screen exposure contribute to the uptick in retinal diseases. These lifestyle aspects can exacerbate diabetes and hypertension, heightening the risk of retinal disorders.
The escalating prevalence of retinal diseases underscores the necessity for targeted and efficient treatments, making retinal biologics indispensable in contemporary ophthalmology.
The fact highlights the ongoing need for research, development, and accessibility of biologic therapies to effectively manage and treat retinal diseases, thus propelling market growth.
High Development and Manufacturing Costs of Retinal Biologics Products
The retinal biologics market faces substantial constraints due to the significant costs associated with development and manufacturing, which impede its growth and accessibility.
The intricate and prolonged development process, encompassing extensive research, preclinical and clinical trials, demands considerable financial resources and investments.
Manufacturing biologics necessitates specialized facilities, strict quality control measures, and advanced biomanufacturing technologies, all contributing to elevated production expenses.
Financial challenges often result in high prices for retinal biologic therapies, creating barriers to patient access and complicating reimbursement negotiations with payers.
New entrants, and smaller companies encounter difficulties due to these high costs, potentially hindering competition and innovation within the market.
Overcoming the obstacles requires strategic investments in technology, collaborative initiatives, and streamlined regulatory frameworks to foster a sustainable and inclusive market environment for retinal biologics.
The significant development and manufacturing costs serve as a substantial impediment to the retinal biologics market, leading to higher product prices, limiting market entry for smaller players, and posing reimbursement challenges.
Tackling these issues demands targeted investments, cooperation, and regulatory enhancements to ensure the market's viability and enhance patient access to essential therapies.
Leveraging Autophagy in the Retinal Biologics Market
Autophagy, a critical cellular pathway centered around lysosomes and essential for maintaining cellular balance, presents a notable opportunity in the retinal biologics sector.
This process is pivotal for eliminating damaged cellular components, supplying nutrients during metabolic stress, and safeguarding against genomic damage.
Autophagy encompasses various mechanisms like macroautophagy, microautophagy, and chaperone-mediated autophagy, which identify, engulf, and transport intracellular components to lysosomes for degradation.
These mechanisms are crucial for cellular quality control by eliminating damaged proteins and organelles, and ensuring the availability of essential nutrients, especially under stressful conditions.
Given its pivotal role in cellular health, autophagy is implicated in numerous human diseases, including cancer and neurodegenerative disorders, acting both protectively and detrimentally depending on the context.
In the context of retinal diseases like age-related macular degeneration (AMD) and diabetic retinopathy, manipulating autophagy pathways holds promise for developing novel therapeutic strategies.
Retinal biologics companies can explore autophagy modulation's potential to create innovative treatments. For instance, boosting autophagic activity could aid in clearing damaged cellular components in retinal cells, potentially slowing disease progression and enhancing cell survival.
Targeting specific autophagy forms, such as mitophagy for damaged mitochondria or xenophagy for pathogens, could lead to more precise and effective therapies.
By seizing this opportunity, companies in the market can drive innovation, expand patient accessibility, and achieve sustainable growth in this dynamic industry.
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Category |
Projected CAGR through 2031 |
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Product – VEGF-A Antagonists |
8.7% |
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Indication – Macular Degeneration |
8.5% |
VEGF-A Antagonists Lead the Product Type Category
VEGF-A antagonists have gained broad acceptance in the retinal biologics market and expected to record 8.7% CAGR. compared to TNF-α inhibitors due to their targeted approach against the underlying mechanisms of prevalent and severe retinal diseases.
These diseases include age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy. These conditions are characterized by abnormal blood vessel growth and leakage in the retina, driven by vascular endothelial growth factor (VEGF).
Drugs such as ranibizumab (Lucentis), and aflibercept (Eylea), which are VEGF-A antagonists, effectively inhibit VEGF, halting disease progression and improving visual outcomes. Their efficacy is well-established through extensive clinical trials and subsequent FDA approvals, leading to widespread clinical adoption.
Substantial investments in research and development have fueled continuous innovations in VEGF-A antagonists, enhancing their therapeutic effectiveness and patient adherence.
TNF-α inhibitors are primarily utilized for systemic inflammatory conditions and lack the specificity needed for optimal treatment of retinal diseases. Consequently, positioning VEGF-A antagonists as the preferred option in the retinal market.
Macular Degeneration to Record 8.5% CAGR through 2031
The retinal biologics market primarily prioritizes addressing macular degeneration, especially age-related macular degeneration (AMD), over diabetic macular edema (DME), diabetic retinopathy, uveitis, and other indications.
It is due to AMD's high prevalence and significant impact on vision. AMD stands as a leading cause of blindness among older adults, creating a substantial patient base requiring effective treatments.
Biologics, notably VEGF-A antagonists, have been extensively studied and approved for AMD, particularly its neovascular (wet) form, effectively slowing its progression.
Clinical trials have demonstrated the significant efficacy of these treatments, leading to widespread adoption by ophthalmologists.
Moreover, the economic burden and quality-of-life implications of AMD drive substantial investment in researching and developing new therapies. These further ensure ongoing innovation and enhancement of treatment options.
While DME, diabetic retinopathy, and uveitis are also serious conditions, they have lower overall prevalence rates and impact, resulting in relatively less emphasis in the retinal biologics market.
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Region |
Projected CAGR through 2031 |
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North America |
8.2% |
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Europe |
8.9% |
North America Takes the Charge in the Market
North America's leadership in the retinal biologics market is attributed to various factors. North America is estimated to secure a CAGR of 8.2% through 2031.
The region boasts advanced healthcare infrastructure, including cutting-edge medical facilities and a well-connected network of healthcare providers. It facilitates the research, development, and distribution of innovative biologic drugs for retinal disorders.
North America is home to numerous pharmaceutical and biotechnology firms with robust research and development capabilities, making substantial investments in creating novel therapies.
The high prevalence of retinal disorders in North America, coupled with a robust regulatory framework governed by entities like the US FDA, provides an environment conducive to the development and approval of retinal biologics.
The region's significant healthcare expenditure, clinical expertise, market demand, and focus on patient outcomes collectively contribute to its leadership role in advancing retinal disease treatments through biologic interventions.
Europe to Emerge as Rapidly Growing Regional Market for Retinal Biologics
Europe is emerging as a significantly growing region in the global market of retinal biologics for several compelling reasons.
The region benefits from a well-developed healthcare infrastructure, encompassing leading medical institutions, specialized clinics, and a skilled workforce dedicated to retinal care.
Europe has a strong emphasis on research and development, with numerous pharmaceutical and biotechnology companies actively pursuing advancements in biologic therapies for retinal disorders.
The prevalence of retinal diseases in Europe, including age-related macular degeneration and diabetic retinopathy, has spurred significant market demand for effective treatments, driving investment and innovation.
Additionally, the regulatory landscape in Europe provides a streamlined pathway for the approval and commercialization of retinal biologics, encouraging companies to bring their cutting-edge therapies to market swiftly.
Different factors, combined with increasing awareness among healthcare providers and patients about the benefits of biologic interventions, position Europe as a dynamic and rapidly growing region in the market for retinal biologics.
Collaborations, and partnership to develop innovative products, and accelerate the grant by regulatory bodies are the key growth strategies followed by the prominent players in the market.
Companies are continuously investing in research and development to introduce innovative and breakthrough retinal biologics products.
Recent Industry Developments
October 2023
SpliceBio partners with Spark Therapeutics to develop gene targeting retinal disease. The platform offers the potential to address diseases that currently cannot be treated with gene therapies because the necessary gene is too large to be delivered by adeno-associated virus (AAV) vectors.
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Attributes |
Details |
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Forecast Period |
2024 to 2031 |
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Historical Data Available for |
2019 to 2023 |
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Market Analysis |
US$ Billion for Value |
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Key Regions Covered |
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Key Market Segments Covered |
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Key Companies Profiled |
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Report Coverage |
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Customization & Pricing |
Available upon request |
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Some of the key players operating in the market are Spark Therapeutics, Inc., F. Hoffmann-La Roche Ltd., and Regeneron Pharmaceuticals, Inc.
Macular degeneration type is estimated to record a significant market share through 2031.
The VEGF-A antagonists type is estimated to secure a significant market share through 2031.
Leveraging autophagy in the retinal biologics market presents key opportunities for the market players.
Increasing prevalence of retinal diseases is gaining traction in the market.
