망막 생물제제 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, retinal biologics market size in 2026 is estimated at USD 25.39 billion, growing from 2025 value of USD 23.78 billion with 2031 projections showing USD 35.25 billion, growing at 6.79% CAGR over 2026-2031.

This report is Segmented by Drug Class (VEGF-A Antagonist and More), Molecule Type (Monoclonal Antibodies and More), Indication (AMD and More), Route of Administration (Intravitreal Injection and More), Distribution Channel (Hospital Pharmacies and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Retinal Biologics Market Trends and Insights

Rapid Rise in Retinal Disease Burden & Diabetic Population

Escalating diabetes prevalence is fuelling diabetic retinopathy, which records a 9.26% CAGR and now represents the fastest-growing indication within the retinal biologics market. Emerging economies see parallel gains in diagnostic capacity that expose latent disease pools. One-time modalities such as ABBV-RGX-314 showed clinically meaningful improvements in diabetic retinopathy severity scores in the ALTITUDE study, reducing vision-threatening events and hinting at lower lifetime treatment costs. Payers see value, given the USD 134.2 billion economic burden tied to vision loss in the United States alone. Asia-Pacific markets face the steepest climb, combining high myopia rates with accelerating metabolic disease. The driver's long-term trajectory supports sustained demand for biologics with durable activity.

Accelerated R&D Output & FDA/EMA Approvals of Novel Biologics

Regulatory momentum underpins a vibrant pipeline. In March 2025 the FDA cleared ENCELTO for Macular Telangiectasia type 2, establishing a gene-based precedent. EMA's positive opinions for OCU410 and OCU410ST reinforce a harmonised European path for advanced therapies. Capital is flowing into capacity: Ritedose is investing USD 81 million in blow-fill-seal lines capable of producing 2.6 billion ophthalmic units annually. AI-driven trial design, exemplified by RetinAI collaborations with Boehringer Ingelheim, is elevating success odds. Together, these factors raise innovation velocity and broaden the retinal biologics market.

Stringent Regulatory Hurdles & Cap-Ex Intensity

Post-marketing safety issues heighten oversight, as seen when faricimab's label was updated to flag retinal vasculitis risk. FDA warning letters, including one issued to Regenerative Processing Plant in August 2024 for CGMP violations, illustrate rising compliance costs. Gene therapy programmes face multi-year follow-up mandates that smaller firms find capital-intensive. Recent FDA refusals of Nesvategrast and Outlook Therapeutics' wet AMD biologic underscore higher efficacy thresholds that elongate timelines and inflate budgets. These pressures restrain pipeline throughput despite strong investor interest.

Other drivers and restraints analyzed in the detailed report include:

1. Ageing Demographics Driving AMD Cases
2. Strong Clinical Adoption of Anti-VEGF Injections
3. High Drop-Out Rates from Burdensome Injection Schedules

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Gene therapies validated by ENCELTO's 2025 approval herald a shift from chronic injection regimens, yet VEGF-A antagonists still commanded a 58.12% retinal biologics market share in 2025. That dominance springs from long-established safety profiles and insurance coverage pathways. However, gene therapies are projected to expand at a 13.09% CAGR, the fastest within the retinal biologics market, reflecting clinician enthusiasm for durable protein expression platforms. Bispecific VEGF/Ang-2 inhibitors such as faricimab offer a bridging technology that lengthens dosing intervals while leveraging proven VEGF biology.

Growth prospects are also buoyed by complement inhibitors like pegcetacoplan and avacincaptad pegol, which widen the mechanism spectrum beyond angiogenesis. TNF-a inhibitors stay niche, primarily treating uveitic entities where systemic inflammation drives pathology-an "Others" bucket houses tyrosine kinase inhibitors and cell-based constructs that could upend today's hierarchy. Diversifying mechanisms and payer appetite for outcomes-based contracting reinforce the gene therapy growth curve inside the retinal biologics market.

Monoclonal antibodies undergirded 45.74% of the 2025 retinal biologics market size and will continue to post solid volume through brand maturity and biosimilar entry. Yet gene vectors, primarily adeno-associated viruses, will register a 11.98% CAGR, aided by sustained intraocular expression of anti-VEGF proteins in ABBV-RGX-314 trials. Fusion proteins retain relevance owing to aflibercept's clinical ubiquity, while antibody fragments provide potential cost and penetration advantages.

RNA-based candidates, led by ProQR's editing platform, target single-mutation diseases and attract orphan-drug incentives. Manufacturing advances such as modular vector suites accelerate lot release and reduce cost per dose. Payers weigh curative promise against upfront cost, yet outcome-based deals are emerging that could normalise one-time prices. As vectors cross regulatory hurdles, gene therapies are positioned to erode antibody hegemony in the retinal biologics market.

Complete Report Scope:

• By Drug Class
  • VEGF-A Antagonists
  • Bispecific VEGF/Ang-2 Inhibitors
  • Complement Inhibitors
  • TNF-? Inhibitors
  • Gene Therapies
  • Others
• By Molecule Type
  • Monoclonal Antibodies
  • Fusion Proteins
  • Antibody Fragments
  • Gene Therapy Vectors
  • RNA-based Biologics
• By Indication
  • Age-Related Macular Degeneration (AMD)
  • Diabetic Retinopathy
  • Uveitis
  • Other Retinal Disorders
• By Route of Administration
  • Intravitreal Injection
  • Suprachoroidal Injection
  • Sustained-Release Implant
  • Topical Delivery
  • Other Routes
• By Distribution Channel
  • Hospital Pharmacies
  • Specialty Clinics
  • Retail & Online Pharmacies
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 39.21% of the retinal biologics market size in 2025 and will grow at a 6.45% CAGR through 2031, buoyed by reimbursement frameworks that accept premium biologics despite intensifying step-therapy protocols. FDA designations hasten regional approvals, while domestic manufacturing expansions such as Ritedose's blow-fill-seal project position the United States as a supply hub. Biosimilar entry compresses pricing power, yet innovation cycles remain anchored in the region.

Asia-Pacific will deliver the fastest 8.12% CAGR, driven by demographic aging, diabetes growth, and government investment in ophthalmology infrastructure. Constraints include uneven specialist distribution and sporadic quality lapses; FDA citations of Indian fill-finish plants for sterility failures illustrate lingering hurdles. Multinationals such as Alcon are committing capital to local research centres and physician training programmes to build sustainable demand.

Europe enjoys 6.83% CAGR, aided by advanced therapy regulations and proactive biosimilar policies. EMA approval of Lytenava, a purpose-formulated bevacizumab, addresses off-label use and may reset price anchors. EMA designations for OCU410 variants further cement Europe's weight in gene therapy roll-out. Middle East & Africa and South America grow from smaller bases at 7.65% and 7.12% CAGRs respectively, offering longer-term upside to early entrants.

1. Abbvie
2. AbCellera Biologics
3. Adverum Biotechnologies
4. Amgen
5. Bausch Health
6. Bayer
7. Bioeq AG
8. Chengdu Kanghong Biotech
9. Roche
10. Genentech USA
11. GenSight Biologics S.A.
12. Astellas Pharma
13. Kodiak Sciences Inc.
14. Lumos Pharma, Inc.
15. MeiraGTx Holdings PLC
16. Novartis
17. Outlook Therapeutics Inc.
18. Oxurion
19. Regeneron Pharmaceuticals
20. Samsung Group
21. SemaThera
22. Viatris

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Market's Name is Retinal Biologics Market

2 Introduction

• 2.1 Study Assumptions & Market Definition
• 2.2 Scope of the Study

3 Research Methodology

4 Executive Summary

5 Market Landscape

• 5.1 Market Overview
• 5.2 Market Drivers
  • 5.2.1 Rapid Rise in Retinal Disease Burden & Diabetic Population
  • 5.2.2 Accelerated R&D Output & FDA/EMA Approvals of Novel Biologics
  • 5.2.3 Ageing Demographics Driving AMD Cases
  • 5.2.4 Strong Clinical Adoption of Anti-VEGF Injections
  • 5.2.5 Long-Acting Delivery Platforms Unlocking New Patient Pools
  • 5.2.6 Payer-Led Biosimilar Uptake in Cost-Sensitive Regions
• 5.3 Market Restraints
  • 5.3.1 Stringent Regulatory Hurdles & Cap-Ex Intensity
  • 5.3.2 Safety-Related Label Updates
  • 5.3.3 Sterile Fill-Finish Capacity Bottlenecks
  • 5.3.4 High Drop-Out Rates from Burdensome Injection Schedules
• 5.4 Supply Chain Analysis
• 5.5 Regulatory Landscape
• 5.6 Technological Outlook
• 5.7 Porter's Five Forces Analysis
  • 5.7.1 Threat of New Entrants
  • 5.7.2 Bargaining Power of Buyers
  • 5.7.3 Bargaining Power of Suppliers
  • 5.7.4 Threat of Substitutes
  • 5.7.5 Competitive Rivalry

6 Market Size & Growth Forecasts (Value)

• 6.1 By Drug Class
  • 6.1.1 VEGF-A Antagonists
  • 6.1.2 Bispecific VEGF/Ang-2 Inhibitors
  • 6.1.3 Complement Inhibitors
  • 6.1.4 TNF-? Inhibitors
  • 6.1.5 Gene Therapies
  • 6.1.6 Others
• 6.2 By Molecule Type
  • 6.2.1 Monoclonal Antibodies
  • 6.2.2 Fusion Proteins
  • 6.2.3 Antibody Fragments
  • 6.2.4 Gene Therapy Vectors
  • 6.2.5 RNA-based Biologics
• 6.3 By Indication
  • 6.3.1 Age-Related Macular Degeneration (AMD)
  • 6.3.2 Diabetic Retinopathy
  • 6.3.3 Uveitis
  • 6.3.4 Other Retinal Disorders
• 6.4 By Route of Administration
  • 6.4.1 Intravitreal Injection
  • 6.4.2 Suprachoroidal Injection
  • 6.4.3 Sustained-Release Implant
  • 6.4.4 Topical Delivery
  • 6.4.5 Other Routes
• 6.5 By Distribution Channel
  • 6.5.1 Hospital Pharmacies
  • 6.5.2 Specialty Clinics
  • 6.5.3 Retail & Online Pharmacies
• 6.6 By Geography
  • 6.6.1 North America
    • 6.6.1.1 United States
    • 6.6.1.2 Canada
    • 6.6.1.3 Mexico
  • 6.6.2 Europe
    • 6.6.2.1 Germany
    • 6.6.2.2 United Kingdom
    • 6.6.2.3 France
    • 6.6.2.4 Italy
    • 6.6.2.5 Spain
    • 6.6.2.6 Rest of Europe
  • 6.6.3 Asia-Pacific
    • 6.6.3.1 China
    • 6.6.3.2 Japan
    • 6.6.3.3 India
    • 6.6.3.4 Australia
    • 6.6.3.5 South Korea
    • 6.6.3.6 Rest of Asia-Pacific
  • 6.6.4 Middle East and Africa
    • 6.6.4.1 GCC
    • 6.6.4.2 South Africa
    • 6.6.4.3 Rest of Middle East and Africa
  • 6.6.5 South America
    • 6.6.5.1 Brazil
    • 6.6.5.2 Argentina
    • 6.6.5.3 Rest of South America

7 Competitive Landscape

• 7.1 Market Concentration
• 7.2 Competitive Benchmarking
• 7.3 Market Share Analysis
• 7.4 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 7.4.1 AbbVie Inc.
  • 7.4.2 AbCellera Biologics
  • 7.4.3 Adverum Biotechnologies Inc.
  • 7.4.4 Amgen Inc.
  • 7.4.5 Bausch Health Companies Inc.
  • 7.4.6 Bayer AG
  • 7.4.7 Bioeq AG
  • 7.4.8 Chengdu Kanghong Biotech
  • 7.4.9 F. Hoffmann-La Roche Ltd
  • 7.4.10 Genentech USA
  • 7.4.11 GenSight Biologics S.A.
  • 7.4.12 Astellas Pharma Inc.
  • 7.4.13 Kodiak Sciences Inc.
  • 7.4.14 Lumos Pharma, Inc.
  • 7.4.15 MeiraGTx Holdings PLC
  • 7.4.16 Novartis AG
  • 7.4.17 Outlook Therapeutics Inc.
  • 7.4.18 Oxurion NV
  • 7.4.19 Regeneron Pharmaceuticals Inc.
  • 7.4.20 Samsung Biologics
  • 7.4.21 SemaThera Inc.
  • 7.4.22 Viatris Inc.

8 Market Opportunities & Future Outlook

• 8.1 White-space & Unmet-need Assessment