Roots Analysis

Roots Analysis has done a detailed study on Ophthalmic Drugs Contract Manufacturing Market: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms (Ophthalmic Drops, Emulsions, Gels, Injections, Lotions, Ointments, Suspensions, and Tablets / Capsules), 2020-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

Key Market Insights

• Over 240 companies across the globe claim to have the required capabilities to offer variety of services on a contract basis, working at different scales of operation, for a wide range of ophthalmic APIs and drug FDFs
• The market is fragmented, featuring the presence of both established players and small firms based in different geographies that claim to be capable of manufacturing ophthalmic products
• Presently, majority of the CMOs are offering services for ophthalmic drug FDFs packaged in a variety of formats; popular types of containers include glass / plastic bottles, ointment tubes and ampoules / vials
• In order to acquire competencies across the supply chain and cater to evolving needs of sponsors, companies have established presence across different regions, having been certified by various regulatory authorities
• Several players involved in this domain are steadily expanding their capabilities in order to enhance their respective service portfolios and maintain a competitive edge
• In the past few years, over 10,700 trials, enrolling approximately 4.6 million patients, suffering from a wide range of chronic eye conditions, have been registered across the globe by different sponsors
• Most of the installed, global ophthalmic drug manufacturing capacity belongs to larger and more established CMOs, accounting for over 80% of available capacity across various geographies
• The demand for manufacturing services for ophthalmic drug products is expected to increase in the coming years; we believe stakeholders may have to expand their respective capacities to ensure consistent supply
• We expect ophthalmic drug developers to continue to outsource their development and manufacturing operations in the short to mid-term, causing service-based revenues to grow at an annualized rate of over 8%
• In the long-term, the projected opportunity is anticipated to be well distributed across various packaging formats, scales of operation and sizes of contract service providers
• Eminent representatives from prominent ophthalmic drug contract manufacturing companies confirm the importance of outsourcing, highlighting prevalent and anticipated trends within this domain

Table of Contents

1. PREFACE
   • Scope of the Report
   • Research Methodology
   • Chapter Outlines
2. EXECUTIVE SUMMARY
4. INTRODUCTION
   • Context and Background
   • Introduction to Ophthalmology
     • Chronic Eye Conditions and Associated Economic Burden
   • Common Ophthalmic Drug Dosage Forms
     • Types of Oral Drug Formulations
       • Tablets
       • Capsules
       • Eye Supplements
     • Types of Semi-solid Formulations
       • Ointments

3.5.2.2.    Gels

3.5.2.3.    Emulsions

• Types of Liquid Drug Formulations
  • Solutions
  • Suspensions

3.5.3.1.    Sterile Injectables

• Intraocular Inserts

• Common Primary Packaging Formats for Ophthalmic Drugs
• Overview of Contract Manufacturing
• Outsourcing in the Ophthalmology Industry
  • Need for Outsourcing
  • Commonly Outsourced Operations
  • Guidelines for Selecting a Contract Manufacturing Organization (CMO) Partner
  • Advantages of Outsourcing Manufacturing Operations
  • Challenges Associated with Ophthalmic Drugs Contract Manufacturing
  • Growth Drivers and Roadblocks to Ophthalmic Drugs Contract Manufacturing
  • Recent Developments and Upcoming Trends

1. CURRENT MARKET LANDSCAPE
   • Chapter Overview
   • Ophthalmic Drug Contract Manufacturers: Overall Market Landscape
     • Analysis by Year of Establishment
     • Analysis by Company Size
     • Analysis by Scale of Operation
     • Analysis by Geographical Location
     • Analysis by Location of Manufacturing Facilities
     • Analysis by Type of Product
     • Analysis by Type of FDF Manufactured
     • Analysis by Type of Primary Packaging
     • Analysis by Type of Service(s) Offered
     • Analysis by Regulatory Accreditations / Certifications

1. COMPANY COMPETITVENESS ANALYSIS
   • Chapter Overview
   • Key Assumptions and Methodology
   • Competitiveness Analysis: Ophthalmic API Contract Manufacturers
     • Ophthalmic API Contract Manufacturers in North America
     • Ophthalmic API Contract Manufacturers in Europe
     • Ophthalmic API Contract Manufacturers in Asia-Pacific
   • Competitiveness Analysis: Ophthalmic Drug FDF Contract Manufacturers
     • Ophthalmic Drug FDF Contract Manufacturers in North America
     • Ophthalmic Drug FDF Contract Manufacturers in Europe
     • Ophthalmic Drug FDF Contract Manufacturers in Asia-Pacific

1. OPHTHALMIC DRUGS CONTERACT MANUFACTURING IN NORTH AMERICA: COMPANY PROFILES
   • Chapter Overview
   • Akorn
     • Company Overview
     • Financial Information
     • Service Portfolio
     • Recent Developments and Future Outlook
   • Catalent
     • Company Overview
     • Financial Information
     • Service Portfolio

6.2.4.       Recent Developments and Future Outlook

• Cayman Chemical
  • Company Overview
  • Service Portfolio
  • Recent Developments and Future Outlook
• Pillar5 Pharma
  • Company Overview
  • Service Portfolio
  • Recent Developments and Future Outlook
• Sterling Pharmaceutical Services
  • Company Overview
  • Service Portfolio
  • Recent Developments and Future Outlook

1. OPHTHALMIC DRUGS CONTERACT MANUFACTURING IN EUROPE: COMPANY PROFILES
   • Chapter Overview
   • FARMIGEA
     • Company Overview
     • Service Portfolio
     • Recent Developments and Future Outlook
   • Lomapharm
     • Company Overview
     • Service Portfolio

7.3.3        Recent Developments and Future Outlook

• Medichem
  • Company Overview
  • Service Portfolio
  • Recent Developments and Future Outlook
• Recipharm
  • Company Overview
  • Financial Information
  • Service Portfolio
  • Recent Developments and Future Outlook
• Salvat
  • Company Overview

7.6.2        Service Portfolio

• Recent Developments and Future Outlook

1. OPHTHALMIC DRUGS CONTERACT MANUFACTURING IN ASIA-PACIFIC: COMPANY PROFILES
   • Chapter Overview
   • Akums
     • Company Overview
     • Service Portfolio
     • Recent Developments and Future Outlook
   • Bal Pharma
     • Company Overview
     • Financial Information
     • Service Portfolio

8.2.4.       Recent Developments and Future Outlook

• Entod Pharmaceuticals
  • Company Overview
  • Service Portfolio
  • Recent Developments and Future Outlook
• Glenmark Pharmaceuticals
  • Company Overview
  • Service Portfolio
  • Recent Developments and Future Outlook
• Indiana Ophthalmics
  • Company Overview
  • Service Portfolio
  • Recent Developments and Future Outlook
• Sunways India
  • Company Overview
  • Service Portfolio
  • Recent Developments and Future Outlook

1. CLINICAL TRIAL ANALYSIS
   • Chapter Overview
   • Scope and Methodology
   • Ophthalmic Drug Trial Analysis
     • Analysis by Trial Registration Year
     • Geographical Analysis by Number of Clinical Trials
     • Geographical Analysis by Enrolled Patient Population
     • Analysis by Phase of Development
     • Analysis by Trial Recruitment Status
     • Analysis by Type of Sponsor / Collaborator
     • Most Active Players in Terms of Number of Registered Trials
     • Analysis by Type of Intervention
     • Analysis by Trial Focus
     • Analysis by Target Indication
     • Benchmark Analysis of Active Industry Players
   • CAPACITY ANALYSIS
     • Chapter Overview
     • Key Assumptions and Methodology
     • Ophthalmic API Contract Manufacturers: Global Production Capacity
       • Analysis by Geography
         • Overall Production Capacity in North America
         • Overall Production Capacity in Europe
         • Overall Production Capacity in Asia-Pacific
         • Overall Production Capacity in Rest of the World
       • Analysis by Scale of Operation
         • Overall Clinical Scale Production Capacity
         • Overall Commercial Scale Production Capacity
         • Both Clinical and Commercial Scale Production Capacity
       • Analysis by Company Size
         • Overall Production Capacity of Small-sized Companies
         • Overall Production Capacity of Mid-sized Companies
         • Overall Production Capacity of Large Companies
         • Overall Production Capacity of Very Large Companies
       • Ophthalmic Drug FDF Contract Manufacturers: Global Production Capacity
         • Analysis by Geography
           • Overall Production Capacity in North America
           • Overall Production Capacity in Europe
           • Overall Production Capacity in Asia-Pacific
           • Overall Production Capacity in Rest of the World
         • Analysis by Scale of Operation
           • Overall Clinical Scale Production Capacity
           • Overall Commercial Scale Production Capacity
           • Both Clinical and Commercial Scale Production Capacity
         • Analysis by Company Size
           • Overall Production Capacity of Small-sized Companies
           • Overall Production Capacity of Mid-sized Companies
           • Overall Production Capacity of Large Companies
           • Overall Production Capacity of Very Large Companies
         • Analysis by Type of Primary Packaging
           • Overall Production Capacity of Ampoules / Vials
           • Overall Production Capacity of Glass / Plastic Bottles
           • Overall Production Capacity of Ointment Tubes
           • Overall Production Capacity of Blister Packing
           • Overall Production Capacity of Other Packaging Forms
         • DEMAND ANALYSIS
           • Chapter Overview
           • Key Assumptions and Methodology
           • Global Commercial Demand for Ophthalmic Drugs Contract Manufacturing
             • Commercial Demand for Ophthalmic API Contract Manufacturing
               • Analysis by Geography
               • Analysis by Target Indication
             • Commercial Demand for Ophthalmic Drug FDF Contract Manufacturing
               • Analysis by Geography
               • Analysis by Target Indication
               • Analysis by Type of Primary Packaging
             • Global Clinical Demand for Ophthalmic Drugs Contract Manufacturing
               • Clinical Demand for Ophthalmic API Contract Manufacturing
                 • Analysis by Geography
                 • Analysis by Target Indication
               • Clinical Demand for Ophthalmic Drug FDF Contract Manufacturing
                 • Analysis by Geography
                 • Analysis by Target Indication
                 • Analysis by Type of Primary Packaging
               • Demand and Supply Analysis
             • MARKET FORECAST
               • Chapter Overview
               • Key Assumptions and Forecast Methodology
               • Overall Ophthalmic Drugs Contract Manufacturing Market, 2020-2030
               • Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Product
                 • Ophthalmic API Contract Manufacturing Market, 2020-2030
                 • Ophthalmic Drug FDF Contract Manufacturing Market, 2020-2030
                   • Ophthalmic Drug FDF Contract Manufacturing Market, 2020-2030: Distribution by Type of FDF Manufactured
                     • Ophthalmic Drugs Contract Manufacturing Market for Solids, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Semi-solids, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Liquids / Suspensions, 2020-2030
                   • Ophthalmic Drug FDF Contract Manufacturing Market, 2020-2030: Distribution by Type of Primary Packaging
                     • Ophthalmic Drugs Contract Manufacturing Market for Ampoules / Vials, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Glass / Plastic Bottles, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Ointment Tubes, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Blister Packing, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Other Packaging Forms, 2020-2030
                   • Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Target Disease Indication
                     • Ophthalmic Drugs Contract Manufacturing Market for Age-related Macular Degeneration, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Dry Eye, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Glaucoma, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Other Eye Disorders, 2020-2030
                   • Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Scale of Operation
                     • Ophthalmic Drugs Contract Manufacturing Market for Clinical Scale Operations, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Commercial Scale Operations, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Both Clinical and Commercial Scale Operations, 2020-2030
                   • Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Size of Manufacturers
                     • Ophthalmic Drugs Contract Manufacturing Market for Small-sized Companies, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Mid-sized Companies, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Large Companies, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market for Very Large Companies, 2020-2030
                   • Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Geographical Regions
                     • Ophthalmic Drugs Contract Manufacturing Market in North America, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in the US, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Canada, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Mexico, 2020-203
                     • Ophthalmic Drugs Contract Manufacturing Market in Europe, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in the UK, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Germany, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in France, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Spain, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Italy, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Rest of Europe, 2020-2030
                     • Ophthalmic Drugs Contract Manufacturing Market in Asia-Pacific, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in India, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in China, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Japan, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Australia, 2020-2030
                       • Ophthalmic Drugs Contract Manufacturing Market in Rest of Asia-Pacific, 2020-2030
                     • CASE STUDY: COMPARISON OF SMALL MOLECULE AND LARGE MOLECULE OPHTHALMIC DRUGS / THERAPIES
                       • Chapter Overview
                       • Small Molecule Drugs and Biologics in Ophthalmology
                         • Comparison of Strengths and Weakness of Small Molecules and Biologics
                         • Comparison of Key Specifications
                         • Comparison of Manufacturing Processes
                         • Comparison of Key Manufacturing-related Challenges
                       • SWOT ANALYSIS
                         • Chapter Overview
                         • Comparison of SWOT Factors
                       • SURVEY ANALYSIS
                         • Chapter Overview
                         • Overview of Respondents
                           • Seniority Level of Respondents
                         • Survey Insights
                           • Type of Product
                           • Type of Primary Packaging
                           • Scale of Operation
                           • Manufacturing Capacity
                           • Location of Manufacturing Facilities
                           • Regulatory Accreditations / Certifications of Manufacturing Facilities
                           • Extent of Outsourcing
                           • Current Market Opportunity
                         • EXECUTIVE INSIGHTS
                           • Chapter Overview
                           • Caplin Point Laboratories
                             • Company Snapshot
                             • Interview Transcript: Ashok Partheeban, Director, Latin American Operations and Vivek Partheeban, Chief Operating Officer
                           • Gland Pharma
                             • Company Snapshot
                             • Interview Transcript: Iranna Bavalatti, Head of Manufacturing Science and Technology
                           • Selvok Pharmaceutical
                             • Company Snapshot
                             • Interview Transcript: Rahul Gupta, Chief Executive Officer
                           • Phytex Australia

16.4.1.     Company Snapshot

16.4.2.     Interview Transcript: Stuart Smith, Managing Director

• FUTURE GROWTH OPPORTUNITIES
  • Chapter Overview
  • Integration / Adoption of New and Innovative Technologies
  • Capability and Expertise Expansions by CMOs
  • Offshoring Outsourcing Activities
  • Growing Investments in Existing Infrastructure
  • Evolving Client / Sponsor and CMO / CDMO Relationships
  • Challenges Faced by Both Sponsors and Service Providers
    • Concerns Related to Single Use Systems
    • Concerns Related to Capacity Fluctuations
  • APPENDIX 1: LIST OF OPHTHALMIC MEDICAL DEVICE CONTRACT
  • MANUFACTURERS
  • APPENDIX 2: TABULATED DATA
  • APPENDIX 3: LIST OF COMPANIES AND ORGANIZATIONS

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