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.
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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
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Table of Contents
- PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
- EXECUTIVE SUMMARY
- INTRODUCTION
3.1. Context and Background
3.2. Introduction to Ophthalmology
3.2.1. Chronic Eye Conditions and Associated Economic Burden
3.3. Common Ophthalmic Drug Dosage Forms
3.3.1. Types of Oral Drug Formulations
3.3.1.1. Tablets
3.3.1.2. Capsules
3.3.1.3. Eye Supplements
3.3.2. Types of Semi-solid Formulations
3.3.2.1. Ointments
3.5.2.2. Gels
3.5.2.3. Emulsions
3.3.3. Types of Liquid Drug Formulations
3.3.3.1. Solutions
3.3.3.2. Suspensions
3.5.3.1. Sterile Injectables
3.3.4. Intraocular Inserts
3.4. Common Primary Packaging Formats for Ophthalmic Drugs
3.5. Overview of Contract Manufacturing
3.6. Outsourcing in the Ophthalmology Industry
3.6.1. Need for Outsourcing
3.6.2. Commonly Outsourced Operations
3.6.3. Guidelines for Selecting a Contract Manufacturing Organization (CMO) Partner
3.6.4. Advantages of Outsourcing Manufacturing Operations
3.6.5. Challenges Associated with Ophthalmic Drugs Contract Manufacturing
3.6.6. Growth Drivers and Roadblocks to Ophthalmic Drugs Contract Manufacturing
3.6.7. Recent Developments and Upcoming Trends
- CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Ophthalmic Drug Contract Manufacturers: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Scale of Operation
4.2.4. Analysis by Geographical Location
4.2.5. Analysis by Location of Manufacturing Facilities
4.2.6. Analysis by Type of Product
4.2.7. Analysis by Type of FDF Manufactured
4.2.8. Analysis by Type of Primary Packaging
4.2.9. Analysis by Type of Service(s) Offered
4.2.10. Analysis by Regulatory Accreditations / Certifications
- COMPANY COMPETITVENESS ANALYSIS
5.1. Chapter Overview
5.2. Key Assumptions and Methodology
5.3. Competitiveness Analysis: Ophthalmic API Contract Manufacturers
5.3.1. Ophthalmic API Contract Manufacturers in North America
5.3.2. Ophthalmic API Contract Manufacturers in Europe
5.3.3. Ophthalmic API Contract Manufacturers in Asia-Pacific
5.4. Competitiveness Analysis: Ophthalmic Drug FDF Contract Manufacturers
5.4.1. Ophthalmic Drug FDF Contract Manufacturers in North America
5.4.2. Ophthalmic Drug FDF Contract Manufacturers in Europe
5.4.3. Ophthalmic Drug FDF Contract Manufacturers in Asia-Pacific
- OPHTHALMIC DRUGS CONTERACT MANUFACTURING IN NORTH AMERICA: COMPANY PROFILES
6.1. Chapter Overview
6.2. Akorn
6.2.1. Company Overview
6.2.2. Financial Information
6.2.3. Service Portfolio
6.2.4. Recent Developments and Future Outlook
6.3. Catalent
6.3.1. Company Overview
6.3.2. Financial Information
6.3.3. Service Portfolio
6.2.4. Recent Developments and Future Outlook
6.4. Cayman Chemical
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.3. Recent Developments and Future Outlook
6.5. Pillar5 Pharma
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Recent Developments and Future Outlook
6.6. Sterling Pharmaceutical Services
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.3. Recent Developments and Future Outlook
- OPHTHALMIC DRUGS CONTERACT MANUFACTURING IN EUROPE: COMPANY PROFILES
7.1. Chapter Overview
7.2. FARMIGEA
7.2.1. Company Overview
7.2.2. Service Portfolio
7.2.3. Recent Developments and Future Outlook
7.3. Lomapharm
7.3.1. Company Overview
7.3.2. Service Portfolio
7.3.3 Recent Developments and Future Outlook
7.4. Medichem
7.4.1. Company Overview
7.4.2. Service Portfolio
7.4.3. Recent Developments and Future Outlook
7.5. Recipharm
7.5.1. Company Overview
7.5.2. Financial Information
7.5.3. Service Portfolio
7.5.4. Recent Developments and Future Outlook
7.6. Salvat
7.6.1. Company Overview
7.6.2 Service Portfolio
7.6.3. Recent Developments and Future Outlook
- OPHTHALMIC DRUGS CONTERACT MANUFACTURING IN ASIA-PACIFIC: COMPANY PROFILES
8.1. Chapter Overview
8.2. Akums
8.2.1. Company Overview
8.2.2. Service Portfolio
8.2.3. Recent Developments and Future Outlook
8.3. Bal Pharma
8.3.1. Company Overview
8.3.2. Financial Information
8.3.3. Service Portfolio
8.2.4. Recent Developments and Future Outlook
8.4. Entod Pharmaceuticals
8.4.1. Company Overview
8.4.2. Service Portfolio
8.4.3. Recent Developments and Future Outlook
8.5. Glenmark Pharmaceuticals
8.5.1. Company Overview
8.5.2. Service Portfolio
8.5.3. Recent Developments and Future Outlook
8.6. Indiana Ophthalmics
8.6.1. Company Overview
8.6.2. Service Portfolio
8.6.3. Recent Developments and Future Outlook
8.7. Sunways India
8.7.1. Company Overview
8.7.2. Service Portfolio
8.7.3. Recent Developments and Future Outlook
- CLINICAL TRIAL ANALYSIS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Ophthalmic Drug Trial Analysis
9.3.1. Analysis by Trial Registration Year
9.3.2. Geographical Analysis by Number of Clinical Trials
9.3.3. Geographical Analysis by Enrolled Patient Population
9.3.4. Analysis by Phase of Development
9.3.5. Analysis by Trial Recruitment Status
9.3.6. Analysis by Type of Sponsor / Collaborator
9.3.7. Most Active Players in Terms of Number of Registered Trials
9.3.8. Analysis by Type of Intervention
9.3.9. Analysis by Trial Focus
9.3.10. Analysis by Target Indication
9.3.11. Benchmark Analysis of Active Industry Players
- CAPACITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.3. Ophthalmic API Contract Manufacturers: Global Production Capacity
10.3.1. Analysis by Geography
10.3.1.1. Overall Production Capacity in North America
10.3.1.2. Overall Production Capacity in Europe
10.3.1.3. Overall Production Capacity in Asia-Pacific
10.3.1.4. Overall Production Capacity in Rest of the World
10.3.2. Analysis by Scale of Operation
10.3.2.1. Overall Clinical Scale Production Capacity
10.3.2.2. Overall Commercial Scale Production Capacity
10.3.2.3. Both Clinical and Commercial Scale Production Capacity
10.3.3. Analysis by Company Size
10.3.3.1. Overall Production Capacity of Small-sized Companies
10.3.3.2. Overall Production Capacity of Mid-sized Companies
10.3.3.3. Overall Production Capacity of Large Companies
10.3.3.4. Overall Production Capacity of Very Large Companies
10.4. Ophthalmic Drug FDF Contract Manufacturers: Global Production Capacity
10.4.1. Analysis by Geography
10.4.1.1. Overall Production Capacity in North America
10.4.1.2. Overall Production Capacity in Europe
10.4.1.3. Overall Production Capacity in Asia-Pacific
10.4.1.4. Overall Production Capacity in Rest of the World
10.4.2. Analysis by Scale of Operation
10.4.2.1. Overall Clinical Scale Production Capacity
10.4.2.2. Overall Commercial Scale Production Capacity
10.4.2.3. Both Clinical and Commercial Scale Production Capacity
10.4.3. Analysis by Company Size
10.4.3.1. Overall Production Capacity of Small-sized Companies
10.4.3.2. Overall Production Capacity of Mid-sized Companies
10.4.3.3. Overall Production Capacity of Large Companies
10.4.3.4. Overall Production Capacity of Very Large Companies
10.4.4. Analysis by Type of Primary Packaging
10.4.4.1. Overall Production Capacity of Ampoules / Vials
10.4.4.2. Overall Production Capacity of Glass / Plastic Bottles
10.4.4.3. Overall Production Capacity of Ointment Tubes
10.4.4.4. Overall Production Capacity of Blister Packing
10.4.4.5. Overall Production Capacity of Other Packaging Forms
- DEMAND ANALYSIS
11.1. Chapter Overview
11.2. Key Assumptions and Methodology
11.3. Global Commercial Demand for Ophthalmic Drugs Contract Manufacturing
11.3.1. Commercial Demand for Ophthalmic API Contract Manufacturing
11.3.1.1. Analysis by Geography
11.3.1.2. Analysis by Target Indication
11.3.2. Commercial Demand for Ophthalmic Drug FDF Contract Manufacturing
11.3.2.1. Analysis by Geography
11.3.2.2. Analysis by Target Indication
11.3.2.3. Analysis by Type of Primary Packaging
11.4. Global Clinical Demand for Ophthalmic Drugs Contract Manufacturing
11.4.1. Clinical Demand for Ophthalmic API Contract Manufacturing
11.4.1.1. Analysis by Geography
11.4.1.2. Analysis by Target Indication
11.4.2. Clinical Demand for Ophthalmic Drug FDF Contract Manufacturing
11.4.2.1. Analysis by Geography
11.4.2.2. Analysis by Target Indication
11.4.2.3. Analysis by Type of Primary Packaging
11.5. Demand and Supply Analysis
- MARKET FORECAST
12.1. Chapter Overview
12.2. Key Assumptions and Forecast Methodology
12.3. Overall Ophthalmic Drugs Contract Manufacturing Market, 2020-2030
12.4. Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Type of Product
12.4.1. Ophthalmic API Contract Manufacturing Market, 2020-2030
12.4.2. Ophthalmic Drug FDF Contract Manufacturing Market, 2020-2030
12.4.2.1. Ophthalmic Drug FDF Contract Manufacturing Market, 2020-2030: Distribution by Type of FDF Manufactured
12.4.2.1.1. Ophthalmic Drugs Contract Manufacturing Market for Solids, 2020-2030
12.4.2.1.2. Ophthalmic Drugs Contract Manufacturing Market for Semi-solids, 2020-2030
12.4.2.1.3. Ophthalmic Drugs Contract Manufacturing Market for Liquids / Suspensions, 2020-2030
12.4.2.2. Ophthalmic Drug FDF Contract Manufacturing Market, 2020-2030: Distribution by Type of Primary Packaging
12.4.2.2.1. Ophthalmic Drugs Contract Manufacturing Market for Ampoules / Vials, 2020-2030
12.4.2.2.2. Ophthalmic Drugs Contract Manufacturing Market for Glass / Plastic Bottles, 2020-2030
12.4.2.2.3. Ophthalmic Drugs Contract Manufacturing Market for Ointment Tubes, 2020-2030
12.4.2.2.4. Ophthalmic Drugs Contract Manufacturing Market for Blister Packing, 2020-2030
12.4.2.2.5. Ophthalmic Drugs Contract Manufacturing Market for Other Packaging Forms, 2020-2030
12.5. Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Target Disease Indication
12.5.1. Ophthalmic Drugs Contract Manufacturing Market for Age-related Macular Degeneration, 2020-2030
12.5.2. Ophthalmic Drugs Contract Manufacturing Market for Dry Eye, 2020-2030
12.5.3. Ophthalmic Drugs Contract Manufacturing Market for Glaucoma, 2020-2030
12.5.4. Ophthalmic Drugs Contract Manufacturing Market for Other Eye Disorders, 2020-2030
12.6. Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Scale of Operation
12.6.1. Ophthalmic Drugs Contract Manufacturing Market for Clinical Scale Operations, 2020-2030
12.6.2. Ophthalmic Drugs Contract Manufacturing Market for Commercial Scale Operations, 2020-2030
12.6.3. Ophthalmic Drugs Contract Manufacturing Market for Both Clinical and Commercial Scale Operations, 2020-2030
12.7. Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Size of Manufacturers
12.7.1. Ophthalmic Drugs Contract Manufacturing Market for Small-sized Companies, 2020-2030
12.7.2. Ophthalmic Drugs Contract Manufacturing Market for Mid-sized Companies, 2020-2030
12.7.3. Ophthalmic Drugs Contract Manufacturing Market for Large Companies, 2020-2030
12.7.4. Ophthalmic Drugs Contract Manufacturing Market for Very Large Companies, 2020-2030
12.8. Ophthalmic Drugs Contract Manufacturing Market, 2020-2030: Distribution by Geographical Regions
12.8.1. Ophthalmic Drugs Contract Manufacturing Market in North America, 2020-2030
12.8.1.1. Ophthalmic Drugs Contract Manufacturing Market in the US, 2020-2030
12.8.1.2. Ophthalmic Drugs Contract Manufacturing Market in Canada, 2020-2030
12.8.1.3. Ophthalmic Drugs Contract Manufacturing Market in Mexico, 2020-2030
12.8.2. Ophthalmic Drugs Contract Manufacturing Market in Europe, 2020-2030
12.8.2.1. Ophthalmic Drugs Contract Manufacturing Market in the UK, 2020-2030
12.8.2.2. Ophthalmic Drugs Contract Manufacturing Market in Germany, 2020-2030
12.8.2.3. Ophthalmic Drugs Contract Manufacturing Market in France, 2020-2030
12.8.2.4. Ophthalmic Drugs Contract Manufacturing Market in Spain, 2020-2030
12.8.2.5. Ophthalmic Drugs Contract Manufacturing Market in Italy, 2020-2030
12.8.2.6. Ophthalmic Drugs Contract Manufacturing Market in Rest of Europe, 2020-2030
12.8.3. Ophthalmic Drugs Contract Manufacturing Market in Asia-Pacific, 2020-2030
12.8.3.1. Ophthalmic Drugs Contract Manufacturing Market in India, 2020-2030
12.8.3.2. Ophthalmic Drugs Contract Manufacturing Market in China, 2020-2030
12.8.3.3. Ophthalmic Drugs Contract Manufacturing Market in Japan, 2020-2030
12.8.3.4. Ophthalmic Drugs Contract Manufacturing Market in Australia, 2020-2030
12.8.3.5. Ophthalmic Drugs Contract Manufacturing Market in Rest of Asia-Pacific, 2020-2030
- CASE STUDY: COMPARISON OF SMALL MOLECULE AND LARGE MOLECULE OPHTHALMIC DRUGS / THERAPIES
13.1. Chapter Overview
13.2. Small Molecule Drugs and Biologics in Ophthalmology
13.2.1. Comparison of Strengths and Weakness of Small Molecules and Biologics
13.2.2. Comparison of Key Specifications
13.2.3. Comparison of Manufacturing Processes
13.2.4. Comparison of Key Manufacturing-related Challenges
- SWOT ANALYSIS
14.1. Chapter Overview
14.2. Comparison of SWOT Factors
- SURVEY ANALYSIS
15.1. Chapter Overview
15.2. Overview of Respondents
15.2.1. Seniority Level of Respondents
15.3. Survey Insights
15.3.1. Type of Product
15.3.2. Type of Primary Packaging
15.3.3. Scale of Operation
15.3.4. Manufacturing Capacity
15.3.5. Location of Manufacturing Facilities
15.3.6. Regulatory Accreditations / Certifications of Manufacturing Facilities
15.3.7. Extent of Outsourcing
15.3.8. Current Market Opportunity
- EXECUTIVE INSIGHTS
16.1. Chapter Overview
16.2. Caplin Point Laboratories
16.2.1. Company Snapshot
16.2.2. Interview Transcript: Ashok Partheeban, Director, Latin American Operations and Vivek Partheeban, Chief Operating Officer
16.3. Gland Pharma
16.3.1. Company Snapshot
16.3.2. Interview Transcript: Iranna Bavalatti, Head of Manufacturing Science and Technology
16.4. Selvok Pharmaceutical
16.4.1. Company Snapshot
16.4.2. Interview Transcript: Rahul Gupta, Chief Executive Officer
16.4. Phytex Australia
16.4.1. Company Snapshot
16.4.2. Interview Transcript: Stuart Smith, Managing Director
- FUTURE GROWTH OPPORTUNITIES
17.1. Chapter Overview
17.2. Integration / Adoption of New and Innovative Technologies
17.3. Capability and Expertise Expansions by CMOs
17.4. Offshoring Outsourcing Activities
17.5. Growing Investments in Existing Infrastructure
17.6. Evolving Client / Sponsor and CMO / CDMO Relationships
17.7. Challenges Faced by Both Sponsors and Service Providers
17.7.1. Concerns Related to Single Use Systems
17.7.2. 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
Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
gaurav.chaudhary@rootsanalysis.com
