The ophthalmic drugs contract manufacturing market is projected to grow at an annualized rate of ~8%, till 2030

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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

 

1.                PREFACE

1.1.              Scope of the Report

1.2.              Research Methodology

1.3.              Chapter Outlines


2.                EXECUTIVE SUMMARY

 

3.                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

 

4.                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

 

5.                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

 

6.                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

 

7.                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

 

8.                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

 

9.                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

 

10.               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

 

11.               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

 

12.               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

 

13.               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

 

14.               SWOT ANALYSIS

14.1.            Chapter Overview

14.2.            Comparison of SWOT Factors

 

15.               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

 

16.               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          

 

17.               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

 

18.               APPENDIX 1: LIST OF OPHTHALMIC MEDICAL DEVICE CONTRACT MANUFACTURERS

 

19.               APPENDIX 2: TABULATED DATA

 

20.               APPENDIX 3: LIST OF COMPANIES AND ORGANIZATIONS

 

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com