The contract manufacturing market for live biotherapeutics and microbiome products

Roots Analysis has done a detailed study on Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2020-2030: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms, 2020-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

 

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Key Market Insights

  • The microbiome therapies pipeline features 260 drugs under evaluation across different phases of development; contract service providers have become an integral part of the supply chain owing to their technical expertise.
  • Presently, over 25 firms across the globe claim to possess the required know-how and infrastructure to offer contract manufacturing services for live biotherapeutic products and microbiome therapies
  • The market is fragmented, featuring the presence of established players and mid-sized firms across different global regions, with capabilities to manufacture aerobic and / or anaerobic strains, at varying scales of operation
  • Most of the installed, global live biotherapeutic contract manufacturing capacity presently belongs to dedicated large and mid-sized CMOs, accounting for over 90% of what is available across various geographies
  • Future growth of the market is likely to be driven by increased demand for these therapeutics; we expect the service-based revenues to grow at an annualized rate of over 46% in the coming decade
  • In the long-term, the projected market opportunity is anticipated to be well distributed across different types of formulations, sizes of contract service providers and geographical regions

 

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Table of Contents

 

  1. PREFACE

1.1.       Scope of the Report

1.2.       Research Methodology

1.3.       Chapter Outlines

 

  1. EXECUTIVE SUMMARY

 

  1. INTRODUCTION

3.1.       Chapter Overview

3.2.       Concept of Human Microbiota and Microbiome

3.3.       Overview of Gut Flora

3.2.3.    Role of Gut Flora in Healthy Individuals

3.2.4.    Factors Affecting Human Gut Flora

 

3.4.       The Human Microbiome Project (HMP)

3.5.       Overview of Microbiome Therapies

3.5.1.    Types of Microbiome Therapies

3.5.1.1. Probiotics

3.5.1.2. Prebiotics

 

3.5.2.    Applications of Microbiome Therapies

3.5.3.    Microbiome Therapies Supply Chain

 

3.6.       Microbiome-based Product Manufacturing

3.6.1.    Key Steps Involved

3.6.2.    Associated Challenges

3.6.3.    Role of Contract Manufacturing Organizations (CMOs)

3.6.4.    Demand for Contract Manufacturing Services

 

3.7.       Key Considerations for Selecting a Suitable CMO Partner

 

  1. MARKET LANDSCAPE

4.1.       Chapter Overview

4.2.       CMOs Offering Contract Manufacturing for Microbiome Therapeutics: List of Companies

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 Location of Headquarters

4.2.5.    Analysis by Type of Service Offered

4.2.6.    Analysis by Type of Product Manufactured

4.2.7.    Analysis by Type of Drug Molecule

4.2.8.    Analysis by Type of Fermentation Required

4.2.9.    Analysis by Type of Formulation

4.2.10.  Analysis by Type of Primary Packaging Used

4.2.11. Analysis by Number of Manufacturing Facilities

4.2.12. Analysis by Location of Manufacturing Facilities

4.2.13. Analysis by Type of Regulatory Certifications / Accreditations

 

4.3.       Microbiome Therapeutics In-House Manufacturers: List of Companies

4.3.1.    Analysis by Year of Establishment

4.3.2.    Analysis by Company Size

4.3.3.    Analysis by Scale of Operation

4.3.4.    Analysis by Location of Headquarters

4.3.5.    Analysis by Location of Manufacturing Facilities

  1. COMPANY PROFILES

5.1.       Chapter Overview

5.2.       CMOs Headquartered in North America

5.2.1.    Capsugel

5.2.1.1. Company Overview

5.2.1.2. Microbiome-Related Service Portfolio

5.2.1.3. Facilities Dedicated to Microbiome Manufacturing

5.2.1.4. Recent Developments and Future Outlook

 

5.2.2.    Paragon Bioservices

5.2.2.1. Company Overview

5.2.2.2. Microbiome-Related Service Portfolio

5.2.2.3. Facilities Dedicated to Microbiome Manufacturing

5.2.2.4. Recent Developments and Future Outlook

 

5.2.3.    UAS Labs

5.2.3.1. Company Overview

5.2.3.2. Microbiome-Related Service Portfolio

5.2.3.3. Facilities Dedicated to Microbiome Manufacturing

5.2.3.4. Recent Developments and Future Outlook

 

5.3.       CMOs Headquartered in Europe

5.3.1.    Biose

5.3.1.1. Company Overview

5.3.1.2. Microbiome-Related Service Portfolio

5.3.1.3. Facilities Dedicated to Microbiome Manufacturing

5.3.1.4. Recent Developments and Future Outlook

 

5.3.2.    Cobra Biologics

5.3.2.1. Company Overview

5.3.2.2. Financial Information

5.3.2.3. Microbiome-Related Service Portfolio

5.3.2.4. Facilities Dedicated to Microbiome Manufacturing

5.3.2.5. Recent Developments and Future Outlook

 

5.3.3.    Cerbios

5.3.3.1. Company Overview

5.3.3.2. Microbiome-Related Service Portfolio

5.3.3.3. Facilities Dedicated to Microbiome Manufacturing

5.3.3.4. Recent Developments and Future Outlook

 

5.3.4.    Inpac Probiotics

5.3.4.1. Company Overview

5.3.4.2. Microbiome-Related Service Portfolio

5.3.4.3. Facilities Dedicated to Microbiome Manufacturing

5.4.       CMOs Headquartered in Asia-Pacific and Rest of the World

5.4.1.    BJP Laboratories

5.4.1.1. Company Overview

5.4.1.2. Microbiome-Related Service Portfolio

5.4.1.3. Facilities Dedicated to Microbiome Manufacturing

 

  1. REGIONAL CAPABILITY ANALYSIS

6.1.       Chapter Overview

6.2.       Key Assumptions and Methodology

6.3.       Regional Capability Analysis: Microbiome Contract Manufacturers in North America

6.4.       Regional Capability Analysis: Microbiome Contract Manufacturers in Europe

6.5.       Regional Capability Analysis: Microbiome Contract Manufacturers in Asia-Pacific and Rest of the World

6.6.       Concluding Remarks

                       

  1. LIKELY PARTNER ANALYSIS

7.1.       Chapter Overview

7.2.       Scope and Methodology

7.3.       Potential Strategic Partners for Microbiome Contract Manufacturers

7.3.1.    Opportunities in North America

7.3.2.    Opportunities in Europe and Asia-Pacific

 

  1. CLINICAL TRIAL ANALYSIS

8.1.       Chapter Overview

8.2.       Scope and Methodology

8.3.       Clinical Trial Analysis (Industry Players)

8.3.1.    Analysis by Trial Registration Year

8.3.2.    Analysis by Trial Phase

8.3.3.    Analysis by Trial Recruitment Status

8.3.4.    Analysis by Trial Registration Year and Recruitment Status

8.3.5.    Analysis by Trial Registration Year and Number of Patients Enrolled

8.3.6.    Analysis by Study Design

8.3.7.    Analysis by Trial Focus

8.3.8.    Analysis by Trial Phase and Type of Intervention Model

8.3.9.    Analysis by Sponsor / Collaborator

8.3.10. Analysis by Type of Organization

8.3.11.  Popular Therapeutic Areas: Analysis by Number of Clinical Trials and Registration Year

8.3.12. Geographical Analysis by Number of Clinical Trials

8.3.13.  Geographical Analysis by Trial Recruitment Status

 

8.4.       Clinical Trial Analysis (Non-Industry Players)

8.4.1.    Analysis by Trial Registration Year

8.4.2.    Analysis by Trial Phase

8.4.3.    Analysis by Trial Recruitment Status

8.4.4.    Analysis by Trial Registration Year and Recruitment Status

8.4.5.    Analysis by Trial Registration Year and Number of Patients Enrolled

8.4.6.    Analysis by Study Design

8.4.7.    Analysis by Trial Focus

8.4.8.    Analysis by Trial Phase and Type of Intervention Model

8.4.9.    Analysis by Sponsor / Collaborator

8.4.10. Analysis by Type of Organization

8.4.11.  Popular Therapeutic Areas: Analysis by Number of Clinical Trials and Registration Year

8.4.12. Geographical Analysis by Number of Clinical Trials

8.4.13.  Geographical Analysis by Trial Recruitment Status

 

  1. CAPACITY ANALYSIS

9.1.       Chapter Overview

9.2.       Key Assumptions and Methodology

9.3.       Microbiome Contract Manufacturers: Global Production Capacity

9.3.1.    Analysis by Company Size

9.3.1.1. Overall Production Capacity of Small-sized Companies 

9.3.1.2. Overall Production Capacity of Mid-sized Companies

9.3.1.3. Overall Production Capacity of Large Companies

 

9.3.2.    Analysis by Scale of Operation

9.3.2.1. Overall Clinical Scale Production Capacity

9.3.2.2. Overall Commercial Scale Production Capacity

 

9.3.3.    Analysis by Location of Manufacturing Facility

9.3.3.1. Overall Production Capacity in North America

9.3.3.2. Overall Production Capacity in Europe

9.3.3.3. Overall Production Capacity in Asia-Pacific and Rest of the World

 

9.4.       Concluding Remarks

 

  1. DEMAND ANALYSIS

10.1.     Chapter Overview

10.2.     Scope and Methodology

10.3.     Global Clinical Demand for Microbiome Contract Manufacturing

 

10.3.1. Geographical Analysis of Demand

10.3.1.1. Clinical Demand in North America

10.3.1.2. Clinical Demand in Europe

10.3.1.3. Clinical Demand in Asia-Pacific and Rest of the World

 

10.3.2. Phase-Wise Analysis of Demand

10.3.2.1. Clinical Demand in Phase I

10.3.2.2. Clinical Demand in Phase II

10.3.2.3. Clinical Demand in Phase III

 

10.3.3. Sponsor Wise Analysis of Demand

10.3.2.1. Clinical Demand for Industry Sponsors

10.3.2.2. Clinical Demand for Non-Industry Sponsors

 

10.4      Concluding Remarks

 

  1. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

11.1.     Chapter Overview

11.2.     Make versus Buy Decision Making: Assumptions and Parameter Definitions

11.2.1.  Scenario 1: High Value Addition / Low Complexity

11.2.1.  Scenario 2: High Value Addition / High Complexity

11.2.1.  Scenario 3: Low Value Addition / Low Complexity

11.2.1.  Scenario 4: Low Value Addition / High Complexity

11.3.     Contract Manufacturer’s Perspective

11.4.     Concluding Remarks

 

  1. MICROBIOME RELATED INITIATIVES OF BIG PHARMACEUTICAL PLAYERS

12.1.     Chapter Overview

12.2.     Scope and Methodology

 

12.3.     Initiatives of Big Pharmaceutical Players

12.3.1.  Analysis by Portfolio Diversity

12.3.2.  Analysis by Phase of Development

12.3.3. Analysis by Type of Therapeutic

12.3.4. Analysis by Type of Drug Molecule

12.3.5. Heat Map: Analysis by Target Therapeutic Areas

 

12.4.     Benchmark Analysis of Big Pharmaceutical Players

12.4.1. Spider Web Analysis: Company A

12.4.2. Spider Web Analysis: Company B

12.4.3. Spider Web Analysis: Company C

12.4.4.  Spider Web Analysis: Company D

12.4.5. Spider Web Analysis: Company E

12.4.6. Spider Web Analysis: Company F

12.4.7. Spider Web Analysis: Company G

12.4.8. Spider Web Analysis: Company H

12.4.9. Spider Web Analysis: Company I

12.4.10. Spider Web Analysis: Company J

12.4.11. Spider Web Analysis: Company K

 

12.5.     Concluding Remarks

 

  1. MARKET FORECAST

13.1.     Chapter Overview

13.2.     Forecast Methodology and Key Assumptions

13.3.     Overall Microbiome Contract Manufacturing Market, 2020-2030

 

13.4      Microbiome Contract Manufacturing Market, 2020-2030: Distribution by Product Manufactured

13.4.1.  Microbiome Contract Manufacturing Market for APIs, 2020-2030

13.4.2.  Microbiome Contract Manufacturing Market for FDFs, 2020-2030

 

13.5.     Microbiome Contract Manufacturing Market, 2020-2030: Distribution by Type of Formulation

13.5.1.  Microbiome Contract Manufacturing Market for Solid Formulations, 2020-2030

13.5.2.  Microbiome Contract Manufacturing Market for Oral Liquids, 2020-2030

13.5.3.  Microbiome Contract Manufacturing Market for Injectables, 2020-2030

13.5.4.  Microbiome Contract Manufacturing Market for Others, 2020-2030

 

13.6.     Microbiome Contract Manufacturing Market, 2020-2030: Distribution by Scale of Operation

13.6.1.  Microbiome Contract Manufacturing Market for Clinical Scale Operations, 2020-2030

13.6.2.  Microbiome Contract Manufacturing Market for Commercial Scale Operations, 2020-2030

 

13.7.     Microbiome Contract Manufacturing Market, 2020-2030: Distribution by Company Size

13.7.1.  Microbiome Contract Manufacturing Market for Small-sized Companies, 2020-2030

13.7.2.  Microbiome Contract Manufacturing Market for Mid-sized Companies, 2020-2030

13.7.3.  Microbiome Contract Manufacturing Market for Large Companies, 2020-2030

 

13.8.     Microbiome Contract Manufacturing Market, 2020-2030: Geographical Distribution

13.8.1.  Microbiome Contract Manufacturing Market in North America, 2020-2030

13.8.2. Microbiome Contract Manufacturing Market in Europe, 2020-2030

13.8.3. Microbiome Contract Manufacturing Market in Asia-Pacific and Rest of the World, 2020-2030

13.9.     Concluding Remarks

 

  1. CONCLUSION

14.1.     Chapter Overview

14.2.     Key Takeaways

 

  1. EXECUTIVE INSIGHTS

15.1.     Chapter Overview

15.2.     S-Biomedic

15.2.1.  Company Snapshot

15.2.2.  Interview Transcript: Veronika Oudova, Co-founder and Chief Executive Officer

 

15.3.     Meteoric Biopharmaceuticals

15.3.1.  Company Snapshot

15.3.2.  Interview Transcript: Gaurav Kaushik, Managing Director and Chief Executive Officer

 

15.4.     BiomX

15.4.1.  Company Snapshot

15.4.2.  Interview Transcript: Assaf Oron, Chief Business Officer

 

15.5.     Universal Stabilization Technologies

15.5.1   Company Snapshot

15.5.2.  Interview Transcript: Alexander Segal, Vice President, Business Development

15.6.     List Biological Laboratories

15.6.1.  Company Snapshot

15.6.2.  Interview Transcript: Debbie Pinkston, Vice President, Sales and Business Development

 

15.7.     Assembly Biosciences

15.7.1.  Company Snapshot

15.7.2.  Interview Transcript: JP Benya, Vice President, Business Development

 

15.8.     Wacker Biotech

15.8.1   Company Snapshot

15.8.2.  Interview Transcript: Rob van Dijk, Business Development Manager

 

15.9.     Chung Mei Pharmaceutical

15.9.1.  Company Snapshot

15.9.2.  Interview Transcript: Alexander Lin, Associate General Manager

 

  1. APPENDIX I: TABULATED DATA

 

  1. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

 

  1. APPENDIX III: LIST OF PROBIOTIC SUPPLEMENT CONTRACT MANUFACTURERS AND MICROBIAL CONTACT SERVICE PROVIDERS

 

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

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