Global Outlook for Live Biotherapeutic Products and Microbiome Contract Manufacturing Market 2020-2030

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Jul 23, 2020, 09:00 ET

DUBLIN, July 23, 2020 /PRNewswire/ -- The "Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

Despite the evident increase in interest in this field, manufacturing live microbial therapeutics remains a largely unaddressed area of concern. In fact, experts believe that the lack of sufficient manufacturing capacity is one of the major impediments to the commercialization of such products. Other challenges include absence of the required industry standards related to manufacturing live biotherapeutics, reproducibility (batch-to-batch consistency) related concerns, lack of expertise and infrastructure to handle anaerobic microbial strains, scaling up existing manufacturing protocols, intellectual property related issues (existing patent law prohibits patenting live organisms and naturally occurring materials) and uncertainties related to regulatory review and product approval. Owing to the aforementioned reasons and several others, such as need for specialized facilities, equipment and operational expertise, innovator companies have begun relying on contract manufacturers for their microbiome-related development and production needs. Outsourcing is known to offer several benefits, which include reductions in capital investment, access to larger production capacities, expediting time-to-market, and commercial risk handling and mitigation (to a significant extent). Presently, a number of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) claim to offer services for manufacturing microbiome-related products. In fact, some have even developed end-to-end capabilities, starting from drug development to regulatory filings, and commercial scale production, in this field.

This report features detailed transcripts of discussions held with the following individuals:

Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic)
Gaurav Kaushik (Chief Executive Officer and Managing Director, Meteoric Biopharmaceuticals)
Assaf Oron (Chief Business Officer, BiomX)
Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies)
Debbie Pinkston (Vice President, Sales and Business Development, List Biological Laboratories)
JP Benya (Vice President, Business Development, Assembly Biosciences)
Rob van Dijk (Business Development Manager, Wacker Biotech)
Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)

Key Questions Answered

Who are the leading CMOs offering microbiome contract manufacturing services, across the world?
What are the key challenges faced by microbiome contract manufacturers?
Who are the most likely partners (microbiome-based live biotherapeutic drug developers) for microbiome contract manufacturers?
What is the annual clinical demand for microbiome-based live biotherapeutic products?
What is the current, installed contract manufacturing capacity for live biotherapeutics?
What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision in this field?
What are the various initiatives undertaken by big pharma players in this domain?
What percentage of live biotherapeutics manufacturing operations are outsourced to service providers?
How is the current and future market opportunity likely to be distributed across key market segments?
What are the anticipated future trends related to live biotherapeutics manufacturing?

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Concept of Human Microbiota and Microbiome
3.3. Overview of Gut Flora
3.4. The Human Microbiome Project (HMP)
3.5. Overview of Microbiome Therapies
3.6. Microbiome-based Product Manufacturing
3.7. Key Considerations for Selecting a Suitable CMO Partner

4. MARKET LANDSCAPE

5. COMPANY PROFILES
5.1. Chapter Overview
5.2. CMOs Headquartered in North America
5.2.1. Capsugel
5.2.2. Paragon Bioservices
5.2.3. UAS Labs
5.3. CMOs Headquartered in Europe
5.3.1. Biose
5.3.2. Cobra Biologics
5.3.3. Cerbios
5.3.4. Inpac Probiotics
5.4. CMOs Headquartered in Asia-Pacific and Rest of the World
5.4.1. BJP Laboratories

6. REGIONAL CAPABILITY ANALYSIS

7. LIKELY PARTNER ANALYSIS

8. CLINICAL TRIAL ANALYSIS

9. CAPACITY ANALYSIS

10. DEMAND ANALYSIS

11. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

12. MICROBIOME RELATED INITIATIVES OF BIG PHARMACEUTICAL PLAYERS

13. MARKET FORECAST

14. CONCLUSION

15. EXECUTIVE INSIGHTS

16. APPENDIX I: TABULATED DATA

17. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/hhgel

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