Insights on the Live Biotherapeutic Products and Microbiome Manufacturing Market to 2035 - Industry Trends and Global Forecasts

DUBLIN, March 21, 2022 /PRNewswire/ -- The "Live Biotherapeutic Products and Microbiome Manufacturing Market by Type of Product Manufactured, Type of Formulation, Type of Primary Packaging Used, Scale of Operation, Company Size and Key Geographical Regions: Industry Trends and Global Forecasts, 2022 - 2035" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study on the in- house and contract manufacturing organizations within the microbiome industry. The study also includes an elaborate discussion on the future potential of this evolving market. 

Given the advancement of several promising microbiome-based live biotherapeutic products through clinical pipeline, this upcoming therapeutic segment is anticipated to become one of the fastest growing markets within the pharmaceutical industry in the coming years. Specifically, in 2020, around 575 IND applications were filed for such therapies, targeting a myriad of diseases indications, including autoimmune, gastrointestinal, infectious, metabolic and oncological disorders, indicating remarkable scientific progress of these breakthrough drug candidates.

It is also worth highlighting that SER-109, a microbiome-based therapy developed by Seres Therapeutics, is expected to receive marketing approval from the US Food and Drug Administration (FDA) in 2022; this is further likely to propel the growth in this domain. Further, over 640 patents focused on microbiome therapeutics were granted approval in the year 2020. In addition, during the same time frame, USD 1.5 billion was invested for the development of microbiome-based therapeutics.

Although a lot has been achieved in terms of development of live biotherapeutic products, there are certain challenges associated with the complexity of the process. Other key concerns shared by contemporary innovators include limited availability of expertise, lack of specialized infrastructure, requirement for exorbitant capital investment, and constraints associated with ensuring compliance to good manufacturing practices (GMP) and capacity.

In order to address the technical and operational challenges outlined above, several microbiome developers prefer to rely on contract manufacturing organizations (CMOs). It is worth highlighting that, currently, over 50 players engaged in the manufacturing of microbiome-related products carry out operations either in-house or on contract basis. The current market landscape of microbiome contract manufacturers is highly fragmented, featuring a mix of start-ups, mid-sized firms and established players. Moreover, in recent years, several players engaged in this domain have forged strategic alliances and / or acquired other players, in order to further enhance their respective service offerings and operate as one-stop-shops. As stakeholders strive to mitigate existing challenges and focus on innovation to improve the microbiome production process, we believe that the microbiome manufacturing market is expected to witness significant growth over the next decade.

Key Questions Answered

• Who are the key players engaged in offering contract manufacturing services for microbiome therapeutics?
• 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 biotherapeutics?
• 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

4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Scale of Operation
4.2.5. Analysis by Type of Product Manufactured
4.2.6. Analysis by Type of Formulation
4.2.7. Analysis by Scale of Operation and Type of Formulation
4.2.8. Analysis by Type of Primary Packaging Used
4.2.9. Analysis by Type of Formulation and Type of Primary Packaging Used
4.2.10. Analysis by Type of Fermentation
4.2.11. Analysis by Type of Fermentation and Location of Headquarters
4.2.12. Analysis by Type of Service(s) Offered
4.2.13. Analysis by Number of Manufacturing Facilities
4.2.14. Analysis by Location of Manufacturing Facilities
4.3. Live Biotherapeutic Products and Microbiome In-House Manufacturers: Market Landscape
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

5. REGIONAL CAPABILITY ANALYSIS
5.1. Chapter Overview
5.2. Key Assumptions and Methodology
5.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Facilities in North America
5.4. Live Biotherapeutic Products and Microbiome Contract Manufacturing Facilities in Europe
5.5. Live Biotherapeutic Products and Microbiome Contract Manufacturing Facilities in Asia-Pacific

6. COMPANY COMPETITIVENESS ANALYSIS
6.1. Chapter Overview
6.2. Key Assumptions and Parameters
6.3. Methodology
6.4. Company Competitiveness: North America
6.5. Company Competitiveness: Europe
6.6. Company Competitiveness: Asia-Pacific
6.7. Capability Benchmarking of Top Microbiome Contract Manufactures

7. COMPANY PROFILES
7.1. Chapter Overview
7.2. CMOs Headquartered in North America
7.2.1. Capsugel
7.2.1.1. Company Overview
7.2.1.2. Service Portfolio
7.2.1.3. Facilities Dedicated to Microbiome Manufacturing
7.2.1.4. Recent Developments and Future Outlook
7.2.2. Jeneil Biotech
7.2.2.1. Company Overview
7.2.2.2. Service Portfolio
7.2.2.3. Facilities Dedicated to Microbiome Manufacturing
7.2.2.4. Recent Developments and Future Outlook
7.2.3. UAS Labs
7.2.3.1. Company Overview
7.2.3.2. Service Portfolio
7.2.3.3. Facilities Dedicated to Microbiome Manufacturing
7.2.3.4. Recent Developments and Future Outlook
7.3. CMOs Headquartered in Europe
7.3.1. Biose
7.3.1.1. Company Overview
7.3.1.2. Service Portfolio
7.3.1.3. Facilities Dedicated to Microbiome Manufacturing
7.3.1.4. Recent Developments and Future Outlook
7.3.2. Cerbios-Pharma
7.3.2.1. Company Overview
7.3.2.2. Financial Information
7.3.2.3. Service Portfolio
7.3.2.4. Facilities Dedicated to Microbiome Manufacturing
7.3.2.5. Recent Developments and Future Outlook
7.3.3. Inpac Probiotics
7.3.3.1. Company Overview
7.3.3.2. Service Portfolio
7.3.3.3. Facilities Dedicated to Microbiome Manufacturing
7.3.3.4. Recent Developments and Future Outlook
7.3.4. NIZO
7.3.4.1. Company Overview
7.3.4.2. Service Portfolio
7.3.4.3. Facilities Dedicated to Microbiome Manufacturing
7.3.4.4. Recent Developments and Future Outlook
7.3.5 Winclove Probiotics
7.3.5.1. Company Overview
7.3.5.2. Service Portfolio
7.3.5.3. Facilities Dedicated to Microbiome Manufacturing
7.3.5.4. Recent Developments and Future Outlook
7.4. CMOs Headquartered in Asia-Pacific and Rest of the World
7.4.1. BJP Laboratories
7.4.1.1. Company Overview
7.4.1.2. Service Portfolio
7.4.1.3. Facilities Dedicated to Microbiome Manufacturing
7.4.1.4. Recent Developments and Future Outlook

8. LIKELY PARTNER ANALYSIS
8.1. Chapter Overview
8.2. Scoring Criteria and Key Assumptions
8.3. Scope and Methodology
8.4. Key Potential Strategic Partners for Live Biotherapeutic Products and Microbiome Manufacturers
8.4.1. Likely Partner Opportunities in North America
8.4.2. Likely Partner Opportunities in Europe
8.4.3. Likely Partner Opportunities in Asia-Pacific

9. MICROBIOME RELATED INITIATIVES OF BIG PHARMACEUTICAL PLAYERS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Microbiome Related Initiatives of Big Pharmaceutical Players
9.3.1. Analysis by Portfolio Diversity
9.3.2. Analysis by Phase of Development
9.3.3. Analysis by Type of Therapy
9.3.4. Analysis by Type of Drug Molecule
9.3.5. Analysis by Target Therapeutic Areas
9.4. Benchmark Analysis of Big Pharmaceutical Players
9.4.1. Spider Web Analysis: AbbVie
9.4.2. Spider Web Analysis: AstraZeneca
9.4.3. Spider Web Analysis: Bristol-Myers Squibb
9.4.4. Spider Web Analysis: Johnson and Johnson
9.4.5. Spider Web Analysis: Merck
9.4.6. Spider Web Analysis: Novartis
9.4.7. Spider Web Analysis: Novo Nordisk
9.4.8. Spider Web Analysis: Pfizer
9.4.9. Spider Web Analysis: Roche
9.4.10. Spider Web Analysis: Takeda Pharmaceutical
9.5. Concluding Remarks

10. RECENT DEVELOPMENTS AND INITIATIVES
10.1. Chapter Overview
10.2. Partnership Models
10.3. Live Biotherapeutic Products and Microbiome: Recent Partnerships and Collaborations
10.3.1. Analysis by Year of Partnership
10.3.2. Analysis by Type of Partnership
10.3.3. Analysis by Year and Type of Partnership
10.3.4. Analysis by Type of Organization
10.3.5. Analysis by Type of Partnership and Type of Organization
10.3.6. Analysis by Target Therapeutic Area
10.3.7. Most Active Players: Analysis by Number of Partnerships
10.3.8. Analysis by Region
10.3.8.1. Intracontinental and Intercontinental Agreements
10.3.8.2. Local and International Agreements
10.3.9. Cumulative Year-wise Trend of Merger / Acquisition
10.3.10. Analysis by Type of Acquisition
10.3.11. Analysis by Key Value Drivers
10.3.12. Analysis by Year of Acquisition and Key Value Drivers
10.4. Live Biotherapeutic Products and Microbiome: Recent Expansions
10.4.1. Analysis by Year of Expansion
10.4.2. Analysis by Purpose of Expansion
10.4.3. Analysis by Year and Purpose of Expansion
10.4.4. Analysis by Scale of Operation
10.4.5. Analysis by Purpose of Expansion and Scale of Operation
10.4.6. Analysis by Region
10.4.6.1. Analysis by Location of Manufacturing Facility (Continent-wise)
10.4.6.2. Analysis by Location of Manufacturing Facility (Country-wise)
10.4.7. Analysis by Purpose of Expansion and Location of Manufacturing Facility

11. CLINICAL TRIAL ANALYSIS

12. CAPACITY ANALYSIS

13. DEMAND ANALYSIS

14. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
14.1. Chapter Overview
14.2. Assumptions and Key Parameter
14.3. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Make versus Buy Decision Making
14.3.1. Scenario 1
14.3.2. Scenario 2
14.3.3. Scenario 3
14.3.4. Scenario 4
14.4. Concluding Remarks

15. CASE STUDY: LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT RESEARCH ORGANIZATIONS (CROs) AND DIETARY SUPPLEMENT MANUFACTURERS
15.1. Chapter Overview
15.2. Live Biotherapeutic Products and Microbiome CROs: Overall Market Landscape
15.2.1. Analysis by Year of Establishment
15.2.2. Analysis by Company Size
15.2.3. Analysis by Location of Headquarters
15.3. Microbiome Dietary Supplement Manufacturers: Overall Market Landscape
15.3.1. Analysis by Year of Establishment
15.3.2. Analysis by Company Size
15.3.3. Analysis by Location of Headquarters

16. MARKET FORECAST

17. CONCLUSION

18. INTERVIEW TRANSCRIPTS

19. APPENDIX I: TABULATED DATA

20. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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