Summary

Microbiome Manufacturing Market (3rd Edition): Distribution by Type of Product Manufactured (API and FDF), Type of Formulation (Solid, Liquid and Others), Type of Primary Packaging Used (Blister Packs, Glass / Plastic Bottles, Pouches / Sachets and Vials), Scale of Operation (Clinical and Commercial), Company Size (Small, Mid-sized, and Large and Very Large), Key Geographical Regions (North America, Europe, Asia-Pacific, and Rest of the World) and Leading Developers: 2023-2035
Report Link: https://www.rootsanalysis.com/reports/microbiome-contract-manufacturing/306.html
The microbiome manufacturing market is valued at USD 27 million in 2023 growing at a CAGR of 17% during the forecast period 2023-2035.
The human body hosts diverse microbial communities, collectively known as microbiota, which include beneficial and harmful species. The microbiome refers to the ecological system of microorganisms residing within a host, comprising commensal, symbiotic, and pathogenic organisms. Given their significance in disease development, interest in microbiome-based therapeutics has grown within the medical science community. Over the past two decades, significant progress has been made in microbiome therapy research and applications. Live biotherapeutic products (LBPs), a category of microbiome therapy, utilize live microorganisms like bacteria, viruses, or fungi to prevent or treat diseases. These products are meticulously designed for therapeutic purposes and are regulated as medicinal products or biologics in many countries. They typically involve specific, extensively researched microorganism strains tested through clinical trials for safety and efficacy in treating specific conditions. Furthermore, microbiome-based therapies hold promise in tailoring treatment options based on patient microbiome composition through gene sequencing.
An important milestone occurred in November 2022 when the US Food and Drug Administration (FDA) approved the first microbiome-based therapy, RBX2660 developed by Rebiotix, for recurrent Clostridium difficile infection treatment.
The emergence of microbiome-based live biotherapeutic products in clinical pipelines suggests this therapeutic segment will be a rapidly growing market within the pharmaceutical industry. Despite advancements, challenges persist in microbiome manufacturing, particularly for live bacterial therapies. These challenges include lengthy development timelines, strict temperature control requirements, complex engineering of aerobic/anaerobic strains, and quality attribute inconsistencies in final products. To address these challenges, human microbiome therapy developers are turning to Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) for outsourcing manufacturing. These entities, part of the broader biologics contract manufacturing market, are increasingly integrating novel technologies to streamline microbiome manufacturing processes, enhance production efficiency, and improve quality. This trend is expected to drive growth in both the microbiome and microbiome manufacturing markets.


Key Market Segments
Type of Product Manufactured
API
FDF
Type of Formulation
Solid
Liquid
Others
Type of Primary Packaging Used
Blister Packs
Glass / Plastic Bottles
Pouches / Sachets
Vials
Scale of Operation
Clinical
Commercial
Company Size
Small
Mid-sized
Large and Very Large
Key Geographical Regions
North America
Europe
Asia-Pacific
Rest of the World
Leading Developers
Infant Bacterial Therapeutics
MaaT Pharma
Microbiomik Healthcare
OxThera
Rebiotix
Seres Therapeutics
Research Coverage:
The report studies the microbiome manufacturing market based on type of product manufactured, type of formulation, type of primary packaging used, scale of operation, company size, key geographical regions and leading developers
The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.
The report forecasts the revenue of market segments with respect to four major regions
The report offers a comprehensive overview of the human microbiota and microbiome concept, encompassing information on different types of microbiome therapeutics. It delves into the functions of the microbiota, emphasizing key insights from the Human Microbiome Project (HMP). Additionally, the chapter outlines the manufacturing process of microbiome therapeutics, including associated challenges and the increasing trend of outsourcing in this field. Lastly, it presents a list of crucial factors for innovator companies to consider when selecting a Contract Manufacturing Organization (CMO) partner.
Comprehensive analysis of the current landscape of microbiome manufacturing services for the development of microbiome therapeutics considering parameters such as establishment year, company size, headquarters, scale of operation, type of product manufactured, primary packaging used, type of microbe used, type of service offered, number of manufacturing facilities and type of microbial species used. Further, report also features details on in-house manufacturers of live biotherapeutic products and microbiomes.
An in-depth overview of microbiome manufacturing facilities strategically positioned in major geographical regions (North America, Europe, and Asia-Pacific), emphasizing pivotal manufacturing centers for microbiome products.
Detailed company competitiveness evaluation of microbiome manufacturing service providers, considering supplier strength in terms of year of establishment, portfolio strength in terms of scale of operation, type of product manufactured, type of formulation, type of primary packaging used and number of manufacturing facilities, and number of services offered.
In-depth profiles of companies offering contract manufacturing services for live biotherapeutic products at both clinical and commercial scales of operations, focusing on company overviews, service portfolio, microbiome manufacturing facilities, recent advancements, and informed future prospects.
An evaluation of microbiome-centric endeavors pursued by major pharmaceutical corporations. This assessment includes heat map depictions illustrating these companies' activities, such as partnerships, financial commitments, early-stage and late-stage pipeline development, therapeutic focus areas, and portfolio breadth. Additionally, a spider web analysis is conducted to compare the initiatives of these major pharmaceutical entities across various pertinent parameters.
A comprehensive examination of completed, ongoing, and anticipated clinical trials involving diverse microbiome therapeutics, considering several parameters such as trial registration date, trial status, phase of the trial, patient enrollment demographics, sponsoring entity type, leading industry participants, study methodology, therapeutic focus, and primary geographical regions.
An estimation of the total manufacturing capacity for microbiome-based therapies, derived from data disclosed by industry participants in publicly available sources. This analysis emphasizes the allocation of capacity across different company scales and major geographic regions.
Estimating the annual clinical and commercial demand for microbiome therapeutics involves analyzing the target patient population participating in ongoing and planned clinical trials sponsored by both industry and non-industry entities. This estimation considers factors such as disease prevalence, trial enrollment numbers, and market trends.
A qualitative assessment outlining key considerations for microbiome therapeutics developers when determining whether to internally manufacture their products or outsource to a Contract Manufacturing Organization (CMO).
A case study examining the present market environment of contract research organizations specializing in microbiome studies and providers of dietary supplements, detailing their founding year, organizational size, and headquarters location.

Key Benefits of Buying this Report
The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
The report provides stakeholders with a pulse on the microbiome manufacturing market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Key Market Companies
Biose
BJP Laboratories
Capsugel
Chr. Hansen
Inpac Probiotics
NIZO
WACKER
Winclove

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Table of Contents

1. PREFACE
1.1. Live Biotherapeutic Products and Microbiome Manufacturing Market Overview
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Inclusions and Exclusions
1.5. Key Questions Answered
1.6. Chapter Outlines

2. RESEARCH METHODOLOGY
2.1. Chapter Overview
2.2. Research Assumptions
2.3. Project Methodology
2.4. Forecast Methodology
2.5. Robust Quality Control
2.6. Key Market Segmentations
2.7. Key Considerations
2.7.1. Demographics
2.7.2. Economic Factors
2.7.3. Government Regulations
2.7.4. Supply Chain
2.7.5. COVID Impact / Related Factors
2.7.6. Market Access
2.7.7. Healthcare Policies
2.7.8. Industry Consolidation

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
3.1. Chapter Overview
3.2. Market Dynamics
3.2.1. Time Period
3.2.1.1. Historical Trends
3.2.1.2. Current and Future Estimates
3.2.2. Currency Coverage
3.2.2.1. Overview of Major Currencies Affecting the Market
3.2.2.2. Impact of Currency Fluctuations on the Industry
3.2.3. Foreign Exchange Impact
3.2.3.1. Evaluation of Foreign Exchange Rates and Their Impact on Market
3.2.3.2. Strategies for Mitigating Foreign Exchange Risk
3.2.4. Recession
3.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
3.2.5. Inflation
3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
3.2.5.2. Potential Impact of Inflation on the Market Evolution

4. EXECUTIVE SUMMARY
4.1. Chapter Overview
5. INTRODUCTION
5.1. Chapter Overview
5.2. Concept of Human Microbiota and Microbiome
5.3. Overview of Gut Flora
5.3.1. Role of Gut Flora in Healthy Individuals
5.3.2. Factors Affecting Human Gut Flora
5.4. The Human Microbiome Project (HMP)
5.5. Overview of Microbiome Therapies
5.5.1. Types of Microbiome Therapies
5.5.1.1. Probiotics
5.5.1.2. Prebiotics
5.5.2. Applications of Microbiome Therapies
5.5.3. Microbiome Therapies Supply Chain
5.6. Manufacturing of Microbiome-based Therapeutics
5.6.1. Key Steps Involved
5.6.2. Challenges Associated with Manufacturing of Microbiome Therapeutics
5.6.3. Demand for Contract Manufacturing Services
5.7. Key Considerations while Selecting a Suitable CMO Partner
5.8. Concluding Remarks

6. MARKET LANDSCAPE
6.1. Chapter Overview
6.2. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Market Landscape
6.2.1. Analysis by Year of Establishment
6.2.2. Analysis by Company Size
6.2.3. Analysis by Location of Headquarters
6.2.4. Analysis by Scale of Operation
6.2.5. Analysis by Type of Product Manufactured
6.2.6. Analysis by Type of Formulation
6.2.7. Analysis by Scale of Operation and Type of Formulation
6.2.8. Analysis by Type of Primary Packaging Used
6.2.9. Analysis by Type of Formulation and Type of Primary Packaging Used
6.2.10. Analysis by Type of Microbe Used
6.2.11. Analysis by Type of Microbe Used and Location of Headquarters
6.2.12. Analysis by Type of Service Offered
6.2.13. Analysis by Number of Manufacturing Facilities (Region)
6.2.14. Analysis by Number of Manufacturing Facilities (Country)
6.2.15. Analysis by Type of Microbial Species Used
6.3. Live Biotherapeutic Products and Microbiome In-House Manufacturers: Market Landscape
6.3.1. Analysis by Year of Establishment
6.3.2. Analysis by Company Size
6.3.3. Analysis by Location of Headquarters
6.3.4. Analysis by Scale of Operation
6.3.5. Analysis by Location of Manufacturing Facilities

7. REGIONAL CAPABILITY ANALYSIS
7.1. Chapter Overview
7.2. Key Assumptions and Parameters
7.3. Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
7.4. Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
7.5. Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific

8. COMPANY COMPETITIVENESS ANALYSIS
8.1. Chapter Overview
8.2. Key Assumptions and Parameters
8.3. Methodology
8.4. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Company Competitiveness Analysis:
8.5. Capability Benchmarking of Top Microbiome Contract Manufactures

9. COMPANY PROFILES
9.1. Chapter Overview
9.2. Leading Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
9.2.1. Capsugel (Acquired by Lonza)
9.2.1.1. Company Overview
9.2.1.2. Service Portfolio
9.2.1.3. Facilities Dedicated to Microbiome Manufacturing
9.2.1.4. Recent Developments and Future Outlook
9.3. Other Prominent Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
9.3.1. Arranta Bio
9.3.1.1. Company Overview
9.3.1.2. Service Portfolio
9.3.2. FUJIFILM Diosynth Biotechnologies
9.3.2.1. Company Overview
9.3.2.2. Service Portfolio
9.3.3. List Biological Laboratories
9.3.3.1. Company Overview
9.3.3.2. Service Portfolio
9.3.4. ProbioFerm
9.3.4.1. Company Overview
9.3.4.2. Service Portfolio
9.4. Leading Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
9.4.1. Biose Industrie
9.4.1.1. Company Overview
9.4.1.2. Service Portfolio
9.4.1.3. Facilities Dedicated to Microbiome Manufacturing
9.4.1.4. Recent Developments and Future Outlook
9.4.2. Cerbios-Pharma
9.4.2.1. Company Overview
9.4.2.2. Service Portfolio
9.4.2.3. Facilities Dedicated to Microbiome Manufacturing
9.4.2.4. Recent Developments and Future Outlook
9.4.3. Chr. Hansen
9.4.3.1. Company Overview
9.4.3.2. Financial Information
9.4.3.3. Service Portfolio
9.4.3.4. Facilities Dedicated to Microbiome Manufacturing
9.4.3.5. Recent Developments and Future Outlook
9.4.4. Inpac Probiotics
9.4.4.1. Company Overview
9.4.4.2. Service Portfolio
9.4.4.3. Facilities Dedicated to Microbiome Manufacturing
9.4.4.4. Recent Developments and Future Outlook
9.4.5. NIZO
9.4.5.1. Company Overview
9.4.5.2. Service Portfolio
9.4.5.3. Facilities Dedicated to Microbiome Manufacturing
9.4.5.4. Recent Developments and Future Outlook
9.4.6. WACKER
9.4.6.1. Company Overview
9.4.6.2. Service Portfolio
9.4.6.3. Facilities Dedicated to Microbiome Manufacturing
9.4.6.4. Recent Developments and Future Outlook
9.4.7 Winclove Probiotics
9.4.7.1. Company Overview
9.4.7.2. Service Portfolio
9.4.7.3. Facilities Dedicated to Microbiome Manufacturing
9.4.7.4. Recent Developments and Future Outlook
9.5. Other Prominent Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
9.5.1. BacThera
9.5.1.1. Company Overview
9.5.1.2. Service Portfolio
9.5.2. Evologic Technologies
9.5.2.1 Company Overview
9.5.2.2. Service Portfolio
9.5.3. Probiotical
9.5.3.1. Company Overview
9.5.3.2. Service Portfolio
9.5.4. QUAY Pharma
9.5.4.1. Company Overview
9.5.4.2. Service Portfolio
9.6. Leading Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
9.6.1. BJP Laboratories
9.6.1.1. Company Overview
9.6.1.2. Service Portfolio
9.6.1.3. Facilities Dedicated to Microbiome Manufacturing
9.6.1.4. Recent Developments and Future Outlook
9.7. Other Prominent Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
9.7.1. Aumgene Biosciences
9.7.1.1 Company Overview
9.7.1.2. Service Portfolio
9.7.2. AcuraBio
9.7.2.1. Company Overview
9.7.2.2. Service Portfolio
9.7.3. Meteoric Biopharmaceuticals
9.7.3.1. Company Overview
9.7.3.2. Service Portfolio
9.7.4. Probiotics Australia
9.7.4.1. Company Overview
9.7.4.2. Service Portfolio
9.7.5. Unique Biotech
9.7.5.1 Company Overview
9.7.5.2. Service Portfolio

10. LIKELY PARTNER ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Key Parameters
10.3. Scope and Methodology
10.4. Key Potential Strategic Partners for Live Biotherapeutic Products and Microbiome Contract Manufacturers
10.4.1. Likely Partners in North America
10.4.2. Likely Partners in Europe
10.4.3. Likely Partners in Asia-Pacific

11. BIG PHARMA INITIATIVES
11.1. Chapter Overview
11.2. Methodology
11.3. Live Biotherapeutic Products and Microbiome-related Initiatives of Big Pharmaceutical Players
11.3.1. Analysis by Portfolio Diversity
11.3.2. Analysis by Trial Phase
11.3.3. Analysis by Type of Therapy
11.3.4. Analysis by Type of Molecule
11.3.5. Analysis by Therapeutic Area

12. RECENT DEVELOPMENTS AND INITIATIVES
12.1. Chapter Overview
12.2. Partnerships and Collaborations
12.2.1. Partnership Models
12.2.2. Live Biotherapeutic Products and Microbiome Manufacturing: List of Partnerships and Collaborations
12.2.3. Analysis by Year of Partnership
12.2.4. Analysis by Type of Partnership
12.2.5. Analysis by Year and Type of Partnership
12.2.6. Analysis by Type of Organization
12.2.7. Analysis by Type of Partnership and Type of Organization
12.2.8. Analysis by Therapeutic Area
12.2.9. Most Active Players: Analysis by Number of Partnerships
12.2.10. Analysis by Geography
12.2.10.1. Intracontinental and Intercontinental Agreements
12.2.10.2. Local and International Agreements
12.3. Live Biotherapeutic Products and Microbiome Manufacturing: Mergers and Acquisitions
12.3.1. Cumulative Year-wise Trend of Merger / Acquisition
12.3.2. Analysis by Key Value Drivers
12.3.3. Analysis by Year of Acquisition and Key Value Drivers
12.4. Live Biotherapeutic Products and Microbiome Manufacturing: Recent Expansions
12.4.1. Analysis by Year of Expansion
12.4.2. Analysis by Purpose of Expansion
12.4.3. Analysis by Year and Purpose of Expansion
12.4.4. Analysis by Scale of Operation
12.4.5. Analysis by Purpose of Expansion and Scale of Operation
12.4.6. Analysis by Geography
12.4.6.1. Analysis by Location of Expanded Facility (Region)
12.4.6.2. Analysis by Location of Expanded Facility (Country)
12.4.7. Analysis by Purpose of Expansion and Location of Expanded Facility (Region)

13. CLINICAL TRIAL ANALYSIS
13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Live Biotherapeutic Products and Microbiome Manufacturing: Clinical Trial Analysis
13.3.1. Analysis by Trial Registration Year
13.3.2. Analysis by Trial Status
13.3.3. Analysis by Trial Registration Year and Trial Status
13.3.4. Analysis by Trial Phase
13.3.5. Analysis by Trial Registration Year and Trial Phase
13.3.6. Analysis of Enrolled Patient Population by Trial Registration Year
13.3.7. Analysis of Enrolled Patient Population by Trial Phase
13.3.8. Analysis by Type of Sponsor
13.3.9. Most Active Players: Analysis by Number of Registered Trials
13.3.10. Analysis by Study Design
13.3.11. Analysis by Therapeutic Area
13.3.12. Analysis of Number of Registered Trials by Geography
13.3.13. Analysis of Number of Registered Trials by Trial Status and Geography
13.3.14. Analysis of Enrolled Patient Population by Geography
13.3.15. Analysis of Enrolled Patient Population by Trial Status and Geography

14. CAPACITY ANALYSIS
14.1. Chapter Overview
14.2. Key Assumptions
14.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing: Global Installed Capacity
14.3.1. Analysis by Company Size
14.3.2. Analysis by Geography
14.3.2.1. Analysis of Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in North America
14.3.2.2. Analysis of Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in Europe
14.3.2.3. Analysis of Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity Asia-Pacific and Rest of the World

15. DEMAND ANALYSIS
15.1. Chapter Overview
15.2. Methodology
15.3. Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing
15.3.1. Analysis by Number of Trials Conducted
15.3.2. Analysis by Enrolled Patient Population
15.3.3. Analysis by Trial Phase
15.3.4. Analysis by Geography
15.3.4.1. Clinical Demand in North America
15.3.4.2. Clinical Demand in Europe
15.3.4.3. Clinical Demand in Asia-Pacific and Rest of the World
15.4. Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing

16. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
16.1. Chapter Overview
16.2. Key Assumptions and Parameters
16.3. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Make versus Buy Decision Making Framework
16.3.1. Scenario 1
16.3.2. Scenario 2
16.3.3. Scenario 3
16.3.4. Scenario 4
16.4. Concluding Remarks

17. CASE STUDY: LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT RESEARCH ORGANIZATIONS (CROs) AND DIETARY SUPPLEMENT MANUFACTURERS
17.1 Chapter Overview
17.2. Live Biotherapeutic Products and Microbiome CROs
17.3. Live Biotherapeutic Products and Microbiome CROs: Market Landscape
17.3.1. Analysis by Year of Establishment
17.3.2. Analysis by Company Size
17.3.3. Analysis by Location of Headquarters
17.4. Microbiome Dietary Supplement Manufacturers: Market Landscape
17.4.1. Analysis by Year of Establishment
17.4.2. Analysis by Company Size
17.4.3. Analysis by Location of Headquarters

18. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES
18.1. Chapter Overview
18.2. Market Drivers
18.3. Market Restraints
18.4. Market Opportunities
18.5. Market Challenges
18.6. Conclusion

19. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET
19.1. Chapter Overview
19.2. Key Assumptions and Methodology
19.3. Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2023-2035
19.4. Scenario Analysis
19.4.1. Conservative Scenario
19.4.2. Optimistic Scenario
19.5. Key Market Segmentations

20. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF PRODUCT MANUFACTURED
20.1. Chapter Overview
20.2. Key Assumptions and Methodology
20.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Product Manufactured, 2023 and 2035
20.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for API, 2023-2035
20.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for FDF, 2023-2035
20.4. Data Triangulation

21. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF FORMULATION
21.1. Chapter Overview
21.2. Key Assumptions and Methodology
21.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Formulation, 2023 and 2035
21.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Solids, 2023-2035
21.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Liquids, 2023-2035
21.3.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Others, 2023-2035
21.4. Data Triangulation

22. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF PRIMARY PACKAGING USED
22.1. Chapter Overview
22.2. Key Assumptions and Methodology
22.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Primary Packaging Used, 2023 and 2035
22.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Blister Packs, 2023-2035
22.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Glass / Plastic Bottles, 2023-2035
22.3.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Sachets / Pouches, 2023-2035
22.3.4. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Vials, 2023-2035
22.4. Data Triangulation

23. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY SCALE OF OPERATION
23.1. Chapter Overview
23.2. Key Assumptions and Methodology
23.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Scale of Operation, 2023 and 2035
23.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Clinical, 2023-2035
23.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Commercial, 2023-2035
23.4. Data Triangulation

24. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY COMPANY SIZE
24.1. Chapter Overview
24.2. Key Assumptions and Methodology
24.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Company Size, 2023 and 2035
24.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Small Companies, 2023-2035
24.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Mid-sized Companies, 2023-2035
24.3.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Large and Very Large Companies, 2023-2035
24.4. Data Triangulation

25. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY KEY GEOGRAPHICAL REGIONS
25.1. Chapter Overview
25.2. Key Assumptions and Methodology
25.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Key Geographical Regions, 2023 and 2035
25.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in North America, 2023-2035
25.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Europe, 2023-2035
25.3.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Asia-Pacific, 2023-2035
25.3.4. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Rest of the World, 2023-2035
25.4. Data Triangulation

26. LEADING DEVELOPERS FOR LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME THERAPIES
26.1. Chapter Overview
26.2. Key Assumptions and Methodology
26.3. Live Biotherapeutic Products and Microbiome Therapeutics Market: Distribution by Leading Developers
26.4. Data Triangulation

27. EXECUTIVE INSIGHTS
27.1. Chapter Overview
27.2. Osel
27.2.1. Company Snapshot
27.2.2. Interview Transcript: Peter P. Lee, Founder and Executive Chairman
27.3. Unique Biotech
27.3.1. Company Snapshot
27.3.2. Interview Transcript: Ratna Sudha and Jayanthi, Managing Director and Scientific Head
27.4. Meteoric Biopharmaceuticals
27.4.1. Company Snapshot
27.4.2. Interview Transcript: Gaurav Kaushik, Managing Director and Chief Executive Officer
27.5. Biomedic
27.5.1. Company Snapshot
27.5.2. Interview Transcript: Veronika Oudova, Co- Founder and Chief Executive Officer
27.6. Siolta Therapeutics
27.6.1. Company Snapshot
27.6.2. Interview Transcript: Nikole Kimes, Founder and Chief Executive Officer
27.7. BiomX
27.7.1. Company Snapshot
27.8.2. Interview Transcript: Assaf Oron, Chief Business Officer
27.8. Vedanta Biosciences
27.8.1. Company Snapshot
27.8.2. Interview Transcript: Daniel Couto, Chief Operating Officer
27.9. Universal Stabilization Technologies
27.9.1. Company Snapshot
27.9.2. Interview Transcript: Alexander Segal, Former Vice President, Business Development
\27.10. Arranta Bio
27.10.1. Company Snapshot
27.10.2. Interview Transcript: Traci Kyes, Former Vice President, Commercial Operations
27.11. Assembly Biosciences
27.11.1. Company Snapshot
27.11.2. Interview Transcript: JP Benya, Former Vice President, Business Development
27.12. List Biological Laboratories
27.12.1. Company Snapshot
27.12.2. Interview Transcript: Debbie Pinkston, Former Vice President. Sales and Business Development
27.13. Luina Bio
27.13.1. Company Snapshot
27.13.2. Interview Transcript: Max Rosetto, Head of Business Development
27.14. WACKER
27.14.1. Company Snapshot
27.14.2. Interview Transcript: Rob Van Dijk, Business Development Manager

28. CONCLUDING REMARKS
29. APPENDIX I: TABULATED DATA
30. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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List of Tables/Graphs

Table 5.1 Different Types of Microbiota in the Gastrointestinal Tract
Table 5.2 Various Food Items Containing Prebiotics
Table 5.3 Harvey Ball Analysis: Comparison of Key Factors for the Selection of CMOs
Table 6.1 List of Live Biotherapeutic Products and Microbiome Contract Manufacturers: Market Landscape
Table 6.2 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Product Manufactured
Table 6.3 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Formulation
Table 6.4 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Primary Packaging Used
Table 6.5 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Microbe Used
Table 6.6 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Service Offered
Table 6.7 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Manufacturing Facilities
Table 6.8 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Microbial Species Used
Table 6.9 List of Live Biotherapeutic Products and Microbiome In-House Manufacturers: Market Landscape
Table 7.1 List of Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
Table 7.2 List of Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
Table 7.3 List of Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
Table 9.1 Capsugel: Company Overview
Table 9.2. Arranta Bio: Company Overview
Table 9.3. FUJIFILM Diosynth Biotechnologies: Company Overview
Table 9.4 List Biological Laboratories: Company Overview
Table 9.5 ProbioFerm: Company Overview
Table 9.6 Biose: Company Overview
Table 9.7 Biose: Recent Developments and Future Outlook
Table 9.8 Cerbios-Pharma: Company Overview
Table 9.9 Cerbios Pharma: Recent Developments and Future Outlook
Table 9.10 Chr. Hansen: Company Overview
Table 9.11 Chr Hansen: Recent Developments and Future Outlook
Table 9.12 Inpac Probiotics: Company Overview
Table 9.13 Inpac Probiotics: Recent Developments and Future Outlook
Table 9.14 NIZO: Company Overview
Table 9.15 NIZO: Recent Developments and Future Outlook
Table 9.16 WACKER: Company Overview
Table 9.17 WACKER: Recent Developments and Future Outlook
Table 9.18 Winclove Probiotics: Company Overview
Table 9.19 Winclove Probiotics: Recent Developments and Future Outlook
Table 9.20 BacThera: Company Overview
Table 9.21 Evologic Technologies: Company Overview
Table 9.22 Probiotical: Company Overview
Table 9.23 QUAY Pharma: Company Overview
Table 9.24 BJP Laboratories: Company Overview
Table 9.25 BJP Laboratories: Recent Developments and Future Outlook
Table 9.26 Aumgene Biosciences: Company Overview
Table 9.27 AcuraBio: Company Overview
Table 9.28 Meteoric Biopharmaceuticals: Company Overview
Table 9.29 Probiotics Australia: Company Overview
Table 9.30: Unique Biotech: Company Overview
Table 10.1 Likely Partners for Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
Table 10.2 Likely Partners for Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
Table 10.3 Likely Partners for Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
Table 12.1 Live Biotherapeutic Products and Microbiome Manufacturing: List of Partnerships and Collaborations, 2016-2023
Table 12.2 Partnerships and Collaborations: Information on Type of Agreement, 2016-2023
Table 12.3 Mergers and Acquisitions: Information on Key Value Drivers, 2016-2022
Table 12.4 Live Biotherapeutic Products and Microbiome Manufacturing: List of Recent Expansions, 2019-2023
Table 14.1 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Total Capacity (Sample Data Set)
Table 14.2 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Average Capacity by Company Size (Sample Data Set)
Table 15.1 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing: Information on Number of Enrolled Patients and Trial Phase
Table 15.2 Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing: List of Microbiome-based Live Biotherapeutic Products
Table 17.1 List of Live Biotherapeutic Products and Microbiome CROs: Market Landscape
Table 17.2 Microbiome Dietary Supplement Manufacturers: Market Landscape
Table 26.1 List of Leading Live Biotherapeutic Product and Microbiome Contract Manufacturing Companies
Table 27.1 Osel: Company Snapshots
Table 27.2 Unique Biotech: Company Snapshots
Table 27.3 Meteoric Biopharmaceuticals: Company Snapshots
Table 27.4 Biomedic: Company Snapshots
Table 27.5 Siolta Therapeutics: Company Snapshots
Table 27.6 BiomX: Company Snapshots
Table 27.7 Vedanta Biosciences: Company Snapshots
Table 27.8 Universal Stabilization Technologies: Company Snapshots
Table 27.9 Arranta Bio: Company Snapshots
Table 27.10 Assembly Biosciences: Company Snapshots
Table 27.11 List Biological Laboratories: Company Snapshots
Table 27.12 Luina Bio: Company Snapshots
Table 27.13 WACKER: Company Snapshots
Table 29.1 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Year of Establishment
Table 29.2 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Company Size
Table 29.3 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Location of Headquarters
Table 29.4 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Scale of Operation
Table 29.5 Microbiome Therapeutics Contract Manufacturers: Distribution by Type of Product Manufactured
Table 29.6 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Formulation
Table 29.7 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Scale of Operation and Type of Formulation
Table 29.8 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Primary Packaging Used
Table 29.9 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Formulation and Type of Primary Packaging Used
Table 29.10 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbe Used
Table 29.11 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbe Used and Location of Headquarters
Table 29.12 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Service Offered
Table 29.13 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Number of Manufacturing Facilities (Region)
Table 29.14 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Number of Manufacturing Facilities (Country)
Table 29.15 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbial Species Used
Table 29.16 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Year of Establishment
Table 29.17 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Company Size
Table 29.18 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Location of Headquarters
Table 29.19 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Scale of Operation
Table 29.20 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Location of Manufacturing Facilities
Table 29.21 Partnerships and Collaborations: Distribution by Year of Partnership
Table 29.22 Partnerships and Collaborations: Distribution by Type of Partnership
Table 29.23 Partnerships and Collaborations: Distribution by Year and Type of Partnership
Table 29.24 Partnerships and Collaborations: Distribution by Type of Organization
Table 29.25 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Organization
Table 29.26 Partnerships and Collaborations: Distribution by Therapeutic Area
Table 29.27 Most Active Players: Distribution by Number of Partnerships
Table 29.28 Partnerships and Collaborations: Intracontinental and Intercontinental Agreements
Table 29.29 Partnerships and Collaborations: Local and International Agreements
Table 29.30 Mergers and Acquisitions: Year-wise Cumulative Trend, 2016-2023
Table 29.31 Mergers and Acquisitions: Distribution by Key Value Drivers
Table 29.32 Mergers and Acquisitions: Distribution by Year of Mergers and Acquisitions and Key Value Drivers
Table 29.33 Recent Expansions: Distribution by Year of Expansion
Table 29.34 Recent Expansions: Distribution by Purpose of Expansion
Table 29.35 Recent Expansions: Distribution by Year and Purpose of Expansion
Table 29.36 Recent Expansions: Distribution by Scale of Operation
Table 29.37 Recent Expansions: Distribution by Purpose of Expansion and Scale of Operation
Table 29.38 Recent Expansions: Distribution by Location of Expanded Facility (Region)
Table 29.39 Recent Expansions: Distribution by Location of Expanded Facility (Country)
Table 29.40 Recent Expansions: Distribution by Purpose of Expansion and Location of Expanded Facility (Region)
Table 29.41 Clinical Trial Analysis: Distribution by Trial Registration Year, Pre-2015-2023
Table 29.42 Clinical Trial Analysis: Distribution by Trial Status
Table 29.43 Clinical Trial Analysis: Distribution by Trial Registration Year and Trial Status, Pre-2015-2023
Table 29.44 Clinical Trial Analysis: Distribution by Trial Phase
Table 29.45 Clinical Trial Analysis: Distribution by Trial Registration Year and Trial Phase, Pre-2007-Post-2018
Table 29.46 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Registration Year, Pre-2015-2023
Table 29.47 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase
Table 29.48 Clinical Trial Analysis: Distribution by Type of Sponsor
Table 29.49 Most Active Players: Distribution by Number of Registered Trials
Table 29.50 Clinical Trial Analysis: Distribution by Study Design
Table 29.51 Clinical Trial Analysis: Distribution by Therapeutic Area
Table 29.52 Clinical Trial Analysis: Distribution of Number of Registered Trials by Geography
Table 29.53 Clinical Trial Analysis: Distribution of Number of Registered Trials by Trial Status and Geography
Table 29.54 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Geography
Table 29.55 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Status and Geography
Table 29.56 Capacity Analysis: Distribution by Company Size
Table 29.57 Capacity Analysis: Distribution by Geography
Table 29.58 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in North America
Table 29.59 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in Europe
Table 29.60 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in Asia-Pacific and Rest of the World
Table 29.61 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Number of Trials Conducted
Table 29.62 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Number of Enrolled Patient Population
Table 29.63 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing: Distribution by Trial Phase
Table 29.64 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing: Distribution by Geography
Table 29.65 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in North America, 2023-2035
Table 29.66 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in Europe, 2023-2035
Table 29.67 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in Asia-Pacific, 2023-2035
Table 29.68 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in Rest of the World, 2023-2035
Table 29.69 Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Number of Target Patient Population (in Million)
Table 29.70 Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035 (in cfu)
Table 29.71 Live Biotherapeutic Products and Microbiome CROs: Distribution by Year of Establishment
Table 29.72 Live Biotherapeutic Products and Microbiome CROs: Distribution by Company Size
Table 29.73 Live Biotherapeutic Products and Microbiome CROs: Distribution by Location of Headquarters
Table 29.74 Microbiome Dietary Supplement Manufacturers: Distribution by Year of Establishment
Table 29.75 Microbiome Dietary Supplement Manufacturers: Distribution by Company Size
Table 29.76 Microbiome Dietary Supplement Manufacturers: Distribution by Location of Headquarters
Table 29.77 Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, Conservative, Base and Optimistic Scenarios, 2023-2035 (USD Million)
Table 29.78 Live Biotherapeutic Products and Microbiome Contract Manufacturing
Table 29.79 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for APIs: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.80 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for FDFs: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.81 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Product Formulation, 2023 and 2035 (USD Million)
Table 29.82 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Solid: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.83 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Liquid: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.84 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Others: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.85 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Primary Packaging Used, 2023 and 2035 (USD Million)
Table 29.86 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Blister Packs: Future Estimates (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.87 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Glass / Plastic Bottles: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.88 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Sachets / Pouches: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.89 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Vials: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.90 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Scale of Operation, 2023 and 2035 (USD Million)
Table 29.91 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Clinical: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.92 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Commercial: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.93 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Company Size, 2023 and 2035 (USD Million)
Table 29.94 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Small Companies: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.95 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Mid-sized Companies: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.96 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Large and Very Large Companies: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.97 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Key Geographical Regions, 2023 and 2035 (USD Million)
Table 29.98 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in North America: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.99 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Europe (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.100 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Asia-Pacific: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.101 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Rest of the World: (2023-2035) Conservative, Base and Optimistic (USD Million)
Table 29.102 Live Biotherapeutic Products and Microbiome Therapeutics Market, Distribution by Leading Developers, 2035