Live Biotherapeutic Products and Microbiome Manufacturing Market by Type of Product Manufactured (API and FDF), Type of Formulation (Solids, Oral Liquids and Injectables), 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 Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022 – 2035
The projected value of microbiome manufacturing market is expected to be valued at USD 23 million in 2022 and is anticipated to grow at a CAGR of 20% during the forecast period 2022-2035.
In light of the remarkable progress witnessed in the clinical development of microbiome-based live biotherapeutic products, it is foreseen that this emerging therapeutic sector will emerge as one of the most rapidly expanding markets within the pharmaceutical industry in the forthcoming years. Specifically, in 2020, a noteworthy 575 Investigational New Drug (IND) applications were submitted for these therapies, demonstrating a concerted effort to address a diverse range of disease indications such as autoimmune, gastrointestinal, infectious, metabolic, and oncological disorders. This surge in applications underscores the considerable scientific advancements achieved by these groundbreaking drug candidates.
Of particular significance is the imminent marketing approval expected in 2022 for SER-109, a microbiome-based therapy developed by Seres Therapeutics, by the United States Food and Drug Administration (FDA). This impending approval is poised to catalyze further growth within this sector. Additionally, the year 2020 witnessed the approval of over 640 patents specifically focused on microbiome therapeutics, coupled with a substantial investment of USD 1.5 billion dedicated to the development of microbiome-based therapeutic interventions.
Despite the considerable strides made in the development of live biotherapeutic products, challenges persist due to the intricacies of the manufacturing process. Concurrently, contemporary innovators express concerns regarding the limited availability of expertise, inadequate specialized infrastructure, the necessity for substantial capital investment, and the challenges associated with ensuring compliance with Good Manufacturing Practices (GMP) and capacity constraints.
To effectively address the technical and operational challenges highlighted above, numerous microbiome developers are increasingly relying on contract manufacturing organizations (CMOs). Presently, more than 50 entities engaged in the manufacturing of microbiome-related products operate either in-house or on a contractual basis. The current landscape of microbiome contract manufacturers is characterized by a high degree of fragmentation, featuring a blend of start-ups, mid-sized firms, and established players. Notably, in recent years, strategic alliances and acquisitions have been forged among various industry players, aiming to augment their respective service offerings and evolve into comprehensive one-stop-shops.
As stakeholders actively seek solutions to overcome existing challenges and prioritize innovation to enhance the microbiome production process, we anticipate substantial growth in the microbiome manufacturing market over the next decade.
Research Coverage
In light of the remarkable progress witnessed in the clinical development of microbiome-based live biotherapeutic products, it is foreseen that this emerging therapeutic sector will emerge as one of the most rapidly expanding markets within the pharmaceutical industry in the forthcoming years. Specifically, in 2020, a noteworthy 575 Investigational New Drug (IND) applications were submitted for these therapies, demonstrating a concerted effort to address a diverse range of disease indications such as autoimmune, gastrointestinal, infectious, metabolic, and oncological disorders. This surge in applications underscores the considerable scientific advancements achieved by these groundbreaking drug candidates.
Of particular significance is the imminent marketing approval expected in 2022 for SER-109, a microbiome-based therapy developed by Seres Therapeutics, by the United States Food and Drug Administration (FDA). This impending approval is poised to catalyze further growth within this sector. Additionally, the year 2020 witnessed the approval of over 640 patents specifically focused on microbiome therapeutics, coupled with a substantial investment of USD 1.5 billion dedicated to the development of microbiome-based therapeutic interventions.
Despite the considerable strides made in the development of live biotherapeutic products, challenges persist due to the intricacies of the manufacturing process. Concurrently, contemporary innovators express concerns regarding the limited availability of expertise, inadequate specialized infrastructure, the necessity for substantial capital investment, and the challenges associated with ensuring compliance with Good Manufacturing Practices (GMP) and capacity constraints.
To effectively address the technical and operational challenges highlighted above, numerous microbiome developers are increasingly relying on contract manufacturing organizations (CMOs). Presently, more than 50 entities engaged in the manufacturing of microbiome-related products operate either in-house or on a contractual basis. The current landscape of microbiome contract manufacturers is characterized by a high degree of fragmentation, featuring a blend of start-ups, mid-sized firms, and established players. Notably, in recent years, strategic alliances and acquisitions have been forged among various industry players, aiming to augment their respective service offerings and evolve into comprehensive one-stop-shops.
As stakeholders actively seek solutions to overcome existing challenges and prioritize innovation to enhance the microbiome production process, we anticipate substantial growth in the microbiome manufacturing market over the next decade.
Research Coverage
- An introduction to the human microbiome, exploring various types of microbiome therapeutics. The chapter covers microbiota functions, insights from the Human Microbiome Project (HMP), manufacturing steps, challenges, and the increasing need for outsourcing. It concludes with factors for innovators to consider when choosing a Contract Manufacturing Organization (CMO) partner.
- An overview of the microbiome contract manufacturing landscape, analyzing 25+ contract manufacturers based on parameters like establishment year, company size, service offerings, and more.
- Detailed microbiome manufacturing facilities in key regions (North America, Europe, Asia-Pacific), including map representations and highlighting manufacturing hubs.
- A company competitiveness analysis of microbiome manufacturing service providers, considering product and service strengths.
- Detailed profiles of key industry players in North America, Europe, and Asia-Pacific, providing overviews, service portfolios, manufacturing facilities, and recent developments.
- Recent developments in the microbiome manufacturing industry, covering partnerships, collaborations, mergers, acquisitions, and expansions from 2016 to 2021.
- An in-depth analysis of completed, ongoing, and planned clinical studies of microbiome therapeutics, considering various parameters.
- Installed capacity for manufacturing microbiome-based therapies, highlighting distribution by scale of operation, company size, and geographical regions.
- An informed estimate of the annual clinical and commercial demand for microbiome therapeutics, considering ongoing and planned trials.
- A qualitative analysis, outlining factors for microbiome therapeutics developers to consider when deciding to manufacture in-house or engage CMO services.
- Capsugel
- Jeneil Biotech
- UAS Labs
- Biose
- Cerbios-Pharma
- Inpac Probiotics
- NIZO
- Winclove Probiotics
- BJP Laboratories
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
2.1. Chapter Overview
3. INTRODUCTION
3.1. Chapter Overview
3.2. Concept of Human Microbiota and Microbiome
3.3. Overview of Gut Flora
3.3.1. Role of Gut Flora in Healthy Individuals
3.3.2. 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 while Selecting a Suitable CMO Partner
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
11.1. Chapter Overview
11.2. Scope and Methodology
11.3. Live Biotherapeutic Products and Microbiome: Clinical Trial Analysis
11.3.1. Analysis by Trial Registration Year
11.3.2. Analysis by Trial Status
11.3.3. Analysis by Trial Phase
11.3.4. Analysis by Trial Registration Year and Trial Recruitment Status
11.3.5. Analysis by Trial Registration Year and Enrolled Patient Population
11.3.6. Analysis by Study Design
11.3.7. Most Active Players: Analysis by Number of Registered Trials
11.3.7. Emerging Focus Area
11.3.9. Analysis by Therapeutic Area
11.3.10. Geographical Analysis by Number of Registered Trials
11.3.11. Geographical Analysis by Enrolled Patient Population
12. CAPACITY ANALYSIS
12.1. Chapter Overview
12.2. Key Assumptions and Methodology
12.3. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Global Production Capacity
12.3.1. Analysis by Company Size
12.3.2. Analysis by Scale of Operation
12.3.3. Analysis by Region
12.3.3.1. Capacity Analysis: North America
12.3.3.2. Capacity Analysis: Europe
12.3.3.3. Capacity Analysis: Asia-Pacific
12.4. Concluding Remarks
13. DEMAND ANALYSIS
13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Global Clinical Demand for Live Biotherapeutic Products and Microbiome Contract Manufacturing
13.4. Global Clinical Demand for Live Biotherapeutic Products and Microbiome Contract Manufacturing
13.4.1. Geographical Analysis of Clinical Demand
13.4.1.1. Clinical Demand in North America
13.4.1.2. Clinical Demand in Europe
13.4.1.3. Clinical Demand in Asia-Pacific and Rest of the World
13.4.2. Analysis of Clinical Demand by Trial Phase
13.5. Global Commercial Demand for Live Biotherapeutic Products and Microbiome Contract Manufacturing
13.6. Concluding Remarks
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
14.3.2. Scenario
14.3.3. Scenario
14.3.4. Scenario
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
16.1. Chapter Overview
16.2. Forecast Methodology
16.3. Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2022-2035
16.4 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Analysis by Type of Product Manufactured
16.4.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for APIs, 2022-2035
16.4.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for FDFs, 2022-2035
16.5. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Analysis by Type of Formulation
16.5.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Solid Formulations, 2022-2035
16.5.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Oral Liquids, 2022-2035
16.5.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Injectables, 2022-2035
16.5.4. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Others, 2022-2035
16.6. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Analysis by Scale of Operation
16.6.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Clinical Operations, 2022-2035
16.6.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Commercial Operations, 2022-2035
16.7. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Analysis by Company Size
16.7.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Small Companies, 2022-2035
16.7.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Mid-sized Companies, 2022-2035
16.7.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Large Companies, 2022-2035
16.8. Microbiome Contract Manufacturing Market: Analysis by Geography
16.8.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in North America, 2022-2035
16.8.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Europe, 2022-2035
16.8.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Asia-Pacific and Rest of the World, 2022-2035
16.9. Concluding Remarks
17. CONCLUSION
17.1. Chapter Overview
18. INTERVIEW TRANSCRIPTS
18.1. Chapter Overview
18.2. Traci Kyes, Vice President of Commercial Operations, Arranta Bio
18.2.1. Arranta Bio: Key Highlights
18.2.2. Interview Transcript
18.2. JP Benya, Vice President, Business Development, Assembly Biosciences
18.2.1. Assembly Biosciences: Key Highlights
18.2.2. Interview Transcript
18.3. Assaf Oron, Chief Business Officer, BiomX
18.3.1. BiomX: Key Highlights
18.3.2. Interview Transcript
18.4. Alexander Lin, Associate General Manager, Chung Mei Pharmaceutical
18.4.1. Chung Mei Pharmaceutical: Key Highlights
18.4.2. Interview Transcript
18.5. Debbie Pinkston, Vice President, Sales and Business Development, List
18.5.1. List Biological Laboratories: Key Highlights
18.5.2. Interview Transcript
18.6. Max Rosetto, Head of Business Development, Luina Bio
18.6.1. Luina Bio: Key Highlights
18.6.2. Interview Transcript
18.7. Gaurav Kaushik, Managing Director and Chief Executive Officer, Meteoric
18.7.1. Meteoric Biopharmaceuticals: Key Highlights
18.7.2. Interview Transcript
18.8. Veronika Oudova, Co-founder and Chief Executive Officer, S-Biomedic
18.8.1. S-Biomedic: Key Highlights
18.8.2. Interview Transcript
18.9. Nikole Kimes, Founder and Chief Executive Officer, Siolta Therapeutics
18.9.1. Siolta Therapeutics: Key Highlights
18.9.2. Interview Transcript
18.10. Alexander Segal, Vice President, Business Development, Universal
18.10.1. Universal Stabilization Technologies: Key Highlights
18.10.2. Interview Transcript
18.11. Rob Van Dijk, Business Development Manager, Wacker Biotech
18.11.1. Wacker Biotech: Key Highlights
18.11.2. Interview Transcript
19. APPENDIX I: TABULATED DATA
20. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
2.1. Chapter Overview
3. INTRODUCTION
3.1. Chapter Overview
3.2. Concept of Human Microbiota and Microbiome
3.3. Overview of Gut Flora
3.3.1. Role of Gut Flora in Healthy Individuals
3.3.2. 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 while Selecting a Suitable CMO Partner
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
11.1. Chapter Overview
11.2. Scope and Methodology
11.3. Live Biotherapeutic Products and Microbiome: Clinical Trial Analysis
11.3.1. Analysis by Trial Registration Year
11.3.2. Analysis by Trial Status
11.3.3. Analysis by Trial Phase
11.3.4. Analysis by Trial Registration Year and Trial Recruitment Status
11.3.5. Analysis by Trial Registration Year and Enrolled Patient Population
11.3.6. Analysis by Study Design
11.3.7. Most Active Players: Analysis by Number of Registered Trials
11.3.7. Emerging Focus Area
11.3.9. Analysis by Therapeutic Area
11.3.10. Geographical Analysis by Number of Registered Trials
11.3.11. Geographical Analysis by Enrolled Patient Population
12. CAPACITY ANALYSIS
12.1. Chapter Overview
12.2. Key Assumptions and Methodology
12.3. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Global Production Capacity
12.3.1. Analysis by Company Size
12.3.2. Analysis by Scale of Operation
12.3.3. Analysis by Region
12.3.3.1. Capacity Analysis: North America
12.3.3.2. Capacity Analysis: Europe
12.3.3.3. Capacity Analysis: Asia-Pacific
12.4. Concluding Remarks
13. DEMAND ANALYSIS
13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Global Clinical Demand for Live Biotherapeutic Products and Microbiome Contract Manufacturing
13.4. Global Clinical Demand for Live Biotherapeutic Products and Microbiome Contract Manufacturing
13.4.1. Geographical Analysis of Clinical Demand
13.4.1.1. Clinical Demand in North America
13.4.1.2. Clinical Demand in Europe
13.4.1.3. Clinical Demand in Asia-Pacific and Rest of the World
13.4.2. Analysis of Clinical Demand by Trial Phase
13.5. Global Commercial Demand for Live Biotherapeutic Products and Microbiome Contract Manufacturing
13.6. Concluding Remarks
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
14.3.2. Scenario
14.3.3. Scenario
14.3.4. Scenario
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
16.1. Chapter Overview
16.2. Forecast Methodology
16.3. Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2022-2035
16.4 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Analysis by Type of Product Manufactured
16.4.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for APIs, 2022-2035
16.4.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for FDFs, 2022-2035
16.5. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Analysis by Type of Formulation
16.5.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Solid Formulations, 2022-2035
16.5.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Oral Liquids, 2022-2035
16.5.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Injectables, 2022-2035
16.5.4. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Others, 2022-2035
16.6. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Analysis by Scale of Operation
16.6.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Clinical Operations, 2022-2035
16.6.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Commercial Operations, 2022-2035
16.7. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Analysis by Company Size
16.7.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Small Companies, 2022-2035
16.7.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Mid-sized Companies, 2022-2035
16.7.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Large Companies, 2022-2035
16.8. Microbiome Contract Manufacturing Market: Analysis by Geography
16.8.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in North America, 2022-2035
16.8.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Europe, 2022-2035
16.8.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Asia-Pacific and Rest of the World, 2022-2035
16.9. Concluding Remarks
17. CONCLUSION
17.1. Chapter Overview
18. INTERVIEW TRANSCRIPTS
18.1. Chapter Overview
18.2. Traci Kyes, Vice President of Commercial Operations, Arranta Bio
18.2.1. Arranta Bio: Key Highlights
18.2.2. Interview Transcript
18.2. JP Benya, Vice President, Business Development, Assembly Biosciences
18.2.1. Assembly Biosciences: Key Highlights
18.2.2. Interview Transcript
18.3. Assaf Oron, Chief Business Officer, BiomX
18.3.1. BiomX: Key Highlights
18.3.2. Interview Transcript
18.4. Alexander Lin, Associate General Manager, Chung Mei Pharmaceutical
18.4.1. Chung Mei Pharmaceutical: Key Highlights
18.4.2. Interview Transcript
18.5. Debbie Pinkston, Vice President, Sales and Business Development, List
18.5.1. List Biological Laboratories: Key Highlights
18.5.2. Interview Transcript
18.6. Max Rosetto, Head of Business Development, Luina Bio
18.6.1. Luina Bio: Key Highlights
18.6.2. Interview Transcript
18.7. Gaurav Kaushik, Managing Director and Chief Executive Officer, Meteoric
18.7.1. Meteoric Biopharmaceuticals: Key Highlights
18.7.2. Interview Transcript
18.8. Veronika Oudova, Co-founder and Chief Executive Officer, S-Biomedic
18.8.1. S-Biomedic: Key Highlights
18.8.2. Interview Transcript
18.9. Nikole Kimes, Founder and Chief Executive Officer, Siolta Therapeutics
18.9.1. Siolta Therapeutics: Key Highlights
18.9.2. Interview Transcript
18.10. Alexander Segal, Vice President, Business Development, Universal
18.10.1. Universal Stabilization Technologies: Key Highlights
18.10.2. Interview Transcript
18.11. Rob Van Dijk, Business Development Manager, Wacker Biotech
18.11.1. Wacker Biotech: Key Highlights
18.11.2. Interview Transcript
19. APPENDIX I: TABULATED DATA
20. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS
