The contract manufacturing market for live biotherapeutics and microbiome products
Roots Analysis has done a detailedstudy on Live Biotherapeutic Products andMicrobiome Contract Manufacturing Market, 2020-2030: Focus on ActivePharmaceutical Ingredients and Finished Dosage Forms, 2020-2030, covering keyaspects of the industry’s evolution and identifying potential future growthopportunities.
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Key Market Insights
§ The microbiometherapies pipeline features 260 drugs under evaluation across different phasesof development; contract service providers have become an integral part of thesupply chain owing to their technical expertise.
§ Presently, over 25firms across the globe claim to possess the required know-how andinfrastructure to offer contract manufacturing services for live biotherapeuticproducts and microbiome therapies
§ The market isfragmented, featuring the presence of established players and mid-sized firmsacross different global regions, with capabilities to manufacture aerobic and /or anaerobic strains, at varying scales of operation
§ Most of theinstalled, global live biotherapeutic contract manufacturing capacity presentlybelongs to dedicated large and mid-sized CMOs, accounting for over 90% of whatis available across various geographies
§ Future growth of themarket is likely to be driven by increased demand for these therapeutics; weexpect the service-based revenues to grow at an annualized rate of over 46% inthe coming decade
§ In the long-term, theprojected market opportunity is anticipated to be well distributed acrossdifferent types of formulations, sizes of contract service providers andgeographical regions
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Table of Contents
1. PREFACE
1.1. Scope ofthe Report
1.2. ResearchMethodology
1.3. ChapterOutlines
2. EXECUTIVESUMMARY
3. INTRODUCTION
3.1. ChapterOverview
3.2. Concept ofHuman Microbiota and Microbiome
3.3. Overview ofGut Flora
3.2.3. Role of GutFlora in Healthy Individuals
3.2.4. FactorsAffecting Human Gut Flora
3.4. The HumanMicrobiome Project (HMP)
3.5. Overview ofMicrobiome Therapies
3.5.1. Types ofMicrobiome Therapies
3.5.1.1. Probiotics
3.5.1.2. Prebiotics
3.5.2. Applicationsof Microbiome Therapies
3.5.3. MicrobiomeTherapies Supply Chain
3.6. Microbiome-basedProduct Manufacturing
3.6.1. Key StepsInvolved
3.6.2. AssociatedChallenges
3.6.3. Role ofContract Manufacturing Organizations (CMOs)
3.6.4. Demand forContract Manufacturing Services
3.7. KeyConsiderations for Selecting a Suitable CMO Partner
4. MARKETLANDSCAPE
4.1. ChapterOverview
4.2. CMOsOffering Contract Manufacturing for Microbiome Therapeutics: List of Companies
4.2.1. Analysis byYear of Establishment
4.2.2. Analysis byCompany Size
4.2.3. Analysis byScale of Operation
4.2.4. Analysis byLocation of Headquarters
4.2.5. Analysis byType of Service Offered
4.2.6. Analysis byType of Product Manufactured
4.2.7. Analysis byType of Drug Molecule
4.2.8. Analysis byType of Fermentation Required
4.2.9. Analysis byType of Formulation
4.2.10. Analysis byType of Primary Packaging Used
4.2.11. Analysis byNumber of Manufacturing Facilities
4.2.12. Analysis byLocation of Manufacturing Facilities
4.2.13. Analysis byType of Regulatory Certifications / Accreditations
4.3. MicrobiomeTherapeutics In-House Manufacturers: List of Companies
4.3.1. Analysis byYear of Establishment
4.3.2. Analysis byCompany Size
4.3.3. Analysis byScale of Operation
4.3.4. Analysis byLocation of Headquarters
4.3.5. Analysis byLocation of Manufacturing Facilities
5. COMPANYPROFILES
5.1. ChapterOverview
5.2. CMOsHeadquartered in North America
5.2.1. Capsugel
5.2.1.1. CompanyOverview
5.2.1.2. Microbiome-RelatedService Portfolio
5.2.1.3. FacilitiesDedicated to Microbiome Manufacturing
5.2.1.4. RecentDevelopments and Future Outlook
5.2.2. ParagonBioservices
5.2.2.1. CompanyOverview
5.2.2.2. Microbiome-RelatedService Portfolio
5.2.2.3. FacilitiesDedicated to Microbiome Manufacturing
5.2.2.4. RecentDevelopments and Future Outlook
5.2.3. UAS Labs
5.2.3.1. CompanyOverview
5.2.3.2. Microbiome-RelatedService Portfolio
5.2.3.3. FacilitiesDedicated to Microbiome Manufacturing
5.2.3.4. RecentDevelopments and Future Outlook
5.3. CMOsHeadquartered in Europe
5.3.1. Biose
5.3.1.1. CompanyOverview
5.3.1.2. Microbiome-RelatedService Portfolio
5.3.1.3. FacilitiesDedicated to Microbiome Manufacturing
5.3.1.4. RecentDevelopments and Future Outlook
5.3.2. CobraBiologics
5.3.2.1. CompanyOverview
5.3.2.2. FinancialInformation
5.3.2.3. Microbiome-RelatedService Portfolio
5.3.2.4. FacilitiesDedicated to Microbiome Manufacturing
5.3.2.5. RecentDevelopments and Future Outlook
5.3.3. Cerbios
5.3.3.1. CompanyOverview
5.3.3.2. Microbiome-RelatedService Portfolio
5.3.3.3. FacilitiesDedicated to Microbiome Manufacturing
5.3.3.4. RecentDevelopments and Future Outlook
5.3.4. InpacProbiotics
5.3.4.1. CompanyOverview
5.3.4.2. Microbiome-RelatedService Portfolio
5.3.4.3. FacilitiesDedicated to Microbiome Manufacturing
5.4. CMOsHeadquartered in Asia-Pacific and Rest of the World
5.4.1. BJPLaboratories
5.4.1.1. CompanyOverview
5.4.1.2. Microbiome-RelatedService Portfolio
5.4.1.3. FacilitiesDedicated to Microbiome Manufacturing
6. REGIONALCAPABILITY ANALYSIS
6.1. ChapterOverview
6.2. KeyAssumptions and Methodology
6.3. RegionalCapability Analysis: Microbiome Contract Manufacturers in North America
6.4. RegionalCapability Analysis: Microbiome Contract Manufacturers in Europe
6.5. Regional Capability Analysis: MicrobiomeContract Manufacturers in Asia-Pacific and Rest of the World
6.6. ConcludingRemarks
7. LIKELYPARTNER ANALYSIS
7.1. ChapterOverview
7.2. Scope and Methodology
7.3. PotentialStrategic Partners for Microbiome Contract Manufacturers
7.3.1. Opportunitiesin North America
7.3.2. Opportunitiesin Europe and Asia-Pacific
8. CLINICALTRIAL ANALYSIS
8.1. ChapterOverview
8.2. Scope andMethodology
8.3. ClinicalTrial Analysis (Industry Players)
8.3.1. Analysis byTrial Registration Year
8.3.2. Analysis byTrial Phase
8.3.3. Analysis byTrial Recruitment Status
8.3.4. Analysis byTrial Registration Year and Recruitment Status
8.3.5. Analysis byTrial Registration Year and Number of Patients Enrolled
8.3.6. Analysis byStudy Design
8.3.7. Analysis byTrial Focus
8.3.8. Analysis byTrial Phase and Type of Intervention Model
8.3.9. Analysis bySponsor / Collaborator
8.3.10. Analysis byType of Organization
8.3.11. PopularTherapeutic Areas: Analysis by Number of Clinical Trials and Registration Year
8.3.12. GeographicalAnalysis by Number of Clinical Trials
8.3.13. GeographicalAnalysis by Trial Recruitment Status
8.4. ClinicalTrial Analysis (Non-Industry Players)
8.4.1. Analysis byTrial Registration Year
8.4.2. Analysis byTrial Phase
8.4.3. Analysis byTrial Recruitment Status
8.4.4. Analysis byTrial Registration Year and Recruitment Status
8.4.5. Analysis byTrial Registration Year and Number of Patients Enrolled
8.4.6. Analysis byStudy Design
8.4.7. Analysis byTrial Focus
8.4.8. Analysis byTrial Phase and Type of Intervention Model
8.4.9. Analysis bySponsor / Collaborator
8.4.10. Analysis byType of Organization
8.4.11. PopularTherapeutic Areas: Analysis by Number of Clinical Trials and Registration Year
8.4.12. GeographicalAnalysis by Number of Clinical Trials
8.4.13. GeographicalAnalysis by Trial Recruitment Status
9. CAPACITYANALYSIS
9.1. ChapterOverview
9.2. KeyAssumptions and Methodology
9.3. MicrobiomeContract Manufacturers: Global Production Capacity
9.3.1. Analysis byCompany Size
9.3.1.1. Overall Production Capacity of Small-sizedCompanies
9.3.1.2. OverallProduction Capacity of Mid-sized Companies
9.3.1.3. Overall Production Capacity of Large Companies
9.3.2. Analysis byScale of Operation
9.3.2.1. Overall Clinical Scale Production Capacity
9.3.2.2. OverallCommercial Scale Production Capacity
9.3.3. Analysis byLocation of Manufacturing Facility
9.3.3.1. Overall Production Capacity in North America
9.3.3.2. Overall Production Capacity in Europe
9.3.3.3. OverallProduction Capacity in Asia-Pacific and Rest of the World
9.4. ConcludingRemarks
10. DEMAND ANALYSIS
10.1. ChapterOverview
10.2. Scope andMethodology
10.3. GlobalClinical Demand for Microbiome Contract Manufacturing
10.3.1. GeographicalAnalysis of Demand
10.3.1.1. Clinical Demand in North America
10.3.1.2. Clinical Demand in Europe
10.3.1.3. Clinical Demand in Asia-Pacific and Rest of theWorld
10.3.2. Phase-WiseAnalysis of Demand
10.3.2.1. Clinical Demand in Phase I
10.3.2.2. Clinical Demand in Phase II
10.3.2.3. Clinical Demand in Phase III
10.3.3. Sponsor WiseAnalysis of Demand
10.3.2.1. Clinical Demand for Industry Sponsors
10.3.2.2. Clinical Demand for Non-Industry Sponsors
10.4 ConcludingRemarks
11. MAKE VERSUSBUY DECISION MAKING FRAMEWORK
11.1. ChapterOverview
11.2. Make versusBuy Decision Making: Assumptions and Parameter Definitions
11.2.1. Scenario 1:High Value Addition / Low Complexity
11.2.1. Scenario 2:High Value Addition / High Complexity
11.2.1. Scenario 3:Low Value Addition / Low Complexity
11.2.1. Scenario 4:Low Value Addition / High Complexity
11.3. ContractManufacturer’s Perspective
11.4. ConcludingRemarks
12. MICROBIOMERELATED INITIATIVES OF BIG PHARMACEUTICAL PLAYERS
12.1. ChapterOverview
12.2. Scope andMethodology
12.3. Initiativesof Big Pharmaceutical Players
12.3.1. Analysis by PortfolioDiversity
12.3.2. Analysis byPhase of Development
12.3.3. Analysis byType of Therapeutic
12.3.4. Analysis byType of Drug Molecule
12.3.5. Heat Map:Analysis by Target Therapeutic Areas
12.4. BenchmarkAnalysis of Big Pharmaceutical Players
12.4.1. Spider WebAnalysis: Company A
12.4.2. Spider WebAnalysis: Company B
12.4.3. Spider WebAnalysis: Company C
12.4.4. Spider WebAnalysis: Company D
12.4.5. Spider WebAnalysis: Company E
12.4.6. Spider WebAnalysis: Company F
12.4.7. Spider WebAnalysis: Company G
12.4.8. Spider WebAnalysis: Company H
12.4.9. Spider WebAnalysis: Company I
12.4.10. Spider Web Analysis: Company J
12.4.11. Spider Web Analysis: Company K
12.5. ConcludingRemarks
13. MARKETFORECAST
13.1. Chapter Overview
13.2. ForecastMethodology and Key Assumptions
13.3. OverallMicrobiome Contract Manufacturing Market, 2020-2030
13.4 MicrobiomeContract Manufacturing Market, 2020-2030: Distribution by Product Manufactured
13.4.1. MicrobiomeContract Manufacturing Market for APIs, 2020-2030
13.4.2. MicrobiomeContract Manufacturing Market for FDFs, 2020-2030
13.5. MicrobiomeContract Manufacturing Market, 2020-2030: Distribution by Type of Formulation
13.5.1. MicrobiomeContract Manufacturing Market for Solid Formulations, 2020-2030
13.5.2. MicrobiomeContract Manufacturing Market for Oral Liquids, 2020-2030
13.5.3. MicrobiomeContract Manufacturing Market for Injectables, 2020-2030
13.5.4. MicrobiomeContract Manufacturing Market for Others, 2020-2030
13.6. MicrobiomeContract Manufacturing Market, 2020-2030: Distribution by Scale of Operation
13.6.1. MicrobiomeContract Manufacturing Market for Clinical Scale Operations, 2020-2030
13.6.2. MicrobiomeContract Manufacturing Market for Commercial Scale Operations, 2020-2030
13.7. MicrobiomeContract Manufacturing Market, 2020-2030: Distribution by Company Size
13.7.1. MicrobiomeContract Manufacturing Market for Small-sized Companies, 2020-2030
13.7.2. MicrobiomeContract Manufacturing Market for Mid-sized Companies, 2020-2030
13.7.3. MicrobiomeContract Manufacturing Market for Large Companies, 2020-2030
13.8. MicrobiomeContract Manufacturing Market, 2020-2030: Geographical Distribution
13.8.1. MicrobiomeContract Manufacturing Market in North America, 2020-2030
13.8.2. MicrobiomeContract Manufacturing Market in Europe, 2020-2030
13.8.3. MicrobiomeContract Manufacturing Market in Asia-Pacific and Rest of the World, 2020-2030
13.9. ConcludingRemarks
14. CONCLUSION
14.1. ChapterOverview
14.2. Key Takeaways
15. EXECUTIVEINSIGHTS
15.1. ChapterOverview
15.2. S-Biomedic
15.2.1. CompanySnapshot
15.2.2. InterviewTranscript: Veronika Oudova, Co-founder and Chief Executive Officer
15.3. MeteoricBiopharmaceuticals
15.3.1. CompanySnapshot
15.3.2. InterviewTranscript: Gaurav Kaushik, Managing Director and Chief Executive Officer
15.4. BiomX
15.4.1. CompanySnapshot
15.4.2. InterviewTranscript: Assaf Oron, Chief Business Officer
15.5. UniversalStabilization Technologies
15.5.1 CompanySnapshot
15.5.2. InterviewTranscript: Alexander Segal, Vice President, Business Development
15.6. ListBiological Laboratories
15.6.1. CompanySnapshot
15.6.2. InterviewTranscript: Debbie Pinkston, Vice President, Sales and Business Development
15.7. AssemblyBiosciences
15.7.1. CompanySnapshot
15.7.2. InterviewTranscript: JP Benya, Vice President, Business Development
15.8. WackerBiotech
15.8.1 CompanySnapshot
15.8.2. InterviewTranscript: Rob van Dijk, Business Development Manager
15.9. Chung Mei Pharmaceutical
15.9.1. CompanySnapshot
15.9.2. InterviewTranscript: Alexander Lin, Associate General Manager
16. APPENDIX I:TABULATED DATA
17. APPENDIXII: LIST OF COMPANIES AND ORGANIZATIONS
18. APPENDIX III: LIST OF PROBIOTICSUPPLEMENT CONTRACT MANUFACTURERS AND MICROBIAL CONTACT SERVICE PROVIDERS
Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
