DUBLIN–(BUSINESS WIRE)–The “Live Biotherapeutic Products and Microbiome Manufacturing Market by Type of Product Manufactured, Type of Formulation, Type of Primary Packaging Used, Scale of Operation, Company Size and Key Geographical Regions: Industry Trends and Global Forecasts, 2022 – 2035” report has been added to ResearchAndMarkets.com’s offering.
This report features an extensive study on the in- house and contract manufacturing organizations within the microbiome industry. The study also includes an elaborate discussion on the future potential of this evolving market.
Given the advancement of several promising microbiome-based live biotherapeutic products through clinical pipeline, this upcoming therapeutic segment is anticipated to become one of the fastest growing markets within the pharmaceutical industry in the coming years. Specifically, in 2020, around 575 IND applications were filed for such therapies, targeting a myriad of diseases indications, including autoimmune, gastrointestinal, infectious, metabolic and oncological disorders, indicating remarkable scientific progress of these breakthrough drug candidates.
It is also worth highlighting that SER-109, a microbiome-based therapy developed by Seres Therapeutics, is expected to receive marketing approval from the US Food and Drug Administration (FDA) in 2022; this is further likely to propel the growth in this domain. Further, over 640 patents focused on microbiome therapeutics were granted approval in the year 2020. In addition, during the same time frame, USD 1.5 billion was invested for the development of microbiome-based therapeutics.
Although a lot has been achieved in terms of development of live biotherapeutic products, there are certain challenges associated with the complexity of the process. Other key concerns shared by contemporary innovators include limited availability of expertise, lack of specialized infrastructure, requirement for exorbitant capital investment, and constraints associated with ensuring compliance to good manufacturing practices (GMP) and capacity.
In order to address the technical and operational challenges outlined above, several microbiome developers prefer to rely on contract manufacturing organizations (CMOs). It is worth highlighting that, currently, over 50 players engaged in the manufacturing of microbiome-related products carry out operations either in-house or on contract basis. The current market landscape of microbiome contract manufacturers is highly fragmented, featuring a mix of start-ups, mid-sized firms and established players.
Moreover, in recent years, several players engaged in this domain have forged strategic alliances and / or acquired other players, in order to further enhance their respective service offerings and operate as one-stop-shops. As stakeholders strive to mitigate existing challenges and focus on innovation to improve the microbiome production process, we believe that the microbiome manufacturing market is expected to witness significant growth over the next decade.
Companies Mentioned
- 4D Pharma
- AbbVie
- ABCO Laboratories
- ABH Pharma
- Adare Pharmaceuticals
- ADM Biopolis
- Advanced Enzymes
- Allianz Biosciences
- AmpliPhi Biosciences
- AOBiome Therapeutics
- Arena Pharmaceuticals
- Armata Pharmaceuticals
- Arranta Bio
- AsiaBiome
- Assembly Biosciences
- AstraZeneca
- Atlantic Essential Products
- Aumgene Biosciences
- Axial Therapeutics
- Azabu University
- Azitra
- BacThera
- Biena
- Bifodan
- BIOASTER
- BioCare
- Biocodex
- BioGaia
- Biomar Microbial Technologies
- Biomcare
- Bio-Me
- Biomica (a subsidary of Evogene)
- Biomillenia
- BiomX
- Biose
- Biosortia Pharmaceuticals
- BJP Laboratories
- Bloom Science
- Blue Turtle Bio
- Boehringer Ingelheim
- Bristol-Myers Squibb
- C3J Therapeutics
- Caelus Health
- Cambridge University Hospitals NHS Foundation Trust
- Cancer Research UK
- Capsugel
- Captozyme
- And Many More Companies!
Key Questions Answered
- Who are the key players engaged in offering contract manufacturing services for microbiome therapeutics?
- What are the key challenges faced by microbiome contract manufacturers?
- Who are the most likely partners (microbiome-based live biotherapeutic drug developers) for microbiome contract manufacturers?
- What is the annual clinical demand for microbiome-based live biotherapeutics?
- What is the current, installed contract manufacturing capacity for live biotherapeutics?
- What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision in this field?
- What are the various initiatives undertaken by big pharma players in this domain?
- What percentage of live biotherapeutics manufacturing operations are outsourced to service providers?
- How is the current and future market opportunity likely to be distributed across key market segments?
- What are the anticipated future trends related to live biotherapeutics manufacturing?
Key Topics Covered:
1. PREFACE
2. EXECUTIVE SUMMARY
3. INTRODUCTION
4. MARKET LANDSCAPE
5. REGIONAL CAPABILITY ANALYSIS
6. COMPANY COMPETITIVENESS ANALYSIS
7. COMPANY PROFILES
8. LIKELY PARTNER ANALYSIS
9. MICROBIOME RELATED INITIATIVES OF BIG PHARMACEUTICAL PLAYERS
10. RECENT DEVELOPMENTS AND INITIATIVES
11. CLINICAL TRIAL ANALYSIS
12. CAPACITY ANALYSIS
13. DEMAND ANALYSIS
14. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
15. CASE STUDY: LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT RESEARCH ORGANIZATIONS (CROs) AND DIETARY SUPPLEMENT MANUFACTURERS
16. MARKET FORECAST
17. CONCLUSION
18. INTERVIEW TRANSCRIPTS
19. APPENDIX I: TABULATED DATA
20. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS
For more information about this report visit https://www.researchandmarkets.com/r/jpb6br
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