The global microbiome manufacturing market is estimated to grow from USD 40.6 million in the current year to USD 186.7 million by 2035, at a CAGR of 14.9% during the forecast period, till 2035.
Microbiome based therapeutics provide an effective and alternative treatment option for a range of conditions, such as obesity, diabetes, immune system disorders, and digestive or gastrointestinal disorders. Microbiome-based live biotherapeutic products (LBPs) are formulations containing live microorganisms, such as bacteria or yeasts, designed to restore, modulate, or enhance the gut microbiome to treat or prevent diseases. It is worth highlighting that more than 165 clinical trials are currently underway to explore various microbiome-based therapeutic products across diverse regions. This trend is indicative of the extensive development efforts being undertaken by stakeholders in this domain.
However, microbiome-based therapeutics production is associated with several complexities, including prolonged development timelines, stringent temperature control requirements, complex engineering of diverse aerobic / anaerobic strains (depending on the type of microbe) and inconsistencies related to quality attributes of the final product. The lack of manufacturing capacity is another concern for companies developing intestinal microbiome strains. In the past few years, some players have circumvented this challenges by establishing in-house manufacturing capabilities. Nonetheless, some companies still require proof-of-concept data before investing in the establishment of a new in-house manufacturing facility. Such companies are currently outsourcing their operations to CMOs for live microbiome therapies. This provides significant opportunities for a few contract manufacturers with varying capabilities in this domain. With the ongoing pace of efforts to optimize the manufacturing of microbiome-based products, the CMO market is anticipated to witness steady growth in the coming decade.
Microbiome Manufacturing Market: Growth and Trends
The human body contains many communities of microbes, encompassing both advantageous and harmful species, which are collectively called microbiota. Similarly, the ecological system of commensal, symbiotic, and pathogenic microorganisms living within a host system is referred to as the microbiome. Considering the influence of microbiota on disease development and pathogenesis, the concept of microbiome-targeted therapies has gradually captivated the attention of the medical research communities.Microbiome based therapeutics provide an effective and alternative treatment option for a range of conditions, such as obesity, diabetes, immune system disorders, and digestive or gastrointestinal disorders. Microbiome-based live biotherapeutic products (LBPs) are formulations containing live microorganisms, such as bacteria or yeasts, designed to restore, modulate, or enhance the gut microbiome to treat or prevent diseases. It is worth highlighting that more than 165 clinical trials are currently underway to explore various microbiome-based therapeutic products across diverse regions. This trend is indicative of the extensive development efforts being undertaken by stakeholders in this domain.
However, microbiome-based therapeutics production is associated with several complexities, including prolonged development timelines, stringent temperature control requirements, complex engineering of diverse aerobic / anaerobic strains (depending on the type of microbe) and inconsistencies related to quality attributes of the final product. The lack of manufacturing capacity is another concern for companies developing intestinal microbiome strains. In the past few years, some players have circumvented this challenges by establishing in-house manufacturing capabilities. Nonetheless, some companies still require proof-of-concept data before investing in the establishment of a new in-house manufacturing facility. Such companies are currently outsourcing their operations to CMOs for live microbiome therapies. This provides significant opportunities for a few contract manufacturers with varying capabilities in this domain. With the ongoing pace of efforts to optimize the manufacturing of microbiome-based products, the CMO market is anticipated to witness steady growth in the coming decade.
Microbiome Manufacturing Market: Key Insights
The report delves into the current state of the microbiome manufacturing market and identifies potential growth opportunities within industry. Some key findings from the report include:
- The current market landscape features the presence of over 20 well-established players and new entrants that are engaged in the production of live biotherapeutics products, on contractual basis.
- Stakeholders claim to offer a range of services across different scales of operation; a relatively larger proportion of the finished drug products are manufactured in solid and liquid forms.
- Majority (50%) of the players having in-house manufacturing facilities in the US are mid-sized; these firms primarily have capabilities for pre-clinical / clinical scale production.
- In the past decade, a shift in trend has been observed in the microbiome manufacturing market as more players have set up manufacturing facilities in Europe.
- In pursuit of gaining a competitive edge, industry stakeholders are actively upgrading existing capabilities and enhancing their microbiome-focused service portfolios.
- To keep pace with the growing demand, many contract manufacturers have undertaken strategic initiatives, such as entering into mutually beneficial partnerships and expanding their capacities.
- More than 165 clinical trials (with nearly 22,000 enrolled patients) are currently underway to investigate microbiome based-therapeutic products, across different geographies.
- Microbiome contract manufacturers are anticipated to continue to form strategic alliances with players engaged in the development of microbiome therapeutics for contract manufacturing of their products.
- The global, installed contract manufacturing capacity is spread across various geographies; interestingly, around 43% of the total capacity is installed at the facilities owned by small players.
- Given the rapidly growing pipeline and the increasing demand for effective therapeutic interventions, microbiome developers prefer to leverage the expertise of contract manufacturers to ensure high quality of end-products.
- As more developers outsource various aspects of their respective drug manufacturing operations, it is anticipated that the microbiome CMOs market to grow at an annualized rate of over 14.9% in the coming decade.
Microbiome Manufacturing Market: Key Segments
Currently, API Occupies the Largest Share of the Microbiome Manufacturing Market
Based on the type of product manufactured, the market is segmented into API and FDF. At present, the API segment holds the maximum share of the microbiome manufacturing market. This trend is unlikely to change in the near future.Currently, Liquid Formulation Segment Accounts for the Largest Share of the Microbiome Manufacturing Market
Based on the type of formulation, the market is segmented into solid, liquid and other formulations. Currently, liquid formulation holds the maximum share of the microbiome manufacturing market. This trend is likely to remain the same in the forthcoming years.Sachets / Pouches is the Fastest Growing Segment in the Microbiome Manufacturing Market During the Forecast Period
Based on the type of primary packaging used, the market is segmented into blister packs, glass / plastic bottles, sachets / pouches and vials. It is worth highlighting that, at present, sachets / pouches hold a larger share of the microbiome manufacturing market. This trend is likely to remain the same in the coming decade.By Scale of Operation, Commercial Scale is Likely to Dominate the Microbiome Manufacturing Market During the Forecast Period
Based on the scale of operation, the market is segmented into clinical and commercial scales. Whilst commercial scale manufacturing will be the primary driver of the overall market, it is worth highlighting that the microbiome manufacturing market at the clinical scale is likely to grow at a relatively higher CAGR.Currently, Small Companies Occupies the Largest Share of the Microbiome Manufacturing Market
Based on the company size, the market is segmented into small, mid-sized, and large and very large companies. At present, small companies generate maximum revenue of the microbiome manufacturing market. This trend is unlikely to change in the near future.Europe Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the world. Majority of the current microbiome manufacturing market is captured by Europe. It is worth highlighting that the market in the rest of the world is expected to grow at a higher CAGR in the coming years.Example Players in the Microbiome Manufacturing Market
- Biose
- BJP Laboratories
- Capsugel
- Chr. Hansen
- Infant Bacterial Therapeutics
- Inpac Probiotics
- MaaT Pharma
- Microbiomik Healthcare
- NIZO
- OxThera
- Rebiotix
- Seres Therapeutics
- WACKER
- Winclove
Primary Research Overview
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:- Founder and Executive Chairman, Company A
- Managing Director and Scientific Head, Company B
- Managing Director and Chief Executive Officer, Company C
- Co- Founder and Chief Executive Officer, Company D
- Founder and Chief Executive Officer, Company E
- Chief Business Officer, Company F
- Chief Operating Officer, Company G
- Former Vice President, Business Development, Company H
- Former Vice President, Commercial Operations, Company I
- Former Vice President, Business Development, Company J
- Former Vice President. Sales and Business Development, Company K
- Head of Business Development, Company L
- Business Development Manager, Company M
Microbiome Manufacturing Market: Research Coverage
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the microbiome manufacturing market, focusing on key market segments, including [A] type of product manufactured, [B] type of formulation, [C] type of primary packaging used, [D] scale of operation, [E] company size and [F] key geographical regions.
- Market Landscape: A comprehensive evaluation of microbiome manufacturing service providers, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] scale of operation, [E] type of product manufactured, [F] type of formulation, [G] type of primary packaging used, [H] type of microbe used, [I] type of service offered, [J] number and location of manufacturing facilities and bioprocessing capacity, and [K] type of microbial species used.
- Regional Capability Analysis: A detailed landscape of the microbiome manufacturing facilities established across key geographical regions (North America, Europe and Asia-Pacific), highlighting the key manufacturing hubs for microbiomes.
- Company Competitiveness Analysis: A comprehensive competitive analysis of microbiome manufacturing service providers, examining factors, such as [A] supplier strength [B] portfolio diversity and [C] number of services offered.
- Company Profiles: In-depth profiles of key microbiome manufacturing service providers offering contract services for live biotherapeutic products at both clinical and commercial scale, focusing on [A] company overviews, [B] microbiome-related service portfolio, [C] microbiome manufacturing facilities, [D] recent developments and [E] an informed future outlook.
- Likely Partner Analysis: A detailed evaluation of nearly 70 microbiome-focused drug developers that are most likely to collaborate with contract manufacturers. This analysis considers various relevant parameters, including [A] developer strength (in terms of company size and its experience), [B] pipeline maturity (which takes into account the number of pipeline drugs and their affiliated stage of development), [C] pipeline strength (which takes into account the number of microbiome drugs in the company’s pipeline), and [D] availability of in-house manufacturing capabilities.
- Big Pharma Analysis: A comprehensive examination of various microbiome-focused initiatives undertaken by major pharmaceutical companies. This analysis includes heat map visualizations that illustrate the distribution of leading pharmaceutical firms, as well as spider web diagrams that compare their initiatives across multiple relevant parameters.
- Recent Development and Initiatives: An analysis of recent trends, covering partnerships and collaborations, mergers and acquisitions, and expansion initiatives held in this domain.
- Clinical Trials Analysis: Examination of completed, ongoing, and planned clinical studies of various microbiome therapeutics, based on parameters, such as [A] trial registration year, [B] trial status, [C] trial phase, [D] enrolled patient population, [E] type of sponsor, [F] most active industry players (in terms of number of trials conducted), [G] study design, [H] therapeutic area and [I] key geographical regions.
- Capacity Analysis: Estimation of global microbiome-based therapies manufacturing capacity, derived from data provided by various industry stakeholders in the public domain. This analysis emphasizes the distribution of the available capacity on the basis of company size (small, mid-sized, and large and very large) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).
- Demand Analysis: Informed estimates of the annual commercial and clinical demand for microbiome therapeutics, taking into account the target patient population in ongoing and planned clinical trials of microbiome therapeutics, sponsored by both industry and non-industry players.
- Make Versus Buy Decision Making Framework: An insightful framework that emphasizes the key indicators and factors that need to be considered by microbiome therapeutics developers to determine whether to manufacture their respective products in-house or outsource the manufacturing operation to contract service providers.
- Case Study: A case study on the current market landscape of microbiome contract research organizations and dietary supplement providers, including information on their year of establishment, company size and location of headquarters.
Key Questions Answered in this Report
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What is the current global capacity of microbiome manufacturers?
- Which microbiome therapy developers are most likely to collaborate with service providers?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
Reasons to Buy this Report
- The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
- Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
- The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
Additional Benefits
- Complimentary PPT Insights Packs
- Complimentary Excel Data Packs for all Analytical Modules in the Report
- 15% Free Content Customization
- Detailed Report Walkthrough Session with the Research Team
- Free Update if the Report is 6+ Months Old
Table of Contents
1. PREFACE
2. RESEARCH METHODOLOGY
3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
5. INTRODUCTION
6. MARKET LANDSCAPE
7. REGIONAL CAPABILITY ANALYSIS
8. COMPANY COMPETITIVENESS ANALYSIS
9. COMPANY PROFILES
10. LIKELY PARTNER ANALYSIS
11. BIG PHARMA INITIATIVES
12. RECENT DEVELOPMENTS AND INITIATIVES
13. CLINICAL TRIAL ANALYSIS
14. CAPACITY ANALYSIS
15. DEMAND ANALYSIS
16. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
17. CASE STUDY: LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT RESEARCH ORGANIZATIONS (CROs) AND DIETARY SUPPLEMENT MANUFACTURERS
18. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES
19. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET
20. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF PRODUCT MANUFACTURED
21. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF FORMULATION
22. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF PRIMARY PACKAGING USED
23. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY SCALE OF OPERATION
24. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY COMPANY SIZE
25. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY KEY GEOGRAPHICAL REGIONS
26. LEADING DEVELOPERS FOR LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME THERAPIES
27. EXECUTIVE INSIGHTS
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 4D Pharma
- AbbVie
- ABCO Laboratories
- ABH Pharma
- AcuraBio (formerly known as Luina Bio)
- ADM
- Advanced Enzymes
- Allianz Biosciences
- Ampersand Capital Partners
- AmpliPhi Biosciences
- AOBiome Therapeutics
- Arena Pharmaceuticals
- Armata Pharmaceuticals
- Arranta Bio
- AsiaBiome (acquired by Holobiome)
- Assembly Biosciences
- AstraZeneca
- Atlantia Clinical Trials
- Atlantic Essential Products
- Aumgene Biosciences
- Axial Biotherapeutics
- Axial Therapeutics
- Azabu University
- Bacthera (a joint venture of Lonza and Chr Hansen)
- Bayer
- Biena
- Bifodan
- BIOASTER
- BioCare Copenhagen
- Biocodex
- BioGaia
- Biomcare
- Bio-Me
- Biomica
- Biomillenia
- Biomodels
- BiomX
- Biose Industrie
- BJP Laboratories
- Bloom Science
- Boehringer Ingelheim
- Brigham and Women’s Hospital
- Bristol-Myers Squibb
- C3J Therapeutics
- Cambridge University Hospitals
- Cancer Research UK
- Capsugel (acquired by Lonza)
- Captozyme
- Cathay Capital
- Cell Biotech
- Cerbios-Pharma
- CHAIN Biotechnology
- Charles River Laboratories
- Chr. Hansen
- Clinical Microbiomics
- CoreBiome
- CosmosID
- Crestovo
- Crohn’s & Colitis Foundation
- Custom Probiotics
- Debiopharm
- Deerland Probiotics & Enzymes
- DermBiont
- Diversigen
- DuPont Nutrition & Biosciences
- Emerge Health
- EMF
- Emulate
- EnteroBiotix
- Enterome
- Evelo Biosciences
- EverImmune
- Evologic Technologies
- EXDEN
- Exeliom Biosciences
- Exim Pharma
- EzBiome
- Ferring Pharmaceuticals
- Finch Therapeutics
- Fonterra
- FUJIFILM Diosynth Biotechnologies
- Ganeden Biotech
- Genetic Analysis
- GENIBIO
- Genome & Company
- Gilead Sciences
- Ginkgo Bioworks
- GSK
- Gustave Roussy
- Gusto Global
- iCarbonX
- IFF
- IGEN BIOLAB
- Imperial College London
- Inpac Probiotics
- Instituto Biomar
- Ion Labs
- John Theurer Cancer Center (a part of Hackensack Universityu Medical Center)
- Johnson and Johnson
- JW Nutritional
- Kaleido Biosciences
- Karolinska Institutet
- Karyotica Biologicals
- Kendy Pharma
- Kibow Biotech
- Lallemand
- Leiden University Medical Center (LUMC)
- L-GAM
- List Biological Laboratories
- Liveome
- LNC Therapeutics
- Locus Biosciences
- Lonza
- Luina Bio
- MaaT Pharma
- Massachusetts General Hospital
- Mayo Clinic
- Medella Naturals
- Medical University of Graz
- Memorial Sloan Kettering Cancer Center
- Merck
- MeriCal
- MetaboGen
- Meteoric Biopharmaceuticals
- Microbax
- Microbiome Insights
- MicrobiomeDx
- Microbiotica
- Mirna Therapeutics
- Miyarisan Pharmaceutical
- Molecular Partners AG
- MRM Health
- MSD
- MyBiotics
- Nestle Health Science
- New Bellus
- NHS
- NIZO
- Norax Supplements
- North Zealand University Hospital
- Novo Nordisk
- NutraScience Labs
- NYU Langone Medical Center
- Oncodesign Services
- Osel
- OxThera
- Pace Life Sciences
- Parkinson’s Institute and Clinical Center
- Pendulum Therapeutics
- Pfizer
- Phylagen
- Precigen ActoBio
- Probi
- ProbioFerm
- Probiotical
- Probiotics Australia
- ProDigest
- Quay Pharma
- Rebiotix
- Recipharm
- Research Institute of St. Joe’s Hamilton
- Resphera Biosciences
- RIKEN
- Roche
- RondinX
- Roswell Park Comprehensive Cancer Center
- Sabinsa
- Sacco
- Sanofi
- S-Biomedic
- SBT Instruments
- Second Genome
- Seres Therapeutics
- Servatus
- SeylanMED
- SGS
- Siolta Therapeutics
- Sirio Pharma
- Specialty Enzymes & Probiotics
- Stanford Cancer Institute
- Stanford Medicine
- Syngen Biotech
- Synlogic
- Takeda Pharmaceutical
- The University of Tokyo
- Theriva Biologics
- UAS Labs
- Unique Biotech
- Ruprecht Karl University of Heidelberg
- University of Adelaide
- University of Nottingham
- University of Oxford
- University of Pennsylvania
- University of Reading
- University of Texas MD Anderson Cancer Center
- Vaiomer
- Vedanta Biosciences
- VITA-gen Laboratories
- Vitakem
- WACKER
- Washington University School of Medicine
- Whiterock Capital
- Winclove Probiotics
- YSOPIA Bioscience
- Zeta Farmaceutici
Methodology
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