マイクロバイオーム治療学の世界市場：2027年までに15億ドル規模へ

出版：BCC Research（BCCリサーチ）　出版年月：2023年 1月

Microbiome Therapeutics: Global Markets
マイクロバイオーム治療学の世界市場：2027年までに15億ドル規模へ

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Report Highlights

The global market for microbiome therapeutics is estimated to increase from $164.8 million in 2022 to reach $1.5 billion by 2027, at a compound annual growth rate (CAGR) of 54.8% from 2022 through 2027.

Summary:

The microbiome has become a buzz word and attracted millions of dollars in federal grants, awards and funding from venture capitalists. Technological advancements in next-generation sequencing and data analytics clubbed with modern approaches of systems biology and genetic engineering have greatly expanded the knowledge of commensal microbial populations and interactions with human hosts.

The Human Microbiome Project (HMP), MetaHIT and other independent efforts fueling the exploration of microbiome and its association with human health have led to a research explosion in this area in the last decade. Myriad studies abound showing how the microbiome mediate many physiological processes (metabolism, nutrition, immunity, etc.). Many clinical studies show alterations in microbial populations or microbial dysbiosis can lead to disease. Restoration of the microbiome addresses many unmet medical needs. Diseases that still do not have definitive cures or with available treatments that are either not satisfactory or are cost-prohibitive, are actively targeted by microbiome therapeutics.

There are many active players in the field of microbiome therapeutics, ranging from discovery and clinical-stage to late-stage companies that are exploiting different approaches to modulate the microbiome. Fecal microbial transplants (FMTs) have been in practice for some time and the use of live biotherapeutic products (LBPs) in the form of single strains or microbial consortia is a popular strategy with targeted mechanisms and controlled production processes. The development of small molecule drugs (postbiotics) and the use of phages are being actively explored.

Currently, no microbiome therapeutic is approved in the U.S. or in any other market. There are some candidates in Phase 3 trials (Seres Therapeutics SER109 and Rebiotix’s RBX2660) that are being evaluated for the treatment of recurrent Clostridium difficile infection. Despite an expansive patent portfolio and a large number of clinical trials in the field of microbiome therapeutics, the market is facing some challenges. The absence of any regulatory framework brings uncertainty for many developers in this novel market. The complexity of the human microbiome and variations among different individuals add to difficulties in the design of clinical trials. Additional hurdles are expected during scaling.

For the microbiome therapeutics market to grow, a strong collaborative effort is needed from all stakeholders, including the regulatory agencies. Statistically-relevant results and proof-of-concept studies driven by technological advancements in biomarkers, functional assays and computational biology are required that will eventually pave the way for product approvals.

Report Scope:

BCC Research’s new report, Microbiome Therapeutics: Global Markets, provides a comprehensive analysis of the microbiome therapeutics market in global context, including market forecasts and sales through 2027. The report analyzes the market by segmenting it into the various types of microbiome therapeutics, based on the strategies used for treatment: additive (fecal matter transplants or FMTs, live biotherapeutic products or LBPs), modulatory (postbiotics, prebiotics) and subtractive microbiome therapeutics (phages and antimicrobials). This study surveys the microbiome therapeutics market by application or disease segment: infectious diseases, metabolic diseases, cancer, gut-brain axis, and others. The market is assessed in the following geographic regions: North America, Europe, and emerging markets. Emerging markets include countries like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, and Latin America.

The report features leading clinical trials indicating the status and phase of development. New developments and patents are boosting growth of this market in the global context.

The new BCC report provides comprehensive profiles of market players in the industry. The industry structure chapter focuses on the changing market trends, market players and leading pipeline candidates. This chapter covers influential mergers and acquisitions and other collaborations or partnerships that happened during the evaluation period of this report.

Strengths, weaknesses, threats, and opportunities that are expected to play a role in the microbiome therapeutics market are evaluated in detail.

The markets for prebiotics and probiotics labeled as nutritional or dietary supplements are excluded from this report. Prebiotics and probiotics are included when used in the context of microbiome therapy.

Report Includes:

– 32 data tables and 44 additional tables
– An up-to-date overview and analysis of the global and regional markets for microbiome therapeutics
– Analyses of the global market trends, with historic market revenue (sales data) for 2021, estimates for 2022 and 2023, and projections of compound annual growth rates (CAGRs) through 2027
– Discussion of the industry growth driving factors and major technology challenges and issues affecting the market for microbiome therapeutics as a basis for projecting demand over the next few years (2022-2027)
– Estimation of the actual market size and revenue forecast for global microbiome therapeutics market in USD million terms, and corresponding market share analysis by technology type, application, and region
– Highlights of this innovation driven market covering current trends in genome sequencing industry, disease areas of application, clinical trials and their stages, and recent breakthrough innovations etc.
– Assessment of the recent industry structure for microbiome therapeutics, ongoing research (R&D) activities, analysis of competitive environment, and the COVID-19 impact on the marketplace
– Review of the patents and patent applications on microbiome therapeutics, and related scientific publications during the analysis period
– Competitive landscape of this market featuring leading biopharmaceutical companies, their product portfolios, financial updates, and market share analysis based on recent segmental revenues
– Profile description of the major market participants, including Assembly Biosciences, Finch Therapeutics, Second Genome, Evelo Biosciences, Ysopia Bioscience and Evelo Biosciences

目次

Table of Contents
Chapter 1 Introduction
1.1 Study Goals and Objectives
1.2 Reasons for Doing This Study
1.3 What’s New in This Report?
1.4 Scope of Report
1.5 Information Sources
1.6 Methodology
1.7 Geographic Breakdown
1.8 Analyst’s Credentials
1.9 BCC Custom Research
1.10 Related BCC Research Reports
Chapter 2 Summary and Highlights
2.1 Key Highlights
Chapter 3 Market and Technology Background
3.1 Benefits
3.2 The Human Microbiome
3.2.1 Different Microbiomes in Humans
3.2.2 Microbiome, Human Health and Disease
3.2.3 Technologies Aiding Microbiome Research
3.2.4 Microbiome Research Projects
3.3 Microbiome Therapeutics
3.3.1 Strategies for the Development of Microbiome Therapeutics
3.3.2 Microbiome Therapeutics Disease Areas
3.3.3 Regulatory Landscape for Microbiome Therapeutics
Chapter 4 Market Breakdown by Type of Therapeutic
4.1 Introduction
4.2 Market Overview
4.2.1 Market Revenue
4.2.2 Market Shares
4.3 Additive Microbiome Therapeutics
4.3.1 Fecal Microbiota Transplants (FMTs)
4.3.2 Live Biotherapeutic Products (LBPs)
4.3.3 Market Overview
4.3.4 Market Revenue
4.3.5 Market Shares
4.4 Modulatory Microbiome Therapeutics
4.4.1 Mechanism of Action
4.4.2 Current Status
4.4.3 Market Overview
4.4.4 Market Revenue
4.4.5 Market Shares
4.5 Subtractive Microbiome Therapeutics
4.5.1 Mechanism of Action
4.5.2 Current Status
4.5.3 Market Overview
4.5.4 Market Revenue
4.5.5 Market Shares
Chapter 5 Market Breakdown by Application
5.1 Introduction
5.1.1 Market Revenue
5.1.2 Market Shares
5.2 Infections
5.2.1 Clostridium Difficile Infection (CDI)
5.2.2 Urinary Tract Infection (UTI)
5.2.3 COVID-19
5.2.4 Market Overview
5.2.5 Market Revenue
5.3 Gastrointestinal (GIT) Diseases
5.3.1 Market Overview
5.3.2 Market Revenue
5.4 Metabolic Diseases
5.4.1 Market Overview
5.4.2 Market Revenue
5.5 Cancer
5.5.1 Market Overview
5.5.2 Market Revenue
5.6 Gut-Brain Axis Diseases
5.6.1 Market Overview
5.6.2 Market Revenue
5.7 Other Diseases
5.7.1 Market Overview
5.7.2 Market Revenue
5.8 Regional Markets Globally
5.8.1 Market Shares
Chapter 6 Industry Structure
6.1 Investment in Microbiome Therapeutics
6.1.1 Public Funding Initiatives
6.1.2 Private Funding Initiatives
6.2 Collaborations and Partnerships
6.3 Licensing and Manufacturing Agreements
6.4 Mergers and Acquisitions
6.5 Leading Market Players in the Market for Microbiome Therapeutics
6.5.1 Leading Market Players in Market for Additive Microbiome Therapeutics
6.5.2 Leading Market Players in the Market for Modulatory Microbiome Therapeutics
6.5.3 Leading Market Players in the Market for Subtractive Microbiome Therapeutics
6.6 BCC Research Select Insights from Industry Leaders
Chapter 7 Patent Analysis
7.1 Patent Analysis
7.1.1 Patents by Year
7.1.2 Patents by Type
7.1.3 Patents by Type of Disease
7.1.4 Patents by Company
7.1.5 Patents by Country
7.1.6 Patents by Assignee
Chapter 8 Clinical Trials
8.1 Clinical Trials by Disease Category
8.1.1 Distribution Shares of Clinical Trials
8.2 Clinical Trials by Type of Therapeutic
8.2.1 Distribution Shares of Clinical Trials by Type of Therapeutic
8.3 Clinical Trials by Company
8.3.1 Distribution Shares of Clinical Trials by Company
8.3.2 Microbiome Therapeutics in Discovery and Preclinical Development
8.3.3 Microbiome Therapeutics in Phase 3 Clinical Trials
Chapter 9 Analysis of Market Opportunities
9.1 SWOT Analysis
9.1.1 Strengths of Market for Microbiome Therapeutics
9.1.2 Challenges in the Market for Microbiome Therapeutics
9.1.3 Opportunities in the Market for Microbiome Therapeutics
9.1.4 Threats to the Market for Microbiome Therapeutics
Chapter 10 Company Profiles
4D PHARMA
AO BIOME LLC
ASSEMBLY BIOSCIENCES INC.
ARMATA PHARMACEUTICALS
AZITRA INC.
BIOMICA
BIOMX
CHAIN BIOTECHNOLOGY LTD.
ELIGO BIOSCIENCE SAS
ENTEROME SA
EVELO BIOSCIENCES
FINCH THERAPEUTICS GROUP INC.
INTRALYTIX INC.
MAAT PHARMA
OSEL INC.
PYLUM BIOSCIENCES INC.
QUORUM INNOVATIONS LLC
REBIOTIX INC. (A FERRING COMPANY)
SECOND GENOME
SENDA BIOSCIENCES INC.
SERES THERAPEUTICS INC.
SFA THERAPEUTICS INC.
SYNLOGIC
THERIVA BIOLOGICS INC.
VEDANTA BIOSCIENCES INC.
YSOPIA BIOSCIENCE INC.
Chapter 11 Appendix: Acronyms
List of Tables
Summary Table : Global Market for Microbiome Therapeutics, by Type of Disease, Through 2027
Table 1 : Technology for Microbiome Research
Table 2 : Dysbiosis in Microbiome
Table 3 : Leading Pharmaceutical/Microbiome Therapeutics Partnerships
Table 4 : Global Market for Microbiome Therapeutics, by Type, Through 2027
Table 5 : Global Market Shares of Microbiome Therapeutics, by Type, 2027
Table 6 : LBPs in Microbiome Therapeutics
Table 7 : Global Market for Additive Microbiome Therapeutics, by Type, Through 2027
Table 8 : Global Market Shares of Additive Microbiome Therapeutics, by Type, 2027
Table 9 : Modulatory Microbiome Therapeutics
Table 10 : Global Market for Modulatory Microbiome Therapeutics, by Type, Through 2027
Table 11 : Global Market Shares of Modulatory Microbiome Therapeutics, by Type, 2027
Table 12 : Global Market for Subtractive Microbiome Therapeutics, by Type, Through 2027
Table 13 : Global Market Shares of Subtractive Microbiome Therapeutics, by Type, 2027
Table 14 : R&D Expenditures in Microbiome Therapeutics, by Company, 2017-2019
Table 15 : Global Market for Microbiome Therapeutics, by Type of Disease, Through 2027
Table 16 : Global Market Shares of Microbiome Therapeutics, by Type of Disease, 2027
Table 17 : Microbiome Therapeutics for Infections
Table 18 : Global Market for Microbiome Therapeutics for Infections, by Region, Through 2027
Table 19 : Microbiome Therapeutics for GIT Diseases
Table 20 : Global Market for Microbiome Therapeutics for GIT Diseases, by Region, Through 2027
Table 21 : Microbiome Therapeutics for Metabolic Diseases
Table 22 : Global Market for Microbiome Therapeutics for Metabolic Diseases, by Region, Through 2027
Table 23 : Microbiome Therapeutics for Cancer
Table 24 : Global Market for Microbiome Therapeutics for Cancer, by Region, Through 2027
Table 25 : Microbiome Therapeutics for Gut-Brain Axis Diseases
Table 26 : Global Market for Microbiome Therapeutics for Gut-Brain Axis Diseases, by Region, Through 2027
Table 27 : Microbiome Therapeutics for Other Diseases
Table 28 : Global Market for Microbiome Therapeutics for Other Diseases, by Region, Through 2027
Table 29 : Global Market for Microbiome Therapeutics, by Region, Through 2027
Table 30 : Global Market Shares of Microbiome Therapeutics, by Region, 2027
Table 31 : Historical Funding Activity, Microbiome Therapeutics, 2015 and 2016
Table 32 : Public Funding, Microbiome Therapeutics, 2018-2022
Table 33 : Venture Funding, Microbiome Therapeutics, 2017-Aug. 2020
Table 34 : Collaborations and Partnerships in the Market for Microbiome Therapeutics, 2017-2022
Table 35 : Licensing and Manufacturing Agreements in the Market for Microbiome Therapeutics, 2017-Aug. 2020
Table 36 : Leading Developers of Additive Microbiome Therapeutics, 2022
Table 37 : Leading Developers of Modulatory Microbiome Therapeutics, 2022
Table 38 : Leading Developers of Subtractive Microbiome Therapeutics, 2022
Table 39 : Patents Issued on Microbiome Therapeutics, by Year, 2017–2022
Table 40 : Patents Issued on Microbiome Therapeutics, by Type, 2017–2022
Table 41 : Patents Issued on Microbiome Therapeutics, by Type of Disease, 2017–2022
Table 42 : Patents Issued on Microbiome Therapeutics, by Company, 2017–2022
Table 43 : Patents Issued on Microbiome Therapeutics, by Country, 2017–2022
Table 44 : Patents Issued on Microbiome Therapeutics, by Assignee, 2017–Aug. 2020
Table 45 : Distribution of Clinical Trials on Microbiome Therapeutics, by Type of Disease, 2022
Table 46 : Distribution Shares of Clinical Trials on Microbiome Therapeutics, by Type of Disease, 2022
Table 47 : Distribution Shares of Clinical Trials on Microbiome Therapeutics, by Type of Therapeutic
Table 48 : Distribution Shares of Clinical Trials on Microbiome Therapeutics, by Type of Therapeutic
Table 49 : Distribution Shares of Clinical Trials on Microbiome Therapeutics, by Company
Table 50 : Distribution Shares of Clinical Trials on Microbiome Therapeutics for the Top 10 Companies
Table 51 : Microbiome Therapeutics, Discovery and Preclinical Development
Table 52 : Microbiome Therapeutics in Phase 3 Clinical Trials
Table 53 : 4D Pharma: Pipeline
Table 54 : AO Biome: Pipeline
Table 55 : Assembly Biosciences: Pipeline
Table 56 : Armata Pharmaceuticals: Pipeline
Table 57 : Azitra: Pipeline
Table 58 : Biomica: Pipeline
Table 59 : BiomX: Pipeline
Table 60 : Enterome: Pipeline
Table 61 : Evelo Biosciences: Pipeline
Table 62 : Finch Therapeutics: Pipeline
Table 63 : Intralytix: Pipeline
Table 64 : MaaT Pharma: Pipeline
Table 65 : Osel: Pipeline
Table 66 : Quorum Innovations: Pipeline
Table 67 : Rebiotix: Pipeline
Table 68 : Second Genome: Pipeline
Table 69 : Seres Therapeutics: Pipeline
Table 70 : SFA Therapeutics: Pipeline
Table 71 : Synlogic: Pipeline
Table 72 : Theriva Biologics: Pipeline
Table 73 : Vedanta Biosciences: Pipeline
Table 74 : Ysopia Bioscience: Pipeline
Table 75 : Acronyms Used in This Report
List of Figures
Summary Figure : Global Market for Microbiome Therapeutics, by Type of Disease, 2021-2027
Figure 1 : Differences between the Human Genome and the Microbiome
Figure 2 : Bacterial Distribution, by Body Site
Figure 3 : Essential Functions, Human Microbiome
Figure 4 : Dysbiosis and Human Health
Figure 5 : Summary of NIH Funding for Microbiome Research, 2012-2016
Figure 6 : Global Market for Microbiome Therapeutics, by Type, 2021-2027
Figure 7 : Global Market Shares of Microbiome Therapeutics, by Type, 2027
Figure 8 : Global Market for Additive Microbiome Therapeutics, by Type, 2021-2027
Figure 9 : Global Market Shares of Additive Microbiome Therapeutics, by Type, 2027
Figure 10 : Global Market for Modulatory Microbiome Therapeutics, by Type, 2021-2027
Figure 11 : Global Market Shares of Modulatory Microbiome Therapeutics, by Type, 2027
Figure 12 : Global Market for Subtractive Microbiome Therapeutics, by Type, 2021-2027
Figure 13 : Global Market Shares of Subtractive Microbiome Therapeutics, by Type, 2027
Figure 14 : Global Market for Microbiome Therapeutics, by Type of Disease, 2021-2027
Figure 15 : Global Market Shares of Microbiome Therapeutics, by Type of Disease, 2027
Figure 16 : Global Market for Microbiome Therapeutics for Infections, by Region, 2021-2027
Figure 17 : Global Market for Microbiome Therapeutics for GIT Diseases, by Region, 2021-2027
Figure 18 : Global Market for Microbiome Therapeutics for Metabolic Diseases, by Region, 2021-2027
Figure 19 : Global Market for Microbiome Therapeutics for Cancer, by Region, 2021-2027
Figure 20 : Global Market for Microbiome Therapeutics for Gut-Brain Axis Diseases, by Region, 2021-2027
Figure 21 : Global Market for Microbiome Therapeutics for Other Diseases, by Region, 2021-2027
Figure 22 : Global Market for Microbiome Therapeutics, by Region, 2021-2027
Figure 23 : Global Market Shares of Microbiome Therapeutics, by Region, 2027
Figure 24 : Patents Issued on Microbiome Therapeutics, by Year, 2017-2022
Figure 25 : Patents Issued on Microbiome Therapeutics, by Type, 2017-2022
Figure 26 : Patents Issued on Microbiome Therapeutics, by Type of Disease, 2017–2022
Figure 27 : Patents Issued on Microbiome Therapeutics, by Company, 2017-2022
Figure 28 : Patents Issued on Microbiome Therapeutics, by Country, 2017–2022
Figure 29 : Patents Issued on Microbiome Therapeutics, by Assignee, 2017–Aug. 2020
Figure 30 : Distribution Shares of Clinical Trials on Microbiome Therapeutics, by Type of Disease, 2022
Figure 31 : Distribution Shares of Clinical Trials on Microbiome Therapeutics by Type of Therapeutic
Figure 32 : Distribution Shares of Clinical Trials on Microbiome Therapeutics for the Top 10 Companies
Figure 33 : SWOT Analysis of the Market for Microbiome Therapeutics