Summary:
The microbiome has become a buzz word and attracted millions of dollars in federal grants, awards and funding from venture capitalists. Technological advances 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 their interactions with the 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 of studies abound that show that microbiome has a role in mediating many physiological processes such as metabolism, nutrition and immunity. It has been observed in many clinical studies that alterations in the microbial populations or microbial dysbiosis can lead to diseases. As such, modulations of the microbiome such that its normal condition is restored or pathogenic bacteria is eliminated have become potential strategies to address many unmet medical needs. Diseases that still do not have any definitive cure, or available treatments are either not satisfactory or costprohibitive, are being actively targeted as treatment indications by microbiome therapeutics.
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Leading Players
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. Although fecal microbial transplants (FMTs) have been in practice for some time, the use of live biotherapeutic products (LBPs) in the form of single strains or microbial consortia is becoming a widely popular strategy due to targeted mechanisms and controlled production processes. The development of small molecule drugs (postbiotics) and use of phages are also being actively explored.
4D PHARMA
AO BIOME LLC
ARMATA PHARMACEUTICALS
ASSEMBLY BIOSCIENCES INC.
AZITRA INC.
BIOMICA
BIOMX
CHAIN BIOTECHNOLOGY LTD.
ELIGO BIOSCIENCE SAS
ENTEROME SA
EVELO BIOSCIENCES
FINCH THERAPEUTICS GROUP INC.
INTRALYTIX INC.
KALEIDO BIOSCIENCES
KINTAI THERAPEUTICS INC.
LNC THERAPEUTICS INC.
MAAT PHARMA
OSEL INC.
PYLUM BIOSCIENES INC.
QUORUM INNOVATIONS LLC
REBIOTIX INC. (ACQUIRED BY FERRING PHARMACEUTICALS)
SECOND GENOME
SERES THERAPEUTICS INC.
SFA THERAPEUTICS INC.
SYNLOGIC
SYNTHETIC BIOLOGICS INC.
VEDANTA BIOSCIENCES INC.
Currently, no microbiome therapeutic has been approved in the U.S. or in any other market. There are some candidates in Phase 3 trials, such as 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 has created an uncertain situation for many developers in this novel market. The complexity of the human microbiome and variations among different individuals add to the difficulties in the design of clinical trials. Additionally, hurdles are
expected during the scaling-up of processes and proving the functional aspects of these drugs.
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 advances in biomarkers, functional assays, and computational biology are required that will eventually pave the way for product approvals.
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Report Scope:
The new report, “Microbiome Therapeutics: Global Markets,” provides a comprehensive analysis of the microbiome therapeutics market in global context, including market forecasts and sales through 2025. 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 segments: infectious diseases, metabolic diseases, cancer, gut-brain axis and others. The market is also 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 the growth of this market in the global context.
The new report provides comprehensive profiles of market players in the industry. The industry structure chapter focuses on the changing market trends, market players and their leading pipeline candidates. This chapter also covers the mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that are expected to shape the industry.
Factors such as strengths, weaknesses, threats and opportunities that are expected to play a role in the microbiome therapeutics market are evaluated in detail.
Excluded from this report are the markets for prebiotics and probiotics labeled as nutritional or dietary supplements. Prebiotics and probiotics, if included, only pertain to when used in the context of microbiome therapy.
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Report Includes:
– 32 data tables and 47 additional tables
– An in-depth overview of the global microbiome therapeutics market
– Analyses of the global market trends, with data corresponding to market size for 2021-2025, and projections of compound annual growth rates (CAGRs) through 2026
– Latest information on market drivers and opportunities, challenges and restraints, technological developments, and regulatory updates, along with their impact on the stakeholders in this market
– Evaluation of market potential for microbiome therapeutics market, their market share analysis on the basis of product types, applications, and regions
– Highlights of this innovation driven microbiome therapeutics market covering current trends, disease areas of application, clinical trials and their stages, and new developments
– Impact of COVID-19 pandemic on the global economy and delay in the clinical trial activity and financial effects on the overall growth of this market
– Competitive landscape of this market featuring leading biopharmaceutical companies, their products pipeline and company share analysis
– Key merger and acquisition deals, collaborations and partnerships, licensing and manufacturing agreements, and other notable investment strategies within this market
– Patent review and deep-dive of the issued patents on the basis of categories such as type, year, disease type, company, country, and assignee
– Profile description of the major market participants, including Azitra Inc., Evelo Biosciences, LNC Therapeutics, Second Genome and Vedanta Biosciences Inc.
Table of Contents
Chapter 1 Introduction
Chapter 2 Summary and Highlights
Chapter 3 Market and Technology Background
Chapter 4 Market Breakdown by Technology Type
Chapter 5 Market Breakdown by Application
Chapter 6 Industry Structure
Chapter 7 Patent Analysis
Chapter 8 Clinical Trial Analysis
Chapter 9 Analysis of Market Opportunities
Chapter 10 Company Profiles
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