Microbiome-Targeting Therapeutics in Infectious Diseases – Thematic Research

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Microbiome Therapeutics Market Analysis Report Overview

Microbiome is the community of microorganisms such as fungi, bacteria, and viruses, and their genetic material existing in and on the human body. Although the primary site of aggregated microbes is in the gastrointestinal (GI) tract, populations of microorganisms are also found on the surface of the skin, in the upper and lower respiratory tract, and in the genitourinary tracts.

Microbiome-targeting drugs aim to alter the microbial composition of the gut through the administration of live microbes (probiotics), or other compounds called prebiotics, to avoid administering live bacteria. These compounds are administered to regulate and change the human microbiome composition or function beneficially. Small and mid-sized biotech companies currently dominate the pipeline for microbiome-targeting therapeutics. Players from large pharma companies, such as Takeda, have partnered with smaller biotech companies and academic labs to expedite the development of microbiome-targeting therapeutics in infectious diseases.

The microbiome-targeting therapeutics thematic intelligence report provides an overview of microbiome-targeting drugs for infectious diseases including classification of therapy and technologies, regulatory and market access details as well as product & company profiles.

Key Trends

The key trends that are shaping the microbiome theme can be classified into two categories: industry trends and regulatory trends.

  • Industry Trends – No microbiome-targeting therapy has received marketing approval yet. Although regulatory agencies are adapting pre-existing guidance for other types of drugs to microbiome-targeting therapies, specific guidance for this new class of drugs will likely be established over the next decade. Challenges in the drug development process that need to be addressed include the preservation of the live microbial strains in the product until they are administered to the patient.
  • Regulatory trends – In the US, microbiome-targeting therapies are classified under the category of live biotherapeutic products (LBPs), which are regulated as biologic products and include viruses, therapeutic serums, toxins, antitoxins, vaccines, blood, blood components or derivatives, allergenic products, proteins (except any chemically synthesized polypeptide), and analogous products. Despite this new regulatory designation, there are not currently any guidelines specific to New Drug Applications for LBPs. 

For more insights on key trends shaping the microbiome theme, download a free report sample

Microbiome-Targeting Therapeutics in Infectious Diseases – Industry Analysis

GlobalData expects that late-stage microbiome-targeting pipeline agents will begin launching in the US as early as late 2022. Since most drugs in the pipeline are in earlier stages of clinical development, most drug launches will likely take place after 2024.

The microbiome-targeting therapeutics in infectious diseases industry analysis also covers:

  • Market Outlook for Rebiotix Inc’s RBX-2660
  • Market Outlook for Finch Therapeutic’s CP-101
  • Market Outlook for Infant Bacterial Therapeutics’ IBP-9414
  • Market Outlook for Evelo Biosciences’ EDP-1815

Microbiome-Targeting Therapeutics in Infectious Diseases - Value Chain Analysis

GlobalData’s microbiome value chain comprises six segments: oral live biotherapeutic product, oral small molecule, fecal microbiota transplantation, enema live biotherapeutic product, topical live biotherapeutic product, and intranasal live biotherapeutic product.

Oral LBP: Live microbes formulated into capsules for targeted intestinal delivery

Oral Small Molecule: Small molecule is taken orally to target the microbiome

Microbiome Value Chain Analysis

Microbiome Value Chain Analysis

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Leading Companies

The leading microbiome-targeting therapeutic companies are:

  • Rebiotix Inc
  • Nexbiome Therapeutics
  • Finch Therapeutics Group Inc
  • Evelo Biosciences
  • Infant Bacterial Therapeutics AB
  • Osel Inc
  • Mikrobiomik Healthcare Company SL
  • Seres Therapeutics Inc

To know more about microbiome-targeting therapeutic companies, download a free report sample

Drug Development Thematic Scorecard – Microbiome Theme

  • GlobalData’s Drug Development Thematic Scorecard provides a comprehensive outlook for players in the drug development sector over the next two to four years, based on 10 of the major themes set to transform the landscape including Microbiome.
  • It includes 53 companies from across the industry, including biopharmaceutical companies, biosimilar, and generic manufacturers, contract development and manufacturing organizations, and contract research organizations.
  • Using GlobalData’s core datasets, such as sales forecasts and deals, companies are scored on a scale of 1 to 5, where 1 is vulnerable and 5 is dominant.

Drug Development Thematic Scorecard

Drug Development Thematic Scorecard

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Microbiome-Targeting Therapeutics Market Report Overview

Report Pages 59
Regions Covered Global
Key Trends Industry Trends and Regulatory Trends
Value Chains Oral Live Biotherapeutic Product, Oral Small Molecule, Fecal Microbiota Transplantation, Enema Live Biotherapeutic Product, Topical Live Biotherapeutic Product, and Intranasal Live Biotherapeutic Product
Leading Companies Rebiotix Inc, Nexbiome Therapeutics, Finch Therapeutics Group Inc, Evelo Biosciences, Infant Bacterial Therapeutics AB, Osel Inc, Mikrobiomik Healthcare Company SL, and Seres Therapeutics Inc

Reasons to Buy

  • What impact will late-stage pipeline agents have on the market? Which class of IO drugs will have the highest peak sales, and why?
  • What are the current unmet needs and which pipeline drugs or strategies are positioned to counter these unmet needs? What are the opportunities for R&D in microbiome-targeting in the ID space?
  • How is the field of microbiome-targeting therapies in ID going to move forward? Which indications are the most promising for combination therapy?
  • What is the regulatory landscape for live biotherapeutic products (LBP) in the US and 5EU?
  • What is the current and future outlook for microbiome-targeting therapeutics according to KOLs?

Rebiotix Inc
Nexbiome Therapeutics
Finch Therapeutics Group
Evelo Biosciences
Infant Bacterial Therapeutics
Osel Inc
Mikrobiomik Healthcare
Seres Therapeutics

Table of Contents

1. Preface

1.1. Table of Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

2.1. Key Findings

3. Overview

3.1. What is the Microbiome?

3.2. Microbiome of the Gut

3.3. Microbiome of the Respiratory Tract

3.4. Microbiome of the Skin

4. Trends

4.1. Industry Trends

4.2. Regulatory Trends

4.3. Deal-Making Trends

5. Value Chain

5.1. Microbiome Value Chain

6. Marketed Products

6.1. Fecal Microbiota Transplants

6.2. Fecal Microbiota Transplants – Clinical Trial Mapping in the 7MM

6.3. Current Therapies – KOL Perspectives

7. Pipeline Products

7.1. Pipeline Microbiome-Targeting Drugs for Infectious Diseases in the 7MM

7.2. Clinical Trials – Pipeline Microbiome Targeting Drugs

7.3. Overview of Phase III Pipeline Drugs Targeting the Microbiome for ID in the 7MM

7.4. Late-Stage Pipeline Products – FDA Review Designations

7.5. Pipeline Therapies – KOL Perspectives

8. Market Analysis

8.1. Anticipated Key Launch Dates – Phase III Pipeline Agents

8.2. Market Outlook for Rebiotix Inc’s RBX-2660

8.3. Market Outlook for Finch Therapeutic’s CP-101

8.4. Market Outlook for Infant Bacterial Therapeutics’ IBP-9414

8.5. Market Outlook for Evelo Biosciences’ EDP-1815

9. Opportunities, Challenges, and Unmet Needs

9.1. Unmet Needs in Microbiome Targeting Therapies for Infectious Diseases

9.2. Unmet Needs – KOL Perspectives

9.3. Challenges in Immuno-oncology Clinical Trials – KOLs Perspective

10. Company Profiles

10.1 Rebiotix Inc

10.2 Nexbiome Therapeutics

10.3 Finch Therapeutics Group

10.4 Evelo Biosciences

10.5 Infant Bacterial Therapeutics

10.6 Osel Inc

10.7 Mikrobiomik Healthcare

10.8 Seres Therapeutics

11. Drug Development Thematic Scorecard

12. Appendix

12.1. Bibliography

12.2. Primary Research

12.3. Key Themes Impacting the Pharmaceutical Industry

12.4. Our Thematic Research Methodology

12.5. About the Authors

12.6. Contact Us

12.7. Disclaimer

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