Microbiome – Targeted Therapeutics in Immunology – Thematic Research

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The microbiome is considered the genetic material of all microorganisms existing in and on the human body. Although the primary site of aggregated microbes is in the gastrointestinal (tract, populations of microorganisms are also found on the surface of the skin as well as in the upper and lower respiratory tract.

The microbiome-targeting therapeutics in immunology thematic research report will help you in developing and designing your in-licensing and out-licensing strategies, using a detailed overview of current deals and technologies to identify companies with the highest potential. This report will also help you to develop business strategies by understanding the trends shaping and driving the global microbiome-targeting therapy market.

Microbiome-Targeting Therapeutics in Immunology: Key Trends and Opportunities

The key trends that are associated with microbiome-targeting therapeutics in immunology theme can be classified into industry trends and regulatory trends.  Some of the key industry trends impacting microbiome-targeting therapeutics in immunology include therapy approval, partnerships with big pharma, and others. Numerous partnerships and mergers and acquisitions (M&A are expected to occur in the future as the space continues to mature.

Even though there are currently low-priced generic products for mild to moderate patients, they are often not effective enough to provide complete relief. Mild to moderate patients are the focus of many microbiome-targeting drugs currently in development, including late-stage agents such as SER 287 B 244.

Microbiome-Targeting Therapeutics in Immunology: Value Chain

The key value chain components of microbiome-targeting therapeutics in the immunology theme are GI indications, dermatological indications, and respiratory indications.

Dermatological indications: The key layers of dermatological indications are Acne, AD, and PsO. There are 13 microbiome targeting drugs currently being developed for the treatment of GI diseases, the majority of which target UC Almost all of them are formulated for oral administration and work via targeted release of microbial strains to restore the intestinal microflora.

Microbiome-Targeting Therapeutics in Immunology Value Chain

Microbiome-Targeting Therapeutics in Immunology Value Chain

To know more about microbiome-targeting therapeutics in the immunology value chain download a free report sample

Microbiome-Targeting Therapeutics in Immunology: Current Therapy

The only microbiome-targeting therapy currently available is fecal microbiota transplant, which is being explored in clinical trials for the treatment of GI indications such as IBD and IBS. Among ongoing trials of FMT in the US and 5EU, the majority are studying the use of the treatment in IBD, particularly UC.

Microbiome-Targeting Therapeutics in Immunology: Pipeline Products

The key products in the pipeline in microbiome-targeting therapeutics in immunology are Thetanix, Sibofimloc, RBX-2660, JNJ-72537634, BX003, and others. There are currently more than 20 microbiome-targeting therapeutics in development in the US and 5EU. Most are being developed by small to mid-size biotech companies specializing in the microbiome space.

Microbiome-Targeting Therapeutics in Immunology - Competitive Landscape

Some of the leading companies developing microbiome-targeting therapeutics in immunology are 4D Pharma, Enterome & Takeda, Seres Therapeutics, Rebiotix, Intralytix & Ferring International, Vedanta Biosciences, and others.

Microbiome-Targeting Therapeutics in Immunology Industry Overview

Report Pages 110
Regions Covered Global
Key Trends Industry Trends and Regulatory Trends
Key Therapy Fecal Microbiota Transplant
Key Pipeline Products Thetanix, Sibofimloc, RBX-2660, JNJ-72537634, BX003, and Others
Leading Companies 4D Pharma, Enterome & Takeda, Seres Therapeutics, Rebiotix, Intralytix & Ferring International, Vedanta Biosciences, and Others

Scope

  • Overview of microbiome therapies including classification of therapy and technologies, regulatory and market access details, and product & company profiles.
  • Quotes from US- and 5EU-based key opinion leaders.
  • Key topics covered for microbiome therapy in immunology in the US and 5EU include trends, value chains, market analysis, opportunities, challenges, unmet needs, and high-value deals.
  • Pipeline analysis: Comprehensive data split across different phases and indications, emerging novel trends under development, and analysis of the most promising late-stage pipeline drugs for classes of microbiome therapies.
  • Analysis of the key dynamics of the microbiome-targeting therapy market. Insightful review of the key industry drivers and challenges. Deals and R&D strategies covered to highlight business opportunities.

Key Highlights

  • The main drivers of growth include increased development interest from large pharmaceutical companies and partnerships with small and mid-size biotechs.

  • The main barriers to growth include market access issues such as the potential lack of reimbursement by payors for some indications and potential safety concerns, such as those seen in the use of fecal microbiota transplant (FMT).

  • The most important unmet needs for microbiome therapies include the need for additional therapy options for mild-to-moderate patients, the lack of knowledge and clinical data regarding the mechanism of action, as well as current low utilization of microbiome therapies like FMT.

  • The regulatory agencies of the US and 5EU are beginning to develop the definition of LBPs to describe microbiome-targeting therapies derived from live strains. However, a unique formal regulatory approval track has not yet been defined.

Reasons to Buy

The report will enable you to:

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current deals and technologies to identify companies with the highest potential.
  • Develop business strategies by understanding the trends shaping and driving the global microbiome-targeting therapy market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global microbiome-targeting therapy market in the future.
  • Design your development strategy through a review of potential novel targets or combinations across indications.
  • Understand the challenges and strategies impacting the development of microbiome-targeting therapy agents in preclinical studies and clinical trials.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the classes of microbiome-targeting therapy and indications that present maximum opportunities for consolidations, investments, and strategic partnerships.

4D Pharma
Enterome Bioscience
Takeda Pharmaceuticals
Seres Therapeutics
Rebiotix
Intralytix
Ferring International
Vedanta Biosciences
BiomX
Johnson & Johnson
NuBiyota
KoBioLabs
Kaleido Biosciences
AOBiome
MatriSys Bioscience
Siolta Therapeutics
Forte Biosciences
Naked Biome
Evelo Biosciences

Table of Contents

1. Table of Contents (PowerPoint Deck)

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?

3.1.1. Definition of the microbiome and overview of the microbiomes of the gut, skin, and respiratory tract

3.2. Microbiome Dysbiosis in Gastrointestinal Diseases

3.2.1. Overview of microbiome dysbiosis in Crohn’s disease, ulcerative colitis, and irritable bowel syndrome

3.2.2. Epidemiology forecasts for select gastrointestinal conditions impacted by microbiome dysbiosis

3.3. Microbiome Dysbiosis in Dermatological Diseases

3.3.1. Overview of microbiome dysbiosis in acne vulgaris, atopic dermatitis, and psoriasis

3.3.2. Epidemiology forecasts for select dermatological conditions impacted by microbiome dysbiosis

3.4. Microbiome Dysbiosis in Respiratory Diseases

3.4.1. Overview of microbiome dysbiosis in asthma and allergic rhinitis

3.4.2. Epidemiology forecasts for select respiratory conditions impacted by microbiome dysbiosis

4. Trends

4.1. Industry Trends

4.2. Regulatory Trends

5. Value Chain

5.1. Microbiome Value Chain

5.2. Gastrointestinal Indications

5.3. Dermatological Indications

5.4. Respiratory Indications

6. Current Therapies

6.1. Fecal Microbiota Transplant

6.1.1. Fecal Microbiota Transplants – KOLs Perspective

6.1.2. Fecal Microbiota Transplants – Clinical Trial Mapping and Design

7. Pipeline Products

7.1. Microbiome Pipeline Products in the US and 5EU

7.2. Pipeline Overview of Microbiome-Targeting Therapies for Select Immunological Indications

7.3. Clinical Trial Mapping of the Gut Microbiome

7.3.1. Overview of Pipeline Therapies Targeting the Gut Microbiome in the US and 5EU

7.3.2. Clinical Trials for Microbiome-Targeting Agents in Gastrointestinal Indications

7.3.3. Competitive Assessment – Late-Stage Agents in Gastrointestinal Indications

7.3.3.1. Pipeline Therapies in Gastrointestinal Indications – KOLs Perspective

7.4. Clinical Trial Mapping of the Skin Microbiome

7.4.1. Overview of Pipeline Therapies Targeting the Skin Microbiome in the US and 5EU

7.4.2. Clinical Trials of Microbiome Targeting Therapies in Dermatological Indications

7.4.3. Competitive Assessment – Late-Stage Agents Targeting the Skin Microbiome

7.4.3.1. Pipeline Therapies in Dermatological Indications – KOLs Perspective

7.5. Clinical Trial Mapping of the Respiratory Microbiome

7.5.1. Overview of Pipeline Therapies Targeting the Respiratory Microbiome in the US and 5EU

7.5.2. Clinical Trials for Microbiome Targeting Therapies in Respiratory Indications

8. Market Analysis

8.1. Anticipated Key Launch Dates

8.2. Market Outlook for 4D Pharma’s Blautix

8.3. Market Outlook for Seres Therapeutics’ SER-287

8.4. Market Outlook for AOBiome’s B-244

8.5. Market Outlook for Evelo Biosciences’ EDP-1815

8.6. Top 10 Deals – Microbiome-Targeting Therapies in Select Immunology Indications

9. Regulatory and Market Access

9.1. Regulatory – US

9.2. Regulatory – Europe

9.3. Market Access – US

9.4. Market Access – Europe

9.5. Market Access – Payor Perspective – IBD

9.6. Market Access – Payor Perspective – IBS

9.7. Market Access – Payor Perspective – Acne

9.8. Market Access – Payor Perspective – AD

9.9. Market Access – Payor Perspective – PsO

9.10. Market Access – Payor Perspective – Asthma

9.11. Market Access – Payor Perspective – AR

10. Opportunities, Challenges, and Unmet Needs

10.1. Role of Microbiome in Clinical Unmet Needs – Gap Analysis

10.2. Unmet Needs – KOLs Perspective

11. Companies

11.1. Drug Development Scorecard – Microbiome

11.2. Companies Developing Microbiome-Targeting Therapies for Immunology Indications

11.3. Key Players in Gastrointestinal Indications

11.4. Key Players in Dermatological Indications

11.5. Key Players in Respiratory Indications

12. Appendix

12.1. Sources

12.2. Primary Research – KOLs and Payors

12.3. Methodology

12.4. Key Themes Impacting the Pharmaceutical Industry

12.5. Our thematic research methodology

12.6. About the Authors

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