The microbiome is considered the genetic material of all microorganisms existing in and on the human body. Large resident microbial communities exist in the gastrointestinal (GI) tract, skin, and respiratory tract, and an imbalance or compromised variety in these populations can contribute to immunological disorders. Emerging therapies and increasing knowledge around the microbiome are expected to help meet the unmet needs of patients across various indications in Immunology. Therapies targeting the microbiome have been termed Live Biotherapeutic Products (LBPs) by regulatory authorities and each of them aims to address disease by altering the microbiome.
23 microbiome-targeting therapeutics are currently being developed in the US and 5EU (France, Germany, Italy, Spain, UK) for GI, dermatological, and respiratory conditions. The majority of these drugs target GI indications and are in earlier stages of clinical development. Four pipeline agents are in late-stage Phase II trials: 4D Pharma’s Blautix for irritable bowel syndrome, AOBiome’s B-244 for acne vulgaris and atopic dermatitis, Evelo Biosciences’ EDP-1815 for psoriasis, and Seres Therapeutics’ SER-287 for ulcerative colitis. These drugs are expected to launch within the next five to six years.
KEY QUESTIONS ANSWERED
• Which early- and late-stage microbiome-targeting pipeline therapies are in clinical development for immunology indications?
• What are the current unmet needs that microbiome therapies can address in the treatment of autoimmune, autoinflammatory, and allergic disorders? What are the opportunities for R&D?
• What is the regulatory landscape for microbiome therapies in the US and the 5EU?
• How will the field of microbiome-targeting therapy move forward in the future? What are the key M&A deals in the field?
Overview of microbiome therapies including classification of therapy and technologies, regulatory and market access details, 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 chain, market analysis, opportunities, challenges and 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.
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 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, lack of knowledge and clinical data regarding 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.
Johnson & Johnson
Table of Contents
1. Table of Contents (PowerPoint Deck)
1.1. Table of Contents
1.3. Related Reports
2. Executive Summary
2.1. Key Findings
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
4.1. 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
22.214.171.124. 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
126.96.36.199. 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
11.1. 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
12.2. Primary Research – KOLs and Payors
12.4. Key Themes Impacting the Pharmaceutical Industry
12.5. Our thematic research methodology
12.6. About the Authors