Human Microbiome Market Distribution : Industry Trends and Global Forecasts by Type of Product, Type of Molecule, Target Indication, Therapeutic Area, Route of Administration and Key Geographical Regions
As per Roots Analysis, the global human microbiome market is estimated to grow from USD 791 million in the current year to USD 6,091 million by 2035, at a CAGR of 20.4% during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Product
Probiotic Drugs
Other Drugs
Type of Molecule
Small Molecules
Biologics
Target Indication
Colorectal Cancer
Diabetes Mellitus
Inflammatory Bowel Disease
Irritable Bowel Syndrome
Graft vs. Host Disease
Necrotizing Enterocolitis
Primary Hyperoxaluria
Recurrent CDI
Therapeutic Area
Digestive and Gastrointestinal Disorders
Infectious Diseases
Metabolic Disorders
Oncological Disorders
Rare Disorders
Route of Administration
Oral
Rectal
Key Geographical Regions
North America
Europe
Asia-Pacific
Rest of the World
HUMAN MICROBIOME MARKET: GROWTH AND TRENDS
The term microorganism were previously associated with harmful disease-causing agents, until the discovery of certain beneficial microbial colonies in the human system. Humans and a variety of microbial species of bacteria, yeast and protozoa, are known to co-exist in mutually beneficial relationships. Moreover, it is estimated that the human gut microbiome consists of about 100 trillion microorganisms. Notably, this figure significantly outnumbers the total number of cells in the human body.
The majority of microorganisms provide significant benefits to humans by conferring traits and capabilities that would otherwise be absent. The healthy variety of bacteria in the gut has significant potential to enhance immunity and offer a wide range of health benefits. This has led to extensive research and development efforts by human microbiome based live biotherapeutics / diagnostic developers to make significant strides, in terms of progressing proprietary product candidates into the clinic. In addition, owing to the strong association between the human microbiome and health, a myriad of therapeutic interventions based on manipulation of commensal microbes are under development.
HUMAN MICROBIOME MARKET: KEY INSIGHTS
The report delves into the current state of the human microbiome market and identifies potential growth opportunities within industry. Some key findings from the report include:
Presently, over 70 companies, worldwide, have taken initiatives to develop therapies that can manipulate the human microbiome; the market is characterized by the presence of small companies.
The pipeline features 230+ human microbiome therapeutics that are currently being evaluated across different phases of development; the majority of these are designed for oral delivery.
Nearly 30% of the pipeline drugs are in clinical phase of development, while more than 150 drugs are in preclinical and discovery stages. Clinical stage drugs are primarily being developed for infectious diseases and digestive disorders, while candidates in preclinical and discovery stages are focused on oncological disorders.
Currently, over 40 companies, worldwide, are engaged in providing various diagnostics and screening / profiling test kits for the purpose of disease detection and analysis of human microflora composition and function.
More than 75 diagnostics and screening / profiling test are available / under development.
Of these, around 80% of the tests are available in the market, while rest are under development.
Over 70 microbiome focused diagnostic and screening / profiling tests are available in the market; such test kits allow testing of different sample types across various therapeutic areas.
Presently, FMTs are the only commercially available microbiome product; in fact, more than 400 clinical trials evaluating FMTs, sponsored by non-industry players, have been registered in the past decade.
Several well-funded start-ups have entered this domain; our proprietary start-up health indexing analysis confirms the presence of a number of players that offer significant promise in developing microbiome therapeutics.
The rising interest is also reflected in the wide array of partnerships being established between various stakeholders in the recent past; research agreements emerged as the most popular type of partnership model.
Partnership activity in this domain increased at a CAGR of 26%, since 2017. It is worth highlighting that majority of the deals were R&D agreements, representing over 35% of the total number of partnerships signed in the given time period.
Numerous investors, having realized the benefits and future opportunities of microbiome therapeutics in the treatment of various disorders, have invested more than USD 1 billion in start-ups, since 2019.
Of the total amount invested, over USD 563 million was raised through venture capital financing, representing over 56% of the overall funding activity in this domain. Further, 36 instances of grants / awards were also reported, wherein players collectively raised more than USD 137 million.
More than 25 industry players claim to be engaged in the manufacturing of microbiome-based biologics for various therapeutic purposes; majority of these firms are headquartered in Europe.
Driven by ongoing research and advancements, the human microbiome therapeutics and diagnostics market is anticipated to grow at a significant pace in the coming years.
Specifically, the human microbiome therapeutics market is anticipated to grow at a CAGR of 20.4%; the opportunity is likely to be well-distributed across different products, therapeutic areas and geographies.
In the coming decade, we anticipate the opportunity for microbiome diagnostics market to grow at an annualized rate of ~53% across different supply channels.
As late-stage therapeutics will get approved by the FDA in the foreseen future, microbiome therapeutics are anticipated to capture more than 60% share of total microbiome market by 2035.
Example Players in the Human Microbiome Market
4D Pharma
Biosotia Microbiomics
DNA Genotek
Finch Therapeutics
GoodGut
Infant Bacterial Therapeutics
Invivo Healthcare
MaaT Pharma
OxThera
Qu Biologics
Rebiotix
Seres Therapeutics
Servatus
Shoreline Biome
HUMAN MICROBIOME MARKET: RESEARCH COVERAGE
Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global human microbiome market, focusing on key market segments, including [A] type of product, [B] type of molecule, [C] target indication, [D] therapeutic area, [E] route of administration and [F] key geographical regions.
Microbiome Therapeutics Market Landscape: A comprehensive evaluation of microbiome therapeutics, based on several relevant parameters, such as [A] phase of development of product candidates, [B] type of molecule, [C] type of therapy, [D] target indication(s), [E] therapeutic area(s), [F] route of administration, [G] type of drug formulation, [H] type of microbiome therapy, [I] combination drug, [J] dosing frequency and [K] special drug designations (if any). Additionally, a comprehensive evaluation of the microbiome companies engaged in the development of microbiome therapeutics, based on several relevant parameters, such as [A] year of establishment, [B] company size and [C] location of headquarters.
Microbiome Therapeutics Company and Drug Profiles: In-depth profiles of key players that are currently engaged in the development of microbiome therapeutics, focusing on [A] overview of the company, [B] financial information (if available) [C] microbiome-based drug portfolio, [D] information on clinical trial and [E] recent developments and an informed future outlook. Additionally, in-depth profiles of key players that are currently engaged in more than six therapeutic programs, focusing on [A] overview of the company, [B] financial information (if available), [C] drug portfolio and [D] informed future outlook.
Microbiome Diagnostics and Screening / Profiling Tests Market Landscape: A comprehensive evaluation of various types of microbiome diagnostic and screening / profiling tests, based on several relevant parameters, such as [A] stage of development, [B] type of sample analyzed, [C] type of screening technique. [D] target indication(s), [E] key therapeutic area(s) and [F] purpose of diagnosis. Additionally, a comprehensive evaluation of diagnostics and screening / profiling test providers(s), based on several relevant parameters, such as [A] year of establishment, [B] company size and [C] location of headquarters.
Microbiome Diagnostics and Screening / Profiling Tests Providers Company Profiles: In-depth profiles of key players that are currently engaged in the development of microbiome diagnostics and screening / profiling tests, focusing on [A] overview of the company, [B] financial information (if available) [C] diagnostic or screening / profiling test portfolio and [D] recent developments and an informed future outlook.
Clinical Trial Analysis: An insightful analysis of clinical trials related to fecal transplant, based on several parameters, such as [A] trial status, [B] trial registration year, [C] trial phase, [D] year-wise trend of completed and recruiting trials, [E] study design, [F] number of patients enrolled, [G] age category of the patients enrolled, [H] type of sponsor / collaborator, [I] active industry and non-industry players, and [J] location of the trials. Furthermore, an insightful analysis of various stool banks based on [A] year of establishment and [B] location of headquarters, along with brief profiles of the most prominent stool banks located across the globe.
Attractiveness Competitiveness (AC) Matrix: A comprehensive business portfolio analysis based on an attractiveness and competitiveness (AC) framework, featuring the current market attractiveness and competition across the most popular disease indication(s) for which microbiome therapeutics are under investigation.
Start-Up Health Indexing: An assessment of the start-ups / small-sized players that are engaged in the development of microbiome therapeutics and diagnostics, based on relevant parameters, such as [A] number of microbiome therapeutics under development, [B] diversity of product portfolio, [C] funding amount, [D] partnership activity and [E] disease indication(s) being treated.
Key Therapeutic Areas: In-depth analysis of the most commonly targeted therapeutic indications and information on microbiome-based drugs that are being developed against them, based on [A] key epidemiological facts about specific diseases, [B] available methods of diagnosis and [C] currently available treatment options and their side effects.
Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the human microbiome market, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] type of product, [D] target indication, [E] therapeutic area, [F] type of company, [G] type of partner, [H] most active players and [I] geographical distribution of the partnership activity.
Funding and Investments: An in-depth analysis of the fundings raised by human microbiome companies, based on relevant parameters, such as [A] year of investment, [B] amount invested, [C] type of funding, [D] type of company, [E] purpose of funding, [F] type of product, [G] target indication, [H] therapeutic area, [I] geographical analysis, [J] most active players and [K] most active investors.
Case Study: A detailed discussion on the various steps involved in the development and manufacturing of microbiome therapeutics, along with information of contract manufacturers, focusing on [A] year of establishment, [B] location of headquarters, [C] company size, [D] scale of operation, [E] type of product manufactured and [F] type of formulation. Additionally, a detailed discussion on the key considerations that are required for selecting a CMO / CRO partner.
Big Data and Microbiome Therapeutics: A comprehensive assessment of the emerging role of big data, representing efforts made to develop and implement various algorithms / tools to analyze data generated from microbiome research. Further, a detailed google trends analysis demonstrating a rising interest in stakeholders to use big data tools for supporting microbiome research over the past decade.
KEY QUESTIONS ANSWERED IN THIS REPORT
How many companies are currently engaged in this market?
Which are the leading companies in this market?
What factors are likely to influence the evolution of this market?
What is the current and future market size?
What is the CAGR of this market?
How is the current and future market opportunity likely to be distributed across key market segments?
REASONS TO BUY THIS REPORT
The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
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TABLE OF CONTENTS
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.2.1. Research Assumptions
1.2.2. Project Methodology
1.2.3. Forecast Methodology
1.2.4. Robust Quality Control
1.2.5. Key Considerations
1.2.5.1. Demographics
1.2.5.2. Economic Factors
1.2.5.3. Government Regulations
1.2.5.4. Supply Chain
1.2.5.5. COVID Impact / Related Factors
1.2.5.6. Market Access
1.2.5.7. Healthcare Policies
1.2.5.8. Industry Consolidation
1.3 Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Concept of Microbiota and Microbiome
3.2.1. Discovery of the Human Microbiome
3.2.2. Functions of the Human Microbiome
3.3. Overview of Gut Flora
3.3.1. Role of Gut Flora in Human Health
3.3.2. Factors Affecting Gut Flora
3.3.2.1. Antibiotic Consumption
3.3.2.2. Age and Pregnancy
3.3.2.2.1. Mode of Childbirth
3.3.2.2.2. Type of Feeding
3.3.2.2.3. Antibiotic Consumption by Mother
3.3.2.3. Stress-related Factors
3.3.2.4. Dietary Factors
3.3.2.5. Impact of Lifestyle
3.4. Microbiome and Associated Diseases
3.4.1. Cancer
3.4.2. Inflammatory Bowel Disease (IBD)
3.4.3. Obesity
3.4.4. Parkinson's Disease
3.4.5. Type 2 Diabetes
3.4.6. Other Disease Indications
3.5. Impact of Microbiota on Drug Pharmacokinetics
3.6. Impact of Microbiota on Therapeutic Outcomes
3.7. Microbiome Therapeutics
3.7.1. Probiotics
3.7.1.1. Beneficial Bacterial Strains
3.7.1.1.1. Lactobacilli
3.7.1.1.2. Bifidobacteria
3.7.1.1.3. Others
3.7.1.2. Key Therapeutic Areas
3.7.1.2.1. Antibiotic-Associated Diarrhea (AAD)
3.7.1.2.2. Bacterial Vaginosis
3.7.1.2.3. High Blood Pressure
3.7.1.2.4. Hypercholesterolemia
3.7.1.2.5. Infectious Childhood Diarrhea (ICD)
3.7.1.2.6. Inflammatory Bowel Disease (IBD)
3.7.1.2.7. Lactose Intolerance
3.7.1.2.8. Vitamin Production
3.7.1.2.9. Weight Management
3.7.1.3. Side Effects of Probiotics
3.7.2. Prebiotics
3.7.2.1. Sources of Prebiotics
3.7.2.2. Types of Prebiotics
3.7.2.2.1. Fructo-Oligosaccharides (FOS)
3.7.2.2.2. Galacto-Oligosaccharides (GOS)
3.7.2.2.3. Inulin
3.7.2.3. Key Therapeutic Areas
3.7.2.3.1. Antibiotic Associated Diarrhea (AAD)
3.7.2.3.2. Constipation
3.7.2.3.3. Gastrointestinal Diseases
3.7.2.3.4. Dysbiosis
3.7.2.4. Side Effects of Prebiotics
3.8. The Human Microbiome Project (HMP)
3.8.1. Project Approach
3.8.2. Project Initiatives
3.8.3. Project Achievements
3.9. Regulatory Guidelines for Live Biotherapeutic Products (LBPs)
3.10. Key Challenges Associated with the Development of Microbiome Therapeutics
3.11. Future Perspectives
4. MICROBIOME THERAPEUTICS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Microbiome Therapeutics: Clinical Pipeline
4.2.1. Analysis by Phase of Development
4.2.2. Analysis by Type of Molecule
4.2.3. Analysis by Phase of Development and Type of Molecule