Microbiome Diagnostics Market Size, Share & Trends Analysis Report By Product (Reagents & Kits, Instruments), By Technology (16S rRNA Sequencing, Shot Gun Metagenomics, Metatranscriptomics, Other Technology), By Sample (Feces, Saliva, Skin, Other Sample), By Application (Disease Diagnostics Application (Gastrointestinal Disorders, Metabolic Diseases, Other Application), Research Application), By End-User (Hospitals, Academic and Research Institutes, Biotechnology and Pharmaceutical Companies), By Region, And By Segment Forecasts, 2024-2031

Report Id: 2398 Pages: 179 Last Updated: 19 March 2024 Format: PDF / PPT / Excel / Power BI
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Microbiome Diagnostics Market Size is valued at USD 154.9 Mn in 2023 and is predicted to reach USD 488.2 Mn by the year 2031 at a 15.6% CAGR during the forecast period for 2024-2031.

Microbiome Diagnostics Market info

Utilizing advanced genomic and bioinformatic techniques, these diagnostics can profile microbial DNA from samples (e.g., gut, skin, oral cavity) to understand the composition and function of the microbiome. Applications range from disease diagnosis and risk assessment to personalized medicine and predicting drug responses, by identifying specific microbiome signatures associated with certain diseases or health states.

The Microbiome Diagnostics market growth can be attributed to its use of progressive scientific procedures and technologies to inspect the configuration and operation of microbiomes in particular environments, especially within the human body. The microbiome diagnostics market is witnessing steady growth, driven by increasing awareness of the role of microbial communities in health and disease. Advancements in technologies and bioinformatics have enabled more accurate and comprehensive microbiome analysis. However, challenges such as standardization of testing protocols and regulatory hurdles remain, shaping the landscape of this rapidly evolving Market.

The COVID-19 pandemic has positively as well as negatively impacted the microbiome diagnostics market. While there has been increased interest in understanding the pivotal role of the microbiome in immunity and disease susceptibility, disruptions in healthcare systems and reduced research funding have slowed market growth. However, the pandemic has increased the adoption of remote healthcare solutions, leading to a surge in demand for microbiome diagnostics for telemedicine and home testing. Overall, the Market has faced challenges regarding supply chain disruptions and reduced access to healthcare facilities. Still, opportunities have emerged in remote diagnostics and personalized medicine.

Competitive Landscape

Some Major Key Players In The Microbiome Diagnostics Market:

  • Yakult Honsha Co.
  • AOBiome
  • Enterome Biosciences SA
  • Metabiomics Corp. (BioSpherex LLC)
  • Microbiome Therapeutics LLC
  • Osel, Inc.
  • Rebiotix, Inc.
  • Second Genome
  • Seres Therapeutics
  • Synthetic Biologics, Inc.
  • Vedanta Biosciences
  • 4D Pharma
  • Du Pont De Nemours and Co.
  • Ferring Pharmaceuticals
  • Genetic Analysis AS
  • Atlas Biomed
  • Biome Oxford Ltd.
  • Illumina Inc.
  • Microba Life Sciences
  • Dna Genotek (Orasure Technologies, Inc.)
  • Viome Life Sciences
  • Sun Genomics
  • Becton, Dickinson And Company
  • Daytwo
  • OraSure Technologies, Inc.
  • Other Prominent Players

Market Segmentation:

The Microbiome Diagnostics Market is segmented by product, Technology, sample, application, end-user, and region. The segmentation based on the products is Reagents & Kits and Instruments. The sample segment comprises Fecal, Saliva, and Skin. Based on application, the segmentation includes Disease Diagnostics Applications, Gastrointestinal Disorders, Metabolic Diseases, and Other Applications. Based on End-User, the segmentation includes Hospitals, Academic and Research Institutes, Biotechnology, and Pharmaceutical Companies. 

The Kits & Reagents Accounted For The Largest Share Of The Microbiome Diagnostics Market By Product Segment.

High consumption of consumables such as kits and reagents and their repeated purchases, along with the increasing number of microbiome diagnostic tests performed across the globe, support the growth of the reagents & kits product segment. The demand for microbiome diagnostics is rising as the instruments play an important role in sanctioning the correct and precise investigation of microbiome samples. Next-generation sequencing apparatus, mass spectrometers, and quantitative PCR gadgets are important in this field. NGS devices are important for sequencing DNA and RNA from microbiome samples, offering comprehensive particulars about the configuration of microbial sections.

The Pharmaceutical And Biotechnologies Segment Based On End-Users Has Also Witnessed Rapid Growth.

The Pharmaceutical and Biotechnologies Segment dominated the Market based on end users. They appear as a sizeable fragment of microbiome diagnostics end users. The microbiome diagnostics market trends include utilizing microbiome data to fabricate inventive remedies, customized medicines, and progressive probiotics. These firms are entrenched in disentangling the complex associations between the human microbiome and varied illnesses. By engaging microbiome diagnostics, they project to distinguish contemporary drug targets, enhance drug efficacy, and lessen the prevalence of unfavourable outcomes. 

North America Is The Region That Has A Significant Revenue Share In The Microbiome Diagnostics Market.

North America emerges as the most dominant Market due to the region's strong healthcare framework, the notable pervasiveness of gastrointestinal illnesses, and growing consciousness regarding the importance of microbiome balance, which are important elements pushing the assimilation of microbiome diagnostics within the region. North America dominates the microbiome market because of the strong base of healthcare facilities, rising investment from key players, a growing number of processes about drug development, and a rising number of research activities in this region. The joint ventures regarding research between leading economies of this region also boost the market growth. There is an increase in government initiatives to promote awareness, growing research and education activities in the region, a rise in the incidences of lifestyle-related diseases and autoimmune disorders, and a growing demand for quality healthcare.

Recent Developments

  • In July 2022, OraSure Technologies, Inc. has made its OMNIgene®•GUT DNA and RNA product (OMR-205) available to researchers studying the gut microbiota. OraSure technology is a prominent worldwide frontrunner in the field of point-of-care and home diagnostic testing, as well as sample collecting technology. The product facilitated the collection, preservation, storage, and transfer of microbial DNA and RNA at room temperature for the purpose of analyzing the gut microbiome. The product was manufactured by DNA Genotek, a subsidiary of OraSure.
  • In Aug 2021, A partnership between Second Genome and Arena Pharmaceuticals to identify gastrointestinal biomarkers was recently disclosed. A proof-of-concept study utilizing microbiome signals was conducted by Second Genome as part of Arena's CULTIVATE Phase 2/3 clinical trial for Crohn's disease. 

Microbiome Diagnostics Market Report Scope

Report Attribute Specifications
Market Size Value In 2023 USD 154.9 Mn
Revenue Forecast In 2031 USD 488.2 Mn
Growth Rate CAGR CAGR of 15.6 % from 2024 to 2031
Quantitative Units Representation of revenue in US$ Million and CAGR from 2024 to 2031
Historic Year 2019 to 2023
Forecast Year 2024-2031
Report Coverage The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends
Segments Covered By Product, Technology, Sample, Application, End-User
Regional Scope North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Country Scope U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; Southeast Asia; South Korea
Competitive Landscape Yakult Honsha Co., AOBiome, Enterome Biosciences SA, Metabiomics Corp., Microbiome Therapeutics LLC, Osel, Inc., Rebiotix, Inc., Second Genome, Seres Therapeutics, Synthetic Biologics, Vedanta Biosciences, 4D Pharma, Du Pont De Nemours and Co., Ferring Pharmaceuticals, Genetic Analysis AS, Atlas Biomed, Biome Oxford Ltd., Illumina Inc., Microba Life Sciences, Dna Genotek (Orasure Technologies, Inc.), Viome Life Sciences, Sun Genomics, Becton, Dickinson And Company, Daytwo, OraSure Technologies, Inc.
Customization Scope Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape.
Pricing And Available Payment Methods Explore pricing alternatives that are customized to your particular study requirements.

Segmentation of Microbiome Diagnostics Market-

Microbiome Diagnostics Market By Product-

  • Reagents & Kits
  • Instruments

Microbiome Diagnostics Market seg

Microbiome Diagnostics Market By Technology-

  • 16S rRNA Sequencing
  • Shot Gun Metagenomics
  • Metatranscriptomics
  • Other Technology

Microbiome Diagnostics Market By Sample-

  • Feces
  • Saliva
  • Skin
  • Other Sample

Microbiome Diagnostics Market By Application-

  • Disease Diagnostics Application
    • Gastrointestinal Disorders
    • Metabolic Diseases
    • Other Application
  • Research Application

Microbiome Diagnostics Market By End-User-

  • Hospitals
  • Academic and Research Institutes
  • Biotechnology and Pharmaceutical Companies

Microbiome Diagnostics Market By Region-

North America-

  • The US
  • Canada
  • Mexico

Europe-

  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe

Asia-Pacific-

  • China
  • Japan
  • India
  • South Korea
  • South East Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South Africa
  • Rest of Middle East and Africa

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Research Design and Approach

This study employed a multi-step, mixed-method research approach that integrates:

  • Secondary research
  • Primary research
  • Data triangulation
  • Hybrid top-down and bottom-up modelling
  • Forecasting and scenario analysis

This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.

Secondary Research

Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.

Sources Consulted

Secondary data for the market study was gathered from multiple credible sources, including:

  • Government databases, regulatory bodies, and public institutions
  • International organizations (WHO, OECD, IMF, World Bank, etc.)
  • Commercial and paid databases
  • Industry associations, trade publications, and technical journals
  • Company annual reports, investor presentations, press releases, and SEC filings
  • Academic research papers, patents, and scientific literature
  • Previous market research publications and syndicated reports

These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.

Secondary Research

Primary Research

Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.

Stakeholders Interviewed

Primary interviews for this study involved:

  • Manufacturers and suppliers in the market value chain
  • Distributors, channel partners, and integrators
  • End-users / customers (e.g., hospitals, labs, enterprises, consumers, etc., depending on the market)
  • Industry experts, technology specialists, consultants, and regulatory professionals
  • Senior executives (CEOs, CTOs, VPs, Directors) and product managers

Interview Process

Interviews were conducted via:

  • Structured and semi-structured questionnaires
  • Telephonic and video interactions
  • Email correspondences
  • Expert consultation sessions

Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.

Data Processing, Normalization, and Validation

All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.

The data validation process included:

  • Standardization of units (currency conversions, volume units, inflation adjustments)
  • Cross-verification of data points across multiple secondary sources
  • Normalization of inconsistent datasets
  • Identification and resolution of data gaps
  • Outlier detection and removal through algorithmic and manual checks
  • Plausibility and coherence checks across segments and geographies

This ensured that the dataset used for modelling was clean, robust, and reliable.

Market Size Estimation and Data Triangulation

Bottom-Up Approach

The bottom-up approach involved aggregating segment-level data, such as:

  • Company revenues
  • Product-level sales
  • Installed base/usage volumes
  • Adoption and penetration rates
  • Pricing analysis

This method was primarily used when detailed micro-level market data were available.

Bottom Up Approach

Top-Down Approach

The top-down approach used macro-level indicators:

  • Parent market benchmarks
  • Global/regional industry trends
  • Economic indicators (GDP, demographics, spending patterns)
  • Penetration and usage ratios

This approach was used for segments where granular data were limited or inconsistent.

Hybrid Triangulation Approach

To ensure accuracy, a triangulated hybrid model was used. This included:

  • Reconciling top-down and bottom-up estimates
  • Cross-checking revenues, volumes, and pricing assumptions
  • Incorporating expert insights to validate segment splits and adoption rates

This multi-angle validation yielded the final market size.

Forecasting Framework and Scenario Modelling

Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.

Forecasting Methods

  • Time-series modelling
  • S-curve and diffusion models (for emerging technologies)
  • Driver-based forecasting (GDP, disposable income, adoption rates, regulatory changes)
  • Price elasticity models
  • Market maturity and lifecycle-based projections

Scenario Analysis

Given inherent uncertainties, three scenarios were constructed:

  • Base-Case Scenario: Expected trajectory under current conditions
  • Optimistic Scenario: High adoption, favourable regulation, strong economic tailwinds
  • Conservative Scenario: Slow adoption, regulatory delays, economic constraints

Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.

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Frequently Asked Questions

Microbiome Diagnostics Market Size is valued at USD 154.9 Mn in 2023 and is predicted to reach USD 488.2 Mn by the year 2031

Microbiome Diagnostics Market is expected to grow at a 15.6% CAGR during the forecast period for 2024-2031.

Yakult Honsha Co., AOBiome, Enterome Biosciences SA, Metabiomics Corp., Microbiome Therapeutics LLC, Osel, Inc., Rebiotix, Inc., Second Genome
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