Microbiome Diagnostics Market – By Product (Kits and Reagents, Instruments), Technology (16S rRNA Sequencing, Shotgun Metagenomics), Sample (Fecal Samples, Saliva Samples), Application (Disease diagnostic), End-use – Global Forecast (2024 – 2032)

Microbiome Diagnostics Market – By Product (Kits and Reagents, Instruments), Technology (16S rRNA Sequencing, Shotgun Metagenomics), Sample (Fecal Samples, Saliva Samples), Application (Disease diagnostic), End-use – Global Forecast (2024 – 2032)

Microbiome Diagnostics Market Size

Microbiome Diagnostics Market size was valued at around USD 143.1 million in 2023 and is estimated to grow at 13.4% CAGR from 2024 to 2032. Microbiome diagnostics refers to the application of advanced technologies and analytical methods to characterize and analyze the composition, diversity, and functional attributes of microbial communities residing within the human body, environmental samples, or other habitats.

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It encompasses the identification, quantification, and profiling of microorganisms including bacteria, archaea, viruses, fungi, and other microbes using techniques such as next-generation sequencing, metagenomics, metatranscriptomics, metabolomics, and bioinformatics analysis. The increasing prevalence of chronic disease diseases includes cardiovascular diseases, diabetes, and cancer serves as a substantial impetus for market growth. For instance, according to the World Health Organization (WHO), in 2022, there were an estimated 20 million new cancer cases and 9.7 million deaths from cancer worldwide. Thus, the advancement and widespread adoption of microbiome diagnostics are essential for enhancing the diagnosis, treatment management, and risk prediction of cancer. 

Furthermore, rising demand of personalized medicine, growing awareness about importance of human microbiomes, and rising funding & investments in microbiome research are the contributing factors stimulating the market growth.
 

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Microbiome Diagnostics Market Trends

Microbiome research has risen to prominence drawing substantial investment due to its wide-ranging effects on human health, environmental equilibrium, and agricultural productivity. Comprising myriad microorganisms inhabiting diverse bodily niches, the human microbiome, stands pivotal in maintaining holistic wellness and internal balance. Concurrently, the progression of sequencing technologies, advances in bioinformatics analysis, and interdisciplinary collaborations have propelled a surge in global microbiome research initiatives.

• Increased funding allows for the development and adoption of cutting-edge technologies in microbiome research such as high-throughput sequencing platforms, single-cell analysis techniques, and advanced bioinformatics tools. These technologies enable more comprehensive and detailed profiling of microbial communities, enhancing the accuracy and resolution of microbiome diagnostics.
• Enhanced funding enables the translation of microbiome research findings into clinically relevant diagnostic tools and applications. This includes the development of microbiome-based tests for disease diagnosis, prognosis, treatment monitoring, and personalized healthcare interventions, ultimately improving patient outcomes.
• Additionally, microbiome research funded by precision medicine initiatives integrate microbial data into personalized healthcare. Microbiome-based diagnostics guide treatment decisions, predict therapy responses, and stratify patient populations based on microbial profiles, enhancing intervention effectiveness, thereby escalating the growth of the market.

Microbiome Diagnostics Market Analysis

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Based on product, the market is divided into kits & reagents, and instruments. The kits and reagents segment is estimated to account for USD 296.6 million by the end of 2032.

• Kits and reagents provide standardized protocols and formulations ensuring consistency and reproducibility in microbiome sample preparation, processing, and analysis. This standardization minimizes variability between laboratories and improves the reliability of results.
• Ready-to-use kits and pre-formulated reagents simplify the experimental workflow reducing the need for complex preparation steps and specialized equipment. This ease of use makes microbiome diagnostics accessible to researchers with varying levels of expertise, streamlining experimental procedures.
• Further, kits and reagents accelerate the experimental process by eliminating the need for manual formulation and optimization of protocols. Researchers can save time on experimental setup allowing for higher throughput and faster turnaround times in microbiome analysis.

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Based on technology, the microbiome diagnostics market is bifurcated into 16S rRNA sequencing, shotgun metagenomics, metatranscriptomics, and other technologies. The 16S rRNA sequencing segment accounted for USD 76.5 million in 2023.

• 16S rRNA sequencing allows for the simultaneous profiling of microbial communities present in complex samples such as those derived from the gut, skin, oral cavity, or environmental samples. This high-throughput capability enables comprehensive analysis of microbial diversity and composition within diverse ecosystems.
• It provides taxonomic information at various phylogenetic levels allowing for the identification and classification of bacteria and archaea present in microbiome samples. This resolution facilitates the characterization of microbial communities and the detection of rare or low-abundance taxa that may be relevant to health or disease.
• Further, 16S rRNA sequencing can be used for quantitative analysis of microbial abundance within a sample. By sequencing the 16S rRNA gene amplicons and quantifying the abundance of operational taxonomic units (OTUs), researchers can assess the relative abundance of different microbial taxa and track changes in microbial composition over time or in response to interventions. Thus, such aforementioned factors are expected to augment the segmental growth.

Based on sample, the microbiome diagnostics market is segmented into fecal samples, saliva samples, skin samples, and other samples. The fecal samples segment is estimated to account for USD 166.3 million revenue by the end of 2032.

• Fecal sample collection is non-invasive and easily accessible making it suitable for large-scale population studies and longitudinal monitoring of microbiome dynamics. It eliminates the need for invasive procedures such as tissue biopsies or blood draws, enhancing participant compliance and minimizing discomfort.
• This sample provides a representative snapshot of the gut microbiota composition and diversity. The gut microbiota plays a crucial role in human health and disease, influencing various physiological processes such as digestion, metabolism, immune function, and neurobehavioral regulation.
• Further, fecal microbiome analysis is diagnostically relevant for gastrointestinal disorders including inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS), and colorectal cancer. Fecal biomarkers such as microbial diversity indices, specific taxa abundance, and functional profiles indicate disease risk, severity, and treatment response.
• Thus, the aforementioned factors are anticipated to boost segmental growth.

Based on application, the microbiome diagnostics market is bifurcated into disease diagnostic and research applications. The disease diagnostic is further bifurcated into gastrointestinal disorders, metabolic disorders, and other disease diagnostics. The disease diagnostic segment accounted for USD 81.2 million in 2023.

• Microbiome analysis can detect microbial dysbiosis and imbalances in microbial communities before clinical symptoms manifest enabling early detection of diseases such as gastrointestinal disorders, inflammatory conditions, and infections.
• It provides a comprehensive assessment of the microbial communities inhabiting various body sites, offering insights into the role of the microbiome in health and disease. This holistic approach allows for a more thorough understanding of disease mechanisms and contributing factors.
• Further, microbiome-based diagnostics enable personalized medicine approaches by identifying microbial biomarkers and patterns associated with individual disease risks, responses to treatment, and prognosis. This personalized information can guide tailored therapeutic interventions and improve patient outcomes, thereby propelling the growth of the market.

Based on end-use, the microbiome diagnostics market is classified into hospitals, academic and research institutes, pharmaceuticals, and biotechnology companies. The hospitals segment accounted for USD 63.9 million in 2023.

• Hospitals can utilize microbiome diagnostics to improve the accuracy and efficiency of disease diagnosis. By analyzing the composition and functionality of microbial communities associated with various diseases, clinicians can identify microbial signatures and biomarkers that aid in diagnosing infections, gastrointestinal disorders, inflammatory conditions, and other health issues.
• Microbiome diagnostics empower hospitals to customize treatment plans for patients by utilizing their unique microbial profiles. Clinicians can identify specific microbiome alterations contributing to disease and prescribe personalized therapies such as antibiotics, probiotics, prebiotics, and dietary interventions to restore microbial balance and enhance treatment efficacy.
• Moreover, microbiome diagnostics in hospitals facilitate the ongoing monitoring of disease progression and treatment response by analyzing changes in microbial composition, diversity, and functionality over time.

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U.S. microbiome diagnostics market is anticipated to grow at CAGR of 13.1% during the analysis timeframe.

• The U.S. boasts world-renowned research institutions, academic centers, and biotechnology companies at the forefront of microbiome research. These institutions contribute to advancements in sequencing technologies, bioinformatics analysis, and microbiome-based diagnostics.
• It has a significant prevalence of chronic diseases such as cancer, cardiovascular diseases, and diabetes. For instance, The National Diabetes Statistics Report for 2022 by the CDC (Centers for Disease Control) reveals that the prevalence of diabetes has increased, reached an estimated 37.3 million cases. This accounted for 11.3% of the U.S. population. Among these cases, 28.7 million people received a diabetes diagnosis, while approximately 8.6 million individuals have diabetes but remain undiagnosed.

UK is anticipated to witness robust growth in the global microbiome diagnostics market.

• The UK government provides significant support for biomedical research through funding agencies such as UK Research and Innovation (UKRI), the National Institute for Health Research (NIHR), and the Medical Research Council (MRC). This support fosters innovation and drives advancements in microbiome diagnostics.
• The UK faces a notable burden of chronic diseases such as  cancer, cardiovascular diseases, and diabetes. For instance, data from The British Diabetic Association revealed that more than 4.3 million people in the UK were managing with diabetes, while 850,000 people have diabetes but remain to undiagnosed in 2021.

China microbiome diagnostics market is anticipated to witness lucrative growth between 2024 – 2032.

• China's vast population and diverse demographic groups provide a rich resource for microbiome research. The country's diverse ethnicities, diets, lifestyles, and environmental exposures offer opportunities to study microbiome variability and its impact on health and disease across different populations.
• China has made rapid advancements in next generation sequencing (NGS) technologies and bioinformatics analysis. This expertise in high-throughput sequencing enables comprehensive analysis of microbial communities, facilitating microbiome diagnostics and research, thereby boosting market growth.

South Korea microbiome diagnostics market is expected to grow significantly over the years.

• South Korea is known for its advanced technology infrastructure including high-performance computing facilities, next-generation sequencing platforms, and bioinformatics expertise. This technological capability enables comprehensive analysis of microbial communities and facilitates microbiome diagnostics research.
• Additionally, South Korea has a well-developed healthcare infrastructure with modern hospitals, clinics, and medical centers equipped with state-of-the-art diagnostic and therapeutic facilities.

Microbiome Diagnostics Market Share

The microbiome diagnostics industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products and services based on different technologies is among a key market strategy. Some of the leading industry players have a notable presence in the market.

Microbiome Diagnostics Market Companies

Some of the eminent market participants operating in the microbiome diagnostics industry include

• Becton, Dickinson, and Company
• Biome Technologies plc
• Genetic Analysis AS
• Illumina, Inc.
• Microba Life Sciences Limited
• Micronoma, Inc.
• OraSure Technologies, Inc.
• Oxford Nanopore Technologies plc
• Quantbiome, Inc.
• ViennaLab Diagnostics GmbH

Microbiome Diagnostics Industry News

• In January 2023, Genetic Analysis AS entered into an agreement with Microbiome Research Pvt. Ltd. The collaboration resulted in MRPL launching a test service portfolio based on the GA-map Dysbiosis Test, marking it as the first CE-IVD marked standardized gut microbiome test available on the Indian market. This partnership benefited Genetic Analysis AS by expanding its market reach and providing access to the Indian market for its CE-IVD marked gut microbiome test.
• In June 2021, Illumina and Microba Life Sciences formed a partnership to advance understanding of the human gut microbiome. By combining Illumina's NGS tools with Microba's analysis platform, the collaboration facilitated the generation of accurate metagenomic data, empowering researchers to make new discoveries. This collaboration benefited both companies by enhancing research capabilities and accelerating scientific breakthroughs in gut microbiome research.

The microbiome diagnostics market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments

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Market, By Product

• Kits and reagents
• Instruments

Market, By Technology

• 16S rRNA sequencing
• Shotgun metagenomics
• Metatranscriptomics
• Other technologies

Market, By Sample

• Fecal samples
• Saliva samples
• Skin samples
• Other samples        

Market, By Application

• Disease diagnostic
  • Gastrointestinal disorders             
  • Metabolic disorders            
  • Other disease diagnostics    
• Research applications                   

Market, By End-use

• Hospitals                           
• Academic and research institutes                       
• Pharmaceuticals and biotechnology companies

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa