Companion Diagnostics Market Size, Share, Trends & Competitive Analysis By Type: Immunohistochemistry, Polymerase Chain Reaction, In Situ Hybridization, Next-Generation Sequencing, FISH, Others By Application: Oncology, Infectious Diseases, Neurology, Cardiovascular Diseases, Autoimmune Diseases, Others By End User: By Regions, and Industry Forecast, Global Report 2024-2032

  • Report ID: FDS1394
  • Forecast Period: 2023-2030
  • No. of Pages: 150+
  • Industry: Medical Devices

The global Companion Diagnostics Market size was valued at USD 6.95 Billion in 2023 and is projected to expand at a compound annual growth rate (CAGR) of 12.3% during the forecast period, reaching a value of USD 19.68 Billion by 2030.

Companion Diagnostics Market research report by Future Data Stats, offers a comprehensive view of the Market's historical data from 2019 to 2022, capturing trends, growth patterns, and key drivers. It establishes 2023 as the base year, analyzing the Market landscape, consumer behavior, competition, and regulations. Additionally, the report presents a well-researched forecast period from 2024 to 2032, leveraging data analysis techniques to project the Market's growth trajectory, emerging opportunities, and anticipated challenges.


Companion diagnostics are a crucial tool in modern medicine, aiding physicians in making informed decisions about patient treatment plans. These specialized tests help determine whether a particular therapy is suitable for an individual based on their unique genetic makeup or other biomarkers. By analyzing biomarkers alongside clinical data, companion diagnostics assist in identifying the most effective treatment options while minimizing the risk of adverse reactions. In essence, companion diagnostics personalize medicine, ensuring that patients receive tailored therapies that are more likely to result in successful outcomes.

In addition to guiding treatment decisions, companion diagnostics play a pivotal role in advancing precision medicine initiatives. By accurately pinpointing which patients are most likely to benefit from specific therapies, these tests contribute to more targeted and efficient healthcare delivery. Furthermore, companion diagnostics facilitate the development of novel therapies by enabling researchers to identify appropriate patient populations for clinical trials.


The increasing demand for personalized medicine, which emphasizes the importance of tailoring treatments to individual patients based on their genetic profiles and biomarkers. This growing emphasis on precision medicine fuels the adoption of companion diagnostics, as these tests play a critical role in identifying suitable patients for specific therapies, thereby optimizing treatment outcomes. Additionally, advancements in technology, such as next-generation sequencing and molecular imaging techniques, enhance the accuracy and efficiency of companion diagnostics, further propelling market growth.

Regulatory challenges and complexities surrounding the approval and reimbursement of companion diagnostics pose significant barriers to market growth. Moreover, the high costs associated with developing and commercializing companion diagnostic tests may limit their accessibility, particularly in emerging markets. However, opportunities abound for market players to overcome these challenges and capitalize on untapped potential.



Immunohistochemistry (IHC) stands out as a prominent type of companion diagnostic, offering the ability to detect specific proteins in tissue samples. Its widespread use in cancer diagnostics, particularly in assessing tumor biomarkers, contributes significantly to its dominance in the market. Polymerase Chain Reaction (PCR) also holds a strong position, leveraging its high sensitivity and specificity to amplify and detect nucleic acid sequences. PCR-based companion diagnostics find application across various disease areas, including infectious diseases and genetic disorders, driving their prominence in the market.

In Situ Hybridization (ISH) technology emerges as another influential factor in the companion diagnostics market, enabling the visualization and localization of specific nucleic acid sequences within cells and tissues. This technique, which includes fluorescence in situ hybridization (FISH), plays a critical role in identifying genetic abnormalities associated with cancer and other diseases. Next-Generation Sequencing (NGS) represents a cutting-edge technology that offers high-throughput sequencing capabilities, allowing for the comprehensive analysis of genetic variations. As NGS becomes increasingly integrated into clinical practice, its role in companion diagnostics expands, particularly in guiding targeted cancer therapies based on genomic alterations.

While these technologies dominate the companion diagnostics market, other innovative approaches also contribute to its diversity and growth. Emerging diagnostic modalities, such as liquid biopsy and circulating tumor DNA (ctDNA) analysis, hold promise for non-invasive detection and monitoring of cancer biomarkers. Additionally, advancements in multiplex assays and digital pathology are reshaping the landscape of companion diagnostics, offering enhanced sensitivity, specificity, and automation.


Oncology stands out as the primary application area, driving a significant portion of the market demand. Companion diagnostics play a critical role in oncology by guiding treatment decisions, identifying appropriate patient populations for targeted therapies, and monitoring treatment response. The integration of companion diagnostics in oncology has led to more personalized and effective cancer treatment strategies, ultimately improving patient outcomes and survival rates.

Infectious diseases represent another crucial application area for companion diagnostics, especially in the era of emerging infectious threats and antimicrobial resistance. Companion diagnostics aid in the rapid and accurate detection of pathogens, guiding appropriate treatment selection and helping to mitigate the spread of infectious diseases. Furthermore, companion diagnostics facilitate the monitoring of treatment efficacy and the emergence of drug-resistant strains, enabling timely adjustments to treatment regimens. This role of companion diagnostics in infectious diseases underscores their importance in public health efforts aimed at controlling and preventing infectious outbreaks.

Beyond oncology and infectious diseases, companion diagnostics find application in a diverse range of medical specialties, including neurology, cardiovascular diseases, autoimmune diseases, and others. In neurology, companion diagnostics assist in the diagnosis and management of neurological disorders by identifying biomarkers associated with disease progression and treatment response. Similarly, in cardiovascular diseases, companion diagnostics play a role in risk assessment, prognosis, and personalized treatment selection. Moreover, companion diagnostics hold promise in autoimmune diseases by aiding in the identification of biomarkers for early disease detection and guiding immunotherapy approaches.


Hospitals and clinics represent one of the primary end users of companion diagnostics, utilizing these tools to guide therapeutic interventions and improve clinical outcomes. Companion diagnostics integrated into hospital and clinic settings enable healthcare professionals to tailor treatment strategies based on individual patient characteristics, thereby optimizing the effectiveness of interventions across various medical specialties.

Diagnostic laboratories also play a crucial role in driving the companion diagnostics market forward. These specialized facilities are equipped with the expertise and infrastructure necessary to perform complex diagnostic tests, including molecular and genetic analyses. By offering comprehensive testing services, diagnostic laboratories support healthcare providers in accurately diagnosing diseases, monitoring treatment response, and predicting patient outcomes. Additionally, the increasing demand for personalized medicine fuels the expansion of diagnostic laboratory services, further propelling market growth.

Pharmaceutical companies represent another key end user of companion diagnostics, leveraging these tools to support drug development and precision medicine initiatives. Companion diagnostics enable pharmaceutical companies to identify patient populations most likely to benefit from specific therapies, facilitating targeted clinical trial recruitment and improving the efficiency of drug development pipelines. Moreover, companion diagnostics play a vital role in pharmaceutical research and development by providing insights into disease mechanisms, biomarker identification, and therapeutic efficacy assessment.


North America emerges as a leading region in this market, driven by factors such as robust healthcare infrastructure, significant investment in research and development, and a growing emphasis on personalized medicine. Moreover, the presence of key market players and regulatory bodies supportive of companion diagnostics adoption further propels market growth in North America. The region benefits from collaborations between pharmaceutical companies, diagnostic firms, and academic institutions, fostering innovation and driving advancements in companion diagnostics technology.

Europe also holds a significant share in the companion diagnostics market, characterized by increasing awareness about personalized medicine, favorable reimbursement policies, and a strong focus on healthcare innovation. Countries within Europe, such as Germany, France, and the United Kingdom, are key contributors to market growth, driven by their advanced healthcare systems and active research and development activities.


  • Roche Diagnostics
  • Abbott Laboratories
  • Thermo Fisher Scientific Inc.
  • Agilent Technologies, Inc.
  • Siemens Healthineers
  • Qiagen N.V.
  • Myriad Genetics, Inc.
  • Illumina, Inc.
  • Bio-Rad Laboratories, Inc.
  • Danaher Corporation
  • Foundation Medicine, Inc.
  • NanoString Technologies, Inc.
  • Exact Sciences Corporation
  • Sysmex Corporation
  • Biocartis Group NV
  • Guardant Health, Inc.
  • Hologic, Inc.
  • BD (Becton, Dickinson and Company)
  • Invivoscribe, Inc.
  • Leica Biosystems Nussloch GmbH
  • F. Hoffmann-La Roche AG
  • Genomic Health, Inc.
  • Menarini Silicon Biosystems
  • Personal Genome Diagnostics Inc. (PGDx)
  • BioMérieux SA

Table of Contents
Executive Summary
Market Dynamics
Companion Diagnostics Market Segmentation
By Type
By Application
By End User
By Region
Competitive Landscape
Company Profiles

Companion Diagnostics Market Segmentation

By Type:

  • Immunohistochemistry (IHC)
  • Polymerase Chain Reaction (PCR)
  • In Situ Hybridization (ISH)
  • Next-Generation Sequencing (NGS)
  • FISH (Fluorescence In Situ Hybridization)
  • Others

By Application:

  • Oncology
  • Infectious Diseases
  • Neurology
  • Cardiovascular Diseases
  • Autoimmune Diseases
  • Others

By End User:

  • Hospitals & Clinics
  • Diagnostic Laboratories
  • Pharmaceutical Companies
  • Academic & Research Institutes
  • Others

By Geography:

  • North America (USA, Canada, Mexico)
  • Europe (Germany, UK, France, Russia, Italy, Rest of Europe)
  • Asia-Pacific (China, Japan, South Korea, India, Southeast Asia, Rest of Asia-Pacific)
  • South America (Brazil, Argentina, Columbia, Rest of South America)
  • Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Rest of MEA)

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With a collective industry experience of about 70 years of analysts and experts, Future Data Stats encompasses the most infallible research methodology for its market intelligence and industry analysis. Not only does the company dig deep into the innermost levels of the market, but also examines the minutest details for its market estimates and forecasts.

This approach helps build a greater market-specific view of size, shape, and industry trends within each industry segment. Various industry trends and real-time developments are factored into identifying key growth factors and the future course of the market. The research proceeds are the results of high-quality data, expert views & analysis, and valuable independent opinions. The research process is designed to deliver a balanced view of the global markets and allows stakeholders to make informed decisions, to attain their highest growth objectives.

Future Data Stats offers its clients exhaustive research and analysis, based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. These analytical tools and models distill the data & statistics and enhance the accuracy of our recommendations and advice.

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With this strong methodology, Future Data Stats ensures that its research and analysis is most reliable and guarantees sound business planning.

The research methodology of the global market involves extensive primary and secondary research. Primary research includes about 24 hours of interviews and discussions with a wide range of stakeholders that include upstream and downstream participants. Primary research typically is a bulk of our research efforts, coherently supported by extensive secondary research. Over 3000 product literature, industry releases, annual reports, and other such documents of key industry participants have been reviewed to obtain a better market understanding and gain enhanced competitive intelligence. In addition, authentic industry journals, trade associations’ releases, and government websites have also been reviewed to generate high-value industry insights.

Primary Research:

Primary Research


Desk Research


Company Analysis


•       Identify key opinion leaders

•       Questionnaire design

•       In-depth Interviews

•       Coverage across the value chain


•       Company Website

•       Company Annual Reports

•       Paid Databases

•       Financial Reports


•       Market Participants

•       Key Strengths

•       Product Portfolio

•       Mapping as per Value Chain

•       Key focus segment


Primary research efforts include reaching out to participants through emails, telephonic conversations, referrals, and professional corporate relations with various companies that make way for greater flexibility in reaching out to industry participants and commentators for interviews and discussions.

The aforementioned helps to:

  • Validate and improve data quality and strengthen the research proceeds
  • Develop a market understanding and expertise
  • Supply authentic information about the market size, share, growth, and forecasts

The primary research interview and discussion panels comprise experienced industry personnel.

These participants include, but are not limited to:

  • Chief executives and VPs of leading corporations specific to an industry
  • Product and sales managers or country heads; channel partners & top-level distributors; banking, investments, and valuation experts
  • Key opinion leaders (KOLs)

Secondary Research:

A broad array of industry sources for the secondary research typically includes, but is not limited to:

  • Company SEC filings, annual reports, company websites, broker & financial reports, and investor  presentations for a competitive scenario and shape of the industry
  • Patent and regulatory databases to understand technical & legal developments
  • Scientific and technical writings for product information and related preemptions
  • Regional government and statistical databases for macro analysis
  • Authentic news articles, web-casts, and other related releases to evaluate the market
  • Internal and external proprietary databases, key market indicators, and relevant press releases for  market estimates and forecasts



•       Top executives of end-use industries

•       C-level executives of the leading Parenteral Nutrition companies

•       Sales manager and regional sales manager of the Parenteral Nutrition companies

•       Industry Consultants

•       Distributors/Suppliers


•       Annual Reports

•       Presentations

•       Company Websites

•       Press Releases

•       News Articles

•       Government Agencies’ Publications

•       Industry Publications

•       Paid Databases


Analyst Tools and Models:



·         Arriving at
Global Market Size

·         Arriving at
Market Size

·         Market Share
of Key Players

·         Key Market Players

·         Key Market Players

·         Market Share
of Key Players

·         Arriving at
Market Size

·         Arriving at
Global Market Size


Companion Diagnostics Market Dynamic Factors


  • Growing demand for personalized medicine fuels the adoption of companion diagnostics.
  • Increasing prevalence of chronic diseases like cancer drives the demand for companion diagnostics.
  • Advancements in biomarker identification and validation techniques contribute to market growth.
  • Regulatory support and streamlined approval processes enhance market prospects.
  • Collaborations between pharmaceutical companies and diagnostic firms drive market expansion.


  • High development costs and lengthy approval processes hinder market growth.
  • Limited reimbursement policies pose a challenge to market adoption.
  • Regulatory complexities and stringent approval requirements impede market expansion.
  • Challenges related to biomarker discovery and validation slow down market progression.
  • Concerns regarding data privacy and security impact market adoption rates.


  • Expanding applications in oncology and other therapeutic areas offer growth opportunities.
  • Emerging markets present untapped potential for market expansion.
  • Integration of artificial intelligence and machine learning enhances diagnostic accuracy.
  • Technological advancements in next-generation sequencing drive market innovation.
  • Shift towards point-of-care testing creates new avenues for market growth.


  • Lack of standardized regulatory guidelines across regions poses challenges to market players.
  • Issues related to assay reproducibility and reliability impact market adoption.
  • Limited awareness among healthcare professionals about the benefits of companion diagnostics.
  • Reimbursement uncertainties and pricing pressures affect market sustainability.
  • Competition from alternative diagnostic technologies poses a threat to market growth.

Frequently Asked Questions

The global Companion Diagnostics Market size was valued at USD 6.95 Billion in 2023 and is projected to expand at a compound annual growth rate (CAGR) of 12.3% during the forecast period, reaching a value of USD 19.68 Billion by 2030.

Key factors propelling the growth of the Companion Diagnostics Market include advancements in precision medicine, rising incidences of chronic diseases, and a growing emphasis on personalized healthcare.

Current trends in the Companion Diagnostics Market include the integration of artificial intelligence in diagnostic tools, the development of multiplex assays for simultaneous analysis, and collaborations between pharmaceutical and diagnostic companies for comprehensive patient care.

Regions such as North America and Europe are expected to dominate the Companion Diagnostics Market due to their advanced healthcare infrastructure, supportive regulatory environment, and significant investments in research and development.

Major challenges in the Companion Diagnostics Market include regulatory hurdles, reimbursement issues, and the need for standardization in testing procedures.
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