Companion Diagnostics Market by Product (Kits & Reagents, Software & Services, Assay); by Indication (Cancer, Cardiovascular, Infectious Diseases, Neurological Diseases, Others); by End User (Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organization, Others); by Region (North America, Europe, Asia-Pacific, Latin America, Middle East & Africa): Global Forecasts 2021 To 2027

The Global Companion Diagnostics Market Size was valued at USD 2.6 Bn in 2020 is expected to reach USD 8.5 Bn by 2027, with a growing CAGR of 18.5% during the forecast period

Companion diagnostics is a medical device used along with therapeutic drug to analyse the effect & applicability of drug on specific human body. Companion diagnostics are developed along with drug for selecting or excluding group of patients based on their characteristics which they respond to the therapy. This device helps the healthcare professional to analyse whether a particular treatment is beneficial to the patient. Recently, in 2020, Roche received FDA approval for cobas EGFR Mutation Test v2 companion diagnostic for EGFR tyrosine kinase inhibitor for the treatment for lung cancer.

Global Companion Diagnostic Market Size

The driving factors for global companion diagnostics market include an increase in the prevalence of different types of cancer such as blood cancer, lungs cancer etc and rise in demand for accurate diagnostics for cancer & treatment. Rising need for companion diagnostics, growing demand for targeted therapy, and rising applications of companion diagnostics drives the growth of companion diagnostics market. Further increase in next-generation sequencing, rising side effects of cancer drugs, increase in number of clinical trials expected to boost the growth of companion diagnostics in coming years.

Companion Diagnostics Market Segmentation:

By Product

  • Kits & Reagents
  •  Software & Service
  • Assay

By Indication

  • Cancer
  • Infectious Diseases
  • Cardiovascular Diseases
  • Neurological Diseases
  • Others

By End-User

  • Pharmaceutical & Biopharmaceutical Companies
  • Reference Laboratories
  • Contract Research Organization
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa

Based on product, kits & reagents segment is expected to hold the largest market share during forecast period owing to increase in demand for high-performance diagnostics kits

Based on product, companion diagnostics market segment includes kits & reagents, software & services, and assay. Kits and reagents are expected to drive the growth of companion diagnostics market due to rise in surge for cancer diagnostics and assessment of treatment to reduce the side effects. Moreover, increase in demand for high throughput diagnostic kits and development in sample processing supports the growth of companion diagnostics market. Reagents plays important role in sample processing, next-generation sequencing, DNA/RNA extraction and synthesis of molecules or cDNA. Growing demand for kits & reagents in clinical trials and commercial application drives the growth of companion diagnostics market.

Based on indication, cancer segment account for the largest market share in 2020 and expected to increase more during forecast period owing to increase in number of cancer patients and rising innovation in anticancer drugs

Based on indication, companion diagnostics market is segmented into cancer, cardiovascular, infectious diseases, and neurological diseases. Cancer segments hold maximum share in companion diagnostics market due to increase in demand for new anti-cancer drugs and side effects associated with drugs, increase in number of cancer patients thrives the growth of companion diagnostics market. Companion diagnostics hold the promise to improve the predictability of antic-cancer drugs & its development process and become an important tool for oncologist in terms of choice of prescribing treatment for the individual patients. The well-known example for companion diagnostics test for cancer are Gleevec and Herceptin. Further, rise in early diagnosis of cancer patients, government support in terms of funds & grants for research fuels the growth of this segment in companion diagnostics market.

Based on end user, pharmaceutical & biopharmaceutical companies accounted for the largest market share in 2020 due to increase in demand for innovative diagnostics procedures

Based on end user, companion diagnostics market is segmented into pharmaceutical & biopharmaceutical companies, reference laboratories and contract research organization. Pharmaceutical &biopharmaceutical companies hold maximum market share due to increase in collaboration, partnership, and acquisitions of companies to expand their portfolio in companion diagnostics. For instance, in June 2020, Thermo Fisher Scientific Inc. And Agios Pharmaceuticals joined hands to co-develop second companion diagnostics platform for cancer therapy. Rapid increase in diagnostics procedures drives the demand for usage for companion diagnostics test, rise in drug development process boost the growth of companion diagnostics market across globe. 

Based on geographical region, North America hold the maximum market share in 2020 due to rapid development in healthcare infrastructure and rising demand for personalized medicine

Geographically, North America accounted for the highest market share of about 35% in 2020 due to increase in government support for research and growing demand for precision drug therapy. Factors that contribute to the growth of companion diagnostics market in this region are rise in product launch, increase in government spending, increase in manufacturing & research units and ever rising prevalence for cancer diseases.

On the contrary, Asia-pacific anticipate the fastest market growth with the highest CAGR during forecast period owing to increase in number of cancer patients, rise in research activities and technological advances in medical devices in healthcare system. 

Company Profiles and Competitive Intelligence

The key players operating in the companion diagnostics market are:

  • F. Hoffmann-La Roche Ltd.
  • Agilent Technologies, Inc.
  • Abbott Laboratories, Inc.
  • Almac Group
  • Danaher Corporation
  • Illumina, Inc.
  • bioMérieux SA
  • Myriad Genetics, Inc.
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc
  • Abnova Corporation
  • Guardant Health, Inc
  • Icon Plc
  • Biogenex Laboratories, Inc
  • Amgen
  • HalioDx SAS
  • Bayer AG
  • ARUP Laboratories, Inc
  • Foundation Medicine, Inc
  • Roche

Global Companion Diagnostics Market, Geographical Snapshot

Companion Diagnostics Market by Region


The report also provides an in-depth analysis of companion diagnostics market dynamics such as drivers, restraints opportunities and challenges


  • Increase in incidence of cancer
  • Growth in genomics and proteomics research
  • Rise in government spending in R&D
  • Increase in product approvals and launches
  • Increase in technological advances in healthcare


  • Stringent government policies for product approvals
  • Lack of trained professionals
  • High companion diagnostics tests cost


  • Increase in demand for next generation sequencing and demand for biomarkers


  • Increase in key market players and rise in innovations

COVID-19 Impact on the Companion Diagnostics Market Analysis

Covid-19 has highly affected the industries in terms of growth, economy, health, and mental wellbeing of every individual. In this challenging situation, every industry is trying to give best services in terms of quality and safety. Initial times of covid-19 outbreak has badly impacted the supply of raw materials, equipment, and products across the world. Government granted restrictions on movement within countries to prevent the spread of infectious disease. Lately, early covid-19 diagnosis became important in the market to prevent spread of infection. The most commonly diagnostic test used was PCR. PCR gained huge importance during covid outbreak. In November 2020, TScan Therapeutics signed agreement with Qiagen to develop covid-19 immune response test to prevent the infection. Moreover, Roche developed highly effective & sensitive SARS-CoV-2 antibody test which would provide accurate and fast results. This introduction of diagnostic test kit created huge opportunity for other players in the companion diagnostics market for innovating more precise test across world.

The report also provides in-depth analysis of key trends in companion diagnostics market

  • Increase in government initiatives, development in innovative diagnostics techniques and demand for diagnostics tools & kits drives the growth of companion diagnostics market.
  • The lockdown and restrictions related to social distancing and movement implemented by government in COVID-19 countries had negatively impacted the supply chain of diagnostic products and affected the growth of companion diagnostics market.

The report also provides an in-depth analysis of recent news developments and investments

  • In March 2021, Agilent Technologies Inc acquired Resolution Biosciences Inc., a leader in the development of next-generation sequencing-based precision oncology solutions. This acquisition was signed to expand Agilent’s capabilities in NGS cancer diagnostics and provide innovative technology to serve a fast-growing precision market.
  • In March 2021, Personalis, Inc collaborated with MapKure, LLC to use a clinical trial assay based on the Presonalis NeXT Platform to support development of BGB-3245 in patients with advanced solid tumors and companion diagnostic tests.
  • In January 2021, Tempus, a leader in precision medicine collaborated with A2 Biotherapeutics to develop companion diagnostic test for its new therapy targeting patients with loss of Heterozygosity
  • In September 2020, Foundation Medicine, Inc. collaborated with Takeda Pharmaceutical for the development of Foundation Medicine's tissue & blood-based companion diagnostics for last stage cancer portfolio
  • In December 2020, HalioDx SAS announced exclusive distribution deal in Brazil with Diagnosticos da America (DASA) SA to commercialize their product Immunoscore and expand their business across globe.

The unique insights provided by this report also includes the following:

  • In-depth value chain analysis
  • Opportunity mapping
  • Sector snapshot
  • Key players positioning matrix
  • Regulatory scenario
  • Strategies adopted-benchmarking heat map
  • Market trends
  • Covid-19 impact analysis
  • Product comparison
  • Pre & post COVID 19 impacts on companion diagnostics market
  • Competitive landscape

Frequently Asked Questions (FAQs)

The global companion diagnostic was valued at USD 2.6 Bn in 2020 and is anticipated to reach USD 8.5 Bn by 2027.

The market is estimated to grow at a compound annual growth rate (CAGR) of 18.5% during the forecast period.

In the base year 2020, North America accounted for about 35% share in the companion diagnostic market.

High treatment cost and lack of skilled healthcare professionals' restraint the growth of global companion diagnostic market.

Few key players include, but not limit up to: F. Hoffmann-La Roche Ltd, bioMérieux SA Agilent Technologies, Inc., Abbott Laboratories, Inc., Danaher Corporation, QIAGEN N.V., Almac Group, Illumina, Inc., Sysmex Corporation, Myriad Genetics, Inc.

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  1.  Introduction
    1. Product Outline
    2. What is Companion Diagnostics?
    3. Analysis of Companion Diagnostics
    4. Covid -19 Impact
    5. Market Dynamics
      1. Drivers
      2. Restraints
      3. Opportunities
      4. Threats
    6. Technology Overview
  2. Regulatory Landscape for Companion Diagnostics
    1. Regulations and Standards
  3. Companion Diagnostics Market by Product
    1. Kits & Reagents
    2. Software & Services
    3. Assay
  4. Companion Diagnostics Market by Indication
    1. Cancer
    2. Cardiovascular
    3. Infectious Diseases
    4. Neurological Diseases
    5. Others
  5. Companion Diagnostics Market by End User
    1. Pharmaceutical & Biopharmaceutical Companies
    2. Reference Laboratories
    3. Contract Research Organization
    4. Others
  6. Regional Analysis
    1. North America
      1. US
      2. Canada
    2. Europe
      1. Germany
      2. UK
      3. France 
      4. Spain
      5. Italy
      6. Rest Of Europe
    3. Asia Pacific
      1. China
      2. India
      3. Japan
      4. Australia
      5. Rest Of Asia Pacific
    4. Latin America
      1. Brazil
      2. Mexico
      3. Rest of LATAM
    5. Middle East & Africa
      1. GCC
      2. Rest of MEA
  7. Key Strategic Insights
  8. Market Analysis
    1. New Applications
    2. Emerging Technologies
    3. Opportunity Mapping
    4. Critical Success Factors
    5. Customer Preferences
  9. Key Market Trends / Recent Developments
  10. Competitive Scenario
    1. Mergers and Acquisitions
    2. Investments
    3. Joint Ventures
    4. New Product Launches
    5. Ranking of Key Players
    6. Presence of Players by Geographies
  11. Key Global Players
    1. F. Hoffmann-La Roche Ltd.
    2. Agilent Technologies, Inc.
    3. QIAGEN N.V.
    4. Abbott Laboratories, Inc.
    5. Almac Group
    6. Danaher Corporation
    7. Illumina, Inc.
    8. bioMérieux SA
    9. Myriad Genetics, Inc.
    10. Sysmex Corporation
    11. Thermo Fisher Scientific Inc
    12. Abnova Corporation
    13. Guardant Health, Inc
    14. Icon, Plc
    15. Biogenex Laboratories, Inc

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