Companion Diagnostics Market

Companion Diagnostics Market by Product & Service (Assay, Kit, Software & Service), Technology (PCR, NGS, ISH, IHC), Indication (Breast, Lung & Colorectal Cancer, Cardiovascular Disease), End-User (Pharma Companies, CRO), Region - Global Forecast to 2024

Report Code: MD 5463 Sep, 2019, by

[240 Pages Report] The global companion diagnostics market is projected to reach USD 7.3 billion by 2024 from USD 3.5 billion in 2019, at a CAGR of 15.7%. Advantages of companion diagnostics, the growing need for targeted therapy, the rising importance of personalized medicine, the increasing global incidence of cancer, and the ever-increasing application areas of companion diagnostics are driving the growth of the global companion diagnostics industry. The increasing demand for next-generation sequencing, the growing significance of companion diagnostics in drug development, and the rising number of clinical trials are the major factors driving the growth of this market.

Companion Diagnostics Market

Polymerase chain reaction (PCR) segment to account for the largest share of the companion diagnostics market, by technology, in 2019

The extractables/leachables testing services segment is expected to dominate the companion diagnostics market in 2019. The large share of this segment can be attributed to the ease of use and widespread availability of PCR kits & reagents in companion diagnostic testing, growing applications of PCR in the high-throughput detection of mutants with a limited or low allele frequency of genes, and high turnaround time of PCR as compared to other technologies.

Pharmaceutical & biopharmaceutical companies are estimated to be the largest end-users of companion diagnostics in 2019

Pharmaceutical & biopharmaceutical companies are expected to account for the largest share of the companion diagnostics market in 2019. The large share of this segment can majorly be attributed to the extensive usage of companion diagnostics in these industries owing to their growing prominence in drug development and the increasing importance of companion diagnostic biomarkers. The increasing demand for personalized medicine as well as the high demand for targeted therapies for various diseases and disorders are also expected to drive the demand and uptake of companion diagnostics among pharmaceutical & biopharmaceutical companies.

Companion Diagnostics Market

APAC market is estimated to grow at the highest CAGR during the forecast period

The companion diagnostics market in the APAC is estimated to grow at the highest CAGR during the forecast period. The high incidence of cancer, increasing proteomics & genomics research, growing research funding, rising investments by pharmaceutical and biotechnology companies, and growing awareness about personalized therapeutics in several APAC countries are expected to drive the growth of the APAC market.

Key Market Players

The prominent players operating in the global companion diagnostics market are F. Hoffmann-La Roche AG (Switzerland), Agilent Technologies, Inc. (US), QIAGEN N.V. (Germany), Abbott Laboratories, Inc. (US), Almac Group (UK), Danaher Corporation (US), Illumina, Inc. (US), bioMérieux SA (France), Myriad Genetics, Inc., (US), Sysmex Corporation (Japan), Thermo Fisher Scientific Inc. (US), Abnova Corporation (Taiwan), and Guardant Health, Inc. (US).

F. Hoffmann-La Roche AG is one of the leading providers of companion diagnostics across the globe. It provides a comprehensive portfolio of companion diagnostic products for pharmaceutical companies and research institutes.  With a strong brand name and extensive geographic coverage in more than 180 countries, Roche has a well-established presence in the companion diagnostics market. In the companion diagnostics market, the company focuses on strategies, such as product launches & approvals, to increase its presence. With regard to this, the company launched the VENTANA HER2 Dual ISH companion diagnostic test in May 2019. This test will provide Roche’s CDx customers with a product for the detection of the HER2 biomarker in breast & gastric cancer, thus supporting pharmaceuticals in developing personalized medicines and targeted therapies. In line with launching innovative products, Roche invests a significant amount of its sales revenue in R&D. In 2018, it invested approximately 20% of its sales revenue in R&D activities. These investments enable the company to extend its technological capabilities and provide superior-quality products, thereby helping the firm achieve long-term growth.

Agilent Technologies is another leading provider of comprehensive companion diagnostics for to pharmaceutical companies, reference laboratories, hospitals, and other medical academic centers. The company offers robust companion diagnostic assays & kits where the products are based majorly on immunohistochemistry (IHC) and in-situ hybridization (ISH) technologies. The company provides companion diagnostic products to the end-users through its strong distribution network across the globe. Agilent’s business strategy includes product launches and approvals for new therapeutic areas. For instance, in April 2019, Agilent received an expanded FDA approval for its companion diagnostic assay, PD-L1 IHC 22C3 pharmDx, in non-small cell lung cancer (NSCLC) for first-line treatment with KEYTRUDA, a targeted anti-PD-1 therapy manufactured by Merck and Co. However, the company could also focus on other strategies such as partnerships & agreements and acquisitions to further strengthen its position in the market.

Scope of the Report:

Report Metric


Market size available for years


Base year considered


Forecast period


Forecast units

Value (USD)

Segments covered

Product & service, technology, indication and end-user

Geographies covered

North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa.

Companies covered

F. Hoffmann-La Roche AG (Switzerland), Agilent Technologies, Inc. (US), QIAGEN N.V. (Germany), Abbott Laboratories, Inc. (US), Almac Group (UK), Danaher Corporation (US), Illumina, Inc. (US), bioMérieux SA (France), Myriad Genetics, Inc., (US), Sysmex Corporation (Japan), Thermo Fisher Scientific Inc. (US), Abnova Corporation (Taiwan), and Guardant Health, Inc. (US)

This research report categorizes the market into the following segments and subsegments:

Companion diagnostics Market, by Product & Service

  • Assay kits & Reagents
  • Software & Services

Companion diagnostics Market, by Technology

  • Polymerase Chain Reaction (PCR) 
  • In Situ Hybridization (ISH) 
  • Next-Generation Sequencing (NGS)
  • Immunohistochemistry (IHC) 
  • Others (Multiplex Assay and Cellular Imaging Technologies)

Companion diagnostics Market, by Indication

  • Cardiovascular
  • Neurological Diseases
  • Cancer
    • Breast Cancer 
    • Lung Cancer 
    • Colorectal Cancer 
    • Melanoma 
    • Gastric Cancer 
  • Infectious Diseases 
  • Others (inflammatory and inherited diseases)

Companion diagnostics Market, by End User

  • Pharmaceutical & Biopharmaceutical Companies
  • Reference Laboratories
  • CROs
  • Others (Physicians, Hospitals, Academic Medical Centers, Payers)

Companion diagnostics Market, by Region

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • UK
    • Switzerland
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa

Recent Developments

  • In May 2019, QIAGEN N.V. launched the therascreen PIK3CA RGQ PCR Kit in PIQRAY (alpelisib) therapy in the US to enhance its product portfolio in the companion diagnostics market.
  • In April 2019, Myriad Genetics, Inc. (US) and AstraZeneca plc (UK) and Merck Group (Germany) entered into a partnership, to identify unmet medical needs in men related to metastatic castration-resistant prostate cancer and expand the company’s patient access in the market.
  •  In September 2017, Abbott Laboratories (US) acquired Alere Inc. (US). This company enhances its point of care diagnostics segment in fast-growing diagnostics channels, thus significantly advancing Abbott's global diagnostics presence and leadership.
  • In September 2017, Abnova Corporation entered into third-party diagnostics by offering molecular diagnostics in precision medicine and liquid biopsy testing services in China. This will help the company to establish its position in the Chinese market.

Critical Questions the Report Answers:

  • Where will all these developments take the industry in the medium-to-long-term?
  • What are the major trends in companion diagnostics?
  • Who are the major end-users of companion diagnostics?
  • Which product & service are used mainly for companion diagnostics?
  • Which technology has a higher adoption rate of companion diagnostics?

To speak to our analyst for a discussion on the above findings, click Speak to Analyst

Table of Contents

1 Introduction (Page No. - 21)
    1.1 Objectives of the Study
    1.2 Market Definition
    1.3 Market Scope
           1.3.1 Markets Covered
           1.3.2 Years Considered for the Study
    1.4 Currency
    1.5 Limitations
    1.6 Stakeholders

2 Research Methodology (Page No. - 25)
    2.1 Research Data
           2.1.1 Secondary Data
           Key Data From Secondary Sources
           2.1.2 Primary Data
           Key Data From Primary Sources
           Key Industry Insights
    2.2 Market Size Estimation
    2.3 Market Breakdown and Data Triangulation
    2.4 Assumptions for the Study

3 Executive Summary (Page No. - 34)

4 Premium Insights (Page No. - 39)
    4.1 Companion Diagnostics: Market Overview
    4.2 Asia Pacific: Companion Diagnostics Market, By End User (2018)
    4.3 Regional Mix: Companion Diagnostics Market
    4.4 Companion Diagnostics Market: Developing Vs. Developed Countries
    4.5 Geographical Snapshot of the Companion Diagnostics Market

5 Market Overview (Page No. - 43)
    5.1 Introduction
    5.2 Market Dynamics
           5.2.1 Drivers
           Advantages of Companion Diagnostics
           Growing Need for Targeted Therapy
           Growing Importance of Personalized Medicine
           Increasing Global Incidence of Cancer
           Growing Application Areas of Companion Diagnostics
           5.2.2 Restraints
           High Cost of Companion Diagnostic Tests
           Uncertain Reimbursement Scenario in Different Regions
           5.2.3 Opportunities
           Increasing Demand for Next-Generation Sequencing
           Growing Significance of Companion Diagnostics in Drug Development
           Increasing Number of Clinical Trials
           5.2.4 Challenges
           Shortage of Trained Professionals

6 Industry Insights (Page No. - 52)
    6.1 Introduction
    6.2 Industry Trends
           6.2.1 Growing Focus on Liquid Biopsy in Companion Diagnostics
           6.2.2 Increasing Collaborations
    6.3 Regulatory Analysis
           6.3.1 North America
           6.3.2 Europe
           6.3.3 APAC
           6.3.4 Brazil
    6.4 Product Pipeline Analysis

7 Companion Diagnostics Market, By Product & Service (Page No. - 64)
    7.1 Introduction
    7.2 Assays, Kits, & Reagents
           7.2.1 With the Growing Need for Personalized Medicine, the Volume of Companion Diagnostic Tests Performed in Laboratories is Increasing, Which Supports the Adoption of Assays & Kits
    7.3 Software & Services
           7.3.1 the Need for Effective Data Management Software Within Laboratories is Increasing, Contributing to the Growth of the Companion Diagnostic Software & Services Market

8 Companion Diagnostics Market, By Technology (Page No. - 69)
    8.1 Introduction
    8.2 Polymerase Chain Reaction (PCR)
           8.2.1 Growing Applications of PCR Technologies in the Field of Personalized Medicine and Companion Diagnostics Drive the Growth of This Segment
    8.3 Next-Generation Sequencing (NGS)
           8.3.1 the NGS Segment is Expected to Grow at the Highest CAGR During the Forecast Period
    8.4 in Situ Hybridization (ISH)
           8.4.1 Increasing Adoption of ISH is Mainly Due to Advancements in Hybridization and Its Demand in Small-Tumor Diagnostics
    8.5 Immunohistochemistry (IHC)
           8.5.1 Increasing Demand for USer-Friendly and Cost-Effective Technologies in Companion Diagnostics to Drive the Growth of This Segment
    8.6 Other Technologies

9 Companion Diagnostics Market, By Indication (Page No. - 81)
    9.1 Introduction
    9.2 Cancer
           9.2.1 Breast Cancer
           Breast Cancer is the Most Common Cancer Among Women—A Key Factor Contributing to the Large Share of This Market Segment
           9.2.2 Lung Cancer
           Growing Demand for Therapeutic Drugs and Their High EffiCACy in the Treatment of Lung Cancer Increase the Adoption of Companion Diagnostics in This Segment
           9.2.3 Colorectal Cancer
           Growing Need for Molecular Profiling of Primary Tumors in Colorectal Cancer to Drive Growth in This Market Segment
           9.2.4 Melanoma
           9.2.5 Gastric Cancer
           Increasing Focus of Market Players on the Development of Tests and Kits for Gastric Cancer Indications to Drive Market Growth
    9.3 Neurological Diseases
           9.3.1 Growing Number of Diagnostic Technologies for the Treatment of Neurological Diseases to Boost the Adoption of Companion Diagnostics in This Segment
    9.4 Infectious Diseases
           9.4.1 Growing Focus of Companion Diagnostic Players on Orphan Indications to Propel the Growth of This Segment During the Forecast Period
    9.5 Cardiovascular Diseases
           9.5.1 Growing Demand for Targeted Therapies Due to High Incidence and Mortality Rate of Cardiovascular Diseases to Drive Growth in This Segment
    9.6 Other Indications

10 Companion Diagnostics Market, By End User (Page No. - 98)
     10.1 Introduction
     10.2 Pharmaceutical & Biopharmaceutical Companies
             10.2.1 Wide Usage of Companion Diagnostics in Pharmaceutical & Biopharmaceutical Companies Owing to Their Growing Prominence in Drug Development to Drive Market Growth
     10.3 Reference Laboratories
             10.3.1 Growing Incidence of Diseases Such as Cancer and the Rising Demand for Targeted Therapies to Drive the Growth of This End-User Segment
     10.4 Contract Research Organizations
             10.4.1 Cros Offer a Complete Range of Companion Diagnostic Services Ranging From Companion Diagnostic Development to Targeted Therapy-Related Clinical Trials
     10.5 Other End Users

11 Companion Diagnostics Market, By Region (Page No. - 105)
     11.1 Introduction
     11.2 North America
             11.2.1 US
              US is the Largest Market for Companion Diagnostics in North America
             11.2.2 Canada
              Government Initiatives to Promote Companion Diagnostics in Various Indications are Expected to Drive Market Growth in Canada
     11.3 Europe
             11.3.1 Germany
              Germany is a Major Market for Pharmaceutical and Biotechnology Products in Europe
             11.3.2 UK
              Growth in the Country’s Life Science Industry and Increasing Research are Key Factors Driving Market Growth in the UK
             11.3.3 Switzerland
              Switzerland Boasts a Strong Research-Oriented Pharma Industry
             11.3.4 France
              Increasing Government Funding for Genomics and Personalized Therapeutics R&D is Driving Market Growth
             11.3.5 Italy
              Growing Disease Prevalence has Contributed to the Demand for Better, More Powerful Therapeutics in Italy
             11.3.6 Spain
              Medical Institutes in Spain are Increasingly Focusing on Cancer Biomarker Research
             11.3.7 Rest of Europe
     11.4 Asia Pacific
             11.4.1 Japan
              Japan Holds the Largest Share of the Market in Apac
             11.4.2 China
              China is One of the Most Prominent Research Markets, Worldwide
             11.4.3 India
              Indian Government has Focused on Tackling the Problem of a Growing Cancer Incidence
             11.4.4 Australia
              Rising Burden of Geriatric Population has Resulted in Initiatives to Enhance Healthcare Access and Infrastructure
             11.4.5 Rest of Asia Pacific
     11.5 Latin America
             11.5.1 Brazil
              Brazil Dominates the Latin American Companion Diagnostics Market
             11.5.2 Mexico
              Mexico is Emerging as a Prominent Medical Tourism Hub
             11.5.3 Rest of Latin America
     11.6 Middle East and Africa
             11.6.1 Rising Cancer Incidence Rate has Attracted Stakeholder Attention to Regional Markets in Mea

12 Competitive Landscape (Page No. - 186)
     12.1 Overview
     12.2 Market Share Analysis
     12.3 Competitive Leadership Mapping, 2018
     12.4 Vendor Inclusion Criteria
     12.5 Vendor Dive
             12.5.1 Visionary Leaders
             12.5.2 Innovators
             12.5.3 Emerging Companies
             12.5.4 Dynamic Differentiators
     12.6 Competitive Situations and Trends
             12.6.1 Partnerships, Collaboration, and Agreements
             12.6.2 Acquisitions

13 Company Profiles (Page No. - 196)
     13.1 F. Hoffmann-La Roche AG
             13.1.1 Business Overview
             13.1.2 Products Offered
             13.1.3 Recent Developments
             13.1.4 MnM View
     13.2 Agilent Technologies, Inc.
             13.2.1 Business Overview
             13.2.2 Products Offered
             13.2.3 Recent Developments
             13.2.4 MnM View
     13.3 QIAGEN N.V.
             13.3.1 Business Overview
             13.3.2 Products Offered
             13.3.3 Recent Developments
             13.3.4 MnM View
     13.4 Abbott Laboratories, Inc.
             13.4.1 Business Overview
             13.4.2 Product Offered
             13.4.3 Recent Developments
             13.4.4 MnM View
     13.5 Almac Group
             13.5.1 Business Overview
             13.5.2 Services Offered
             13.5.3 Recent Developments
             13.5.4 MnM View
     13.6 Danaher Corporation
             13.6.1 Business Overview
             13.6.2 Products Offered
             13.6.3 Recent Developments
             13.6.4 MnM View
     13.7 Illumina Inc.
             13.7.1 Business Overview
             13.7.2 Products Offered
             13.7.3 Recent Developments
             13.7.4 MnM View
     13.8 bioMérieux SA
             13.8.1 Business Overview
             13.8.2 Products Offered
             13.8.3 MnM View
     13.9 Myriad Genetics, Inc.
             13.9.1 Business Overview
             13.9.2 Products Offered
             13.9.3 Recent Developments
             13.9.4 MnM View
     13.10 Sysmex Corporation
               13.10.1 Business Overview
               13.10.2 Products and Services Offered
               13.10.3 Recent Developments
               13.10.4 MnM View
     13.11 Thermo Fisher Scientific, Inc.
               13.11.1 Business Overview
               13.11.2 Products & Services Offered
               13.11.3 Recent Developments
               13.11.4 MnM View
     13.12 Abnova Corporation
               13.12.1 Business Overview
               13.12.2 Services Offered
               13.12.3 Recent Developments
               13.12.4 MnM View
     13.13 Guardant Health, Inc.
               13.13.1 Business Overview
               13.13.2 Products Offered
               13.13.3 Recent Developments
               13.13.4 MnM View

14 Appendix (Page No. - 231)
     14.1 Insights of Industry Experts
     14.2 Discussion Guide
     14.3 Knowledge Store: Marketsandmarkets’ Subscription Portal
     14.4 Available Customizations
     14.5 Related Reports
     14.6 Author Details

This study involved the extensive use of primary and secondary sources and involved an in-depth analysis of the various factors affecting the growth of the global companion diagnostics market. Both primary and secondary research was used to identify the segmentation types, trends, key players, key market dynamics, and key player strategies as well as derive the competitive leadership mapping and competitive landscape in this market.

Secondary Research

The secondary research process involved the widespread use of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B Hoovers), white papers, annual reports, company house documents, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the companion diagnostics market. It was also used to obtain important information about the key players and market classification & segmentation according to industry trends to the bottom-most level, and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.

Primary Research

In the primary research process, industry experts from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. Industry experts from the supply side include suppliers, distributors, CEOs, vice presidents, marketing and sales directors, business development managers, and technology and innovation directors of companion diagnostics providers; whereas, industry experts from the demand side include company vice presidents, c-level executives, directors of pharmaceutical companies, companion diagnostic application managers, hospital directors, product managers, NGS specialists, IVD suppliers, pharmaceutical firm R&D heads, companion diagnostic department heads, research scientists, and other related key opinion leaders.

A breakdown of the primary respondents is provided below:

Companion Diagnostics Market

To know about the assumptions considered for the study, download the pdf brochure

Market Size Estimation

The market size estimates and forecasts provided in this study are derived through a mix of the bottom-up approach (revenue share analysis of leading players) and the top-down approach (assessment of utilization/adoption/penetration trends, by product & service, technology, indication, end-user, and region).

Data Triangulation

After arriving at the market size, the total companion diagnostics market was divided into several segments and subsegments. Data triangulation and market breakdown procedures were employed, wherever applicable, to complete the overall market engineering process and arrive at the exact statistics for all segments & subsegments.

Objectives of the Study

  • To define, describe, and forecast the companion diagnostics market based on product & service, technology, indication, end-user, and region
  • To provide detailed information regarding the factors influencing market growth (such as drivers, restraints, opportunities, and challenges)
  • To analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall companion diagnostics market
  • To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
  • To strategically profile the key players in the companion diagnostics market and comprehensively analyze their market shares and core competencies2
  • To strategically analyze five geographical regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa
  • To track and analyze competitive developments such as joint ventures & acquisitions; product developments & enhancements; agreements & partnerships; expansions; and funding activities in the companion diagnostics market.

Available Customizations

With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players

Geographic Analysis

  • A further breakdown of the Rest of Asia Pacific companion diagnostics market into South Korea, New Zealand, and others  
  • A further breakdown of the companion diagnostics market in the Rest of Latin America into Argentina, Chile, Peru, Colombia, and others
Report Code
MD 5463
Published ON
Sep, 2019
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