Companion Diagnostics Market: By Application (Breast Cancer, Colorectal Cancer, Lung Cancer, Urology, Melanoma, Gastric Cancer, Others), By Technology (Immunohistochemistry, Molecular Diagnostics, In-Situ Hybridization, FISH, CISH, Real-Time PCR, Gene Sequencing), By End-User (Hospitals, Diagnostic Centres, Others) and Geography

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Companion Diagnostics Market size was valued at USD 5.4 billion in 2022 and is poised to grow at a CAGR of 10.9% from 2023-2029. Companion diagnostics are medical devices, often in-vitro device that provides the information that is essential for safe and effective use of the corresponding drug or biotechnology product. Companion diagnostics are often developed along with drugs to aid in selecting or excluding the patient groups for the treatment with particular drug on basis of their biological characteristics. Companion diagnostics are developed based on biomarkers technology to predict response or severe toxicity of the drugs or biotechnological compounds. Companion diagnostics are majorly used in the oncology area. The Global companion diagnostics market growth is highly fragmented due to the presence of several established large and small suppliers. The competition in the market will intensify during the forecast period as vendors adopt strategies like M&A to develop new technologies. Product approval and launch will also help to increase the volume of available diagnostic devices in the market. In addition, the vendors also work on differentiating their products based on quality, the accuracy of results, and other value-added services as it will help them to gain a competitive edge over their peers.

Companion Diagnostics Market Key Developments:

  • In June 2015, Ventana Medical Systems, Inc. (RocheGroup) has received U.S. FDA approval for its ventana alk cdx assay, companion diagnostics to aid in the identification of patients for, xalkori (crizotinib) (Pfizer's FDA approved targeted therapy)
  • In July 2014, AstraZeneca collaborated with Roche to develop a plasma-based companion diagnostic test to support azd9291, for non-small-cell lung cancer

Global Companion Diagnostics Market Summary

Study Period

2024-2030

Base Year

2023

CAGR

13.3%

Largest Market

North America

Fastest Growing Market

Asia-Pacific
Companion Diagnostics Market Dynamics

Some of the factors like improved efficacy and safety profiles of drugs, accelerated drug regulatory approvals, reduced healthcare expenditure and drug development costs, increasing partnerships between market players, government organizations and other research firms over the use of co diagnostics, emergence of new pharmaceuticals and diagnostics are driving the growth of the market. However, due to the regulatory uncertainty, complex clinical trial procedures and intellectual property issues in certain areas are the few issues which are restraining the growth.

Key Features of the Reports

  • The companion diagnostics market report provides granular level information about the market size, regional market share, historic market (2018-2022) and forecast (2023-2029)
  • The report covers in-detail insights about the competitors overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments and startups details that are actively working in the market
  • The report provides plethora of information about market entry strategies, regulatory framework and reimbursement scenario
  • The report analyses the impact of the socio-political environment through PESTLE Analysis and competition through Porters Five Force Analysis in addition to recent technology advancements and innovations in the market

Global Companion Diagnostics Market Segmentation

By Application
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Urology
  • Melanoma
  • Gastric Cancer
  • Others
By Technology
  • Immunohistochemistry
  • Molecular Diagnostics
  • In-situ Hybridization
  • FISH
  • CISH
  • Real-Time PCR
  • Gene Sequencing
By End User
  • Hospitals
  • Diagnostic Centres
  • Others
By Geography
  • North America
  • Asia Pacific
  • Europe
  • Latin America
  • Middle East and Africa

Frequently Asked Questions

The companion diagnostics market is projected to expand at a CAGR of 10.9% during the forecast period

Pfizer Inc., (U.S), F. Hoffmann-La Roche Ltd.(Switzerland), Qiagen Ltd. (Germany), ARUP Laboratories (U.S.), Abbott Laboratories (U.S.), Biogenex Laboratories, Inc. (U.S.)

Asia Pacific is the fastest-growing region for companion diagnostics market

1.Executive Summary
2.Global Companion Diagnostics Market Introduction 
2.1.Global Companion Diagnostics Market  - Taxonomy
2.2.Global Companion Diagnostics Market  - Definitions
2.2.1.Application
2.2.2.Technology
2.2.3.End User
2.2.4.Region
3.Global Companion Diagnostics Market Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Product Landscape
3.6. New Product Launches
3.7. Impact of COVID 19 on Market
4.Global Companion Diagnostics Market Analysis, 2018 - 2022 and Forecast 2023 - 2029
4.1.  Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
4.2.  Year-Over-Year (Y-o-Y) Growth Analysis (%) 
4.3.  Market Opportunity Analysis 
5.Global Companion Diagnostics Market  By Application, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
5.1. Breast Cancer
5.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.1.3. Market Opportunity Analysis 
5.2. Colorectal Cancer
5.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.2.3. Market Opportunity Analysis 
5.3. Lung Cancer
5.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.3.3. Market Opportunity Analysis 
5.4. Urology
5.4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
5.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.4.3. Market Opportunity Analysis 
5.5. Melanoma
5.5.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
5.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.5.3. Market Opportunity Analysis 
5.6. Gastric Cancer
5.6.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
5.6.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.6.3. Market Opportunity Analysis 
5.7. Others
5.7.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
5.7.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.7.3. Market Opportunity Analysis 
6.Global Companion Diagnostics Market  By Technology, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
6.1. Immunohistochemistry
6.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.1.3. Market Opportunity Analysis 
6.2. Molecular Diagnostics
6.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.2.3. Market Opportunity Analysis 
6.3. In-situ Hybridization
6.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.3.3. Market Opportunity Analysis 
6.4. FISH
6.4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
6.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.4.3. Market Opportunity Analysis 
6.5. CISH
6.5.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
6.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.5.3. Market Opportunity Analysis 
6.6. Real-Time PCR
6.6.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
6.6.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.6.3. Market Opportunity Analysis 
6.7. Gene Sequencing
6.7.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
6.7.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.7.3. Market Opportunity Analysis 
7.Global Companion Diagnostics Market  By End User, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
7.1. Hospitals
7.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.1.3. Market Opportunity Analysis 
7.2. Diagnostic Centres
7.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.2.3. Market Opportunity Analysis 
7.3. Others
7.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.3.3. Market Opportunity Analysis 
8.Global Companion Diagnostics Market  By Region, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
8.1. North America
8.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
8.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.1.3. Market Opportunity Analysis 
8.2. Europe
8.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
8.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.2.3. Market Opportunity Analysis 
8.3. Asia Pacific (APAC)
8.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
8.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.3.3. Market Opportunity Analysis 
8.4. Middle East and Africa (MEA)
8.4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
8.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.4.3. Market Opportunity Analysis 
8.5. Latin America
8.5.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million)
8.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.5.3. Market Opportunity Analysis 
9.North America Companion Diagnostics Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
9.1. Application Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.1.1.Breast Cancer
9.1.2.Colorectal Cancer
9.1.3.Lung Cancer
9.1.4.Urology
9.1.5.Melanoma
9.1.6.Gastric Cancer
9.1.7.Others
9.2.  Technology Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.2.1.Immunohistochemistry
9.2.2.Molecular Diagnostics
9.2.3.In-situ Hybridization
9.2.4.FISH
9.2.5.CISH
9.2.6.Real-Time PCR
9.2.7.Gene Sequencing
9.3.  End User Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.3.1.Hospitals
9.3.2.Diagnostic Centres
9.3.3.Others
9.4.  Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.4.1.United States of America (USA)
9.4.2.Canada
10.Europe Companion Diagnostics Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
10.1. Application Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.1.1.Breast Cancer
10.1.2.Colorectal Cancer
10.1.3.Lung Cancer
10.1.4.Urology
10.1.5.Melanoma
10.1.6.Gastric Cancer
10.1.7.Others
10.2.  Technology Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.2.1.Immunohistochemistry
10.2.2.Molecular Diagnostics
10.2.3.In-situ Hybridization
10.2.4.FISH
10.2.5.CISH
10.2.6.Real-Time PCR
10.2.7.Gene Sequencing
10.3.  End User Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.3.1.Hospitals
10.3.2.Diagnostic Centres
10.3.3.Others
10.4.  Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.4.1.Germany
10.4.2.France
10.4.3.Italy
10.4.4.United Kingdom (UK)
10.4.5.Spain
10.4.6.Rest of EU
11.Asia Pacific (APAC) Companion Diagnostics Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
11.1. Application Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.1.1.Breast Cancer
11.1.2.Colorectal Cancer
11.1.3.Lung Cancer
11.1.4.Urology
11.1.5.Melanoma
11.1.6.Gastric Cancer
11.1.7.Others
11.2.  Technology Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.2.1.Immunohistochemistry
11.2.2.Molecular Diagnostics
11.2.3.In-situ Hybridization
11.2.4.FISH
11.2.5.CISH
11.2.6.Real-Time PCR
11.2.7.Gene Sequencing
11.3.  End User Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.3.1.Hospitals
11.3.2.Diagnostic Centres
11.3.3.Others
11.4.  Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.4.1.China
11.4.2.India
11.4.3.Australia and New Zealand (ANZ)
11.4.4.Japan
11.4.5.Rest of APAC
12.Middle East and Africa (MEA) Companion Diagnostics Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
12.1. Application Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.1.1.Breast Cancer
12.1.2.Colorectal Cancer
12.1.3.Lung Cancer
12.1.4.Urology
12.1.5.Melanoma
12.1.6.Gastric Cancer
12.1.7.Others
12.2.  Technology Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.2.1.Immunohistochemistry
12.2.2.Molecular Diagnostics
12.2.3.In-situ Hybridization
12.2.4.FISH
12.2.5.CISH
12.2.6.Real-Time PCR
12.2.7.Gene Sequencing
12.3.  End User Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.3.1.Hospitals
12.3.2.Diagnostic Centres
12.3.3.Others
12.4.  Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.4.1.GCC Countries
12.4.2.South Africa
12.4.3.Rest of MEA
13.Latin America Companion Diagnostics Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million)
13.1. Application Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.1.1.Breast Cancer
13.1.2.Colorectal Cancer
13.1.3.Lung Cancer
13.1.4.Urology
13.1.5.Melanoma
13.1.6.Gastric Cancer
13.1.7.Others
13.2.  Technology Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.2.1.Immunohistochemistry
13.2.2.Molecular Diagnostics
13.2.3.In-situ Hybridization
13.2.4.FISH
13.2.5.CISH
13.2.6.Real-Time PCR
13.2.7.Gene Sequencing
13.3.  End User Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.3.1.Hospitals
13.3.2.Diagnostic Centres
13.3.3.Others
13.4.  Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.4.1.Brazil
13.4.2.Mexico
13.4.3.Rest of LA
14. Competition Landscape
14.1.  Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) 
14.2.1.Pfizer Inc., (U.S)
14.2.2.F. Hoffmann-La Roche Ltd.(Switzerland)
14.2.3.Qiagen Ltd. (Germany)
14.2.4.ARUP Laboratories (U.S.)
14.2.5.Abbott Laboratories (U.S.)
14.2.6.Biogenex Laboratories, Inc. (U.S.)
14.2.7.Thermo Fisher Scientific (U.S)
14.2.8.Ventana Medical Systems Inc. (U.S)
14.2.9.Myriad Genetics Inc. (U.S)
14.2.10.Danaher (U.S)
15. Research Methodology 
16. Appendix and Abbreviations 
  • Pfizer Inc., (U.S)
  • F. Hoffmann-La Roche Ltd.(Switzerland)
  • Qiagen Ltd. (Germany)
  • ARUP Laboratories (U.S.)
  • Abbott Laboratories (U.S.)
  • Biogenex Laboratories, Inc. (U.S.)
  • Thermo Fisher Scientific (U.S)
  • Ventana Medical Systems Inc. (U.S)
  • Myriad Genetics Inc. (U.S)
  • Danaher (U.S)

Adjacent Markets