Companion Diagnostics Market - Global Size, Share, Trend Analysis, Opportunity and Forecast Report, 2019–2029, Segmented By Product & Service (Assays, Kits & Reagents, Software & Services); By Technology (Polymerase Chain Reaction, Next-generation Sequenc

Companion Diagnostics Market - Global Size, Share, Trend Analysis, Opportunity and Forecast Report, 2019–2029, Segmented By Product & Service (Assays, Kits & Reagents, Software & Services); By Technology (Polymerase Chain Reaction, Next-generation Sequencing, In-Situ Hybridization, Immunohistochemistry); By Indication (Cancer, Neurological Disorders, Cardiovascular Diseases, Infectious Diseases); By End User (Pharmaceutical & Biopharmaceutical, Reference Laboratories, Contract Research Organizations); By Region (North America, Europe, Asia Pacific (APAC), Latin America, Middle East and Africa (MEA))

Global Companion Diagnostics Market Size More Than Doubles to Touch USD 13.6 billion by 2029

Global companion diagnostics market is flourishing because rising co-development of drug and diagnostic technology, surging incidences of adverse drug reactions, and increasing need for personalized treatment.

BlueWeave Consulting, a leading strategic consulting and market research firm, in its recent study, estimated global companion diagnostics market size at USD 6.12 billion in 2022. During the forecast period between 2023 and 2029, BlueWeave expects global companion diagnostics market size to grow at a significant CAGR of 12.15% reaching a value of USD 13.57 billion by 2029. Major growth factors of global companion diagnostics market include increasing requirement for personalized treatment, broad application areas of companion diagnostics, surging demand for focused therapy, growing cancer occurrences, and development of new biomarkers for various illnesses. Personalized medicine is becoming increasingly popular as the field of genetics and genetic engineering expands fast. It is now possible to provide the correct medicine to the right individual at the right time based on a person's genetic features. As part of a patient-centric drug development approach, many pharmaceutical and biopharmaceutical companies are developing targeted medication therapies. Numerous third-party companion diagnostic services provide similar services to enterprises that face a greater financial strain. As a result, the issue of high startup expenses has been effectively handled. These reasons are projected to drive the companion diagnostics market during the forecast period. However, increasing expense of drug development and associated clinical trials during the period in analysis.

Global Companion Diagnostics Market – Overview

A companion diagnostics device is a medical gadget that is used in conjunction with therapeutic medications to assess the effect and applicability of drugs on a specific human body. Companion diagnostics are developed in tandem with medications to select or exclude patient groups based on the features to which they respond to therapy. This device assists the healthcare provider in determining whether a specific treatment is beneficial to the patient. In 2020, Roche gained FDA approval for Cobas EGFR Mutation Test v2 companion diagnostic for EGFR tyrosine kinase inhibitor for lung cancer treatment. Companion Diagnostic (CDx) is a clinical test created in collaboration with a therapeutic medicine to identify responders and non-responders to that therapy. It is done to determine which patient groups may and cannot be treated with the relevant medicine. CDx assists practitioners in determining the benefits, side effects, and hazards connected with therapeutic drug intake, guaranteeing patient safety. Growing patient preferences for customized therapy, expanding applications of personalized medications, increased prevalence of chronic diseases, and rising occurrences of allergies in patients as a result of medication adverse effects all contribute to the development of customized CDx, propelling the global Companion Diagnostics Market forward. Furthermore, CDx tests' features, such as cost-effectiveness, high sensitivity, and rapid and precise results in short timeframes, aid in the expansion of the companion diagnostics market.

Impact of COVID-19 on Global Companion Diagnostics Market

COVID-19 had a detrimental impact on the companion diagnostics market. In addition, prominent market participants witnessed a considerable drop in income owing to a fall in testing volume and other variables. In terms of sales, the market grew by 15.1% in 2020, compared to 19.8% in 2019. Revenue generated by the major players decreased significantly in 2020. However, the lifting of lockdown restrictions, stay-at-home orders in many nations, the introduction of novel diagnostic tests, and the re-establishment of the supply chain network were major contributors in the recovery of testing in 2021. As a result, the restart of cancer diagnostics testing, and the introduction of novel diagnostic tests boosted demand in 2021.

Global Companion Diagnostics Market – By Indication

Based on indication, global companion diagnostics market is divided into Cancer, Neurological Disorders, Cardiovascular Diseases, and Infectious Diseases. In 2022, the cancer segment held the highest market share. Increased cancer prevalence, an increase in the number of cancer R&D activities, an increase in the number of unmet needs for cancer treatment, an increase in the number of FDA-approved companion diagnostics, and increased patient awareness about personalized medicine are some of the key factors driving the growth of the oncology segment. The cancer segment includes lung cancer, breast cancer, blood cancer, and colorectal cancer. Amongst them, lung cancer holds the highest market share. Companion diagnostic tests (CDXs) are regarded mandatory in the decision-making process for lung cancer treatment with targeted treatments. Individuals with lung cancer who undergo companion diagnostics as part of their initial treatment have a higher chance of surviving than those who do not. Globally, the increasing incidence rate of non-small cell lung cancer (NSCLC), combined with an increase in the development of oncology companion diagnostic tests for the disease, is likely to drive sector growth.

Competitive Landscape

Major players operating in global companion diagnostics market include Abbott Laboratories Inc., Agilent Technologies Inc., F. Hoffmann-La Roche Ltd, Biomerieux SA, Qiagen NV, Siemens Healthcare, Thermo Fisher Scientific Inc., Danaher Corporation (Beckman Coulter Inc.), Almac Group, Illumina Inc., Myriad Genetics Inc., Sysmex Corporation, Abnova Corporation, and Guardant Health Inc. To further enhance their market share, these companies employ various strategies, including mergers and acquisitions, partnerships, joint ventures, license agreements, and new product launches.

The in-depth analysis of the report provides information about growth potential, upcoming trends, and statistics of Global Companion Diagnostics Market. It also highlights the factors driving forecasts of total market size. The report promises to provide recent technology trends in Global Companion Diagnostics Market and industry insights to help decision-makers make sound strategic decisions. Furthermore, the report also analyzes the growth drivers, challenges, and competitive dynamics of the market.


1. Research Framework
1.1. Research Objective
1.2. Product Overview
1.3. Market Segmentation
2. Executive Summary
3. Global Companion Diagnostics Market Insights
3.1. Industry Value Chain Analysis
3.2. DROC Analysis
3.2.1. Growth Drivers
3.2.1.1. Increasing Cases of Adverse Drug Reactions
3.2.1.2. Co-development of Drug and Diagnostic Technology
3.2.2. Restraints
3.2.2.1. High Cost of Drug Development and Associated Clinical Trials
3.2.3. Opportunities
3.2.3.1. Rising Demand for Next Generation Sequencing
3.2.4. Challenges
3.2.4.1. Reimbursement Issues Among Many Countries
3.3. Technology Advancements/Recent Developments
3.4. Regulatory Framework
3.5. Porter’s Five Forces Analysis
3.5.1. Bargaining Power of Suppliers
3.5.2. Bargaining Power of Buyers
3.5.3. Threat of New Entrants
3.5.4. Threat of Substitutes
3.5.5. Intensity of Rivalry
4. Global Companion Diagnostics Market Overview
4.1. Market Size & Forecast, 2019–2029
4.1.1. By Value (USD Billion)
4.2. Market Share & Forecast
4.2.1. By Product & Service
4.2.1.1. Assays, Kits & Reagents
4.2.1.2. Software & Services
4.2.2. By Technology
4.2.2.1. Polymerase Chain Reaction
4.2.2.2. Next-generation Sequencing
4.2.2.3. In Situ Hybridization
4.2.2.4. Immunohistochemistry
4.2.2.5. Others
4.2.3. By Indication
4.2.3.1. Cancer
4.2.3.1.1. Lung Cancer
4.2.3.1.2. Breast Cancer
4.2.3.1.3. Blood Cancer
4.2.3.1.4. Colorectal Cancer
4.2.3.1.5. Others
4.2.3.2. Neurological Disorders
4.2.3.3. Cardiovascular Diseases
4.2.3.4. Infectious Diseases
4.2.3.5. Others
4.2.4. By End User
4.2.4.1. Pharmaceutical & Biopharmaceutical
4.2.4.2. Reference Laboratories
4.2.4.3. Contract Research Organizations
4.2.4.4. Others
4.2.5. By Region
4.2.5.1. North America
4.2.5.2. Europe
4.2.5.3. Asia Pacific (APAC)
4.2.5.4. Latin America (LATAM)
4.2.5.5. Middle East and Africa (MEA)
5. North America Companion Diagnostics Market
5.1. Market Size & Forecast, 2019–2029
5.1.1. By Value (USD Billion)
5.2. Market Share & Forecast
5.2.1. By Product & Service
5.2.2. By Technology
5.2.3. By Indication
5.2.4. By End User
5.2.5. By Country
5.2.5.1. US
5.2.5.1.1. By Product & Service
5.2.5.1.2. By Technology
5.2.5.1.3. By Indication
5.2.5.1.4. By End User
5.2.5.2. Canada
5.2.5.2.1. By Product & Service
5.2.5.2.2. By Technology
5.2.5.2.3. By Indication
5.2.5.2.4. By End User
6. Europe Companion Diagnostics Market
6.1. Market Size & Forecast, 2019–2029
6.1.1. By Value (USD Billion)
6.2. Market Share & Forecast
6.2.1. By Product & Service
6.2.2. By Technology
6.2.3. By Indication
6.2.4. By End User
6.2.5. By Country
6.2.5.1. Germany
6.2.5.1.1. By Product & Service
6.2.5.1.2. By Technology
6.2.5.1.3. By Indication
6.2.5.1.4. By End User
6.2.5.2. UK
6.2.5.2.1. By Product & Service
6.2.5.2.2. By Technology
6.2.5.2.3. By Indication
6.2.5.2.4. By End User
6.2.5.3. Italy
6.2.5.3.1. By Product & Service
6.2.5.3.2. By Technology
6.2.5.3.3. By Indication
6.2.5.3.4. By End User
6.2.5.4. France
6.2.5.4.1. By Product & Service
6.2.5.4.2. By Technology
6.2.5.4.3. By Indication
6.2.5.4.4. By End User
6.2.5.5. Spain
6.2.5.5.1. By Product & Service
6.2.5.5.2. By Technology
6.2.5.5.3. By Indication
6.2.5.5.4. By End User
6.2.5.6. The Netherlands
6.2.5.6.1. By Product & Service
6.2.5.6.2. By Technology
6.2.5.6.3. By Indication
6.2.5.6.4. By End User
6.2.5.7. Rest of Europe
6.2.5.7.1. By Product & Service
6.2.5.7.2. By Technology
6.2.5.7.3. By Indication
6.2.5.7.4. By End User
7. Asia-Pacific Companion Diagnostics Market
7.1. Market Size & Forecast, 2019–2029
7.1.1. By Value (USD Billion)
7.2. Market Share & Forecast
7.2.1. By Product & Service
7.2.2. By Technology
7.2.3. By Indication
7.2.4. By End User
7.2.5. By Country
7.2.5.1. China
7.2.5.1.1. By Product & Service
7.2.5.1.2. By Technology
7.2.5.1.3. By Indication
7.2.5.1.4. By End User
7.2.5.2. India
7.2.5.2.1. By Product & Service
7.2.5.2.2. By Technology
7.2.5.2.3. By Indication
7.2.5.2.4. By End User
7.2.5.3. Japan
7.2.5.3.1. By Product & Service
7.2.5.3.2. By Technology
7.2.5.3.3. By Indication
7.2.5.3.4. By End User
7.2.5.4. South Korea
7.2.5.4.1. By Product & Service
7.2.5.4.2. By Technology
7.2.5.4.3. By Indication
7.2.5.4.4. By End User
7.2.5.5. Australia & New Zealand
7.2.5.5.1. By Product & Service
7.2.5.5.2. By Technology
7.2.5.5.3. By Indication
7.2.5.5.4. By End User
7.2.5.6. Indonesia
7.2.5.6.1. By Product & Service
7.2.5.6.2. By Technology
7.2.5.6.3. By Indication
7.2.5.6.4. By End User
7.2.5.7. Malaysia
7.2.5.7.1. By Product & Service
7.2.5.7.2. By Technology
7.2.5.7.3. By Indication
7.2.5.7.4. By End User
7.2.5.8. Singapore
7.2.5.8.1. By Product & Service
7.2.5.8.2. By Technology
7.2.5.8.3. By Indication
7.2.5.8.4. By End User
7.2.5.9. Philippines
7.2.5.9.1. By Product & Service
7.2.5.9.2. By Technology
7.2.5.9.3. By Indication
7.2.5.9.4. By End User
7.2.5.10. Vietnam
7.2.5.10.1. By Product & Service
7.2.5.10.2. By Technology
7.2.5.10.3. By Indication
7.2.5.10.4. By End User
7.2.5.11. Rest of APAC
7.2.5.11.1. By Product & Service
7.2.5.11.2. By Technology
7.2.5.11.3. By Indication
7.2.5.11.4. By End User
8. Latin America Companion Diagnostics Market
8.1. Market Size & Forecast, 2019–2029
8.1.1. By Value (USD Billion)
8.2. Market Share & Forecast
8.2.1. By Product & Service
8.2.2. By Technology
8.2.3. By Indication
8.2.4. By End User
8.2.5. By Country
8.2.5.1. Brazil
8.2.5.1.1. By Product & Service
8.2.5.1.2. By Technology
8.2.5.1.3. By Indication
8.2.5.1.4. By End User
8.2.5.2. Mexico
8.2.5.2.1. By Product & Service
8.2.5.2.2. By Technology
8.2.5.2.3. By Indication
8.2.5.2.4. By End User
8.2.5.3. Argentina
8.2.5.3.1. By Product & Service
8.2.5.3.2. By Technology
8.2.5.3.3. By Indication
8.2.5.3.4. By End User
8.2.5.4. Peru
8.2.5.4.1. By Product & Service
8.2.5.4.2. By Technology
8.2.5.4.3. By Indication
8.2.5.4.4. By End User
8.2.5.5. Rest of LATAM
8.2.5.5.1. By Product & Service
8.2.5.5.2. By Technology
8.2.5.5.3. By Indication
8.2.5.5.4. By End User
9. Middle East & Africa Companion Diagnostics Market
9.1. Market Size & Forecast, 2019–2029
9.1.1. By Value (USD Billion)
9.2. Market Share & Forecast
9.2.1. By Product & Service
9.2.2. By Technology
9.2.3. By Indication
9.2.4. By End User
9.2.5. By Country
9.2.5.1. Saudi Arabia
9.2.5.1.1. By Product & Service
9.2.5.1.2. By Technology
9.2.5.1.3. By Indication
9.2.5.1.4. By End User
9.2.5.2. UAE
9.2.5.2.1. By Product & Service
9.2.5.2.2. By Technology
9.2.5.2.3. By Indication
9.2.5.2.4. By End User
9.2.5.3. Qatar
9.2.5.3.1. By Product & Service
9.2.5.3.2. By Technology
9.2.5.3.3. By Indication
9.2.5.3.4. By End User
9.2.5.4. Kuwait
9.2.5.4.1. By Product & Service
9.2.5.4.2. By Technology
9.2.5.4.3. By Indication
9.2.5.4.4. By End User
9.2.5.5. South Africa
9.2.5.5.1. By Product & Service
9.2.5.5.2. By Technology
9.2.5.5.3. By Indication
9.2.5.5.4. By End User
9.2.5.6. Nigeria
9.2.5.6.1. By Product & Service
9.2.5.6.2. By Technology
9.2.5.6.3. By Indication
9.2.5.6.4. By End User
9.2.5.7. Algeria
9.2.5.7.1. By Product & Service
9.2.5.7.2. By Technology
9.2.5.7.3. By Indication
9.2.5.7.4. By End User
9.2.5.8. Rest of MEA
9.2.5.8.1. By Product & Service
9.2.5.8.2. By Technology
9.2.5.8.3. By Indication
9.2.5.8.4. By End User
10. Competitive Landscape
10.1. List of Key Players and Their Offerings
10.2. Global Companion Diagnostics Company Market Share Analysis, 2022
10.3. Competitive Benchmarking, By Operating Parameters
10.4. Key Strategic Developments (Mergers, Acquisitions, Partnerships, etc.)
11. Impact of Covid-19 on Global Companion Diagnostics Market
12. Company Profile (Company Overview, Financial Matrix, Competitive Landscape, Key Personnel, Key Competitors, Contact Address, Strategic Outlook, SWOT Analysis)
12.1. Abbott Laboratories Inc.
12.2. Agilent Technologies Inc.
12.3. F. Hoffmann-La Roche Ltd
12.4. Biomerieux SA
12.5. Qiagen NV
12.6. Siemens Healthcare
12.7. Thermo Fisher Scientific Inc.
12.8. Danaher Corporation (Beckman Coulter Inc.)
12.9. Almac Group
12.10. Illumina Inc.
12.11. Myriad Genetics Inc.
12.12. Sysmex Corporation
12.13. Abnova Corporation
12.14. Guardant Health Inc
12.15. Other Prominent Players
13. Key Strategic Recommendations
14. Research Methodology
14.1. Qualitative Research
14.1.1. Primary & Secondary Research
14.2. Quantitative Research
14.3. Market Breakdown & Data Triangulation
14.3.1. Secondary Research
14.3.2. Primary Research
14.4. Breakdown of Primary Research Respondents, By Region
14.5. Assumptions & Limitations

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook
Cookie Settings