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Companion Diagnostics Market

Companion Diagnostics Market Size, Share, Trends, Growth: By Product: Assays, Kits & Reagents, Software & Services; By Technology: Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Others; By Indication: Lung Cancer, Breast Cancer, Others; By End User; Regional Analysis; Supplier Landscape; 2024-2032

Global Companion Diagnostics Market Size

The global companion diagnostics market was valued at USD 7.45 billion in 2023, driven by increasing incidence of cancer and chronic diseases across the globe. The market is expected to grow at a CAGR of 12.0% during the forecast period of 2024-2032, with the values likely to reach USD 20.26 billion by 2032.

 

Global Companion Diagnostics Market Outlook

  • The demand for companion diagnostics is on the rise, to combat the burden of cancer and other chronic diseases. Approximately 1 in 5  people develop cancer in their lifetime.
  • One of the major market trends includes rising collaborations between key companies to provide improved diagnostics procedures for patients.
  • The North America region is likely to experience notable growth in the forecast period. Increased healthcare infrastructure spending and the strong regulatory support is boosting its market value.

 

Companion Diagnostics Market

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Global Companion Diagnostics Market Overview

Companion diagnostics are in vitro medical devices used to determine if a particular treatment is suitable for a specific patient. This diagnostic method is fundamental in personalized treatment. It aims to improve the efficacy of a treatment regimen and minimize side effects and is mostly used in oncology where targeted therapies can be used to battle cancer. According to the American  Cancer Society, the number of cancer cases based on the projected population growth are predicted to increase to 35 million by 2050. The market growth is further driven by adoption of personalized treatment, and technological advancements like next-generation sequencing among others.

 

Global Companion Diagnostics Market Growth Drivers

Increasing Prevalence of Cancer Cases to Affect the Market Landscape Significantly

 

With rising incidence of cancer, the market has been expressing an influx of new and innovative products to provide enhanced patient outcomes. In October  2023, QIAGEN and Myriad Genetics partnered to develop advanced companion diagnostics for cancer. The collaboration focused on developing advance diagnostic tests so that cancer treatments can be patient specific. The initial projects under this partnership were expected to utilize next-generation sequencing and QIAGEN’s digital PCR platform, QIAcuity, to develop assays for various cancer types.

 

Growth in Strategic Partnerships and Mergers to Meet Rising Companion Diagnostics Market Demand

 

In February 2024, Roche  entered into a collaboration agreement with PathAI to expand its digital pathology capabilities specifically for companion diagnostics. This partnership with PathAI aimed on developing artificial intelligence (AI)-enabled digital pathology algorithms with Roche Tissue Diagnostics (RTD). The use of the algorithm would be aimed at advancing the filed of pathology and boosting precision in diagnostics leading to clinical care and drug development.

 

In January 2024, Agilent  Technologies Inc., collaborated with Incyte to develop companion diagnostics in oncology and hematology. The collaboration is intended to utilize Agilent’s capabilities in developing and marketing in-vitro diagnostic assays alongside Incyte’s growing portfolio of therapeutic products.

 

Global Companion Diagnostics Market Trends

The market is witnessing several trends and developments to improve the current global scenario. Some of the notable trends are as follows:

 

Key Trends Impact
Expanding Indications Started from oncology, companion diagnostics is utilized in other therapeutic areas like infectious diseases, inflammatory conditions, and cardiovascular diseases. The widespread use is acknowledged by the fact that it can enhance outcomes across several fields and provide tailored treatment based on specific patient profiles.
Focus On Precision Medicine Precision medicine includes tailoring medical treatments to the requirements of individual patients, generally based on biomolecular, genetic, or clinical data. This optimizes clinical outcomes and companion diagnostics are vital medical devices offering information about patient’s condition or expected response to a treatment.
Rising healthcare Expenditures Increasing healthcare investments aimed at improving the healthcare infrastructure is one the major market trends. Healthcare providers and payers are willing to adapt advanced diagnostic technologies that can improve patient outcomes and reduce overall healthcare costs.
Advancements in Technologies Robust advancement in technologies is crucial for improving the precision and duration of tests to identify molecular and genetic marker. Technology like next-generation sequencing (NGS), allows deeper analysis of DNA with high sensitivity in detecting genomic variations. Polymerase chain reaction (PCR) amplifies tiny strands of DNA which can be analyzed effectively and hence provide precision in examination. This improves diagnostic accuracy leading to better alternatives for patients.

 

Global Companion Diagnostics Market Segmentation

Market Breakup by Product

  • Assays
  • Kits & Reagents
  • Software & Services

 

Market Breakup by Technology

  • Next-Generation Sequencing
  • In Situ Hybridization
  • Immunohistochemistry
  • Others

 

Market Breakup by Indication

  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Others

 

Market Breakup by End User

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

 

Market Breakup by Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

 

Companion Diagnostics Market By Segments

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Global Companion Diagnostics Market Share

Market Segmentation Based on Product is Anticipated to Grow Significantly

 

Based on product, the market segmentation includes assays, kits and reagents, along with software and services. Assays are used in the identification of therapeutic targets like biomarkers or genetic profiles in patients to provide effective treatment plan, particularly in oncology. They act a core component, driving precision in treatments and hence contributes to the companion diagnostics market value. For the continuity of diagnostics, kits and reagents facilitates these assays by supplying the essential tools and consumables.

 

Fastest growth is projected in the software and services segment, attributed to its function in interpretation and integration of data into healthcare systems. With rise in personalized treatments, demand for software solution to manage complex diagnostic data is on the rise, leading to the increase in companion diagnostics market value.

 

Lung Cancer is Expected to Hold a Significant the Market Share

The segments by indication include lung cancer, breast cancer, colorectal cancer, and others. According to the World  Cancer Research Fund International, worldwide lung cancer is the second most common type of cancer. Due to the high incidence and the crucial need for targeted therapies, lung cancer is projected to lead the market, propelling the demand for companion diagnostics to identify targeted treatments relied on genetic markers.

 

With advancements and better insights of genetic mutations in the BRCA1 and BRCA2 markers, breast cancer diagnostics is also reflecting significant growth. Exploration and development of biomarkers and therapies for melanoma are on the rise. The diversity in cancer and the genomic precision are driving the market value.

 

Companion Diagnostics Market By Region

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Global Companion Diagnostics Market Analysis by Region

Regionally, the market report offers an insight into North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America leads the market followed by Europe, robust healthcare infrastructure with high spending and strong regulatory support with government initiatives promoting targeted therapies along with research conducted in oncology diagnostics, propels the regional market share.

 

Asia Pacific is anticipated to experience considerable growth, which can be attributed to the increase in healthcare expenditure, awareness regarding personalized treatment options, and the swift development of healthcare infrastructure in emerging economies like India, Japan, South Korea and China.

 

Leading Players in the Global Companion Diagnostics Market

The key features of the market report include patent analysis, grants analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

 

  • F. Hoffmann-La Roche Ltd
  • Agilent Technologies, Inc.
  • QIAGEN
  • Thermo Fisher Scientific Inc.
  • Almac Group
  • Resonance Health Ltd
  • Illumina, Inc.
  • BIOMÉRIEUX
  • Myriad Genetics, Inc.
  • Siemens Healthcare Private Limited
  • Abbott
  • Exact Sciences Corporation
  • Guardant Health
  • ASURAGEN, INC.

 

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2017-2023
Forecast Period 2024-2032
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Product
  • Technology
  • Indication
  • End User
  • Region
Breakup by Product
  • Assays
  • Kits & Reagents
  • Software & Services
Breakup by Technology
  • Next-Generation Sequencing
  • In Situ Hybridization
  • Immunohistochemistry
  • Others
Breakup by Indication
  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Others
Breakup by End User
  • Pharmaceutical & Biopharmaceutical Companies
  • Reference Laboratories
  • Contract Research Organizations
  • Others
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered F. Hoffmann-La Roche Ltd
Agilent Technologies, Inc.
QIAGEN
Thermo Fisher Scientific Inc.
Almac Group
Resonance Health Ltd
Illumina, Inc.
BIOMÉRIEUX
Myriad Genetics, Inc.
Siemens Healthcare Private Limited
Abbott
Exact Sciences Corporation
Guardant Health
ASURAGEN, INC.

 

Key Questions Answered in the Global Companion Diagnostics Market Report

  • What was the global companion diagnostics market value in 2023?

  • What is the global companion diagnostics market forecast outlook for 2024-2032?
  • What are the regional markets covered in the EMR report?
  • What is market segmentation based on product?
  • What is the market breakup based on indication?
  • Who are the major end users in the market?
  • What type of technologies are present in the market?
  • What are the major factors aiding the global companion diagnostics market demand? 
  • How has the companion diagnostics market performed so far and how is it anticipated to perform in the coming years?
  • What are the market's major drivers, opportunities, and restraints? 
  • Which regional market is expected to lead the market share in the forecast period? 
  • Which country is expected to witness expedited growth during the forecast period? 
  • How does the prevalence and incidence of cancer affect the market landscape?
  • What are the major global companion diagnostics market trends?
  • What product will dominate the market share? 
  • Which technology type will experience the highest demand in the market segment?
  • Who are the key players involved in the companion diagnostics market?
  • What is patent landscape of the market?
  • What are the current unmet needs and challenges in the market?
  • How are partnerships, collaborations, mergers and acquisitions among the key market players shaping the market dynamics?

 

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1    Preface
    1.1    Objectives of the Study
    1.2    Key Assumptions
    1.3    Report Coverage – Key Segmentation and Scope 
    1.4    Research Methodology                  
2    Executive Summary
3     Global Companion Diagnostics Market Overview 

    3.1     Global Companion Diagnostics Market Historical Value (2017-2023) 
    3.2     Global Companion Diagnostics Market Forecast Value (2024-2032)
4     Global Companion Diagnostics Market Landscape*
    4.1     Global Companion Diagnostics Market: Developers Landscape
        4.1.1    Analysis by Year of Establishment
        4.1.2    Analysis by Company Size
        4.1.3    Analysis by Region
    4.2     Global Companion Diagnostics Market: Product Landscape
        4.2.1    Analysis by Product
        4.2.2    Analysis by Technology
        4.2.3    Analysis by Indication
        4.2.4    Analysis by End Users
5    Global Companion Diagnostics Market Dynamics
    5.1    Market Drivers and Constraints
    5.2    SWOT Analysis
        5.2.1    Strengths
        5.2.2    Weaknesses
        5.2.3    Opportunities
        5.2.4    Threats
    5.3    Porter’s Five Forces Model
        5.3.1    Bargaining Power of Suppliers
        5.3.2    Bargaining Power of Buyers
        5.3.3    Threat of New Entrants
        5.3.4    Threat of Substitutes
        5.3.5    Degree of Rivalry
    5.4    Key Demand Indicators 
    5.5    Key Price Indicators
    5.6    Industry Events, Initiatives, and Trends  
    5.7    Value Chain Analysis
6     Global Companion  Diagnostics Market Segmentation (2017-2032)
    6.1     Global Companion Diagnostics Market (2017-2032) by Product
        6.1.1    Market Overview
        6.1.2    Assays
        6.1.3    Kits & Reagents
        6.1.4    Software & Services
    6.2    Global Companion Diagnostics Market (2017-2032) by Technology
        6.2.1    Market Overview  
        6.2.2    Next-Generation Sequencing
        6.2.3    In Situ Hybridization
        6.2.4    Immunohistochemistry
        6.2.5    Others
    6.3    Global Companion Diagnostics Market (2017-2032) by Indication
        6.3.1    Market Overview  
        6.3.2    Lung Cancer
        6.3.3    Breast Cancer
        6.3.4    Colorectal Cancer
        6.3.5    Others
    6.4    Global Companion Diagnostics Market (2017-2032) by End User
        6.4.1    Market Overview  
        6.4.2    Pharmaceutical & Biopharmaceutical Companies
        6.4.3    Reference Laboratories
        6.4.4    Contract Research Organizations
        6.4.5    Others
    6.5    Global Companion Diagnostics Market (2017-2032) by Region
        6.5.1    Market Overview
        6.5.2    North America
        6.5.3    Europe 
        6.5.4    Asia Pacific
        6.5.5    Latin America
        6.5.6    Middle East and Africa
7    North America Companion Diagnostics Market (2017-2032)
    7.1     North America Companion Diagnostics Market (2017-2032) by Product 
        7.1.1    Market Overview
        7.1.2    Assays
        7.1.3    Kits & Reagents
        7.1.4    Software & Services
    7.2    North America Companion Diagnostics Market (2017-2032) by Technology
        7.2.1    Market Overview  
        7.2.2    Next-Generation Sequencing
        7.2.3    In Situ Hybridization
        7.2.4    Immunohistochemistry
        7.2.5    Others
    7.3    North America Companion Diagnostics Market (2017-2032) by Country
        7.3.1    Market Overview  
        7.3.2    United States of America
        7.3.3    Canada
8    Europe Companion Diagnostics Market (2017-2032)
    8.1     Europe Companion Diagnostics Market (2017-2032) by Product
        8.1.1    Market Overview
        8.1.2    Assays
        8.1.3    Kits & Reagents
        8.1.4    Software & Services
    8.2    Europe Companion Diagnostics Market (2017-2032) by Technology
        8.2.1    Market Overview  
        8.2.2    Next-Generation Sequencing
        8.2.3    In Situ Hybridization
        8.2.4    Immunohistochemistry
        8.2.5    Others
    8.3    Europe Companion Diagnostics Market (2017-2032) by Country
        8.3.1    Market Overview  
        8.3.2    United Kingdom
        8.3.3    Germany
        8.3.4    France
        8.3.5    Italy
        8.3.6    Others
9    Asia Pacific Companion Diagnostics Market (2017-2032)
    9.1    Asia Pacific Companion Diagnostics Market (2017-2032) by Product 
        9.1.1    Market Overview
        9.1.2    Assays
        9.1.3    Kits & Reagents
        9.1.4    Software & Services
    9.2    Asia Pacific Companion Diagnostics Market (2017-2032) by Technology
        9.2.1    Market Overview  
        9.2.2    Next-Generation Sequencing
        9.2.3    In Situ Hybridization
        9.2.4    Immunohistochemistry
        9.2.5    Others
    9.3    Asia Pacific Companion Diagnostics Market (2017-2032) by Country
        9.3.1    Market Overview  
        9.3.2    China
        9.3.3    Japan
        9.3.4    India
        9.3.5    ASEAN
        9.3.6    Australia
        9.3.7    Others
10    Latin America Companion Diagnostics Market (2017-2032)
    10.1       Latin America Companion Diagnostics Market (2017-2032) by Product 
        10.1.1    Market Overview
        10.1.2    Assays
        10.1.3    Kits & Reagents
        10.1.4    Software & Services
    10.2    Latin America Companion Diagnostics Market (2017-2032) by Technology
        10.2.1    Market Overview  
        10.2.2    Next-Generation Sequencing
        10.2.3    In Situ Hybridization
        10.2.4    Immunohistochemistry
        10.2.5    Others
    10.3    Latin America Companion Diagnostics Market (2017-2032) by Country
        10.3.1    Market Overview  
        10.3.2    Brazil
        10.3.3    Argentina
        10.3.4    Mexico
        10.3.5    Others
11    Middle East and Africa Companion Diagnostics Market (2017-2032)
    11.1      Middle East and Africa Companion Diagnostics Market (2017-2032) by Product 
        11.1.1    Market Overview
        11.1.2    Assays
        11.1.3    Kits & Reagents
        11.1.4    Software & Services
    11.2    Middle East and Africa Companion Diagnostics Market (2017-2032) by Technology
        11.2.1    Next-Generation Sequencing
        11.2.2    In Situ Hybridization
        11.2.3    Immunohistochemistry
        11.2.4    Others
    11.3    Middle East and Africa Companion Diagnostics Market (2017-2032) by Country
        11.3.1    Market Overview  
        11.3.2    Saudi Arabia
        11.3.3    United Arab Emirates
        11.3.4    Nigeria
        11.3.5    South Africa
        11.3.6    Others
12    Regulatory Framework
    12.1     Regulatory Overview
        12.1.1    US FDA
        12.1.2    EU EMA
        12.1.3    INDIA CDSCO
        12.1.4    JAPAN PMDA
        12.1.5    Others
13    Patent  Analysis
    13.1     Analysis by Component of Patent
    13.2     Analysis by Publication year
    13.3     Analysis by Issuing Authority
    13.4     Analysis by Patent Age
    13.5     Analysis by CPC Analysis
    13.6     Analysis by Patent Valuation 
    13.7     Analysis by Key Players
14    Grants  Analysis
    14.1     Analysis by Year
    14.2     Analysis by Amount Awarded
    14.3     Analysis by Issuing Authority
    14.4     Analysis by Grant Product
    14.5     Analysis by Funding Institute
    14.6     Analysis by Departments
    14.7     Analysis by Recipient Organization 
15    Funding and Investment Analysis
    15.1     Analysis by Funding Instances
    15.2     Analysis by Component of Funding
    15.3     Analysis by Funding Amount
    15.4     Analysis by Leading Players
    15.5     Analysis by Leading Investors
    15.6     Analysis by Geography
16    Partnership and Collaborations Analysis
    16.1     Analysis by Partnership Instances
    16.2     Analysis by Component of Partnership
    16.3     Analysis by Leading Players
    16.4     Analysis by Geography
17    Supplier Landscape
    17.1    Market Share by Top 5 Companies
    17.2    F. Hoffmann-La Roche Ltd
        17.2.1    Financial Analysis
        17.2.2    Product Portfolio
        17.2.3    Demographic Reach and Achievements
        17.2.4    Mergers and Acquisitions
        17.2.5    Certifications 
    17.3    Agilent Technologies, Inc.
        17.3.1    Financial Analysis
        17.3.2    Product Portfolio
        17.3.3    Demographic Reach and Achievements
        17.3.4    Mergers and Acquisitions
        17.3.5    Certifications
    17.4     QIAGEN
        17.4.1    Financial Analysis
        17.4.2    Product Portfolio
        17.4.3    Demographic Reach and Achievements
        17.4.4    Mergers and Acquisitions
        17.4.5    Certifications
    17.5    Thermo Fisher Scientific Inc.
        17.5.1    Financial Analysis
        17.5.2    Product Portfolio
        17.5.3    Demographic Reach and Achievements
        17.5.4    Mergers and Acquisitions
        17.5.5    Certifications
    17.6    Almac Group
        17.6.1    Financial Analysis
        17.6.2    Product Portfolio
        17.6.3    Demographic Reach and Achievements
        17.6.4    Mergers and Acquisitions
        17.6.5    Certifications
    17.7    Resonance Health Ltd
        17.7.1    Financial Analysis
        17.7.2    Product Portfolio
        17.7.3    Demographic Reach and Achievements
        17.7.4    Mergers and Acquisitions
        17.7.5    Certifications
    17.8    Illumina, Inc.
        17.8.1    Financial Analysis
        17.8.2    Product Portfolio
        17.8.3    Demographic Reach and Achievements
        17.8.4    Mergers and Acquisitions
        17.8.5    Certifications
    17.9    BIOMÉRIEUX
        17.9.1    Financial Analysis
        17.9.2    Product Portfolio
        17.9.3    Demographic Reach and Achievements
        17.9.4    Mergers and Acquisitions
        17.9.5    Certifications
    17.10    Myriad Genetics, Inc.
        17.10.1    Financial Analysis
        17.10.2    Product Portfolio
        17.10.3    Demographic Reach and Achievements
        17.10.4    Mergers and Acquisitions
        17.10.5    Certifications
    17.11    Siemens Healthcare Private Limited
        17.11.1    Financial Analysis
        17.11.2    Product Portfolio
        17.11.3    Demographic Reach and Achievements
        17.11.4    Mergers and Acquisitions
        17.11.5    Certifications 
    17.12    Abbott
        17.12.1    Financial Analysis
        17.12.2    Product Portfolio
        17.12.3    Demographic Reach and Achievements
        17.12.4    Mergers and Acquisitions
        17.12.5    Certifications                     
    17.13    Exact Sciences Corporation
        17.13.1    Financial Analysis
        17.13.2    Product Portfolio
        17.13.3    Demographic Reach and Achievements
        17.13.4    Mergers and Acquisitions
        17.13.5    Certifications                 
    17.14    Guardant Health
        17.14.1    Financial Analysis
        17.14.2    Product Portfolio
        17.14.3    Demographic Reach and Achievements
        17.14.4    Mergers and Acquisitions
        17.14.5    Certifications
    17.15    ASURAGEN, INC.
        17.15.1    Financial Analysis
        17.15.2    Product Portfolio
        17.15.3    Demographic Reach and Achievements
        17.15.4    Mergers and Acquisitions
        17.15.5    Certifications                      
18    Global Companion Diagnostics Market – Distribution Model (Additional Insight)
    18.1     Overview 
    18.2     Potential Distributors 
    18.3     Key Parameters for Distribution Partner Assessment 
19    Key Opinion Leaders (KOL) Insights (Additional Insight)
20    Company Competitiveness Analysis (Additional Insight)

    20.1     Very Small Companies
    20.2     Small Companies
    20.3     Mid-Sized Companies
    20.4     Large Companies
    20.5     Very Large Companies
21    Payment Methods (Additional Insight)
    21.1     Government Funded
    21.2     Private Insurance
    21.3     Out-of-Pocket

 

*Additional insights provided are customisable as per client requirements.

 

* The coverage of the Market Landscape section depends on the data availability and may cover a minimum of 80% of the total market. The EMR team strives to make this section as comprehensive as possible.

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