Companion Diagnostic Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product and Services, By Technology, By Disease Indication, By Application, By End User, By Region and Competition, 2020-2030F

Description

Global Companion Diagnostic Market was valued at USD 6.17 Billion in 2024 and is expected to reach USD 12.14 Billion by 2030 with a CAGR of 11.94% during the forecast period. Companion diagnostics are medical devices used in conjunction with therapeutic drugs to assess the impact and suitability of drugs for specific individuals. These diagnostics are developed alongside drugs to identify patient groups that respond to or are not suitable for the therapy based on their characteristics. Healthcare professionals utilize this device to evaluate the effectiveness of a particular treatment for a patient. In 2020, Roche obtained FDA approval for the Cobas EGFR Mutation Test v2 companion diagnostic, which assists in determining the appropriate use of EGFR tyrosine kinase inhibitors for lung cancer treatment. Companion Diagnostic (CDx) is a clinical test co-developed with a therapeutic drug to identify patients who will respond or not respond to the drug. It enables the identification of patient groups that can or cannot be treated with the corresponding drug. CDx helps practitioners evaluate the benefits, side effects, and associated risks of therapeutic drugs, ensuring patient safety.

Market Overview
Forecast Period	2026-2030
Market Size 2024	USD 6.17 Billion
Market Size 2030	USD 12.14 Billion
CAGR 2025-2030	11.94%
Fastest Growing Segment	Oncology
Largest Market	North America

The global Companion Diagnostics Market is driven by factors such as increasing patient demand for tailored therapy, expanded applications of personalized medications, higher prevalence of chronic diseases, and growing incidence of medication-related allergies. These factors contribute to the development of customized CDx, promoting market growth. Additionally, CDx tests offer advantages such as cost-effectiveness, high sensitivity, and rapid and accurate results within shorter time frames, further fueling the growth of the Companion Diagnostics Market.

Key Market Drivers

Increasing Demand for NGS-Based Technology

The growing demand for next-generation sequencing (NGS) technology, with its exceptional capability to identify rare variants, plays a critical role in the continued success and wider distribution of companion diagnostics solutions in the companion diagnostics market. By utilizing NGS panels, a single test has the potential to aid in the treatment of numerous types of cancers, offering a more comprehensive approach to personalized medicine.

For instance, in July 2022, Almac Diagnostic forged a strategic partnership with AstraZeneca, a leading pharmaceutical company, to collaboratively develop and commercialize multiple companion diagnostic (CDx) products. These innovative CDx solutions will be based on cutting-edge NGS (next-generation sequencing) and qPCR-based (quantitative polymerase chain reaction) technologies, further advancing the field of precision medicine and enhancing patient care. Through this collaboration, Almac Diagnostic and AstraZeneca aim to improve the accuracy and effectiveness of diagnostics, enabling targeted therapies and personalized treatment plans for patients. This partnership demonstrates the commitment of both companies to drive innovation in the field of companion diagnostics and contribute to the advancement of precision medicine.

By leveraging the power of NGS and qPCR technologies, Almac Diagnostic and AstraZeneca envision a future where companion diagnostics play a pivotal role in guiding treatment decisions and improving patient outcomes across various therapeutic areas. This collaboration represents a significant step forward in the development of advanced diagnostic solutions that will revolutionize the way diseases are diagnosed and treated. With the combination of cutting-edge technologies and strategic partnerships, the field of precision medicine is poised to make significant strides in improving patient care and transforming healthcare on a global scale.

Key Market Challenges

Lack of Awareness and High Cost of Companion Diagnostics Techniques

While immunotherapy has shown significant promise in the treatment of cancer, its high cost has limited widespread patient access. As a result, physicians may opt to combine treatments, which can extend the duration of treatment from five months to over three years. With longer treatment duration comes a greater financial burden, as the cost of personalized immunotherapies is also substantial. In fact, the cost of cancer immunotherapies can far exceed that of other treatment options such as chemotherapy or radiation therapy. Consequently, the high cost of immuno-oncology treatments is believed to impede the growth of the companion diagnostics market. This financial barrier highlights the need for continued research and innovation to develop more affordable and accessible immunotherapies for cancer patients.

Key Market Trends

Growing Importance of Promotional Activities

The increasing significance of promotional activities represents a key trend in the companion diagnostics market. Companion diagnostics, due to their specificity in being applicable only to particular drugs, are not as extensively marketed as other available test kits and devices in the market. Therefore, it is crucial to give greater attention to improving the distribution network and enhancing the availability of products to end users. In terms of advertising sources, internet channels and search engines are among the most vital, considering their higher visibility and the limited return on investment and visibility of other media.

Furthermore, besides boosting sales, emphasis is placed on product functionality, accuracy, and vendors' after-sales services, while marketing communication takes a back seat. Limited promotion activities pose challenges in reaching the target market and understanding a company's competitive position. To attract customers to a company website, the publication of multiple blogs and newsletters can be beneficial. This approach allows businesses to sustain their marketing campaigns over an extended period and attract repeat visitors. As the market continues to witness product enhancements, vendors are increasingly recognizing the importance of promotional activities, and this trend is expected to gain momentum, thereby supporting the growth of the global companion diagnostics market throughout the forecast period.

Key Market Players

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.)
Myriad Genetics Inc.
Illumina Inc.

Report Scope:

In this report, the Global Companion Diagnostic Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Companion Diagnostic Market, By Product and Services:

Kits and Reagents
Assays
Software
Services

Companion Diagnostic Market, By Technology:

PCR
NGS
In-Situ Hybridization
Immunohistochemistry
Others

Companion Diagnostic Market, By Disease Indication:

Oncology
Neurology
Cardiology
Infectious Diseases
Others

Companion Diagnostic Market, By Application:

In-Vitro Diagnostics
Drug Discovery
Others

Companion Diagnostic Market, By End User:

Pharmaceutical & Biotechnology Companies
Research Laboratories
Contract Research Organization Others

Companion Diagnostic Market, By Region:

North America
- United States
- Canada
- Mexico
Europe
- France
- United Kingdom
- Italy
- Germany
- Spain
Asia-Pacific
- China
- India
- Japan
- Australia
- South Korea
South America
- Brazil
- Argentina
- Colombia
Middle East & Africa
- South Africa
- Saudi Arabia
- UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Companion Diagnostic Market.

Available Customizations:

Global Companion Diagnostic market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

1. Product Overview

1.1. Market Definition
1.2. Scope of the Market
- 1.2.1. Markets Covered
- 1.2.2. Years Considered for Study
- 1.2.3. Key Market Segmentations

2. Research Methodology

2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validations
2.7. Assumptions and Limitations

3. Executive Summary

3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Companion Diagnostic Market Outlook

5.1. Market Size & Forecast
- 5.1.1. By Value
5.2. Market Share & Forecast
- 5.2.1. By Product and Services (Kits and Reagents, Assays, Software, and Services)
- 5.2.2. By Technology (PCR, NGS, In-Situ Hybridization, Immunohistochemistry, and Others)
- 5.2.3. By Disease Indication (Oncology, Neurology, Cardiology, Infectious Diseases, and Others)
- 5.2.4. By Application (In-Vitro Diagnostics, Drug Discovery, and Others)
- 5.2.5. By End User (Pharmaceutical & Biotechnology Companies, Research Laboratories, Contract Research Organization, and Others)
- 5.2.6. By Region
- 5.2.7. By Company (2024)
5.3. Market Map

6. North America Companion Diagnostic Market Outlook

6.1. Market Size & Forecast
- 6.1.1. By Value
6.2. Market Share & Forecast
- 6.2.1. By Product and Services
- 6.2.2. By Technology
- 6.2.3. By Disease Indication
- 6.2.4. By Application
- 6.2.5. By End User
- 6.2.6. By Country
6.3. North America: Country Analysis
- 6.3.1. United States Companion Diagnostic Market Outlook
  - 6.3.1.1. Market Size & Forecast
    - 6.3.1.1.1. By Value
  - 6.3.1.2. Market Share & Forecast
    - 6.3.1.2.1. By Product and Services
    - 6.3.1.2.2. By Technology
    - 6.3.1.2.3. By Disease Indication
    - 6.3.1.2.4. By Application
    - 6.3.1.2.5. By End User
- 6.3.2. Canada Companion Diagnostic Market Outlook
  - 6.3.2.1. Market Size & Forecast
    - 6.3.2.1.1. By Value
  - 6.3.2.2. Market Share & Forecast
    - 6.3.2.2.1. By Product and Services
    - 6.3.2.2.2. By Technology
    - 6.3.2.2.3. By Disease Indication
    - 6.3.2.2.4. By Application
    - 6.3.2.2.5. By End User
- 6.3.3. Mexico Companion Diagnostic Market Outlook
  - 6.3.3.1. Market Size & Forecast
    - 6.3.3.1.1. By Value
  - 6.3.3.2. Market Share & Forecast
    - 6.3.3.2.1. By Product and Services
    - 6.3.3.2.2. By Technology
    - 6.3.3.2.3. By Disease Indication
    - 6.3.3.2.4. By Application
    - 6.3.3.2.5. By End User

7. Europe Companion Diagnostic Market Outlook

7.1. Market Size & Forecast
- 7.1.1. By Value
7.2. Market Share & Forecast
- 7.2.1. By Product and Services
- 7.2.2. By Technology
- 7.2.3. By Disease Indication
- 7.2.4. By Application
- 7.2.5. By End User
- 7.2.6. By Country
7.3. Europe: Country Analysis
- 7.3.1. Germany Companion Diagnostic Market Outlook
  - 7.3.1.1. Market Size & Forecast
    - 7.3.1.1.1. By Value
  - 7.3.1.2. Market Share & Forecast
    - 7.3.1.2.1. By Product and Services
    - 7.3.1.2.2. By Technology
    - 7.3.1.2.3. By Disease Indication
    - 7.3.1.2.4. By Application
    - 7.3.1.2.5. By End User
- 7.3.2. United Kingdom Companion Diagnostic Market Outlook
  - 7.3.2.1. Market Size & Forecast
    - 7.3.2.1.1. By Value
  - 7.3.2.2. Market Share & Forecast
    - 7.3.2.2.1. By Product and Services
    - 7.3.2.2.2. By Technology
    - 7.3.2.2.3. By Disease Indication
    - 7.3.2.2.4. By Application
    - 7.3.2.2.5. By End User
- 7.3.3. Italy Companion Diagnostic Market Outlook
  - 7.3.3.1. Market Size & Forecast
    - 7.3.3.1.1. By Value
  - 7.3.3.2. Market Share & Forecast
    - 7.3.3.2.1. By Product and Services
    - 7.3.3.2.2. By Technology
    - 7.3.3.2.3. By Disease Indication
    - 7.3.3.2.4. By Application
    - 7.3.3.2.5. By End User
- 7.3.4. France Companion Diagnostic Market Outlook
  - 7.3.4.1. Market Size & Forecast
    - 7.3.4.1.1. By Value
  - 7.3.4.2. Market Share & Forecast
    - 7.3.4.2.1. By Product and Services
    - 7.3.4.2.2. By Technology
    - 7.3.4.2.3. By Disease Indication
    - 7.3.4.2.4. By Application
    - 7.3.4.2.5. By End User
- 7.3.5. Spain Companion Diagnostic Market Outlook
  - 7.3.5.1. Market Size & Forecast
    - 7.3.5.1.1. By Value
  - 7.3.5.2. Market Share & Forecast
    - 7.3.5.2.1. By Product and Services
    - 7.3.5.2.2. By Technology
    - 7.3.5.2.3. By Disease Indication
    - 7.3.5.2.4. By Application
    - 7.3.5.2.5. By End User

8. Asia-Pacific Companion Diagnostic Market Outlook

8.1. Market Size & Forecast
- 8.1.1. By Value
8.2. Market Share & Forecast
- 8.2.1. By Product and Services
- 8.2.2. By Technology
- 8.2.3. By Disease Indication
- 8.2.4. By Application
- 8.2.5. By End User
- 8.2.6. By Country
8.3. Asia-Pacific: Country Analysis
- 8.3.1. China Companion Diagnostic Market Outlook
  - 8.3.1.1. Market Size & Forecast
    - 8.3.1.1.1. By Value
  - 8.3.1.2. Market Share & Forecast
    - 8.3.1.2.1. By Product and Services
    - 8.3.1.2.2. By Technology
    - 8.3.1.2.3. By Disease Indication
    - 8.3.1.2.4. By Application
    - 8.3.1.2.5. By End User
- 8.3.2. India Companion Diagnostic Market Outlook
  - 8.3.2.1. Market Size & Forecast
    - 8.3.2.1.1. By Value
  - 8.3.2.2. Market Share & Forecast
    - 8.3.2.2.1. By Product and Services
    - 8.3.2.2.2. By Technology
    - 8.3.2.2.3. By Disease Indication
    - 8.3.2.2.4. By Application
    - 8.3.2.2.5. By End User
- 8.3.3. Japan Companion Diagnostic Market Outlook
  - 8.3.3.1. Market Size & Forecast
    - 8.3.3.1.1. By Value
  - 8.3.3.2. Market Share & Forecast
    - 8.3.3.2.1. By Product and Services
    - 8.3.3.2.2. By Technology
    - 8.3.3.2.3. By Disease Indication
    - 8.3.3.2.4. By Application
    - 8.3.3.2.5. By End User
- 8.3.4. South Korea Companion Diagnostic Market Outlook
  - 8.3.4.1. Market Size & Forecast
    - 8.3.4.1.1. By Value
  - 8.3.4.2. Market Share & Forecast
    - 8.3.4.2.1. By Product and Services
    - 8.3.4.2.2. By Technology
    - 8.3.4.2.3. By Disease Indication
    - 8.3.4.2.4. By Application
    - 8.3.4.2.5. By End User
- 8.3.5. Australia Companion Diagnostic Market Outlook
  - 8.3.5.1. Market Size & Forecast
    - 8.3.5.1.1. By Value
  - 8.3.5.2. Market Share & Forecast
    - 8.3.5.2.1. By Product and Services
    - 8.3.5.2.2. By Technology
    - 8.3.5.2.3. By Disease Indication
    - 8.3.5.2.4. By Application
    - 8.3.5.2.5. By End User

9. South America Companion Diagnostic Market Outlook

9.1. Market Size & Forecast
- 9.1.1. By Value
9.2. Market Share & Forecast
- 9.2.1. By Product and Services
- 9.2.2. By Technology
- 9.2.3. By Disease Indication
- 9.2.4. By Application
- 9.2.5. By End User
- 9.2.6. By Country
9.3. South America: Country Analysis
- 9.3.1. Brazil Companion Diagnostic Market Outlook
  - 9.3.1.1. Market Size & Forecast
    - 9.3.1.1.1. By Value
  - 9.3.1.2. Market Share & Forecast
    - 9.3.1.2.1. By Product and Services
    - 9.3.1.2.2. By Technology
    - 9.3.1.2.3. By Disease Indication
    - 9.3.1.2.4. By Application
    - 9.3.1.2.5. By End User
- 9.3.2. Argentina Companion Diagnostic Market Outlook
  - 9.3.2.1. Market Size & Forecast
    - 9.3.2.1.1. By Value
  - 9.3.2.2. Market Share & Forecast
    - 9.3.2.2.1. By Product and Services
    - 9.3.2.2.2. By Technology
    - 9.3.2.2.3. By Disease Indication
    - 9.3.2.2.4. By Application
    - 9.3.2.2.5. By End User
- 9.3.3. Colombia Companion Diagnostic Market Outlook
  - 9.3.3.1. Market Size & Forecast
    - 9.3.3.1.1. By Value
  - 9.3.3.2. Market Share & Forecast
    - 9.3.3.2.1. By Product and Services
    - 9.3.3.2.2. By Technology
    - 9.3.3.2.3. By Disease Indication
    - 9.3.3.2.4. By Application
    - 9.3.3.2.5. By End User

10. Middle East and Africa Companion Diagnostic Market Outlook

10.1. Market Size & Forecast
- 10.1.1. By Value
10.2. Market Share & Forecast
- 10.2.1. By Product and Services
- 10.2.2. By Technology
- 10.2.3. By Disease Indication
- 10.2.4. By Application
- 10.2.5. By End User
- 10.2.6. By Country
10.3. MEA: Country Analysis
- 10.3.1. South Africa Companion Diagnostic Market Outlook
  - 10.3.1.1. Market Size & Forecast
    - 10.3.1.1.1. By Value
  - 10.3.1.2. Market Share & Forecast
    - 10.3.1.2.1. By Product and Services
    - 10.3.1.2.2. By Technology
    - 10.3.1.2.3. By Disease Indication
    - 10.3.1.2.4. By Application
    - 10.3.1.2.5. By End User
- 10.3.2. Saudi Arabia Companion Diagnostic Market Outlook
  - 10.3.2.1. Market Size & Forecast
    - 10.3.2.1.1. By Value
  - 10.3.2.2. Market Share & Forecast
    - 10.3.2.2.1. By Product and Services
    - 10.3.2.2.2. By Technology
    - 10.3.2.2.3. By Disease Indication
    - 10.3.2.2.4. By Application
    - 10.3.2.2.5. By End User
- 10.3.3. UAE Companion Diagnostic Market Outlook
  - 10.3.3.1. Market Size & Forecast
    - 10.3.3.1.1. By Value
  - 10.3.3.2. Market Share & Forecast
    - 10.3.3.2.1. By Product and Services
    - 10.3.3.2.2. By Technology
    - 10.3.3.2.3. By Disease Indication
    - 10.3.3.2.4. By Application
    - 10.3.3.2.5. By End User

11. Market Dynamics

11.1. Drivers
11.2. Challenges

12. Market Trends & Developments

12.1. Recent Development
12.2. Mergers & Acquisitions
12.3. Product Launches

13. Global Companion Diagnostic Market: SWOT Analysis

14. Porter's Five Forces Analysis

14.1. Competition in the Industry
14.2. Potential of New Entrants
14.3. Power of Suppliers
14.4. Power of Customers
14.5. Threat of Substitute Products

15. Competitive Landscape

15.1. Abbott Laboratories Inc.
- 15.1.1. Business Overview
- 15.1.2. Company Snapshot
- 15.1.3. Products & Services
- 15.1.4. Financials (As Reported)
- 15.1.5. Recent Developments
- 15.1.6. Key Personnel Details
- 15.1.7. SWOT Analysis
15.2. Agilent Technologies Inc.
15.3. F.Hoffmann-La Roche Ltd
15.4. Biomerieux SA
15.5. Qiagen NV
15.6. Siemens Healthcare
15.7. Thermo Fisher Scientific Inc.
15.8. Danaher Corporation (Beckman Coulter Inc.)
15.9. Myriad Genetics Inc.
15.10. Illumina Inc.