The North America companion diagnostics market size was valued at USD 1.88 Billion in 2024. The market is further projected to grow at a CAGR of 15.50% between 2025 and 2034, reaching a value of USD 7.94 Billion by 2034.
Base Year
Historical Year
Forecast Year
In the United States alone, around 1,958,310 new cases of cancer were detected in 2023.
In June 2023, the U.S. Food and Drug Administration unveiled a new voluntary pilot program targeting specific oncology drugs and their corresponding in vitro diagnostic tests. This initiative aims to assist clinicians in choosing suitable cancer treatments for patients.
By the end of 2020, the FDA had granted approval to a total of 44 CDx assays. These assays are nearly all associated with various drugs for haematological and oncological conditions.
Value in USD Billion
2025-2034
North America Companion Diagnostics Market Outlook
*this image is indicative*
The North America companion diagnostics market growth is fuelled by several factors, including the push for personalised medicine, the growing use of next-generation sequencing (NGS), among others. The capability of CDx to pinpoint patients who are likely to respond to treatments based on specific biomarkers has catalysed partnerships between pharmaceutical and diagnostic firms, resulting in the creation and introduction of integrated products.
The co-development of personalised medicine and companion diagnostics (Rx-CDx) plays a crucial role in the product lifecycle, significantly influencing market accessibility. It expands the range of treatment options available for several serious diseases, including cancer. However, the field of companion diagnostics is particularly susceptible to changes in regulatory and reimbursement environments, requiring tailored strategies for market access.
Recent FDA approvals in the companion diagnostics market
North America Companion Diagnostics Market Report and Forecast 2025-2034 offers a detailed analysis of the market based on the following segments:
Market Breakup by Technology:
Market Breakup by Indication:
Market Breakup by End User:
Market Breakup by Country:
Market players are heavily investing in research and development and are focusing on personalised medicines to stay ahead in the market.
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
Get in touch with us for a customized solution tailored to your unique requirements and save upto 35%!
In 2024, the market reached an approximate value of USD 1.88 Billion.
The market is expected to grow at a CAGR of 15.50% between 2025 and 2034.
The market is expected to reach a value of USD 7.94 Billion by 2034.
Rising significance of personalised medicine and growing demand for NGS-based technology are the key market drivers for the market.
Companion diagnostics are tests or assays used to determine which patients are most likely to respond positively to a specific therapy or drug.
By 2020, 44 CDx assays were approved by the FDA.
Major countries in the market are the USA and Canada.
Key players in the market include Quest Diagnostics Incorporated, Agilent Technologies, Inc, F. Hoffmann-La Roche Ltd, Qiagen, Siemens AG, Thermo Fisher Scientific Inc, Laboratory Corporation of America Holdings, bioMérieux SA, and Amgen Inc, among others.
Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.
| REPORT FEATURES | DETAILS |
| Base Year | 2024 |
| Historical Period | 2018-2024 |
| Forecast Period | 2025-2034 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|
| Breakup by Technology |
|
| Breakup by Indication |
|
| Breakup by End User |
|
| Breakup by Region |
|
| Market Dynamics |
|
| Competitive Landscape |
|
| Companies Covered |
|
Datasheet
One User
USD 2,699
USD 2,429
tax inclusive*
Single User License
One User
USD 4,299
USD 3,869
tax inclusive*
Five User License
Five User
USD 5,799
USD 4,949
tax inclusive*
Corporate License
Unlimited Users
USD 6,999
USD 5,949
tax inclusive*
*Please note that the prices mentioned below are starting prices for each bundle type. Kindly contact our team for further details.*
Flash Bundle
Small Business Bundle
Growth Bundle
Enterprise Bundle
*Please note that the prices mentioned below are starting prices for each bundle type. Kindly contact our team for further details.*
Flash Bundle
Number of Reports: 3
20%
tax inclusive*
Small Business Bundle
Number of Reports: 5
25%
tax inclusive*
Growth Bundle
Number of Reports: 8
30%
tax inclusive*
Enterprise Bundle
Number of Reports: 10
35%
tax inclusive*
How To Order
Our step-by-step guide will help you select, purchase, and access your reports swiftly, ensuring you get the information that drives your decisions, right when you need it.
Select License Type
Choose the right license for your needs and access rights.
Click on ‘Buy Now’
Add the report to your cart with one click and proceed to register.
Select Mode of Payment
Choose a payment option for a secure checkout. You will be redirected accordingly.
Track prices with detailed trend reports.
Analyse trade data for supply chain insights.
Leverage cost reports for smart savings
Enhance supply chain with partnerships.
Gain insights to stay ahead and seize opportunities.
Get insights & trends for a competitive edge.
Track prices with detailed trend reports.
Analyse trade data for supply chain insights.
Leverage cost reports for smart savings
Enhance supply chain with partnerships.
Gain insights to stay ahead and seize opportunities.
Get insights & trends for a competitive edge.
Track prices with detailed trend reports.
Analyse trade data for supply chain insights.
Connect For More Information
Our expert team of analysts will offer full support and resolve any queries regarding the report, before and after the purchase.
Our expert team of analysts will offer full support and resolve any queries regarding the report, before and after the purchase.
We employ meticulous research methods, blending advanced analytics and expert insights to deliver accurate, actionable industry intelligence, staying ahead of competitors.
Our skilled analysts offer unparalleled competitive advantage with detailed insights on current and emerging markets, ensuring your strategic edge.
We offer an in-depth yet simplified presentation of industry insights and analysis to meet your specific requirements effectively.
Australia
63 Fiona Drive, Tamworth, NSW
+61-448-061-727
India
C130 Sector 2 Noida, Uttar Pradesh 201301
+91-723-689-1189
Philippines
40th Floor, PBCom Tower, 6795 Ayala Avenue Cor V.A Rufino St. Makati City,1226.
+63-287-899-028, +63-967-048-3306
United Kingdom
6 Gardner Place, Becketts Close, Feltham TW14 0BX, Greater London
+44-753-713-2163
United States
30 North Gould Street, Sheridan, WY 82801
+1-415-325-5166
Vietnam
193/26/4 St.no.6, Ward Binh Hung Hoa, Binh Tan District, Ho Chi Minh City
+84-865-399-124
United States (Head Office)
30 North Gould Street, Sheridan, WY 82801
+1-415-325-5166
Australia
63 Fiona Drive, Tamworth, NSW
+61-448-061-727
India
C130 Sector 2 Noida, Uttar Pradesh 201301
+91-723-689-1189
Philippines
40th Floor, PBCom Tower, 6795 Ayala Avenue Cor V.A Rufino St. Makati City, 1226.
+63-287-899-028, +63-967-048-3306
United Kingdom
6 Gardner Place, Becketts Close, Feltham TW14 0BX, Greater London
+44-753-713-2163
Vietnam
193/26/4 St.no.6, Ward Binh Hung Hoa, Binh Tan District, Ho Chi Minh City
+84-865-399-124
Share