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North America Companion Diagnostics Market Size, Forecast: By Technology: Immunohistochemistry (IHC), Polymerase Chain Reaction (PCR), In-situ Hybridization (ISH), Real-time PCR (RT-PCR), Gene Sequencing, Others; By Indication: Lung Cancer, Breast Cancer, Others; By End User; Regional Analysis; Competitive Landscape; 2024-2032
North America Companion Diagnostics Market Outlook
The North America companion diagnostics market size was valued at USD 1.88 billion in 2023. The market is further projected to grow at a CAGR of 15.5% between 2024 and 2032, reaching a value of USD 7.16 billion by 2032.
Key Takeaways
- 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.
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
- In November 2023, the FDA approved the FoundationOne® CDx as a companion diagnostic tool for identifying patients with advanced hormone receptor–positive, HER2-negative breast cancer who could benefit from the capivasertib and fulvestrant treatment combination.
- In August 2023, the FDA approved QIAGEN's therascreen PDGFRA RGQ PCR kit. This diagnostic tool aids in the detection of the PDGFRA D842V mutation in patients with inoperable or metastatic gastrointestinal stromal tumours, determining their eligibility for treatment with AYVAKIT® (avapritinib).
- In October 2022, F. Hoffmann-La Roche Ltd secured FDA approval for the first companion diagnostic designed to determine eligibility for Enhertu treatment in patients with HER2 low metastatic breast cancer.
Market Segmentation
North America Companion Diagnostics Market Report and Forecast 2024-2032 offers a detailed analysis of the market based on the following segments.
Market Breakup by Technology
- Immunohistochemistry (IHC)
- Polymerase Chain Reaction (PCR)
- In-situ Hybridisation (ISH)
- Real-time PCR (RT-PCR)
- Gene Sequencing
- Others
Market Breakup by Indication
- Lung Cancer
- Breast Cancer
- Colorectal Cancer
- Leukaemia
- Melanoma
- Others
Market Breakup by End User
- Pharmaceutical and Biotechnology Companies
- Reference Laboratories
- Contract Research Organisations
- Others
Market Breakup by Country
- United States of America
- Canada
Competitive Landscape
Market players are heavily investing in research and development and are focusing on personalised medicines to stay ahead in the market.
- 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
- Amgen Inc.
- Others
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:
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| Breakup by Technology |
|
| Breakup by Indication |
|
| Breakup by End User |
|
| Breakup by Region |
|
| Market Dynamics |
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| Competitive Landscape |
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| Companies Covered |
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*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
2 Report Coverage – Key Segmentation and Scope
3 Report Description
3.1 Market Definition and Outlook
3.2 Properties and Applications
3.3 Market Analysis
3.4 Key Players
4 Key Assumptions
5 Executive Summary
5.1 Overview
5.2 Key Drivers
5.3 Key Developments
5.4 Competitive Structure
5.5 Key Industrial Trends
6 Market Snapshot
7 Opportunities and Challenges in the Market
8 Global Companion Diagnostics Market Overview
8.1 Key Industry Highlights
8.2 Global Companion Diagnostics Historical Market (2017-2023)
8.3 Global Companion Diagnostics Market Forecast (2024-2032)
8.4 Global Companion Diagnostics Market Share by Region
8.4.1 North America
8.4.2 Europe
8.4.3 Asia Pacific
8.4.4 Latin America
8.4.5 Middle East and Africa
9 North America Companion Diagnostics Market Overview
9.1 Key Industry Highlights
9.2 North America Companion Diagnostics Historical Market (2017-2023)
9.3 North America Companion Diagnostics Market Forecast (2024-2032)
10 North America Companion Diagnostics Market by Technology
10.1 Immunohistochemistry (IHC)
10.1.1 Historical Trend (2017-2023)
10.1.2 Forecast Trend (2024-2032)
10.2 Polymerase Chain Reaction (PCR)
10.2.1 Historical Trend (2017-2023)
10.2.2 Forecast Trend (2024-2032)
10.3 In-situ Hybridization (ISH)
10.3.1 Historical Trend (2017-2023)
10.3.2 Forecast Trend (2024-2032)
10.4 Real-time PCR (RT-PCR)
10.4.1 Historical Trend (2017-2023)
10.4.2 Forecast Trend (2024-2032)
10.5 Gene Sequencing
10.5.1 Historical Trend (2017-2023)
10.5.2 Forecast Trend (2024-2032)
10.6 Others
11 North America Companion Diagnostics Market by Indication
11.1 Lung Cancer
11.1.1 Historical Trend (2017-2023)
11.1.2 Forecast Trend (2024-2032)
11.2 Breast Cancer
11.2.1 Historical Trend (2017-2023)
11.2.2 Forecast Trend (2024-2032)
11.3 Colorectal Cancer
11.3.1 Historical Trend (2017-2023)
11.3.2 Forecast Trend (2024-2032)
11.4 Leukaemia
11.4.1 Historical Trend (2017-2023)
11.4.2 Forecast Trend (2024-2032)
11.5 Melanoma
11.5.1 Historical Trend (2017-2023)
11.5.2 Forecast Trend (2024-2032)
11.6 Others
12 North America Companion Diagnostics Market by End User
12.1 Pharmaceutical and Biotechnology Companies
12.1.1 Historical Trend (2017-2023)
12.1.2 Forecast Trend (2024-2032)
12.2 Reference Laboratories
12.2.1 Historical Trend (2017-2023)
12.2.2 Forecast Trend (2024-2032)
12.3 Contract Research Organisations
12.3.1 Historical Trend (2017-2023)
12.3.2 Forecast Trend (2024-2032)
12.4 Others
13 North America Companion Diagnostics Market by Country
13.1 United States of America
13.1.1 Historical Trend (2017-2023)
13.1.2 Forecast Trend (2024-2032)
13.2 Canada
13.2.1 Historical Trend (2017-2023)
13.2.2 Forecast Trend (2024-2032)
14 Market Dynamics
14.1 SWOT Analysis
14.1.1 Strengths
14.1.2 Weaknesses
14.1.3 Opportunities
14.1.4 Threats
14.2 Porter’s Five Forces Analysis
14.2.1 Supplier’s Power
14.2.2 Buyer’s Power
14.2.3 Threat of New Entrants
14.2.4 Degree of Rivalry
14.2.5 Threat of Substitutes
14.3 Key Indicators for Demand
14.4 Key Indicators for Price
15 Competitive Landscape
15.1 Market Structure
15.2 Company Profiles
15.2.1 Quest Diagnostics Incorporated
15.2.1.1 Company Overview
15.2.1.2 Product Portfolio
15.2.1.3 Demographic Reach and Achievements
15.2.1.4 Certifications
15.2.2 Agilent Technologies, Inc.
15.2.2.1 Company Overview
15.2.2.2 Product Portfolio
15.2.2.3 Demographic Reach and Achievements
15.2.2.4 Certifications
15.2.3 F. Hoffmann-La Roche Ltd
15.2.3.1 Company Overview
15.2.3.2 Product Portfolio
15.2.3.3 Demographic Reach and Achievements
15.2.3.4 Certifications
15.2.4 Qiagen
15.2.4.1 Company Overview
15.2.4.2 Product Portfolio
15.2.4.3 Demographic Reach and Achievements
15.2.4.4 Certifications
15.2.5 Siemens AG
15.2.5.1 Company Overview
15.2.5.2 Product Portfolio
15.2.5.3 Demographic Reach and Achievements
15.2.5.4 Certifications
15.2.6 Thermo Fisher Scientific Inc
15.2.6.1 Company Overview
15.2.6.2 Product Portfolio
15.2.6.3 Demographic Reach and Achievements
15.2.6.4 Certifications
15.2.7 Laboratory Corporation of America Holdings
15.2.7.1 Company Overview
15.2.7.2 Product Portfolio
15.2.7.3 Demographic Reach and Achievements
15.2.7.4 Certifications
15.2.8 bioMérieux SA
15.2.8.1 Company Overview
15.2.8.2 Product Portfolio
15.2.8.3 Demographic Reach and Achievements
15.2.8.4 Certifications
15.2.9 Amgen Inc.
15.2.9.1 Company Overview
15.2.9.2 Product Portfolio
15.2.9.3 Demographic Reach and Achievements
15.2.9.4 Certifications
15.2.10 Others
16 Key Trends and Developments in the Market
List of Key Figures and Tables
1. Global Companion Diagnostics Market: Key Industry Highlights, 2017 and 2032
2. North America Companion Diagnostics Market: Key Industry Highlights, 2017 and 2032
3. North America Companion Diagnostics Historical Market: Breakup by Technology (USD Billion), 2017-2023
4. North America Companion Diagnostics Market Forecast: Breakup by Technology (USD Billion), 2024-2032
5. North America Companion Diagnostics Historical Market: Breakup by Indication (USD Billion), 2017-2023
6. North America Companion Diagnostics Market Forecast: Breakup by Indication (USD Billion), 2024-2032
7. North America Companion Diagnostics Historical Market: Breakup by End User (USD Billion), 2017-2023
8. North America Companion Diagnostics Market Forecast: Breakup by End User (USD Billion), 2024-2032
9. North America Companion Diagnostics Historical Market: Breakup by Country (USD Billion), 2017-2023
10. North America Companion Diagnostics Market Forecast: Breakup by Country (USD Billion), 2024-2032
11. North America Companion Diagnostics Market Structure
Key Questions Answered in the Report
In 2023, the market reached an approximate value of USD 1.88 billion.
The market is expected to grow at a CAGR of 15.5% between 2024 and 2032.
The market is expected to reach a value of USD 7.16 billion by 2032.
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.
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