North America Companion Diagnostics Market Report and Forecast 2025-2034

North America Companion Diagnostics Market Outlook

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 15.5% between 2025 and 2034, reaching a value of USD 7.16 billion by 2034.

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 2025-2034 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