| Study Period | 2019 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| Historical Data Period | 2019 - 2023 |
| CAGR | 18.50 % |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
North America Companion Diagnostics Devices Market Analysis
The North America Companion Diagnostics Devices Market is expected to register a CAGR of 18.5% during the forecast period.
COVID-19 has impacted the growth of the companion diagnostics devices market. For instance, according to an article published by Systematic Reviews in Pharmacy, in May 2022, serological antibody tests were used as SARS-CoV-2 vaccination companion diagnostics to enhance COVID-19 immunization schedules. In addition, as per the same source, SARS-CoV-2 vaccination companion diagnostics offered several advantages, including long-lasting, dependable immune protection through monitoring with a particular test combination and, consequently, medical security against COVID-19. This has increased the demand for companion diagnostics during the pandemic. Moreover, the emerging new or treatment-resistant variants has increased the demand for alternative therapies and rapid companion diagnostics for combatting acute infections as well as to understand the short- and long-term impact of variants on health. Thus, the studied market has witness significant growth and is expected to grow over the forecast period.
Factors such as the increasing demand and awareness for personalized medicines and targeted therapy, increasing cases of adverse drug reactions, and technological advancements in the devices are expected to boost market growth over the forecast period.
The growing company's focus on adopting various key strategies such as collaboration, partnerships, and others to improve access to personalized medicines as well as increasing awareness regarding targeted therapies among the population is expected to increase the adoption of companion diagnostic tests. This in turn is anticipated to fuel market growth. For instance, in May 2021, Hoffmann-La Roche Limited, Canada, signed a joint initiative with BC Cancer and the Canadian Personalized Healthcare Innovation Network (CPHIN) to co-create a real-world evidence (RWE) framework in British Columbia. The PREDiCT initiative generates and assesses RWE, which can be used to shape new sustainable reimbursement pathways for personalized cancer treatments.
Furthermore, a surge in research and development of targeted therapies is also expected to increase the demand for companion diagnostics tests and devices, hence contributing to the market growth. For instance, in May 2021, the United States FDA approved Rybrevant (amivantamab) as a targeted therapy for treating adult patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Moreover, the growing company activities in developing technologically advanced products, and increasing new product launches and approvals are also expected to bolster the market growth in the region over the forecast period. For instance, in July 2021, Labcorp launched therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib). Similarly, in May 2021, QIAGEN N.V. launched an expanded scope of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit after the United States as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRAST approval.
Therefore, owing to the aforementioned factors, the studied market is anticipated to grow over the forecast period. However, the high cost of drug development and associated clinical trials are likely to impede the growth of the companion diagnostics devices market over the forecast period.
North America Companion Diagnostics Devices Market Trends
The In-situ Hybridization (ISH) Segment is Expected to Exhibit the Fastest Growth Rate over the Forecast Period
The breast cancer segment is anticipated to witness significant growth in the companion diagnostics devices market over the forecast period owing to the factors such as the rising burden of breast cancer cases, growing awareness regarding breast cancer, and increasing new product approvals.
The increasing incidence and prevalence of breast cancer among the population raises the demand for effective and safe administration of a drug or a biological product to treat breast cancer which is only possible by companion diagnostics devices hence propelling the market growth. For instance, according to the statistics published by the Canadian Cancer Society, in May 2022, breast cancer is the most prevalent malignancy and is the second-leading cause of cancer-related death in Canadian women. As per the same source, 28,600 Canadian women are expected to be diagnosed with breast cancer in 2022, which represents 25% of all new cancer cases in women in 2022. Additionally, as per 2023 statistics published by the ACS, about 297,790 new cases of invasive breast cancer and 55,720 new cases of ductal carcinoma in situ (DCIS) are expected to be diagnosed in the United States in 2023.
Furthermore, the rising new product approvals increase the availability of advanced diagnostic devices in the region which is also expected to boost the segment's growth over the forecast period. For instance, in October 2022, Roche received the United States FDA approval for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, first companion diagnostics, to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment.
Therefore, due to the aforementioned factors, such as the high burden of breast cancer and increasing new product launches, the studied market is anticipated to grow over the forecast period.
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United States is Expected to Have the Significant Market Share Over the Forecast Period
The United States is expected to hold a significant market share in the companion diagnostics market in the North American region over the forecast period owing to the factors such as the rising burden of cancers, growing demand for personalized medicines and targeted therapy, high healthcare expenditure and growing technological advancements in devices.
The increasing incidences and prevalence of various types of cancers in the country raise the need for early detection of cancer and diagnosis of the condition. This is anticipated to fuel the market growth in the country. For instance, as per 2023 statistics published by ACS, about 1,958,310 new cancer cases are expected to be diagnosed in the United States in 2023. In addition, as per the same source, an estimated 238,340 new lung cancer cases, 153,020 new colon/rectum cancer cases, and 297,790 breast cancer cases are expected to be diagnosed in the United States in 2023.
Furthermore, the growing number of new product launches and product approvals increases the availability of novel diagnostics devices in the country, hence propelling market growth. For instance, in August 2022, the United States FDA granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target test as a companion diagnostic (CDx) to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor (EGFR) Exon20-insertion mutations for potential treatment with RYBREVANT targeted therapy. Also, in October 2021, the United States FDA approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which aids in identifying patients with early breast cancer (EBC) at high risk of disease recurrence.
Therefore, owing to the aforementioned factors, such as the high burden of cancers and new product launches, the studied market is anticipated to grow over the forecast period in the United States.
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North America Companion Diagnostics Devices Industry Overview
The North American companion diagnostics devices market is highly competitive due to the presence of a large number of players. Some of the key companies in the market are Abbott Laboratories, Agilent Technologies Inc., Biomerieux SA, F. Hoffmann-La Roche Ltd, Qiagen NV, Siemens Healthcare, and Thermo Fisher Scientific Inc., among others.
North America Companion Diagnostics Devices Market Leaders
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Abbott
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F. Hoffmann-La Roche Ltd
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Biomerieux SA
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Qiagen NV
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Agilent Technologies Inc.
- *Disclaimer: Major Players sorted in no particular order
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North America Companion Diagnostics Devices Market News
- January 2023: QIAGEN entered into an exclusive strategic partnership with Helix o advance companion diagnostics for hereditary diseases such as cardiovascular, metabolic, neurodegenerative, auto-immune diseases, and others. Under the terms of the agreement, QIAGEN will be the exclusive marketing and contracting partner in the United States for Helix's companion diagnostic services.
- December 2022: QIAGEN received the United States FDA approval for its therascreen KRAS RGQ PCR kit as a companion diagnostic test to Mirati Therapeutic's drug KRAZATI (adagrasib) for non-small cell lung cancer (NSCLC).
North America Companion Diagnostics Devices Industry Segmentation
As per the scope of the report, Companion diagnostic tests provide information that is essential for the safe and effective use of a corresponding drug or biological product. The North America Companion Diagnostics Devices Market is Segmented by Technology (Immunohistochemistry (IHC), Polymerase Chain Reaction (PCR), In-situ Hybridization (ISH), Real-time PCR (RT-PCR), Gene Sequencing, and Other Technologies), Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Leukemia, Melanoma, and Other Indications) and Geography. The report offers the value (in USD million) for the above segments.
| Technology | Immunohistochemistry (IHC) | ||
| Polymerase Chain Reaction (PCR) | |||
| In-situ Hybridization (ISH) | |||
| Real-time PCR (RT-PCR) | |||
| Gene Sequencing | |||
| Other Technologies | |||
| Indication | Lung Cancer | ||
| Breast Cancer | |||
| Colorectal Cancer | |||
| Leukemia | |||
| Melanoma | |||
| Other Indications | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
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North America Companion Diagnostics Devices Market Research FAQs
What is the current North America Companion Diagnostics Devices Market size?
The North America Companion Diagnostics Devices Market is projected to register a CAGR of 18.5% during the forecast period (2025-2030)
Who are the key players in North America Companion Diagnostics Devices Market?
Abbott, F. Hoffmann-La Roche Ltd, Biomerieux SA, Qiagen NV and Agilent Technologies Inc. are the major companies operating in the North America Companion Diagnostics Devices Market.
What years does this North America Companion Diagnostics Devices Market cover?
The report covers the North America Companion Diagnostics Devices Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the North America Companion Diagnostics Devices Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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North America Companion Diagnostics Devices Industry Report
Statistics for the 2025 North America Companion Diagnostics Devices market share, size and revenue growth rate, created by Mordor Intelligenceā¢ Industry Reports. North America Companion Diagnostics Devices analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
