Top Companion Diagnostics Companies

Skyquest Technology's expert advisors have carried out comprehensive research and identified these companies as industry leaders in the Companion Diagnostics Market. This Analysis is based on comprehensive primary and secondary research on the corporate strategies, financial and operational performance, product portfolio, market share and brand analysis of all the leading Companion Diagnostics industry players.

Companion Diagnostics Market Competitive Landscape

The primary factors driving the global companion diagnostics market include the increasing demand for personalized medicine, which is defined as treatment tailored to an individual’s genetic profile. As the market favours precision health care, utilization of companion diagnostics will arise as the identification of patients most likely to benefit from specific therapies increases and is minimized through adverse effects.

Industry Overview

According to SkyQuest Technology “Companion Diagnostics Market By Product & Service (Assays, Kits, and Reagents, Instruments & Systems, Software & Services), By Technology (PCR, ISH, NGS, IHC), By Indication (Cancer, Neurological Diseases, Cardiovascular Diseases), By Sample Type (Tissue, Blood, Bone Marrow Samples), By End User (Academic and Research, Pharmaceutical & Biotechnology Companies), By Region- Industry Forecast 2025-2032,” Global Companion Diagnostics Market is projected to grow at a CAGR of over 11.80% by 2032, on account of urgent need for automating quantified data. The rising prevalence of cancer and other chronic diseases has expedited demand for targeted medicines supported by diagnostic tests. The demand for diagnostics to initialize the appropriate patients for targeted therapy development will continue to enhance the clinical and commercial success of companion diagnostics alongside existing collaboration between pharmaceutical companies and diagnostics developers to launch companion tests as novel drugs are developed and marketed.

Top 10 Global Companion Diagnostics Companies

Company

Est. Year

Headquarters

Revenue

Key Services

F. Hoffmann‑La Roche Ltd. (Roche Diagnostics)

1896

Basel, Switzerland

USD 2.1 billion (2024)

Development and commercialization of companion diagnostic assays for targeted therapies in oncology

Thermo Fisher Scientific Inc.

1956

Waltham, USA

USD 1.6 billion (2024)

Genomics, PCR, NGS and assay platforms supporting companion diagnostics

QIAGEN N.V.

1984

Hilden, Germany / Netherlands

USD 0.9 billion (2024)

Molecular diagnostics and biomarker-based companion assays

Illumina Inc.

1998

San Diego, USA

USD 850 Million (2024)

Next-generation sequencing platforms and companion-diagnostic workflows

Agilent Technologies, Inc.

1999

Santa Clara, USA

USD 750 Million (2024)

Immunohistochemistry assays and companion diagnostics reagents

Abbott Laboratories

1888

Chicago, USA

USD 700 million (2024)

Diagnostic platforms and assays co-developed with pharma for companion use

Foundation Medicine Inc.

2010

Cambridge, USA

USD 550 million (2024)

Comprehensive genomic profiling tests for oncology companion diagnostics

Guardant Health Inc.

2012

Redwood City, USA

USD 500 million (2024)

Liquid-biopsy companion diagnostic tests and partnerships with pharma

Myriad Genetics Inc.

1991

Salt Lake City, USA

USD 450 billion (2024)

HRD and other biomarker assays utilized as companion diagnostics

Adaptive Biotechnologies Corp.

2012

Seattle, USA

USD 400 billion (2024)

T-cell receptor-based diagnostics aligned with companion therapeutic strategies

1. F. Hoffmann-La Roche Ltd. (Roche Diagnostics)

Roche Diagnostics, a division of F. Hoffmann-La Roche Ltd., is among the world leaders in companion diagnostics. The company focuses on developing diagnostics that are closely linked to targeted therapies, especially in the oncology field. Roche is a pioneer in personalized healthcare and the integration of diagnostics with a given therapeutic drug, which ultimately leads to better decisions by clinicians.

2. Thermo Fisher Scientific Inc.

Thermo Fisher Scientific is a significant player in molecular diagnostics and companion diagnostic products. The company offers a wide array of technologies, including next-generation sequencing (NGS), real-time PCR, and molecular platforms facilitating biomarker discovery and companion test development.

3. QIAGEN N.V.

QIAGEN is a biotechnology company based in the Netherlands known for its work in molecular testing and sample-to-insight diagnostic workflows. QIAGEN develops companion diagnostics used in conjunction with targeted therapies, primarily for cancer and infectious diseases. QIAGEN can co-develop diagnostic assays approved by regulatory agencies like the FDA and EMA because of its collaboration with major pharmaceutical companies. QIAGEN's therascreen assays, are among the most established products in the companion diagnostics market.

4. Illumina Inc.

Illumina is the pioneer of genomic sequencing and a key player in the companion diagnostics sector. Its sequencing technologies serve as the backbone of many diagnostics and precision medicine initiatives. Illumina's platforms can be used for comprehensive genomic profiling, which is a critical step to identify patients that are most likely to benefit from targeted treatments.

5. Agilent Technologies, Inc.

Agilent Technologies is a large life sciences and diagnostics organization that offers a wide range of products and solutions for genomic, proteomic, and cellular analysis. Agilent is particularly strong in the companion diagnostics space with its immunohistochemistry (IHC) assays and in situ hybridization assays, which are commonly used oncology diagnostics to identify biomarkers responsible for directing targeted therapies. Agilent also has co-development partnerships with several biopharma companies to create companion diagnostic assays with regulatory approvals.

6. Abbott Laboratories

Abbott Laboratories covers a variety of pharma categories and has an extensive operation within diagnostic technologies. Abbott's range of companion diagnostics include molecular testing systems and biomarker assays that feed into the targeted therapy development process. Abbott has a strong history of partnerships with pharmaceutical manufacturers, which have driven diagnostic solutions for oncology, cardiovascular, and infectious disease.

7. Foundation Medicine Inc.

Foundation Medicine is a genomics company owned by Roche that specializes in comprehensive genomic profiling for cancer. The company is developing companion diagnostic assays to identify genomic alterations relevant to treatment selection for targeted therapies.

8. Guardant Health Inc.

Guardant Health is a pioneer in companion diagnostics using blood-based liquid biopsy. The company's blood tests detect mutations associated with specific cancer therapies by analyzing circulating tumor DNA (ctDNA) in patients' blood samples. The company's flagship FDA-approved tests, including Guardant360 CDx, serve as companion diagnostics for several targeted therapies.

9. Myriad Genetics Inc.

Myriad Genetics is a molecular diagnostic company that specializes in hereditary cancer testing and biomarker-based testing and is a leader in hereditary cancer testing. Myriad offers several companion diagnostic tests that assess heterologous recombination deficiency (HRD) and other genetic markers to help guide treatment selection in breast and ovarian cancer.

10. Adaptive Biotechnologies Corp.

Adaptive Biotechnologies focuses on immune-driven diagnostics based on T-cell receptor sequencing technology. The company's proprietary platform for immune medicine generates diagnostics to assess immune responses as they relate to disease progression and response to treatment.

Other Leading Global Companion Diagnostics Companies

  • Biocartis Group NV
  • Invitae Corporation
  • NanoString Technologies, Inc.
  • ArcherDX, Inc.
  • BioMérieux SA
  • Sysmex Corporation
  • Roche Sequencing Solutions
  • Siemens Healthineers AG
  • Hologic, Inc.
  • Exact Sciences Corporation
  • Natera, Inc.
  • Thermo Fisher Scientific’s Clinical Sequencing Division

Conclusion

In summary, the companion diagnostics market is expected to experience continuous growth as healthcare continues to evolve toward personalized and precision medicine. The growth of the market is supported by ongoing technological developments in genomics, the discovery of biomarkers, and molecular testing technologies, which improve the accuracy and accessibility of targeted therapies. Partnerships between pharmaceutical and diagnostic companies actively support the development of drugs for regulatory approval. The global burden of cancer and chronic diseases continue to encourage the acceptance of companion diagnostics to improve effectiveness and safety of therapies.

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FAQs

Global Companion Diagnostics market size was valued at USD 8.72 Billion in 2024 and is poised to grow from USD 9.75 Billion in 2025 to USD 23.8 Billion by 2033, growing at a CAGR of 11.8% in the forecast period (2026–2033).

F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (United States), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (United States), Abbott Laboratories (United States), Danaher Corporation (United States), Guardant Health, Inc. (United States), Illumina, Inc. (United States), bioMérieux (France), ICON plc (Ireland), Myriad Genetics, Inc. (United States), Sysmex Corporation (Japan), The McClay Foundation (Almac Group) (United Kingdom), ARUP Laboratories (United States), Abnova Corporation (Taiwan), BioGenex (United States), Invivoscribe, Inc. (United States), Laboratory Corporation oof America (ArcherDX, Inc.) (United States), Amoy Diagnostics Co., Ltd. (China), Bio-Techne (Asuragen, Inc.) (United States)

The key driver of the companion diagnostics market is the increasing demand for personalized medicine, which relies on diagnostic tests to identify patients likely to benefit from specific therapies, improving treatment efficacy, safety, and overall patient outcomes.

A key market trend in the companion diagnostics market is the growing integration of molecular diagnostics and biomarker-based testing, enabling more precise patient stratification, targeted therapies, and the development of personalized treatment plans in oncology and other therapeutic areas.

North America accounted for the largest share in the companion diagnostics market, driven by advanced healthcare infrastructure, strong adoption of precision medicine, significant R&D investments, and the presence of leading diagnostic and pharmaceutical companies.

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Global Companion Diagnostics Market
Companion Diagnostics Market

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