Forecasting Growth: Companion Diagnostics Market Set for $13.6 Billion Valuation by 2029

Companion Diagnostics Market

The global companion diagnostics market is projected to reach USD 13.6 billion by 2029 from USD 7.5 billion in 2024, at a CAGR of 12.6% during the forecast period. The growth of the companion diagnostics market is primarily driven by several key factors, including a large patient pool undergoing advanced medical testing, high levels of drug development activity, a structured regulatory framework in the region, and policy programs aimed at providing effective care to patients with cancer.

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Based on product & service, the companion diagnostics market is categorized into assays, kits & reagents, instruments/systems and software & services. In 2023, the segment comprising assays, kits, & reagents held the largest share of the companion diagnostics market. This substantial share is due to the wide array of available products, the increasing utilization of assays and kits across various therapeutic fields, and the growing demand for these products in both basic research and commercial applications.

Based on technology, the companion diagnostics market is segmented into into polymerase chain reaction (PCR), in situ hybridization (ISH), next-generation sequencing (NGS), immunohistochemistry (IHC), and other technologies.  In 2023, the PCR segment held the predominant market share in the companion diagnostics market. This significant share is attributed to the user-friendly nature and widespread accessibility of PCR kits & reagents in companion diagnostic testing. Additionally, the expanding applications of PCR in the high-throughput detection of gene mutants with limited or low allele frequency, coupled with its quick turnaround time compared to other technologies, contribute to the dominance of the PCR segment.

Based on indication, the companion diagnostics market is categorized into segments including cancer, cardiovascular diseases (CVDs), neurological diseases, infectious diseases, and other indications (inflammatory and inherited diseases, among others). In 2023, the cancer segment held the largest portion of the market. This notable share is driven by several factors, including the rising global incidence of cancer, the expanding role of companion diagnostics in personalized medicine treatments for cancer, the growing importance of biomarkers in cancer diagnosis, advancements in molecular-level cancer diagnostics technology, and the availability of funding for cancer research.

Based on sample type, the companion diagnostics market is segmented into liquid, blood, and other sample types. In 2023, the tissue sample segment accounted for the largest share of the companion diagnostics market. Using tissue samples in companion diagnostics testing offers several advantages, primarily in providing more accurate and reliable results compared to other types of sample.

Categorized by end user, the companion diagnostics market is divided into pharmaceutical & biotechnology companies, reference laboratories, CROs, and other end users (including physician & hospital laboratories, and academic medical centers). In 2023, the pharmaceutical & biotechnology companies segment dominated the companion diagnostics market. This segment’s significant share is linked to the increasing utilization of companion diagnostics in drug development and the rising importance of companion diagnostic biomarkers. Furthermore, the increasing demand for personalized medicine and the necessity for targeted therapies across diverse diseases and disorders are anticipated to fuel the adoption and demand for companion diagnostics among pharmaceutical & biotechnology companies.

The global companion diagnostics market is divided into six primary regions: North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC countries. Among these regions, North America held the largest regional market share for companion diagnostics. The substantial presence of leading companion diagnostics vendors and national clinical laboratories, coupled with the easy access to technologically advanced devices and instruments, contribute to North America’s significant share in this market. Furthermore, the highly developed healthcare systems in the US and Canada also play a role in this regional dominance.

The major players in this market are F. Hoffmann-La Roche Ltd (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (US) and Abbott (US). These players lead the market because of their extensive product portfolios and wide geographic presence. These dominant market players also have numerous advantages, such as more robust marketing and distribution networks, larger budgets for R&D, and better brand recognition.

Recent Developments of Companion Diagnostics Industry

In August 2023, Agilent Technologies, Inc. (US) received European IVDR Certification for Companion Diagnostic Assay.

In August 2023, QIAGEN (Netherlands). received FDA approval for companion diagnostic to Blueprint Medicines’ AYVAKIT (avapritinib) in gastrointestinal stromal tumors.

In March 2023, F. Hoffmann-La Roche Ltd (Switzerland) received FDA approval of label expansion for VENTANA PD- L1 (SP263) Assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo.

In September 2022, Thermo Fisher Scientific Inc. (US) announced FDA Approval of Oncomine Dx Target Test as the First NGS-Based Companion Diagnostic to Aid in Therapy Selection for Patients with RET Mutations/Fusions in Thyroid Cancers.

In January 2021, F. Hoffmann-La Roche Ltd (Switzerland) launched two digital pathology image analysis algorithms for precision patient diagnosis in breast cancer.