Global Companion Diagnostics Market to Surpass USD 13.6 Billion by 2029 | MarketsandMarkets™

Rapid innovation in targeted therapies accelerates adoption of companion diagnostics worldwide

Delray Beach, FL, Sept. 30, 2025 (GLOBE NEWSWIRE) -- The global companion diagnostics market, valued at US$6.8 billion in 2023, stood at US$7.5 billion in 2024 and is projected to advance at a resilient CAGR of 12.6% from 2024 to 2029, culminating in a forecasted valuation of US$13.6 billion by the end of the period. This growth underscores the increasing role of precision medicine in reshaping modern healthcare and the rising reliance on diagnostic technologies to improve therapeutic outcomes.

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Why It Matters
Companion diagnostics are transforming how life sciences companies, clinicians, and healthcare systems deliver care. By linking diagnostic insights with targeted therapies, these technologies enable personalized treatment decisions, reduce the risk of adverse events, and accelerate time-to-market for new drugs. Their adoption is particularly significant in oncology, where identifying biomarkers can define therapeutic pathways and improve survival rates.

Market Dynamics and Growth Drivers
The expansion of the market is driven by three critical factors:

• What’s driving adoption? Growing significance of companion diagnostics in drug development pipelines and regulatory approvals.
• Why now? Rising cancer prevalence worldwide is prompting pharmaceutical companies and healthcare providers to deploy diagnostics that can match patients with precision therapies.
• How does this impact healthcare? The shift towards personalized medicine ensures treatments are more effective, lowering the burden of ineffective therapies and unnecessary costs.

However, the market also faces restraints such as high capital investment requirements, complex biomarker validation processes, and a shortage of adequately trained laboratory professionals, especially in emerging economies.

Opportunities in Drug Development
The co-development of diagnostics and therapeutics offers a competitive edge to pharmaceutical companies. By integrating diagnostics into early clinical development, firms can accelerate commercialization, optimize regulatory pathways, and improve patient safety. This dynamic positions companion diagnostics as a core enabler of next-generation drug launches.

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Market Insights: Key Segments

• By Product & Service: Assays, kits & reagents held the largest market share in 2023, owing to wide clinical adoption and availability across therapeutic areas.
• By Technology: PCR remained the dominant technology in 2023, attributed to its accessibility and growing use in detecting low-frequency gene mutations.
• By Indication: Cancer accounted for the largest share, highlighting the pivotal role of diagnostics in oncology treatment strategies.
• By Sample Type: Tissue samples led the market in 2023 due to their ability to provide comprehensive biomarker analysis.
• By End User: Pharmaceutical & biotechnology companies emerged as the largest end-user group, reflecting the surge in drug–diagnostic partnerships.

Regional Outlook
North America leads the global market, supported by advanced regulatory approvals, strong R&D infrastructure, and early adoption of novel diagnostic solutions. For instance, Roche’s FDA-approved companion diagnostic for HER2 low metastatic breast cancer in 2022 highlights the pace of innovation. Meanwhile, Asia Pacific presents high-growth potential, with China, India, and Japan expected to become pivotal markets due to rising investments in precision medicine.

Key Players and Competitive Landscape
The market is shaped by global leaders including F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (US), and Abbott (US). These companies leverage strong distribution networks, robust R&D pipelines, and expanding digital pathology platforms to sustain growth.

Recent developments include:

• Agilent’s European IVDR Certification for companion diagnostic assays (August 2023).
• QIAGEN’s FDA approval for a companion diagnostic for gastrointestinal stromal tumors (August 2023).
• Roche’s FDA label expansion for its VENTANA PD-L1 assay to support lung cancer treatment eligibility (March 2023).
• Thermo Fisher’s FDA approval for the first NGS-based companion diagnostic aiding therapy selection for thyroid cancers (September 2022).

Strategic Implications for Decision-Makers
For CEOs, CFOs, and CMOs, the rise of companion diagnostics signals a strategic inflection point:

• Investors should recognize the high-growth trajectory of diagnostics tied to precision medicine.
• Pharmaceutical leaders must integrate diagnostics into R&D strategies to accelerate approvals and strengthen market positioning.
• Healthcare providers should prepare for increased demand in oncology and other therapeutic areas as biomarker-driven treatments become standard care.

About the Report
The analysis highlights key growth trends, segment insights, and competitive strategies shaping the companion diagnostics market through 2029. It addresses critical questions including:

• Which technologies will dominate companion diagnostics?
• How will regulatory shifts impact drug–diagnostic co-development?
• Which regions represent the most lucrative opportunities for global expansion?

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