Companion Diagnostics Market to Hit USD 15.62 Billion by 2030, Driven by Liquid Biopsy Uptake and Demand for Precision Medicine

Introduction: Precision-Driven Testing Gains Ground

The companion diagnostics (CDx) market is projected to grow from USD 8.70 billion in 2025 to USD 15.62 billion by 2030, at a compound annual growth rate (CAGR) of 12.42%, according to Mordor Intelligence. As healthcare systems pivot toward personalized treatment pathways, companion diagnostics have become critical tools in matching therapies to patients' unique molecular profiles.

These diagnostics are increasingly integrated into clinical and regulatory decision-making, aligning treatment with test results across oncology, immunology, and other therapeutic areas. Pharmaceutical firms, testing laboratories, and contract research organizations are adjusting development timelines, business models, and operational frameworks to reflect the growing influence of CDx in modern medicine.

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Key Trends: What's Steering the Market Forward

Liquid Biopsy Expansion

Liquid biopsy is the fastest-growing sample type in the CDx market, with an expected CAGR of 18.9%. This technique offers a non-invasive alternative to tissue sampling, enabling clinicians to monitor tumor genetics in real time. The flexibility of liquid biopsy is leading to more dynamic and repeatable testing protocols, particularly in oncology. Recent FDA approvals, including Foundation One Liquid CDx, highlight the pace at which this approach is being adopted, although test sensitivity varies by tumor type and disease stage.

Companion Diagnostics Embedded in Drug Development

Once seen as supplementary tools, CDx tests are now integral to therapy access and reimbursement. The FDA currently lists 168 approved drug-biomarker combinations requiring specific diagnostics. Pharmaceutical companies are embedding CDx development into early-stage trials to ensure regulatory alignment and optimize patient targeting. This has led to increased demand for clinical validation services and earlier collaboration with contract research organizations, who are taking on larger roles in strategy and execution.

Next-Generation Sequencing Gains Momentum

Next-generation sequencing (NGS) is transforming how diagnostic data is captured and interpreted. With an anticipated CAGR of 14.3% between 2025 and 2030, NGS platforms provide a wide genetic view, allowing for more targeted treatments. Laboratories are integrating artificial intelligence to manage the surge in data volume, shifting labor needs from lab technicians to bioinformaticians. As a result, academic programs and start-ups are focusing on training and developing tools that support rapid variant interpretation.

Increased Cancer Incidence Intensifies CDx Utilization

Cancer diagnoses continue to climb, creating additional demand for diagnostic precision. Faster turnaround from testing to treatment is influencing how oncology practices and sponsors design workflows and trials. Institutions are refining consent forms to reflect that eligibility for treatment now often depends on molecular profiling, highlighting how CDx is becoming embedded in patient care decisions.

Market Segmentation: A Closer Look at Key Areas

By Technology:

- PCR (Polymerase Chain Reaction): Holds 22.2% of market share in 2024 but is expected to be overtaken.
- NGS (Next-Generation Sequencing): Projected to grow rapidly, favored for its throughput and versatility.
- Other Technologies: Including IHC and ISH, continue to play supportive roles in tissue analysis.

By Indication:

- Lung Cancer: High adoption due to clear biomarker-drug links.
- Melanoma: Expected to grow at 13.6% CAGR as immunotherapy use increases.
- Breast, Colorectal, and Gastric Cancers: Maintain a steady share of diagnostic demand.

By Product and Service:

- Assays and Kits: Represent 66.3% of spending due to direct alignment with approved drugs.
- Software Platforms: Fastest-growing at 15.8% CAGR, critical for interpreting complex data.

By Sample Type:

- Tissue Biopsy: Still accounts for 78.5% of 2024 volumes.
- Liquid Biopsy: Rapid growth prompts labs to adjust infrastructure and workflows.

By End User:

- Pharma and Biotech Firms: Use CDx to guide therapy development.
- CROs: Expected to grow at 13.2% CAGR as they become strategic partners in test validation.

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Key Players: Collaborations and Data Shape Competitive Landscape

The companion diagnostics market features a mix of established firms and specialized entrants. Roche, Qiagen NV, Agilent Technologies Inc., Abbott, and Biomerieux are among the leading companies shaping the field. Roche's deep network of over 200 drug partnerships positions it favorably in clinical trials and commercial launch planning.

Smaller companies like Guardant Health are making headway through expertise in liquid biopsy. Ownership of large genomic datasets is becoming a strategic advantage, allowing companies to refine their algorithms and deliver more accurate results. Data control is emerging as a new battleground, offering an edge that's hard for reagent-focused players to replicate.

Contract research organizations (CROs) are gaining relevance beyond operational support. Their involvement in biomarker validation and regulatory processes enables smaller biotech companies to meet the demands of co-developing CDx. With trial timelines becoming more compressed, CROs are negotiating shared-risk contracts and contributing more directly to product success.

Conclusion: Companion Diagnostics Moving Toward Clinical Standard

As the global companion diagnostics market heads toward USD 15.62 billion by 2030, it is becoming a fixture in healthcare delivery and pharmaceutical development. Precision medicine strategies are no longer aspirational-they are being implemented at scale, and CDx is central to making them work.

Challenges persist, particularly around regulatory timelines in Europe, development costs, and inconsistent reimbursement in emerging markets. But the alignment between diagnostics and therapy development is stronger than ever, supported by growing investments in technology, infrastructure, and cross-sector partnerships.

As the market matures, success will increasingly depend on data access, test accuracy, and the ability to work across regulatory and clinical systems. Stakeholders who prioritize early integration of diagnostics into their strategies will be best positioned to lead in a healthcare environment that is quickly becoming more personalized and data-driven.

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