Global Precision Oncology Companion Diagnostics (CDx) Market Size, Share, Trends and Forecasts 2031

Key Findings

• Precision oncology companion diagnostics (CDx) are essential tools for identifying patients most likely to benefit from targeted cancer therapies based on molecular biomarkers.

• CDx adoption is directly linked to the growth of targeted therapies, immuno-oncology drugs, and biomarker-driven treatment pathways.

• Regulatory agencies increasingly mandate approved CDx tests alongside new oncology drug approvals, strengthening market dependency on pharma pipelines.

• Next-generation sequencing (NGS) platforms are transforming CDx from single-gene assays into comprehensive genomic profiling solutions.

• Pharmaceutical–diagnostic co-development partnerships are central to accelerating approvals and commercial adoption.

• CDx integration into routine oncology workflows improves treatment outcomes, reduces trial-and-error prescribing, and supports precision medicine economics.

Precision Oncology Companion Diagnostics Market Size and Forecast

The global precision oncology companion diagnostics market was valued at USD 7.4 billion in 2024 and is projected to reach USD 17.9 billion by 2031, growing at a CAGR of 13.5%. Market growth is driven by the rising number of oncology drug approvals requiring biomarker-based patient selection and the expanding use of molecular testing at diagnosis, relapse, and treatment progression. Companion diagnostics linked to blockbuster targeted therapies and immunotherapies continue to generate recurring and predictable diagnostic demand across major cancer types.

Over the forecast period, growth will be further supported by broader reimbursement coverage for genomic testing, expansion of CDx into earlier treatment lines, and increasing global cancer incidence. Advances in multiplex testing, liquid biopsy technologies, and faster turnaround times are improving clinical adoption rates. Emerging markets are also contributing as oncology infrastructure and precision medicine initiatives mature. Collectively, these factors position CDx as a foundational component of modern oncology care through 2031.

Market Overview

Precision oncology companion diagnostics are in vitro diagnostic tests designed to guide the safe and effective use of specific cancer therapies by identifying actionable biomarkers. These diagnostics detect genetic mutations, gene amplifications, fusions, protein expression, and other molecular signatures that predict therapeutic response.

CDx tests are typically co-developed with targeted drugs and approved concurrently by regulatory authorities. The market includes PCR-based assays, immunohistochemistry, in situ hybridization, NGS panels, and liquid biopsy platforms. Adoption is strongest in solid tumors such as lung, breast, colorectal, and melanoma, where biomarker-driven therapy selection is now standard clinical practice.

Future Outlook

The CDx market is expected to expand steadily as oncology drug development becomes increasingly biomarker-centric and data-driven. Pan-cancer biomarkers, multi-gene panels, and AI-enabled interpretation tools will reshape diagnostic strategies. Liquid biopsy–based CDx will gain wider acceptance for treatment monitoring and resistance detection.

Regulatory harmonization across regions is expected to support faster global launches. Over time, CDx platforms may evolve from single-drug companions into comprehensive decision-support systems across oncology care pathways.

Precision Oncology Companion Diagnostics Market Trends

Expansion of NGS-Based Comprehensive Genomic Profiling
NGS-based CDx platforms are increasingly replacing single-gene assays by enabling simultaneous detection of multiple actionable alterations in a single test. This approach reduces tissue consumption and minimizes the need for repeat biopsies in advanced cancer patients. Clinicians benefit from broader molecular insight that supports therapy sequencing and combination strategies. Pharma companies favor NGS CDx because they maximize eligible patient identification across diverse mutations. Regulatory agencies are increasingly comfortable with multi-gene CDx submissions. This shift is fundamentally transforming CDx development and commercialization models.

Rising Adoption of Liquid Biopsy Companion Diagnostics
Liquid biopsy CDx tests enable non-invasive detection of tumor biomarkers using blood-based samples, improving patient comfort and access. These tests are particularly valuable when tissue samples are insufficient or unavailable. Liquid biopsies allow real-time monitoring of resistance mutations and disease evolution. Faster turnaround times support timely clinical decision-making in aggressive cancers. Ongoing clinical validation is expanding their use beyond late-stage disease settings. Liquid biopsy adoption is steadily strengthening overall CDx market penetration.

Early Integration of CDx in Drug Discovery and Clinical Trials
Companion diagnostics are increasingly embedded early in oncology drug discovery and trial design rather than added post hoc. Biomarker-based enrollment improves trial efficiency, reduces heterogeneity, and increases probability of clinical success. Early CDx integration aligns regulatory timelines for drug and diagnostic approvals. This approach also reduces post-approval access barriers and delays. Pharma–diagnostic collaborations are becoming deeper and longer-term. Early CDx integration is now a standard practice in precision oncology pipelines.

Shift Toward Pan-Cancer and Tumor-Agnostic Biomarkers
The market is witnessing a shift from tumor-specific biomarkers to pan-cancer and tumor-agnostic targets. CDx tests now support therapies approved across multiple cancer types based on shared molecular alterations. This expands the addressable market for both diagnostics and drugs. Tumor-agnostic strategies also simplify clinical decision-making and testing workflows. Regulators increasingly support this paradigm when backed by strong evidence. Pan-cancer biomarkers are reshaping CDx positioning and value propositions.

Digital Pathology and AI-Driven Interpretation Integration
Digital pathology and artificial intelligence are increasingly integrated into CDx workflows to improve accuracy and consistency. AI-assisted interpretation reduces inter-observer variability in biomarker assessment. These tools enhance scalability across decentralized laboratory networks. Automated analysis shortens turnaround times and supports high-throughput testing. Integration of AI also enables richer data generation for real-world evidence. Digital augmentation is becoming a differentiator in advanced CDx platforms.

Market Growth Drivers

Rapid Expansion of Targeted and Immuno-Oncology Therapies
The oncology drug pipeline is increasingly dominated by targeted therapies and immunotherapies that require precise biomarker identification. CDx tests are mandatory to determine patient eligibility and ensure safe, effective use of these drugs. Growing numbers of drug approvals directly increase associated diagnostic demand. Precision treatment approaches are now embedded in clinical guidelines across major cancers. Pharma dependence on biomarker-driven strategies strengthens long-term CDx utilization. This tight drug–diagnostic linkage is a primary growth driver.

Regulatory Mandates for Companion Diagnostics
Regulatory authorities frequently require approved CDx tests as part of targeted drug labeling and commercialization. This creates protected demand for diagnostics linked to approved therapies. Regulatory clarity reduces uncertainty for CDx developers and investors. Co-approval pathways streamline simultaneous drug and diagnostic launches. Mandatory testing ensures consistent clinical adoption. Regulatory mandates strongly reinforce sustained CDx market growth.

Increasing Clinical Adoption of Precision Medicine
Oncologists increasingly rely on molecular diagnostics to guide treatment selection and sequencing decisions. Precision medicine improves response rates and reduces unnecessary toxicity from ineffective therapies. Clinical guidelines now recommend biomarker testing at diagnosis and progression for many cancers. Hospitals and cancer centers continue investing in molecular pathology infrastructure. Patient awareness and demand for personalized treatment are also rising. Widespread clinical adoption continues to expand CDx utilization globally.

Advances in Diagnostic Technology and Test Accessibility
Technological advancements are improving sensitivity, specificity, and speed of CDx assays. Multiplex testing reduces cost per biomarker and streamlines workflows. Automation and standardization improve reproducibility across laboratories. Improved accessibility encourages broader testing even in community oncology settings. Faster turnaround times support timely treatment initiation. Technology innovation directly accelerates CDx market growth.

Growing Pharma–Diagnostic Strategic Partnerships
Pharmaceutical companies increasingly form strategic partnerships with diagnostic developers to co-create CDx solutions. These collaborations align incentives and accelerate development timelines. Shared clinical data improves biomarker validation and regulatory confidence. Partnerships also enhance commercial reach and global launch readiness. Integrated development reduces post-approval access barriers. Strategic alliances are a powerful driver of CDx market expansion.

Challenges in the Market

Complex Regulatory and Co-Development Pathways
CDx development requires tight coordination with therapeutic clinical trials and regulatory submissions. Delays or failures in drug programs directly affect associated diagnostics. Regulatory expectations differ across regions, complicating global launch strategies. Analytical validation and clinical utility requirements are stringent. Synchronizing drug and diagnostic timelines is operationally challenging. Regulatory complexity increases development cost and execution risk.

Reimbursement and Pricing Uncertainty Across Markets
Reimbursement for companion diagnostics varies widely by geography and payer type. Inconsistent coverage can limit adoption despite strong clinical evidence. Pricing pressure is increasing as multiplex assays become more common. Demonstrating cost-effectiveness is essential for payer acceptance. Delayed reimbursement decisions slow market penetration. Economic uncertainty remains a major commercialization challenge.

Operational and Infrastructure Limitations in Testing
Advanced CDx tests require specialized laboratory infrastructure and skilled molecular pathology personnel. Many healthcare systems lack access to high-quality genomic testing. Sample quality and pre-analytical variability can affect diagnostic accuracy. Turnaround time delays may impact treatment decisions. Scaling access in emerging markets is particularly difficult. Infrastructure gaps constrain full market potential.

Rapid Evolution of Oncology Standards of Care
Oncology treatment paradigms evolve quickly, with new biomarkers and therapies emerging frequently. CDx tests may become obsolete if linked drugs are displaced by newer options. Continuous updating of test panels increases development and maintenance costs. Laboratories must frequently revalidate assays. Rapid change increases commercial and operational uncertainty. Keeping pace with innovation is an ongoing challenge.

Data Management, Interpretation, and Integration Challenges
CDx platforms generate large volumes of genomic and clinical data requiring secure management. Interpretation complexity increases with multi-gene and pan-cancer panels. Integrating results into electronic health records remains inconsistent. Data standardization across laboratories is limited. Clinician education is required to interpret complex reports. Data-related challenges can slow adoption and scalability.

Precision Oncology Companion Diagnostics Market Segmentation

By Technology

• Next-Generation Sequencing (NGS)

• Polymerase Chain Reaction (PCR)

• Immunohistochemistry (IHC)

• In Situ Hybridization (ISH)

• Liquid Biopsy Assays

By Biomarker Type

• Genetic Mutations

• Gene Amplifications and Fusions

• Protein Expression

• Tumor Mutational Burden

By Cancer Type

• Lung Cancer

• Breast Cancer

• Colorectal Cancer

• Melanoma

• Other Solid Tumors

By End User

• Hospitals and Cancer Centers

• Reference Laboratories

• Pharmaceutical and Biotechnology Companies

Leading Key Players

• Roche Diagnostics

• Agilent Technologies

• Thermo Fisher Scientific

• Illumina

• Qiagen

• Guardant Health

• Foundation Medicine

• Abbott Laboratories

Recent Developments

• Roche Diagnostics expanded its oncology CDx portfolio aligned with targeted therapy launches.

• Agilent Technologies strengthened NGS-based CDx capabilities through platform enhancements.

• Thermo Fisher Scientific advanced multiplex CDx assays supporting pan-cancer biomarker detection.

• Guardant Health expanded liquid biopsy CDx use for therapy selection and resistance monitoring.

• Qiagen increased pharma collaborations to accelerate co-development of oncology CDx solutions.

This Market Report Will Answer the Following Questions

• Which biomarkers and cancer types will drive the highest CDx demand through 2031?

• How will NGS, liquid biopsy, and AI technologies reshape CDx development strategies?

• What regulatory and reimbursement factors most influence CDx commercialization success?

• How do pharma–diagnostic partnerships impact competitive dynamics in the CDx market?

• What infrastructure investments are required to scale precision oncology diagnostics globally?