Companion Diagnostics Market Research on Size, Share, Trends, Segments, Regions & Competition

The Companion Diagnostics Market Report Segments the Industry Into Technology (Immunohistochemistry, Polymerase Chain Reaction, and More), Indication (Lung Cancer, Breast Cancer, and More), Product Type (Assays and Kits, and Instruments and Analyzers, and More), Sample Type (Tissue Biopsy, Liquid Biopsy, and More), End-User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations (CROs), and More), and Geography

Companion Diagnostics Market Size and Share

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Companion Diagnostics Market Analysis by Mordor Intelligence

The market size is valued at USD 8.70 billion in 2025 and is forecast to expand to USD 15.62 billion by 2030, reflecting a 12.42 % CAGR. Companion diagnostics integrate molecular testing with targeted therapeutics, aligning diagnostic information with optimal therapy choices. The widening application of precision medicine is simultaneously shifting investment priorities for drug makers and reshaping payer reimbursement models as policy makers recognize diagnostics as pivotal cost-containment tools.

Key Report takeaways

  • Market expansion is driven less by incremental test volume and more by the diversification of molecular targets, creating a revenue multiplier for diagnostics companies that hold broad assay menus.
  • Although North America commands 40.4% market share in 2024, payer coverage decisions are spreading globally, compressing the reimbursement gap between established and emerging markets.
  • Liquid biopsy is the fastest-growing sample type at an 18.9% CAGR, and its adoption is prompting oncology practices to redesign patient-flow models around same-day phlebotomy.
  • Contract Research Organizations (CROs) are on course to capture a larger slice of downstream revenue as sponsors outsource biomarker strategy, effectively positioning CROs as molecular co-strategists.
  • The European Union’s In Vitro Diagnostic Regulation (IVDR) is extending approval timelines, and the resulting bottleneck is encouraging test developers to stage United States and Asia-Pacific launches ahead of Europe, shifting traditional geographic launch sequences.

Segment Analysis

Segment Analysis Technology: NGS Disrupts Traditional Testing Paradigms

PCR still owns the largest 2024 slice at 22.2 % market share, yet NGS is expected to outpace all other technologies. NGS market size in companion diagnostics is forecast to outpace PCR-based alternatives, expanding at 14.3% CAGR between 2025-2030. Hospital procurement committees increasingly run total-cost-of-ownership analyses that reveal high sample throughput offsets higher NGS consumable costs over a three-year amortization window. Consequently, instrument vendors now bundle analytics software into reagent contracts, an arrangement that shifts revenue recognition from one-time hardware sales to recurring service streams—reshaping quarterly earnings visibility.

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Note: Segment shares of all individual segments available upon report purchase

Indication: Melanoma Emerges as Growth Frontier

Melanoma companion diagnostics will capture a market share acceleration to 13.6% CAGR through 2030 as immunotherapy combinations proliferate. The downstream impact is that dermatology clinics must coordinate closely with molecular labs to ensure rapid reflex testing, effectively blending two historically separate clinical silos. This integration forces electronic medical record vendors to adapt order-entry modules to accommodate reflex molecular panels, an IT adjustment that, although minor on the surface, represents a notable administrative investment across health systems.

Product and Service: Software Solutions Accelerate Growth

Assays and kits account for 66.3 % of 2024 spending, driven by their one-to-one linkage with specific drug launches. However, software-driven interpretive platforms represent the fastest-growing product category at 15.8% CAGR (2025-2030). Diagnostic accuracy hinges on variant classification pipelines that are now subject to continuous machine-learning updates, prompting regulators to contemplate post-market algorithm change controls. A parallel business consequence is emerging: laboratories may incur liability if they decline software upgrades that could materially improve clinical calls, implicitly threading software-maintenance clauses into laboratory accreditation audits.

Sample Type: Liquid Biopsy Transforms Testing Paradigms

Tissue biopsy still represents 78.5 % of 2024 volumes because confirmatory histology remains the regulatory gold standard. The liquid biopsy market size is projected to expand 18.9% CAGR through 2030. Oncology practices are already reallocating phlebotomy staff to accommodate the surge, subtly increasing demand for point-of-care blood-processing devices. Laboratories that historically specialized in tissue histopathology must now invest in plasma-DNA extraction systems, creating operating-expense tension that influences capital-budget cycles.

Market Share
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Note: Segment shares of all individual segments available upon report purchase

End-user: CROs Emerge as Strategic Partners

CROs’ companion diagnostics market size is set to climb 13.2% CAGR (2025-2030). Their breadth of biomarker-validation experience allows smaller biotechs to access regulatory pathways that would otherwise be prohibitive. This positioning gives CROs leverage to negotiate risk-sharing fee models tied to trial milestones, shifting them from service vendors toward quasi-development partners—a nuance that alters revenue recognition and could improve margin stability.

Geography Analysis

North America holds 40.4% market share in 2024. UnitedHealthcare’s policy to cover FDA-approved companion diagnostics when matched with the corresponding drug signals payer endorsement that directly influences adoption velocity. An inferred outcome is that private insurers outside the UnitedHealthcare umbrella may emulate the policy to remain competitive, leading to a cascade that can stabilize test reimbursement rates industry-wide. [4]UnitedHealthcare, “Coverage Summary: Molecular Diagnostics and Genetic Testing,” UnitedHealthcare, uhc.com

Asia-Pacific is projected to log a 12.7% CAGR from 2025-2030. Japan’s government-supported cancer genome profiling (CGP) program forecasts a 54 billion-yen CGP market by 2035, prompting domestic labs to scale sequencing capacity. This governmental commitment sets a precedent that neighboring countries may replicate, harmonizing regulatory expectations and spurring cross-border clinical-trial enrollment that accelerates data accumulation in under-studied Asian populations.

Europe’s In Vitro Diagnostic Regulation environment is prompting companies to reexamine launch strategies. The limited capacity of notified bodies amplifies time-to-market risk, causing diagnostic firms to consider centralized testing models as interim solutions. Such centralization may inadvertently strengthen select reference laboratories, creating a quasi-oligopoly that could sway pricing dynamics once test volumes peak.

Companion Diagnostics Market
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Competitive Landscape

The competitive environment blends diversified players like Roche with agile specialists such as Guardant Health. Strategic co-development agreements remain pivotal: Roche’s portfolio of 200-plus pharmaceutical collaborations anchors its diagnostics in many clinical-trial protocols, ensuring near-automatic uptake at commercial launch. A subtle competitive vector is emerging around data ownership; companies that control large real-world genomic datasets can refine predictive algorithms faster, granting them an iterative advantage unlikely to be replicated by reagent-only competitors.

Companion Diagnostics Industry Leaders

  1. Qiagen NV

  2. Agilent Technologies Inc.

  3. Abbott

  4. Biomerieux

  5. F. Hoffmann-La Roche Ltd

  6. *Disclaimer: Major Players sorted in no particular order
Companion Diagnostics Market Concentration
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Recent Industry Developments

  • January 2025: Roche received FDA label expansion for PATHWAY anti-HER2/neu antibody to include HR-positive, HER2-ultralow metastatic breast cancer
  • December 2024: Agilent’s PD-L1 IHC 28-8 pharmDx secured EU IVDR certification.
  • November 2024: Roche obtained CE mark for the VENTANA FOLR1 RxDx Assay.

Table of Contents for Companion Diagnostics Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rapid adoption of liquid-biopsy CDx in oncology practices
    • 4.2.2 Advancements in Personalized Medicine and Precision Oncology
    • 4.2.3 Technological Innovations in Diagnostic Tools
    • 4.2.4 Growing Prevalence of Chronic Diseases
    • 4.2.5 ADC-focused oncology pipeline requiring multiplex CDx platforms
    • 4.2.6 Rising Investment from Pharmaceutical Companies
  • 4.3 Market Restraints
    • 4.3.1 High Development Costs
    • 4.3.2 FDA post-market evidence obligations raising lifecycle costs
    • 4.3.3 Stringent Regulatory Policies
    • 4.3.4 Limited infrastructure in Emerging Countries
  • 4.4 Supply-Chain Analysis
  • 4.5 Regulatory Outlook
  • 4.6 Porter’s Five Forces Analysis
    • 4.6.1 Threat of New Entrants
    • 4.6.2 Bargaining Power of Buyers
    • 4.6.3 Bargaining Power of Suppliers
    • 4.6.4 Threat of Substitutes
    • 4.6.5 Competitive Rivalry

5. Market Size & Growth Forecasts (Value, USD)

  • 5.1 By Technology
    • 5.1.1 Immunohistochemistry (IHC)
    • 5.1.2 Polymerase Chain Reaction (PCR)
    • 5.1.3 Real-Time PCR (RT-PCR)
    • 5.1.4 In-Situ Hybridization (ISH)
    • 5.1.5 Next-Generation / Gene Sequencing (NGS)
    • 5.1.6 Other Technologies
  • 5.2 By Indication
    • 5.2.1 Lung Cancer
    • 5.2.2 Breast Cancer
    • 5.2.3 Colorectal Cancer
    • 5.2.4 Leukemia
    • 5.2.5 Melanoma
    • 5.2.6 Gastric Cancer
    • 5.2.7 Prostate Cancer
    • 5.2.8 Other Indications
  • 5.3 By Product & Service
    • 5.3.1 Assays & Kits
    • 5.3.2 Instruments & Analyzers
    • 5.3.3 Software & Services
  • 5.4 By Sample Type
    • 5.4.1 Tissue Biopsy
    • 5.4.2 Liquid Biopsy
    • 5.4.3 Cytology Smears
  • 5.5 By End-user
    • 5.5.1 Pharmaceutical & Biotechnology Companies
    • 5.5.2 Contract Research Organizations (CROs)
    • 5.5.3 Clinical Reference Laboratories
    • 5.5.4 Hospital & Cancer Centers
  • 5.6 By Geography
    • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
    • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
    • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
    • 5.6.4 Middle East
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East
    • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Strategic Moves
  • 6.3 Market Share Analysis
  • 6.4 Company Profiles (includes Global-level Overview, Market-level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
    • 6.4.1 Abbott
    • 6.4.2 Agilent Technologies Inc.
    • 6.4.3 F. Hoffmann-La Roche Ltd
    • 6.4.4 bioMérieux SA
    • 6.4.5 QIAGEN N.V.
    • 6.4.6 Siemens Healthineers AG
    • 6.4.7 Thermo Fisher Scientific Inc.
    • 6.4.8 Danaher Corp. (Beckman Coulter)
    • 6.4.9 Illumina Inc.
    • 6.4.10 Myriad Genetics Inc.
    • 6.4.11 Guardant Health Inc.
    • 6.4.12 Sysmex Corp.
    • 6.4.13 Abnova Corp.
    • 6.4.14 Biogenex Laboratories Inc.
    • 6.4.15 Tempus Labs Inc.
    • 6.4.16 Foundation Medicine Inc.
    • 6.4.17 Exact Sciences Corp.
    • 6.4.18 PerkinElmer Inc.
    • 6.4.19 Invivoscribe Inc.

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-Need Assessment
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Global Companion Diagnostics Market Report Scope

As per the scope of the report, companion diagnostic tests provide information essential for safely and effectively using a corresponding drug or biological product.

The companion diagnostics market is segmented by technology, indication, and geography. The technology segment is divided into immunohistochemistry (IHC), polymerase chain reaction (PCR), in-situ hybridization (ISH) , real-time PCR (RT-PCR), g ene sequencing, and other technologies. The indication segment is divided into lung cancer, breast cancer, colorectal cancer, leukemia, melanoma, and other indications. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value in USD for these segments.

By Technology Immunohistochemistry (IHC)
Polymerase Chain Reaction (PCR)
Real-Time PCR (RT-PCR)
In-Situ Hybridization (ISH)
Next-Generation / Gene Sequencing (NGS)
Other Technologies
By Indication Lung Cancer
Breast Cancer
Colorectal Cancer
Leukemia
Melanoma
Gastric Cancer
Prostate Cancer
Other Indications
By Product & Service Assays & Kits
Instruments & Analyzers
Software & Services
By Sample Type Tissue Biopsy
Liquid Biopsy
Cytology Smears
By End-user Pharmaceutical & Biotechnology Companies
Contract Research Organizations (CROs)
Clinical Reference Laboratories
Hospital & Cancer Centers
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
South Korea
Australia
Rest of Asia-Pacific
Middle East GCC
South Africa
Rest of Middle East
South America Brazil
Argentina
Rest of South America
By Technology
Immunohistochemistry (IHC)
Polymerase Chain Reaction (PCR)
Real-Time PCR (RT-PCR)
In-Situ Hybridization (ISH)
Next-Generation / Gene Sequencing (NGS)
Other Technologies
By Indication
Lung Cancer
Breast Cancer
Colorectal Cancer
Leukemia
Melanoma
Gastric Cancer
Prostate Cancer
Other Indications
By Product & Service
Assays & Kits
Instruments & Analyzers
Software & Services
By Sample Type
Tissue Biopsy
Liquid Biopsy
Cytology Smears
By End-user
Pharmaceutical & Biotechnology Companies
Contract Research Organizations (CROs)
Clinical Reference Laboratories
Hospital & Cancer Centers
By Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
South Korea
Australia
Rest of Asia-Pacific
Middle East GCC
South Africa
Rest of Middle East
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

How big is the Companion Diagnostics Market?

The Companion Diagnostics Market size is expected to reach USD 8.70 billion in 2025 and grow at a CAGR of 12.42% to reach USD 15.62 billion by 2030.

What is the current Companion Diagnostics Market size?

In 2025, the Companion Diagnostics Market size is expected to reach USD 8.70 billion.

Who are the key players in Companion Diagnostics Market?

Qiagen NV, Agilent Technologies Inc., Abbott, Biomerieux and F. Hoffmann-La Roche Ltd are the major companies operating in the Companion Diagnostics Market.

Which is the fastest growing region in Companion Diagnostics Market?

Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).

Which region has the biggest share in Companion Diagnostics Market?

In 2025, the North America accounts for the largest market share in Companion Diagnostics Market.

What years does this Companion Diagnostics Market cover, and what was the market size in 2024?

In 2024, the Companion Diagnostics Market size was estimated at USD 7.62 billion. The report covers the Companion Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Companion Diagnostics Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.

Page last updated on: June 4, 2025

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