Companion Diagnostics Market Growth, Analysis, and Forecast by 2031

Historic Data: 2021-2023 | Base Year: 2024 | Forecast Period: 2025-2031

Coverage: Companion Diagnostics Market covers analysis by Technology Type ( Immunohistochemistry, Polymerase Chain Reaction [PCR], Next Generation Sequencing [NGS], In Situ Hybridization, Others ); Indication ( Oncology, Neurology, Others ), and Geography (North America, Europe, Asia Pacific, and South and Central America)

Report Date : Aug 2025
Report Code : TIPRE00011772

Category : Life Sciences
Status : Upcoming

Available Report Formats :
No. of Pages : 150

Analysis Strategic Insights Market Drivers Regional Insights Report Scope Recent Developments FAQs

The Companion Diagnostics Market is expected to register a CAGR of 12.5% from 2025 to 2031, with a market size expanding from US$ XX million in 2024 to US$ XX Million by 2031.

The Companion Diagnostics Market report covers analysis by Technology Type ( Immunohistochemistry, Polymerase Chain Reaction [PCR], Next Generation Sequencing [NGS], In Situ Hybridization, Others ); Indication ( Oncology, Neurology, Others ). The global analysis is further broken-down at regional level and major countries. The Report Offers the Value in USD for the above analysis and segments.

Purpose of the Report

The report Companion Diagnostics Market by The Insight Partners aims to describe the present landscape and future growth, top driving factors, challenges, and opportunities. This will provide insights to various business stakeholders, such as:

Technology Providers/Manufacturers: To understand the evolving market dynamics and know the potential growth opportunities, enabling them to make informed strategic decisions.
Investors: To conduct a comprehensive trend analysis regarding the market growth rate, market financial projections, and opportunities that exist across the value chain.
Regulatory bodies: To regulate policies and police activities in the market with the aim of minimizing abuse, preserving investor trust and confidence, and upholding the integrity and stability of the market.

Companion Diagnostics Market Segmentation

Technology Type

Immunohistochemistry
Polymerase Chain Reaction
Next Generation Sequencing
In Situ Hybridization

Indication

Oncology
Neurology

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Companion Diagnostics Market: Strategic Insights

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Companion Diagnostics Market Growth Drivers

Growth of Companion Diagnostics with Personalized Medicine: The increasing popularity of companion diagnostics aligns with the shift toward genetically-based therapies, driving market expansion through partnerships between pharmaceutical companies and diagnostic makers for targeted treatments.
Cancer Diagnosis and Treatment Driving Growth: The focus on cancer diagnosis and treatment is fueling market growth, with PEST analysis highlighting favorable regulatory environments and competitive analysis emphasizing oncology's key role in expanding global market share.
Advancements in Biomarker Identification and Genomic Testing: Progress in biomarker identification and genomic testing is boosting market growth, with increasing R&D investments in innovative diagnostic tools to enhance accuracy and efficacy.

Companion Diagnostics Market Future Trends

Next-Generation Sequencing Revolutionizing Diagnostics: Next-generation sequencing is transforming companion diagnostics with high-throughput analysis, driving significant growth as precision medicine becomes more prevalent.
Competition and Partnerships for Growth: Players are competing to form partnerships that expand their assay portfolios and expedite regulatory approvals, supporting market growth.
Favorable Regulatory Frameworks Driving Adoption: Favorable regulatory environments in developed markets are accelerating the adoption of companion diagnostics, with opportunities for faster approvals but threats from stringent compliance standards. Key players are adapting strategies to align with evolving global regulations.

Companion Diagnostics Market Opportunities

Oncology Transitioning to Precision Medicine: The oncology field is shifting towards precision medicine, focusing on understanding tumor biology and matching therapeutic agents, creating significant growth opportunities through innovation in biomarkers and targeted therapies.
Favorable Regulatory Frameworks in North America and Europe: The favorable regulatory environments in North America and Europe are supporting the development and commercialization of companion diagnostic solutions, driving industry growth.
Strategic Partnerships for Growth: Strategic partnerships between drug and diagnostic companies present significant growth opportunities, with accelerated product development and expanded geographic market opportunities advancing these collaborations.

Companion Diagnostics Market Regional Insights

The regional trends and factors influencing the Companion Diagnostics Market throughout the forecast period have been thoroughly explained by the analysts at Insight Partners. This section also discusses Companion Diagnostics Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

companion-diagnostics-market-global-geography

Get the Regional Specific Data for Companion Diagnostics Market

Companion Diagnostics Market Report Scope

Report Attribute	Details
Market size in 2024	US$ XX million
Market Size by 2031	US$ XX Million
Global CAGR (2025 - 2031)	12.5%
Historical Data	2021-2023
Forecast period	2025-2031
Segments Covered	By Technology Type Immunohistochemistry Polymerase Chain Reaction Next Generation Sequencing In Situ Hybridization By Indication Oncology Neurology
Regions and Countries Covered	North America US Canada Mexico Europe UK Germany France Russia Italy Rest of Europe Asia-Pacific China India Japan Australia Rest of Asia-Pacific South and Central America Brazil Argentina Rest of South and Central America Middle East and Africa South Africa Saudi Arabia UAE Rest of Middle East and Africa
Market leaders and key company profiles	Abbott Laboratories Molecular, Inc. Agilent (Dako Denmark A/S) ARUP Laboratories BioMerieux SA Danaher Corporation (Leica Microsystems) Foundation Medicine, Inc. Myriad Genetics, Inc. Qiagen N.V. Roche (Ventana Medical Systems, Inc.)

Companion Diagnostics Market Players Density: Understanding Its Impact on Business Dynamics

The Companion Diagnostics Market market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.

Major Companies operating in the Companion Diagnostics Market are:

Abbott Laboratories Molecular, Inc.
Agilent (Dako Denmark A/S)
ARUP Laboratories
BioMerieux SA
Danaher Corporation (Leica Microsystems)

Disclaimer: The companies listed above are not ranked in any particular order.

Get the Companion Diagnostics Market top key players overview

Key Selling Points

Comprehensive Coverage: The report comprehensively covers the analysis of products, services, types, and end users of the Companion Diagnostics Market, providing a holistic landscape.
Expert Analysis: The report is compiled based on the in-depth understanding of industry experts and analysts.
Up-to-date Information: The report assures business relevance due to its coverage of recent information and data trends.
Customization Options: This report can be customized to cater to specific client requirements and suit the business strategies aptly.

The research report on the Companion Diagnostics Market can, therefore, help spearhead the trail of decoding and understanding the industry scenario and growth prospects. Although there can be a few valid concerns, the overall benefits of this report tend to outweigh the disadvantages.

Frequently Asked Questions

What are the options available for the customization of this report?

Some of the customization options available based on request are additional 3-5 company profiles and country-specific analysis of 3-5 countries of your choice. Customizations are to be requested/discussed before making final order confirmation, as our team would review the same and check the feasibility.

What are the deliverable formats of this report?

The report can be delivered in PDF/PPT format; we can also share excel dataset based on the request.

Which are the key players in the Companion Diagnostics Market?

Key companies of this market are: Abbott Laboratories Molecular, Inc., Agilent (Dako Denmark A/S), ARUP Laboratories, BioMerieux SA, Danaher Corporation (Leica Microsystems), Foundation Medicine, Inc., Myriad Genetics, Inc., Qiagen N.V., Roche (Ventana Medical Systems, Inc.).

What are the future trends in the Companion Diagnostics Market?

Key future trends in this market are targeted cancer therapy advancements, regulatory support for growth opportunities, and collaborations across the industry landscape.

What is the expected CAGR of the Companion Diagnostics Market?

The Companion Diagnostics Market is estimated to witness a CAGR of 12.5% from 2023 to 2031.

What are the driving factors impacting the Companion Diagnostics Market?

The major factors driving the market are: Personalized medicine adoption, Advancements in biomarker discovery, Increasing cancer diagnostics

研究マネージャー

Mrinal Kerhalkar

Manager,
Market Research & Consulting

Mrinal is a seasoned research analyst with over 8 years of experience in Life Sciences Market Intelligence and Consulting. With a strategic mindset and unwavering commitment to excellence, she has built deep expertise in pharmaceutical forecasting, market opportunity assessment, and developing industry benchmarks. Her work is anchored in delivering actionable insights that empower clients to make informed strategic decisions.

Mrinal’s core strength lies in translating complex quantitative datasets into meaningful business intelligence. Her analytical acumen is instrumental in shaping go-to-market (GTM) strategies and uncovering growth opportunities across the pharmaceutical and medical device sectors. As a trusted consultant, she consistently focuses on streamlining workflow processes and establishing best practices, thereby driving innovation and operational efficiency for her clients.

What are the Companion Diagnostics Market report deliverables?

Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
PEST and SWOT Analysis
Market Size Value / Volume - Global, Regional, Country
Industry and Competitive Landscape
Excel Dataset

Companion Diagnostics Market Report Snapshots

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