Report Descriptions:

The Global Oncology Companion Diagnostic Market was estimated at USD 5.44 billion in 2026 and is projected to reach USD 14.59 billion by 2035, reflecting a robust CAGR of 10.37% over the forecast period from 2026 to 2035. The Oncology Companion Diagnostic market report offers a comprehensive and nuanced view of the industry, moving beyond conventional analysis. It provides a thorough examination of the markets dynamics, encompassing a detailed exploration of the factors propelling growth, such as evolving economic conditions, advancements in technology, shifts in regulatory policies, and changes in consumer behavior. Furthermore, the report discusses the projected Compound Annual Growth Rate (CAGR), providing stakeholders with a clear understanding of the market's expected growth trajectory and offering data-driven insights into future market dynamics.

The Oncology Companion Diagnostic market under analysis is characterized by dynamic growth and evolving trends that are reshaping the competitive landscape. With 2025 serving as the base year for this Oncology Companion Diagnostic market study, recent data highlights a significant expansion driven by technological advancements, rising consumer demand, and a growing focus on innovation. Companies are refining their go-to-market (GTM) strategies to effectively capture these emerging opportunities and respond to the rapidly changing market dynamics.

Key trends influencing the Oncology Companion Diagnostic market include the rapid adoption of digital technologies, the integration of sustainable practices, and the increasing importance of customer experience. These trends are not only driving growth but also creating new challenges for industry participants, who must adapt their GTM strategies to navigate regulatory changes, supply chain disruptions, and fluctuating economic conditions. Despite these challenges, the Oncology Companion Diagnostic market is poised for sustained growth, with emerging markets playing a critical role in the expansion of the industry.

Looking ahead, the Oncology Companion Diagnostic market is forecasted to continue its upward momentum through 2035, supported by ongoing investments in research and development, strategic partnerships, and mergers and acquisitions. Companies that can effectively tailor their GTM strategies to the evolving market landscape, innovate, and meet shifting consumer demands are likely to achieve sustained success. Oncology Companion Diagnostic market report provides a comprehensive analysis of the current market environment and offers valuable insights into the key drivers, challenges, and opportunities that will shape the industry's future over the next decade. This report offers a comprehensive analysis of market dynamics across various segments, regions, and countries, incorporating both qualitative and quantitative data. It covers the period from 2017 to 2035, providing a detailed examination of historical performance, current market conditions, and future projections.

Historical Analysis (2017-2024): The report presents a thorough review of market trends, performance metrics, and growth trajectories for the years 2017 through 2024. This historical perspective is crucial for understanding past market behavior and identifying patterns that influence current and future market dynamics.

Forecast and Projections (2026-2035) : Building on historical data, the report provides forward-looking insights, including market forecasts and growth projections from 2026 to 2035. It details anticipated market trends, emerging opportunities, and potential challenges across different segments, regions, and countries.

Compound Annual Growth Rate (CAGR): The report includes a precise calculation of the compound annual growth rate (CAGR) for the forecast period of 2026 to 2035. This metric will be instrumental in assessing the expected growth trajectory and the overall market potential during the forecast period.

Oncology Companion Diagnostic Market

Oncology Companion Diagnostic Market

The Oncology Companion Diagnostic Market plays a critical role in the advancement of precision medicine by offering medical devices and in vitro diagnostics (IVDs) that guide the safe and effective use of cancer therapies. These diagnostics help identify which patients are most likely to benefit from a particular treatment, those at higher risk of adverse reactions, and those who need monitoring during therapy.

Technologies such as Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Immunohistochemistry (IHC), and In Situ Hybridization (ISH), including Fluorescence in Situ Hybridization (FISH), are commonly employed to support tumour profiling, biomarker identification, and predictive diagnostics. By tailoring treatments to individual patients based on their genetic and molecular profiles, companion diagnostics significantly enhance therapeutic outcomes, minimize harmful side effects, and improve the overall effectiveness of targeted therapies, immunotherapies, and chemotherapies.

What are the drivers of oncology companion diagnostic market

• The rising global cancer burdenwith 20 million new cases and 9.7 million deaths reported in 2022drives demand for advanced diagnostics that guide targeted therapies, improving survival rates and quality of life. For example, HER2 testing in breast cancer enables effective use of trastuzumab.
• A fundamental industry shift toward precision medicine, moving from one-size-fits-all to personalized treatment plans based on individual tumour profiles and genetic markers. Companion diagnostics such as EGFR mutation analysis help tailor therapies for non-small cell lung cancer patients.
• Technological advancements including next-generation sequencing (NGS), polymerase chain reaction (PCR), and multiplex biomarker assays enhance diagnostic speed, accuracy, and affordability.
• Regulatory agencies actively supporting innovation, with the FDA encouraging early collaboration between drug and diagnostic developers and piloting programs to improve transparency around oncology biomarker test standards.

What are the challenges and restraining factors of oncology companion diagnostic market

• High costs of advanced tests, especially NGS, limiting accessibility in lower-income regions.
• Inconsistent reimbursement policies and delays in insurance coverage hinder adoption of new diagnostics.
• Regulatory complexity requiring companion diagnostics to be approved alongside therapies, leading to lengthy development timelines and higher costs.
• Varying regional regulatory requirements complicate global market entry.
• Clinician awareness gaps and reluctance to incorporate companion diagnostics into routine care.
• Ensuring analytical and clinical validity of biomarkers demands extensive validation and standardization; variability between labs can erode trust.

What are the regional trends of oncology companion diagnostic market

North America continues to lead, driven by strong funding from institutions like the National Cancer Institute and a supportive regulatory environment. The U.S. FDAs proactive approvals, such as Illuminas TruSight Oncology Comprehensive test, bolster adoption. Despite challenges like high costs and reimbursement complexities, mature healthcare infrastructure and high cancer incidence support steady market growth.

Europe maintains a leading role, supported by advanced healthcare infrastructure, stringent regulatory frameworks (CE marking), and a growing emphasis on personalized medicine. Germany, France, and the UK are innovation hubs, with collaborations like AstraZenecas partnership with Foundation Medicine expanding access to companion diagnostics. Regulatory harmonization remains a challenge but offers future streamlining potential.

Asia Pacific is the fastest-growing region due to rising cancer burden, aging populations, and increased access to genomic testing. China, India, Japan, and South Korea lead growth, supported by government initiatives and healthcare reforms. Challenges include uneven infrastructure and diverse regulations, but the outlook remains highly promising.

Latin America experiences steady growth with increased cancer burden and gradual precision medicine adoption. Improving healthcare infrastructure and growing awareness help patient access to targeted therapies. Barriers include limited funding, slower regulatory approvals, and uneven technology access.

Middle East & Africa show promising growth potential fueled by rising cancer incidence and healthcare investments. Low current adoption due to funding, awareness, and facility constraints is gradually improving through government and private sector initiatives. Regulatory and infrastructure challenges still need addressing.

Country-Wise Outlook:

• United States: The largest and most advanced market with high cancer burden and robust healthcare infrastructure. The FDA accelerates approval of breakthrough diagnostics. Key players include Thermo Fisher Scientific, Illumina, and Guardant Health. Innovations include FDA-approved genomic profiling and AI-powered diagnostics. Challenges include high costs and reimbursement complexities, but precision oncology remains a top investment area.
• Germany: Pivotal European market supported by advanced healthcare, regulatory rigor (EMA, CE marking), and clinician familiarity. Home to leading companies like QIAGEN and BioMerieux. Strong government cancer research backing fuels adoption of NGS and multiplex assays. Regulatory complexity and reimbursement delays persist but are offset by high healthcare spending and active clinical trials.
• Japan: Rapidly evolving with strong government support, fast molecular diagnostic adoption, and a high aging population cancer incidence. The PMDA offers streamlined approval for therapies and companion diagnostics. Domestic and global companies develop NGS and IHC assays. Challenges include cost, reimbursement limits, and urban-rural access disparities, yet strong healthcare investment sustains growth.

Competitive Analysis:

Competition hinges on securing timely regulatory approvals through FDA and EMA pathways, granting first-mover advantages. Technological innovation with NGS, liquid biopsies, multiplex panels, and AI platforms enhances diagnostic precision and speed.

Strategic partnerships with pharmaceutical firms ensure diagnostics co-develop and launch alongside cancer drugs. Reimbursement depends on demonstrating clinical utility and cost-effectiveness. Differentiation relies on accuracy, fast turnaround, protocol integration, and patient conveniencefavoring non-invasive liquid biopsies.

Key players in the market include Roche Diagnostics, Thermo Fisher Scientific, Agilent Technologies, Illumina, Qiagen, Myriad Genetics, Foundation Medicine, bioMerieux, Abbott Laboratories, Becton Dickinson, Guardant Health, EntroGen, Sysmex Corporation, Leica Biosystems, Adaptive Biotechnologies, and others.

Recent Development:

• In May 2025, Roche received FDA approval for the VENTANA MET (SP44) RxDx Assaythe first companion diagnostic cleared to identify non-squamous non-small cell lung cancer (NSCLC) patients eligible for Emrelis treatment. This milestone advances personalized oncology by matching therapies to tumour profiles.
• In April 2025, Agilent Technologies announced a new alliance at the AACR Annual Meeting, showcasing innovations and collaborations to advance precision oncology research, diagnostics, and treatment.

Study Period for the Oncology Companion Diagnostic Market:

Oncology Companion Diagnostic Market

Report Highlights:

Our team of experienced researchers has meticulously gathered and analyzed data to deliver a thorough examination of market dynamics, competitive landscape, and emerging technologies. With a focus on delivering actionable intelligence, this report aims to empower decision-makers with the information needed to make informed choices and stay ahead of the competition. Whether you are a seasoned industry player or a new entrant, our market research report serves as a strategic tool to navigate the complexities of the market, aiding in successful business planning and growth strategies.

Key Chapters of our Oncology Companion Diagnostic Market Report includes:

Market Dynamics, Variables, and Industry Analysis:

This chapter of our Oncology Companion Diagnostic market report provides an in-depth examination of the factors shaping the industry landscape. This section typically encompasses several key elements to offer a comprehensive understanding of the industry landscape such as market drivers & restraints analysis, market opportunities & trend analysis, market size & growth analysis, competitive analysis, SWOT analysis, business environment tools such as Porter's five forces & PESTEL analysis, Ansoff Matrix analysis, penetration & growth prospect analysis, regulatory framework & reimbursement scenario analysis, impact of macro & micro economic factors analysis such as Covid-19 impact, GDP growth, market inflation, U.S.- China trade war, Russia-Ukraine war impact, and supply chain analysis.

Segment Analysis & Forecast to 2035:

The segment analysis chapter of Oncology Companion Diagnostic market report is a critical section that delves into a detailed examination of the market's various segments. Segmentation involves dividing the market into distinct categories based on certain criteria to better understand and address the diverse needs of consumers. This chapter typically follows the introduction and provides a more granular view of the market, offering valuable insights for businesses and stakeholders. The components of the chapter lude segment definitions to understand the inclusions and exclusions of the study, assumptions, market size estimates and growth trend analysis of each segment, qualitative analysis of the segment, technological advancements, market penetration rate, market adoption rate, market share examination by each segment, segment growth drivers and restraint barriers, consumer behaviour and challenge analysis.

Regional Market Analysis & Forecast to 2035:

The chapter in Oncology Companion Diagnostic market research report is a pivotal section that examines and predicts the market dynamics and trends specific to different geographical regions. This chapter is crucial for businesses and stakeholders seeking a comprehensive understanding of how the market behaves across various locations, enabling them to tailor strategies and make informed decisions based on regional variations. The regional analysis chapter of our Oncology Companion Diagnostic market report is classified into regions & country-level. The chapter consists of North America (U.S., Canada), Europe (UK, Germany, France, Italy, Spain, Russia, Sweden, Denmark, Norway, Rest of Europe), Asia Pacific (Japan, China, India, Australia, South Korea, Thailand, Rest of Asia Pacific), Latin America (Brazil, Mexico, Argentina, Colombia, Rest of Latin America), Middle East & Africa (South Africa, Saudi Arabia, UAE, Kuwait, Rest of Middle East & Africa).

Oncology Companion Diagnostic Market

Competitive Analysis & Company Profiles:

This section of a Oncology Companion Diagnostic market report is a crucial segment that provides a comprehensive overview of the competitive landscape within the market. This section is vital for businesses, investors, and stakeholders seeking insights into key players, their market positioning, strengths, weaknesses, strategies, and potential impacts on the overall market dynamics. The chapter includes research methodology used to analyse the market competition, list of key players operating in the market, detailed company profile section which includes company overview, business verticals, financial performance, product/services benchmarking, geographical presence, and strategic initiatives.

Key Players Operating in the Oncology Companion Diagnostic Market are as follows:

• Roche Diagnostics
• Thermo Fisher Scientific
• Agilent Technologies
• Illumina
• Qiagen
• Myriad Genetics
• Foundation Medicine
• bioMerieux
• Abbott Laboratories
• Becton Dickinson
• Guardant Health
• EntroGen
• Sysmex Corporation
• Leica Biosystems
• Adaptive Biotechnologies

Oncology Companion Diagnostic Market

Report Scope:

Quintile Reports has segmented the Oncology Companion Diagnostic market into the following segments:

Based on Product & Service, the Oncology Companion Diagnostic market is segmented into:

• Instruments
• Consumables
• Services

Based on Allergene Type, the Oncology Companion Diagnostic market is segmented into:

• Food (Dairy Products
• Poultry Product
• Tree Nuts
• Peanuts
• Shellfish
• Wheat
• Soys
• Other Food Allergens)
• Inhaled
• Drug
• Other Allergens

Based on Test, the Oncology Companion Diagnostic market is segmented into:

• In Vivo Test
• Skin Prick Test
• Intradermal Test
• Patch Test
• In Vitro Test

Based on End User, the Oncology Companion Diagnostic market is segmented into:

• Hospitals & Clinics
• Diagnostics Laboratories
• Research Institutions
• Specialty Clinics
• Academic Research Institutes
• Others

Report Scope	Details
Report Version	2025
Growth Rate	CAGR of 10.37 from 2026 to 2035
Base year	2025
Actual estimates/Historical data	2017 - 2024
Forecast period	2026 - 2035
Quantitative units	Revenue in USD million/billion & CAGR from 2026 to 2035
Country scope	North America (U.S., Canada), Europe (UK, Germany, France, Italy, Spain, Russia, Sweden, Denmark, Norway, Rest of Europe), Asia Pacific (Japan, China, India, Australia, South Korea, Thailand, Rest of Asia Pacific), Latin America (Brazil, Mexico, Argentina, Colombia, Rest of Latin America), Middle East & Africa (South Africa, Saudi Arabia, UAE, Kuwait, Rest of Middle East & Africa).
The Segment covered by Product & Service	Instruments Consumables Services
The Segment covered by Allergene Type	Food (Dairy Products Poultry Product Tree Nuts Peanuts Shellfish Wheat Soys Other Food Allergens) Inhaled Drug Other Allergens
Companies covered	Roche Diagnostics Thermo Fisher Scientific Agilent Technologies Illumina Qiagen Myriad Genetics Foundation Medicine bioMerieux Abbott Laboratories Becton Dickinson Guardant Health EntroGen Sysmex Corporation Leica Biosystems Adaptive Biotechnologies
Report coverage	Revenue forecast, company share, competitive landscape, growth factors, and trends
Free customization scope (equivalent to 5 analyst working days)	If you need specific information, which is not currently within the scope of the report, we will provide it to you as a part of the customization

Key Reasons to Acquire the Oncology Companion Diagnostic Market Research Report:

• This report offers a comprehensive analysis of the Oncology Companion Diagnostic market from 2017 to 2035, including market segments, current trends, estimations, and dynamics
• It also provides information on key drivers, restraints, and opportunities
• Porter's five forces analysis is used to assess the potency of buyers and suppliers, helping stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network
• The report includes an in-depth analysis of the Oncology Companion Diagnostic market segmentation to identify prevailing market opportunities
• Major countries in each region are mapped according to their revenue contribution to the global market
• Market player positioning is also analyzed to facilitate benchmarking and provide a clear understanding of the present position of the market players
• The report includes an analysis of the regional and global Oncology Companion Diagnostic market trends, key players, market segments, application areas, and market growth strategies

Oncology Companion Diagnostic Market

Available Customizations:

With the given market data, Quintile Reports offers customizations according to the company's specific needs. The following customization options are available for the report:

• You may ask for a global, regional, or country-specific report.
• You may ask if there are any particular types, applications, or products on which you would like to focus.
• You may ask for specific competitors/players to be profiled.

Oncology Companion Diagnostic Market Report

Statistics for the 2025 Oncology Companion Diagnostic market share, size, and revenue growth rate were created by Quintile Report™. Oncology Companion Diagnostic analysis includes a market forecast outlook for 2035 and a historical overview. Get a free PDF sample of this market analysis, please get in touch with our principal analyst at sales@quintilereports.com