Oncology Companion Diagnostic Market Size, Share And Growth Report 2035

(MENAFN- Quintile Reports) 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

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.

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