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UK Companion Diagnostics Oncology Market

ID: MRFR/MED/48450-HCR
200 Pages
Rahul Gotadki
October 2025

UK Companion Diagnostics Oncology Market Research Report By Technology (Next Generation Sequencing, Polymerase Chain Reaction, In Situ Hybridization, Immunohistochemistry), By Applications (Therapeutic Monitoring, Patient Stratification, Predictive Testing, Disease Diagnosis), By End-user (Hospitals, Diagnostic Laboratories, Research Institutions, Pharmaceutical Companies), and By Test Type (Genetic Tests, Protein Biomarker Tests, MicroRNA Tests, Pathological Analysis)- Forecast to 2035

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UK Companion Diagnostics Oncology Market Summary

As per MRFR analysis, the UK companion diagnostics-oncology market size was estimated at 357.04 USD Million in 2024. The UK companion diagnostics-oncology market is projected to grow from 383.39 USD Million in 2025 to 781.38 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 7.38% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The UK companion diagnostics-oncology market is poised for growth driven by technological advancements and regulatory support.

  • Integrating genomic testing is transforming the companion diagnostics landscape in oncology.
  • Regulatory support and innovation are fostering a conducive environment for the development of new diagnostic tools.
  • Collaborative efforts between industry and academia are accelerating advancements in companion diagnostics.
  • The rising incidence of cancer and the increased focus on personalized medicine are key drivers of market growth.

Market Size & Forecast

2024 Market Size 357.04 (USD Million)
2035 Market Size 781.38 (USD Million)
CAGR (2025 - 2035) 7.38%

Major Players

Roche (CH), Thermo Fisher Scientific (US), Abbott (US), Agilent Technologies (US), Illumina (US), Qiagen (DE), Myriad Genetics (US), Hologic (US), BioMérieux (FR)

UK Companion Diagnostics Oncology Market Trends

The companion diagnostics-oncology market is currently experiencing notable growth, driven by advancements in personalized medicine and the rising prevalence of cancer. This market focuses on the development of diagnostic tests that help identify specific biomarkers in patients, enabling healthcare providers to tailor treatment plans effectively. The integration of genomic testing into clinical practice appears to enhance patient outcomes, as it allows for more precise targeting of therapies. Furthermore, regulatory support from health authorities in the UK is fostering innovation and encouraging the adoption of these diagnostics in oncology settings. In addition, the rising awareness among healthcare professionals and patients regarding the benefits of companion diagnostics is likely to propel market expansion. As more stakeholders recognize the importance of personalized treatment approaches, the demand for these diagnostic tools is expected to increase. Collaborations between pharmaceutical companies and diagnostic developers may further enhance the availability of companion diagnostics, ensuring that patients receive the most effective therapies based on their unique genetic profiles. Overall, the companion diagnostics-oncology market is poised for continued growth, reflecting a shift towards more individualized cancer care.

Integration of Genomic Testing

The incorporation of genomic testing into oncology practices is becoming increasingly prevalent. This trend suggests that healthcare providers are recognizing the value of understanding a patient's genetic makeup to inform treatment decisions. By identifying specific mutations or biomarkers, clinicians can select therapies that are more likely to be effective, thereby improving patient outcomes.

Regulatory Support and Innovation

Regulatory bodies in the UK are actively promoting the development and approval of companion diagnostics. This support indicates a commitment to enhancing patient care through innovative diagnostic solutions. As regulations evolve, they may facilitate faster market entry for new tests, encouraging further advancements in the field.

Collaborative Efforts in Development

There is a growing trend of collaboration between pharmaceutical companies and diagnostic developers. Such partnerships appear to be essential for the successful integration of companion diagnostics into treatment protocols. By working together, these entities can streamline the development process and ensure that diagnostic tools are aligned with therapeutic advancements.

UK Companion Diagnostics Oncology Market Drivers

Advancements in Technology

Technological advancements in molecular biology and genomics are significantly influencing the companion diagnostics-oncology market. Innovations such as next-generation sequencing (NGS) and digital PCR have enhanced the accuracy and efficiency of diagnostic tests. These technologies enable the identification of specific biomarkers associated with various cancers, facilitating the development of tailored therapies. The UK has seen a notable increase in research funding, with investments reaching over £200 million in the last year alone, aimed at improving diagnostic capabilities. This influx of resources is likely to accelerate the introduction of novel companion diagnostics, thereby expanding the market. Furthermore, the integration of artificial intelligence in data analysis is expected to streamline the diagnostic process, making it more accessible and reliable for clinicians and patients alike.

Rising Incidence of Cancer

The increasing incidence of cancer in the UK is a primary driver for the companion diagnostics-oncology market. According to recent statistics, cancer cases are projected to rise by approximately 10% over the next decade. This surge necessitates the development of targeted therapies, which rely heavily on companion diagnostics to identify suitable patients for specific treatments. The companion diagnostics-oncology market is thus positioned to expand as healthcare providers seek to improve patient outcomes through personalized medicine. The National Health Service (NHS) has also recognized the importance of these diagnostics, integrating them into treatment protocols to enhance the efficacy of cancer therapies. As the population ages and lifestyle factors contribute to higher cancer rates, the demand for companion diagnostics is likely to grow, driving innovation and investment in this sector.

Regulatory Framework Enhancements

The evolving regulatory landscape in the UK is fostering growth in the companion diagnostics-oncology market. Recent initiatives by the Medicines and Healthcare products Regulatory Agency (MHRA) aim to expedite the approval process for innovative diagnostics. This regulatory support is crucial for companies developing companion diagnostics, as it reduces time-to-market and encourages investment in research and development. The UK government has also introduced policies that promote collaboration between regulatory bodies and industry stakeholders, enhancing the overall efficiency of the approval process. As a result, the companion diagnostics-oncology market is likely to witness an influx of new products, which could improve patient access to cutting-edge therapies and ultimately lead to better health outcomes.

Increased Focus on Personalized Medicine

The shift toward personalized medicine significantly drives the companion diagnostics-oncology market. Healthcare providers in the UK are increasingly recognizing the value of tailoring treatments to individual patient profiles, which necessitates the use of companion diagnostics. This approach not only improves treatment efficacy but also minimizes adverse effects, leading to enhanced patient satisfaction. The market is projected to grow as more oncologists adopt personalized treatment plans, with estimates suggesting a potential increase of 15% in the use of companion diagnostics over the next five years. Additionally, patient advocacy groups are actively promoting awareness of personalized medicine, further driving demand for these diagnostics in oncology.

Collaboration Between Industry and Academia

Collaboration between industry and academic institutions is emerging as a vital driver for the companion diagnostics-oncology market. Partnerships facilitate the sharing of knowledge and resources, leading to accelerated research and development of innovative diagnostic tools. In the UK, several universities have established alliances with biotech firms to advance the field of oncology diagnostics. These collaborations often result in the development of cutting-edge technologies that can be rapidly translated into clinical practice. The companion diagnostics-oncology market stands to benefit from these synergies, as they enhance the pipeline of new products and foster a culture of innovation. As more partnerships are formed, the market is likely to experience a surge in novel diagnostic solutions that address unmet clinical needs.

Market Segment Insights

By Technology: Next Generation Sequencing (Largest) vs. Polymerase Chain Reaction (Fastest-Growing)

In the UK companion diagnostics-oncology market, the distribution of market share is significantly influenced by Next Generation Sequencing (NGS), which holds the largest portion due to its advanced capabilities and high throughput. Polymerase Chain Reaction (PCR) follows as another vital segment, characterized by its reliability and established presence in molecular diagnostics. In Situ Hybridization (ISH) and Immunohistochemistry (IHC) are also prominent but account for smaller shares as they cater to more specific diagnostic needs. Growth trends in this segment indicate a notable shift towards Next Generation Sequencing, driven by rising demand for personalized medicine and targeted therapies. The PCR segment is also witnessing rapid expansion, buoyed by advancements in technology and increasing applications in oncology. Moreover, the growth of companion diagnostics is supported by investments in R&D and the integration of advanced technologies, enhancing diagnostic precision and patient outcomes.

Technology: NGS (Dominant) vs. PCR (Emerging)

Next Generation Sequencing stands out as the dominant technology in the UK companion diagnostics-oncology market. Its ability to analyze multiple genes simultaneously and provide comprehensive genetic profiles makes it an invaluable tool in personalized medicine. Conversely, Polymerase Chain Reaction is emerging rapidly, appreciated for its speed and simplicity in detecting specific genetic alterations. While NGS is primarily used for complex genomic analysis, PCR plays a critical role in routine diagnostics, making it essential for quickly validating treatment responses. Together, these technologies reflect the dynamic landscape of oncological diagnostics, showcasing both depth in capabilities and breadth in applications.

By Applications: Therapeutic Monitoring (Largest) vs. Patient Stratification (Fastest-Growing)

In the UK companion diagnostics-oncology market, Therapeutic Monitoring holds the largest market share as it plays a crucial role in assessing treatment efficacy in patients. This segment benefits significantly from the increasing adoption of targeted therapies, enabling healthcare providers to make informed decisions based on real-time data. On the other hand, Patient Stratification is gaining momentum due to its ability to identify patient subgroups that are likely to respond to specific treatments, leading to better therapeutic outcomes. The growth trend in the Applications segment is driven by advancements in technology and a shift towards personalized medicine. As healthcare systems increasingly focus on patient-centered approaches, predictive testing is emerging as a critical component in identifying genetic predispositions and tailoring therapies. Disease Diagnosis, while still essential, is being enhanced by the integration of companion diagnostics, further pushing the growth of intelligent testing methodologies in oncology.

Therapeutic Monitoring (Dominant) vs. Patient Stratification (Emerging)

Therapeutic Monitoring is characterized by its established role in ensuring the efficacy of cancer treatments, allowing clinicians to adapt therapies in real-time based on patient responses. This dominant value benefits from comprehensive frameworks and established methodologies that support its utilization in clinical environments. In contrast, Patient Stratification is an emerging segment that leverages genetic and biomarker profiling to create personalized treatment pathways. This segment is rapidly evolving as more sophisticated algorithms and tests are developed, enhancing the precision of oncology treatments, thus attracting attention from both healthcare providers and patients seeking optimized outcomes.

By End User: Hospitals (Largest) vs. Diagnostic Laboratories (Fastest-Growing)

In the UK companion diagnostics-oncology market, hospitals represent the largest end user segment, capturing a significant share due to their extensive resources and access to advanced technologies. This segment has been pivotal in integrating companion diagnostics into routine oncology practices, facilitating personalized treatment plans that enhance patient outcomes. Conversely, diagnostic laboratories are witnessing rapid growth as they innovate and expand their testing capabilities, playing a crucial role in driving the adoption of companion diagnostics through specialized services. The growth trends in this segment are primarily influenced by the increasing prevalence of cancer and the need for personalized medicine, which emphasizes the importance of accurate diagnostics. Hospitals are likely to continue their dominance, supported by substantial investments in advanced diagnostic tools and collaboration with pharmaceutical companies. At the same time, diagnostic laboratories are emerging rapidly, owing to technological advancements and growing partnerships with healthcare providers, enhancing their service offerings and market reach.

Hospitals: Dominant vs. Diagnostic Laboratories: Emerging

Hospitals are critical stakeholders in the UK companion diagnostics-oncology market, serving as the dominant end user due to their comprehensive infrastructure and ability to implement cutting-edge diagnostic tools effectively. These institutions are equipped to handle a wide array of oncology cases, emphasizing personalized treatments that leverage companion diagnostics. On the other hand, diagnostic laboratories are seen as an emerging segment, characterized by their ability to adapt quickly to technological advancements and market demands. They focus on providing specialized testing services, often collaborating with research institutions and pharmaceutical companies. This agility allows them to penetrate the market rapidly, complementing the hospital sector by offering advanced diagnostic services tailored to oncological treatments.

By Test Type: Genetic Tests (Largest) vs. Protein Biomarker Tests (Fastest-Growing)

In the UK companion diagnostics-oncology market, Genetic Tests hold the largest market share, driven by their established role in personalizing cancer treatments and their ability to identify specific genetic mutations in tumors. In contrast, Protein Biomarker Tests are gaining traction and are recognized as the fastest-growing segment due to increasing investments in research and advancements in technology that enhance the detection of cancer-related proteins. The growth trends indicate a strong demand for accurate diagnostics as healthcare providers strive for targeted therapies in oncology. Factors such as the rising prevalence of cancer, advancements in testing technologies, and a shift towards personalized medicine fuel the expansion of both Genetic Tests and Protein Biomarker Tests. The continuous innovation and increased awareness about companion diagnostics will likely strengthen their roles in the treatment landscape.

Genetic Tests (Dominant) vs. Pathological Analysis (Emerging)

Genetic Tests, being the dominant segment, are integral in identifying mutations that inform tailored treatment strategies for cancer patients. Their ability to provide specific genetic profiles enhances treatment efficacy and patient outcomes. On the other hand, Pathological Analysis remains an emerging segment that, while traditional, is rapidly evolving with the integration of advanced technologies. This segment focuses on the examination of tissue samples to understand the nature and cause of cancer, thus playing a vital role in diagnosis. With the push towards more precise and individualized treatment protocols, the significance of Pathological Analysis is expected to grow, complementing the advancements in Genetic Testing for comprehensive cancer care.

Get more detailed insights about UK Companion Diagnostics Oncology Market

Key Players and Competitive Insights

The companion diagnostics-oncology market is characterized by a dynamic competitive landscape, driven by the increasing demand for personalized medicine and advancements in genomic technologies. Key players such as Roche (CH), Thermo Fisher Scientific (US), and Illumina (US) are at the forefront, leveraging their extensive research capabilities and innovative product offerings. Roche (CH) focuses on integrating diagnostics with therapeutic solutions, enhancing its position through strategic partnerships and collaborations. Meanwhile, Thermo Fisher Scientific (US) emphasizes its commitment to innovation, particularly in next-generation sequencing (NGS) technologies, which are pivotal in companion diagnostics. Illumina (US) continues to expand its market presence through aggressive R&D investments and strategic acquisitions, thereby shaping the competitive environment towards a more integrated approach to oncology diagnostics.

The business tactics employed by these companies reflect a concerted effort to optimize supply chains and localize manufacturing processes. The market structure appears moderately fragmented, with a mix of established players and emerging biotech firms. This fragmentation allows for diverse approaches to market entry and product development, fostering a competitive atmosphere where innovation is paramount. The collective influence of these key players is significant, as they not only drive technological advancements but also set industry standards that smaller firms often follow.

In September 2025, Roche (CH) announced a collaboration with a leading biotech firm to develop a novel biomarker for breast cancer treatment. This strategic move is expected to enhance Roche's portfolio in personalized medicine, aligning with the growing trend towards targeted therapies. The partnership underscores Roche's commitment to innovation and its proactive approach to addressing unmet medical needs in oncology.

In October 2025, Thermo Fisher Scientific (US) launched a new NGS platform designed specifically for companion diagnostics applications. This platform aims to streamline the testing process, making it more accessible for healthcare providers. The introduction of this technology is likely to solidify Thermo Fisher's position as a leader in the diagnostics space, as it addresses the increasing demand for rapid and accurate testing solutions.

In August 2025, Illumina (US) expanded its partnership with a prominent pharmaceutical company to enhance the development of companion diagnostics for immuno-oncology therapies. This collaboration is strategically important as it not only broadens Illumina's product offerings but also reinforces its role in the rapidly evolving field of immunotherapy, which is gaining traction in oncology treatment protocols.

As of November 2025, current trends in the companion diagnostics-oncology market are heavily influenced by digitalization, sustainability, and the integration of artificial intelligence (AI) into diagnostic processes. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise to accelerate innovation. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on technological advancements, innovation, and supply chain reliability. This shift indicates a growing recognition of the importance of quality and efficacy in companion diagnostics, which will be crucial for companies aiming to maintain a competitive edge.

Key Companies in the UK Companion Diagnostics Oncology Market market include

Industry Developments

The UK Companion Diagnostics Oncology Market has seen notable developments recently, especially with companies like Illumina and Merck making strides in precision medicine. In September 2023, Illumina announced partnerships aimed at enhancing their genomic profiling capabilities, contributing to a significant boost in their market valuation.

Bristol-Myers Squibb also emphasized integrating companion diagnostics into their treatment pathways, reflecting a trend toward tailored therapies. Acquisitions have been prominent, with BioRad Laboratories acquiring a smaller diagnostics firm in August 2023, a move that is expected to fortify their portfolio in oncology diagnostics.

On the other hand, Thermo Fisher Scientific launched a new assay in July 2023, enhancing capabilities for detecting genetic mutations associated with various cancers. The UK government continues to support the landscape through initiatives aimed at fostering innovation in biotechnology, allowing companies like Agilent Technologies and Roche to thrive in this environment.

The market is witnessing a growth trajectory, driven by increasing investments and advancements in technology, positioning the UK as a competitive player in the field of oncology companion diagnostics, reflecting a broader trend in personalized medicine.

Future Outlook

UK Companion Diagnostics Oncology Market Future Outlook

The Companion Diagnostics Oncology Market is projected to grow at a 7.38% CAGR from 2024 to 2035, driven by advancements in personalized medicine, regulatory support, and increasing cancer prevalence.

New opportunities lie in:

  • Development of AI-driven diagnostic platforms for enhanced accuracy
  • Expansion of partnerships with pharmaceutical companies for co-development
  • Investment in telehealth solutions for remote patient monitoring and diagnostics

By 2035, the market is expected to achieve substantial growth, reflecting its critical role in oncology.

Market Segmentation

UK Companion Diagnostics Oncology Market End User Outlook

  • Hospitals
  • Diagnostic Laboratories
  • Research Institutions
  • Pharmaceutical Companies

UK Companion Diagnostics Oncology Market Test Type Outlook

  • Genetic Tests
  • Protein Biomarker Tests
  • MicroRNA Tests
  • Pathological Analysis

UK Companion Diagnostics Oncology Market Technology Outlook

  • Next Generation Sequencing
  • Polymerase Chain Reaction
  • In Situ Hybridization
  • Immunohistochemistry

UK Companion Diagnostics Oncology Market Applications Outlook

  • Therapeutic Monitoring
  • Patient Stratification
  • Predictive Testing
  • Disease Diagnosis

Report Scope

MARKET SIZE 2024 357.04(USD Million)
MARKET SIZE 2025 383.39(USD Million)
MARKET SIZE 2035 781.38(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 7.38% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled Roche (CH), Thermo Fisher Scientific (US), Abbott (US), Agilent Technologies (US), Illumina (US), Qiagen (DE), Myriad Genetics (US), Hologic (US), BioMérieux (FR)
Segments Covered Technology, Applications, End User, Test Type
Key Market Opportunities Integration of artificial intelligence in companion diagnostics-oncology market enhances personalized treatment strategies.
Key Market Dynamics Rising regulatory scrutiny drives innovation and competition in the companion diagnostics-oncology market.
Countries Covered UK

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FAQs

What is the expected market size of the UK Companion Diagnostics Oncology Market in 2024?

The UK Companion Diagnostics Oncology Market is expected to be valued at 256.95 million USD in 2024.

What is the projected market size for the UK Companion Diagnostics Oncology Market by 2035?

By 2035, the market is projected to reach a value of 580.0 million USD.

What is the expected compound annual growth rate (CAGR) for the UK Companion Diagnostics Oncology Market between 2025 to 2035?

The expected CAGR for the UK Companion Diagnostics Oncology Market is 7.682% from 2025 to 2035.

Which technology segment is projected to have the highest market value in 2035?

The Next Generation Sequencing segment is anticipated to reach a value of 168.0 million USD in 2035.

What is the market value for the Polymerase Chain Reaction segment in 2024?

The Polymerase Chain Reaction segment is valued at 65.0 million USD in 2024.

Who are the key players in the UK Companion Diagnostics Oncology Market?

Major players include Illumina, Hologic, Bristol Myers Squibb, BioRad Laboratories, and Merck.

How much is the Immunohistochemistry segment valued at in 2024?

The Immunohistochemistry segment is valued at 70.0 million USD in 2024.

What is the anticipated market value for In Situ Hybridization in 2035?

In Situ Hybridization is projected to reach a market value of 100.0 million USD by 2035.

What growth opportunities exist within the UK Companion Diagnostics Oncology Market?

Emerging trends include advancements in personalized medicine and an increasing focus on targeted therapies.

How do the key market players impact the UK Companion Diagnostics Oncology Market?

The presence of key competitors enhances innovation, drives market expansion, and influences pricing strategies.

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