Oncology Companion Diagnostic Market Size, Share & Trends Analysis Report By Product & Service, By Technology (IHC, NGS), By Disease Type (Breast Cancer, Leukemia), By End Use, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global oncology companion diagnostic market size was estimated at USD 4.78 billion in 2023 and is projected to grow at a CAGR of 8.7% from 2024 to 2030. The growth of the market is attributed to the increasing prevalence of cancer, the growing adoption of companion diagnostics, and a rising emphasis on personalized medicine. The demand for oncology companion diagnostic tests and technologies is driven by the rising prevalence of cancers worldwide. According to the Pan American Health Organization (PAHO), around 20 million new cancer cases and 10 million deaths were expected in 2023, and the annual reported cases of cancer are likely to reach 30 million by 2040. The need to develop diagnostic options that can detect cancer at an early stage, which can help improve disease management & reduce mortality, is anticipated to propel the overall market growth.

Companion diagnostics can enhance the treatment effects of different diseases by providing doctors with clear clinical grounds for diagnosis & treatment, as well as proper management of patient resources and national insurance policies by reducing unnecessary treatment of costly targeted chemotherapy drugs. The application of companion diagnostics, in combination with the therapy, can enable patients to benefit from individualized treatment. Due to the growing demand for targeted agents and the reduction in the cost of new drug development, this market is anticipated to witness lucrative growth over the forecast period.

Key beneficiaries of theranostics include patients, pharmaceutical companies, regulatory agencies, and clinicians. Theranostics aid in reducing time, targeted recruitment of patients, and clinical trial costs. Comorbid diagnostics impact regulatory agencies by curtailing healthcare costs as it reduces cost and time. This enables the government to monitor the share of healthcare GDP. Recently, in March 2024, the Radiological Society Of North America highlighted the use of theranostic agents in cancer treatment, which combine diagnostics and therapeutics to personalize care. Theranostics is particularly beneficial for neuroendocrine tumors and prostate cancer, improving outcomes through targeted approaches. The approach enables physicians to detect tumors with high precision and deliver treatment directly to cancer cells, minimizing adverse effects.

Furthermore, a growing focus on the development of new companion diagnostic tests for early-stage cancer detection and treatment is another factor expected to boost the market. For instance, in June 2022, GRAIL and AstraZeneca announced a strategic collaboration to develop companion diagnostic tests for early-stage cancer treatment. This partnership aimed to leverage GRAIL's multi-cancer early detection technology with AstraZeneca’s expertise in targeted therapies. The goal was to create diagnostic tools that could identify cancer at earlier stages, enabling more effective and personalized treatment options. The collaboration focused on improving outcomes for cancer patients by integrating cutting-edge diagnostics with innovative therapeutic approaches.

Precision medicine tailors treatment plans based on a patient’s unique biological makeup, environment, and lifestyle. It uses biomarkers to reveal specific pathological processes or responses to interventions, shifting from a “one size fits all” to a “targeted testing and treatment” approach. This involves pairing targeted treatments with companion diagnostic tests to determine patient suitability and response. Companion diagnostics are crucial for the success of precision medicine, enabling timely treatment of diseases by identifying suitable candidates for targeted therapies and allowing early initiation of effective treatments.

However, stringent regulations for companion diagnostics may significantly restrain market growth. Companion diagnostics are designed to identify patients who are most likely to benefit from a particular therapy. This requires a deep understanding of both the diagnostic & therapeutic modalities and their interplay. The specificity of companion diagnostics means they are often linked to drugs and must demonstrate efficacy in the context of specific patient populations. Hence, regulations can vary significantly from one country to another for companion diagnostics, requiring manufacturers to navigate multiple sets of rules and standards. For instance, several regulatory bodies, such as the FDA, EMA, and PMDA, have distinct requirements and processes for approval. This variability can complicate global market entry and compliance.

Industry Dynamics

The degree of innovation is high in market, particularly in the innovations such as plasma fluidic chips, which are the size of a postage stamp. For instance, in August 2022, Roche announced the launch of the Digital LightCycler System, a digital PCR system for accurately detecting cancer.

The product expansion activities is moderate in the market. Several players adopt this strategy to increase the outreach of their products in the market and increase the availability of their products in diverse geographic areas.

The use of companion diagnostics often involves sensitive patient data, which must be handled in accordance with privacy regulations and ethical considerations. Hence, maintaining compliance with evolving regulations and standards throughout the lifecycle of the diagnostic device adds an additional layer of complexity. For instance, as of now, there are no dedicated guidelines or regulatory frameworks in India specifically for the approval and regulation of companion diagnostics.

The expansion of global partnerships between leading academic medical centers and international healthcare organizations is further contributing to the segment growth. For instance, in February 2023, the University of Texas, MD Anderson Cancer Center, announced a collaboration with the Ministry of Health of the Republic of Indonesia to share best practices in cancer education, prevention, research, and treatment. By leveraging their expertise and resources, academic medical centers can help build local capacity for cancer diagnosis & treatment worldwide, ensuring that more patients have access to advanced companion diagnostics and personalized therapies.

The market shows a high end-user concentration, with a significant portion of revenue generated from a limited number of key customers, primarily in the hospital. With the growing adoption, hospitals are increasingly embracing advancements in diagnostics. The evolution of hospital laboratories plays a vital role in meeting the changing demands of patients.

Product & Services Insights

Products segment dominated the market with a share of 66.3% in 2023 driven by advancements in personalized medicine and the increasing prevalence of cancer. This segment includes various types of products, such as instruments, consumables, and software. These diagnostics help oncologists tailor treatment plans based on a patient's tumor's molecular profile, improving treatment efficacy and minimizing adverse effects. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) established guidelines to approve companion diagnostics, ensuring these tests are safe and effective before they reach the market. For instance, in December 2022, QIAGEN obtained approval from the FDA for a companion diagnostic associated with Mirati Therapeutics' KRAZATI, specifically for its application in treating Non-Small Cell Lung Cancer (NSCLC).

Services segment is expected to register fastest CAGR during the forecast period. The growth of the service segment is expected to be driven by the presence of service providers such as Covance, LabCorp, and Q2 Solutions which offer services for developing Companion Diagnostics (CDx). In June 2023, the FDA initiated a pilot program to mitigate the risks associated with laboratory tests for identifying cancer biomarkers. This initiative is designed to assist healthcare professionals in selecting appropriate cancer treatments for their patients. Furthermore, data management and analytics services are increasingly becoming integral to the diagnostic landscape of oncology companions.

Technology Insights

Polymerase Chain Reaction (PCR) segment dominated the market with a share of 22.0% in 2023. The real-time PCR assays available in the market offer high specificity and sensitivity, making them the go-to method for cancer diagnosis. In addition, real-time PCR techniques are favorable options for analyzing cancer markers. In clinical laboratories, real-time PCR offers benefits such as simultaneous analysis of multiple genes, low reagent costs, internal controls, and preservation of precious samples for tumor profiling. For instance, in November 2023, Roche launched the next-generation LightCycler PRO qPCR system to enhance molecular diagnostics and tackle public health challenges, improving performance and usability for clinical & research applications.

Next-generation Sequencing (NGS) segment is expected to register fastest CAGR during the forecast period. With the emergence of NGS in the past decade, cancer diagnostics have tremendously evolved. Advances in NGS technology supported the development in various areas of cancer research. NGS analysis of tumor genomics, transcriptomics, and epigenomics drive biomarker discovery in cancer diagnostics & tumor stratification. The benefits of NGS technology include the detection of minor possible mutations, the combined detection of SNP & more extensive abnormalities, and a combination of high throughput, speed, & resolution. Owing to these benefits, the use of the NGS technique in cancer diagnosis is anticipated to increase.

Disease Type Insights

Non-small cell lung cancer segment dominated the market with a share of 30.3% in 2023. The increasing number of Non-small Cell Lung Cancer (NSCLC) cases worldwide is a major driver for the companion diagnostics market. According to the American Cancer Society, NSCLC constitutes roughly 80% to 85% of all lung cancer diagnoses. This increasing prevalence underscores the urgent need for effective diagnostic tools to inform treatment decisions, thereby driving market growth. As the burden of NSCLC rises, the demand for CDx becomes critical in ensuring patients receive the most appropriate therapies. These diagnostics are essential for identifying specific biomarkers to guide targeted treatments, improving patient outcomes, and optimizing healthcare resources.

Breast cancer segment is expected to register fastest CAGR during the forecast period. The growing integration of advanced screening tools and Artificial Intelligence (AI) in oncology is a significant market driver for the oncology companion diagnostic market. For instance, in January 2024, Weill Cornell Medicine was awarded a USD 2.4 million grant from the U.S. Department of Defense Breast Cancer Research Program to validate a new blood test designed for early breast cancer detection. This test, known as Syantra DX Breast Cancer, utilizes an AI algorithm to identify cancer at its earliest stages, even before symptoms manifest or are detectable by mammograms. Moreover, the collaboration between pharmaceutical companies and diagnostic developers to create patient-centric diagnostic frameworks is enhancing the effectiveness of CDx.

End Use Insights

Hospitals segment dominated the oncology companion diagnostic market with a share of 51.8% in 2023. Hospitals typically have a wide array of cancer diagnostic tests. Due to the high prevalence of cancer and an aging population, hospitals are witnessing an increase in the use of cancer diagnostic products over the past few years. With the growing adoption, hospitals are increasingly embracing advancements in diagnostics. The evolution of hospital laboratories plays a vital role in meeting the changing demands of patients. Consequently, more healthcare facilities are striving to offer a diverse array of services within their environments.Hospitals are increasingly investing in advanced diagnostic technologies and collaborating with pharmaceutical companies to enhance their capabilities in personalized cancer treatment. For instance, in May 2023, the newly launched Rapid Cancer Diagnostic Service (RCDS) at NHS Borders represents a significant advancement in early cancer detection, particularly for patients presenting with vague, nonspecific symptoms.

Pathology/Diagnostic laboratory segment is anticipated to grow at fastest growth over the forecast period. The Pathology/Diagnostic laboratory plays a crucial role in the oncology companion diagnostic market. These labs are responsible for developing and implementing tests that help identify specific biomarkers in cancer patients, enabling the selection of appropriate targeted therapies. They work closely with pharmaceutical companies, healthcare providers, and patients to ensure accurate test results & effective treatment decisions. The establishment of advanced laboratories dedicated to companion diagnostic development is a significant driver of the pathology/diagnostic labs segment in the market. For instance, in July 2024, Danaher is planning to establish a CLIA and CAP-certified laboratory in the UK, followed by another facility in the U.S.

Regional Insights

North America dominated the market with largest revenue share of 40.4% in 2023. The dominance of the region is attributed to the presence of advanced healthcare infrastructure and substantial healthcare expenditure in North America that are driving the widespread adoption of diagnostic technologies. In addition, leading research institutions and biotechnology firms are dedicated to developing innovative diagnostic methods. Along with a robust regulatory framework that ensures timely approval and commercialization of new diagnostic tools, these factors are anticipated to significantly propel the North America oncology companion diagnostic market over the forecast period.

U.S. Oncology Companion Diagnostic Market Trends

U.S. oncology companion diagnostic market is expected to grow over the forecast perioddue to the high cancer prevalence in the country and consequent rapid adoption of companion diagnostics.Furthermore, significant technological advancements, increasing FDA approvals for tests, and rising competition among biotechnology companies are projected to boost the market over the forecast period.

Europe Oncology Companion Diagnostic Market Trends

Europe accounted for a significant share of the global oncology companion diagnostic market. This can be attributed to the presence of developed economies, such as Germany, Spain, the UK, France, and Italy. These countries have advanced infrastructure, which is anticipated to significantly boost clinical research prospects in the region.

UK oncology companion diagnostic market is growing primarily due to the presence of advanced healthcare infrastructure, strategic collaborations, and introduction of innovative products are expected to drive market growth in the UK.

Oncology companion diagnostic market in France is expected to grow over the forecast period.Companies and research institutes are entering several unique partnerships to offer in-house CDx genomic testing for cancer patients in France, significantly enhancing market growth by improving diagnostic precision and personalized treatment options.

Germany oncology companion diagnostic market in is expected to witness substantial growth. The rising incidence of cancer disease is anticipated to boost demand for CDx products over the forecast period.

Asia Pacific Oncology Companion Diagnostic Market Trends

The Asia-Pacific market is expected to witness the fastest CAGR of over the projected period driven by healthcare reforms, enhanced infrastructure, a growing population, and an increasing number of local companies entering the market. With a large population and high cancer prevalence, the region is a significant focus for oncology advancements. According to Global Cancer Statistics 2022, nearly half of all global cancer cases and approximately 56.1% of cancer deaths in 2022 were reported in Asia.

In addition, GLOBOCAN data indicates that Asia Pacific accounted for the highest share of global cancer incidences in 2022, representing 45.5%, with a total of 232,537 cases. The favorable growth conditions in the Asia Pacific region, including healthcare improvements and market entry by local companies, are likely to drive the demand for companion diagnostics. The high cancer prevalence and incidence underscore the need for effective diagnostic solutions, making the region a key market for oncology companion diagnostics.

The oncology companion diagnostic market in China is expected to grow over the forecast period, due to lifestyle changes, dietary habits, and an aging population. Companies are engaged in developing new therapies to treat oncology CDx.

Japan The oncology companion diagnostic market is expected to grow over the forecast period driven by substantial government investments aimed at reducing cancer incidence. Japan has a significantly aging population, with over 10% of its citizens aged 80 or older, making it consistently have the world's oldest population.

Latin America Oncology Companion Diagnostic Market Trends

Latin America oncology companion diagnostic market was identified as a lucrative region in this industry. The region has experienced significant growth in precision medicine technology, driven by various initiatives to boost R&D. Furthermore, collaborations among pharmaceutical companies, diagnostics firms, and service providers are enhancing access to precision medicine technologies.

The oncology companion diagnostic market in Brazil is expected to grow over the forecast period. The market is evolving with advancements in genetic testing technologies and a growing emphasis on precision medicine, driven by collaborations between global innovators and local healthcare providers.

MEA Oncology Companion Diagnostic Market Trends

MEA oncology companion diagnostic market was identified as a lucrative region in this industry. The market is witnessing significant growth opportunities, as the majority of market is untapped due to the absence of structured cancer screening programs in underdeveloped African economies has impeded early detection efforts.

The oncology companion diagnostic market in Saudi Arabia is expected to grow over the forecast period attributed to the increasing involvement of the government and the rising awareness about benefits of noninvasive diagnostic procedures.

Key Oncology Companion Diagnostic Company Insights

Some of the leading players operating in the market include Agilent Technologies, Inc., Illumina Inc., and Merck KGaA. These players are involved in developing novel Next-Generation Sequencing (NGS) products, panels, kits and IHC systems that offer portability and sequencing efficiency.Research & Development (R&D) pertaining to the introduction of new technologies in collaboration with pharmaceutical entities & biotechnology organizations.These players have strong product portfolios with the presence of advanced products and a focus on investing more in R&D activities.

Biosystems, Guardant Health, Inc., and EntroGen, Inc. are some of the emerging market participants in the market. These players are collaborating with other major & local players to gain a competitive edge. These players focus on regional expansion by exploring possibilities to develop companion diagnostics, NGS platforms, and services that enable clinical testing in laboratories.

Recent Developments

• In November 2023, Agilent Technologies, Inc announced that the FDA approved the PD-L1 IHC 22C3 pharmDx diagnostic test to identify patients with gastric or gastroesophageal junction adenocarcinoma who are eligible for treatment with the PD-1 inhibitor pembrolizumab.

• In November 2023, The FDA approved a companion diagnostic test to identify patients with advanced HR-positive, HER2-negative breast cancer who are eligible for treatment with the combination of capivasertib (Truqap, AstraZeneca Pharmaceuticals) and fulvestrant. FDA also announced the approval of the FoundationOne CDx assay as a companion diagnostic device to recognize patients with breast cancer for treatment with fulvestrant with capivasertib.

• In April 2023, Merck announced the acquisition of Prometheus Biosciences, Inc., a biotechnology company specializing in the development of precision therapies for immune-mediated diseases. The acquisition aimed to strengthen Merck’s immunology pipeline and expand its capabilities in precision medicine.

Oncology Companion Diagnostic Market Report Scope

Global Oncology Companion Diagnostic Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global oncology companion diagnostic market report based on product & services, technology, disease type, end-use and region.

• Product & Services Outlook (Revenue, USD Million, 2018 - 2030)

  • Product

    • Instrument

    • Consumables

    • Software

  • Services

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Polymerase Chain Reaction (PCR)

  • Next-generation Sequencing (NGS)

  • Immunohistochemistry (IHC)

  • In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)

  • Other Technologies

• Disease Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Breast Cancer

  • Non-small Cell Lung Cancer

  • Colorectal Cancer

  • Leukemia

  • Melanoma

  • Prostate Cancer

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospital

  • Pathology/Diagnostic Laboratory

  • Academic Medical Center

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait