Tag: oncology companion diagnostics market size

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Oncology Companion Diagnostics Market Revenue Growth Supported By A CAGR Of 6.49% Through 2030

The market for companion diagnostics in oncology has experienced substantial expansion recently, projected to escalate from $3.79 billion in 2025 to $4.29 billion in 2026, reflecting a compound annual growth rate of 13.0%. This upward trajectory in the historical period is underpinned by several key factors including the increasing incidence of cancers like breast, colorectal, and melanoma, a heightened emphasis on individualized treatment approaches, a growing need for precise targeted therapy selection, the proliferation of diagnostic laboratories and healthcare facilities, and advancements in molecular and genetic testing methodologies.

The market for oncology companion diagnostics is poised for substantial expansion over the coming years, projected to reach $6.5 billion by 2030, reflecting a compound annual growth rate of 10.9%. This anticipated surge is fueled by several key factors: the increasing embrace of next-generation sequencing (NGS) and PCR-based diagnostic methods, enhanced partnerships between pharmaceutical and diagnostic firms, a growing number of regulatory approvals for companion diagnostics, a heightened demand for personalized cancer treatments, and a greater utilization of bioinformatics and decision-support software within the diagnostic landscape. Significant trends expected to shape this market during the forecast period include the growing adoption of digital platforms for managing companion diagnostic data, a more pronounced integration of artificial intelligence in analyzing biomarkers and stratifying patient populations, the expanding application of genomics and precision medicine in the development of targeted cancer therapies, increased automation in diagnostic testing and laboratory processes, and the rising use of the Internet of Things (IoT) for monitoring diagnostic equipment and consumables.

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Oncology Companion Diagnostics Market Growth Factors: Which Forces Are Supporting Market Expansion?

The projected increase in cancer incidence is anticipated to be a primary catalyst for the expansion of the oncology companion diagnostics market. Cancer, characterized by the uncontrolled proliferation and dissemination of aberrant cells within the body, is on the rise due to a confluence of factors including altered lifestyles, environmental influences, the global obesity crisis, tobacco consumption, and hereditary predispositions. Within the realm of oncology, companion diagnostics are instrumental in advancing personalized medicine, transforming patient care by facilitating tailored treatment choices, boosting therapeutic effectiveness, mitigating unwanted side effects, streamlining participation in clinical studies, and improving the oversight of treatment progress. Illustrating this trend, data from the US National Cancer Institute in May 2024 reported approximately 20 million new cancer diagnoses and 9.7 million fatalities linked to the disease in 2022, with projections suggesting an annual toll of 15.3 million deaths and 29.9 million new cases by the year 2040. Consequently, the escalating number of cancer diagnoses directly fuels the growth trajectory of the oncology companion diagnostics market.

Oncology Companion Diagnostics Market Segment Analysis Highlighting Growth Areas

The oncology companion diagnostics market covered in this report is segmented –

1) By Product: Instrument, Consumables, Software

2) By Disease Type: Melanoma, Breast Cancer, Colorectal Cancer, Leukemia, Prostate Cancer, Other Disease Types

3) By Technology: Immunohistochemistry (IHC), In Situ Hybridization (ISH) Or Fluorescence In Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Other Technologies

4) By End User: Hospital, Pathology Or Diagnostic Laboratory, Academic Medical Center, Other End-Users

Subsegments:

1) By Instrument: Polymerase Chain Reaction (PCR) Instruments, Next-Generation Sequencing (NGS) Systems, Immunohistochemistry (IHC) Instruments, Fluorescence In Situ Hybridization (FISH) Instruments, Microarray Platforms

2) By Consumables: Reagents And Kits (DNA Or RNA Extraction Kits, PCR Reagents), Biopsy Needles, Testing Slides And Chips, Control And Calibration Samples

3) By Software: Data Analysis Software, Bioinformatics Software (For Gene Expression Analysis), Companion Diagnostic Decision Support Software, Clinical Workflow Management Software

Oncology Companion Diagnostics Market Industry Trends: What Changes Are Reshaping Demand?

Leading entities within the oncology companion diagnostics sector are prioritizing the advancement of sophisticated, high-volume sequencing methodologies. A prime example is the adoption of the c-MET companion diagnostic assay, which aids in therapeutic decision-making for individuals diagnosed with advanced non-small cell lung cancer. This application serves to bolster precision oncology initiatives and refine the selection of personalized treatment regimens. Specifically, the implementation of the c-MET companion diagnostic assay for guiding therapy in advanced NSCLC involves the utilization of a specialized detection test. This test identifies c-MET genetic variations in patients afflicted with advanced non-small cell lung cancer, thereby empowering healthcare providers to choose suitable treatments, maximize therapeutic effectiveness, and champion precision medicine strategies. To illustrate, in May 2025, NeoGenomics, Inc., a prominent American oncology diagnostics firm, introduced its c-MET CDx Assay. This assay is intended to inform therapeutic choices for patients presenting with advanced Non-Small Cell Lung Cancer (NSCLC). The c-MET CDx Assay functions as a companion diagnostic tool, designed to identify c-MET protein overexpression within tumor samples, thereby yielding swift and precise outcomes that pinpoint patients who could benefit from therapies targeting the MET pathway. This assay is characterized by its exceptional sensitivity and specificity, expedited processing times, consistent testing protocols, and seamless integration into standard clinical procedures, positioning it as an invaluable asset for advancing precision oncology and customizing patient care plans.

Oncology Companion Diagnostics Market Leading Companies: Who Holds Significant Market Presence?

Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Laboratory Corporation of America Holdings (LabCorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Illumina Inc., PerkinElmer Inc., bioMérieux SA, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N.V., Exact Sciences Corporation, BGI Genomics Co. Ltd., Natera Inc., Myriad Genetics Inc., ARUP Laboratories, NeoGenomics Laboratories Inc., Guardant Health, Ambry Genetics Corporation, Biocartis SA, CENTOGENE N.V., Invivoscribe Inc., Pillar Biosciences Inc.

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Oncology Companion Diagnostics Market Leading Geography: Which Region Generates The Most Revenue?

North Americawas the largest region in the oncology companion diagnostic market in 2025. Asia-Pacificis expected to be the fastest-growing region in the forecast period. The regions covered in the oncology companion diagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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How Will The Market Value Of The Oncology Companion Diagnostics Market Increase Between 2026 And 2030?

Recent years have witnessed significant expansion in the size of the oncology companion diagnostics market. Projections indicate that it will increase from $3.79 billion in 2025 to $4.29 billion in 2026, achieving a compound annual growth rate (CAGR) of 13.0%. This historical growth can be attributed to several factors, including the rising incidence of cancer types like breast, colorectal, and melanoma, a growing emphasis on personalized medicine, the increasing need for targeted therapy selection, the proliferation of diagnostic laboratories and hospitals, and advancements in molecular and genetic testing technologies.

The oncology companion diagnostics market size is anticipated to expand substantially over the coming years. It is projected to reach $6.5 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 10.9%. This projected expansion during the forecast period is primarily driven by the increasing integration of next-generation sequencing (ngs) and pcr-based diagnostics, heightened collaboration between pharmaceutical and diagnostic enterprises, a rise in regulatory clearances for companion diagnostics, growing demand for precision oncology, and the expanded utilization of bioinformatics and decision support software in diagnostics. Prominent trends for this period encompass the escalating adoption of digital platforms for managing companion diagnostic data, greater incorporation of ai in biomarker analysis and patient stratification, the expanding application of genomics and precision medicine in targeted cancer therapy, increased automation in diagnostic testing and laboratory workflows, and the rising deployment of iot-enabled monitoring for diagnostic instruments and reagents.

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Which Significant Factors Are Encouraging Growth In The Oncology Companion Diagnostics Market?

The anticipated increase in cancer cases is set to fuel the expansion of the oncology companion diagnostics market. Cancer refers to a multifaceted array of illnesses stemming from anomalous cells within the body that multiply and disseminate without regulation. This surge in cancer occurrences can be attributed to evolving lifestyles, environmental elements, the widespread obesity epidemic, tobacco consumption, and inherited genetic predispositions. Oncology companion diagnostics play a crucial role in precision medicine within oncology, fundamentally transforming cancer treatment by allowing for individualized therapy choices, boosting the effectiveness of treatments, reducing negative side effects, assisting in clinical trial participation, and refining the oversight of patient care. To illustrate, data released in May 2024 by the National Cancer Institute, a US-based government agency, reported approximately 20 million new cases and 9.7 million cancer-related deaths annually in 2022, with projections suggesting that by 2040, these figures could reach 15.3 million deaths and 29.9 million new cases per year. Consequently, the escalating number of cancer cases is a significant driver for the oncology companion diagnostics market.

How Is The Oncology Companion Diagnostics Market Examined Through Segment Analysis?

The oncology companion diagnostics market covered in this report is segmented –

1) By Product: Instrument, Consumables, Software

2) By Disease Type: Melanoma, Breast Cancer, Colorectal Cancer, Leukemia, Prostate Cancer, Other Disease Types

3) By Technology: Immunohistochemistry (IHC), In Situ Hybridization (ISH) Or Fluorescence In Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Other Technologies

4) By End User: Hospital, Pathology Or Diagnostic Laboratory, Academic Medical Center, Other End-Users

Subsegments:

1) By Instrument: Polymerase Chain Reaction (PCR) Instruments, Next-Generation Sequencing (NGS) Systems, Immunohistochemistry (IHC) Instruments, Fluorescence In Situ Hybridization (FISH) Instruments, Microarray Platforms

2) By Consumables: Reagents And Kits (DNA Or RNA Extraction Kits, PCR Reagents), Biopsy Needles, Testing Slides And Chips, Control And Calibration Samples

3) By Software: Data Analysis Software, Bioinformatics Software (For Gene Expression Analysis), Companion Diagnostic Decision Support Software, Clinical Workflow Management Software

Which Trends Are Expected To Shape The Oncology Companion Diagnostics Market?

Key companies operating within the oncology-based in vivo CRO market are focusing on developing novel solutions like CAR T-cell therapies to achieve a competitive advantage. CAR T-cell therapy is a form of immunotherapy that utilizes specifically modified T cells to combat cancer. As an illustration, in May 2023, Seattle Children’s Hospital and Research Institute, a US-based entity, launched BrainChild Bio to expedite CAR T-cell therapies for children suffering from brain tumors. The initial pediatric brain tumors BrainChild Bio intends to target with CAR T-cell therapy are diffuse intrinsic pontine gliomas (DIPG), an incurable childhood condition that originates in the brainstem. BrainChild Bio represents a next-generation CAR T-cell treatment platform that integrates synthetic technologies to maximize the effectiveness of CAR T-cell therapies for CNS malignancies. After securing pediatric registration for DIPG, BrainChild Bio plans to apply its innovative CAR T-cell therapy to treat a wider range of challenging adult and pediatric brain tumors, such as glioblastoma and brain metastases.

Who Are The Key Market Participants In The Oncology Companion Diagnostics Market?

Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Laboratory Corporation of America Holdings (LabCorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Illumina Inc., PerkinElmer Inc., bioMérieux SA, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N.V., Exact Sciences Corporation, BGI Genomics Co. Ltd., Natera Inc., Myriad Genetics Inc., ARUP Laboratories, NeoGenomics Laboratories Inc., Guardant Health, Ambry Genetics Corporation, Biocartis SA, CENTOGENE N.V., Invivoscribe Inc., Pillar Biosciences Inc.

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Which Regional Market Leads The Oncology Companion Diagnostics Market?

North America was the largest region in the oncology companion diagnostic market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the oncology companion diagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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By 2030, What Market Size Is The Oncology Companion Diagnostics Market Expected To Reach Based On Its 2026 Value?

The oncology companion diagnostics market size has experienced rapid growth in recent years. It is expected to expand from $3.79 billion in 2025 to $4.29 billion in 2026, demonstrating a compound annual growth rate (CAGR) of 13.0%. The expansion observed historically is attributable to the increasing prevalence of cancer types such as breast, colorectal, and melanoma, a stronger emphasis on personalized medicine, the rising need for targeted therapy selection, the growth of diagnostic laboratories and hospitals, and the evolution of molecular and genetic testing technologies.

The oncology companion diagnostics market size is anticipated to undergo significant growth in the coming years. It is projected to expand to $6.5 billion by 2030, at a compound annual growth rate (CAGR) of 10.9%. The market’s expansion during this forecast period is attributable to the rising adoption of next-generation sequencing (ngs) and pcr-based diagnostics, increasing collaboration between pharma and diagnostic companies, growth in regulatory approvals for companion diagnostics, rising demand for precision oncology, and increasing use of bioinformatics and decision support software in diagnostics. Key trends in the forecast period include the rising adoption of digital platforms for companion diagnostic data management, increasing integration of AI in biomarker analysis and patient stratification, growing use of genomics and precision medicine in targeted cancer therapy, rising automation in diagnostic testing and laboratory workflows, and increasing IoT-enabled monitoring of diagnostic instruments and reagents.

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What Major Factors Are Driving The Oncology Companion Diagnostics Market Forward?

The increasing incidence of cancer is anticipated to drive the future expansion of the oncology companion diagnostics market. Cancer encompasses a complex group of illnesses stemming from abnormal cells in the body that proliferate and spread uncontrollably. This escalation in cancer cases is attributable to shifts in lifestyle, environmental influences, the prevalence of obesity, tobacco use, and inherited genetic factors. Oncology companion diagnostics are integral to precision medicine strategies in oncology, transforming cancer care by enabling customized treatment selection, enhancing therapeutic effectiveness, minimizing adverse reactions, facilitating enrollment in clinical trials, and improving treatment monitoring. For instance, in May 2024, the National Cancer Institute, a US-based government agency, reported approximately 20 million new cases and 9.7 million cancer-related deaths annually in 2022, with projections indicating a rise to 15.3 million deaths and 29.9 million new cases per year by 2040. Thus, an increase in cancer cases is a key driver for the oncology companion diagnostics market.

What Are The Different Segment Types In The Oncology Companion Diagnostics Market Segment Breakdown?

The oncology companion diagnostics market covered in this report is segmented –

1) By Product: Instrument, Consumables, Software

2) By Disease Type: Melanoma, Breast Cancer, Colorectal Cancer, Leukemia, Prostate Cancer, Other Disease Types

3) By Technology: Immunohistochemistry (IHC), In Situ Hybridization (ISH) Or Fluorescence In Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Other Technologies

4) By End User: Hospital, Pathology Or Diagnostic Laboratory, Academic Medical Center, Other End-Users

Subsegments:

1) By Instrument: Polymerase Chain Reaction (PCR) Instruments, Next-Generation Sequencing (NGS) Systems, Immunohistochemistry (IHC) Instruments, Fluorescence In Situ Hybridization (FISH) Instruments, Microarray Platforms

2) By Consumables: Reagents And Kits (DNA Or RNA Extraction Kits, PCR Reagents), Biopsy Needles, Testing Slides And Chips, Control And Calibration Samples

3) By Software: Data Analysis Software, Bioinformatics Software (For Gene Expression Analysis), Companion Diagnostic Decision Support Software, Clinical Workflow Management Software

Which Trends Are Impacting The Progress Of The Oncology Companion Diagnostics Market?

Leading companies within the oncology companion diagnostics market are concentrating on developing advanced high-throughput sequencing technologies, such as the implementation of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer, with the goal of enhancing precision oncology and individualized treatment selection. The application of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer involves deploying a targeted diagnostic test to detect c-MET gene alterations in patients with advanced non-small cell lung cancer (NSCLC), enabling clinicians to choose appropriate therapies, optimize treatment efficacy, and support precision medicine approaches. For example, in May 2025, NeoGenomics, Inc., a US-based oncology testing company, launched its c-MET CDx Assay to guide treatment decisions for patients with advanced Non-Small Cell Lung Cancer (NSCLC). This c-MET CDx Assay is a companion diagnostic test specifically designed to detect c-MET protein overexpression in tumor tissue, offering rapid and accurate results to identify patients who could benefit from MET-targeted therapies. The assay provides high sensitivity and specificity, fast turnaround times, standardized testing procedures, and is compatible with routine clinical workflows, making it highly suitable for precision oncology and personalized treatment planning.

Who Are The Well-Known Companies In The Oncology Companion Diagnostics Market?

Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Laboratory Corporation of America Holdings (LabCorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Illumina Inc., PerkinElmer Inc., bioMérieux SA, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N.V., Exact Sciences Corporation, BGI Genomics Co. Ltd., Natera Inc., Myriad Genetics Inc., ARUP Laboratories, NeoGenomics Laboratories Inc., Guardant Health, Ambry Genetics Corporation, Biocartis SA, CENTOGENE N.V., Invivoscribe Inc., Pillar Biosciences Inc.

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Which Region Is The Top Contributor To The Oncology Companion Diagnostics Market By Share?

North America was the largest region in the oncology companion diagnostic market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the oncology companion diagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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The Business Research Company’s 2026 market reports include new capabilities such as market attractiveness scoring and analysis, total addressable market analysis, company scoring matrix, interactive excel data dashboard, improved supply chain analysis, upcoming startups in the market, and overview of key products, aimed at improving the depth, usability, and strategic value of the insights delivered.

What Market Value Is Anticipated For The Oncology Companion Diagnostics Market Over The Period 2026–2030?

The oncology companion diagnostics market has experienced significant expansion in recent years. This market is projected to grow from $3.79 billion in 2025 to $4.29 billion in 2026, showing a compound annual growth rate (CAGR) of 13.0%. The growth observed in the historical period can be attributed to several factors, including the increasing prevalence of cancer types such as breast, colorectal, and melanoma, a heightened focus on personalized medicine, a rising demand for targeted therapy selection, the expansion of diagnostic laboratories and hospitals, and the development of molecular and genetic testing technologies.

The oncology companion diagnostics market is anticipated to undergo significant expansion over the next few years, with its size projected to reach $6.5 billion by 2030, demonstrating a compound annual growth rate (CAGR) of 10.9%. This growth during the forecast period is fueled by the increasing adoption of next-generation sequencing (NGS) and PCR-based diagnostics, a rise in collaborations between pharmaceutical and diagnostic firms, a growing number of regulatory approvals for companion diagnostics, escalating demand for precision oncology, and the broader application of bioinformatics and decision support software in diagnostics. Key trends expected in this period involve the increasing use of digital platforms for managing companion diagnostic data, greater integration of artificial intelligence (AI) in biomarker analysis and patient stratification, expanding utilization of genomics and precision medicine in targeted cancer therapy, rising automation in diagnostic testing and laboratory workflows, and enhanced internet of things (IoT)-enabled monitoring of diagnostic instruments and reagents.

Download the Free Sample Report to Explore Key Market Insights:

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What Underlying Factors Are Accelerating The Growth Of The Oncology Companion Diagnostics Market?

The anticipated increase in cancer occurrences is projected to stimulate the expansion of the oncology companion diagnostics market moving forward. Cancer is a complex set of illnesses characterized by abnormal cells that grow and spread uncontrollably within the body. This surge in cancer cases is attributable to shifts in lifestyle, environmental elements, the obesity epidemic, tobacco consumption, and genetic predispositions. Oncology companion diagnostics are integral to precision medicine strategies in oncology, revolutionizing cancer care by enabling customized treatment selection, enhancing therapeutic effectiveness, minimizing adverse reactions, facilitating enrollment in clinical trials, and improving treatment monitoring. For instance, in May 2024, data from the National Cancer Institute, a US-based government agency, indicated that roughly 20 million new cases and 9.7 million cancer-related deaths were recorded annually in 2022, with forecasts suggesting that by 2040, there would be 15.3 million deaths and 29.9 million new cases per year. Hence, the growing number of cancer cases propels the oncology companion diagnostics market.

How Is The Oncology Companion Diagnostics Market Divided Into Its Major Segments?

The oncology companion diagnostics market covered in this report is segmented –

1) By Product: Instrument, Consumables, Software

2) By Disease Type: Melanoma, Breast Cancer, Colorectal Cancer, Leukemia, Prostate Cancer, Other Disease Types

3) By Technology: Immunohistochemistry (IHC), In Situ Hybridization (ISH) Or Fluorescence In Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Other Technologies

4) By End User: Hospital, Pathology Or Diagnostic Laboratory, Academic Medical Center, Other End-Users

Subsegments:

1) By Instrument: Polymerase Chain Reaction (PCR) Instruments, Next-Generation Sequencing (NGS) Systems, Immunohistochemistry (IHC) Instruments, Fluorescence In Situ Hybridization (FISH) Instruments, Microarray Platforms

2) By Consumables: Reagents And Kits (DNA Or RNA Extraction Kits, PCR Reagents), Biopsy Needles, Testing Slides And Chips, Control And Calibration Samples

3) By Software: Data Analysis Software, Bioinformatics Software (For Gene Expression Analysis), Companion Diagnostic Decision Support Software, Clinical Workflow Management Software

What Major Market Trends Are Driving Changes In The Oncology Companion Diagnostics Market?

Key players in the oncology companion diagnostics sector are concentrating on advancing high-throughput sequencing technologies, including the application of c-MET companion diagnostic assays for therapeutic direction in advanced non-small cell lung cancer, with the goal of enhancing precision oncology and individualized treatment choices. The implementation of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer specifically involves deploying a targeted diagnostic tool to identify c-MET gene alterations in patients with advanced NSCLC, thereby empowering clinicians to select appropriate therapies, maximize treatment efficacy, and support precision medicine approaches. For example, in May 2025, NeoGenomics, Inc., an oncology testing company located in the US, launched its c-MET CDx Assay to aid treatment decisions for individuals with advanced Non-Small Cell Lung Cancer. This c-MET CDx Assay serves as a companion diagnostic test engineered to identify c-MET protein overexpression in tumor tissue, delivering quick and accurate outcomes to ascertain patients who may benefit from MET-targeted therapies. The assay boasts high sensitivity and specificity, swift turnaround times, standardized testing procedures, and seamless integration with routine clinical workflows, making it exceptionally suitable for precision oncology and personalized treatment planning.

Who Are The Prominent Organizations Shaping The Oncology Companion Diagnostics Market?

Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Laboratory Corporation of America Holdings (LabCorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Illumina Inc., PerkinElmer Inc., bioMérieux SA, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N.V., Exact Sciences Corporation, BGI Genomics Co. Ltd., Natera Inc., Myriad Genetics Inc., ARUP Laboratories, NeoGenomics Laboratories Inc., Guardant Health, Ambry Genetics Corporation, Biocartis SA, CENTOGENE N.V., Invivoscribe Inc., Pillar Biosciences Inc.

Read the full oncology companion diagnostics market report here:

https://www.thebusinessresearchcompany.com/report/oncology-companion-diagnostics-global-market-report

Which Region Is Projected To Dominate The Oncology Companion Diagnostics Market During The Forecast Period?

North America was the largest region in the oncology companion diagnostic market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the oncology companion diagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

Request A Tailored Oncology Companion Diagnostics Market Research Report For Competitive Advantage:

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https://www.thebusinessresearchcompany.com/report/ablation-technology-global-market-report

Get in touch with us:

The Business Research Company: https://www.thebusinessresearchcompany.com/

Americas +1 310-496-7795

Asia +44 7882 955267 & +91 8897263534

Europe +44 7882 955267

Email us at info@tbrc.info

Follow us on:

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The Business Research Company’s 2026 market reports include new capabilities such as market attractiveness scoring and analysis, total addressable market analysis, company scoring matrix, interactive excel data dashboard, improved supply chain analysis, upcoming startups in the market, and overview of key products, aimed at improving the depth, usability, and strategic value of the insights delivered.

What Market Value Is Anticipated For The Oncology Companion Diagnostics Market Over The Period 2026–2030?

The oncology companion diagnostics market has experienced significant expansion in recent years. This market is projected to grow from $3.79 billion in 2025 to $4.29 billion in 2026, showing a compound annual growth rate (CAGR) of 13.0%. The growth observed in the historical period can be attributed to several factors, including the increasing prevalence of cancer types such as breast, colorectal, and melanoma, a heightened focus on personalized medicine, a rising demand for targeted therapy selection, the expansion of diagnostic laboratories and hospitals, and the development of molecular and genetic testing technologies.

The oncology companion diagnostics market is anticipated to undergo significant expansion over the next few years, with its size projected to reach $6.5 billion by 2030, demonstrating a compound annual growth rate (CAGR) of 10.9%. This growth during the forecast period is fueled by the increasing adoption of next-generation sequencing (NGS) and PCR-based diagnostics, a rise in collaborations between pharmaceutical and diagnostic firms, a growing number of regulatory approvals for companion diagnostics, escalating demand for precision oncology, and the broader application of bioinformatics and decision support software in diagnostics. Key trends expected in this period involve the increasing use of digital platforms for managing companion diagnostic data, greater integration of artificial intelligence (AI) in biomarker analysis and patient stratification, expanding utilization of genomics and precision medicine in targeted cancer therapy, rising automation in diagnostic testing and laboratory workflows, and enhanced internet of things (IoT)-enabled monitoring of diagnostic instruments and reagents.

Download the Free Sample Report to Explore Key Market Insights:

https://www.thebusinessresearchcompany.com/sample.aspx?id=15623&type=smp

What Underlying Factors Are Accelerating The Growth Of The Oncology Companion Diagnostics Market?

The anticipated increase in cancer occurrences is projected to stimulate the expansion of the oncology companion diagnostics market moving forward. Cancer is a complex set of illnesses characterized by abnormal cells that grow and spread uncontrollably within the body. This surge in cancer cases is attributable to shifts in lifestyle, environmental elements, the obesity epidemic, tobacco consumption, and genetic predispositions. Oncology companion diagnostics are integral to precision medicine strategies in oncology, revolutionizing cancer care by enabling customized treatment selection, enhancing therapeutic effectiveness, minimizing adverse reactions, facilitating enrollment in clinical trials, and improving treatment monitoring. For instance, in May 2024, data from the National Cancer Institute, a US-based government agency, indicated that roughly 20 million new cases and 9.7 million cancer-related deaths were recorded annually in 2022, with forecasts suggesting that by 2040, there would be 15.3 million deaths and 29.9 million new cases per year. Hence, the growing number of cancer cases propels the oncology companion diagnostics market.

How Is The Oncology Companion Diagnostics Market Divided Into Its Major Segments?

The oncology companion diagnostics market covered in this report is segmented –

1) By Product: Instrument, Consumables, Software

2) By Disease Type: Melanoma, Breast Cancer, Colorectal Cancer, Leukemia, Prostate Cancer, Other Disease Types

3) By Technology: Immunohistochemistry (IHC), In Situ Hybridization (ISH) Or Fluorescence In Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Other Technologies

4) By End User: Hospital, Pathology Or Diagnostic Laboratory, Academic Medical Center, Other End-Users

Subsegments:

1) By Instrument: Polymerase Chain Reaction (PCR) Instruments, Next-Generation Sequencing (NGS) Systems, Immunohistochemistry (IHC) Instruments, Fluorescence In Situ Hybridization (FISH) Instruments, Microarray Platforms

2) By Consumables: Reagents And Kits (DNA Or RNA Extraction Kits, PCR Reagents), Biopsy Needles, Testing Slides And Chips, Control And Calibration Samples

3) By Software: Data Analysis Software, Bioinformatics Software (For Gene Expression Analysis), Companion Diagnostic Decision Support Software, Clinical Workflow Management Software

What Major Market Trends Are Driving Changes In The Oncology Companion Diagnostics Market?

Key players in the oncology companion diagnostics sector are concentrating on advancing high-throughput sequencing technologies, including the application of c-MET companion diagnostic assays for therapeutic direction in advanced non-small cell lung cancer, with the goal of enhancing precision oncology and individualized treatment choices. The implementation of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer specifically involves deploying a targeted diagnostic tool to identify c-MET gene alterations in patients with advanced NSCLC, thereby empowering clinicians to select appropriate therapies, maximize treatment efficacy, and support precision medicine approaches. For example, in May 2025, NeoGenomics, Inc., an oncology testing company located in the US, launched its c-MET CDx Assay to aid treatment decisions for individuals with advanced Non-Small Cell Lung Cancer. This c-MET CDx Assay serves as a companion diagnostic test engineered to identify c-MET protein overexpression in tumor tissue, delivering quick and accurate outcomes to ascertain patients who may benefit from MET-targeted therapies. The assay boasts high sensitivity and specificity, swift turnaround times, standardized testing procedures, and seamless integration with routine clinical workflows, making it exceptionally suitable for precision oncology and personalized treatment planning.

Who Are The Prominent Organizations Shaping The Oncology Companion Diagnostics Market?

Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Laboratory Corporation of America Holdings (LabCorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Illumina Inc., PerkinElmer Inc., bioMérieux SA, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N.V., Exact Sciences Corporation, BGI Genomics Co. Ltd., Natera Inc., Myriad Genetics Inc., ARUP Laboratories, NeoGenomics Laboratories Inc., Guardant Health, Ambry Genetics Corporation, Biocartis SA, CENTOGENE N.V., Invivoscribe Inc., Pillar Biosciences Inc.

Read the full oncology companion diagnostics market report here:

https://www.thebusinessresearchcompany.com/report/oncology-companion-diagnostics-global-market-report

Which Region Is Projected To Dominate The Oncology Companion Diagnostics Market During The Forecast Period?

North America was the largest region in the oncology companion diagnostic market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the oncology companion diagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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The Business Research Company’s 2026 market reports include new capabilities such as market attractiveness scoring and analysis, total addressable market analysis, company scoring matrix, interactive excel data dashboard, improved supply chain analysis, upcoming startups in the market, and overview of key products, aimed at improving the depth, usability, and strategic value of the insights delivered.

What Market Value Is Anticipated For The Oncology Companion Diagnostics Market Over The Period 2026–2030?

The oncology companion diagnostics market has experienced significant expansion in recent years. This market is projected to grow from $3.79 billion in 2025 to $4.29 billion in 2026, showing a compound annual growth rate (CAGR) of 13.0%. The growth observed in the historical period can be attributed to several factors, including the increasing prevalence of cancer types such as breast, colorectal, and melanoma, a heightened focus on personalized medicine, a rising demand for targeted therapy selection, the expansion of diagnostic laboratories and hospitals, and the development of molecular and genetic testing technologies.

The oncology companion diagnostics market is anticipated to undergo significant expansion over the next few years, with its size projected to reach $6.5 billion by 2030, demonstrating a compound annual growth rate (CAGR) of 10.9%. This growth during the forecast period is fueled by the increasing adoption of next-generation sequencing (NGS) and PCR-based diagnostics, a rise in collaborations between pharmaceutical and diagnostic firms, a growing number of regulatory approvals for companion diagnostics, escalating demand for precision oncology, and the broader application of bioinformatics and decision support software in diagnostics. Key trends expected in this period involve the increasing use of digital platforms for managing companion diagnostic data, greater integration of artificial intelligence (AI) in biomarker analysis and patient stratification, expanding utilization of genomics and precision medicine in targeted cancer therapy, rising automation in diagnostic testing and laboratory workflows, and enhanced internet of things (IoT)-enabled monitoring of diagnostic instruments and reagents.

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What Underlying Factors Are Accelerating The Growth Of The Oncology Companion Diagnostics Market?

The anticipated increase in cancer occurrences is projected to stimulate the expansion of the oncology companion diagnostics market moving forward. Cancer is a complex set of illnesses characterized by abnormal cells that grow and spread uncontrollably within the body. This surge in cancer cases is attributable to shifts in lifestyle, environmental elements, the obesity epidemic, tobacco consumption, and genetic predispositions. Oncology companion diagnostics are integral to precision medicine strategies in oncology, revolutionizing cancer care by enabling customized treatment selection, enhancing therapeutic effectiveness, minimizing adverse reactions, facilitating enrollment in clinical trials, and improving treatment monitoring. For instance, in May 2024, data from the National Cancer Institute, a US-based government agency, indicated that roughly 20 million new cases and 9.7 million cancer-related deaths were recorded annually in 2022, with forecasts suggesting that by 2040, there would be 15.3 million deaths and 29.9 million new cases per year. Hence, the growing number of cancer cases propels the oncology companion diagnostics market.

How Is The Oncology Companion Diagnostics Market Divided Into Its Major Segments?

The oncology companion diagnostics market covered in this report is segmented –

1) By Product: Instrument, Consumables, Software

2) By Disease Type: Melanoma, Breast Cancer, Colorectal Cancer, Leukemia, Prostate Cancer, Other Disease Types

3) By Technology: Immunohistochemistry (IHC), In Situ Hybridization (ISH) Or Fluorescence In Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Other Technologies

4) By End User: Hospital, Pathology Or Diagnostic Laboratory, Academic Medical Center, Other End-Users

Subsegments:

1) By Instrument: Polymerase Chain Reaction (PCR) Instruments, Next-Generation Sequencing (NGS) Systems, Immunohistochemistry (IHC) Instruments, Fluorescence In Situ Hybridization (FISH) Instruments, Microarray Platforms

2) By Consumables: Reagents And Kits (DNA Or RNA Extraction Kits, PCR Reagents), Biopsy Needles, Testing Slides And Chips, Control And Calibration Samples

3) By Software: Data Analysis Software, Bioinformatics Software (For Gene Expression Analysis), Companion Diagnostic Decision Support Software, Clinical Workflow Management Software

What Major Market Trends Are Driving Changes In The Oncology Companion Diagnostics Market?

Key players in the oncology companion diagnostics sector are concentrating on advancing high-throughput sequencing technologies, including the application of c-MET companion diagnostic assays for therapeutic direction in advanced non-small cell lung cancer, with the goal of enhancing precision oncology and individualized treatment choices. The implementation of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer specifically involves deploying a targeted diagnostic tool to identify c-MET gene alterations in patients with advanced NSCLC, thereby empowering clinicians to select appropriate therapies, maximize treatment efficacy, and support precision medicine approaches. For example, in May 2025, NeoGenomics, Inc., an oncology testing company located in the US, launched its c-MET CDx Assay to aid treatment decisions for individuals with advanced Non-Small Cell Lung Cancer. This c-MET CDx Assay serves as a companion diagnostic test engineered to identify c-MET protein overexpression in tumor tissue, delivering quick and accurate outcomes to ascertain patients who may benefit from MET-targeted therapies. The assay boasts high sensitivity and specificity, swift turnaround times, standardized testing procedures, and seamless integration with routine clinical workflows, making it exceptionally suitable for precision oncology and personalized treatment planning.

Who Are The Prominent Organizations Shaping The Oncology Companion Diagnostics Market?

Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Laboratory Corporation of America Holdings (LabCorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Illumina Inc., PerkinElmer Inc., bioMérieux SA, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N.V., Exact Sciences Corporation, BGI Genomics Co. Ltd., Natera Inc., Myriad Genetics Inc., ARUP Laboratories, NeoGenomics Laboratories Inc., Guardant Health, Ambry Genetics Corporation, Biocartis SA, CENTOGENE N.V., Invivoscribe Inc., Pillar Biosciences Inc.

Read the full oncology companion diagnostics market report here:

https://www.thebusinessresearchcompany.com/report/oncology-companion-diagnostics-global-market-report

Which Region Is Projected To Dominate The Oncology Companion Diagnostics Market During The Forecast Period?

North America was the largest region in the oncology companion diagnostic market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the oncology companion diagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

Request A Tailored Oncology Companion Diagnostics Market Research Report For Competitive Advantage:

https://www.thebusinessresearchcompany.com/customise?id=15623&type=smp

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Asia +44 7882 955267 & +91 8897263534

Europe +44 7882 955267

Email us at info@tbrc.info

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Uncover key drivers, emerging technologies, and competitive movements shaping the oncology companion diagnostics market from 2026–2035 with trusted insights from The Business Research Company

What market expansion outlook does the Oncology Companion Diagnostics Market show for the 2026–2030 period?

The oncology companion diagnostics market has experienced significant expansion in recent years. This market is projected to grow from $3.79 billion in 2025 to $4.29 billion in 2026, achieving a compound annual growth rate (CAGR) of 13.0%. The historical growth can be attributed to several factors, including the increasing prevalence of cancer types such as breast, colorectal, and melanoma, a growing emphasis on personalized medicine, the escalating demand for targeted therapy selection, the expansion of diagnostic laboratories and hospitals, and advancements in molecular and genetic testing technologies.

The oncology companion diagnostics market size is anticipated to undergo significant expansion in the coming years. It is forecast to reach $6.5 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 10.9%. This growth throughout the forecast period is primarily propelled by the increasing adoption of next-generation sequencing (ngs) and pcr-based diagnostics, enhanced collaboration between pharmaceutical and diagnostic companies, an increase in regulatory approvals for companion diagnostics, rising demand for precision oncology, and the expanding use of bioinformatics and decision support software in diagnostics. Prominent trends expected in this period encompass the growing uptake of digital platforms for managing companion diagnostic data, greater integration of artificial intelligence in biomarker analysis and patient stratification, the expanding application of genomics and precision medicine in targeted cancer therapy, heightened automation in diagnostic testing and laboratory workflows, and increased IoT-enabled monitoring of diagnostic instruments and reagents.

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What Drivers Are Shaping The Development Of The Oncology Companion Diagnostics Market?

The anticipated future growth of the oncology companion diagnostics market is expected to be propelled by an increase in cancer cases. Cancer is defined as a complex group of diseases stemming from abnormal cells within the body that grow and spread uncontrollably. The rise in cancer incidents can be attributed to shifts in lifestyle, environmental factors, the obesity epidemic, tobacco consumption, and genetic predispositions. Oncology companion diagnostics play a vital role in precision medicine approaches within oncology, transforming cancer care by enabling personalized treatment selection, enhancing treatment effectiveness, minimizing adverse effects, facilitating clinical trial participation, and improving the monitoring of treatments. For example, in May 2024, the National Cancer Institute, a US-based government agency, reported that around 20 million new cases and 9.7 million cancer-related deaths were recorded annually in 2022, with predictions indicating that by 2040, there would be 15.3 million deaths and 29.9 million new cases per year. Therefore, the increasing number of cancer cases acts as a key driver for the oncology companion diagnostics market.

Which Segments Are Contributing To The Growth Of The Oncology Companion Diagnostics Market?

The oncology companion diagnostics market covered in this report is segmented –

1) By Product: Instrument, Consumables, Software

2) By Disease Type: Melanoma, Breast Cancer, Colorectal Cancer, Leukemia, Prostate Cancer, Other Disease Types

3) By Technology: Immunohistochemistry (IHC), In Situ Hybridization (ISH) Or Fluorescence In Situ Hybridization (FISH), Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Other Technologies

4) By End User: Hospital, Pathology Or Diagnostic Laboratory, Academic Medical Center, Other End-Users

Subsegments:

1) By Instrument: Polymerase Chain Reaction (PCR) Instruments, Next-Generation Sequencing (NGS) Systems, Immunohistochemistry (IHC) Instruments, Fluorescence In Situ Hybridization (FISH) Instruments, Microarray Platforms

2) By Consumables: Reagents And Kits (DNA Or RNA Extraction Kits, PCR Reagents), Biopsy Needles, Testing Slides And Chips, Control And Calibration Samples

3) By Software: Data Analysis Software, Bioinformatics Software (For Gene Expression Analysis), Companion Diagnostic Decision Support Software, Clinical Workflow Management Software

Which Trends Are Influencing The Performance And Direction Of The Oncology Companion Diagnostics Market?

Leading companies within the oncology companion diagnostics market are concentrating on developing advanced high-throughput sequencing technologies, such as the deployment of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer, aiming to enhance precision oncology and individualize treatment selection. This implementation of c-MET companion diagnostic assays for therapeutic guidance in advanced non-small cell lung cancer involves the application of a targeted diagnostic test designed to detect c-MET gene alterations in patients suffering from advanced non-small cell lung cancer (NSCLC), thereby enabling clinicians to select appropriate therapies, optimize treatment efficacy, and support precision medicine approaches. As an illustration, in May 2025, NeoGenomics, Inc., an oncology testing company based in the US, introduced its c-MET CDx Assay to assist in guiding treatment decisions for individuals with advanced Non-Small Cell Lung Cancer (NSCLC). The c-MET CDx Assay functions as a companion diagnostic test designed to identify c-MET protein overexpression within tumor tissue, delivering rapid and accurate results to pinpoint patients who are likely to benefit from MET-targeted therapies. This assay is characterized by its high sensitivity and specificity, quick turnaround times, standardized testing procedures, and compatibility with routine clinical workflows, rendering it optimal for precision oncology and personalized treatment planning.

Who Are The Major Companies Operating In The Oncology Companion Diagnostics Market?

Major companies operating in the oncology companion diagnostics market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Laboratory Corporation of America Holdings (LabCorp), Quest Diagnostics Incorporated, Eurofins Scientific SE, Agilent Technologies Inc., Illumina Inc., PerkinElmer Inc., bioMérieux SA, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N.V., Exact Sciences Corporation, BGI Genomics Co. Ltd., Natera Inc., Myriad Genetics Inc., ARUP Laboratories, NeoGenomics Laboratories Inc., Guardant Health, Ambry Genetics Corporation, Biocartis SA, CENTOGENE N.V., Invivoscribe Inc., Pillar Biosciences Inc.

Access The Complete Report For Deeper Market Insights:

https://www.thebusinessresearchcompany.com/report/oncology-companion-diagnostics-global-market-report

Which Region Is Anticipated To See The Fastest Growth In The Oncology Companion Diagnostics Market?

North America was the largest region in the oncology companion diagnostic market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the oncology companion diagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

Request Your Customized Oncology Companion Diagnostics Market Research Report for Competitive Advantage:

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Email us at info@tbrc.info

Follow us on:

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