Companion Diagnostics For Targeted Therapies Market Report 2026

Companion Diagnostics For Targeted Therapies Market Overview

• Companion Diagnostics For Targeted Therapies market size has reached to $5.76 billion in 2025 • Expected to grow to $11.25 billion in 2030 at a compound annual growth rate (CAGR) of 14.4% • Growth Driver: Growing Demand For Precision Medicine Driving The Market Growth Due To Personalized Respiratory Care Advancements • Market Trend: Next-Generation Genomic Testing Transforming Personalized Cancer Care • North America was the largest region in 2025 and Asia-Pacific is the fastest growing region.

What Is Covered Under Companion Diagnostics For Targeted Therapies Market?

Companion diagnostics for targeted therapies refers to diagnostic testing approaches that identify specific biomarkers, genetic variations, or molecular characteristics in a patient to determine eligibility and expected response to targeted therapeutic treatments. It supports precision medicine by enabling data-driven treatment decisions, improving clinical outcomes, and reducing ineffective therapy exposure through patient-specific molecular insights. These diagnostics are based on advanced molecular and analytical techniques that support accurate detection and interpretation of disease-related biological signals. The main products of companion diagnostics for targeted therapies include assays, kits, and reagents; instruments and systems; and software and services. Assays, kits, and reagents refer to laboratory test components used to identify specific biomarkers for targeted treatment selection. These products are based on technologies including polymerase chain reaction, next generation sequencing, immunohistochemistry, in situ hybridization, and other technologies and are used across indications such as oncology, cardiovascular diseases, neurological diseases, infectious diseases, and other indications. They are applied using sample types including tissue samples, blood samples, and other sample types and are utilized by end users such as hospitals and physician laboratories, reference laboratories, pharmaceutical and biotechnology companies, and academic and research institutes.

What Is The Companion Diagnostics For Targeted Therapies Market Growth Forecast?

The companion diagnostics for targeted therapies market size is expected to see rapid growth in the next few years. It will grow to $11.25 billion in 2030 at a compound annual growth rate (CAGR) of 14.4%. The growth in the forecast period can be attributed to advancement in AI driven diagnostic analytics and clinical decision support systems, increasing adoption of personalized medicine across healthcare systems, growth in pharmaceutical companion diagnostic co development strategies, expansion of next generation sequencing and multi omics platforms, rising regulatory support for biomarker based targeted therapy approvals. Major trends in the forecast period include AI enabled biomarker discovery and companion diagnostic interpretation platforms, integration of multi omics data for precision therapy selection, expansion of next generation sequencing based diagnostic workflows, increasing adoption of automated molecular diagnostic testing systems, growing use of liquid biopsy based companion diagnostic solutions.

Global Companion Diagnostics For Targeted Therapies Market Segmentation

1) By Product: Assays, Kits, And Reagents, Instruments And Systems, Software And Services 2) By Technology: Polymerase Chain Reaction, Next Generation Sequencing, Immunohistochemistry, In Situ Hybridization, Other Technologies 3) By Indication: Oncology, Cardiovascular Diseases, Neurological Diseases, Infectious Diseases, Other Indications 4) By Sample Type: Tissue Samples, Blood Samples, Other Sample Types 5) By End User: Hospitals And Physician Laboratories, Reference Laboratories, Pharmaceutical And Biotechnology Companies, Academic And Research Institutes Subsegments: 1) By Assays, Kits, And Reagents: Diagnostic Assays, Molecular Diagnostic Kits, Immunoassay Reagents, Sequencing Reagents, Polymerase Chain Reaction Reagents, Biomarker Detection Kits, Sample Preparation Reagents, Quality Control Reagents 2) By Instruments And Systems: Diagnostic Analyzers, Sequencing Systems, Polymerase Chain Reaction Systems, Automated Laboratory Instruments, Digital Pathology Systems, Flow Cytometry Systems, Imaging Systems, Data Management Systems 3) By Software And Services: Diagnostic Data Analysis Software, Laboratory Information Management Software, Clinical Decision Support Software, Bioinformatics Services, Data Interpretation Services, Instrument Maintenance Services, Consulting Services, Training And Support Services

What Is The Driver Of The Companion Diagnostics For Targeted Therapies Market?

The rising adoption of precision medicine is expected to propel the growth of the companion diagnostics for targeted therapies market going forward. Precision medicine refers to a medical approach that customizes treatment based on individual patient characteristics such as genetics, biomarkers, and disease phenotypes. The demand for precision medicine is rising due to advancements in biomarker identification and molecular diagnostics, which enable more accurate classification of respiratory conditions and targeted therapy selection. Companion diagnostics for targeted therapies enable precision medicine by identifying patient-specific genetic and biomarker profiles to guide selection of effective targeted treatments and improve outcomes with fewer adverse effects. For instance, in February 2024, according to the Personalized Medicine Coalition, a US-based non-profit organization, in 2023, the FDA approved 16 new personalized therapies for patients with rare diseases, marking a substantial rise from the six approvals recorded in 2022. Therefore, the rising adoption of precision medicine is driving the growth of the companion diagnostics for targeted therapies industry.

Key Players In The Global Companion Diagnostics For Targeted Therapies Market

Major companies operating in the companion diagnostics for targeted therapies market are Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, Danaher Corporation, Abbott Laboratories, Siemens Healthineers AG, Illumina Inc., Qiagen N.V., Agilent Technologies Inc., Exact Sciences Corporation, Bio-Rad Laboratories Inc., Sysmex Corporation, Foundation Medicine Inc., Natera Inc., Guardant Health Inc., bioMérieux S.A., Tempus AI Inc., Myriad Genetics Inc., NeoGenomics Laboratories Inc., Caris Life Sciences Inc., Adaptive Biotechnologies Corporation, Personalis Inc., EntroGen Inc.

Global Companion Diagnostics For Targeted Therapies Market Trends and Insights

Major companies operating in the companion diagnostics for targeted therapies market are focusing on developing innovative solutions, such as next-generation sequencing (NGS)-driven genomic profiling to enable comprehensive detection of actionable genetic mutations for precise patient stratification and targeted therapy selection. Next-generation sequencing (NGS)-driven genomic profiling is a high-throughput DNA sequencing method that analyzes multiple genes at once to detect mutations and biomarkers, helping enable fast, comprehensive identification of actionable alterations for precise targeted therapy selection and personalized treatment decisions. For instance, in August 2024, Illumina Inc., a US-based DNA sequencing and array technology company, launched an expanded oncology menu for its NovaSeq X Series customers, including the high-throughput TruSight Oncology 500 HT (TSO 500 HT) and the updated TruSight Oncology 500 ctDNA v2 assays, designed to enable comprehensive genomic profiling at greater scale. These assays are built on advanced NGS workflows that combine optimized library preparation, high-throughput sequencing chemistry, and bioinformatics-driven variant interpretation to detect actionable genomic alterations across solid tumors and circulating tumor DNA. Key features include significantly faster sequencing run times, expanded batch sizes for higher sample throughput, and improved sequencing economics that reduce overall cost per sample while maintaining clinical-grade accuracy.

What Are Latest Mergers And Acquisitions In The Companion Diagnostics For Targeted Therapies Market?

In February 2024, PathAI, a US-based AI pathology company that specializes in development and supports AI-enabled companion diagnostics for targeted therapies., partnered with Roche Tissue Diagnostics to advance AI-enabled interpretation for companion diagnostics. With this collaboration, PathAI entered into an exclusive strategic agreement with Roche Tissue Diagnostics to develop and deploy artificial intelligence–driven digital pathology solutions aimed at improving the accuracy, consistency, and efficiency of tissue-based companion diagnostic workflows used in clinical decision-making. Roche Tissue Diagnostics is a Switzerland-based diagnostic company that specializes in tissue-based cancer diagnostics and laboratory systems used in precision medicine.

Regional Outlook

North America was the largest region in the companion diagnostics for targeted therapies market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

What Defines the Companion Diagnostics For Targeted Therapies Market?

The companion diagnostics for targeted therapies market consists of revenues earned by entities by providing services such as biomarker identification, genetic and molecular profiling, clinical validation support, and diagnostic result interpretation. The market value includes the value of related goods sold by the service provider or included within the service offering. The companion diagnostics for targeted therapies market also includes sales of laboratory consumables, analytical tools, and computational systems. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

How is Market Value Defined and Measured?

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

What Key Data and Analysis Are Included in the Companion Diagnostics For Targeted Therapies Market Report 2026?

The companion diagnostics for targeted therapies market research report is one of a series of new reports from The Business Research Company that provides companion diagnostics for targeted therapies market statistics, including companion diagnostics for targeted therapies industry global market size, regional shares, competitors with a companion diagnostics for targeted therapies market share, detailed companion diagnostics for targeted therapies market segments, market trends and opportunities, and any further data you may need to thrive in the companion diagnostics for targeted therapies industry. This companion diagnostics for targeted therapies market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.