Companion Diagnostics for Targeted Therapies Market Global Report 2026

The companion diagnostics for targeted therapies market size has grown rapidly in recent years. It will grow from $5.76 billion in 2025 to $6.57 billion in 2026 at a compound annual growth rate (CAGR) of 14.1%. The growth in the historic period can be attributed to increasing prevalence of cancer and chronic diseases driving demand for targeted therapies, growth of molecular diagnostic laboratory infrastructure, rising adoption of precision medicine in oncology treatment protocols, expansion of genomic sequencing research initiatives, advancement of early biomarker identification technologies.

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 advancements in AI-driven diagnostic analytics and clinical decision support technologies, increasing adoption of personalized medicine across healthcare systems, growth in co-development of pharmaceutical companion diagnostics, expansion of next-generation sequencing and multi-omics platforms, and 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 datasets for precision therapy selection, expansion of next-generation sequencing-based diagnostic workflows, increasing use of automated molecular diagnostic testing systems, and growing adoption of liquid biopsy-based companion diagnostic solutions.

The increasing adoption of precision medicine is expected to drive the growth of the companion diagnostics for targeted therapies market going forward. Precision medicine refers to a medical approach that tailors treatment based on individual patient characteristics such as genetics, biomarkers, and disease phenotypes. The demand for precision medicine is increasing 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 support precision medicine by identifying patient-specific genetic and biomarker profiles to guide the 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 increase from the six approvals recorded in 2022. Therefore, the increasing adoption of precision medicine is driving the growth of the companion diagnostics for targeted therapies market.

Key companies operating in the companion diagnostics for targeted therapies market are focusing on the development of 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 approach that analyzes multiple genes simultaneously to detect mutations and biomarkers, enabling rapid and comprehensive identification of actionable alterations for precise targeted therapy selection and personalized treatment decisions. For example, 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 large-scale comprehensive genomic profiling. These assays are based on advanced NGS workflows that integrate optimized library preparation, high-throughput sequencing chemistry, and bioinformatics-driven variant interpretation to identify actionable genomic alterations across solid tumors and circulating tumor DNA. Key features include significantly reduced sequencing run times, expanded batch sizes for higher sample throughput, and improved sequencing economics that lower overall cost per sample while maintaining clinical-grade accuracy.

In February 2024, PathAI, a US-based AI pathology company focused on the development of and support for AI-enabled companion diagnostics for targeted therapies, collaborated with Roche Tissue Diagnostics to enhance AI-powered interpretation for companion diagnostics. Through this partnership, PathAI entered into an exclusive strategic agreement with Roche Tissue Diagnostics to design and implement artificial intelligence-driven digital pathology solutions intended to enhance the accuracy, consistency, and efficiency of tissue-based companion diagnostic workflows utilized in clinical decision-making. Roche Tissue Diagnostics is a Switzerland-based diagnostics company specializing in tissue-based cancer diagnostics and laboratory systems applied in precision medicine.

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.

North America was the dominant region in the companion diagnostics for targeted therapies market in 2025. Asia-Pacific is expected to be the rapidly expanding region in the forecast period. The regions covered in companion diagnostics for targeted therapies report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the companion diagnostics for targeted therapies market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

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.

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.

The companion diagnostics for targeted therapies market research report is one of a series of new reports 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.

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