Opportunities center on precision medicine, AI biomarker analysis, NGS and multi-omics, liquid biopsies, automated testing, and pharma-diagnostic co-development
Companion Diagnostics for Targeted Therapies Market
Dublin, Sept. 03, 2026 (GLOBE NEWSWIRE) — The “Companion Diagnostics for Targeted Therapies Market Global Report 2026” has been added to ResearchAndMarkets.com’s offering.
The global companion diagnostics for targeted therapies market is experiencing rapid growth, driven by the expanding use of precision medicine, advances in genomic sequencing and increasing demand for biomarker-based treatment selection. The market is projected to grow from $5.76 billion in 2025 to $6.57 billion in 2026, representing a compound annual growth rate (CAGR) of 14.1%.
Historical market growth has been supported by the rising prevalence of cancer and chronic diseases, continued investment in molecular diagnostic laboratory infrastructure and the broader adoption of precision oncology protocols. Expansion in genomic sequencing research and improvements in early biomarker identification have also strengthened the role of companion diagnostics in helping healthcare professionals match patients with appropriate targeted therapies.
The companion diagnostics for targeted therapies market is forecast to reach $11.25 billion by 2030, expanding at a CAGR of 14.4%. Growth during the forecast period is expected to be fueled by artificial intelligence-driven diagnostic analytics, clinical decision-support technologies and the increasing integration of personalized medicine into healthcare systems. Pharmaceutical and diagnostic companies are also increasing co-development activities to support the approval and commercialization of biomarker-linked therapies.
Next-generation sequencing and multi-omics platforms are expected to play an increasingly important role in the companion diagnostics market. Key industry trends include AI-enabled biomarker discovery, automated molecular diagnostic testing, liquid biopsy-based diagnostics and the integration of genomic, transcriptomic and proteomic data for more precise therapy selection. These developments are improving testing efficiency while expanding the range of actionable biomarkers available to clinicians.
The growing adoption of precision medicine remains a major driver of companion diagnostics for targeted therapies market growth. Advances in biomarker identification and molecular diagnostics are enabling more accurate patient stratification and targeted treatment selection. Companion diagnostics analyze patient-specific genetic and biomarker profiles, helping clinicians identify therapies that are more likely to deliver effective outcomes while reducing the risk of unnecessary treatment and adverse effects.
Regulatory activity also highlights the growing importance of personalized treatment. According to the Personalized Medicine Coalition, the U.S. Food and Drug Administration approved 16 new personalized therapies for patients with rare diseases in 2023, compared with six approvals in 2022. The increase demonstrates growing regulatory support for biomarker-based therapies and reinforces demand for validated diagnostic tests that can identify eligible patient populations.
Innovation in next-generation sequencing-driven genomic profiling is further advancing the market. In August 2024, Illumina expanded its oncology portfolio for NovaSeq X Series customers with the high-throughput TruSight Oncology 500 HT and updated TruSight Oncology 500 ctDNA v2 assays. The products support large-scale comprehensive genomic profiling across solid tumors and circulating tumor DNA. Their enhanced workflows offer shorter sequencing run times, larger batch sizes and improved cost efficiency while maintaining clinical-grade accuracy.
Strategic collaborations are also supporting the development of AI-enabled companion diagnostics. In February 2024, PathAI entered into an exclusive strategic agreement with Roche Tissue Diagnostics to develop and implement artificial intelligence-powered digital pathology solutions. The collaboration is intended to improve the accuracy, consistency and efficiency of tissue-based companion diagnostic workflows used in clinical decision-making. Such partnerships reflect the increasing convergence of digital pathology, AI and precision oncology.
North America was the dominant region in the companion diagnostics for targeted therapies market in 2025, supported by advanced healthcare infrastructure, strong precision medicine adoption and significant investment in oncology research. Asia-Pacific is expected to be the fastest-expanding region during the forecast period. The market analysis covers Asia-Pacific, Southeast Asia, Western Europe, Eastern Europe, North America, South America, the Middle East and Africa, including Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, the United Kingdom, the United States, Canada, Italy and Spain.
Markets Covered:
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
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 250 |
| Forecast Period | 2026-2030 |
| Estimated Market Value (USD) in 2026 | $6.57 Billion |
| Forecasted Market Value (USD) by 2030 | $11.25 Billion |
| Compound Annual Growth Rate | 14.4% |
| Regions Covered | Global |
Companies Featured
- 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.
For more information about this report visit https://www.researchandmarkets.com/r/e0prb4
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Attachment
- Companion Diagnostics for Targeted Therapies Market
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