Companion Diagnostics Market Research Reports & Industry Analysis
The companion diagnostics market is one of the fastest growing segments of the IVD and clinical lab services markets. In the United States, over half of all FDA approvals for companion diagnostics have occurred since 2010. The closely associated pharmacodiagnostics IVD market is expected to grow annually by over 20%. The wild success of reference laboratories in the companion diagnostics market even prompted the unprecedented expansion of FDA oversight over laboratory developed tests (LDTs).
Companion diagnostics are increasingly integral to the approval of some new pharmaceuticals, illustrating which individuals are most likely to benefit from the drug. With the approval of CDx-assisted therapies, new high-growth markets are opened for lab tests and IVD products.
Companion diagnostics (CDx) include in vivo or medical imaging procedures and in vitro diagnostic (IVD) lab tests used to determine the efficacy of a particular therapy, most commonly pharmaceutical. Genome research in recent decades has illuminated and detailed the role genetics play in drug metabolism and disease etiology. Drugs can now be paired with IVD and medical imaging tests for prescription decisions and therapeutic monitoring. In vitro companion diagnostics are largely molecular assays, though additional formats include immunohistochemistry (IHC) and immunoassays, and are offered as test kits, analyte specific reagents, and laboratory developed tests (LDTs) or a lab testing service.
The majority of companion diagnostics are pharmacodiagnostic lab tests used to assess an individual’s response to drug therapy. Pharmacodiagnostics represents a major front in a healthcare system-wide push towards personalized medicine. Pharmacodiagnostic tests can be used to determine patient response to clopidogrel anticoagulant drugs, appropriate drug dosage, and the prescription of oncology drugs based on genetic markers.
Stay abreast of fast-paced and promising companion diagnostics markets with MarketResearch.com’s collection of market research studies. We offer a wide selection of studies treating companion diagnostic regulation, regional and disease-specific market development, product and test pipelines, and companion diagnostic product market tracking.
Companion Diagnostics Industry Research & Market Reports
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In-vitro Diagnostics (IVD) Reagents Market - Global Outlook & Forecast 2025-2030
... discovery and companion diagnostics is reshaping the IVD reagents market. As personalized medicine continues to advance, the demand for high-quality reagents that enable precise biomarker detection and CDx assays is on the rise. Market players ... Read More
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Precision Medicine Market By Technology (Big Data Analytics, Bioinformatics, Gene Sequencing, Drug Discovery, Companion Diagnostics) By Indication (Oncology, CNS, Immunology, Respiratory diseases, Genetic disorders, Skin diseases, Others) By Application (Diagnostics {Genetic Tests, Biomarker Based Tests, Esoteric Tests} Therapeutics {Inhibitor Drugs, Monoclonal Antibodies, Cell & Gene Therapy, Antiviral & anti-retroviral Drugs, Others) By End-user (Hospitals, Diagnostic Laboratories, Others) Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035
... Esoteric Tests} Therapeutics {Inhibitor Drugs, Monoclonal Antibodies, Cell & Gene Therapy, Antiviral & anti-retroviral Drugs, Others) By End-user (Hospitals, Diagnostic Laboratories, Others) Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles ... Read More
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Companion Diagnostics for Oncology Market
... macroeconomic and microeconomic factors, including the rising number of cancer tests, which significantly contributes to the increasing demand for companion diagnostics in oncology. The latest research report by Evolve Business Intelligence explores the various factors ... Read More
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Cancer Diagnostics Global Market Report 2025
... is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond. Reasons to Purchase Gain a truly global perspective with the ... Read More
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Companion Diagnostics
... CAGR of 0.3% over the analysis period 2024-2030. Assay kits & Reagents, one of the segments analyzed in the report, is expected to record a -0.4% CAGR and reach US$9.7 Billion by the end of ... Read More
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Oncology Companion Diagnostics Global Market Report 2025
... market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond. Reasons to Purchase Gain a truly global perspective ... Read More
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In Vitro Diagnostic (IVD) Trends and Market Update, 2025 [published twice a year]
... in Q4 2025, following the release of Kalorama’s annual 1,600-page study, The Worldwide Market for In Vitro Diagnostics (IVD), 18th Edition—this report serves both as a standalone resource and a companion to Kalorama’s annual flagship ... Read More
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Global Markets for Emerging Medical Device Technologies
... in detail. The report looks at product innovations and item portfolios of major players. The report covers drivers, restraints, opportunities, emerging technologies and a regulatory scenario assessment. The report includes market projections for 2029 and ... Read More
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Genomic Cancer Testing Market, By Test Type (Genomic Profiling Tests, Liquid Biopsy Tests, Companion Diagnostic Tests, Pharmacogenomic Tests, Hereditary Cancer Tests, Other specialized genomic tests), By Cancer Type (Breast Cancer, Lung Cancer, Colorectal Cancer, Prostate Cancer, Ovarian Cancer, Melanoma, Leukemia, Lymphoma, Other specific cancer types), By Technology (Next-Generation Sequencing, Polymerase Chain Reaction, Fluorescence In Situ Hybridization, Microarray, Immunohistochemistry, Other genomic testing technologies), By End-User (Hospitals, Diagnostic Laboratories, Academic and Research Institutions, Cancer Centers, Other healthcare providers), By Biomarker Type (Genetic Biomarkers, Protein Biomarkers, Molecular Biomarkers, Epigenetic Biomarkers), By Service Provider (Diagnostic Laboratories, Biotechnology Companies, Pharmaceutical Companies, Contract Research Organizations), By Application (Targeted Therapy Selection, Disease Monitoring, Prognostic Testing, Companion Diagno
... tailor treatment based on an individual’s genetic profile and select therapeutics that directly target the abnormalities present. The genomic analysis of a tumor helps predict response to certain drugs, checks for genetic markers that may ... Read More
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2024 Diagnostics Research Review
... to increased focus on regulations. These changes can be seen across many countries. The U.S., the largest diagnostics market, is leading the trend with changes intended to make healthcare more affordable. Opportunities for the diagnostics ... Read More
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Next Generation Cancer Diagnostics Market Size, Share, and Outlook, 2025 Report- By Technology (Next-generation Sequencing, qPCR & Multiplexing, Lab-on- a- chip (LOAC) & Reverse Transcriptase-PCR (RT-PCR), Protein Microarrays, DNA Microarrays), By Application (Biomarker Development, CTC Analysis, Proteomic Analysis, Epigenetic Analysis, Genetic Analysis), By Cancer Type (Lung Cancer, Breast Cancer, Colorectal Cancer, Cervical Cancer, Others), By Function, Therapeutic Monitoring, Companion Diagnostics, Prognostics, Cancer Screening, Risk Analysis), 2021-2032
... business that is poised to keep growing and presents potential growth opportunities for companies across the industry value chain. The comprehensive market research report presents 12-year historic and forecast data on Next Generation Cancer Diagnostics ... Read More
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Clinical Oncology Next Generation Sequencing Market Size, Share, and Outlook, 2025 Report- By Technology (Whole Genome Sequencing, Whole Exome Sequencing, Targeted Sequencing & Resequencing Centrifuges), By Workflow (NGS Pre-Sequencing, NGS Sequencing, NGS Data Analysis), By Application (Screening, Companion Diagnostics, Others), By End-User (Hospitals, Clinics, Laboratories), 2021-2032
... is a thriving business that is poised to keep growing and presents potential growth opportunities for companies across the industry value chain. The comprehensive market research report presents 12-year historic and forecast data on Clinical ... Read More
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Companion Diagnostics Market Size, Share & Trends Analysis Report By Product And Services (Assays, Kits, & Reagents, Instruments & Systems, Software & Services), By Indication, By Technology, By Sample Type, By End-use, By Region, And Segment Forecasts, 2025 - 2030
... by Grand View Research, Inc. Companion diagnostics are specialized tests designed to ensure the safe and effective use of specific therapeutic products by identifying corresponding biomarkers in patients. These tests are predominantly employed in oncology, ... Read More
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Companion Diagnostics Market, By Technology Type (Real Time-Polymerase Chain Reactions (PCR), Gene Sequencing, Fluorescence in situ Hybridization, and Others) By Application (Oncology, Cardiovascular Diseases, Infectious Diseases, Neurological Diseases and Others), By End User (Hospitals, Research Laboratories, Biopharmaceutical companies, and Others), By Region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa)
... in personalized healthcare by helping physicians select appropriate targeted treatment options for cancer and other diseases. Companion diagnostics tests evaluate the expression of biomarkers, such as proteins, genes or chromosomes that plays a role in ... Read More
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2025 Global Digital Companion Diagnostics Market Industry (2031 Outlook)
... for a three-year historical trend (2019-2022), a three-year forecast estimate trends (2023-2025), and a five-year outlook projection (2026-2031) for 46 countries. The report also features written analysis on market definitions, market segments, market trends, technology ... Read More
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Companion Diagnostics Market Size, Share, By Offerings (Products and Services), Technology (Polymerase Chain Reaction (PCR), Next-generation Sequencing (NGS), Immunohistochemistry (IHC), Fluorescence In Situ Hybridization (FISH), and, Others), Therapeutic Area (Oncology, Immunology, Neurology, Autoimmune, Cardiovascular, Infectious Disease, and Others), End-User (Pharmaceutical & Biotechnological Companies, Contract Research Laboratories, Diagnostics Laboratories, and Others), and Region - Trends, Analysis, and Forecast till 2035
... Disease, and Others), End-User (Pharmaceutical & Biotechnological Companies, Contract Research Laboratories, Diagnostics Laboratories, and Others), and Region - Trends, Analysis, and Forecast till 2035 Companion diagnostics market is projected to grow from US$ 3.6 Billion ... Read More
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Companion Diagnostics Global Market Report 2025
... is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond. Reasons to Purchase Gain a truly global perspective with the ... Read More
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2025 Global Forecast for Digital Companion Diagnostics Market (2026-2031 Outlook)-High Tech Outlook Report
... product or service category is within the NAICS Medical Laboratories industry. The product or service category is within the NAICS Medical Laboratories industry. The global market is expected to increase from USD xx billion in ... Read More
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2025 Global: Digital Companion Diagnostics Market - Innovative Markets Forecast (2031) report
... industry forecasts based on our proprietary economic models. Our forecasts project the product market size nationally and by regions for 2020 to 2031 using regression analysis in our modeling. and Perry/Hope is the only market ... Read More
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Global Oncology NGS Market: Analysis By Technology, By Workflow, By Application, By End User, By Region Size and Trends with Impact of COVID-19 and Forecast up to 2029
... Considered 2019-2029 Base Year 2023 Forecast Period 2024-2029 Page Count 152 Units Referenced US $ Segments/Key Topics By Technology, By Workflow, By Application, By End User Regions Covered North America (The US, Canada, Mexico), Europe ... Read More
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2025 Global Forecast for Companion Diagnostics Market (2026-2031 Outlook)-High Tech Outlook Report
... category is within the NAICS Computer Systems Design Services industry. The product or service category is within the NAICS Computer Systems Design Services industry. The global market is expected to increase from USD xx billion ... Read More
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2025 Global Companion Diagnostics Market Industry (2031 Outlook)
... Market Outlook reports provide market size data for a three-year historical trend (2019-2022), a three-year forecast estimate trends (2023-2025), and a five-year outlook projection (2026-2031) for 46 countries. The report also features written analysis on ... Read More
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2025 Global Companion Animal Diagnostics Market Industry (2031 Outlook)
... Global Advanced Market Outlook reports provide market size data for a three-year historical trend (2019-2022), a three-year forecast estimate trends (2023-2025), and a five-year outlook projection (2026-2031) for 46 countries. The report also features written ... Read More
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North America Companion Diagnostics Market Outlook to 2028
... diagnostics is fueled by partnerships between pharmaceutical and diagnostic companies, as well as the development of targeted therapies in oncology and other chronic diseases. Additionally, regulatory approvals from the FDA for new companion diagnostic tests ... Read More
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Top 6 Growth Opportunities for Clinical Diagnostics, Global, 2025
... is the silent champion supporting all stages of precision health, including risk stratification, screening, early diagnosis, prognosis, monitoring, and relapse. The discovery and translation of blood-based neurology biomarkers, sustained growth in drug-diagnostic combinations seeking regulatory ... Read More
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