Companion Diagnostic Technologies Global Market Report 2026

Companion diagnostic technologies are specialized diagnostic solutions and testing methods developed to detect specific biomarkers that can predict how a patient will respond to a certain treatment. These technologies are utilized to support the safe and effective administration of targeted therapies by aligning the appropriate medication with the appropriate patient according to their molecular or genetic characteristics. They play an essential role in advancing precision medicine by enhancing treatment effectiveness and minimizing the likelihood of adverse reactions.

The main types of companion diagnostic technologies include immunohistochemistry and molecular diagnostics. Immunohistochemistry refers to diagnostic techniques used to detect specific antigens in tissue samples using antigen-antibody interactions for disease identification and treatment selection. These products are categorized by sample type including tissue, blood, saliva, and other sample types and are based on technologies such as polymerase chain reaction, next generation sequencing, immunohistochemistry, in situ hybridization, microarrays, and liquid biopsy. They are distributed through direct sales and distributors and are used in applications such as oncology, cardiovascular, central nervous system, autoimmune and inflammation, virology, and others.

Tariffs are impacting the companion diagnostic technologies market by increasing the cost of imported sequencing instruments, molecular diagnostic reagents, laboratory automation systems, and semiconductor based diagnostic devices required for biomarker testing and precision medicine applications. This is slowing adoption of advanced diagnostic technologies and personalized treatment workflows, particularly in regions dependent on imports such as Asia-Pacific and Latin America. Technology intensive segments like next generation sequencing, polymerase chain reaction systems, and liquid biopsy diagnostics are most affected due to global supply chain dependencies. However, tariffs are also encouraging local manufacturing, regional supplier diversification, and increased investment in domestic precision diagnostics and biotechnology ecosystems, creating long-term resilience in the market.

The companion diagnostic technologies market research report is one of a series of new reports from The Business Research Company that provides companion diagnostic technologies market statistics, including companion diagnostic technologies industry global market size, regional shares, competitors with a companion diagnostic technologies market share, detailed companion diagnostic technologies market segments, market trends and opportunities, and any further data you may need to thrive in the companion diagnostic technologies industry. This companion diagnostic technologies 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.

The companion diagnostic technologies market size has grown rapidly in recent years. It will grow from $4.44 billion in 2025 to $4.97 billion in 2026 at a compound annual growth rate (CAGR) of 12.0%. The growth in the historic period can be attributed to growth in precision medicine adoption, rising prevalence of cancer and chronic diseases, increasing demand for targeted therapeutic solutions, expansion of molecular diagnostics research activities, growing investment in biomarker discovery programs.

The companion diagnostic technologies market size is expected to see rapid growth in the next few years. It will grow to $7.89 billion in 2030 at a compound annual growth rate (CAGR) of 12.2%. The growth in the forecast period can be attributed to rising development of personalized treatment regimens, increasing adoption of AI enabled diagnostic interpretation platforms, growing demand for non invasive liquid biopsy diagnostics, expansion of pharmaceutical and diagnostic company collaborations, increasing regulatory approvals for companion diagnostic assays. Major trends in the forecast period include increasing adoption of biomarker based targeted therapy selection, rising demand for next generation sequencing companion diagnostics, growing use of liquid biopsy testing solutions, expansion of personalized oncology treatment approaches, increasing integration of multiplex molecular diagnostic testing.

The increasing demand for targeted therapies is expected to propel the growth of the companion diagnostic technologies market going forward. Targeted therapies refer to a form of medical treatment that uses drugs or other substances to precisely identify and attack specific cancer cells or molecular targets, minimizing damage to healthy cells. The demand for targeted therapies is rising due to their ability to precisely attack disease-specific pathways, resulting in improved efficacy with fewer side effects. Companion diagnostic technologies support targeted therapies by enabling the identification of specific genetic mutations, biomarkers, and molecular profiles, thereby helping in selecting the most effective targeted treatment for individual patients, improving treatment accuracy, and enhancing clinical decision-making in oncology and other disease areas. For instance, in July 2023, according to the report published by the American Society of Gene & Cell Therapy (ASGCT), a US-based professional membership organization, at the end of the first quarter (Q1) 2023, there were 247 gene therapies in Phase II, but this number rose by 5% to reach 260 by the end of the second quarter(Q2). Therefore, the increasing demand for targeted therapies is driving the growth of the companion diagnostic technologies market.

Major companies operating in the companion diagnostic technologies market are focusing on developing advanced genomic testing solutions, such as liquid biopsy-based companion diagnostics, to enhance precision medicine, improve targeted therapy selection, and enable more accurate cancer treatment decision-making. Liquid biopsy-based companion diagnostics refer to blood- or fluid-based tests used to detect specific biomarkers that guide and match patients to appropriate targeted therapies. For instance, in October 2024, Foundation Medicine, Inc., a US-based molecular information company, announced the Food and Drug Administration (FDA) approved its Liquid CDx test in combination with Itovebi, strengthening its role in precision oncology diagnostics. The solution is made to help doctors choose better treatments and make clinical decisions by using a blood test that looks at a wide range of genes, which helps them find important mutations and direct cancer treatments more effectively.

In September 2025, Lunit, a South Korea-based provider of AI-powered digital pathology and imaging tools, collaborated with Agilent Technologies Inc. to accelerate precision medicine through AI-powered companion diagnostics. The partnership aims to integrate Lunit's AI-driven cancer analysis with Agilent Technologies' diagnostic and genomics capabilities to develop more accurate and efficient companion diagnostic solutions for targeted therapies. Agilent Technologies Inc. is a US-based company that specializes in the development and commercialization of companion diagnostics (CDx).

Major companies operating in the companion diagnostic technologies market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthineers AG, Danaher Corporation, Becton Dickinson and Company, BioGenex Laboratories Inc., Quest Diagnostics Incorporated, Agilent Technologies Inc., Illumina Inc., bioMerieux S. A., Shimadzu Corporation, Sysmex Corporation, Bio-Rad Laboratories Inc., QIAGEN N. V., DiaSorin S. p. A., Caris Life Sciences Inc., Myriad Genetics Inc., Servier Laboratories, Pillar Biosciences Inc., EntroGen Inc.

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

The countries covered in the companion diagnostic technologies market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The companion diagnostic technologies market consists of revenues earned by entities by providing services such as patient stratification for targeted therapies, biomarker validation support, therapy response monitoring, and clinical trial enrichment. The market value includes the value of related goods sold by the service provider or included within the service offering. The companion diagnostic technologies market also includes sales of consumable test strips, staining reagent kits, and nucleic acid extraction kits. 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.

Companion Diagnostic Technologies Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses companion diagnostic technologies 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.

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Where is the largest and fastest growing market for companion diagnostic technologies ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The companion diagnostic technologies market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

• The market characteristics section of the report defines and explains the market. This section also examines key products and services offered in the market, evaluates brand-level differentiation, compares product features, and highlights major innovation and product development trends.
• The supply chain analysis section provides an overview of the entire value chain, including key raw materials, resources, and supplier analysis. It also provides a list competitor at each level of the supply chain.
• The updated trends and strategies section analyses the shape of the market as it evolves and highlights emerging technology trends such as digital transformation, automation, sustainability initiatives, and AI-driven innovation. It suggests how companies can leverage these advancements to strengthen their market position and achieve competitive differentiation.
• The regulatory and investment landscape section provides an overview of the key regulatory frameworks, regularity bodies, associations, and government policies influencing the market. It also examines major investment flows, incentives, and funding trends shaping industry growth and innovation.
• The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
• The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
• The total addressable market (TAM) analysis section defines and estimates the market potential compares it with the current market size, and provides strategic insights and growth opportunities based on this evaluation.
• The market attractiveness scoring section evaluates the market based on a quantitative scoring framework that considers growth potential, competitive dynamics, strategic fit, and risk profile. It also provides interpretive insights and strategic implications for decision-makers.
• Market segmentations break down the market into sub markets.
• The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
• Expanded geographical coverage includes Taiwan and Southeast Asia, reflecting recent supply chain realignments and manufacturing shifts in the region. This section analyzes how these markets are becoming increasingly important hubs in the global value chain.
• The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
• The company scoring matrix section evaluates and ranks leading companies based on a multi-parameter framework that includes market share or revenues, product innovation, and brand recognition.

Scope

• Markets Covered:1) By Type: Immunohistochemistry; Molecular Diagnostics
• 2) By Sample Type: Tissue; Blood; Saliva; Other Sample Types
• 3) By Technology: Polymerase Chain Reaction; Next Generation Sequencing; Immunohistochemistry; In Situ Hybridization; Microarrays; Liquid Biopsy
• 4) By Distribution Channel: Direct Sales; Distributors
• 5) By Application: Oncology; Cardiovascular; Central Nervous System; Autoimmune And Inflammation; Virology; Other Applications
• Subsegments:
• 1) By Immunohistochemistry: Antibody Based Staining Techniques; Chromogenic Detection Methods; Fluorescent Detection Methods
• 2) By Molecular Diagnostics: Deoxyribonucleic Acid Based Testing; Ribonucleic Acid Based Testing; Protein Biomarker Analysis
• Companies Mentioned: F. Hoffmann-La Roche AG; Thermo Fisher Scientific Inc.; Abbott Laboratories; Siemens Healthineers AG; Danaher Corporation; Becton Dickinson and Company; BioGenex Laboratories Inc.; Quest Diagnostics Incorporated; Agilent Technologies Inc.; Illumina Inc.; bioMerieux S.A.; Shimadzu Corporation; Sysmex Corporation; Bio-Rad Laboratories Inc.; QIAGEN N.V.; DiaSorin S.p.A.; Caris Life Sciences Inc.; Myriad Genetics Inc.; Servier Laboratories; Pillar Biosciences Inc.; EntroGen Inc.
• Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Taiwan; Russia; South Korea; UK; USA; Canada; Italy; Spain
• Regions: Asia-Pacific; South East Asia; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
• 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 Segmentations: country and regional historic and forecast data, market share of competitors, market segments.
• Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
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