The companion diagnostics market size has grown exponentially in recent years. It will grow from $8.69 billion in 2025 to $10.54 billion in 2026 at a compound annual growth rate (CAGR) of 21.3%. The growth in the historic period can be attributed to growth in targeted cancer therapies, expansion of oncology clinical trials, increased collaboration between pharma and diagnostics firms, rising cancer incidence rates, regulatory approvals for companion tests.
The companion diagnostics market size is expected to see exponential growth in the next few years. It will grow to $22.7 billion in 2030 at a compound annual growth rate (CAGR) of 21.1%. The growth in the forecast period can be attributed to increasing demand for personalized treatment selection, rising investments in precision medicine, expansion of immuno-oncology pipelines, growing adoption of ai-driven diagnostic interpretation, increasing regulatory emphasis on diagnostic-drug co-development. Major trends in the forecast period include increasing adoption of precision oncology diagnostics, rising integration of companion diagnostics in drug development, growing use of ngs-based diagnostic platforms, expansion of biomarker-driven therapies, enhanced focus on personalized medicine.
The rising number of targeted therapies is anticipated to drive the growth of the companion diagnostics market. Targeted therapy refers to a pharmacological approach that focuses on specific characteristics of cancer cells to slow down the disease's growth and spread. While these medications circulate throughout the body, they have a more precise effect than chemotherapy and often result in fewer side effects. Companion diagnostic testing based on biological markers is becoming a crucial component of personalized cancer care. For example, in February 2024, the Personalised Medicine Coalition, a US-based hospital and healthcare organization, reported that the FDA approved 16 new personalized treatments for patients with rare diseases in 2023, compared to six in 2022. Consequently, the increase in targeted therapies is fueling growth in the companion diagnostics market.
Major players in the companion diagnostics market are joining forces to create innovative treatment solutions aimed at enhancing personalized medicine, improving patient outcomes, and optimizing the effectiveness of targeted therapies. This collaboration among companies will accelerate the development and commercialization of companion diagnostics (CDx) for hematology and oncology treatments. For instance, in January 2024, Agilent Technologies, Inc., a California-based company providing instruments, software, services, and consumables for laboratories, announced a partnership with Incyte, a US-based pharmaceutical company. This collaboration combines Agilent’s expertise and established track record in developing companion diagnostics (CDx) to support Incyte’s hematology and oncology portfolio. As a result, Agilent will expand its CDx portfolio with new biomarkers, while Incyte will leverage Agilent's proficiency in assay development, regulatory approvals, and commercialization to facilitate clinical trials and CDx registration in the U.S. and Europe.
In September 2023, Exact Sciences, a US-based provider of molecular diagnostics and precision oncology tests, acquired Resolution Bioscience for an undisclosed amount. Through this acquisition, Exact Sciences seeks to strengthen its companion diagnostic capabilities by integrating Resolution Bioscience’s ctDx FIRST liquid biopsy platform and broadening its portfolio of precision oncology assays. Resolution Bioscience is a US-based company that offers next-generation sequencing (NGS)-based liquid biopsy tests to detect actionable tumor mutations and support targeted therapy.
Major companies operating in the companion diagnostics market are F Hoffmann-La Roche Ltd., Agilent Technologies Inc., Qiagen NV, Thermo Fisher Scientific Inc., Abbott Laboratories Inc., Amoy Diagnostics Co. Ltd., Danaher Corporation, Guardant Health Inc., Illumina Inc., Myriad Genetics Inc., Siemens Healthcare GmbH, Almac Group, Caris Life Sciences, Cepheid Inc., Diaceutics plc, Epic Sciences Inc., Foundation Medicine Inc., Genomic Health Inc., Grail Inc., Hologic Inc., HTG Molecular Diagnostics Inc., Inivata Ltd., Invivoscribe Inc., MolecularMD Corporation, Natera Inc., NeoGenomics Laboratories Inc., Personal Genome Diagnostics Inc., Precision Therapeutics Inc., Prometheus Laboratories Inc., Sysmex Corporation, Ventana Medical Systems.
North America was the largest region in the companion diagnostics market in 2025. The regions covered in the companion diagnostics 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 diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Tariffs are influencing the companion diagnostics market by increasing costs of imported reagents, sequencing instruments, assay kits, software platforms, and laboratory consumables. Pharmaceutical companies and reference laboratories in North America and Europe are most affected due to reliance on specialized imported technologies, while Asia-Pacific faces higher export-related costs. These tariffs are raising development and testing expenses and extending commercialization timelines. However, they are also encouraging regional diagnostic manufacturing, local software development, and stronger domestic diagnostics ecosystems.
The companion diagnostics market research report is one of a series of new reports that provides companion diagnostics market statistics, including companion diagnostics industry global market size, regional shares, competitors with a companion diagnostics market share, detailed companion diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the companion diagnostics industry. This companion diagnostics 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.
Companion diagnostics refer to in vitro diagnostic medical tests employed to assess the safety and effectiveness of a corresponding drug or biological product. These tests play a crucial role in helping healthcare professionals match patients with specific drugs or therapies.
The primary products and services in the companion diagnostics market include assays, kits, reagents, software, and related services. Assays, kits, and reagents find applications in various life science, environmental, and research laboratories. Assays are procedures used to examine substances for composition or quality, kits are collections of equipment and materials for specific purposes, and reagents are chemicals used in laboratory testing. Technologies such as polymerase chain reaction, next-generation sequencing, in situ hybridization, and immunohistochemistry are employed in companion diagnostics. These diagnostic tools are instrumental in identifying various cancer diseases like lung, breast, colorectal, leukemia, and melanoma. The primary users of companion diagnostics include pharmaceutical and biopharmaceutical companies, reference laboratories, and contract research organizations.
The companion diagnostics market includes revenues earned by theranostics and monitoring tests. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
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.
This product will be delivered within 1-3 business days.
The companion diagnostics market size is expected to see exponential growth in the next few years. It will grow to $22.7 billion in 2030 at a compound annual growth rate (CAGR) of 21.1%. The growth in the forecast period can be attributed to increasing demand for personalized treatment selection, rising investments in precision medicine, expansion of immuno-oncology pipelines, growing adoption of ai-driven diagnostic interpretation, increasing regulatory emphasis on diagnostic-drug co-development. Major trends in the forecast period include increasing adoption of precision oncology diagnostics, rising integration of companion diagnostics in drug development, growing use of ngs-based diagnostic platforms, expansion of biomarker-driven therapies, enhanced focus on personalized medicine.
The rising number of targeted therapies is anticipated to drive the growth of the companion diagnostics market. Targeted therapy refers to a pharmacological approach that focuses on specific characteristics of cancer cells to slow down the disease's growth and spread. While these medications circulate throughout the body, they have a more precise effect than chemotherapy and often result in fewer side effects. Companion diagnostic testing based on biological markers is becoming a crucial component of personalized cancer care. For example, in February 2024, the Personalised Medicine Coalition, a US-based hospital and healthcare organization, reported that the FDA approved 16 new personalized treatments for patients with rare diseases in 2023, compared to six in 2022. Consequently, the increase in targeted therapies is fueling growth in the companion diagnostics market.
Major players in the companion diagnostics market are joining forces to create innovative treatment solutions aimed at enhancing personalized medicine, improving patient outcomes, and optimizing the effectiveness of targeted therapies. This collaboration among companies will accelerate the development and commercialization of companion diagnostics (CDx) for hematology and oncology treatments. For instance, in January 2024, Agilent Technologies, Inc., a California-based company providing instruments, software, services, and consumables for laboratories, announced a partnership with Incyte, a US-based pharmaceutical company. This collaboration combines Agilent’s expertise and established track record in developing companion diagnostics (CDx) to support Incyte’s hematology and oncology portfolio. As a result, Agilent will expand its CDx portfolio with new biomarkers, while Incyte will leverage Agilent's proficiency in assay development, regulatory approvals, and commercialization to facilitate clinical trials and CDx registration in the U.S. and Europe.
In September 2023, Exact Sciences, a US-based provider of molecular diagnostics and precision oncology tests, acquired Resolution Bioscience for an undisclosed amount. Through this acquisition, Exact Sciences seeks to strengthen its companion diagnostic capabilities by integrating Resolution Bioscience’s ctDx FIRST liquid biopsy platform and broadening its portfolio of precision oncology assays. Resolution Bioscience is a US-based company that offers next-generation sequencing (NGS)-based liquid biopsy tests to detect actionable tumor mutations and support targeted therapy.
Major companies operating in the companion diagnostics market are F Hoffmann-La Roche Ltd., Agilent Technologies Inc., Qiagen NV, Thermo Fisher Scientific Inc., Abbott Laboratories Inc., Amoy Diagnostics Co. Ltd., Danaher Corporation, Guardant Health Inc., Illumina Inc., Myriad Genetics Inc., Siemens Healthcare GmbH, Almac Group, Caris Life Sciences, Cepheid Inc., Diaceutics plc, Epic Sciences Inc., Foundation Medicine Inc., Genomic Health Inc., Grail Inc., Hologic Inc., HTG Molecular Diagnostics Inc., Inivata Ltd., Invivoscribe Inc., MolecularMD Corporation, Natera Inc., NeoGenomics Laboratories Inc., Personal Genome Diagnostics Inc., Precision Therapeutics Inc., Prometheus Laboratories Inc., Sysmex Corporation, Ventana Medical Systems.
North America was the largest region in the companion diagnostics market in 2025. The regions covered in the companion diagnostics 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 diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Tariffs are influencing the companion diagnostics market by increasing costs of imported reagents, sequencing instruments, assay kits, software platforms, and laboratory consumables. Pharmaceutical companies and reference laboratories in North America and Europe are most affected due to reliance on specialized imported technologies, while Asia-Pacific faces higher export-related costs. These tariffs are raising development and testing expenses and extending commercialization timelines. However, they are also encouraging regional diagnostic manufacturing, local software development, and stronger domestic diagnostics ecosystems.
The companion diagnostics market research report is one of a series of new reports that provides companion diagnostics market statistics, including companion diagnostics industry global market size, regional shares, competitors with a companion diagnostics market share, detailed companion diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the companion diagnostics industry. This companion diagnostics 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.
Companion diagnostics refer to in vitro diagnostic medical tests employed to assess the safety and effectiveness of a corresponding drug or biological product. These tests play a crucial role in helping healthcare professionals match patients with specific drugs or therapies.
The primary products and services in the companion diagnostics market include assays, kits, reagents, software, and related services. Assays, kits, and reagents find applications in various life science, environmental, and research laboratories. Assays are procedures used to examine substances for composition or quality, kits are collections of equipment and materials for specific purposes, and reagents are chemicals used in laboratory testing. Technologies such as polymerase chain reaction, next-generation sequencing, in situ hybridization, and immunohistochemistry are employed in companion diagnostics. These diagnostic tools are instrumental in identifying various cancer diseases like lung, breast, colorectal, leukemia, and melanoma. The primary users of companion diagnostics include pharmaceutical and biopharmaceutical companies, reference laboratories, and contract research organizations.
The companion diagnostics market includes revenues earned by theranostics and monitoring tests. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
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.
This product will be delivered within 1-3 business days.
Table of Contents
1. Executive Summary
2. Companion Diagnostics Market Characteristics
3. Companion Diagnostics Market Supply Chain Analysis
4. Global Companion Diagnostics Market Trends and Strategies
5. Companion Diagnostics Market Analysis of End Use Industries
7. Global Companion Diagnostics Strategic Analysis Framework, Current Market Size, Market Comparisons and Growth Rate Analysis
8. Global Companion Diagnostics Total Addressable Market (TAM) Analysis for the Market
9. Companion Diagnostics Market Segmentation
10. Companion Diagnostics Market Regional and Country Analysis
11. Asia-Pacific Companion Diagnostics Market
12. China Companion Diagnostics Market
13. India Companion Diagnostics Market
14. Japan Companion Diagnostics Market
15. Australia Companion Diagnostics Market
16. Indonesia Companion Diagnostics Market
17. South Korea Companion Diagnostics Market
18. Taiwan Companion Diagnostics Market
19. South East Asia Companion Diagnostics Market
20. Western Europe Companion Diagnostics Market
21. UK Companion Diagnostics Market
22. Germany Companion Diagnostics Market
23. France Companion Diagnostics Market
24. Italy Companion Diagnostics Market
25. Spain Companion Diagnostics Market
26. Eastern Europe Companion Diagnostics Market
27. Russia Companion Diagnostics Market
28. North America Companion Diagnostics Market
29. USA Companion Diagnostics Market
30. Canada Companion Diagnostics Market
31. South America Companion Diagnostics Market
32. Brazil Companion Diagnostics Market
33. Middle East Companion Diagnostics Market
34. Africa Companion Diagnostics Market
36. Companion Diagnostics Market Competitive Landscape and Company Profiles
37. Companion Diagnostics Market Other Major and Innovative Companies
40. Companion Diagnostics Market High Potential Countries, Segments and Strategies
41. Appendix
List of Tables
Executive Summary
Companion Diagnostics Market Global Report 2026 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses companion diagnostics 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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Description
Where is the largest and fastest growing market for companion diagnostics? 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 diagnostics market global report 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.
Report Scope
Markets Covered:
1) By Product And Service: Assays; Kits And Reagents; Software And Services2) By Technology: Polymerase Chain Reaction; Next-Generation Sequencing; In Situ Hybridization; Immunohistochemistry
3) By Indication: Lung Cancer; Breast Cancer; Colorectal Cancer; Leukemia; Melanoma
4) By End-User: Pharmaceutical And Biopharmaceutical Companies; Reference Laboratories; Contract Research Organizations
Subsegments:
1) By Assays: Polymerase Chain Reaction (PCR) Assays; Immunohistochemistry (IHC) Assays; Next-Generation Sequencing (NGS) Assays; In Situ Hybridization (ISH) Assays2) By Kits And Reagents: Diagnostic Kits; Detection Reagents; Control Reagents
3) By Software And Services: Data Analysis Software; Interpretation Software; Custom Development Services; Consulting and Support Services
Companies Mentioned: F Hoffmann-La Roche Ltd.; Agilent Technologies Inc.; Qiagen NV; Thermo Fisher Scientific Inc.; Abbott Laboratories Inc.; Amoy Diagnostics Co. Ltd.; Danaher Corporation; Guardant Health Inc.; Illumina Inc.; Myriad Genetics Inc.; Siemens Healthcare GmbH; Almac Group; Caris Life Sciences; Cepheid Inc.; Diaceutics plc; Epic Sciences Inc.; Foundation Medicine Inc.; Genomic Health Inc.; Grail Inc.; Hologic Inc.; HTG Molecular Diagnostics Inc.; Inivata Ltd.; Invivoscribe Inc.; MolecularMD Corporation; Natera Inc.; NeoGenomics Laboratories Inc.; Personal Genome Diagnostics Inc.; Precision Therapeutics Inc.; Prometheus Laboratories Inc.; Sysmex Corporation; Ventana Medical Systems
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 Segmentation: 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.
Delivery Format: Word, PDF or Interactive Report + Excel Dashboard
Added Benefits:
- Bi-Annual Data Update
- Customisation
- Expert Consultant Support
Companies Mentioned
The companies featured in this Companion Diagnostics market report include:- F Hoffmann-La Roche Ltd.
- Agilent Technologies Inc.
- Qiagen NV
- Thermo Fisher Scientific Inc.
- Abbott Laboratories Inc.
- Amoy Diagnostics Co. Ltd.
- Danaher Corporation
- Guardant Health Inc.
- Illumina Inc.
- Myriad Genetics Inc.
- Siemens Healthcare GmbH
- Almac Group
- Caris Life Sciences
- Cepheid Inc.
- Diaceutics plc
- Epic Sciences Inc.
- Foundation Medicine Inc.
- Genomic Health Inc.
- Grail Inc.
- Hologic Inc.
- HTG Molecular Diagnostics Inc.
- Inivata Ltd.
- Invivoscribe Inc.
- MolecularMD Corporation
- Natera Inc.
- NeoGenomics Laboratories Inc.
- Personal Genome Diagnostics Inc.
- Precision Therapeutics Inc.
- Prometheus Laboratories Inc.
- Sysmex Corporation
- Ventana Medical Systems
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 250 |
| Published | February 2026 |
| Forecast Period | 2026 - 2030 |
| Estimated Market Value ( USD | $ 10.54 Billion |
| Forecasted Market Value ( USD | $ 22.7 Billion |
| Compound Annual Growth Rate | 21.1% |
| Regions Covered | Global |
| No. of Companies Mentioned | 32 |
