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Medical Devices & Consumables Global HER2 Assay Kit Market 2026 by Manufacturers, Regions, Type and Application, Forecast to 2032

  • RnM4701873
    • |
  • 21 July, 2026
    • |
  • Global
    • |
  • 127 Pages
    • |
  • GIR
    • |
  • Medical Devices & Consumables

According to our (Global Info Research) latest study, the global HER2 Assay Kit market size was valued at US$ 76.55 million in 2025 and is forecast to a readjusted size of US$ 114 million by 2032 with a CAGR of 5.9% during review period.
HER2 testing kits primarily determine HER2 status by detecting the overexpression of HER2 protein or the amplification of the HER2 gene within tumor tissue. Specifically, the IHC (Immunohistochemistry) method utilizes anti-HER2 antibodies to bind with HER2 proteins in tissue sections; following a chromogenic visualization process, results are categorized as 0, 1+, 2+, or 3+ based on staining intensity. Conversely, ISH/FISH (In Situ Hybridization/Fluorescence In Situ Hybridization) methods employ HER2 gene probes—alongside reference probes such as CEP17—to perform hybridization, assessing gene amplification status based on signal counts and ratios. These products are primarily utilized in the pathological classification, prognostic assessment, and companion diagnostics for breast cancer, gastric cancer, and gastroesophageal junction cancer. Their objective is to assist in identifying patients suitable for HER2-targeted therapies, such as trastuzumab, pertuzumab, and trastuzumab deruxtecan.
The upstream supply chain encompasses fluorescent/chromogenic probes, buffers, enzymatic reagents, microscope slides, quality control materials, anti-fading agents, and pathological testing equipment; the downstream market targets hospital pathology departments, third-party laboratories, and oncology centers.Globally, the average unit price for HER2 testing kits stands at approximately $80 per kit, with global sales reaching approximately 930,000 kits. The industry boasts an annual production capacity of 1.5 million to 2 million kits and maintains a profit margin of approximately 50%.
The global market for human HER2 gene amplification testing kits is poised for growth, driven by advancements in precision medicine, companion diagnostics, and the expanding scope of HER2-targeted therapies. Consequently, market demand is continuously trending toward greater standardization, automation, and high sensitivity. As the demand for HER2 testing rises across breast cancer, gastric cancer, and various other cancer types, technologies such as FISH, CISH, and Dual ISH will increasingly prioritize interpretive consistency, testing efficiency, and compatibility with automated pathology platforms. Future market competition will center on probe stability, result accuracy, reagent compatibility, regulatory compliance, and endorsement by clinical guidelines; concurrently, emerging therapeutic stratification concepts—such as "HER2-low" and "HER2-ultralow"—are expected to drive further refinement and segmentation of clinical testing scenarios.
This report is a detailed and comprehensive analysis for global HER2 Assay Kit market. Both quantitative and qualitative analyses are presented by manufacturers, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.
Key Features:
Global HER2 Assay Kit market size and forecasts, in consumption value ($ Million), sales quantity (K Boxes), and average selling prices (US$/Box), 2021-2032
Global HER2 Assay Kit market size and forecasts by region and country, in consumption value ($ Million), sales quantity (K Boxes), and average selling prices (US$/Box), 2021-2032
Global HER2 Assay Kit market size and forecasts, by Type and by Application, in consumption value ($ Million), sales quantity (K Boxes), and average selling prices (US$/Box), 2021-2032
Global HER2 Assay Kit market shares of main players, shipments in revenue ($ Million), sales quantity (K Boxes), and ASP (US$/Box), 2021-2026
The Primary Objectives in This Report Are:
To determine the size of the total market opportunity of global and key countries
To assess the growth potential for HER2 Assay Kit
To forecast future growth in each product and end-use market
To assess competitive factors affecting the marketplace
This report profiles key players in the global HER2 Assay Kit market based on the following parameters - company overview, sales quantity, revenue, price, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Thermo Fisher Scientific, Agilent Technologies, Leica Biosystems, BD Bioscience, Roche Diagnostics, LSBio, Abcam, Abbott Molecular, Nichirei Biosciences, Dakewe Biotech, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Market Segmentation
HER2 Assay Kit market is split by Type and by Application. For the period 2021-2032, the growth among segments provides accurate calculations and forecasts for consumption value by Type, and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.
Market segment by Type
Fluorescence In Situ Hybridization Kit
Chromogenic In Situ Hybridization Kit
Market segment by Probe Type
HER-2 Single-Color Probe Kit
HER-2 Dual-Color Probe Kit
HER-2/CEP17 Dual-Probe Kit
HER-2 Locus-Specific Probe Kit
HER-2 Copy Number Probe Kit
Market segment by Fluorescent Signal
Single-Color FISH Kit
Dual-Color FISH Kit
Multi-Color FISH Kit
Market segment by Application
Hospital
Clinic
Laboratory
Others
Major players covered
Thermo Fisher Scientific
Agilent Technologies
Leica Biosystems
BD Bioscience
Roche Diagnostics
LSBio
Abcam
Abbott Molecular
Nichirei Biosciences
Dakewe Biotech
Sysmex
ZytoVision
Biolynx
AmoyDx
LBP Medicine
CELNOVTE
Maixin Biotech
Market segment by region, regional analysis covers
North America (United States, Canada, and Mexico)
Europe (Germany, France, United Kingdom, Russia, Italy, and Rest of Europe)
Asia-Pacific (China, Japan, Korea, India, Southeast Asia, and Australia)
South America (Brazil, Argentina, Colombia, and Rest of South America)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa, and Rest of Middle East & Africa)
The content of the study subjects, includes a total of 15 chapters:
Chapter 1, to describe HER2 Assay Kit product scope, market overview, market estimation caveats and base year.
Chapter 2, to profile the top manufacturers of HER2 Assay Kit, with price, sales quantity, revenue, and global market share of HER2 Assay Kit from 2021 to 2026.
Chapter 3, the HER2 Assay Kit competitive situation, sales quantity, revenue, and global market share of top manufacturers are analyzed emphatically by landscape contrast.
Chapter 4, the HER2 Assay Kit breakdown data are shown at the regional level, to show the sales quantity, consumption value, and growth by regions, from 2021 to 2032.
Chapter 5 and 6, to segment the sales by Type and by Application, with sales market share and growth rate by Type, by Application, from 2021 to 2032.
Chapter 7, 8, 9, 10 and 11, to break the sales data at the country level, with sales quantity, consumption value, and market share for key countries in the world, from 2021 to 2026.and HER2 Assay Kit market forecast, by regions, by Type, and by Application, with sales and revenue, from 2027 to 2032.
Chapter 12, market dynamics, drivers, restraints, trends, and Porters Five Forces analysis.
Chapter 13, the key raw materials and key suppliers, and industry chain of HER2 Assay Kit.
Chapter 14 and 15, to describe HER2 Assay Kit sales channel, distributors, customers, research findings and conclusion.


1 Market Overview

  • 1.1 Product Overview and Scope
  • 1.2 Market Estimation Caveats and Base Year
  • 1.3 Market Analysis by Type
    • 1.3.1 Overview: Global HER2 Assay Kit Consumption Value by Type: 2021 Versus 2025 Versus 2032
    • 1.3.2 50 Test Samples
    • 1.3.3 100 Test Samples
  • 1.4 Market Analysis by Application
    • 1.4.1 Overview: Global HER2 Assay Kit Consumption Value by Application: 2021 Versus 2025 Versus 2032
    • 1.4.2 Hospital
    • 1.4.3 Clinic
    • 1.4.4 Research Institutions
    • 1.4.5 Others
  • 1.5 Global HER2 Assay Kit Market Size & Forecast
    • 1.5.1 Global HER2 Assay Kit Consumption Value (2021 & 2025 & 2032)
    • 1.5.2 Global HER2 Assay Kit Sales Quantity (2021-2032)
    • 1.5.3 Global HER2 Assay Kit Average Price (2021-2032)

2 Manufacturers Profiles

  • 2.1 Thermo Fisher Scientific
    • 2.1.1 Thermo Fisher Scientific Details
    • 2.1.2 Thermo Fisher Scientific Major Business
    • 2.1.3 Thermo Fisher Scientific HER2 Assay Kit Product and Services
    • 2.1.4 Thermo Fisher Scientific HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.1.5 Thermo Fisher Scientific Recent Developments/Updates
  • 2.2 Bio-Rad
    • 2.2.1 Bio-Rad Details
    • 2.2.2 Bio-Rad Major Business
    • 2.2.3 Bio-Rad HER2 Assay Kit Product and Services
    • 2.2.4 Bio-Rad HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.2.5 Bio-Rad Recent Developments/Updates
  • 2.3 Boster Bio
    • 2.3.1 Boster Bio Details
    • 2.3.2 Boster Bio Major Business
    • 2.3.3 Boster Bio HER2 Assay Kit Product and Services
    • 2.3.4 Boster Bio HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.3.5 Boster Bio Recent Developments/Updates
  • 2.4 BD Bioscience
    • 2.4.1 BD Bioscience Details
    • 2.4.2 BD Bioscience Major Business
    • 2.4.3 BD Bioscience HER2 Assay Kit Product and Services
    • 2.4.4 BD Bioscience HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.4.5 BD Bioscience Recent Developments/Updates
  • 2.5 Dianova
    • 2.5.1 Dianova Details
    • 2.5.2 Dianova Major Business
    • 2.5.3 Dianova HER2 Assay Kit Product and Services
    • 2.5.4 Dianova HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.5.5 Dianova Recent Developments/Updates
  • 2.6 LSBio
    • 2.6.1 LSBio Details
    • 2.6.2 LSBio Major Business
    • 2.6.3 LSBio HER2 Assay Kit Product and Services
    • 2.6.4 LSBio HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.6.5 LSBio Recent Developments/Updates
  • 2.7 Abcam
    • 2.7.1 Abcam Details
    • 2.7.2 Abcam Major Business
    • 2.7.3 Abcam HER2 Assay Kit Product and Services
    • 2.7.4 Abcam HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.7.5 Abcam Recent Developments/Updates
  • 2.8 Dartmon
    • 2.8.1 Dartmon Details
    • 2.8.2 Dartmon Major Business
    • 2.8.3 Dartmon HER2 Assay Kit Product and Services
    • 2.8.4 Dartmon HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.8.5 Dartmon Recent Developments/Updates
  • 2.9 Zhejiang Century Condor MedicalScience & Technology
    • 2.9.1 Zhejiang Century Condor MedicalScience & Technology Details
    • 2.9.2 Zhejiang Century Condor MedicalScience & Technology Major Business
    • 2.9.3 Zhejiang Century Condor MedicalScience & Technology HER2 Assay Kit Product and Services
    • 2.9.4 Zhejiang Century Condor MedicalScience & Technology HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.9.5 Zhejiang Century Condor MedicalScience & Technology Recent Developments/Updates
  • 2.10 Dakewe Biotech
    • 2.10.1 Dakewe Biotech Details
    • 2.10.2 Dakewe Biotech Major Business
    • 2.10.3 Dakewe Biotech HER2 Assay Kit Product and Services
    • 2.10.4 Dakewe Biotech HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.10.5 Dakewe Biotech Recent Developments/Updates
  • 2.11 GeneTech
    • 2.11.1 GeneTech Details
    • 2.11.2 GeneTech Major Business
    • 2.11.3 GeneTech HER2 Assay Kit Product and Services
    • 2.11.4 GeneTech HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.11.5 GeneTech Recent Developments/Updates
  • 2.12 Xiamen Tongling Biomedical Technology (China)
    • 2.12.1 Xiamen Tongling Biomedical Technology (China) Details
    • 2.12.2 Xiamen Tongling Biomedical Technology (China) Major Business
    • 2.12.3 Xiamen Tongling Biomedical Technology (China) HER2 Assay Kit Product and Services
    • 2.12.4 Xiamen Tongling Biomedical Technology (China) HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.12.5 Xiamen Tongling Biomedical Technology (China) Recent Developments/Updates
  • 2.13 Biolynx
    • 2.13.1 Biolynx Details
    • 2.13.2 Biolynx Major Business
    • 2.13.3 Biolynx HER2 Assay Kit Product and Services
    • 2.13.4 Biolynx HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.13.5 Biolynx Recent Developments/Updates
  • 2.14 CELNOVTE
    • 2.14.1 CELNOVTE Details
    • 2.14.2 CELNOVTE Major Business
    • 2.14.3 CELNOVTE HER2 Assay Kit Product and Services
    • 2.14.4 CELNOVTE HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.14.5 CELNOVTE Recent Developments/Updates
  • 2.15 Maixin Biotech
    • 2.15.1 Maixin Biotech Details
    • 2.15.2 Maixin Biotech Major Business
    • 2.15.3 Maixin Biotech HER2 Assay Kit Product and Services
    • 2.15.4 Maixin Biotech HER2 Assay Kit Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2021-2026)
    • 2.15.5 Maixin Biotech Recent Developments/Updates

3 Competitive Environment: HER2 Assay Kit by Manufacturer

  • 3.1 Global HER2 Assay Kit Sales Quantity by Manufacturer (2021-2026)
  • 3.2 Global HER2 Assay Kit Revenue by Manufacturer (2021-2026)
  • 3.3 Global HER2 Assay Kit Average Price by Manufacturer (2021-2026)
  • 3.4 Market Share Analysis (2025)
    • 3.4.1 Producer Shipments of HER2 Assay Kit by Manufacturer Revenue ($MM) and Market Share (%): 2025
    • 3.4.2 Top 3 HER2 Assay Kit Manufacturer Market Share in 2025
    • 3.4.3 Top 6 HER2 Assay Kit Manufacturer Market Share in 2025
  • 3.5 HER2 Assay Kit Market: Overall Company Footprint Analysis
    • 3.5.1 HER2 Assay Kit Market: Region Footprint
    • 3.5.2 HER2 Assay Kit Market: Company Product Type Footprint
    • 3.5.3 HER2 Assay Kit Market: Company Product Application Footprint
  • 3.6 New Market Entrants and Barriers to Market Entry
  • 3.7 Mergers, Acquisition, Agreements, and Collaborations

4 Consumption Analysis by Region

  • 4.1 Global HER2 Assay Kit Market Size by Region
    • 4.1.1 Global HER2 Assay Kit Sales Quantity by Region (2021-2032)
    • 4.1.2 Global HER2 Assay Kit Consumption Value by Region (2021-2032)
    • 4.1.3 Global HER2 Assay Kit Average Price by Region (2021-2032)
  • 4.2 North America HER2 Assay Kit Consumption Value (2021-2032)
  • 4.3 Europe HER2 Assay Kit Consumption Value (2021-2032)
  • 4.4 Asia-Pacific HER2 Assay Kit Consumption Value (2021-2032)
  • 4.5 South America HER2 Assay Kit Consumption Value (2021-2032)
  • 4.6 Middle East & Africa HER2 Assay Kit Consumption Value (2021-2032)

5 Market Segment by Type

  • 5.1 Global HER2 Assay Kit Sales Quantity by Type (2021-2032)
  • 5.2 Global HER2 Assay Kit Consumption Value by Type (2021-2032)
  • 5.3 Global HER2 Assay Kit Average Price by Type (2021-2032)

6 Market Segment by Application

  • 6.1 Global HER2 Assay Kit Sales Quantity by Application (2021-2032)
  • 6.2 Global HER2 Assay Kit Consumption Value by Application (2021-2032)
  • 6.3 Global HER2 Assay Kit Average Price by Application (2021-2032)

7 North America

  • 7.1 North America HER2 Assay Kit Sales Quantity by Type (2021-2032)
  • 7.2 North America HER2 Assay Kit Sales Quantity by Application (2021-2032)
  • 7.3 North America HER2 Assay Kit Market Size by Country
    • 7.3.1 North America HER2 Assay Kit Sales Quantity by Country (2021-2032)
    • 7.3.2 North America HER2 Assay Kit Consumption Value by Country (2021-2032)
    • 7.3.3 United States Market Size and Forecast (2021-2032)
    • 7.3.4 Canada Market Size and Forecast (2021-2032)
    • 7.3.5 Mexico Market Size and Forecast (2021-2032)

8 Europe

  • 8.1 Europe HER2 Assay Kit Sales Quantity by Type (2021-2032)
  • 8.2 Europe HER2 Assay Kit Sales Quantity by Application (2021-2032)
  • 8.3 Europe HER2 Assay Kit Market Size by Country
    • 8.3.1 Europe HER2 Assay Kit Sales Quantity by Country (2021-2032)
    • 8.3.2 Europe HER2 Assay Kit Consumption Value by Country (2021-2032)
    • 8.3.3 Germany Market Size and Forecast (2021-2032)
    • 8.3.4 France Market Size and Forecast (2021-2032)
    • 8.3.5 United Kingdom Market Size and Forecast (2021-2032)
    • 8.3.6 Russia Market Size and Forecast (2021-2032)
    • 8.3.7 Italy Market Size and Forecast (2021-2032)

9 Asia-Pacific

  • 9.1 Asia-Pacific HER2 Assay Kit Sales Quantity by Type (2021-2032)
  • 9.2 Asia-Pacific HER2 Assay Kit Sales Quantity by Application (2021-2032)
  • 9.3 Asia-Pacific HER2 Assay Kit Market Size by Region
    • 9.3.1 Asia-Pacific HER2 Assay Kit Sales Quantity by Region (2021-2032)
    • 9.3.2 Asia-Pacific HER2 Assay Kit Consumption Value by Region (2021-2032)
    • 9.3.3 China Market Size and Forecast (2021-2032)
    • 9.3.4 Japan Market Size and Forecast (2021-2032)
    • 9.3.5 South Korea Market Size and Forecast (2021-2032)
    • 9.3.6 India Market Size and Forecast (2021-2032)
    • 9.3.7 Southeast Asia Market Size and Forecast (2021-2032)
    • 9.3.8 Australia Market Size and Forecast (2021-2032)

10 South America

  • 10.1 South America HER2 Assay Kit Sales Quantity by Type (2021-2032)
  • 10.2 South America HER2 Assay Kit Sales Quantity by Application (2021-2032)
  • 10.3 South America HER2 Assay Kit Market Size by Country
    • 10.3.1 South America HER2 Assay Kit Sales Quantity by Country (2021-2032)
    • 10.3.2 South America HER2 Assay Kit Consumption Value by Country (2021-2032)
    • 10.3.3 Brazil Market Size and Forecast (2021-2032)
    • 10.3.4 Argentina Market Size and Forecast (2021-2032)

11 Middle East & Africa

  • 11.1 Middle East & Africa HER2 Assay Kit Sales Quantity by Type (2021-2032)
  • 11.2 Middle East & Africa HER2 Assay Kit Sales Quantity by Application (2021-2032)
  • 11.3 Middle East & Africa HER2 Assay Kit Market Size by Country
    • 11.3.1 Middle East & Africa HER2 Assay Kit Sales Quantity by Country (2021-2032)
    • 11.3.2 Middle East & Africa HER2 Assay Kit Consumption Value by Country (2021-2032)
    • 11.3.3 Turkey Market Size and Forecast (2021-2032)
    • 11.3.4 Egypt Market Size and Forecast (2021-2032)
    • 11.3.5 Saudi Arabia Market Size and Forecast (2021-2032)
    • 11.3.6 South Africa Market Size and Forecast (2021-2032)

12 Market Dynamics

  • 12.1 HER2 Assay Kit Market Drivers
  • 12.2 HER2 Assay Kit Market Restraints
  • 12.3 HER2 Assay Kit Trends Analysis
  • 12.4 Porters Five Forces Analysis
    • 12.4.1 Threat of New Entrants
    • 12.4.2 Bargaining Power of Suppliers
    • 12.4.3 Bargaining Power of Buyers
    • 12.4.4 Threat of Substitutes
    • 12.4.5 Competitive Rivalry

13 Raw Material and Industry Chain

  • 13.1 Raw Material of HER2 Assay Kit and Key Manufacturers
  • 13.2 Manufacturing Costs Percentage of HER2 Assay Kit
  • 13.3 HER2 Assay Kit Production Process
  • 13.4 Industry Value Chain Analysis

14 Shipments by Distribution Channel

  • 14.1 Sales Channel
    • 14.1.1 Direct to End-User
    • 14.1.2 Distributors
  • 14.2 HER2 Assay Kit Typical Distributors
  • 14.3 HER2 Assay Kit Typical Customers

15 Research Findings and Conclusion

    16 Appendix

    • 16.1 Methodology
    • 16.2 Research Process and Data Source

    Summary:
    Get latest Market Research Reports on HER2 Assay Kit. Industry analysis & Market Report on HER2 Assay Kit is a syndicated market report, published as Global HER2 Assay Kit Market 2026 by Manufacturers, Regions, Type and Application, Forecast to 2032. It is complete Research Study and Industry Analysis of HER2 Assay Kit market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.

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