Analysis of the Global Tissue Diagnostics Market


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Growth in diagnostic test volume conducted across hospitals worldwide is lending momentum to the global tissue diagnostics market. In addition, the shortage of pathologists to perform these tests favors the automation of anatomic pathology laboratories, further spurring market development.

New research from Frost & Sullivan's Analysis of the Global Tissue Diagnostics Market ( finds the market earned revenue of $2.39 billion in 2012 and estimates this to reach $3.45 billion in 2017. The analysis is aimed at segmenting the market into two broad categories, namely pre-analytical and advance staining.

For more information on this analysis, please email Jennifer Carson, Corporate Communications, at

Published in: Health & Medicine, Business

Analysis of the Global Tissue Diagnostics Market

  1. 1. Analysis of the Global Tissue Diagnostics Market Reimbursement Cuts and Hospital Consolidation Impede the Uptake of Automated Equipment in Laboratories NC76-52 November 2013
  2. 2. Methodology Most of the quantitative and qualitative information in this research service was acquired through primary research regarding reagent and service providers from the microRNA (or miRNA) market. Most consults were vice presidents (VPs) of business units, VPs of marketing, product managers, marketing managers, marketing directors, and business development directors from various companies within the mass spectrometry market. The analysis contained in this research service is based on the following: • information collected through discussions with market participants and from secondary sources— government, industry associations, companies, Web sites, and other credible sources • public announcements and plans by OEMs*, suppliers, new entrants, and others • Frost & Sullivan’s published research, market, and technology expertise Forecasts are based on the data and analyses relating to industry challenges, market drivers and restraints, and market trends. If specific revenues or market sizes were unavailable, estimates were derived through consultations with industry experts augmented by secondary research. Growth trends specific to certain market participants are based on consultations, past growth rates, and technology reviews. Total Tissue Diagnostics Market: Research Industry-specific information obtained includes: Methodology, Global, 2012 • revenue breakdowns by technology segments and Secondary regions specific to tissue diagnostics research, • company revenues, market share estimates, and 20% Primary projected growth rates of various competitors research, • market information, including customer and regional 80% and technology trends • market drivers, restraints, and challenges Note: *original equipment manufacturers (OEMs). All figures are rounded. The base year is 2012. Source: Frost & Sullivan NC76-52 2
  3. 3. Scope and Segmentation Geographic Coverage Global Geographic Segmentation US, Western Europe, APAC, and ROW Technology Segmentation Pre-analytical: histology equipment and reagents, H&E* instruments and reagents Advance stains*: IHC, ISH, SS Study Period 2009–2017 Base Year 2012 Forecast Period 2013–2017 Monetary Unit US Dollars This study aims to cover the 2 technology segments for the following geographic regions: • US • Western Europe: United Kingdom (UK), Germany, Italy, France, Spain, Benelux (Belgium, the Netherlands, and Luxembourg), and Scandinavia • APAC: Singapore, Japan, Taiwan, India, China, South Korea, Australia, New Zealand, the Middle East, and Malaysia • ROW: Africa, Latin America, and Russia Note: Hematoxylin and eosin (H&E); immunohistochemistry (IHC); in-situ hybridisation (ISH); special stains (SS). Source: Frost & Sullivan NC76-52 3
  4. 4. Key Questions This Study Will Answer What are the key technologies currently used for tissue-based diagnosis? Which of the market segments are likely to experience growth? Are the products/services offered currently meeting customer needs, or is additional development needed? Which participants are competing in the areas of pre-analytics and advance stains within the realm of anatomic pathology and why? How will the structure of the market change over time? Is it ripe for acquisitions? How supportive are the current regulatory bodies? What impact do they have in various regions? What are the key challenges that affect the uptake of automated systems in the US, Western Europe, and APAC and ROW? Source: Frost & Sullivan NC76-52 4
  5. 5. Key Companies to Watch Advanced Cell Diagnostics (ACD) (US) Biomarker Strategies LLC (US) HistoRx (Novartis Company) (US) ACD operates in the US and Western Europe (in Europe through a distributor network). The company is currently actively pursing partnership opportunities for their proprietory RNAscope® technology in the area of personalized medicine. ACD offers services based on this automated multiplex chromogenic in-situ hybridization (ISH) platform. The company has already partnered with CST and Definiens in Western Europe to expand its base. This US based company has long-term commercialization plans in Western Europe and Asia for its SnapPath platform. The platform is in research use with many units currently used for preclinical and clinical studies. The platform offers live tumour biopsy processing and testing. Additionally, the company offers ex- in vivo biomarker tests for drug selection. In 2012, the company was acquired by Genoptix which is a part of the pharmaceutical company Novartis. Since 2009, HistroRx has sought active partnerships with Aperio and Caliper, both of which have a strong presence in the area of digital imaging. Histo Rx’s AQUA® technology offers quantitative IHC and delivers multi-parametric analysis of protein in clinical specimens. For additional information on companies, click here. Source: Frost & Sullivan NC76-52 5
  6. 6. Market Segmentation Total Tissue Diagnostics Market: Market Segmentation, Global, 2012 Total Tissue Diagnostics Market Pre-analytical • The pre-analytical segment includes these products: o Tissue embedding equipment o Tissue processing o Microtomes/cryostats o Cover slipping machine o Histology slide stains (H&E) o Routine stains Advance Stains • The advance stains segment includes these products: o IHC and ISH slide stainers o IHC/ISH/SS reagent kits *Note: This study does not include cytology and other imaging products associated with cytology (e.g., cytometry, microscopy). Source: Frost & Sullivan NC76-52 6
  7. 7. Global Market Perspective Key Takeaway: During the forecast period, opportunities in emerging markets loom large. Total Tissue Diagnostics Market: Revenue Breakdown by Geographic Region, Global, 2012 Total Tissue Diagnostics Market: Revenue Breakdown by Geographic Region, Global, 2017 APAC and ROW, 21.0% APAC and ROW, 29.1% US, 44.8% US, 52.0% Western Europe, 27.0% Western Europe, 26.1% Note: All figures are rounded. The base year is 2012. Source: Frost & Sullivan NC76-52 7
  8. 8. Global Revenue Forecast In the overall market for advance stains segment, sales in the emerging countries will grow while in the US market, sales will shrink. In Western Europe, the pre-analytical segment might shrink to 20.4%, thus creating opportunities for the US, APAC, and ROW markets. The trend is due in large part to many laboratories (about 70.0%) in Western Europe that adhere to an automated workflow process. Advance Stains Segment: Global, 2012 Western Europe, 29.5% APAC and ROW, 22.6% Advance Stains Segment: Global, 2017 Western Europe, 29.2% US, 47.9% Pre-analytical Segment: Global, 2012 Western Europe, 23.5% APAC and ROW, 18.8% US, 57.7% APAC and ROW, 30.0% US, 40.8% Pre-analytical Segment: Global, 2017 Western Europe, 20.4% APAC and ROW, 27.7% US, 51.9% Note: All figures are rounded. The base year is 2012. Source: Frost & Sullivan NC76-52 8
  9. 9. Western European Tissue Diagnostics Market—Percent Regional Analysis Key Takeaway: Germany, France, and Italy lead as the top 3 revenue contributors to the Western European tissue diagnostics market. Tissue Diagnostics Market: Percent Regional Analysis, Western Europe, 2012 Scandinavia— 4.2% UK— 12.5% Benelux— 6.1% France— 20.0% Germany— 24.0% Italy— 19.0% Spain— 14.2% Source: Frost & Sullivan NC76-52 9
  10. 10. Market Impact of Top 8 Trends Tissue Diagnostics Market: Impact of Top 8 Trends, Western Europe, 2012 Higher Impact Medium Growth Impact Projected Impact on the Tissue Diagnostics Market Higher Growth Impact Hospital/laboratory consolidation resulting in cuts for new equipment purchase Sluggish Western European economy Reimbursement delays Price pressure due to increasing competition Lack of pathologists necessitating automated workflow Life science market consolidation Funding uncertainty in Western Europe and US (Research grants from NIH, ERC, and vendors) Lower Growth Impact Lower Impact Low Used and refurbished instrument market Certainty High Source: Frost & Sullivan NC76-52 10
  11. 11. New Market Opportunities Total Tissue Diagnostics Market: New Market Opportunities, Global, 2012 Company Current Strategy Roche • Focuses on lean and six sigma across laboratories aiming to provide shortest turn around time for tests • Innovates value-based pricing strategy to combat in price sensitive environment • Increases local production capacity and increased access through Emerging Market strategies in Brazil, China, Mexico, Russia, South Korea, Turkey, and India such as working with local governments and partners • Attracts new top talent and retain talent in emerging markets Leica • Utilizes broadest range of instruments and consumables for histopathology with solutions designed to maximize workflow efficiency • Leverages global market access by strong position in sample preparation, digital pathology and microscopy markets • Invests for growth in India, Brazil, the Middle East, Turkey • Focus on digital marketing: eSales through Leica Direct • Provides consultancy services to effectively manage workflows Unmet Needs • Standardize testing practices • Decrease number of pathologists year on year Source: Frost & Sullivan NC76-52 11
  12. 12. New Market Opportunities (continued) Total Tissue Diagnostics Market: New Market Opportunities, Global, 2012 Company Current Strategy Thermo Fisher • Offers attractive payment schemes to combat customer budget crunching • Strengthens presence in selected geographies (e.g., R&D center in Shanghai and focused expansion in China) • Increases focus on R&D budgets to aim for innovative products Dako (Agilent) • Focuses (early) in Brazil and China recording highest growth performance • Leverages know how in pharma diagnostic partnerships to competitively position products • Strategizes strong positioning in Scandinavian countries that offer very good economies for growth in tissue diagnostics sector • Launches new product s (e.g., new fast Dako IQISH technology enabling laboratories to identify gene status with great speed and accuracy) • Forges strong reagent partnerships and distributor networks fostering growth for antibodies sold in bulk forms to OEMs • Pursues partnership opportunities within personalized medicine and other companies having complementary technologies Unmet Needs • Create more real-time monitoring technologies for biomarkers Source: Frost & Sullivan NC76-52 12
  13. 13. For More Information Jennifer Carson Corporate Communications (+1) 210.247.2450 NC76-52 13
  14. 14. Table of Contents Section Slide Numbers Executive Summary 13 • Key Findings 14 • Scope & Segmentation 16 • Key Questions This Study will Answer 17 • Market Engineering Measurements 18 • CEO’s Perspective 19 • Key Companies to Watch 20 • 3 Big Predictions 21 Market Overview 22 • Market Background 23 • Market Segmentation 26 • Global Market Perspective 27 • Defining Healthcare Trends in Future 28 Competitive Playbook 30 • New Market Opportunities 31 NC77-52 14
  15. 15. Contents (continued) Section Slide Numbers • Merger, Acquisition, and Partnership Assessment 35 Forecasts and Trends—Total Tissue Diagnostics Market 39 • Market Engineering Measurements 40 • Forecast Assumptions and Definitions 41 • Total Global Revenue Forecasts 43 • Global Revenue Forecasts by Segment 44 • Percent Revenue Forecast by Region 45 • Global Revenue Forecast by Region 46 • Revenue Forecast Discussion 47 • Procurement Process 50 Competitive Environment 51 • Competitive Environment 52 • Product Analysis 53 • Top Competitors 55 NC77-52 15
  16. 16. Contents (continued) Section Slide Numbers US Breakdown 60 • Market Analysis 61 • Key Findings 62 • PEST Analysis 63 • Drivers and Restraints 64 o Drivers and Restraints 65 o Market Impact of Top Trends 67 • Forecasts and Trends 68 o Market Engineering Measurements 69 o Revenue Forecasts 70 o Market Share by Tier 72 o Companion Diagnostics Partnerships 76 o 77 Pricing Analysis o Changes to Pathology CPT Codes NC77-52 79 16
  17. 17. Contents (continued) Section Slide Numbers o Key Tissue Diagnostics Service Providers 81 • US Pre-analytical Segment 82 o Revenue Forecast 83 o Revenue Forecast Discussion 84 • US Advance Stains Segment 85 o Revenue Forecast 86 o Revenue Forecast Discussion 87 Western European Breakdown 88 • Market Analysis 89 • Key Findings 90 • PEST Analysis 91 • Drivers and Restraints 93 o Drivers and Restraints o Market Impact of Top Trends NC77-52 94 96 17
  18. 18. Contents (continued) Section Slide Numbers • Forecasts and Trends 97 o Market Engineering Measurements 98 o Revenue Forecasts 99 o Revenue Forecasts by Segment Type 100 o Market Share by Tier 104 o Key Tissue Diagnostics Service Providers 108 Western European Regional Analysis Introduction 111 • Tissue Diagnostics Market Outlook in Western Europe 112 • Regional Analysis–Percentage 113 Germany 114 • Overview 115 • Revenue Forecasts and Discussion 116 NC77-52 18
  19. 19. Contents (continued) Section Slide Numbers France 119 • Overview 120 • Revenue Forecasts and Discussion 121 UK 123 • Overview 124 • Revenue Forecasts and Discussion 125 Italy 128 • Overview 129 • Revenue Forecasts and Discussion 130 Spain 132 • Overview 133 • Revenue Forecasts and Discussion 135 NC77-52 19
  20. 20. Contents (continued) Section Slide Numbers Benelux 138 • Overview 139 • Revenue Forecasts and Discussion 141 Scandinavia 143 • Overview 144 • Revenue Forecasts and Discussion 145 APAC and ROW Breakdown 148 • Market Analysis 149 • Key Findings 150 • PEST Analysis 151 • Forecasts and Trends 152 o Market Engineering Measurements o Revenue Forecast by Segment NC77-52 153 154 20
  21. 21. Contents (continued) Section Slide Numbers o Revenue Forecasts Discussion 156 o Market Share by Tier 159 o Country Trends (China, India, Brazil) 161 Key Companies to Watch 168 • ACD 169 • BioMarker 170 • HistoRx 171 The Last Word 172 • The Last Word 173 • The Last Word Discussion 174 • Legal Disclaimer 178 Appendix 179 • NC77-52 List of Other Companies 180 21
  22. 22. Contents (continued) Section Slide Numbers • Table of Pricing Data 181 • Table of CPT Code Descriptions 187 • US—Drivers Explained 189 • US—Restraints Explained 193 • Western Europe—Drivers Explained 197 • Western Europe—Restraints Explained 201 • Associated Multimedia 207 • Decision Support Database 208 • Market Engineering Methodology 218 • Learn More—Next Steps 219 NC77-52 22