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Analysis of the Global Tissue Diagnostics Market

  • December 2013
  • 219 pages
  • Frost & Sullivan
Report ID: 1922968


Table of Contents

Reimbursement Cuts and Hospital Consolidation Impede Uptake of Automated Equipment in Laboratories

This study investigates the global tissue diagnostics market for the period 2009 to 2017. The geographic regions are the US, Western Europe, APAC, and ROW through which the market is broadly classified by the advance stains segment and the pre-analytical segment. The study also includes a competitive analysis (SWOT), product analysis, revenue forecasts, and market shares for the segments. Major market drivers and restraints for the US and Western Europe are discussed. The base year is 2012, and the forecast period runs from 2013 to 2017. Key histo-pathology laboratories are listed, and an effort has been made to collect the distributors and local suppliers in emerging countries.


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.

Industry-specific information obtained includes:
• revenue breakdowns by technology segments and regions specific to miRNA
• company revenues, market share estimates, and projected growth rates of various competitors
• market information, including customer and regional and technology trends
• market drivers, restraints, and challenges

Key Findings

• The total market for tissue diagnostics accounted for $X billion in 2012 and is estimated to reach $X billion by 2017. The CAGR for 2012–2017 is an estimated X%.
• Within the segments discussed, the global market size for the advance stains was an estimated $Xbillion in 2012. The advance stains segment is expected to reach $X billion by 2017 with a CAGR of X% for the forecast period, 2012–2017.
• The pre-analytical segment of tissue diagnostics is experiencing a significantly slower growth rate than that of the advance stains segment. The United States (US) and Western Europe especially did not see much of an adoption of tissue processors and embedding stations in 2012–2013.
- Globally, the revenues for the pre-analytical segment were an estimated $X million in 2012 and are estimated to reach $X million by 2017. The CAGR for this period is X%.
• Market estimates reveal that in 2012, when most parts of Western Europe and the US experienced a drop in revenues, Asia-Pacific (APAC) countries such as China and Japan along with Latin America experienced strong sales; this boosted the companies’ revenues despite low performances within their dominant geographies. Emerging markets projected healthy growth rates during 2012 and 2013.
- Several companies such as Roche, Dako (Agilent), Leica Biosystems, and Thermo Fisher are heavily investing in research and development (R&D) and manufacturing facilities in these emerging countries to provide local sales support.
• The lack of pathologists and a shortage of technicians in pathology laboratories is generating a demand to automate tissue handling and analysis processes, which drives the adoption for more automated slide stainers and offers an efficient workflow system.
• In the US and Western Europe, hospital consolidation and budget cuts affect purchasing new equipment.

Regional Trends:
• In 2012, aboutX% of the global revenues came from the US, leaving X% to Western Europe and X% to APAC and the Rest of World (ROW) regions. By 2017, Frost & Sullivan predicts that the US market will shrink to X%, leaving the Western European market stable at X%, and as these regions see decline, APAC and ROW will absorb this loss and market share here will grow to X%.
• In the US, customer consolidation and reimbursement cuts have handicapped certain parts of this industry. At the same time, tissue-based companion diagnostics products are generating interest.
• In Western Europe, efficient cancer management and screening programs are presenting huge volumes of samples to be screened. At the same time, a lack of properly defined reimbursement pathways in different parts of Western Europe represents a challenge for test accessibility.
• Besides the key market leaders, APAC and ROW are dominated by local distributors that account for about X% of the market. Favorable government guidelines for hospital upgrades and improved access to the poor have resulted in better equipped hospital facilities, further driving the need for adopting the latest innovative platforms.

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

CEO’s Perspective

1. Major pharmaceutical participants will acquire molecular in-vitro diagnostics (IVD) business as drug diagnostic products become more prevalent.
2. Heavy laboratory consolidation in Western Europe and reimbursement cuts in the US impede investments in clinical IHC systems.
3. Distributors will enjoy large markets in emerging countries where government guidelines such as tax rebates for medical equipment purchases favor market growth.
4. Hospital consolidation can lead to higher prices as hospital deals are also on the rise; this will change purchasing trends.
5. Molecular diagnostic tests will surge and new blood-based tests may negate the need for biopsies, thus shrinking the market.

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?

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