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U.S. Tissue Diagnostics Markets

Frost & Sullivan, Dec 2009, Pages: 101


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This research service analyzes the market for tissue diagnostics within the United States. The market was divided into the pre-analytical and routine staining and advanced staining segments. Each segment covers market trends, technology trends, competitive structure, market share analysis, revenue forecasts, market trends, and technology trends. The key challenges and strategies are covered for the total market overview

Research Overview
This Frost & Sullivan research service titled U.S. Tissue Diagnostics Markets identifies the challenges faced by instrument and test providers in the tissue diagnostic industry and offers recommendations for overcoming a competitive and uncertain marketplace. In this research, Frost & Sullivan's expert analysts thoroughly examine the following markets: the U.S. pre-analytical and routine staining market and the U.S. advanced staining market.

This analysis is available through our Drug Discovery & Clinical Diagnostics Growth Partnership Services program. With continuous access to intelligence and resources from all seven perspectives of the Complex Business Universe, the Growth Partnership Services program ensures that you and your Growth Team™ are able to maintain a 360 Degree Perspective of the market. This comprehensive, objective information allows your company to mitigate risk, identify new opportunities, and drive effective strategies for growth. For more information on this custom subscription service, please click here.

Market Overview

Molecular Based Cancer Tests Trigger Growth in the U.S. Tissue Diagnostics Markets

The U.S. tissue diagnostics markets are in the growth stage. In 2009, revenues reached $1 billion. Despite the maturation of advanced diagnostic technologies, tissue-based diagnostics continues to be important for solid tumor analysis and for diagnosing other diseases. With the expanding base of cancer patients, tissue diagnostics is likely to experience parallel growth. Tissue preparation techniques have not changed fundamentally over the last century; however, the anatomic pathology (AP) laboratory is modernizing as demonstrated by the high rates of integration for the automated histology preparation. Opportunities in companion diagnostics, molecular diagnostics, and digital pathology are also attracting the attention of large healthcare companies and national reference laboratories that seek to expand their businesses into high-growth niche markets. 'Companion diagnostics actualize the ideals of personalized medicine as the necessary tools for matching patient to targeted therapy, and represent a significant opportunity for tissue diagnostic test manufacturers,' notes the analyst of this research service. 'Their association with a life-saving therapy and the clinical importance of the diagnostic result ensures a high value test which translates to a high margin product.' Sales of the HER-2 companion diagnostic, an immunohistochemistry test that determines eligibility for a targeted breast cancer drug, sustains growth in the U.S. tissue diagnostics markets. The rapidly growing molecular-based diagnostic tests are among the most expensive, and these contribute to the double-digit growth that the tissue diagnostics markets are poised to achieve.

The growing role of diagnostics in drug development is also a prominent theme in the tissue diagnostics markets. Several key investments and acquisitions by big pharma in tissue diagnostics companies is evidence of this. However, the limited customer base for the tissue diagnostics market is shrinking further, as regional hospitals and reference laboratories get absorbed by larger entities The competition is heightened by the significant mergers and acquisitions that have occurred within the last 5 years. Tissue diagnostics companies must employ fairly aggressive competitive strategies to compete for limited customer accounts and market share. Suppliers for the tissue diagnostics markets need to understand the challenges that the AP laboratories in hospitals and reference laboratories are facing today. The near-term health of the total tissue diagnostics market is dependent on increasing process standardization in the AP laboratory and expediting laboratory workflows. AP laboratory processes lag behind the quality standards and productivity achieved by the clinical chemistry laboratory. Due to the inherent complexity of tissue preparation and lack of modernization, there are many opportunities for vendors to capitalize on automation solutions, workflow management systems, and newer platforms for digital pathology.

With the wide selection of equipment and consumable products, customers are now in need of high-level, organizational solutions. Products or services that improve diagnostic turn-around-time, prevent errors, and minimize waste are preferred. In addition, companies that are able to provide total laboratory solutions for AP , supplying both the pre-analytical and advanced staining market segments, will be positioned to capitalize on growth opportunities. These companies provide enormous customer value as a trusted source for the entire tissue diagnostics process.

Market Sectors

Expert Frost & Sullivan analysts thoroughly examine the following market sectors in this research:
- Pre-analytical and routine staining
- Advanced staining
- Hematoxylin and eosin (H&E) testing
- General imnunohistochemistry (IHC) testing
- Companion diagnostic IHC testing
- In situ hybridization (ISH) testing
- Special stains testing
- Technologies

The following technologies are covered in this research:
- Automation systems
- Digital pathology


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