Cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. The National Cancer Institute estimates that about ten million Americans have or have had some form of cancer. Pharmaceutical companies are developing more than 300 new medicines for cancer, some of which are in development for more than one type of the disease, for a total of more than 500 ongoing R&D projects. The goal of this report is to review the market for tumor marker testing equipment and supplies using screening reagents and instruments for analysis of individual components in blood, serum or plasma. It defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including: the physician office labs, hospital labs and commercial laboratories.
Additionally, the numbers of institutions using this type of testing and the factors that influence purchases are discussed. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the clinical point-of-care market in the U.S. Each company is discussed in depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position.
Table of Contents
1. Overview 8
2. Introduction to Cancer Biology and the Diagnostic Industry 15
3. Tumor Markers Market Segment Analysis: Size, Growth and Share 24
4. Diagnostic Methods for Cancer Detection 60
5. Implications of Molecular Biology for New Diagnostic Cancer Tests 147
6. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms 149
7. Business Trends in the Industry 188
9. Important New Technology Areas 206
10. New Cancer Markers in Basic Research 219
11. Market Trends and Forecasts 245
List of Figures
Figure 4.1: Model of CRC Development 63
Figure 4.2: Progression of CRC Development 63
Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 96
Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 97
Figure 4.5: The BTA stat Test vs. Cytology 115
Figure 10.1: PCA3 Test Volume in U.S., 2005-2008 244
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