Originally Published IVD Technology January/February 2003
INDUSTRY NEWS
Molecular diagnostics for cancer on the riseImmunoassays and histology may currently command the majority of the cancer diagnostics market, but molecular tests will dominate the market within 5–10 years, predicts a new study by Kalorama Information (New York City). According to the study, titled "The Worldwide Market for Cancer Diagnostics," customary cancer screening technologies such as Pap tests, fecal occult blood tests, and PSA tests will soon give way to more-specific and more-sensitive genetic tests and protein arrays. By 2010, molecular assays and pharmacogenomics will play a major role in cancer diagnostics.
"This should be viewed as very good news for the industry," says Richard Schifreen, PhD, director of technology and market development at Promega Corp. (Madison, WI). "The success of monoclonal antibody therapeutics directed toward specific molecular targets in tumors should help to accelerate the development of companion diagnostic tests to support the selection of therapeutic agents and monitoring of treatment."
The study forecasts clinical and regulatory trends, compiles products in development, profiles 29 companies in the IVD market, and examines the interplay between the in vivo and the in vitro segments of the market.
Immunoassays will draw more revenue than any of the market's other cancer IVDs, generating nearly $1.5 billion in 2006, predicts the study. However, with a compound annual growth rate of 25%, the revenue from molecular assays is expected to grow far faster than that of any other technology on the market (see table).
|
Test
|
Manufacturers'
Revenue ($ millions)
|
|||||
|
2002
|
2003
|
2004
|
2005
|
2006
|
CAGR
(%)
|
|
| Fecal occult blood test |
80
|
90
|
100
|
110
|
120
|
12
|
| H. pylori |
21
|
22
|
23
|
24
|
25
|
4
|
| Prostate-specific antigen |
350
|
400
|
450
|
500
|
550
|
14
|
| Immunoassays |
970
|
1000
|
1200
|
1350
|
1450
|
12
|
| Molecular assays |
50
|
60
|
70
|
80
|
100
|
25
|
| Flow cytometry |
530
|
610
|
690
|
770
|
850
|
15
|
| Histology (IHC/ISH) |
825
|
920
|
1010
|
1100
|
1200
|
11
|
| HER-2 |
24
|
28
|
32
|
36
|
40
|
17
|
| Pap testing |
780
|
835
|
890
|
945
|
990
|
6
|
| Human papilloma virus |
30
|
35
|
40
|
45
|
85
|
19
|
| Total |
3660
|
4000
|
4505
|
4960
|
5410
|
11
|
| Abbreviations: CAGR—compound annual growth rate; IHC—immunohistochemical; ISH—in situ hybridization. | ||||||
| Worldwide market for selected cancer in vitro diagnostics, 2001—2006. Source: Kalorama Information (New York City). | ||||||
Although the report provides a solid analysis of the global market, some do not agree with the report's claim that nucleic acid diagnostics for cancer detection will comprise a large part of the market by 2010. "There still are few markers that are truly unique to common cancers. Cancer is simply too complex a disease, and I believe at least another decade of research is needed before reliable tests will be developed," says Dan Kolk, PhD, staff scientist at Gen-Probe Inc. (San Diego).
The IVD industry expects that molecular diagnostics will eventually prevail as a strong force in the cancer diagnostics market. "While molecular-based testing as a diagnostic for cancer is not widespread yet, its time will soon come," says Shannon Beard, PhD, vice president for technology development at Xtrana Inc. (Broomfield, CO). For more information about this report, contact Kalorama Information at 212/807-2634, or access its Web site at www. KaloramaInformation.com.
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