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Q: CA-125 Market Size ( Answered 4 out of 5 stars,   1 Comment )
Subject: CA-125 Market Size
Category: Health > Medicine
Asked by: zolfinix-ga
List Price: $50.00
Posted: 21 Apr 2006 14:46 PDT
Expires: 21 May 2006 14:46 PDT
Question ID: 721500
How many CA-125 diagnostic tests are sold per year?  The number can be either,
worldwide, North America, US, or any other market as long as it
includes the US.

I have found the number 2,000,000 from a company's web site, but the
origin of that number was not given and I need a more reliable (i.e.
original) source.
Subject: Re: CA-125 Market Size
Answered By: czh-ga on 21 Apr 2006 21:43 PDT
Rated:4 out of 5 stars
Hello zolfinix-ga,

This was a tough search but it lead to some very interesting reading
about the challenging world of ovarian cancer research and treatment.
After much digging I was able to locate a few reports on the market
size for CA-125 diagnostic tests in terms of tests sold and dollar

This information is readily available in some very expensive market
research reports. I?ve included these in case you might have access to
them through your work or on the chance that you might be able to buy
just the relevant pages for a reduced price.

Although you didn?t ask for it, I?ve included some articles about the
state of research on the evolving use of the CA-125 test. I thought
you might find them useful for continuing your explorations. In
addition, I?ve also included links for the assay manufacturers that I
ran across in the course of my research.

Wishing you well for your project.

~ czh ~

Frantz Medical Group is an integrated group of companies dedicated to
the development and manufacturing of medical devices and diagnostics,
and the support of related independent companies in similar fields
through direct investments, investments through our Venture Capital
Fund and providing operational support.

LPL Technologies

The only existing test for ovarian cancer, CA 125, is not actually
approved by the Food and Drug Administration as a diagnostic, but only
as a tool to monitor residual cancer in patients after surgery. The
FDA restricts the indicated use of CA 125 because it has both high
rates of both false positive results in a normal population and high
rates of false negative results in women with cancer. Nevertheless,
one half of CA 125's worldwide sales of 15 million tests in 2000 were
requested by women seeking to use CA 125 as a screening test. LPL
Technologies's LPA test detects ovarian cancer earlier, and far more
accurately, thus LPL Technologies is applying to the FDA for more
expansive claims than those allowed for CA 125. Based upon the target
population size and the sales of CA 125, an annual U.S. market size of
$400 million is realistic for LPL Technologies's superior LPA test.

Ovarian Plus 
Gynecologic Cancer Prevention News For all women and the people who love them

Across America on the television news April 7, 1994, the message came
from the National Institutes of Health (NIH) that the CA-125 serum
marker blood test should not be used to screen women for ovarian

This evil little test was the cause of purportedly countless
"unnecessary" surgeries, and was often inaccurate, according to the
news reports. The 4 million CA-125 tests performed in 1993 burdened
America's health care budget, or so NIH claimed.

Cancer Program Update

IBEX launched its first kallikrein assay, hK10, to the research
community in September 2004. In published studies, hK10 has been shown
to be elevated in ovarian carcinoma. In a recent study examining the
serum of 100 ovarian cancer patients (80 with stage I/II disease), hK6
identified 42% more ovarian cancer patients than CA125. This is a
significant and positive finding, and if verified by additional
studies (ongoing) suggests a valuable role for hK6 in the management
of ovarian cancer. IBEX completed the technical development of hK6,
its second kallikrein assay, during the first quarter of calendar year
2005 and expects to be able to release this assay to the research
community in the second quarter of calendar year 2005. IBEX seeks to
initially establish hK10 and hK6 as complementary assays to CA125, the
current biomarker standard for ovarian cancer, in order to improve
patient management. CA125 has combined annual sales of approximately
US$80 million in the U.S., Europe and Japan

Cancer Diagnostic Testing World Market
Trimark Publications 
 January 12, 2006
 245 Pages - Pub ID: TRI1214105
Price: $3,200

Table of Contents
Table 4.12: Worldwide CA-125              Sales, 2001-2010  
Table 4.13: U.S. CA-125               Sales, 2001-2010



Ovarian Cancer Therapeutics
Global Industry Analysts
August 1, 2004
 195 Pages - Pub ID: GJOB1060370
Price: $3,850

Analysis of Assembly Bill 547 
Ovarian Cancer Screening 
A Report to the 2003-2004 California Legislature 
February 9, 2004 

II. Utilization, Cost, and Coverage Impacts
Present Baseline Cost and Coverage

Current utilization levels and costs of the mandated benefit (Section 3(h))

Up to an estimated 6% of women aged 18 to 64 years currently receive
screening for ovarian cancer. This rate, which reflects the total
number of ultrasound tests done in this age group, is an upper-bound
estimate, because the analysis of this mandate assumes that no women
in this age range are currently covered for this benefit, and that
those who are currently ?screened? do so because of medical
indications or doctors ordered the test despite it not being a covered
benefit. An estimated 5,890,000 women aged 18 to 64 years with private
insurance would be eligible for the mandated benefit in California

(See page 15 of 43 and following. I?ve included this report for its
overview of measuring the potential population of women who might be
consumers of CA-125 tests. It provides a very good discussion of the
medical and financial issues involved in making expensive and not
fully tested therapies available to selective target groups.)

CA-125 test 
A blood test that measures the level of CA-125, a substance found in
blood, other body fluids and some tissues. Increased levels of CA-125
may be a sign of cancer.


CA125 Marker Information
QUESTION: Please may I have some information about ca125 marker? 

RESPONSE: CA-125 is a substance shed by cancer cells, also made by
inflamed normal cells that line body parts. This substance is shed in
body fluids and finds its way into the bloodstream. CA-125II is a new
assay that has less variation from day to day. Since the original
CA-125 test kits are no longer sold to laboratories, it is believed
that few if any old plain CA-125 tests are being given in the United
States since Nov. 1996. CA-125 is a test done on a blood sample drawn
in a laboratory. A blood sample is drawn, just as for a variety of
other laboratory tests. The assay (analysis) assesses the amount of an
antibody that recognizes an antigen in tumor cells.

Aug. 23, 2005
Hope - and hype - in the cancer war

Ovarian cancer test remains elusive

Ovarian Cancer Diagnosis

Several diagnostic approaches can be followed when ovarian cancer is
suspected. The CA125 blood test, which measures a blood protein that
is usually elevated in a woman who has ovarian cancer, should not be
used as a screening or diagnostic tool. Rather, it is a tool for
monitoring disease recurrence in patients.  Women also should know
that Pap smears detect cervical cancer, not ovarian cancer.

14 October 2005
Seeking an ovarian cancer diagnostic test
Proteome Systems has discovered and patented novel markers for
epithelial ovarian cancer using its proprietary proteomic and
glycoproteomic technology platforms

Around one in 56 women will develop ovarian cancer during their lifetime.
Overian Cancer 

Ovarian Cancer

Currently, there is no specific screening test for ovarian cancer.
However, research is ongoing to develop a reliable method for early
detection among asymptomatic women (see news stories, in Related Pages
below). In the meantime, regular physicals, pelvic exams, and an
awareness of family history and symptoms are important.

Testing of symptomatic women includes the following, which have been
shown to be positive in ovarian cancer (although not all of these
tests would be used in an individual patient as they detect different
types of ovarian tumors):

IBEX Technologies
5485 Pare Street 
Montreal Quebec 
H4P 1P7 Canada 
Tel: 1 514 344 4004 
Fax: 1 514 344 8827 

There are significant commercial opportunities globally for effective
cancer diagnostics and Dr. Diamandis and his colleagues? have
published extensively on the potential diagnostic utility of our
kallikreins, especially when used in combination with existing
benchmark tests, such as Prostate Specific Antigen (PSA) for prostate
cancer and CA125 for ovarian cancer. CA125 has combined annual sales
of approximately US$80 million in the US, Europe and Japan, while PSA,
a kallikrein-based diagnostic, has annual sales of approximately
US$350 million. We are currently focused on establishing our
kallikrein-based assays as new clinical diagnostic standards that are
complementary to benchmark tests such as CA125 and PSA.

Cancer Antigen 125 (CA125) is a surface antigen associated with
epithelial ovarian cancer, and to date CA125 is the most sensitive
marker for residual epithelial ovarian cancer. CA125 may also be
elevated in patients with lung, cervical, fallopian tube, and uterine
cancer and endometriosis.
CA125 ELISA Kit kit BC1013 $293

BioProcessing, Inc. is a manufacturer of tumor marker antigens and
antibodies to Ca15-3, Ca27.29, breast tumor antigens, Ca125, ovarian
tumor antigen, Ca19-9, GI tumor antigen, CEA, carcinoembryonic
antigen, AFP, alpha fetoprotein, Ca72.4, Tag-72, NSE, neuron specific
enolase, Cyfra21-1, cytokeratin-19, PSA, prostate specific antigen
using cell culture technologies.

Ovarian Tumor Antigen (Ca125)

14 July 2005
Serial Tumor Marker Measurement in Ovarian Cancer Patients: A Case for
Assay Consistency

Articles reviewing CA125 report sensitivity and specificity, which are
subject to bias based on assay manufacturer and/or type, source of
specimen, and specimen demographics (age, stage, grade, and
histopathological tumor type). There are over 38 commercial assays
reported in published literature that measure CA125 and these assays
fall into 5 major categories: ELISA, IRMA, CLEIA, MEIA, and LIA, in
two generations. Despite over 2000 articles published articles since
1981, no comprehensive meta-analysis has been conducted to evaluate
the performance of the various assays across patient populations and
assay types.

Formerly Centocor Diagnostics, Fujirebio Diagnostics, Inc. (FDI) was
acquired by our parent company, Fujirebio, Inc. of Tokyo, Japan in
November 1998.

CA 125II? Radioimmunoassay
Biomarker for ovarian cancer: CA 125II? is the most widely used tumor
marker worldwide for ovarian cancer and is indicated for use as an aid
in the detection of residual ovarian carcinoma in patients who have
undergone first-line therapy and would be considered for diagnostic
follow-up procedures.


CA-125 Sales
CA-125 tests market
CA-125 diagnostic tests
CA-125 assay sales OR vendors OR makers OR manufacturer
"blood test" industry OR market
ovarian cancer blood test market
diagnostic cancer "blood tests" sold OR performed per year
zolfinix-ga rated this answer:4 out of 5 stars and gave an additional tip of: $10.00
You found a lot of things I hadn't, but it looks like the really
convincing numbers we need to convince investors to invest in a
replacement for the CA-125 test are in those expensive market research
reports.  You clearly put a lot of effort into this search.  I really
apreciate your efforts czh-ga and I wish I could pay you more.

Subject: Re: CA-125 Market Size
From: czh-ga on 02 May 2006 14:46 PDT
Hello zolfinix-ga,

I'm glad I was able to find you some helpful information even if the
exact material you're looking for doesn't seem to be available on the
open web. Thanks for the tip. Best wishes for your project.

~ czh ~

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