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Market Domination By Fecal Blood Tests

shcri.com - The major feature of the in-vitro colorectal cancer (NYSEMKT:CRC) screening testing market is the current domination of fecal occult blood (FOB) tests, by a large variety of manufacturers, with no clear market leader. Increasingly, immuno-FOB tests are preferred over the very dated and obsolete guaiac FOB test. According to In-Vitro Colorectal Cancer Screening Tests - Global Analysis and Market Forecasts, in 2013, FOB tests account for 94% of the market, which is valued at $333m. Despite a lack of any recommendation from published CRC screening guidelines, emerging DNA tests for CRC have gained some ground, accounting for 5.7% of the market. However, this share is distorted by the relatively high price of these tests, compared with FOB tests. In 2012, 50 million FOB tests were carried out, compared to 60.748 DNA tests globally.

FOB tests are used in the major markets (APAC, US and 5EU), but are not used to any significant extent in South America, due to a lack of any organized CRC screening program.

While the in-vitro CRC screening market is defined by a large number of fecal occult blood tests, produced by a great number of manufacturers, three test producers, Eiken Chemical, Beckman Coulter and Immunostics, account for 49% of the in-vitro CRC screening market, largely through positioning in the US, French, the UK and Japanese markets.

Significant Unmet Needs - In-Vitro Colorectal Cancer Screening Tests - Global Analysis and Market Forecasts

Test accuracy remained a significant unmet need, in all markets. FOB tests have a significant false positive result rate, which creates a heavy burden on diagnostic colonoscopy services.

Patient aversion to stool samples is another major unmet need. Poor patient compliance with FOB tests is thought by physicians to be due to an inability to comply with specific dietary instructions, cultural aversion and a lack of awareness of the importance of testing.

Adoption of new screening tests, which test for DNA biomarkers indicative of early-stage CRC, will increase compliance, because they will be more accessible to patients, via their physician. These tests are expected to be more accurate, resulting in a higher percentage of patients referred for a diagnostic colonoscopy being diagnosed with CRC. Compliance will increase, resulting in more people being screened for CRC. The overall costs of CRC treatment will be driven down, due to increased diagnosis of CRC at an early stage, when it is most easily treatable, and at a lower cost. The number of screening colonoscopies will continue to increase, but will level off over time, since a significant portion of the CRC screening population cannot undergo a screening colonoscopy. Increasingly, the colonoscopy will become regarded as a tool to confirm the diagnosis of CRC indicated by a DNA test. - In-Vitro Colorectal Cancer Screening Tests - Global Analysis and Market Forecasts

Future Landscape

Adoption of new tests will be strongly determined by the administration of the local CRC screening program. In the US, where screening is opportunistic, and typified by a wide range of different screening tests, physicians will continue to prefer the colonoscopy for patients, but will increasingly offer alternative tests to the significant proportion of patients who decline a screening colonoscopy. - In-Vitro Colorectal Cancer Screening Tests - Global Analysis and Market Forecasts

Overall, within the forecast period, the use of fecal occult blood tests for CRC screening is expected to decline, in particular within mature economies, as physicians continue to increasingly recommend screening colonoscopy, but also adopt new emerging molecular tests. However, within the developing markets of China and Brazil, adoption of new CRC screening programs towards the end of the forecast period is expected to produce an increase in the use of those tests in those markets. India will continue to be a marginal user of CRC screening tests. - In-Vitro Colorectal Cancer Screening Tests - Global Analysis and Market Forecasts

The introduction of an FDA-approved blood test for CRC, coinciding with a revision in the screening guidelines, expected in early 2014, will likely lead to a rapid uptake in DNA CRC screening tests, which will become the preferred alternative to a colonoscopy. In Europe, with the exception of Germany, screening is expected to prefer the FOB test, since this is administered at a national level. - In-Vitro Colorectal Cancer Screening Tests - Global Analysis and Market Forecasts

In Germany, opportunistic screening is carried out, but physicians are expected to be slower to take up the new DNA tests than their US counterparts.

The APAC region is dominated by Japan, which is the only APAC region country to carry out any significant CRC screening, via a planned population-based screening program. Adoption of new tests is expected to be slow, because of regulatory hurdles that need to be adopted. In China, CRC screening is nascent, but will be seen as increasingly important as the country continues to industrialize. However, it is expected China will prefer to adopt a combination of immuno-FOB tests and health questionnaires to most quickly identify high-risk individuals within a large population. - In-Vitro Colorectal Cancer Screening Tests - Global Analysis and Market Forecasts

The fight for market share among DNA test makers is expected to be between Epigenomics and Exact Sciences, as they launch competing DNA screening products. The clear differentiators between them are the type of sample processed and the complexity of the test. GlobalData expects the victor to be the company whose test is most accessible, by answering the key unmet needs, but is also most easily able to be implemented. Tests that are technically superior, but which are technically difficult to implement, will struggle to find favor when compared to the benchmarked immuno-FOB test. Tests that at least match the performance of the immuno-FOB test, but which answer the key unmet need of patient accessibility, will see a rapid uptake by the population. - In-Vitro Colorectal Cancer Screening Tests - Global Analysis and Market Forecasts