【出版时间及名称】：2010年4月加拿大体外诊断行业研究报告
        【作者】：加拿大皇家商业银行
        【文件格式】：pdf
        【页数】：48
        【目录或简介】：
We believe the in vitro diagnostics (IVD) industry is positioned for continued and
potentially accelerating growth. With advances in cellular biology, genomics, proteomics
and pharmacogenomics, physicians will be increasingly reliant on IVD information to
assess risk, detect disease, evaluate therapeutics and monitor disease progression. Demand
will also be driven by demographics, emerging market adoption and patient awareness.
• We expect to see significant growth in companion diagnostic tests, over time. Companion
diagnostics are tests that are used to determine whether a specific therapy will be safe
and/or effective. We believe a truly meaningful increase in FDA approved products is still
12 to 24 months out from now.
• We expect to see increased clinical applications for gene sequencing, including near-term
utilization for diagnosing certain genetic conditions such as Cystic Fibrosis (CF).
• We expect continued consolidation (i.e., M&A) driven by the desire for increased scale
and scope, and novel content. Capabilities that appear particularly attractive include
sequencing, point-of-care technology and automation for molecular testing. The content
that appears most attractive is companion diagnostic tests. With the large pipeline of
targeted therapeutics, there may be logic to increased Pharma/Biotech-IVD integration.
• We believe continued uncertainty related to FDA regulation of lab developed tests and
ownership of genetic information will be an impediment to multiple expansion for
companies that are levered to these technologies (although we expect minimal near-term
business disruption from either factor).
Investment Recommendations
• For investors with a 12 to 24-month time horizon, we recommend focusing on companies
that are positioned to take share in fast growing markets due to innovative, cost-saving
instrumentation and/or proprietary content with high-clinical utility. Our Outperform-rated
stocks include Hologic, which we expect to gain share in the human papillomavirus (HPV)
market due to its automated instrumentation and proprietary 16/18 genotyping test; and
Gen-Probe due to its leading position in the Chlamydia and Gonorrhea (CT/NG) testing
and blood-screening markets, and its instrument and product pipeline.
• For investors looking out towards 2012 and beyond, we expect to see a paradigm shift,
where success is increasingly driven by clinical differentiation, including proprietary
content with high clinical utility and partnerships with pharmaceutical and biotechnology
companies. Covered companies that appear especially well positioned for the long term
include QIAGEN and Celera.
• Our Underperform-rated stocks include Cepheid, as we believe that potentially slowing
growth in molecular testing for Healthcare Associated Infections (HAIs) could make it
difficult for this company to grow into its multiple; Beckman Coulter, due to concerns that
its recent assay problems could lead to slowing growth and increased expenses; and
QIAGEN, due to our expectation that it will lose HPV share, which could lead to lower
organic growth and multiple contraction.

Investment Thesis ...........................................................................................................................3
Outperform Rated Stocks ..............................................................................................................3
Hologic: First to Market with HPV Automation...............................................................................3
Gen-Probe: Sample-In, Answer-Out Automation for Molecular Diagnostics ..................................3
Industry Overview ..........................................................................................................................4
Industry Consolidation and M&A.................................................................................................7
Segment Analysis ..........................................................................................................................12
Molecular Diagnostics ....................................................................................................................12
Clinical Chemistry ..........................................................................................................................29
Immunoassay .................................................................................................................................30
Hematology....................................................................................................................................31
Flow Cytometry ..............................................................................................................................32
Microbiology .................................................................................................................................33
Blood Typing .................................................................................................................................33
Cervical Cytology ...........................................................................................................................36
Point of Care Applications..............................................................................................................37
Regulation, Legislation and Legal Considerations.....................................................................38
FDA Guidance for IVDMIAs Is a Risk for Genomic Health..........................................................38
IP Risk For Genetic Tests ...............................................................................................................38
Medicare Legislation ......................................................................................................................38
Demographic Considerations.......................................................................................................39
Macroeconomic Considerations...................................................................................................39
Foreign Exchange Rates .................................................................................................................39
Capital Spending and Research Budgets.........................................................................................41
Appendix: Glossary ......................................................................................................................45
Required Disclosures ....................................................................................................................46
Disclaimer......................................................................................................................................48