Strategic Analysis of the U.S. Prenatal Testing Market

Frost & Sullivan, June 2011, Pages: 61

Strategic Analysis of the U.S. Prenatal Testing MarketIncreasing Maternal Age; Improved Screening Algorithms; and Maturation of Noninvasive Prenatal Diagnostics

This research service analyzes the market for prenatal testing with market sizing and forecasts for laboratory service revenues, which are typically reimbursed by the patient's insurance, fee-for-service, or institutional contracts. In this analysis, prenatal testing revenues include the use of clinical laboratory technologies in prenatal applications for detection of chromosomal imbalances and procedures for nuchal translucency prenatal ultrasound. Prenatal testing revenues exclude fetal anatomy ultrasound procedures, single-gene disorders and other inherited diseases, clinical prenatal lab testing using noninvasive prenatal diagnostic technologies, carrier testing, neonatal or postnatal testing, and preimplantation genetic diagnosis.

Introduction

Prenatal testing assesses the risk or the presence of chromosome abnormalities in a fetus. Copy number variation (CNV) or chromosomal imbalances (amplifications and deletions) can have devastating effects such as the loss of the fetus or create lifelong conditions that impede quality of life and cause healthcare burdens. Fetal diagnosis or risk assessment for Down syndrome (DS), which is also known as Trisomy 21, has become a focus in prenatal testing as DS has an incidence of 1/800 to 1/1000 births. As many women are delaying their first pregnancy until later in life, prenatal testing will become an even more important measure for ensuring healthy babies as risk probabilities for DS increase with advancing maternal age.

Prenatal diagnosis is performed by amniocentesis or chorionic villus sampling (CVS). Due to the slight risks of miscarriage (less than 1 in 300-500 for both procedures) and other complications in these invasive procedures, screening tests are used to identify the at-risk women who have a prenatal diagnostic procedure. DS detection rates have improved due to advances in prenatal screen testing algorithms during the last five years. Reports show a reduction in the number of invasive procedures as a result of prenatal screen practices. Looking forward, the industry anticipates the maturation of noninvasive prenatal diagnostic (NIPD) technologies within the next five years. NIPD would enable prenatal diagnosis from fetal cells or fetal DNA obtained from a maternal blood sample.

A primary mission of prenatal testing is to provide early and clear information about fetal disease status in order to make decisions about termination of an affected fetus. The gravity of this decision explains the conservative stance of the American College of Obstetricians and Gynecologists (ACOG) as that body's endorsements greatly influence the adoption of new tests. Conclusive information is time-critical as state law defines a deadline during pregnancy (in the range of 22-24 weeks gestation) for performing a legal abortion. The dynamic of the U.S. prenatal testing market is heavily influenced by social, legal, ethical, and cultural factors.

Increasing maternal age, improved screening algorithms, the clinical utility of prenatal diagnostic array technologies, and the maturation of NIPD technologies are contributing to the long-term demand for prenatal testing. Major market restraints include falling fertility rates, conservative action by ACOG and individual attitudes.

The main market participants are PerkinElmer, Labcorp and Quest Diagnostics. Their market dominance in prenatal testing services will strengthen as the clinical lab market continues to consolidate.

Maternal Serum Market

Nuchal Translucency Market

Karyotype Market

Prenatal FISH Market

Chromosomal Array Market

Appendix

List of Figures

Total Prenatal Testing Market: Industry Challenges and Strategic Recommendations (U.S.), 2011-2017
Total Prenatal Testing Market: Market Drivers Ranked in Order of Impact (U.S.), 2011-2017
Total Prenatal Testing Market: Market Restraints Ranked in Order of Impact (U.S.), 2011-2017
Total Prenatal Testing Market: Noninvasive Prenatal Diagnostics Approach Comparison (U.S.), 2010
Maternal Serum Screen Market: Screening Practices (U.S.), 2010
Maternal Serum Screen Market: Screen Rank Order by Volume (U.S.), 2010
Maternal Serum Screen Market: Product Analysis of First Trimester Screens (U.S.), 2010
Maternal Serum Screen Market: Product Analysis of Second Trimester and Combined Screens (U.S.), 2010
Chromosomal Array Market: Product Analysis (U.S.), 2010

List of Charts

Total Prenatal Testing Market: Market Segmentation (U.S.), 2010
Total Prenatal Testing Market: Market Overview (U.S.), 2010
Total Prenatal Testing Market: Screening Test Algorithm (U.S.), 2010
Total Prenatal Testing Market: Diagnostic Test Algorithm (U.S.), 2010
Total Prenatal Testing Market: Test Volumes (U.S.), 2010
Total Prenatal Testing Market: Current and Future Markets (U.S.), 2010
Total Prenatal Testing Market: Revenue Forecast (U.S.), 2007-2017
Total Prenatal Testing Market: Revenue Forecast for Prenatal Screening (U.S.), 2007-2017
Total Prenatal Testing Market: Revenue Forecast for Prenatal Diagnostics (U.S.), 2007-2017
Total Prenatal Testing Market: Percent of Revenues by Segment Type (U.S.), 2007-2017
Maternal Serum Screen Market: Revenue Forecast (U.S.), 2007-2017
Maternal Serum Screen Market: Market Share Analysis (U.S.), 2010
Nuchal Translucency Market: Revenue Forecast (U.S.), 2007-2017
Karyotype Market: Revenue Forecast (U.S.), 2007-2017
Prenatal FISH Market: Revenue Forecast (U.S.), 2007-2017
Prenatal FISH Market: Market Share Analysis (U.S.), 2010
Chromosomal Array Market: Revenue Forecast (U.S.), 2007-2017
Chromosomal Array Market: Market Share Analysis (U.S.), 2010

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