Non-Invasive Prenatal Testing (NIPT) Market Report

Non-Invasive Prenatal Testing (NIPT) Market Analysis by Gestation Period (0-12 weeks, 13-24 weeks, 25-36 weeks), by Pregnancy RiskLevel (High & Average Risk, Low Risk), By Region (U.S., UK, Germany, Japan, China, Brazil)And Segment Forecasts, 2014 - 2025

Published: December 2016  |  100 Pages  |  Format: PDF  |  Report ID: GVR-1-68038-310-2

Industry Insights

The global Non-Invasive Prenatal Testing (NIPT) market size was valued at USD 1.19 billion in 2015. The anticipated growth in revenue is attributed to the accelerated adoption of these procedures by customers coupled with the expansion in the distribution services of the operating entities, which enables them to capture the potential opportunity.

A gradual shift in the upper ceiling for the global average of maternal age and the rise in the incidence of Down syndrome in newborns have boosted demand to a significant level. Furthermore, increase in the awareness level pertaining to the advantages of Non-invasive fetal diagnosis is one of the key factors contributing to the growth of this industry.

U.S. Non-Invasive prenatal testing market by risk, 2014 - 2025 (USD Million)

U.S. Non-Invasive prenatal testing market

In addition, expansion of coverage by payers to low & average-risk pregnancies over the forecast period in order to save on amniocentesis and the treatment of Down Syndrome is anticipated to enhance the penetration of NIPT products, consequently influencing revenue generation.

Advantages associated with the use of these tests, such as significant reduction in the number of expensive & risky invasive amniocentesis and Chorionic Villus Sampling (CVS) procedures, are estimated to improve the volumetric capabilities of the market at a global level, which would directly translate into the growth in revenue in the bigger picture.

On the other hand, companies playing a pivotal role are focusing on the development of novel technology for determining chromosomal aberrations in the cfDNA (cell free DNA) sample. Application of the technique to analyze approximately 20,000 genetic features in a single reaction in a sensitive and accurate manner for detection of a wide range of genetic disorders with fewer false positives is expected to propel the demand for NIPT products in the coming years.

However, clinical validity of the test with respect to microdeletion is not yet established and is expected to impede growth to certain extent.

Insights for Tests by Gestation Duration

The most of the non-invasive prenatal procedures are carried out in the second trimester of the pregnancy. These tests also cover major complementary tests such as ultrasound and serum screening for the alpha-fetoprotein. The procedure above has led to the gestation period of 13 to 24 weeks accounted for the significant share of the revenue generated in NIPT market. This segment is also expected to maintain this dominance over the forecast period.

Pregnancy Risk Type Insights

The adoption in high- and average-risk pregnancies accounted for the larger share due to the higher uptake of tests in high-risk pregnancies that are observed to have a higher incidence in females over 35 years of age.

The market is well-penetrated with respect to high risk; however, there are few payers that do not have favorable medical coverage decisions for average risk testing. Average risk guideline inclusion in the reimbursement for the NIPT procedures is expected to serve as a forthcoming catalyst for the growth of this vertical in the coming years.

The low-risk testing segment is anticipated to witness lucrative growth over the forecast period as a result of the likelihood of reimbursement procurement and guideline support, given the test's superior accuracy to current screening methods and the potential to reduce the number of risky, invasive diagnostic methods.

NIPT market by region, 2015 (USD Million)

Non-Invasive prenatal testing market

Regional Insights

In 2015, North America accounted for the largest revenue share of over 47.0% with Europe following closely behind. This is a result of the higher percentage of direct sales that the market participants are experiencing in the regions.

Asia Pacific region is anticipated to witness the fastest growth in the coming years owing to the presence of considerable growth possibilities in the economies, such as Japan and India, where in the maternal age is exhibiting significant rise coupled with increasing awareness amongst the population about this technology. The rising maternal age that falls under the high-risk group of 35 years and above represents substantial consumer base, thereby augmenting revenue generation in this region.

Competitive Insights

Some of the major participants include Quest Diagnostics; Roche (Ariosa Diagnostics); Illumina; Sequenom; Natera, and LabCorp. These participants are focusing on obstetrics and gynecology practices as well as maternal fetal medicine specialists, delivering a suite of diagnostic tests across a wide spectrum of prenatal and women's genetics.

Moreover, these entities are involved in the provision of a unique product breadth that allows cross-selling of NIPSwith an array of other procedures including carrier screening and preimplantation screening for in-vitro fertilization.

The market is saturated with the formidable players operating in the NIPT space and these companies are expected to compete on the grounds of cost and functionality. The participants are also engaged in the development and licensing of the software and cloud-based distribution model to enhance technology transfer.

For instance, Natera underwent a licensing agreement with Unilab, which enables Unilab to access the proprietary protocols and key technology of Natera, thus driving revenue share of the company in reproductive genetic testing.

Report Scope

Attribute

Details

Base year for estimation

2015

Actual estimates/Historical data

2014 - 2015

Forecast period

2016 - 2025

Market representation

Revenue in USD Million & CAGR from 2016 to 2024

Regional scope

North America, Europe, Asia Pacific, Latin America & MEA

Country scope

U.S., Canada, UK, Germany, Japan, China, Brazil, Mexico, South Africa

Report coverage             

Revenue forecast, company share, competitive landscape, growth factors and trends

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Segments Covered in the Report

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the non-invasive prenatal testing market on the basis of gestation duration, risk, and region:

  • Gestation Period Outlook (Revenue, USD Million, 2014 - 2025)
    • 0-12 weeks

    • 13-24 weeks

    • 25-36 weeks

  • Risk  Outlook (Revenue, USD Million, 2014 - 2025)
    • High & Average Risk

    • Low Risk

  • Regional Outlook (Revenue, USD Million, 2014 - 2025)
    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • UK

    • Asia Pacific

      • China

      • Japan

    • Latin America

      • Brazil

    • MEA

      • South Africa

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