Published: November 2015
Report Code: LS10347
Category : Medical Devices
Non-Invasive Prenatal Testing (NIPT) Market Overview
The global non-invasive prenatal testing (NIPT) market size was $563.4 million in 2014, which is expected to reach $1.4 billion by 2020, growing at a CAGR of 17.6%. Non-invasive prenatal testing refers to screening method for detecting specific chromosomal abnormalities in a developing baby, from as early as week 10 of pregnancy. The non-invasive prenatal testing market has been segmented on the basis of test type.
Based on test type, the NIPT market is segmented into MaterniT21 PLUS, NIFTY, Harmony test, PrenaTest, Panorama test, Verifi, and others. MaterniT21 PLUS accounted for the largest market share in 2014 in the non-invasive prenatal testing market. However, NIFTY is expected to witness the highest growth during 2015-2020 in the non-invasive prenatal testing market due to its various beneficial features such as a screening for certain genetic conditions from as early as week 10 of pregnancy, over 99% accuracy for the three most common trisomy conditions present at birth, which are Down Syndrome, Edwards Syndrome and Patau Syndrome.
Non-Invasive Prenatal Testing (NIPT) Market Dynamics
The NIPT market is expected to witness significant growth during the forecast period due to the increasing incidence of chromosome syndrome, growing demand for early and non-invasive fetal testing procedures, increasing healthcare expenditure, and increasing average maternal age. However, strict regulatory requirements and ethical hurdles are some of the factors, which are hindering the growth of the global market.
The adoption of NIPT in forthcoming years in emerging economies provides huge growth potential for the players in the NIPT market. The growth is also expected to be driven by the growing focus on early fetal testing and increasing average maternal age. Countries, such as China and India have a large population base, but still lack primary healthcare facilities and genetic counseling for NIPT.
The incidence rates of various genetic disorders and birth defects in fetus, such as Down syndrome and Edwards syndrome, are high in these countries, due to lack of awareness of genetic disorders, and high cost of NIPT. However, healthcare facilities in these countries have not been developed up to that level, so samples are shipped internationally for analysis by testing companies. Moreover, various initiatives have been taken worldwide to create awareness about prenatal testing, and some of the public-sector institutes perform specific prenatal testing. Hence, emerging markets offer ample opportunities for the players in the non-invasive prenatal testing market.
The maternal age plays a major role in the wide range of birth outcomes, such as birth defects, birth weight, and multiple births. High blood pressure, maternal death, still birth, and decreased fertility are the other risk factors, associated with the advanced maternal age. The average maternal age is increasing in high income countries, due to changing pattern of employment, education, and increasing cost of raising a child.
Also, various advancements in assisted reproductive technologies, such as egg donation and in-vitro fertilization (IVF), also increase the incidence of pregnancies among women in advanced maternal age. The average age at which women are giving first birth has been increasing. According to the Centre for Disease Control and Prevention (CDC) report on National Vital Statistics Report 2015, the mean age of mother at first birth was 25.8 years in 2012, and it has increased to 26 years in 2013, in the U.S. Also, children born with Down syndrome have an increased risk of developing conditions, such as hearing problems, Alzheimer’s disease, respiratory problem, childhood leukemia, thyroid conditions, and congenital heart disease. According to the World Health Organization (WHO), each year approximately 3,000 to 5,000 children are born with chromosome disorder. In addition, approximately 60%-80% of the children with Down syndrome have hearing deficit, and 40%-45% have congenital heart disease. Similarly, Patau syndrome is Trisomy 13, which is associated with severe physical abnormalities and intellectual disabilities. According to the National Library of Medicine, the Patau syndrome occurs 1 in 16,000 newborns globally. Turner syndrome is a rare genetic disorder that affects females, characterized by partial or complete loss of one of the X chromosomes. It can lead to various medical and development disorders, such as short height, infertility, learning disabilities and heart defects. According to the National Library of Medicine, globally turner syndrome occurs in 1 out of 2,500 newborn girls. In addition, Klinefelter syndrome is caused due to extra X chromosome in males. According to the National Library of Medicine, the Klinefelter syndrome occurs in 1 out of 500 to 1,000 new born males globally. The increasing prevalence of these genetic disorders is likely to drive the market for non-invasive prenatal testing.
Furthermore, the testing and screening for fetal abnormalities has changed the women’s experience of pregnancy. Prenatal tests are medical tests performed during the pregnancy, in order to determine the development of fetus. Various diagnostic techniques, such as blood test, urine test and ultrasound helps to determine characteristics of the baby, including sex, age, size and placement of the uterus. These tests also help to determine the chances of a baby born with certain birth defects or genetic problems. The demand for early and non-invasive fetal testing procedures is increasing, due to increasing awareness of the birth defects and increasing average maternal age. The NIPT is expected to change the framework of testing and screening in pregnancy. Additionally, the healthcare expenditure is increasing worldwide, due to increasing prevalence of diseases and innovation in medical treatments. According to the WHO, the total healthcare expenditure is increasing globally, which is leading to the improvements in the healthcare infrastructure. The increase in healthcare expenditure is further expected to lead to increase in affordability and accessibility of the new test and treatments for various conditions.
Non-Invasive Prenatal Testing (NIPT) Market Competitive Landscape
Sequenom Inc., BGI, LifeCodexx AG, Quest Diagnostics Incorporated, Hoffmann-La Roche Ltd., Illumina Inc., Berry Genomics Co., Ltd., Laboratory Corporation of America Holdings and Natera Inc. are some of the major companies offering non-invasive prenatal tests.
Some of the companies have acquired other smaller players, for instance, Ariosa Diagnostics Inc. was acquired by F. Hoffmann La-Roche; and Illumina Inc. acquired Verinata Health, Inc., to expand their product offerings and acquire stronger position in the non-invasive prenatal testing market.