Australia Non-Invasive Prenatal Testing (NIPT) Market

Australia Non-Invasive Prenatal Testing (NIPT) Market Industry Overview

The Australia non-invasive prenatal testing (NIPT) market, initially valued at $40.0 million in 2023, is set for substantial growth, projected to surge to $110.7 million by 2033, marking a remarkable compound annual growth rate (CAGR) of 10.71% over the period from 2024 to 2033. Non-invasive prenatal testing (NIPT) refers to a method of examining fetal deoxyribonucleic acid (DNA) to determine the risk of genetic abnormalities in the developing fetus. The Australia non-invasive prenatal testing (NIPT) market shows promising growth, driven by increasing awareness, rising maternal age, and advanced diagnostic technologies. Expanding healthcare access and a preference for non-invasive methods contribute to demand, with potential growth through innovation and competitive pricing strategies.

Market Introduction 

The non-invasive prenatal testing (NIPT) market in Australia has been experiencing significant growth, driven by advancements in genetic testing technology and increasing awareness of prenatal health options among expectant parents. With its non-invasive nature, high sensitivity, and specificity, non-invasive prenatal testing (NIPT) offers a safer alternative to traditional diagnostic methods such as amniocentesis, which carries a risk of miscarriage. Further, the market's expansion is shaped by several factors, including regulatory oversight, ethical considerations, affordability, and accessibility.

Industrial Impact

The Australia non-invasive prenatal testing (NIPT) market is set for steady growth, driven by broader advancements in diagnostic testing and healthcare services. As healthcare systems evolve, there is a growing emphasis on non-invasive, cost-effective diagnostic solutions, particularly in prenatal care. Technological advancements and the increasing focus on precision medicine are enhancing the accuracy and accessibility of genetic screenings. The expansion of diagnostic capabilities and a rising demand for safer, more reliable testing methods are likely to propel the adoption of non-invasive prenatal testing (NIPT).

Increasing maternal age and growing awareness of genetic conditions further contribute to the demand for non-invasive prenatal testing (NIPT). The Australia healthcare system’s ongoing improvements, including funding for advanced medical technologies, provide a conducive environment for market growth. Moreover, policy reforms and healthcare initiatives aimed at expanding access to genetic testing in both urban and rural settings are expected to boost market penetration.

Market Segmentation:

Segmentation 1: by Technology
• Next-generation sequencing (NGS)
• Polymerase chain reaction (PCR) 
• Others

NGS Technology Segment to Dominate the Australia Non-Invasive Prenatal Testing (NIPT) Market (by Technology)

Based on technology, the Australia non-invasive prenatal testing (NIPT) market was led by the NGS technology segment, which held a 54.75% share in 2023. next-generation sequencing (NGS) offers highly accurate, non-invasive genetic screening using a simple maternal blood sample. This technology enables the detection of chromosomal abnormalities, such as trisomies 13, 18, and 21, by analyzing cell-free DNA (cfDNA) fragments from the mother’s blood. Non-invasive prenatal testing (NIPT) using NGS works by identifying specific genetic markers within the cfDNA to assess the risk of chromosomal abnormalities in the fetus. The test provides early results, typically within 5-7 days, allowing parents to make informed decisions early in their pregnancy.

For instance, Illumina, Inc.'s VeriSeq NIPT Solution v2 is a next-generation sequencing-based non-invasive prenatal testing (NIPT) with approximately 99.9% sensitivity. It is a streamlined, accessible solution that offers clinicians reliable results and enables sample reporting in about 26 hours.

Segmentation 2: by Method
• cfDNA
• FCMB

cfDNA Segment to Dominate the Australia Non-Invasive Prenatal Testing (NIPT) Market (by Method)

Based on the method, the Australia non-invasive prenatal testing (NIPT) testing market was led by the cfDNA method segment, which held an 87.25% share in 2023. Cell-free DNA (cfDNA) testing is a widely used method in Australia’s non-invasive prenatal testing (NIPT) market, allowing for the detection of fetal chromosomal abnormalities by analyzing small fragments of fetal DNA in maternal blood. This method offers high accuracy and minimal risk compared to invasive techniques such as amniocentesis. For instance, F. Hoffmann-La Roche Ltd. offers Harmony Test, a prominent offering that utilizes cfDNA technology to screen trisomies 13, 18, and 21 with proven clinical precision. Similarly, Victorian Clinical Genetics Services Limited provides the percept NIPT, leveraging cfDNA to ensure effective early detection of chromosomal anomalies. Healius Limited (Genetic Diagnostics) expands the cfDNA-based offerings with its Generation NIPT, Generation 46, and Generation Plus, which cater to diverse testing needs, including comprehensive assessments for microdeletions and rare genetic conditions. These examples highlight the integral role of cfDNA methods in Australia’s non-invasive prenatal testing (NIPT) advancements.

Segmentation 3: by Application
• Trisomy Detection
• Microdeletion Detection
• Sex Chromosome Aneuploidy Detection
• Others

Trisomy Detection Segment to Dominate the Australia Non-Invasive Prenatal Testing (NIPT) Market (by Application)

Based on application, the Australia non-invasive prenatal testing (NIPT) testing market was led by the trisomy detection application segment, which held a 56.50% share in 2023. Trisomy detection is one of the primary applications of non-invasive prenatal testing (NIPT), focusing on identifying chromosomal abnormalities such as Trisomy 21 (Down Syndrome), Trisomy 18 (Edwards Syndrome), and Trisomy 13 (Patau Syndrome). These conditions occur when there are three copies of a chromosome instead of the normal two, leading to fetal developmental and health complications. For instance, tests offered by Sonic Healthcare, F. Hoffmann-La Roche Ltd., and Healius Limited, among others, namely, percept NIPT, Harmony, and Generation NIPT, offer a highly accurate and reliable method for detecting these trisomies by analyzing cell-free fetal DNA (cffDNA) present in maternal blood.

Segmentation 4: by End User
• Hospital and Clinics
• Diagnostic Laboratories
• Others
 
Hospital and Clinics Segment to Dominate the Australia Non-Invasive Prenatal Testing (NIPT) Market (by End User)

Based on end users, the Australia non-invasive prenatal testing (NIPT) market was led by the hospital and clinics segment, which held a 72.25% share in 2023. The dominance of hospitals in the Australia non-invasive prenatal testing (NIPT) market is underscored by their pivotal role in providing comprehensive healthcare services and incorporating non-invasive prenatal testing (NIPT) into their services to enhance the range of prenatal diagnostics offered to expectant parents. This segment involves the utilization of non-invasive prenatal testing (NIPT) technologies within hospital facilities, allowing for efficient and accurate screening of genetic abnormalities in the fetus. Hospitals may also exist in the private sector, owned by for-profit or nonprofit organizations. In the case of private hospitals, funding is sourced from patients' direct payments for medical services, insurance coverage, government support through national health insurance initiatives, or financial assistance from foreign embassies.

Recent Developments in the Australia Non-Invasive Prenatal Testing (NIPT) Market

• In September 2023, Novacyt acquired Yourgene Health plc. The enlarged group now has a broader product portfolio and complementary expertise, which has strengthened the company’s market position. With Novacyt’s strong financial position, it is well-placed to accelerate the growth of Yourgene’s core non-invasive prenatal testing (NIPT) offerings, Ranger Technology, and PCR portfolio.

Demand – Drivers, Challenges, and Opportunities

Market Drivers:

High Incidence of Genetic Disorders: The high incidence of genetic disorders in Australia is significantly driving the growth of the non-invasive prenatal testing (NIPT) market. Conditions such as Down syndrome, Edwards syndrome, and Patau syndrome have heightened awareness among expectant parents about the importance of early and accurate prenatal screening. NIPT, being a safe and non-invasive method, offers a reliable alternative to traditional invasive procedures, enabling early detection of chromosomal abnormalities without risks to the fetus. According to the National Disability Insurance Agency (NDIA), 2% of all active participants in the National Disability Insurance Scheme (NDIS) had a primary disability of Down Syndrome by the end of December 2023. This substantial incidence of Down Syndrome is expected to drive increased demand for non-invasive prenatal testing (NIPT).

Market Challenges:

Lack of Awareness Regarding Non-Invasive Prenatal Testing (NIPT): The lack of awareness regarding non-invasive prenatal testing (NIPT) among pregnant women in Australia presents a significant barrier to its broader adoption, despite its proven accuracy and safety. NIPT, which screens for chromosomal abnormalities such as Down syndrome, offers a non-invasive alternative to traditional screening methods, but many women remain unaware of its availability, benefits, and affordability. This lack of awareness is partly due to limited public education campaigns, confusion around Medicare and insurance coverage, and the reliance on traditional prenatal care pathways that may not routinely include NIPT. Additionally, misconceptions about who should be tested and what NIPT can detect significantly lower the uptake of NIPT in Australia.

Market Opportunities:

Expansion of NIPT Accessibility and Coverage: Expanding the accessibility and coverage of non-invasive prenatal testing (NIPT) in Australia represents a transformative opportunity to enhance maternal and fetal health outcomes, particularly for women from diverse socioeconomic backgrounds. NIPT is a highly accurate and non-invasive screening method used to detect chromosomal abnormalities such as Down syndrome, Edwards syndrome, and Patau syndrome, with the advantage of being safer than traditional tests such as amniocentesis. However, despite its clinical benefits, NIPT remains largely out of reach for many women, as it is not covered under Medicare and costs around US$290-US$330 (AU$450–AU$500) per test, making it a financial burden for those without private health insurance or the means to self-fund.

Analyst’s Thoughts

According to Swati Sood, Principal Analyst – BIS Research, “The Australia non-invasive prenatal testing (NIPT) market is set for significant growth, driven by increasing incidence of genetic disorders and rising maternal age. Analysts anticipate significant opportunities for expansion of NIPT accessibility and coverage in Australia.”