Global Amniocentesis Needle Market By Product Type (100 to 150 mm, Smaller Than 100 mm, and Larger Than 150 mm), By Application (Amniocentesis Procedures, Fetal Blood Transfusion, Cordocentesis Procedure, Amnioreduction Procedures, and Amnioinfusion Procedure), By End-user (Hospitals & Clinics, Diagnostics Centers, and Others), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2025-2034

Report Overview

The Global Amniocentesis Needle Market size is expected to be worth around US$ 390.0 Million by 2034 from US$ 200.1 Million in 2024, growing at a CAGR of 6.9% during the forecast period 2025 to 2034. In 2024, North America led the market, achieving over 42.2% share with a revenue of US$ 84.4 Million.

Increasing awareness of prenatal screening and diagnostic procedures is driving the growth of the amniocentesis needle market. Amniocentesis, a procedure used to obtain amniotic fluid from a pregnant woman’s uterus for testing, plays a critical role in diagnosing genetic disorders, fetal infections, and determining the baby’s health. Advancements in needle design and techniques are improving the accuracy, safety, and comfort of the procedure, contributing to market growth.

Rising demand for non-invasive prenatal testing and the increasing focus on maternal health are further fueling the adoption of amniocentesis. In February 2022, CooperSurgical finalized the acquisition of Cook Medical’s reproductive health division for US$ 875 million, expanding its offerings in fertility treatments, obstetrics, gynecology, and in vitro fertilization (IVF).

This acquisition strengthens CooperSurgical’s position in the growing reproductive healthcare market, offering more comprehensive solutions for maternal and fetal health. The expanding availability of advanced diagnostic tools, such as amniocentesis needles, will continue to play a pivotal role in shaping the future of reproductive healthcare and maternal care services.

Key Takeaways

• In 2023, the market for amniocentesis needle generated a revenue of US$ 200.1 Million, with a CAGR of 6.9%, and is expected to reach US$ 390.0 Million by the year 2033.
• The product type segment is divided into 100 to 150 mm, smaller than 100 mm, and larger than 150 mm, with 100 to 150 mm taking the lead in 2023 with a market share of 55.2%.
• Considering application, the market is divided into amniocentesis procedures, fetal blood transfusion, cordocentesis procedure, amnioreduction procedures, and amnioinfusion procedure. Among these, amniocentesis procedures held a significant share of 59.3%.
• Furthermore, concerning the end-user segment, the market is segregated into hospitals & clinics, diagnostics centers, and others. The hospitals & clinics sector stands out as the dominant player, holding the largest revenue share of 61.2% in the amniocentesis needle market.
• North America led the market by securing a market share of 42.2% in 2023.

Product Type Analysis

The 100 to 150 mm segment led in 2023, claiming a market share of 55.2% owing to its ability to provide the optimal depth required for accurate sample collection in most cases. Needles in this range are ideal for performing amniocentesis in patients with different body types, ensuring a high degree of safety and efficacy during the procedure.

The growing awareness of prenatal testing and genetic screening is anticipated to drive demand for needles within this range, as they provide the necessary flexibility for various clinical needs. Additionally, technological advancements and the development of more refined needles are projected to contribute to the growth of the 100 to 150 mm segment in the coming years.

Application Analysis

The amniocentesis procedures held a significant share of 59.3% due to an increasing number of prenatal diagnostic tests performed worldwide. As prenatal screenings for genetic disorders such as Down syndrome and other chromosomal abnormalities gain importance, the demand for amniocentesis procedures is likely to rise.

Non-invasive prenatal testing (NIPT) has also increased the awareness and acceptance of amniocentesis as a reliable diagnostic tool. This procedure, which involves extracting amniotic fluid for testing, is anticipated to remain a critical component of prenatal care, driving growth in the market for amniocentesis needles.

End-User Analysis

The hospitals & clinics segment had a tremendous growth rate, with a revenue share of 61.2% as hospitals and healthcare facilities continue to be the primary venues for high-risk prenatal diagnostic procedures. Hospitals are anticipated to account for the majority of amniocentesis procedures due to the presence of specialized medical professionals, advanced equipment, and support services that ensure the safety of both the mother and the fetus.

Additionally, with increasing healthcare infrastructure development and the rising number of diagnostic centers in hospitals and clinics, the demand for amniocentesis needles is expected to rise steadily, contributing to the growth of this segment.

Key Market Segments

By Product Type

• 100 to 150 mm
• Smaller Than 100 mm
• Larger Than 150 mm

By Application

• Amniocentesis Procedures
• Fetal Blood Transfusion
• Cordocentesis  Procedure
• Amnioreduction Procedures
• Amnioinfusion Procedure

By End-user

• Hospitals & Clinics
• Diagnostics centers
• Others

Drivers

Rising Incidence of Genetic Disorders is Driving the Market

The rising incidence of genetic disorders, such as Down syndrome and cystic fibrosis, is a key driver for the amniocentesis needle market. With more pregnancies being screened for chromosomal abnormalities, demand for precise diagnostic tools like amniocentesis needles has surged. According to the Centers for Disease Control and Prevention (CDC), about 1 in 700 babies in the US are born with Down syndrome annually.

Additionally, the World Health Organization (WHO) reports that congenital disabilities affect approximately 3-6% of newborns globally, further propelling market growth. Companies like Medtronic and Becton Dickinson have expanded their product portfolios to cater to this demand. Advanced healthcare infrastructure in North America and Europe also supports higher adoption rates, reinforcing market expansion.

Restraints

High Cost and Invasive Nature are Restraining the Market

Despite its diagnostic accuracy, the high cost and invasive procedure of amniocentesis limit its widespread adoption. The average cost of the procedure ranges between US$1,000 to US$2,500 in the US, according to Medicare data from 2023.

Moreover, the risk of complications, such as miscarriage (estimated at 0.1-0.3% by the American College of Obstetricians and Gynecologists (ACOG)), discourages some patients. Non-invasive alternatives like NIPT (Non-Invasive Prenatal Testing) further challenge market growth. Emerging markets in Asia and Africa show slower uptake due to affordability concerns, restricting revenue potential for key players like CooperSurgical and Cardinal Health.

Opportunities

Technological Advancements are Creating Growth Opportunities

Innovations in needle design and imaging technologies present significant opportunities for market expansion. Companies are introducing ultra-fine, echogenic needles that enhance precision and reduce patient discomfort. Rocket Medical plc reported an increase in 2023 revenue due to its advanced amniocentesis needle line.

Additionally, integration with ultrasound guidance systems has improved success rates, with GE Healthcare’s 2023 report indicating a reduction in procedure-related complications. Emerging economies are also witnessing increased healthcare investments, with India’s prenatal diagnostics market expected to grow in the coming years. Such advancements and supportive policies are likely to sustain long-term demand.

Impact of Macroeconomic / Geopolitical Factors

Rising Preference for Early Prenatal Testing is a Recent Trend

A growing trend toward early and frequent prenatal testing is reshaping the amniocentesis needle market. More women over 35 years, who face higher risks of chromosomal abnormalities, are opting for early screening. The CDC’s 2023 data shows that nearly 20% of US pregnancies involve women aged 35+, driving demand.

Furthermore, increasing awareness campaigns by organizations like March of Dimes have boosted prenatal testing rates. Companies like Thermo Fisher Scientific are capitalizing on this by offering bundled genetic testing solutions. This trend is expected to persist as healthcare systems emphasize preventive care.

Latest Trends

Impact of Macroeconomic and Geopolitical Factors on the Market

Macroeconomic stability and healthcare funding directly influence the amniocentesis needle market, with developed nations maintaining strong demand due to higher disposable incomes and insurance coverage. However, inflation and supply chain disruptions, exacerbated by geopolitical tensions like the Russia-Ukraine war, have increased raw material costs, squeezing profit margins for manufacturers.

Trade restrictions have also delayed medical imports in regions like the Middle East, slowing market growth. Conversely, government initiatives in countries like China and India to improve maternal healthcare are creating new opportunities. Technological collaborations between Western and Asian firms are further mitigating risks, ensuring sustained innovation and accessibility. Despite challenges, the long-term outlook remains positive, driven by rising global health awareness and advancements in medical technology.

Regional Analysis

North America is leading the Amniocentesis Needle Market

North America dominated the market with the highest revenue share of 42.2% owing to rising prenatal diagnostic procedures, increased maternal age, and advancements in genetic testing. According to the Centers for Disease Control and Prevention (CDC), the number of women aged 35 and older giving birth in the US rose by 2.3% in 2023 compared to 2022, driving demand for prenatal testing. The National Institutes of Health (NIH) reported a 12% increase in government funding for fetal medicine research in 2023, supporting innovations in amniocentesis technology.

Hospitals and clinics adopted more refined needles, with companies like Becton Dickinson and CooperSurgical introducing FDA-approved devices with enhanced safety features. The American College of Obstetricians and Gynecologists (ACOG) updated guidelines in late 2023, recommending genetic amniocentesis for high-risk pregnancies, further boosting market growth. Additionally, the Canadian Institute for Health Information (CIHI) noted a rise in prenatal diagnostic procedures in 2023, reinforcing regional demand.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Asia Pacific is expected to grow with the fastest CAGR owing to improving healthcare infrastructure, rising awareness of genetic disorders, and government initiatives promoting prenatal care. India’s Ministry of Health and Family Welfare recorded a surge in prenatal screening centers in 2023, directly increasing the need for amniocentesis equipment.

China’s National Health Commission (NHC) implemented stricter prenatal testing regulations in 2022, leading to a rise in approved diagnostic facilities by 2024. Japan’s Society of Obstetrics and Gynecology noted an annual growth in advanced prenatal procedures since 2022, driven by an aging maternal population.

Key manufacturers, such as Medtronic and Rocket Medical, are projected to expand distribution networks in emerging markets, further accelerating adoption. The Australian government’s 2023 investment in genetic research is expected to enhance amniocentesis accessibility, reinforcing regional market growth.

Key Regions and Countries

North America

• US
• Canada

Europe

• Germany
• France
• The UK
• Spain
• Italy
• Russia
• Netherland
• Rest of Europe

Asia Pacific

• China
• Japan
• South Korea
• India
• Australia
• New Zealand
• Singapore
• Thailand
• Vietnam
• Rest of APAC

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• South Africa
• Saudi Arabia
• UAE
• Rest of MEA

Key Players Analysis

Key players in the amniocentesis needle market drive growth through technological innovation, strategic acquisitions, and expanding global distribution networks. They invest in developing advanced needle designs that enhance safety and precision during prenatal diagnostic procedures. Collaborations with healthcare providers and research institutions facilitate the integration of new technologies and broaden market reach. Additionally, targeting emerging markets with increasing awareness of prenatal diagnostics presents significant growth opportunities.

Cook Medical, headquartered in Bloomington, Indiana, is a leading manufacturer of medical devices, including amniocentesis needles. The company offers products like the EchoTip Disposable Amniocentesis Needle, designed for precise fluid aspiration under ultrasound guidance. Cook Medical emphasizes research and development to deliver innovative solutions that improve patient outcomes. With a strong global presence, the company continues to expand its influence in the prenatal diagnostic market through strategic partnerships and continuous innovation.

Top Key Players

• Smith’s Medical
• Rocket Pharmaceuticals
• Medline
• Laboratoire CCD
• Integra LifeSciences
• Cook Medical
• Biopsybell Srl
• Becton, Dickinson and Company

Recent Developments

• In April 2023, Rocket Pharmaceuticals, a biotechnology innovator, revealed that it was bolstering its leadership team to better align with the rapid development of its gene therapy portfolio, which includes advanced AAV and LV gene therapies. This move will facilitate the acceleration of the company’s research and the commercialization of these promising therapies.
• In June 2023, Becton, Dickinson and Company completed a strategic deal to divest its surgical and laparoscopic instrument divisions, along with its sterilization container business, to STERIS plc. This transaction allows BD to refine its focus and allocate resources toward its core healthcare and diagnostics business areas.

Report Scope