Amniocentesis

Chronicle

2025: Global Amniocentesis Needles Market Size Exceeded $174 Million for the Year

In 2025, costs in the global amniocentesis needle market are estimated at $174.4 million. Almost a third of this amount fell on the North American region. Such data are provided in a Fortune Business Insights study, the results of which were published on December 30, 2025.

Amniocentesis is an invasive prenatal diagnostic procedure in which amniotic fluid (amniotic fluid) is sampled through the abdominal wall of the mother under ultrasound control. Its subsequent analysis allows high accuracy to detect chromosomal abnormalities (for example, Down syndrome), gene diseases (cystic fibrosis), intrauterine infections and other pathologies. The procedure is prescribed by a doctor at high risk, in particular, with abnormal screening results or in case of predisposition to hereditary diseases. A thin sterile needle made of medical steel (often with a special coating to improve ultrasound imaging) is used to take the sample.

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Фото: McKesson Medical-Surgical

One of the market drivers is the increase in the number of children with congenital diseases. The most severe such ailments include heart defects, neural tube defects and Down syndrome. According to the World Health Organization (WHO), published in 2023, about 240 thousand newborn children die from congenital diseases during the first 28 days of life every year. Congenital diseases also cause the death of 170 thousand children aged one month to five years. It is estimated that about 94% of cases of serious congenital diseases are in low- or middle-income countries. Although congenital pathologies can develop under the influence of one or more genetic, infectious, nutritional or environmental factors, it is often difficult to establish the exact causes. Against this background, the number of amniocentesis procedures is growing, which leads to an increase in demand for the corresponding needles.

Another stimulating factor is the expansion of health infrastructure in the developing countries of the Asia-Pacific region and Latin America. At the same time, there is an increase in public awareness of prenatal testing. The authorities of many states organize programs for the protection of motherhood and childhood, which also contributes to an increase in the number of amniocentesis procedures.

But there are also deterrents. Despite the significant diagnostic accuracy of amniocentesis, this invasive procedure leads to cramps or discomfort. In addition, in rare cases, it further increases the risk of infection and miscarriage. The procedure requires the availability of qualified medical specialists.

Geographically, North America was leading in 2025, accounting for 31.5% of expenses, or $55 million. For comparison, a year earlier, the costs here were estimated at $53 million. Major industry players on a global scale are:

• Cook;
• CooperSurgical;
• Laboratoire CCD;
• Medax;
• Biopsybell S.R.L. Società unipersonale;
• ICU Medical;
• Medline Industries;
• Vigeo.

The global amniocentesis needle market is expected to reach $181.3 million in 2026. At the same time, the United States will have $57.1 million, Europe - $50.7 million, Asia-Pacific - $49.2 million. Latin America's contribution is projected at $12.5 million. Fortune Business Insights analysts believe that in the future, the CAGR will be 4.3%. Thus, by 2034, costs may increase to about $254.2 million.^[1]

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