Amniocentesis Needle Market Size & Share, by Application (Diagnostic, Therapeutic); Procedure; End user; Product; Gauze Size; Material Composition - Global Growth Forecasts, Supply & Demand Analysis, and Statistical Report 2026-2035

Amniocentesis Needle Market - Regional Analysis

North America Market Insights

North America in the amniocentesis needle market is projected to be the dominant region by garnering a share of 38.2% by the end of 2035. The market’s growth in the region is propelled by an increase in the non-invasive prenatal testing (NIPT) adoption, which is followed by the presence of reimbursement and litigation environmental codes, provincial formularies, and centralized procurement. As stated in the December 2023 NIH report, 1 in every 33 infants in the U.S. is born with congenital anomalies every year, which is increasing the market’s demand in the region. Besides, the August 2023 NLM report indicated that 25% to 50% of pregnant women from the U.S. readily utilize NIPT, which positively impacts the market’s growth.

The amniocentesis needle sector in the U.S. is growing significantly, owing to the presence of a complicated regulatory-payer landscape, along with technological premiumization. In addition, the existence of a supportive reimbursement framework, guidelines from the American College of Obstetricians and Gynecologists (ACOG), a surge in maternity shift, gauze sourcing, and safety-engineered needles integration are also driving the market in the country. As per the May 2025 EPA report, the Local Governments Reimbursement (LGR) Program made a provision of USD 25,000 per incident to local governments as a fund for responsive actions, thus contributing to the market’s growth.

The amniocentesis needle market in Canada is also growing due to the existence of a province-based healthcare system, public fund provision, and priority for cost control, along with equitable accessibility. As per the December 2024 NLM article, Prison Needle Exchange Programs (PNEPs) were launched in Canada across 2 federal prisons, and during mid-June 2022, approximately 10% of people utilized PNEP for injecting drugs. Therefore, with the presence of government-approved and standard programs, the country readily enforces safety regulations for utilizing needles during any health evaluation.

Gauze 2023 Export and Import in North America

Source: OEC, August 2025

APAC Market Insights

Asia Pacific in the amniocentesis needle market is expected to emerge as the fastest-growing region during the projected timeline. The market’s upliftment in the region is highly fueled by harmonization in regulatory policies, the presence of a national volume-based buying (VBB) strategy, centralized procurement, and critical market polarization, along with out-of-pocket spending. According to an article published by SSM - Health Systems in December 2025, there has been a 30% reduction in medicine expenses after pooled procurement was adopted, which denotes a huge growth opportunity in the market.

The amniocentesis needle industry in China is growing steadily, owing to the National Medical Products Administration (NMPA) enforcement, the presence of strict registration for overall medical devices, the Volume-Based Procurement (VBP) program, and the focus on optimizing prenatal screening rates. As per an article published by NLM in July 2023, the country has successfully integrated 7 rounds of national VBP and effectively diminished the price of almost 294 multiple drug formulations by 53%. Besides, the country has displayed that the pooling of purchasing power is a significant tool to gain bargaining benefits, thereby denoting a positive outlook for the overall market.

The amniocentesis needle market in India is also developing due to significant reliance and vast heterogeneity on out-of-pocket expenses. Additionally, the domestic government’s Ayushman Bharat Digital Mission (ABDM) implementation for developing a suitable health ecosystem and ensuring diagnostic procedure volume is also fueling the market’s exposure in the country. According to the June 2025 Frontiers Organization report, the out-of-pocket spending in the country accounts for 47.1% of the overall health expenditure, and this spending has doubled, resulting in USD 8.5 trillion, which is 9.8% of the international GDP, thereby suitable for the market’s development.

Europe Market Insights

Europe in the amniocentesis needle market is predicted to account for a considerable share by the end of the projected period. The market’s development in the region is highly propelled by the presence of the regional medical device regulation (MDR), administrative harmonization, the provision of an innovation fund, early benefit assessment, syringes sourcing, and the existence of the transparency committee and stringent CE processes. According to the October 2024 NLM article, the 1993 Council Directive 93/42/EEC on medical devices, the first 1990 Council Directive 90/385/EEC on active implantable medical device, and the 1998 Directive 98/79/EC of the Europe-based Parliament have been readily upgraded with the present current device‐related regulations to Regulation (EU) 2017/745, thus suitable for the market’s growth.

The market in Germany is steadily growing, owing to the presence of the federal structure, preference for high-quality and evidence-specific medical technology, the existence of the Institute for the Hospital Remuneration System (InEK), and the robust medical technology sector. As per the May 2025 Deutschland article, there have been the conduct of 524 industry-based clinical trials, based on which the country ranks in fourth position globally, as of 2022. Additionally, 30 drugs with the latest active ingredients were successfully placed in the market in 2023 that targeted infectious, immunological, and cancer diseases, while 400 biotechnological medications with 350 active ingredients received clearance in the country.

The amniocentesis needle industry in France is also developing due to its state-controlled and centralized healthcare system that has prioritized medical benefit and cost control. In addition, the Haute Autorité de Santé (HAS) and the national health insurance coverage are also driving the market’s demand in the country. Besides, the statutory health insurance (SHI) in the country comprises the general scheme, the self-employed scheme, and the agricultural scheme. According to the 2024 Euro Health Observatory article, more than 95% of the population has private health insurance, and nearly 20% benefit from state-funded health insurance, thereby contributing towards the market upliftment.

Syringes 2023 Export and Import in Europe

Source: OEC, July 2025