양수천자침 시장 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The amniocentesis needle market stood at USD 194.79 million in 2025 and is forecast to reach USD 248.403 million by 2030, advancing at a 4.98% CAGR.

A steady yet deliberate expansion reflects the device's indispensable role in amniocentesis, cordocentesis and fetal blood transfusion-procedures that still command definitive diagnostic accuracy despite the meteoric rise of non-invasive prenatal tests. Demand concentrates in high-risk pregnancies, where clinicians insist on highest-precision instrumentation to safeguard maternal and fetal outcomes. Uptake of premium products with enhanced ultrasound visibility and built-in safety stops is rising in tandem with population-level shifts toward older motherhood, greater use of assisted reproduction and widening prenatal screening mandates. While new reimbursement policies fuel procedure migration to outpatient settings, long-term growth remains anchored to hospitals and tertiary centers that can support complex fetal interventions.

Global Amniocentesis Needle Market Trends and Insights

Rising Burden of Genetic and Chromosomal Disorders

Chromosomal abnormalities affect 0.6% of live births worldwide, with trisomy 21 incidence climbing sharply beyond maternal age 35. As national screening programs cast a wider net, confirmatory invasive tests remain the clinical gold standard, keeping the amniocentesis needle market firmly embedded in prenatal pathways. Genetic counselors routinely underscore that screening cannot replace diagnostic certainty, sustaining demand for high-precision needles that reduce repeat insertions and procedure-related anxiety.

Growing Maternal Age and Associated Pregnancy Risks

In 2025, pregnancies in women >= 40 years carry a trisomy 21 risk of 1 in 98, versus 1 in 1,095 at age 29. This demographic reality, driven by career priorities and socioeconomic shifts, anchors a steady pool of patients for whom invasive diagnostics remain recommended irrespective of initial NIPT results. Device makers therefore continue to prioritize ergonomic hubs and echogenic tips that improve single-pass success in diverse maternal anatomies.

Rapid Uptake of cfDNA Screening

Professional-society endorsements have cut invasive diagnostic testing volumes by 44% within two years of NIPT rollout. With 98.6% of low-risk women declining invasive confirmation when cfDNA is negative, base-procedure volumes retreat even as remaining interventions skew toward higher-risk pregnancies that demand premium needles.

Other drivers and restraints analyzed in the detailed report include:

1. Growth in IVF-Related Multiple Pregnancies
2. AI-Guided Ultrasound Improving Puncture Accuracy
3. Shortage of Fetomaternal Medicine Specialists

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

The 100 - 150 mm class captured 54.12% of the amniocentesis needle market share in 2024, a position earned through its adaptability across routine amniocentesis and cordocentesis. User feedback highlights easier handling, consistent ultrasound visibility and lower maternal-discomfort scores, solidifying loyalty among high-volume obstetric units. Longer needles above 150 mm, however, are outpacing the category at a 5.34% CAGR as rising maternal BMI and late-gestation interventions demand deeper uterine reach. Needle innovators now coat shafts with micro-etching and embed stylets that lock once the amniotic cavity or umbilical vein is entered, minimizing the risk of over-penetration. Many hospitals adopt mixed-length trays so clinicians can select the optimal device per patient, a practice that expands overall procurement volume and underpins the amniocentesis needle market size for the segment.

Clinicians also report higher first-pass success when echogenic tip geometry is mated precisely to real-time AI visualization algorithms. Vendors, therefore, pair needle length with proprietary software presets, encouraging facilities to standardize on a single brand ecosystem. As software upgrades roll out over the air, customers feel compelled to refresh inventories to ensure maximum compatibility-an aftermarket dynamic that further supports the amniocentesis needle market.

Amniocentesis Needle Market Report is Segmented by Needle Length(<100mm, 100-150 Mm and > 150 Mm), Procedure (Amniocentesis, Amnioreduction, Fetal Blood Transfusion, Amnioinfusion and Cordocentesis), End User (Hospitals, Specialty Clinics, and Ambulatory Surgical Centers), and Geography (North America, Europe, Asia-Pacific and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America's 37.36% revenue share in 2024 stems from universal insurance coverage of high-risk diagnostics and broad acceptance of prenatal genetics. The 2025 removal of prior authorization for cfDNA by a leading private payer streamlines testing pathways, yet does not eliminate the need for invasive confirmation in abnormal cases, keeping hospitals on a predictable purchasing cycle. Rural maternity deserts remain a concern, but tele-ultrasound partnerships push expertise into smaller units, indirectly bolstering equipment sales across the amniocentesis needle market.

Asia-Pacific is forecast to grow at 6.78% CAGR through 2030, propelled by urbanization, fertility-treatment uptake and delayed parenthood. Nations such as Japan and South Korea now document advanced-maternal-age pregnancy rates rivaling Western peers. Government-funded newborn-disorder initiatives align with this shift, enabling multi-year procurement contracts for fetal medicine devices. Local contract manufacturers have begun to supply stainless-steel cannulae, trimming cost layers and widening adoption of premium-coated needles.

Europe enjoys uniform prenatal guidelines and public-funded screening programs that guarantee baseline demand. Regional focus on cost containment, however, nudges providers toward outpatient settings-an evolution mirroring the United States. Harmonized Medical Device Regulation certification has lengthened market-entry timelines but also reassures clinicians of product safety, encouraging them to upgrade to AI-compatible devices over older stock. Consequently, refresh cycles for the amniocentesis needle market remain synchronized with ultrasound capital refresh programs.

1. Beckton Dickinson
2. The Cooper Companies
3. Cook Group
4. Smiths Group
5. RI.MOS Srl
6. Laboratoire CCD
7. Rocket Medical
8. Sterylab Srl
9. BPB Medica
10. Medex Medical device
11. Vigeo Srl
12. GIMA Italia
13. Tsumani Medical

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Burden Of Genetic And Chromosomal Disorders
  • 4.2.2 Growing Maternal Age And Associated Pregnancy Risks
  • 4.2.3 Growth In Ivf-Related Multiple Pregnancies
  • 4.2.4 Rising Awareness And Government Support For Prenatal Genetic Testing And Screening Programs
  • 4.2.5 AI-Guided Ultrasound Improving Puncture Accuracy
  • 4.2.6 Availability Of Technological Advanced And Prodcut Variety
• 4.3 Market Restraints
  • 4.3.1 Rapid Uptake Of CFDNA Screening
  • 4.3.2 Shortage Of Fetomaternal Medicine Specialists
  • 4.3.3 Litigation Risk In Invasive Procedures
  • 4.3.4 Supply Pinch In Surgical-Grade Stainless Steel
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technology Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size and Growth Forecasts (Value-USD)

• 5.1 By Needle Length
  • 5.1.1 < 100 mm
  • 5.1.2 100 - 150 mm
  • 5.1.3 > 150 mm
• 5.2 By Procedure
  • 5.2.1 Amniocentesis
  • 5.2.2 Amnioreduction
  • 5.2.3 Fetal Blood Transfusion
  • 5.2.4 Amnioinfusion
  • 5.2.5 Cordocentesis
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Specialty Clinics
  • 5.3.3 Ambulatory Surgical Centers
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products and Services, and Recent Developments)
  • 6.3.1 BD
  • 6.3.2 CooperSurgical
  • 6.3.3 Cook Medical
  • 6.3.4 Smiths Medical
  • 6.3.5 RI.MOS Srl
  • 6.3.6 Laboratoire CCD
  • 6.3.7 Rocket Medical
  • 6.3.8 Sterylab Srl
  • 6.3.9 BPB Medica
  • 6.3.10 Medex Medical device
  • 6.3.11 Vigeo Srl
  • 6.3.12 GIMA Italia
  • 6.3.13 Tsumani Medical

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment