胎児・新生児ケアデバイス市場：製品別、エンドユーザー別、地域別、2024年～2031年

胎児・新生児ケアデバイス市場の評価、2024年～2031年

特に新興国市場における出生率の上昇が、胎児・新生児ケアデバイス市場の大きな促進要因となっています。Verified Market Researchのアナリストによると、胎児・新生児ケアデバイス市場は、胎児および新生児ケア機器市場は、2024年に約88億ドルに達し、2031年までに149億3,000万米ドルに達すると推計されています。

多くの政府が、妊産婦と乳幼児の健康状態の改善を目的とした政策やプログラムを実施しています。こうした取り組みには、新生児ケア施設や機器への資金援助が含まれることが多く、2024年から2031年までのCAGRは6.84%で市場は成長します。

胎児・新生児ケアデバイス市場定義/概要

胎児・新生児ケアデバイスとは、妊娠中の胎児や、出生後28日間を含む新生児期の新生児をモニター、サポート、治療するために設計された医療機器の専門カテゴリーを指します。これらの医療機器は、特に早産や複雑な分娩などリスクの高い状況において、母親と新生児の健康と安全を確保する上で重要な役割を果たしています。

これらの機器の主な種類には、胎児の心拍数と子宮収縮を追跡し、分娩中の胎児の健康状態を評価する胎児モニター、未熟児や病気の乳児に最適な温度と湿度を保ちながら管理された環境を提供する保育器、自力で十分な呼吸ができない新生児の呼吸を補助または制御する人工呼吸器などがあります。胎児・新生児ケアデバイスは、現代の産科・小児科医療において欠くことのできないものであり、発育の重要な段階において、脆弱な人々の健康転帰を著しく改善する必要不可欠なサポートを提供しています。

早産の増加は新生児ケア機器の需要にどのような影響を与えるか？

早産児に関連する課題に対応して専門医療機器の必要性が高まるため、早産児の有病率の増加は新生児医療機器の需要に大きく影響します。2020年には、全世界で推定1,340万人の新生児が早産で生まれ、全出生の約9.9％を占め、この公衆衛生問題の規模の大きさを浮き彫りにしています。世界保健機関（WHO）は、早産は新生児死亡の主な原因であり、生存者に長期的な健康合併症を引き起こす可能性があるため、高度な新生児ケアソリューションが必要であると強調しています。

米国では、2022年の早産率は10.4％と報告されており、人種・民族間で大きな格差があります。例えば、アフリカ系アメリカ人女性の早産率は14.6％で、白人の9.4％を大幅に上回っています。これらの統計は、早産児の健康管理に不可欠な保育器、人工呼吸器、モニタリングシステムなどの効果的な新生児ケア機器の緊急の必要性を強調しています。ヘルスケアシステムがこれらの脆弱な集団の転帰を改善しようと努力する中、新生児ケア技術への投資はますます優先されるようになっており、この分野の市場成長と技術革新を促進しています。

胎児・新生児ケアデバイスメーカーが直面する主な規制上のハードルとは？

新生児用に特別に設計された医療機器の安全性と有効性を実証するための広範な臨床試験の要件は、新生児の生理学的反応が成人のそれとは著しく異なる可能性があるため、胎児・新生児ケアデバイスメーカーが直面する主要な課題です。FDAによると、新生児用の医療機器は、安全性と有効性を保証するために新生児臨床試験で厳しい研究を受けなければならず、そのため承認プロセスが長引く可能性があります。さらに、既存の医療機器の多くは、当初は成人用に設計され、後に新生児用に適合されたものであり、多くの場合、この脆弱な集団に対する適合性を保証する集団特有の試験がおろそかにされています。全米人口動態統計報告によると、2020年には米国で妊娠20週以上の胎児死亡事故が20,854件近く報告されており、効果的な新生児ケアソリューションが緊急に必要であることが明らかになっています。

さらに製造業者は、FDAやWHOといった機関が定めた複雑な規制経路を通過しなければならないです。こうした規制の枠組みはリソースを必要とし、小児医療に関する専門的な知識を必要とする場合もあり、開発プロセスをさらに複雑にしています。その結果、これらのハードルは革新的な胎児・新生児ケアデバイスの市場投入の遅れにつながり、最終的には新生児の転帰を改善するために必要な重要な医療技術の利用可能性に影響を与えます。

目次

第1章 世界の胎児・新生児ケアデバイス市場：イントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次インタビュー
• データソース一覧

第4章 世界の胎児・新生児ケアデバイス市場の展望

• 概要
• 市場力学
• 促進要因
• 抑制要因
• 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 胎児・新生児ケアデバイスの世界市場：製品別

• 胎児ケア機器
• 超音波装置
• 胎児MRIシステム
• 胎児モニター
• 胎児パルスオキシメーター
• 新生児ケア機器
• インファントウォーマー
• 保育器
• コンバーチブルウォーマー＆保育器
• 光線治療器
• 呼吸器関連機器
• 新生児監視装置
• 血圧モニター
• 心臓モニター
• パルスオキシメーター
• カプノグラフ
• 統合モニタリング機器

第6章 胎児・新生児ケアデバイスの世界市場：エンドユーザー別

• 病院
• 診療所
• 診断センター
• その他

第7章 胎児・新生児ケアデバイスの世界市場：地域別

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• ドイツ
• 英国
• フランス
• その他欧州
• アジア太平洋
• 中国
• 日本
• インド
• その他アジア太平洋地域
• 世界のその他の地域
• ラテンアメリカ
• 中東・アフリカ

第8章 胎児・新生児ケアデバイスの世界市場：競合情勢

• 概要
• 各社の市場ランキング
• 主な開発戦略

第9章 企業プロファイル

• GE Healthcare
• Philips Healthcare
• Dragerwerk AG & Co.
• Medtronic plc.
• Siemens Healthineers AG
• Atom Medical Corporation
• Dickinson and Company
• Hill-Rom Holdings Inc
• GEA Group AG
• Smith & Nephew plc
• Stryker Corporation
• Zimmer Biomet Holdings Inc
• Abbott Laboratories

第10章 付録

• 関連調査

Fetal And Neonatal Care Devices Market Valuation - 2024-2031

The rising birth rates, particularly in developing countries, are a significant driver of the fetal and neonatal care devices market. According to the analyst from Verified Market Research, the fetal and neonatal care devices market is estimated to reach a valuation of USD 14.93 Billion By 2031 over the forecast subjugating around USD 8.8 Billion valued in 2024.

Many governments are implementing policies and programs aimed at improving maternal and infant health outcomes. These initiatives often include funding for neonatal care facilities and equipment enabling the market to grow at a CAGR of 6.84% from 2024 to 2031.

Fetal And Neonatal Care Devices Market: Definition/ Overview

Fetal and neonatal care devices refer to a specialized category of medical equipment designed to monitor, support, and treat fetuses during pregnancy and newborns in the neonatal period, which encompasses the first 28 days after birth. These devices play a critical role in ensuring the health and safety of both mothers and their infants, particularly in high-risk situations such as premature births or complicated deliveries.

Key types of these devices include fetal monitors, which track fetal heart rate and uterine contractions to assess the well-being of the fetus during labor incubators that provide a controlled environment for premature or ill infants, maintaining optimal temperature and humidity and ventilators that assist or control breathing in newborns who are unable to breathe adequately on their own. Fetal and neonatal care devices are indispensable in modern obstetric and pediatric medicine, providing essential support that significantly improves health outcomes for vulnerable populations during critical stages of development.

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How Does the Increasing Prevalence of Preterm Births Impact the Demand for Neonatal Care Devices?

The increasing prevalence of preterm births significantly impacts the demand for neonatal care devices, as the need for specialized medical equipment rises in response to the challenges associated with premature infants. In 2020, an estimated 13.4 million newborns were born preterm globally, accounting for approximately 9.9% of all births, highlighting the scale of this public health issue. The World Health Organization emphasizes that preterm birth is the leading cause of neonatal mortality and can lead to long-term health complications for survivors, necessitating advanced neonatal care solutions.

In the United States, the preterm birth rate was reported at 10.4% in 2022, with significant disparities among racial and ethnic groups; for instance, the rate among African-American women was 14.6%, which is substantially higher than that of their white counterparts at 9.4%. These statistics underline the urgent need for effective neonatal care devices such as incubators, ventilators, and monitoring systems that are essential for managing the health of preterm infants. As healthcare systems strive to improve outcomes for these vulnerable populations, investments in neonatal care technologies are increasingly prioritized, driving market growth and innovation in this sector.

What are the Major Regulatory Hurdles Faced by Manufacturers of Fetal and Neonatal Care Devices?

The requirement for extensive clinical testing to demonstrate the safety and efficacy of medical devices specifically designed for neonates, as their physiological responses can differ markedly from those of adults are the major challenges face by the manufacturers of fetal and neonatal care devices. According to the FDA, medical products for newborns must undergo rigorous studies in neonatal clinical trials to ensure they are safe and effective, which can prolong the approval process. Additionally, many existing medical devices are initially designed for adult populations and later adapted for use in neonates, often neglecting population-specific testing that guarantees their suitability for this vulnerable group. The National Vital Statistics Reports indicated that in 2020, nearly 20,854 fetal fatalities were reported in the U.S. at 20 weeks of gestation or more, underscoring the urgent need for effective neonatal care solutions.

Furthermore, manufacturers must navigate complex regulatory pathways established by agencies such as the FDA and WHO, which set stringent guidelines for device design and performance standards. These regulatory frameworks can be resource-intensive and may require specialized knowledge of pediatric medicine, further complicating the development process. As a result, these hurdles can lead to delays in bringing innovative fetal and neonatal care devices to market, ultimately affecting the availability of critical health technologies needed to improve outcomes for newborns.

Category-Wise Acumens

What Factors Make Fetal Care Equipment a Leading Segment in the Fetal and Neonatal Care Devices Market?

The fetal care equipment segment has accounted for over 67% of the global market revenue. The increasing application of ultrasound devices to monitor fetal movement and health during pregnancy has been a major contributor to this dominance. According to a study published in 2020, the use of ultrasound in pregnancy more than doubled between 1980 and 1987, rising from 33.5% to 78.8% of pregnancies. Additionally, rising awareness, technological advancements, and ease of use have triggered the growing adoption of portable and do-it-yourself ultrasound devices for home use.

The fetal monitoring equipment segment, which includes devices such as Dopplers, intrapartum and antepartum monitors, and pulse oximeters, has also seen significant growth due to the increasing prevalence of obstetric complications and preterm births. In the U.S., the preterm birth rate reached 10.4% in 2022, with disparities among racial and ethnic groups. These factors have collectively driven the fetal care equipment segment to the forefront of the fetal and neonatal care devices market, underscoring the critical role these technologies play in monitoring and managing high-risk pregnancies.

Why do Hospitals Account for the Largest Share of the Fetal and Neonatal Care Devices Market?

Hospitals account for the largest share of the fetal and neonatal care devices market due to several critical factors that enhance their operational capabilities and patient care. In 2023, the hospital segment represented approximately 57.7% of the market revenue, reflecting the high demand for advanced medical technologies in these settings. The presence of Neonatal Intensive Care Units (NICUs) in hospitals facilitates the immediate access to specialized care required for high-risk pregnancies and premature births, which are increasingly prevalent; in the U.S., the preterm birth rate was reported at 10.4% in 2022.

Furthermore, hospitals are equipped with the latest and most technologically advanced equipment, which is essential for improving patient outcomes and ensuring effective monitoring and treatment of neonates. Government initiatives aimed at reducing infant mortality rates and increasing awareness about neonatal care have led to an increase in hospital admissions for neonatal care, further driving demand for fetal and neonatal devices. The combination of specialized healthcare professionals, comprehensive facilities, and a focus on maternal and child health positions hospitals as the primary users of fetal and neonatal care devices, thereby solidifying their dominant share in this market segment.

Country/Region-wise Acumens

How Does the Strong Presence of Key Market Players in North America Impact the Region's Dominance?

The strong presence of key market players in North America significantly contributes to the region's dominance in the fetal and neonatal care equipment market. According to a report, GE Healthcare holds the leading position in the overall fetal and neonatal care equipment market, with the company adopting several organic and inorganic growth strategies to sustain its leadership position and ensure future growth.

The presence of well-equipped Neonatal Intensive Care Units (NICUs) in the region, along with well-organized healthcare system, further solidifies North America's position as the largest market for fetal and neonatal care equipment. In the United States, the preterm birth rate was reported at 10.4% in 2022, with the percentage of newborn babies with low birth weight accounting for 8.24% in 2020. These statistics highlight the growing demand for advanced neonatal care equipment in the region.

What Factors are Driving the Rapid Growth of the Fetal and Neonatal Care Devices Market in Asia Pacific?

The rapid growth of the fetal and neonatal care devices market in the Asia Pacific region is driven by the increasing rates of preterm births have been reported, with estimates indicating that approximately 11% of all live births in the region are preterm, necessitating specialized neonatal care equipment to improve survival outcomes. Government initiatives aimed at enhancing maternal and child health have played a crucial role, as evidenced by the establishment of over 450 Special Newborn Care Units (SNCUs) in India alone, which provide essential services to nearly 0.9 million neonates annually.

Furthermore, advancements in technology have facilitated the development of affordable and effective neonatal care devices, allowing for their widespread adoption even in rural and underserved areas. As a result, these combined factors are significantly contributing to the rapid expansion of the fetal and neonatal care devices market across the Asia Pacific region.

Competitive Landscape

The Fetal And Neonatal Care Devices Market is characterized by a diversified set of competitors competing to innovate and fulfil the changing needs of healthcare providers and patients. Collaboration with healthcare institutions, strategic partnerships, and mergers and acquisitions all contribute to the competitive environment's dynamic nature, which drives ongoing innovation and growth.

Some of the prominent players operating in the fetal and neonatal care devices market include:

GE Healthcare

Philips Healthcare

Dragerwerk AG & Co. KGaA

Medtronic plc

Masimo Corporation

Natus Medical Incorporated

Phoenix Medical Systems (P) Ltd

Vyaire Medical

Atom Medical Corporation

Becton

Dickinson and Company

Koninklijke Philips NV

Mindray Medical International Limited

Siemens Healthineers AG

Hill-Rom Holdings, Inc.

GEA Group AG

Cerner Corporation

Stryker Corporation

Smith & Nephew plc

Zimmer Biomet Holdings, Inc.

Abbott Laboratories

Latest Developments

In January 2024, GE Healthcare introduced the Novii+ Wireless Patch System, a beltless, wireless maternal/fetal monitoring solution. This innovative device non-invasively measures and displays fetal heart rate, maternal heart rate, and uterine activity, providing a comfortable option for antepartum monitoring and allowing freedom of movement during labor.

In April 2023, Dragerwerk AG & Co. KGaA launched the Babyroo TN300, an FDA-cleared device designed to provide supportive lung protection and temperature stability for newborn infants.

TABLE OF CONTENTS

1. Introduction of Global Fetal And Neonatal Care Devices Market

• Overview of the Market
• Scope of Report
• Assumptions

2. Executive Summary

3. Research Methodology of Verified Market Research

• Data Mining
• Validation
• Primary Interviews
• List of Data Sources

4. Global Fetal And Neonatal Care Devices Market Outlook

• Overview
• Market Dynamics
• Drivers
• Restraints
• Opportunities
• Porters Five Force Model
• Value Chain Analysis

5. Global Fetal And Neonatal Care Devices Market, By Product

• Fetal Care Equipment
• Ultrasound Devices
• Fetal MRI Systems
• Fetal Monitors
• Fetal Pulse Oximeters
• Neonatal Care Equipment
• Infant Warmers
• Incubators
• Convertible Warmers & Incubators
• Phototherapy Equipment
• Respiratory Devices
• Neonatal Monitoring Devices
• Blood Pressure Monitors
• Cardiac Monitors
• Pulse Oximeters
• Capnographs
• Integrated Monitoring Devices

6. Global Fetal And Neonatal Care Devices Market, By End User

• Hospitals
• Clinics
• Diagnostic Centers
• Others

7. Global Fetal And Neonatal Care Devices Market, By Geography

• North America
• U.S.
• Canada
• Mexico
• Europe
• Germany
• UK
• France
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• Rest of Asia Pacific
• Rest of the World
• Latin America
• Middle East & Africa

8. Global Fetal And Neonatal Care Devices Market Competitive Landscape

• Overview
• Company Market Ranking
• Key Development Strategies

9. Company Profiles

• GE Healthcare
• Philips Healthcare
• Dragerwerk AG & Co.
• Medtronic plc.
• Siemens Healthineers AG
• Atom Medical Corporation
• Dickinson and Company
• Hill-Rom Holdings Inc
• GEA Group AG
• Smith & Nephew plc
• Stryker Corporation
• Zimmer Biomet Holdings Inc
• Abbott Laboratories

10. Appendix

• Related Research