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新生儿筛检市场规模、份额和成长分析（按产品、技术、检测方法和地区划分）：产业预测（2026-2033 年）

市场调查报告书

商品编码

1902770

新生儿筛检市场规模、份额和成长分析（按产品、技术、检测方法和地区划分）：产业预测（2026-2033 年）

Newborn Screening Market Size, Share, and Growth Analysis, By Product (Consumables, Instruments), By Technology (Tandem Mass Spectrometry, Pulse Oximetry), By Test, By Region - Industry Forecast 2026-2033

出版日期: 2025年12月23日 | 出版商:

SkyQuest | 英文 177 Pages | 商品交期: 3-5个工作天内

价格

简介目录

预计到 2024 年，新生儿筛检市场规模将达到 13.4 亿美元，到 2025 年将达到 14.3 亿美元，到 2033 年将达到 24.1 亿美元，在预测期（2026-2033 年）内，复合年增长率为 6.8%。

由于出生率上升和婴儿先天性疾病发病率增加，新生儿筛检市场预计将迎来显着成长。意识提升和政府积极主动的倡议，包括各项计划和立法，进一步推动了这一趋势。新生儿先天性疾病的高发生率凸显了全面筛检的必要性，使得调查方法的技术进步至关重要。大量新生儿因这些疾病死亡，凸显了有效筛检方案的迫切需求。代谢紊乱和先天性甲状腺机能低下症尤其在婴儿中发病率较高。公众意识的提高、检测能力的增强以及有利的监管环境，将推动新生儿筛检市场的成长，并为早期发现和介入创造更完善的医疗保健环境。

新生儿筛检市场驱动因素

先天性异常病例的增加是新生儿筛检市场扩张的关键驱动因素。这些异常包括多种疾病，例如遗传性疾病、听力障碍和代谢紊乱。早期诊断至关重要，因为及时介入可以显着改善儿童的生活品质和治疗效果。医疗技术的进步以及人们对早期检测益处的日益重视，进一步凸显了筛检计画的重要性。人们对先天性疾病的认识和关注度不断提高，也进一步推动了对能够在症状出现前识别这些异常的综合筛检方法的需求，最终目标是保护新生儿的长期健康。

新生儿筛检市场限制因素

新生儿筛检的高昂费用构成了一项重大的准入障碍，尤其是在中低收入国家。复杂的基因检测费用对许多家庭来说难以承受，使他们无法获得可能挽救生命的治疗。这种经济障碍会导致检测和介入的延误，进而对受影响新生儿的健康状况产生负面影响。此外，这些检测的普及程度不均凸显了在全球范围内推广公平诊断服务网络的重要性，并需要更多可及且价格合理的筛检倡议。促进婴幼儿健康公平对于改善弱势族群的健康状况至关重要。

新生儿筛检市场趋势

新生儿筛检市场的一大趋势是整合先进的基因检测技术，例如全基因测序(WGS) 和次世代定序(NGS)。这些创新显着提高了对多种遗传疾病的检测准确性，包括传统筛检方法常常遗漏的复杂和罕见疾病。随着基因检测成本的降低和技术的普及，综合筛检方案正在涌现，从而能够更早、更准确地识别基因异常。这项发展不仅改善了临床结果，也促进了新生儿筛检计画的扩展，凸显了新生儿照护向精准医疗的转变。

北美洲
- 美国
- 加拿大
欧洲
- 英国
- 德国
- 西班牙
- 法国
- 义大利
- 其他欧洲地区
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 亚太其他地区
拉丁美洲
- 巴西
- 其他拉丁美洲地区
中东和非洲
- 海湾合作委员会国家
- 南非
- 其他中东和非洲地区

竞争格局

前五大公司对比
主要企业市场定位（2025 年）
主要企业采取的策略
近期市场趋势
主要企业市占率（2025 年）
主要企业简介
- 公司简介
- 产品系列分析
- 依业务板块进行公司股票分析
- 2021-2023年营收年比比较

主要企业简介

Masimo Corp.
Covidien Plc
AB Sciex LLC
Natus Medical Inc.
Agilent Technologies Inc.
PerkinElmer Inc.
GE Healthcare
Bio-Rad Laboratories Inc.
Trivitron Healthcare
Medtronic Inc.
Rady Children's Institute for Genomic Medicine
GE Lifesciences
Waters Corporation
Danaher Corporation
Thermo Fisher Scientific Inc.
ZIVAK TECHNOLOGIES
CAMAG
OTODYNAMICS
ZENTECH
VIVOSONIC

结论与建议

简介目录

Product Code: SQMIG35E2050

Newborn Screening Market size was valued at USD 1.34 Billion in 2024 and is poised to grow from USD 1.43 Billion in 2025 to USD 2.41 Billion by 2033, growing at a CAGR of 6.8% during the forecast period (2026-2033).

The newborn screening market is poised for significant growth driven by a rising birth rate and an increase in congenital illnesses among infants. Heightened consumer awareness and proactive government initiatives, including various programs and legislations, further contribute to this trend. Technological advancements in screening methodologies are pivotal, as the prevalence of congenital disorders in newborns underscores the necessity for comprehensive testing. It's estimated that a substantial number of neonatal deaths result from these conditions, indicating a critical need for effective screening solutions. In particular, metabolic disorders and congenital hypothyroidism exhibit considerable prevalence rates among infants. As awareness and testing capabilities expand, the favorable regulatory environment will propel the growth of the newborn screening market, creating a more robust healthcare landscape for early detection and intervention.

Top-down and bottom-up approaches were used to estimate and validate the size of the Newborn Screening market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Newborn Screening Market Segments Analysis

Global Newborn Screening Market is segmented by Product, Test, technology, end user and region. Based on Product, the market is segmented into Consumables, Instruments, Hearing screening instruments, Pulse oximeters. Based on Test, the market is segmented into Dry blood spot tests, Hearing screening tests, CCHD screening tests. Based on technology, the market is segmented into Immune assays & enzymatic assays, Tandem mass spectrometry, Molecular assays, Hearing screening technologies, Pulse oximetry, Other Technologies. Based on end user, the market is segmented into Clinical Laboratories, Hospitals. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.

Driver of the Newborn Screening Market

The rising prevalence of congenital abnormalities has become a significant driver for the expansion of the newborn screening market. These abnormalities encompass a range of conditions, including genetic disorders, hearing impairments, and metabolic disorders. Early diagnosis of such conditions is vital, as timely intervention can considerably enhance the quality of life for affected infants and improve treatment outcomes. Advancements in medical technology, alongside a deeper understanding of the benefits of early detection, have underscored the importance of screening programs. Growing awareness and focus on congenital diseases further amplify the demand for comprehensive screening methods that identify these anomalies before symptoms manifest, ultimately aiming to safeguard newborns' long-term health.

Restraints in the Newborn Screening Market

The high costs associated with newborn screening tests create significant barriers to access, particularly in low- and middle-income countries. Many families find the expenses of complex genetic testing prohibitive, hindering their ability to obtain potentially lifesaving treatments. This financial obstacle can lead to delays in both detection and intervention, negatively impacting the health outcomes of affected neonates. Furthermore, the uneven availability of these tests highlights the need for more accessible and affordable screening initiatives, supported by networks that promote equitable diagnostic services worldwide. Fostering infant health equality is essential for improving health prospects for vulnerable populations.

Market Trends of the Newborn Screening Market

The Newborn Screening market is experiencing a notable trend towards the integration of advanced genetic testing technologies, such as whole genome sequencing (WGS) and next-generation sequencing (NGS). These innovations significantly enhance the accuracy of detecting a broader spectrum of genetic disorders, including complex and rare conditions often overlooked by traditional screening methods. As the cost of genetic testing decreases and technology becomes more accessible, comprehensive screening panels are emerging, leading to earlier and more accurate identification of genetic abnormalities. This evolution not only improves clinical outcomes but also drives the expansion of newborn screening programs, underscoring a shift toward precision medicine in neonatal care.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Driver & Opportunities
- Restraints & Challenges
Porters Analysis & Impact
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Technological Advancement
Regulatory Landscape
Patent Analysis
Value Chain Analysis
Case Study Analysis
Market Attractiveness Index

Global Newborn Screening Market Size by Product & CAGR (2026-2033)

Market Overview
Consumables
Instruments
Hearing screening instruments
Pulse oximeters

Global Newborn Screening Market Size by Test & CAGR (2026-2033)

Market Overview
Dry blood spot tests
Hearing screening tests
CCHD screening tests

Global Newborn Screening Market Size by Technology & CAGR (2026-2033)

Market Overview
Immune assays & enzymatic assays
Tandem mass spectrometry
Molecular assays
Hearing screening technologies
Pulse oximetry
Other Technologies

Global Newborn Screening Market Size by End User & CAGR (2026-2033)

Market Overview
Clinical Laboratories
Hospitals

Global Newborn Screening Market Size & CAGR (2026-2033)

North America, (Product, Test, Technology, End User)
- US
- Canada
Europe, (Product, Test, Technology, End User)
- UK
- Germany
- Spain
- France
- Italy
- Rest of Europe
Asia-Pacific, (Product, Test, Technology, End User)
- China
- India
- Japan
- South Korea
- Rest of Asia Pacific
Latin America, (Product, Test, Technology, End User)
- Brazil
- Rest of Latin America
Middle East & Africa, (Product, Test, Technology, End User)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2025
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2025
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2021-2023)

Key Company Profiles

Masimo Corp.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Covidien Plc
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
AB Sciex LLC
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Natus Medical Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Agilent Technologies Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
PerkinElmer Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
GE Healthcare
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Bio-Rad Laboratories Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Trivitron Healthcare
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Medtronic Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Rady Children's Institute for Genomic Medicine
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
GE Lifesciences
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Waters Corporation
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Danaher Corporation
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Thermo Fisher Scientific Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
ZIVAK TECHNOLOGIES
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
CAMAG
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
OTODYNAMICS
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
ZENTECH
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
VIVOSONIC
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments