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新生兒篩檢市場規模、佔有率和成長分析（按產品、技術、檢測方法和地區分類）：產業預測（2026-2033 年）

市場調查報告書

商品編碼

1902770

新生兒篩檢市場規模、佔有率和成長分析（按產品、技術、檢測方法和地區分類）：產業預測（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個工作天內

價格

簡介目錄

預計到 2024 年，新生兒篩檢市場規模將達到 13.4 億美元，到 2025 年將達到 14.3 億美元，到 2033 年將達到 24.1 億美元，在預測期（2026-2033 年）內，複合年成長率為 6.8%。

由於出生率上升和嬰兒先天性疾病發病率增加，新生兒篩檢市場預計將迎來顯著成長。意識提升和政府積極主動的舉措，包括各項計劃和立法，進一步推動了這一趨勢。新生兒先天性疾病的高發生率凸顯了全面篩檢的必要性，使得調查方法的技術進步至關重要。大量新生兒因這些疾病死亡，凸顯了有效篩檢方案的迫切需求。代謝紊亂和先天性甲狀腺機能低下症尤其在嬰兒中發病率較高。公眾意識的提高、檢測能力的增強以及有利的監管環境，將推動新生兒篩檢市場的成長，並為早期發現和介入創造更完善的醫療保健環境。

新生兒篩檢市場促進因素

先天性異常病例的增加是新生兒篩檢市場擴張的關鍵促進因素。這些異常包括多種疾病，例如遺傳性疾病、聽力障礙和代謝紊亂。早期診斷至關重要，因為及時介入可以顯著改善兒童的生活品質和治療效果。醫療技術的進步以及人們對早期檢測益處的日益重視，進一步凸顯了篩檢計畫的重要性。人們對先天性疾病的認知和關注度不斷提高，也進一步推動了對能夠在症狀出現前識別這些異常的綜合篩檢方法的需求，最終目標是保護新生兒的長期健康。

新生兒篩檢市場限制因素

新生兒篩檢的高昂費用構成了一項重大的准入障礙，尤其是在中低收入國家。複雜的基因檢測費用對許多家庭來說難以承受，使他們無法獲得可能挽救生命的治療。這種經濟障礙會導致檢測和介入的延誤，進而對受影響新生兒的健康狀況產生負面影響。此外，這些檢測的普及程度不均凸顯了在全球範圍內推廣公平診斷服務網路的重要性，並需要更多可及且價格合理的篩檢舉措。促進嬰幼兒健康公平對於改善弱勢族群的健康狀況至關重要。

新生兒篩檢市場趨勢

新生兒篩檢市場的一大趨勢是整合先進的基因檢測技術，例如全基因測序(WGS) 和次世代定序(NGS)。這些創新顯著提高了對多種遺傳疾病的檢測準確性，包括傳統篩檢方法常常遺漏的複雜和罕見疾病。隨著基因檢測成本的降低和技術的普及，綜合篩檢方案正在湧現，從而能夠更早、更準確地識別基因異常。這項發展不僅改善了臨床結果，也促進了新生兒篩檢計畫的擴展，凸顯了新生兒照護向精準醫療的轉變。

北美洲
- 美國
- 加拿大
歐洲
- 英國
- 德國
- 西班牙
- 法國
- 義大利
- 其他歐洲地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
拉丁美洲
- 巴西
- 其他拉丁美洲地區
中東和非洲
- 海灣合作理事會國家
- 南非
- 其他中東和非洲地區

競爭格局

前五大公司對比
主要企業市場定位（2025 年）
主要企業採取的策略
近期市場趨勢
主要企業市佔率（2025 年）
主要企業簡介
- 公司簡介
- 產品系列分析
- 依業務板塊進行公司股票分析
- 2021-2023年營收年比比較

主要企業簡介

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

結論與建議

簡介目錄

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