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市場調查報告書
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2026810

新生兒篩檢市場預測至2034年—按產品、檢測方法、技術、最終用戶和地區分類的全球分析

Newborn Screening Market Forecasts to 2034 - Global Analysis By Product, Test (Hearing Screening Test, Dried Blood Spot Test, Critical Congenital Heart Defect Test and Other Tests), Technology, End User and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 | 商品交期: 2-3個工作天內

價格

根據 Stratistics MRC 的數據，預計到 2026 年，全球新生兒篩檢市場規模將達到 14 億美元，並在預測期內以 10.3% 的複合年成長率成長，到 2034 年將達到 32 億美元。

新生兒篩檢是一項至關重要的公共衛生措施，旨在對新生兒進行出生後立即篩檢，以發現嚴重但可治療的疾病。篩檢通常透過血液樣本進行，有助於早期識別遺傳性、代謝性和先天性疾病，從而實現快速干預並改善治療效果。雖然不同地區的篩檢流程有所不同，但通常包括苯酮尿症、先天性甲狀腺機能低下症和鐮狀貧血等疾病的檢測。早期發現有助於及時進行醫療干預，預防或最大程度地減少潛在的發育問題，並確保新生兒有更健康的開始。

根據美國疾病管制與預防中心（CDC）的數據，2015年至2017年間，美國新生兒疾病的發生率為每1萬名新生兒中有34例。據估計，每年約有12900名嬰兒罹患某種疾病。

遺傳性疾病盛行率增加

基因檢測技術的進步使得多種先天性疾病的早期發現成為可能，從而導致新生兒篩檢計畫的需求不斷成長。早期識別有助於迅速介入和治療，改善患兒的長期預後。隨著醫療保健系統將全面篩檢措施列為優先事項，人們越來越意識到早期發現對遺傳性疾病管理的重要性，這也促進了新生兒篩檢市場的擴張。

倫理和法律問題

新生兒篩檢的倫理問題主要圍繞著知情同意、隱私以及對家庭潛在的心理影響等議題。法律限制包括不同司法管轄區法規的差異、資料保護法以及製定明確的基因資訊儲存和使用指南的必要性。父母可能面臨如何為嬰兒做出知情決定的兩難。關於隱私洩露和基因資料濫用的擔憂也與保密性有關。因此，這一因素阻礙了市場擴張。

即時檢測解決方案的開發與推廣

即時檢測解決方案的開發和廣泛應用將提供及時便捷的診斷能力，使醫護人員能夠快速評估各種新生兒疾病。向即時檢測的轉變將改善醫療服務可近性，縮短檢測結果獲取時間，並簡化整體篩檢。這一趨勢不僅能夠滿足日益成長的早期準確診斷需求，還有助於改善新生兒預後，並推動新生兒篩檢的進步。

偏見和歧視

污名化和歧視對新生兒篩檢計畫構成重大威脅，導致父母因害怕被貼上標籤和遭受社會批評而猶豫不決。患病嬰兒的家庭可能面臨社會偏見、孤立以及對其孩子病情的誤解。這會導致情緒困擾，並阻礙他們公開討論篩檢過程。歧視也會限制他們獲得支持服務的機會，進一步加重受影響家庭的負擔。

新冠疫情的感染疾病

新冠疫情對新生兒篩檢市場造成了衝擊，原因包括醫療系統中斷、常規篩檢延誤以及資源轉移到與疫情相關的優先事項。新生兒篩檢服務取得受限可能導致某些疾病早期發現延遲。此外，疫情凸顯了建立具有韌性的醫療基礎設施的重要性，以確保包括新生兒篩檢在內的基本服務即使在全球衛生危機面前也能持續提供。後疫情時代也加速了新生兒篩檢市場的發展，並有助於改善兒童醫療保健的整體效果。

在預測期內，乾血斑（DBS）細分市場預計將是最大的。

由於其微創性，乾血斑 (DBS) 檢測技術發展迅速。只需將少量血液採集到濾紙上，乾燥後即可進行分析，以檢測各種代謝、遺傳和內分泌疾病。這種經濟便捷的篩檢方法能夠早期發現苯酮尿症和甲狀腺機能低下症疾病。 DBS 檢測有助於及時干預，從而改善患兒的治療效果，同時也為全體族群的篩檢計畫提供了一種高效且方便的工具。

在預測期內，臨床檢查室領域預計將呈現最高的複合年成長率。

預計在預測期內，臨床檢查室領域將呈現最高的複合年成長率。新生兒篩檢在臨床檢查室中發揮著至關重要的作用，它能夠及早發現兒童的遺傳性疾病。快速的篩檢結果有助於及時進行醫療干預，防止不可逆轉的損害並改善預後。作為預防醫學的基石，臨床檢查室透過高效、準確的篩檢流程，在促進可治療疾病的早期管理和保護新生兒健康方面發揮著不可或缺的作用。

市佔率最大的地區：

由於亞太地區人口密度高、出生率高，且先天性疾病盛行率迅速上升，預計該地區在預測期內將佔據最大的市場佔有率。倫理、文化和法規結構的差異正在影響該地區篩檢措施的實施。基礎設施和醫療保健規劃的改善，以及獲得新的業務拓展機會等因素，預計將在預測期內對推動產業需求發揮重要作用。

複合年成長率最高的地區：

由於出生缺陷盛行率不斷上升以及相關宣傳活動的廣泛發展，預計北美地區在預測期內將呈現最高的複合年成長率。美國在該篩檢佔據主要市場佔有率。在美國，所有新生兒都要接受產後篩檢，即分析出生後第二天採集在濾紙上的血斑樣本中的診斷標記。此外，該地區新服務和產品的推出預計也將對市場產生重大影響。

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目錄

第1章執行摘要

第2章：引言

  • 概括
  • 相關利益者
  • 調查範圍
  • 調查方法
  • 研究材料

第3章 市場趨勢分析

  • 促進因素
  • 抑制因子
  • 機會
  • 威脅
  • 產品分析
  • 技術分析
  • 最終用戶分析
  • 新興市場
  • 新冠疫情的感染疾病

第4章：波特五力分析

  • 供應商的議價能力
  • 買方的議價能力
  • 替代品的威脅
  • 新進入者的威脅
  • 競爭公司之間的競爭

第5章：全球新生兒篩檢市場：依產品分類

  • 裝置
    • 搖晃器
    • 疾病篩檢設備
    • 培養箱
  • 消耗品
    • 列和篩檢卡
    • 檢測試劑盒和試劑
  • 聽力篩檢設備
    • 配件
    • 裝置
  • 脈搏血氧飽和度分析儀

第6章：全球新生兒篩檢市場：依檢測方式分類

  • 聽力篩檢測試
  • 乾血斑測試
  • 嚴重先天性心臟疾病（CCHD）篩檢
  • 其他測試

第7章 全球新生兒篩檢市場：依技術分類

  • 凝膠電泳
  • 串聯式質譜質譜法
  • 酵素法
  • DNA檢測
  • 螢光法
  • 其他技術

第8章：全球新生兒篩檢市場：依最終用戶分類

  • 醫院
  • 臨床檢查室

第9章：全球新生兒篩檢市場：按地區分類

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳洲
    • 紐西蘭
    • 韓國
    • 其他亞太國家
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 其他南美國家
  • 中東和非洲
    • 沙烏地阿拉伯
    • UAE
    • 卡達
    • 南非
    • 其他中東和非洲國家

第10章 主要發展

  • 合約、夥伴關係、合作關係、合資企業
  • 收購與併購
  • 新產品發布
  • 業務拓展
  • 其他關鍵策略

第11章：公司簡介

  • Agilent Technologies Inc.
  • Ab Sciex LLC
  • GE Healthcare
  • Covidien Plc
  • Bio-Rad Laboratories Inc.
  • Natus Medical Incorporated
  • PerkinElmer India Pvt. Limited
  • Rady Children's Institute for Genomic Medicine
  • Waters Corporation
  • Trivitron Healthcare
  • Masimo Corporation
  • Zivak Technologies
  • MP Biomedicals
  • DRG International
  • Regis Technologies
  • Parseq Lab
  • Zentech
  • Danaher Corporation
  • Hill-Rom Holdings Inc.
  • Thermo Fisher Scientific
Product Code: SMRC24629

According to Stratistics MRC, the Global Newborn Screening Market is accounted for $1.4 billion in 2026 and is expected to reach $3.2 billion by 2034 growing at a CAGR of 10.3% during the forecast period. Newborn screening is a vital public health initiative that involves testing infants for serious, yet treatable, conditions shortly after birth. Typically conducted through a blood sample, it helps identify genetic, metabolic, and congenital disorders early on, allowing for prompt intervention and improved outcomes. The screening process varies by region but often includes tests for conditions like phenylketonuria, congenital hypothyroidism, and sickle cell disease. Early detection enables timely medical intervention, preventing or minimizing potential developmental issues, ensuring a healthier start for newborns.

According to the US CDC, during 2015-2017, the prevalence of newborn disorders was 34 per 10,000 live births in the US. Approximately 12,900 infants are expected to be identified each year with a disorder.

Market Dynamics:

Driver:

Rising prevalence of genetic disorders

Advances in genetic testing technologies have enabled early detection of various congenital conditions, prompting higher demand for newborn screening programs. Timely identification allows for prompt intervention and treatment, improving long-term outcomes for affected infants. This rising awareness of the importance of early detection in managing genetic disorders contributes to the expansion of the newborn screening market as healthcare systems prioritize comprehensive screening initiatives.

Restraint:

Ethical and legal concerns

In the newborn screening, ethical concerns revolve around issues such as consent, privacy, and the potential psychological impact on families. Legal constraints include varying regulations across jurisdictions, data protection laws, and the need for clear guidelines on the storage and use of genetic information. Parents may grapple with the dilemma of making informed decisions for their infants. Privacy breaches and misuse of genetic data raise concerns about confidentiality. Therefore, this element hinders the market expansion.

Opportunity:

Development & adoption of point-of-care testing solutions

The development and widespread adoption of point-of-care testing solutions offer timely and convenient diagnostic capabilities, enabling healthcare professionals to quickly assess newborns for various conditions. The shift towards point-of-care testing enhances accessibility, reduces turnaround times, and improves overall screening efficiency. This trend not only meets the growing demand for early and accurate diagnoses but also contributes to better healthcare outcomes for newborns, fostering advancements in the newborn screening.

Threat:

Stigma and discrimination

Stigma and discrimination pose significant threats to newborn screening programs, deterring parents from participating due to fear of labeling or communal judgment. Families with affected infants may face societal bias, isolation, and misconceptions about their child's condition. This can lead to emotional distress and hinder open discussions about the screening process. Discrimination may also result in limited access to support services, exacerbating the burden on affected families.

Covid-19 Impact

The covid-19 pandemic has affected the newborn screening market by disrupting healthcare systems, delaying routine screenings, and diverting resources to pandemic-related priorities. Access to newborn screening services has been limited, potentially leading to delays in early detection of certain disorders. Additionally, the pandemic has underscored the importance of resilient healthcare infrastructure to ensure the continuity of essential services, including newborn screening, in the face of global health crises. Moreover, the post-pandemic era has spurred advancements in the newborn screening market and contributed to the overall improvement of pediatric healthcare outcomes.

The dried blood spot segment is expected to be the largest during the forecast period

The dried blood spot segment is estimated to have a lucrative growth, due to its minimally invasive methods. Small blood drops are collected on filter paper, dried, and then analyzed for various metabolic, genetic, and endocrine disorders. This cost-effective and convenient screening approach allows for early detection of conditions such as phenylketonuria and hypothyroidism. DBS testing facilitates timely intervention, contributing to improved outcomes for affected newborns while providing an efficient and accessible means for population-wide screening programs.

The clinical laboratories segment is expected to have the highest CAGR during the forecast period

The clinical laboratories segment is anticipated to witness the highest CAGR growth during the forecast period. Newborn screening plays a pivotal role in clinical laboratories by detecting inherited disorders early in a child's life. Timely results enable prompt medical interventions, preventing irreversible damage and improving outcomes. As a cornerstone of preventive medicine, it facilitates the early management of treatable conditions, showcasing the indispensable role of clinical laboratories in safeguarding the health of newborns through efficient and accurate screening processes.

Region with largest share:

Asia Pacific is projected to hold the largest market share during the forecast period owing to the high population density, higher birth rate, and soaring prevalence of congenital diseases. Ethical considerations, cultural sensitivities, and variations in regulatory frameworks influence the implementation of screening initiatives in the region. Factors such as improving infrastructure and healthcare plans and the availability of new opportunities for expansion are expected to play a major role in driving industry demand over the forecast period.

Region with highest CAGR:

North America is projected to have the highest CAGR over the forecast period, owing to the growing prevalence of congenital disorders and awareness programmes. United States has the major share the region's market. In the United States, every newborn is screened post-birth, and this screening is performed by the analysis of diagnostic markers in blood spots collected on filter paper on the second day of an infant's life. Further, the launch of new services and products in the region is expected to have a significant impact on the market.

Key players in the market

Some of the key players profiled in the Newborn Screening Market include Agilent Technologies Inc., Ab Sciex LLC, GE Healthcare, Covidien Plc, Bio-Rad Laboratories Inc., Natus Medical Incorporated, PerkinElmer India Pvt. Limited, Rady Children's Institute for Genomic Medicine, Waters Corporation, Trivitron Healthcare, Masimo Corporation, Zivak Technologies, MP Biomedicals, DRG International, Regis Technologies, Parseq Lab, Zentech, Danaher Corporation, Hill-Rom Holdings Inc. and Thermo Fisher Scientific.

Key Developments:

In April 2023, Thermo Fisher Scientific launched the first of 37 CE-IVD-marked real-time PCR assay kits, mostly for infectious diseases, that it plans to roll out this year, providing users of its QuantStudio Dx series of instruments with a menu of company-branded test kits for the first time.

In August 2022, Trivitron Healthcare launched a Centre of Excellence (CoE) with state-of-the-art research and development and manufacturing facilities at AMTZ Campus, Vishakhapatnam, India, for metabolomics, genomics, newborn screening, and molecular diagnostics.

In June 2022, Rady Children's Institute for Genomic Medicine launched a program to advance and evaluate the scalability of a diagnostic and precision medicine guidance tool called BeginNGS (pronounced 'beginnings') to screen newborns for approximately 400 genetic diseases that have known treatment options using rapid whole genome sequencing.

Products Covered:

  • Instruments
  • Consumables
  • Hearing Screening Instruments
  • Pulse oximeters

Tests Covered:

  • Hearing Screening Test
  • Dried Blood Spot Test
  • Critical Congenital Heart Defect (CCHD) Test
  • Other Tests

Technologies Covered:

  • Gel Electrophoresis
  • Tandem Mass Spectrometry
  • Enzyme Based Assays
  • DNA Assays
  • Fluorescence
  • Other Technologies

End Users Covered:

  • Hospitals
  • Clinical Laboratories

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2023, 2024, 2025, 2026, 2027, 2028, 2030, 2032 and 2034
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Product Analysis
  • 3.7 Technology Analysis
  • 3.8 End User Analysis
  • 3.9 Emerging Markets
  • 3.10 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Newborn Screening Market, By Product

  • 5.1 Introduction
  • 5.2 Instruments
    • 5.2.1 Shakers
    • 5.2.2 Disorder Screening Instruments
    • 5.2.3 Incubator
  • 5.3 Consumables
    • 5.3.1 Columns & Screening Cards
    • 5.3.2 Assay kits & Reagents
  • 5.4 Hearing Screening Instruments
    • 5.4.1 Accessories
    • 5.4.2 Devices
  • 5.5 Pulse Oximeters

6 Global Newborn Screening Market, By Test

  • 6.1 Introduction
  • 6.2 Hearing Screening Test
  • 6.3 Dried Blood Spot Test
  • 6.4 Critical Congenital Heart Defect (CCHD) Test
  • 6.5 Other Tests

7 Global Newborn Screening Market, By Technology

  • 7.1 Introduction
  • 7.2 Gel Electrophoresis
  • 7.3 Tandem Mass Spectrometry
  • 7.4 Enzyme Based Assays
  • 7.5 DNA Assays
  • 7.6 Fluorescence
  • 7.7 Other Technologies

8 Global Newborn Screening Market, By End User

  • 8.1 Introduction
  • 8.2 Hospitals
  • 8.3 Clinical Laboratories

9 Global Newborn Screening Market, By Geography

  • 9.1 Introduction
  • 9.2 North America
    • 9.2.1 US
    • 9.2.2 Canada
    • 9.2.3 Mexico
  • 9.3 Europe
    • 9.3.1 Germany
    • 9.3.2 UK
    • 9.3.3 Italy
    • 9.3.4 France
    • 9.3.5 Spain
    • 9.3.6 Rest of Europe
  • 9.4 Asia Pacific
    • 9.4.1 Japan
    • 9.4.2 China
    • 9.4.3 India
    • 9.4.4 Australia
    • 9.4.5 New Zealand
    • 9.4.6 South Korea
    • 9.4.7 Rest of Asia Pacific
  • 9.5 South America
    • 9.5.1 Argentina
    • 9.5.2 Brazil
    • 9.5.3 Chile
    • 9.5.4 Rest of South America
  • 9.6 Middle East & Africa
    • 9.6.1 Saudi Arabia
    • 9.6.2 UAE
    • 9.6.3 Qatar
    • 9.6.4 South Africa
    • 9.6.5 Rest of Middle East & Africa

10 Key Developments

  • 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 10.2 Acquisitions & Mergers
  • 10.3 New Product Launch
  • 10.4 Expansions
  • 10.5 Other Key Strategies

11 Company Profiling

  • 11.1 Agilent Technologies Inc.
  • 11.2 Ab Sciex LLC
  • 11.3 GE Healthcare
  • 11.4 Covidien Plc
  • 11.5 Bio-Rad Laboratories Inc.
  • 11.6 Natus Medical Incorporated
  • 11.7 PerkinElmer India Pvt. Limited
  • 11.8 Rady Children's Institute for Genomic Medicine
  • 11.9 Waters Corporation
  • 11.10 Trivitron Healthcare
  • 11.11 Masimo Corporation
  • 11.12 Zivak Technologies
  • 11.13 MP Biomedicals
  • 11.14 DRG International
  • 11.15 Regis Technologies
  • 11.16 Parseq Lab
  • 11.17 Zentech
  • 11.18 Danaher Corporation
  • 11.19 Hill-Rom Holdings Inc.
  • 11.20 Thermo Fisher Scientific

List of Tables

  • Table 1 Global Newborn Screening Market Outlook, By Region (2023-2034) ($MN)
  • Table 2 Global Newborn Screening Market Outlook, By Product (2023-2034) ($MN)
  • Table 3 Global Newborn Screening Market Outlook, By Instruments (2023-2034) ($MN)
  • Table 4 Global Newborn Screening Market Outlook, By Shakers (2023-2034) ($MN)
  • Table 5 Global Newborn Screening Market Outlook, By Disorder Screening Instruments (2023-2034) ($MN)
  • Table 6 Global Newborn Screening Market Outlook, By Incubator (2023-2034) ($MN)
  • Table 7 Global Newborn Screening Market Outlook, By Consumables (2023-2034) ($MN)
  • Table 8 Global Newborn Screening Market Outlook, By Columns & Screening Cards (2023-2034) ($MN)
  • Table 9 Global Newborn Screening Market Outlook, By Assay kits & Reagents (2023-2034) ($MN)
  • Table 10 Global Newborn Screening Market Outlook, By Hearing Screening Instruments (2023-2034) ($MN)
  • Table 11 Global Newborn Screening Market Outlook, By Accessories (2023-2034) ($MN)
  • Table 12 Global Newborn Screening Market Outlook, By Devices (2023-2034) ($MN)
  • Table 13 Global Newborn Screening Market Outlook, By Pulse Oximeters (2023-2034) ($MN)
  • Table 14 Global Newborn Screening Market Outlook, By Test (2023-2034) ($MN)
  • Table 15 Global Newborn Screening Market Outlook, By Hearing Screening Test (2023-2034) ($MN)
  • Table 16 Global Newborn Screening Market Outlook, By Dried Blood Spot Test (2023-2034) ($MN)
  • Table 17 Global Newborn Screening Market Outlook, By Critical Congenital Heart Defect (CCHD) Test (2023-2034) ($MN)
  • Table 18 Global Newborn Screening Market Outlook, By Other Tests (2023-2034) ($MN)
  • Table 19 Global Newborn Screening Market Outlook, By Technology (2023-2034) ($MN)
  • Table 20 Global Newborn Screening Market Outlook, By Gel Electrophoresis (2023-2034) ($MN)
  • Table 21 Global Newborn Screening Market Outlook, By Tandem Mass Spectrometry (2023-2034) ($MN)
  • Table 22 Global Newborn Screening Market Outlook, By Enzyme Based Assays (2023-2034) ($MN)
  • Table 23 Global Newborn Screening Market Outlook, By DNA Assays (2023-2034) ($MN)
  • Table 24 Global Newborn Screening Market Outlook, By Fluorescence (2023-2034) ($MN)
  • Table 25 Global Newborn Screening Market Outlook, By Other Technologies (2023-2034) ($MN)
  • Table 26 Global Newborn Screening Market Outlook, By End User (2023-2034) ($MN)
  • Table 27 Global Newborn Screening Market Outlook, By Hospitals (2023-2034) ($MN)
  • Table 28 Global Newborn Screening Market Outlook, By Clinical Laboratories (2023-2034) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.