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市场调查报告书
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1403404

到 2030 年新生儿筛检市场预测：按产品、测试、技术、最终用户和地区分類的全球分析

Newborn Screening Market Forecasts to 2030 - 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 200+ Pages | 商品交期: 2-3个工作天内

价格

根据 Stratistics MRC 的数据，2023 年全球新生儿筛检市场规模为 11.5 亿美元，预计到 2030 年将达到 22.9 亿美元，预测期内复合年增长率为 10.3%。

新生儿筛检是一项重要的公共卫生工作，旨在对婴幼儿出生后立即筛检严重但可治疗的疾病。这项测试通常透过血液样本进行，有助于及早识别遗传、代谢和先天性疾病，从而实现快速干预和改善结果。筛检过程因地区而异，但通常包括苯酮尿症、甲状腺机能低下症和镰状细胞疾病的检查。早期发现可以及时进行医疗干预，以预防或尽量减少潜在的发育问题，并确保新生儿健康的开始。

根据美国疾病预防控制中心的数据，2015年至2017年美国新生儿疾病盛行率为每10,000名活产儿中有34例。预计每年约有 12,900 名新生儿被诊断​​出患有这种疾病。

促生长因素：遗传病患病率上升

基因检测技术的进步使得多种先天性疾病的早期检测成为可能，增加了对新生儿筛检计画的需求。及时识别可以及时介入和治疗，改善受影响儿童的长期结果。随着医疗保健系统优先考虑全面筛检倡议，人们越来越认识到早期检测在遗传疾病管理中的重要性，这有助于扩大新生儿筛检市场。

成长抑制因素：道德与法律问题

在新生儿筛检中，伦理问题围绕着同意、隐私以及对家庭的潜在心理影响等问题。法律限制包括因司法管辖区而异的法规、资料保护法以及需要製定有关遗传资讯储存和使用的明确指南。父母可能面临为婴儿做出资讯决定的困境。侵犯隐私和滥用基因资料引发了对保密的担忧。因此，这个因素阻碍了市场的扩张。

机会：开发和采用即时检测解决方案

即时检测解决方案的开发和普及提供了及时、便捷的诊断能力，使医疗保健专业人员能够快速评估新生儿的各种状况。转向即时检测将提高可及性、减少週转时间并提高整体筛检效率。这一趋势不仅满足了对早期准确诊断日益增长的需求，而且有助于改善新生儿医疗保健结果并加速新生儿筛检的进步。

威胁：耻辱和歧视

耻辱和歧视是新生儿筛检计画的重大威胁，父母因担心被贴上标籤和受到社会评判而不敢参与。有受影响婴幼儿的家庭可能面临社会耻辱、孤立和对孩子病情的误解。这可能会导致情绪困扰并阻止人们公开讨论筛检过程。歧视也可能导致获得支持服务的机会有限，从而加重受影响家庭的负担。

COVID-19 的影响

COVID-19 大流行扰乱了医疗保健系统，推迟了常规筛检，并将资源转移到与大流行相关的优先事项上，从而影响了新生儿筛检市场。获得新生儿筛检服务的机会有限，可能导致某些疾病的早期发现延迟。此外，这场大流行凸显了弹性医疗基础设施的重要性，以确保面对全球健康危机时包括新生儿筛检在内的基本服务的连续性。此外，后大流行时代刺激了新生儿筛检市场的进步，有助于儿童医疗保健结果的整体改善。

预计在预测期内，干血斑细分市场规模最大

干血斑片段被认为具有良好的生长，因为它是一种侵入性较小的方法。将少量血液收集在滤纸上、干燥并分析各种代谢、遗传和内分泌疾病。这种经济有效且简单的筛检方法能够及早发现苯酮尿症和甲状腺机能低下症症等疾病。 DBS 检测有助于及时干预，有助于改善受影响新生儿的结局，同时为全民筛检计画提供有效且易于使用的手段。

预计临床测试领域在预测期内复合年增长率最高

预计临床测试领域在预测期内复合年增长率最高。新生儿筛检透过早期检测儿童遗传性疾病，在临床实验室中发挥至关重要的作用。及时的结果有助于及时进行医疗干预，防止不可逆转的损害并改善结果。作为预防医学的基石，它展示了临床实验室在透过高效、准确的筛检过程促进可治疗疾病的早期管理和保护新生儿健康方面的重要作用。

比最大的地区

由于人口密度高、出生率高以及先天性疾病发生率迅速增加，预计亚太地区在预测期内将占据最大的市场占有率。伦理考量、文化敏感度和法律规范的差异影响该地区筛检倡议的实施。基础设施和医疗保健规划的改善、新的扩张机会的可用性等因素预计将在预测期内推动产业需求发挥重要作用。

复合年增长率最高的地区

由于先天性疾病和意识计划的日益流行，预计北美在预测期内将呈现最高的复合年增长率。美国在该地区占有很大的市场份额。在美国，所有新生儿在出生后都要筛检，这种筛检是透过分析出生第二天滤纸上收集的血斑上的诊断标记来进行的。此外，该地区新服务和产品的推出预计将对市场产生重大影响。

提供免费客製化

订阅此报告的客户可以利用以下免费自订选项之一：

  • 公司简介
    • 其他市场公司的综合分析（最多 3 家公司）
    • 主要企业SWOT分析（最多3家企业）
  • 区域分割
    • 根据客户兴趣对主要国家的市场估计、预测和复合年增长率（註：基于可行性检查）
  • 竞争基准化分析
    • 根据产品系列、地理分布和策略联盟对主要企业基准化分析

目录

第一章执行摘要

第二章 前言

  • 概述
  • 相关利益者
  • 调查范围
  • 调查方法
    • 资料探勘
    • 资料分析
    • 资料检验
    • 研究途径
  • 调查来源
    • 主要调查来源
    • 二次调查来源
    • 先决条件

第三章市场趋势分析

  • 促进因素
  • 抑制因素
  • 机会
  • 威胁
  • 产品分析
  • 技术分析
  • 最终用户分析
  • 新兴市场
  • 新型冠状病毒感染疾病（COVID-19）的影响

第4章波特五力分析

  • 供应商的议价能力
  • 买方议价能力
  • 替代品的威胁
  • 新进入者的威胁
  • 公司之间的竞争关係

第五章全球新生儿筛检市场：按产品

  • 用具
    • 摇床
    • 疾病筛检设备
    • 孵化器
  • 消耗品
    • 色谱管柱和筛检卡
    • 检测套件和试剂
  • 听力筛检设备
    • 配件
    • 装置
  • 脉搏血氧仪

第六章 全球新生儿筛检市场：通过测试

  • 听力筛检测试
  • 干血斑试验
  • 严重先天性心臟疾病(CCHD) 检测
  • 其他测试

第七章全球新生儿筛检市场：依技术分类

  • 凝胶电泳
  • 串联式质谱法
  • 基于酵素的测定
  • DNA检测
  • 萤光
  • 其他技术

第八章全球新生儿筛检市场：依最终用户分类

  • 医院
  • 临床实验室

第九章全球新生儿筛检市场：按地区

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙
    • 其他欧洲国家
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳洲
    • 纽西兰
    • 韩国
    • 其他亚太地区
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地区
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 卡达
    • 南非
    • 其他中东和非洲

第10章 主要进展

  • 合约、伙伴关係、协作和合资企业
  • 收购和合併
  • 新产品发布
  • 业务扩展
  • 其他关键策略

第十一章 公司简介

  • 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 $1.15 billion in 2023 and is expected to reach $2.29 billion by 2030 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 2021, 2022, 2023, 2026, and 2030
  • 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 (2021-2030) ($MN)
  • Table 2 Global Newborn Screening Market Outlook, By Product (2021-2030) ($MN)
  • Table 3 Global Newborn Screening Market Outlook, By Instruments (2021-2030) ($MN)
  • Table 4 Global Newborn Screening Market Outlook, By Shakers (2021-2030) ($MN)
  • Table 5 Global Newborn Screening Market Outlook, By Disorder Screening Instruments (2021-2030) ($MN)
  • Table 6 Global Newborn Screening Market Outlook, By Incubator (2021-2030) ($MN)
  • Table 7 Global Newborn Screening Market Outlook, By Consumables (2021-2030) ($MN)
  • Table 8 Global Newborn Screening Market Outlook, By Columns & Screening Cards (2021-2030) ($MN)
  • Table 9 Global Newborn Screening Market Outlook, By Assay kits & Reagents (2021-2030) ($MN)
  • Table 10 Global Newborn Screening Market Outlook, By Hearing Screening Instruments (2021-2030) ($MN)
  • Table 11 Global Newborn Screening Market Outlook, By Accessories (2021-2030) ($MN)
  • Table 12 Global Newborn Screening Market Outlook, By Devices (2021-2030) ($MN)
  • Table 13 Global Newborn Screening Market Outlook, By Pulse Oximeters (2021-2030) ($MN)
  • Table 14 Global Newborn Screening Market Outlook, By Test (2021-2030) ($MN)
  • Table 15 Global Newborn Screening Market Outlook, By Hearing Screening Test (2021-2030) ($MN)
  • Table 16 Global Newborn Screening Market Outlook, By Dried Blood Spot Test (2021-2030) ($MN)
  • Table 17 Global Newborn Screening Market Outlook, By Critical Congenital Heart Defect (CCHD) Test (2021-2030) ($MN)
  • Table 18 Global Newborn Screening Market Outlook, By Other Tests (2021-2030) ($MN)
  • Table 19 Global Newborn Screening Market Outlook, By Technology (2021-2030) ($MN)
  • Table 20 Global Newborn Screening Market Outlook, By Gel Electrophoresis (2021-2030) ($MN)
  • Table 21 Global Newborn Screening Market Outlook, By Tandem Mass Spectrometry (2021-2030) ($MN)
  • Table 22 Global Newborn Screening Market Outlook, By Enzyme Based Assays (2021-2030) ($MN)
  • Table 23 Global Newborn Screening Market Outlook, By DNA Assays (2021-2030) ($MN)
  • Table 24 Global Newborn Screening Market Outlook, By Fluorescence (2021-2030) ($MN)
  • Table 25 Global Newborn Screening Market Outlook, By Other Technologies (2021-2030) ($MN)
  • Table 26 Global Newborn Screening Market Outlook, By End User (2021-2030) ($MN)
  • Table 27 Global Newborn Screening Market Outlook, By Hospitals (2021-2030) ($MN)
  • Table 28 Global Newborn Screening Market Outlook, By Clinical Laboratories (2021-2030) ($MN)

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