新生儿筛检市场 - 2018-2028 年全球产业规模、份额、趋势、机会和预测，按技术、测试类型、最终用户和地区、竞争细分

2022 年，全球新生儿筛检市场价值为8.0107 亿美元，预计到2028 年，预测期内将出现令人印象深刻的成长，复合年增长率为7.37%。新生儿筛检是一项公共卫生计划，涉及对新生儿进行系统检测，以了解新生儿是否存在健康问题。出生后不久就会出现一系列遗传、代谢和先天性疾病。新生儿筛检的主要目标是在生命早期（通常在症状出现之前）识别出面临某些严重或危及生命疾病风险的婴儿，以便能够及时启动适当的医疗干预和治疗。新生儿筛检通常是政府卫生机构管理的公共卫生计划的一部分。它作为出生后不久的常规医疗保健的一部分提供给所有新生儿。新生儿筛检组中包含的特定疾病和筛检时间可能因地区和国家而异。当地医疗保健政策和资源影响新生儿筛检计划的范围。新生儿遗传和代谢疾病盛行率的增加是重要的驱动因素。透过新生儿筛检进行早期发现可以及时干预并更好地管理这些情况。

主要市场驱动因素

市场概况
预测期	2024-2028
2022 年市场规模	80107万美元
2028 年市场规模	12364.6亿美元
2023-2028 年复合年增长率	7.37%
成长最快的细分市场	医院
最大的市场	北美洲

技术进步

新一代定序 (NGS) 透过同时分析与各种遗传和代谢疾病相关的多个基因，彻底改变了新生儿筛检。它可以进行更全面的筛检，包括检测以前难以识别的罕见和新颖的基因突变。 NGS 也能够诊断具有复杂遗传基础的疾病，例如脊髓性肌肉萎缩症 (SMA) 和某些形式的智力障碍。串联质谱 (MS/MS) 技术已成为分析新生儿代谢紊乱的标准工具。它可以同时测量单一血液样本中的多种代谢物，使其高效且经济高效。 MS/MS 扩大了可筛检的疾病范围，包括胺基酸疾病和脂肪酸氧化疾病。多重测定可以同时测量单一样品中的多种生物标记或分析物。这些测定用于检测各种代谢和遗传疾病，包括溶小体贮积症和原发性免疫缺陷。 DBS（干血斑（DBS））技术的进步提高了滤纸上采集的血液样本的稳定性和灵敏度。

DBS 可以轻鬆采集、运输和储存血液样本，使其成为新生儿筛检的实用选择。生物资讯工具和软体在解释 NGS 和其他先进筛选方法产生的复杂资料方面发挥着至关重要的作用。这些工具有助于识别新生儿基因组中致病的突变和变异。 POCT（即时护理测试）设备专为特定的新生儿筛检测试而开发，可在床边快速得出结果。例如，POCT 脉搏血氧测定法用于在出生后不久筛检严重先天性心臟病 (CCHD)。实验室设备的小型化和自动化提高了筛选测试的效率和通量。自动化系统可以处理更多的样品，同时保持准确性并减少人为错误。生物标记发现的进展导致了与各种疾病相关的新标记的鑑定。这些生物标记用于开发新的筛检方法并扩大新生儿筛检的范围。远距医疗和数位健康平台可以与医疗保健提供者和专家有效共享筛检结果。数据与电子健康记录 (EHR) 的整合促进了受影响婴儿的资讯无缝流动和后续护理。品质控制措施和标准提高了新生儿筛检测试的可靠性，确保结果准确。这项因素将有助于全球新生儿筛检市场的发展。

消费者对综合筛检的需求不断增加

如今，准父母和家庭可以获得大量有关医疗保健和医学检测的资讯。资讯获取的增加提高了人们对新生儿综合筛检益处的认识。父母通常希望确保新生儿有最好的开始，并重视及早发现潜在的健康问题。全面筛检可以更全面地评估新生儿的健康状况，让父母更安心。许多私人医疗保健提供者和诊断中心提供全面的新生儿筛检套餐。与标准公共卫生筛检计划相比，这些套餐通常包括更广泛的测试。有些家长喜欢在同一时间在一处进行所有必要的筛检测试的便利性。全面的筛检套餐可以提供这种便利。有些家庭可能有遗传或代谢疾病史，这增加了他们对全面筛检以评估新生儿风险的兴趣。全面的筛检可以让父母更放心，因为他们知道他们的新生儿已经针对各种情况进行了彻底的评估。

在日益全球化的世界中，家庭可能来自不同的背景和地区，采用不同的筛检方案。全面筛检有助于解决筛检实践中的潜在差距或差异。社群媒体平台和线上育儿社群在传播新生儿筛检讯息和影响父母选择方面发挥作用。其他家长分享的正面经验可以鼓励全面筛检。技术和医学研究的进步使全面的新生儿筛检变得更加可行和方便，从而满足了消费者的需求。一些家长可能会寻求客製化筛检小组，以符合他们的特定问题或遗传史，从而推动对个人化筛检选项的需求。这项因素将加快全球新生儿筛检市场的需求。

遗传和代谢疾病的发生率上升

新生儿筛检通常可以在症状出现之前及早发现遗传和代谢疾病。早期介入和治疗可以预防或减轻这些病症的严重程度，从而改善受影响婴儿的长期健康结果。许多遗传和代谢疾病如果未被发现和治疗，可能会导致严重的健康併发症、发育迟缓，甚至死亡。新生儿筛检透过早期医疗管理有助于降低与这些疾病相关的死亡率和发病率。透过新生儿筛检及时诊断和介入可以显着改善受影响婴儿及其家人的生活品质。早期治疗可以防止不可逆转的损害并支持更好的长期结果。透过新生儿筛检识别受影响的婴儿也具有更广泛的公共卫生影响。它有助于透过促进知情的计划生育决策来防止某些遗传性疾病在家庭和人群中的传播。

遗传和代谢疾病的发生率因人群和地区而异，但由于人口结构变化、血缘关係增加和其他遗传风险因素等因素，某些疾病变得更加普遍。筛检技术的进步扩大了可以有效率、准确地筛选的条件范围。这使得在新生儿筛检小组中纳入更多疾病成为可能。随着医疗保健专业人员和家长对新生儿筛检益处的认识不断提高，对这些服务的需求也不断增加。教育和宣传工作强调了早期发现的重要性。在许多国家和地区，新生儿筛检是法律强制规定的，或是标准医疗保健实践的一部分。这些规定有助于提高筛检率和需求。国际卫生组织和倡议推动了新生儿筛检计画的扩大，特别是在遗传和代谢疾病负担可能较高的低收入和中等收入国家。精准医学和基因组学的兴起凸显了早期基因检测和诊断的重要性，进一步强调了新生儿筛检的需求。这项因素将加速全球新生儿筛检市场的需求。

主要市场挑战

教育和意识

许多父母和照顾者可能没有完全意识到新生儿筛检的重要性，或者可能对筛检的目的和好处有误解。缺乏认识可能会导致错失早期发现和介入的机会。包括产科医生、儿科医生和助产士在内的医疗保健专业人员在向父母通报新生儿筛检方面发挥着至关重要的作用。然而，并非所有医疗保健提供者都能掌握最新资讯或在产前和产后护理就诊期间优先讨论新生儿筛检。在多元文化和多语言社会中，语言和文化障碍可能会阻碍新生儿筛检的有效沟通。确保不同人群能够获取和理解资讯是一项挑战。不同的国家和地区有不同的与新生儿筛检相关的医疗保健系统、政策和实践。这可能导致意识和获得筛检服务的差异。在一些低收入和中等收入国家，资源限制可能会限制新生儿筛检教育和宣传活动的能力。这可能会导致讯息传播不充分。在新生儿中筛检的一些遗传和代谢疾病可能人们知之甚少或带有耻辱感。这可能导致家长不愿意参与筛检或后续测试。

罕见疾病和变异性

罕见疾病涵盖范围广泛，每种疾病都有其独特的遗传和临床特征。这种异质性使得开发能够有效检测所有罕见疾病的标准化筛检测试变得具有挑战性。对于许多罕见疾病，可用的流行病学资料和临床研究有限。资讯的缺乏可能会阻碍有效筛检方案的发展。根据定义，罕见疾病在一般人群中的盛行率较低。这意味着筛检计画必须对许多新生儿进行测试，以识别少数受影响的个体，这可能会占用大量资源。罕见疾病的起病和临床表现通常各不相同。一些受影响的婴儿可能直到晚年才会表现出症状，这使得透过新生儿筛检进行早期发现更具挑战性。对于一些罕见疾病，有效的治疗方法可能有限或没有。如果没有可行的治疗方案，早期发现可能无法总是带来更好的结果。导致罕见疾病的基因突变在个体之间可能存在很大差异。开发能够检测所有可能的遗传变异的筛检测试是一项复杂的任务。平衡罕见疾病筛检试验的敏感度和特异性是很困难的。高敏感性可能会导致更多的假阳性，而高特异性可能会导致伪阴性。

主要市场趋势

私人测试的兴起

一些父母愿意支付更广泛的新生儿筛检费用，其中包括比公共卫生计划通常提供的更广泛的遗传和代谢疾病。个人化医疗的趋势影响了新生儿筛检。父母可以根据他们的家族病史或遗传倾向寻求客製化的筛检选项。私人医疗保健提供者和诊断中心经常投资最新的筛检技术和方法，这些技术和方法可以提供更全面、更准确的结果。私人检测设施可以提供更快的筛检结果週转时间，让家长安心，并在需要时进行早期介入。有些家庭重视私人检测中心提供的隐私和保密性，尤其是在遗传资讯方面。私人测试使家长对筛检过程有更多的控制权和自主权，包括测试的选择和测试的时间。私人检测中心可以提供额外的服务，例如遗传咨询、计划生育建议以及为有特定病症的婴儿的家庭提供持续支持。出国旅行或搬迁的家庭可能会选择私人检测，以确保护理的连续性和一致的筛检做法，特别是如果他们来自筛检方案不同的地区。

细分市场洞察

技术洞察

2022 年，全球新生儿筛检市场将由脉搏血氧仪细分市场主导，预计未来几年将继续扩大。脉搏血氧测定法是一种非侵入性且相对简单的测试，可测量新生儿血液中的氧饱和度。这种筛检有助于及早发现患有严重先天性心臟病 (CCHD) 的新生儿，以便及时介入和治疗。脉搏血氧测定是一种无痛、非侵入性的过程，可以快速、轻鬆地进行。它不需要抽血或其他侵入性方法，因此婴儿及其父母具有良好的耐受性。许多国家和地区已将脉搏血氧饱和度筛检作为新生儿筛检指南的一部分，促进了其在 CCHD 检测中的广泛应用。许多医疗保健组织和专业协会建议在新生儿筛检方案中使用脉搏血氧仪，这可能会导致其广泛采用。

测试类型见解

2022 年，全球新生儿筛检市场将由干血斑 (DBS) 细分市场主导，预计未来几年将继续扩大。 DBS 是一种非侵入性且便捷的新生儿血液采样方法。它包括简单的足跟采血以获得几滴血液，然后将其吸收到滤纸上。与传统的静脉抽血相比，这种微创方法对婴儿的耐受性良好，对婴儿和父母的创伤较小。 DBS样品稳定，可以长期保存，可以轻鬆地将样品运送到集中实验室进行检测。这使其成为一个实用的选择，特别是在先进医疗设施有限的地区。与静脉抽血等其他样本采集方法相比，它们具有成本效益。使用滤纸作为收集介质价格低廉，并且样品收集的简单性降低了劳动力和设备成本。

最终使用者见解

2022年，全球新生儿筛检市场最大份额由诊断中心领域主导，预计未来几年将持续扩大。诊断中心通常拥有训练有素的专业人员，他们装备精良，可以执行各种筛检测试。他们拥有准确处理和分析新生儿筛检样本所需的专业知识。诊断中心通常投资最先进的新生儿筛检设备和技术。这包括用于生化、遗传和代谢检测的先进仪器，可以提高筛检的准确性和效率。一些诊断中心提供私人和公共服务。这意味着虽然公共医疗系统可能会将新生儿转介到这些中心，但喜欢私人检测的父母也可以付费使用这些服务。

区域洞察

到2022 年，北美地区将在全球新生儿筛检市场中占据主导地位。由于政府立法、强大的医疗基础设施、该地区出生异常的高盛行率以及该地区营运商在新生儿筛检技术方面的新技术进步，地区。预计美国将在北美地区拥有最大的市场份额。这是由于对复杂系统的需求不断扩大以及新生儿疾病发生率的上升。对婴儿出生第二天滤纸上收集的血点中的诊断标记进行研究是美国每个新生儿出生后进行检查的方式。

目录

第 1 章：产品概述

• 市场定义
• 市场范围
  • 涵盖的市场
  • 考虑学习的年份
  • 主要市场区隔

第 2 章：研究方法

• 研究目的
• 基线方法
• 主要产业伙伴
• 主要协会和二手资料来源
• 预测方法
• 数据三角测量与验证
• 假设和限制

第 3 章：执行摘要

• 市场概况
• 主要市场细分概述
• 主要市场参与者概述
• 重点地区/国家概况
• 市场驱动因素、挑战、趋势概述

第 4 章：COVID-19 对全球新生儿筛检市场的影响

第 5 章：客户之声

第 6 章：全球新生儿筛检市场展望

• 市场规模及预测
  • 按价值
• 市占率及预测
  • 依技术（串联质谱、脉搏血氧测定、酵素测定、DNA 测定和其他技术）
  • 依测试类型（干血斑、听力筛检、严重先天性心臟病 (CCHD) 和其他测试类型）
  • 按最终使用者（医院、诊断中心和其他最终使用者），
  • 按地区
  • 按公司划分 (2022)
• 市场地图

第 7 章：亚太地区新生儿筛检市场展望

• 市场规模及预测
  • 按价值
• 市占率及预测
  • 依技术
  • 按测试类型
  • 按最终用户
  • 按国家/地区
• 亚太地区：国家分析
  • 中国新生儿筛检
  • 印度新生儿筛检
  • 澳洲新生儿筛检
  • 日本新生儿筛检
  • 韩国新生儿筛检

第 8 章：欧洲新生儿筛检市场展望

• 市场规模及预测
  • 按价值
• 市占率及预测
  • 依技术
  • 按测试类型
  • 按最终用户
  • 按国家/地区
• 欧洲：国家分析
  • 法国
  • 德国
  • 西班牙
  • 义大利
  • 英国

第 9 章：北美新生儿筛检市场展望

• 市场规模及预测
  • 按价值
• 市占率及预测
  • 依技术
  • 按测试类型
  • 按最终用户
  • 按国家/地区
• 北美：国家分析
  • 美国
  • 墨西哥
  • 加拿大

第 10 章：南美洲新生儿筛检市场展望

• 市场规模及预测
  • 按价值
• 市占率及预测
  • 依技术
  • 按测试类型
  • 按最终用户
  • 按国家/地区
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第 11 章：中东和非洲新生儿筛检市场展望

• 市场规模及预测
  • 按价值
• 市占率及预测
  • 依技术
  • 按测试类型
  • 按最终用户
  • 按国家/地区
• MEA：国家分析
  • 南非新生儿筛检
  • 沙乌地阿拉伯新生儿筛检
  • 阿联酋新生儿筛检

第 12 章：市场动态

• 司机
• 挑战

第 13 章：市场趋势与发展

• 最近的发展
• 产品发布
• 併购

第 14 章：全球新生儿筛检市场：SWOT 分析

第 15 章：波特的五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 客户的力量
• 替代产品的威胁

第 16 章：大环境分析

第17章：竞争格局

• 商业概览
• 公司概况
• 产品与服务
• 财务（上市公司）
• 最近的发展
• SWOT分析
  • Bio-Rad Laboratories Inc.
  • GE Healthcare
  • Masimo Corporation
  • Medtronic Inc.
  • Natus Medical Incorporated
  • PerkinElmer Inc.
  • Trivitron Healthcare
  • ZenTech SA
  • Demant A/S
  • Thermo Fisher Scientific
  • Hill-Rom Holdings Inc.

第 18 章：策略建议

第 19 章：关于我们与免责声明

Global Newborn Screening Market has valued at USD 801.07 Million in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 7.37% through 2028. Newborn screening is a public health program that involves the systematic testing of newborn infants for a range of genetic, metabolic, and congenital disorders shortly after birth. The primary goal of newborn screening is to identify infants at risk of certain serious or life-threatening conditions early in life, often before symptoms appear, so that appropriate medical intervention and treatment can be initiated promptly. Newborn screening is typically part of a public health program administered by government health agencies. It is offered to all newborns as part of routine healthcare shortly after birth. The specific disorders included in newborn screening panels and the timing of screening can vary by region and country. Local healthcare policies and resources influence the scope of newborn screening programs. The increasing prevalence of genetic and metabolic disorders among newborns is a significant driver. Early detection through newborn screening allows for prompt intervention and better management of these conditions.

Technological advancements, including next-generation sequencing (NGS), mass spectrometry, and improved biochemical assays, have enhanced the accuracy and scope of newborn screening. These innovations attract healthcare providers and laboratories to adopt advanced screening methods. Growing awareness among parents about the availability of comprehensive newborn screening tests has increased consumer demand. Many parents are willing to pay for private screening services that offer more extensive panels. The expansion of newborn screening panels to include a broader range of disorders has increased the market size. This trend is supported by advancements in genetic testing and the inclusion of rare diseases. The emphasis on quality assurance and accreditation for laboratories conducting newborn screening has boosted confidence in the accuracy and reliability of screening results, attracting more healthcare providers and parents.

Key Market Drivers

Market Overview
Forecast Period	2024-2028
Market Size 2022	USD 801.07 Million
Market Size 2028	USD 1236.46 Billion
CAGR 2023-2028	7.37%
Fastest Growing Segment	Hospitals
Largest Market	North America

Advancements in Technology

Next-Generation Sequencing (NGS) has revolutionized newborn screening by enabling the simultaneous analysis of multiple genes associated with various genetic and metabolic disorders. It allows for more comprehensive screening, including the detection of rare and novel genetic mutations that were previously challenging to identify. NGS also enables the diagnosis of conditions with complex genetic underpinnings, such as spinal muscular atrophy (SMA) and some forms of intellectual disability. Tandem Mass Spectrometry (MS/MS) technology has become a standard tool for the analysis of metabolic disorders in newborns. It allows for the simultaneous measurement of multiple metabolites in a single blood sample, making it efficient and cost-effective. MS/MS has expanded the range of disorders that can be screened for, including amino acid disorders and fatty acid oxidation disorders. Multiplex assays enable the simultaneous measurement of multiple biomarkers or analytes within a single sample. These assays are used for the detection of various metabolic and genetic disorders, including lysosomal storage disorders and primary immunodeficiencies. Advances in DBS (Dried Blood Spot (DBS)) technology have improved the stability and sensitivity of blood samples collected on filter paper.

DBS allows for easy collection, transport, and storage of blood samples, making it a practical choice for newborn screening. Bioinformatics tools and software play a crucial role in interpreting the complex data generated by NGS and other advanced screening methods. These tools help identify disease-causing mutations and variations in the newborn's genome. POCT (Point-of-Care Testing) devices have been developed for specific newborn screening tests, allowing for rapid results at the bedside. For example, POCT pulse oximetry is used to screen for critical congenital heart defects (CCHD) shortly after birth. Miniaturization and automation of laboratory equipment have improved the efficiency and throughput of screening tests. Automated systems can process a higher volume of samples while maintaining accuracy and reducing human error. Advances in biomarker discovery have led to the identification of novel markers associated with various disorders. These biomarkers are used to develop new screening assays and expand the scope of newborn screening. Telemedicine and digital health platforms enable the efficient sharing of screening results with healthcare providers and specialists. Data integration with electronic health records (EHRs) facilitates the seamless flow of information and follow-up care for affected infants. Quality control measures and standards have improved the reliability of newborn screening tests, ensuring accurate results. This factor will help in the development of Global Newborn Screening Market.

Increasing Consumer Demand for Comprehensive Screening

Expectant parents and families today have access to a wealth of information about healthcare and medical testing. This increased access to information has raised awareness about the benefits of comprehensive newborn screening. Parents often want to ensure the best possible start for their newborns and value the early detection of potential health issues. Comprehensive screening offers a more thorough assessment of a newborn's health, providing greater peace of mind to parents. Many private healthcare providers and diagnostic centers offer comprehensive newborn screening packages. These packages often include a broader range of tests compared to standard public health screening programs. Some parents prefer the convenience of having all necessary screening tests conducted in one place and at one time. Comprehensive screening packages can provide this convenience. Some families may have a history of genetic or metabolic disorders, increasing their interest in comprehensive screening to assess their newborn's risk. Comprehensive screening can provide additional reassurance to parents, knowing that their newborn has been thoroughly assessed for a wide range of conditions.

In an increasingly globalized world, families may come from diverse backgrounds and regions with varying screening protocols. Comprehensive screening can help address potential gaps or differences in screening practices. Social media platforms and online parenting communities play a role in spreading information about newborn screening and influencing parental choices. Positive experiences shared by other parents can encourage comprehensive screening. Advances in technology and medical research have made comprehensive newborn screening more feasible and accessible, contributing to consumer demand. Some parents may seek customization of screening panels to align with their specific concerns or genetic history, driving the demand for personalized screening options. This factor will pace up the demand of Global Newborn Screening Market.

Rising Incidence of Genetic and Metabolic Disorders

Newborn screening allows for the early detection of genetic and metabolic disorders, often before symptoms appear. Early intervention and treatment can prevent or mitigate the severity of these conditions, improving the long-term health outcomes for affected infants. Many genetic and metabolic disorders, if left undetected and untreated, can lead to severe health complications, developmental delays, and even death. Newborn screening helps reduce the mortality and morbidity associated with these conditions by enabling early medical management. Timely diagnosis and intervention through newborn screening can significantly improve the quality of life for affected infants and their families. Early treatment can prevent irreversible damage and support better long-term outcomes. Identifying affected infants through newborn screening also has broader public health implications. It helps prevent the transmission of certain genetic disorders within families and populations by facilitating informed family planning decisions.

The incidence of genetic and metabolic disorders varies by population and region, but some conditions have become more prevalent due to factors such as changing demographics, increased consanguinity, and other genetic risk factors. Advances in screening technology have expanded the range of conditions that can be screened for efficiently and accurately. This has made it possible to include more disorders in newborn screening panels. As awareness about the benefits of newborn screening has grown among healthcare professionals and parents, there has been increased demand for these services. Education and outreach efforts have emphasized the importance of early detection. In many countries and regions, newborn screening is mandated by law or is part of standard healthcare practices. These mandates have contributed to increased screening rates and demand. International health organizations and initiatives have promoted the expansion of newborn screening programs, especially in low- and middle-income countries where the burden of genetic and metabolic disorders may be higher. The rise of precision medicine and genomics has underscored the importance of early genetic testing and diagnosis, further emphasizing the demand for newborn screening. This factor will accelerate the demand of Global Newborn Screening Market.

Key Market Challenges

Education and Awareness

Many parents and caregivers may not be fully aware of the importance of newborn screening or may have misconceptions about the purpose and benefits of screening. Lack of awareness can result in missed opportunities for early detection and intervention. Healthcare professionals, including obstetricians, pediatricians, and midwives, play a crucial role in informing parents about newborn screening. However, not all healthcare providers may have the latest information or prioritize discussing newborn screening during prenatal and postnatal care visits. In multicultural and multilingual societies, language and cultural barriers can hinder effective communication about newborn screening. Ensuring that information is accessible and understandable to diverse populations is a challenge. Different countries and regions have varying healthcare systems, policies, and practices related to newborn screening. This can lead to disparities in awareness and access to screening services. In some low- and middle-income countries, resource constraints may limit the capacity for education and awareness campaigns about newborn screening. This can result in inadequate dissemination of information. Some genetic and metabolic disorders screened for in newborns may be poorly understood or carry stigmas. This can lead to reluctance among parents to participate in screening or follow-up testing.

Rare Diseases and Variability

Rare diseases encompass a wide range of conditions, each with their unique genetic and clinical characteristics. This heterogeneity makes it challenging to develop standardized screening tests that can detect all rare diseases efficiently. For many rare diseases, there is limited epidemiological data and clinical research available. This lack of information can hinder the development of effective screening protocols. Rare diseases, by definition, have low prevalence in the general population. This means that screening programs must test many newborns to identify a small number of affected individuals, which can be resource intensive. Rare diseases often have variable onset and clinical presentation. Some affected infants may not exhibit symptoms until later in life, making early detection through newborn screening more challenging. For some rare diseases, there may be limited or no effective treatments available. Early detection may not always lead to better outcomes if there are no viable treatment options. Genetic mutations responsible for rare diseases can vary widely between individuals. Developing screening tests that can detect all possible genetic variations is a complex task. Balancing sensitivity and specificity in screening tests for rare diseases is difficult. High sensitivity may lead to more false positives, while high specificity may result in false negatives.

Key Market Trends

Rise in Private Testing

Some parents are willing to pay for more extensive newborn screening panels that include a broader range of genetic and metabolic disorders than what is typically offered in public health programs. The trend toward personalized medicine has influenced newborn screening. Parents may seek customized screening options based on their family medical history or genetic predispositions. Private healthcare providers and diagnostic centers often invest in the latest screening technologies and methods, which can offer more comprehensive and accurate results. Private testing facilities may provide faster turnaround times for screening results, providing parents with peace of mind, and enabling earlier intervention if needed. Some families value the privacy and confidentiality offered by private testing centers, especially when it comes to genetic information. Private testing allows parents to have more control and autonomy over the screening process, including the choice of tests and the timing of testing. Private testing centers may offer additional services such as genetic counseling, family planning advice, and ongoing support for families with infants identified as having specific conditions. Families who travel or relocate internationally may opt for private testing to ensure continuity of care and consistent screening practices, especially if they come from regions with varying screening protocols.

Segmental Insights

Technology Insights

In 2022, the Global Newborn Screening Market dominated by Pulse Oximetry segment and is predicted to continue expanding over the coming years. Pulse oximetry is a non-invasive and relatively simple test that measures the oxygen saturation levels in a newborn's blood. This screening can help identify newborns with critical congenital heart defects (CCHD) early, allowing for prompt intervention and treatment. Pulse oximetry is a painless and non-invasive procedure that can be performed quickly and easily. It doesn't require drawing blood or other invasive methods, making it well-tolerated by infants and their parents. Many countries and regions have included pulse oximetry screening as part of their newborn screening guidelines, contributing to its widespread use for CCHD detection. Many healthcare organizations and professional societies recommend the use of pulse oximetry in newborn screening protocols, which can lead to its widespread adoption.

Test Type Insights

In 2022, the Global Newborn Screening Market dominated by Dried Blood Spot (DBS) segment and is predicted to continue expanding over the coming years. DBS is a non-invasive and convenient method for collecting blood samples from newborns. It involves a simple heel prick to obtain a few drops of blood, which are then absorbed onto filter paper. This minimally invasive approach is well-tolerated by infants and is less traumatic for both the baby and parents compared to traditional venous blood draws. DBS samples are stable and can be stored for an extended period, allowing for the convenient transportation of samples to centralized laboratories for testing. This makes it a practical choice, especially in regions with limited access to advanced healthcare facilities. And they are cost-effective compared to other sample collection methods, such as venous blood draws. The use of filter paper as the collection medium is inexpensive, and the simplicity of sample collection reduces labour and equipment costs.

End User Insights

In 2022, the Global Newborn Screening Market largest share was dominated by Diagnostic Centres segment in the forecast period and is predicted to continue expanding over the coming years. Diagnostic centres often have highly trained and specialized personnel who are well-equipped to perform a wide range of screening tests. They have the expertise required to handle and analyse newborn screening samples accurately. Diagnostic centres typically invest in state-of-the-art equipment and technology for newborn screening. This includes advanced instruments for biochemical, genetic, and metabolic testing, which can improve the accuracy and efficiency of screening. Some diagnostic centres offer both private and public services. This means that while public healthcare systems may refer newborns to these centres, parents who prefer private testing can also avail themselves of these services for a fee.

Regional Insights

The North America region dominates the Global Newborn Screening Market in 2022. Due to government legislation, the availability of a strong healthcare infrastructure, the high prevalence of birth abnormalities in the region, and new technological advancements in newborn screening technologies by the players operating in the region. The United States is predicted to have the greatest market share in the North American area. This is due to both the expanding need for sophisticated systems and the rising incidence rates of diseases in neonates. The study of diagnostic markers in blood spots collected on filter paper on an infant's second day of life is how every newborn in the United States is examined post-birth.

Key Market Players

• Bio-Rad Laboratories Inc.

• GE Healthcare

• Masimo Corporation

• Medtronic Inc.

• Natus Medical Incorporated

• PerkinElmer Inc.

• Trivitron Healthcare

• ZenTech SA

• Demant A/S

• Thermo Fisher Scientific

• Hill-Rom Holdings Inc.

Report Scope:

In this report, the Global Newborn Screening Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Newborn Screening Market, By Technology:

• Tandem Mass Spectrometry
• Pulse Oximetry
• Enzyme Based Assays
• DNA Assays
• Other Technologies

Newborn Screening Market, By Test Type:

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

Newborn Screening Market, By End User:

• Hospitals
• Diagnostic Centers
• Other End Users

Global Newborn Screening Market, By region:

• North America
• United States
• Canada
• Mexico
• Asia-Pacific
• China
• India
• South Korea
• Australia
• Japan
• Europe
• Germany
• France
• United Kingdom
• Spain
• Italy
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE

Competitive Landscape

• Company Profiles: Detailed analysis of the major companies present in the Global Newborn Screening Market.

Available Customizations:

• Global Newborn Screening Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Impact of COVID-19 on Global Newborn Screening Market

5. Voice of Customer

6. Global Newborn Screening Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Technology (Tandem Mass Spectrometry, Pulse Oximetry, Enzyme Based Assays, DNA Assays, and Other Technologies)
  • 6.2.2. By Test Type (Dried Blood Spot, Hearing Screening, Critical Congenital Heart Defect (CCHD), and Other Test Types)
  • 6.2.3. By End User (Hospitals, Diagnostic Centers, and Other End Users),
  • 6.2.4. By Region
  • 6.2.5. By Company (2022)
• 6.3. Market Map

7. Asia Pacific Newborn Screening Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Technology
  • 7.2.2. By Test Type
  • 7.2.3. By End User
  • 7.2.4. By Country
• 7.3. Asia Pacific: Country Analysis
  • 7.3.1. China Newborn Screening Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Technology
      • 7.3.1.2.2. By Test Type
      • 7.3.1.2.3. By End User
  • 7.3.2. India Newborn Screening Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Technology
      • 7.3.2.2.2. By Test Type
      • 7.3.2.2.3. By End User
  • 7.3.3. Australia Newborn Screening Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Technology
      • 7.3.3.2.2. By Test Type
      • 7.3.3.2.3. By End User
  • 7.3.4. Japan Newborn Screening Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Technology
      • 7.3.4.2.2. By Test Type
      • 7.3.4.2.3. By End User
  • 7.3.5. South Korea Newborn Screening Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Technology
      • 7.3.5.2.2. By Test Type
      • 7.3.5.2.3. By End User

8. Europe Newborn Screening Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Technology
  • 8.2.2. By Test Type
  • 8.2.3. By End User
  • 8.2.4. By Country
• 8.3. Europe: Country Analysis
  • 8.3.1. France Newborn Screening Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Technology
      • 8.3.1.2.2. By Test Type
      • 8.3.1.2.3. By End User
  • 8.3.2. Germany Newborn Screening Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Technology
      • 8.3.2.2.2. By Test Type
      • 8.3.2.2.3. By End User
  • 8.3.3. Spain Newborn Screening Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Technology
      • 8.3.3.2.2. By Test Type
      • 8.3.3.2.3. By End User
  • 8.3.4. Italy Newborn Screening Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Technology
      • 8.3.4.2.2. By Test Type
      • 8.3.4.2.3. By End User
  • 8.3.5. United Kingdom Newborn Screening Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Technology
      • 8.3.5.2.2. By Test Type
      • 8.3.5.2.3. By End User

9. North America Newborn Screening Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Technology
  • 9.2.2. By Test Type
  • 9.2.3. By End User
  • 9.2.4. By Country
• 9.3. North America: Country Analysis
  • 9.3.1. United States Newborn Screening Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Technology
      • 9.3.1.2.2. By Test Type
      • 9.3.1.2.3. By End User
  • 9.3.2. Mexico Newborn Screening Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Technology
      • 9.3.2.2.2. By Test Type
      • 9.3.2.2.3. By End User
  • 9.3.3. Canada Newborn Screening Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Technology
      • 9.3.3.2.2. By Test Type
      • 9.3.3.2.3. By End User

10. South America Newborn Screening Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Technology
  • 10.2.2. By Test Type
  • 10.2.3. By End User
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Newborn Screening Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Technology
      • 10.3.1.2.2. By Test Type
      • 10.3.1.2.3. By End User
  • 10.3.2. Argentina Newborn Screening Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Technology
      • 10.3.2.2.2. By Test Type
      • 10.3.2.2.3. By End User
  • 10.3.3. Colombia Newborn Screening Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Technology
      • 10.3.3.2.2. By Test Type
      • 10.3.3.2.3. By End User

11. Middle East and Africa Newborn Screening Market Outlook

• 11.1. Market Size & Forecast
  • 11.1.1. By Value
• 11.2. Market Share & Forecast
  • 11.2.1. By Technology
  • 11.2.2. By Test Type
  • 11.2.3. By End User
  • 11.2.4. By Country
• 11.3. MEA: Country Analysis
  • 11.3.1. South Africa Newborn Screening Market Outlook
    • 11.3.1.1. Market Size & Forecast
      • 11.3.1.1.1. By Value
    • 11.3.1.2. Market Share & Forecast
      • 11.3.1.2.1. By Technology
      • 11.3.1.2.2. By Test Type
      • 11.3.1.2.3. By End User
  • 11.3.2. Saudi Arabia Newborn Screening Market Outlook
    • 11.3.2.1. Market Size & Forecast
      • 11.3.2.1.1. By Value
    • 11.3.2.2. Market Share & Forecast
      • 11.3.2.2.1. By Technology
      • 11.3.2.2.2. By Test Type
      • 11.3.2.2.3. By End User
  • 11.3.3. UAE Newborn Screening Market Outlook
    • 11.3.3.1. Market Size & Forecast
      • 11.3.3.1.1. By Value
    • 11.3.3.2. Market Share & Forecast
      • 11.3.3.2.1. By Technology
      • 11.3.3.2.2. By Test Type
      • 11.3.3.2.3. By End User

12. Market Dynamics

• 12.1. Drivers
• 12.2. Challenges

13. Market Trends & Developments

• 13.1. Recent Developments
• 13.2. Product Launches
• 13.3. Mergers & Acquisitions

14. Global Newborn Screening Market: SWOT Analysis

15. Porter's Five Forces Analysis

• 15.1. Competition in the Industry
• 15.2. Potential of New Entrants
• 15.3. Power of Suppliers
• 15.4. Power of Customers
• 15.5. Threat of Substitute Product

16. PESTLE Analysis

17. Competitive Landscape

• 17.1. Business Overview
• 17.2. Company Snapshot
• 17.3. Products & Services
• 17.4. Financials (In case of listed companies)
• 17.5. Recent Developments
• 17.6. SWOT Analysis
  • 17.6.1. Bio-Rad Laboratories Inc.
  • 17.6.2. GE Healthcare
  • 17.6.3. Masimo Corporation
  • 17.6.4. Medtronic Inc.
  • 17.6.5. Natus Medical Incorporated
  • 17.6.6. PerkinElmer Inc.
  • 17.6.7. Trivitron Healthcare
  • 17.6.8. ZenTech SA
  • 17.6.9. Demant A/S
  • 17.6.10. Thermo Fisher Scientific
  • 17.6.11. Hill-Rom Holdings Inc.

18. Strategic Recommendations

19. About Us & Disclaimer