新生儿筛查市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

  • Report Code : TIPHE100001294
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 226
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【研究报告】2022年新生儿筛查市场规模为12.0674亿美元,预计到2030年将达到24.8416亿美元;预计 2022 年至 2030 年复合年增长率为 9.4%。
市场洞察和分析师观点:
新生儿筛查旨在在症状出现之前识别患有先天性疾病的婴儿,以便尽快开始治疗,以避免或减轻病情的长期影响。美国每个州都实施了多种新生儿筛查程序。一个扩展且标准化的统一小组显示,对所有州的至少 26 种疾病进行了筛查。最完整的筛查小组可筛查 40 种不同的疾病。然而,一些人仍然将新生儿筛查称为“PKU 测试”,因为苯丙酮尿症 (PKU) 是该筛查测试最初设计的条件。政府部门用于新生儿筛查的资金激增、先天性疾病负担的增加以及新生儿疾病患病率的增加是推动新生儿筛查市场增长的关键因素。然而,新生儿筛查政策和实践缺乏统一性阻碍了市场增长。
增长动力和限制:
如果不及早发现和管理,先天性疾病可能会导致终生健康挑战。这些疾病可能导致长期残疾,严重影响家庭、个人、医疗保健系统和社会。世界卫生组织估计,全世界每年有 240,000 名新生儿在出生后 28 天内死于这些疾病。大约有 170,000 名儿童在 1 个月至 5 岁之间因先天性疾病死亡。对许多先天性疾病的遗传基础的日益了解是导致这些疾病负担日益增加的几个因素之一。基因组学和基因检测的进步使医疗保健提供者能够识别新生儿更广泛的基因突变和病症。这些知识的扩展凸显了通过新生儿筛查进行早期诊断以启动及时干预和治疗的重要性。
母亲年龄、环境暴露和生活习惯改变等人口统计数据的变化会增加新生儿患先天性疾病的风险。此外,由于全球人口迅速增长,每天的出生人数不断增加,导致患有先天性疾病的婴儿数量不断增加。医疗保健系统和政策制定者认识到早期疾病检测的长期好处。他们越来越多地将新生儿筛查纳入常规医疗保健方案和保险范围,进一步刺激市场增长。
不同国家筛查条件的差异导致全球新生儿筛查政策和实践的不统一。一些国家对一系列疾病进行全面筛查,而另一些国家则侧重于有限的一组疾病。这种差异给开发筛选测试和技术的公司带来了障碍,因为他们必须针对特定市场修改其产品,从而限制了规模经济。此外,缺乏标准化协议可能会导致质量控制和数据收集实践不一致。这导致筛查结果不准确,并且难以比较地区之间的数据,使研究人员和医疗保健提供者难以评估在研究地点实施的筛查计划的有效性。
此外,缺乏通用标准使监管环境变得复杂。新生儿筛查市场的公司,因为他们需要专注于遵守复杂的法规网络以寻求不同国家的批准,这可能既耗时又昂贵。缺乏统一性还会阻碍国际合作和数据共享,限制新生儿筛查研究和技术开发的潜力。因此,新生儿筛查政策和程序缺乏统一限制了新生儿筛查市场的进步。
战略见解
报告细分和范围:
“全球新生儿筛查市场”根据以下因素进行细分:产品类型、测试类型、技术和最终用户。按产品类型划分,市场分为试剂、检测试剂盒和仪器。根据技术,新生儿筛查市场分为串联质谱(TMS)、分子测定、免疫测定和酶测定、脉搏血氧饱和度筛查技术和其他技术。新生儿筛查市场按测试类型分为干血斑测试、听力筛查测试、危重先天性心脏病测试和其他测试。全球新生儿筛查市场按最终用户分为医院、诊所和诊断实验室。
新生儿筛查市场根据地理位置分为北美(美国、加拿大和墨西哥)、欧洲(德国) 、法国、意大利、英国、俄罗斯和欧洲其他地区)、亚太地区(澳大利亚、中国、日本、印度、韩国和亚太地区其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋和中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。
细分分析:
新生儿筛查市场按产品类型分为试剂和分析套件和仪器。 2022年,试剂和检测试剂盒细分市场占据更大的市场份额,预计2022-2023年期间复合年增长率更高。用于新生儿筛查的不同试剂和检测试剂盒分为基于 DNA 的检测、免疫检测和酶检测。市场上的多家公司开发了一系列专门用于新生儿筛查的试剂和检测试剂盒。 Labsystems Diagnostics 于 2022 年推出了一种基于荧光微孔板的检测方法,用于根据苯丙氨酸含量检测新生儿的苯丙酮尿症 (PKU),因为婴儿苯丙氨酸水平升高会导致智力障碍。该公司提供的所有试剂盒均为手动模块化系统或全自动免提系统。
新生儿筛查市场,按产品类型 - 2022 年和 2030 年
新生儿筛查市场,按技术划分,分为串联质量光谱测定法(TMS)、分子测定、免疫测定和酶测定、脉搏血氧筛查技术等技术。 2022年,脉搏血氧仪筛查技术领域占据最大的市场份额。此外,免疫分析和酶分析领域预计将在 2022 年至 2030 年期间创下最快的复合年增长率。先天性心脏病(CCHD)是最常见的出生缺陷之一,导管依赖性疾病是这种疾病的常见形式。它可能在产前和产后期间被发现,而如果在新生儿期或婴儿期未经诊断和治疗,可能会危及生命。脉搏血氧仪筛查用于检测婴儿的危重 CCHD。这是一种无痛、非侵入性且经济高效的婴儿筛查方法。脉搏血氧计筛查用于确定氧饱和血液中的血红蛋白百分比。 .
新生儿筛查市场按测试类型分为干血斑测试、听力筛查测试、危重先天性心脏病测试和其他测试。 2022年,血斑检测领域占据最大的市场份额。该细分市场的新生儿筛查市场预计在 2022 年至 2030 年期间将以显着的复合年增长率增长。
按最终用户划分,新生儿筛查市场分为医院、诊所和诊断实验室。 2022年,医院和诊所领域占据最大的市场份额。然而,医院和诊所部门预计在 2022 年至 2030 年期间实现复合年增长率。医疗保健提供者在医院的房间或新生儿/托儿所进行新生儿筛查测试。预计未来几年,医院和诊所将在新生儿筛查市场中占据更大份额,因为这些设施接受新生儿筛查的患者人数最多。更好的设施和不同的治疗选择以及一站式提供的良好护理吸引患者前往这些设施进行不同的诊断和治疗程序。
区域分析:
根据地理位置,全球新生儿筛查市场进行了细分分为五个主要区域:北美、欧洲、亚太地区、南美洲和中美洲以及中东和非洲。 2022年,北美占据最大的市场份额。据估计,从 2022 年到 2030 年,亚太地区的新生儿筛查市场复合年增长率最高。
北美的新生儿筛查市场近年来经历了显着增长。随着父母和医疗保健专业人员对早期筛查对于识别和管理先天性疾病重要性的认识不断提高,对新生儿筛查服务的需求显着增加。此外,医疗技术的进步对于增强新生儿筛查能力至关重要——实验室自动化提高了筛查的准确性、速度和成本效益。这使得医疗专业人员能够提供全面的新生儿筛查,涵盖更广泛的遗传和代谢疾病。有利的立法和监管措施也有利于北美的新生儿筛查市场。许多州和省已经实施了强制性新生儿筛查计划,确保所有婴儿在出生后不久就接受筛查。例如,美国每个州都将新生儿筛查作为一项公共卫生计划;每年,约有 400 万婴儿根据该计划接受筛查,检查是否患有在分娩时不常出现的疾病。德克萨斯州卫生与公众服务部于 2021 年 6 月开始对新生儿进行脊髓性肌萎缩症 (SMA) 筛查。
行业发展和未来机遇:
下面列出了全球新生儿筛查市场主要参与者采取的各种举措:
2023 年 5 月,Masimo 推出了 Stork,这是一款革命性的家庭婴儿监控系统。这一创新系统使父母能够深入了解宝宝的健康数据,使他们能够与宝宝保持更紧密的联系。 Masimo Stork 婴儿监视器系统由多个组件组成,并有多种配置可供选择。 Masimo Stork Vitals+ 是旗舰解决方案,由带有传感器的靴子、摄像机和移动应用程序组成。 2022 年 11 月,PerkinElmer Inc. 获得美国食品和药物管理局 (FDA) 销售 EONIS SCID-SMA 检测的授权经认证的实验室使用的体外诊断 (IVD) 试剂盒,可同时检测新生儿脊髓性肌萎缩症 (SMA) 和严重联合免疫缺陷 (SCID)。这是美国第一个获得 FDA 授权的新生儿 SMA 筛查检测方法,也是 PerkinElmer 更广泛的 EONIS 平台的一部分。2022 年 7 月,Baebies Inc. 扩大了与医疗设备供应商 Medical Horizons SrL 的合作关系,以帮助引入新生儿2022 年 7 月,Natus Medical Incorporated 透露,专注于医疗保健行业的领先投资公司 ArchiMed 的 MED Platform II 基金完成了对 Natus 的收购。根据最终协议,Natus 股东每股 Natus 普通股将获得 33.50 美元现金。竞争格局和主要公司:
LifeCell International Pvt Ltd、Zentech SA、Trivitron Healthcare Pvt Ltd、PerkinElmer Inc、Waters Corp、Bio -Rad Laboratories Inc.、Masimo Corp、Natus Medical Inc.、Baebies Inc.、MRC Holland BV 和 Medtronic Plc 是新生儿筛查市场的知名参与者。这些公司专注于新技术、现有产品的进步和地域扩张,以满足全球不断增长的消费者需求并增加其专业产品组合的产品范围。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

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Frequently Asked Questions


What was the estimated newborn screening market size in 2022?

The newborn screening market was valued at US$ 1,206.74 million in 2022.

What are the growth estimates for the newborn screening market till 2030?

The newborn screening market is expected to be valued at US$ 2,484.16 million in 2030.

What is newborn screening?

Testing for babies with a major medical issue is known as newborn screening. Screening newborns for various dangerous or deadly illnesses that are not immediately visible at birth is necessary. These testing procedures include hearing exams, pulse oximetry, and blood tests, and these tests allow medical practitioners to spot and address specific issues that help a baby develop normally and grow up healthy.

Which segment is dominating the newborn screening market?

The global newborn screening market, based on product type, is segmented into reagents and assay kits and instruments. The reagents and assay kits segment held a larger market share in 2022 and is anticipated to register a higher CAGR during the forecast period.

What are the driving and restraining factors for the newborn screening market?

The factors driving the growth of the newborn screening market include rising funding from government sectors for newborn screening, rising burden of congenital diseases, and increasing prevalence of newborn disorders. However, lack of global uniformity in newborn screening policies and practices hamper the growth of the newborn screening market.

Who are the major players in the newborn screening market?

The newborn screening market majorly consists of the players, including Medtronic Plc, PerkinElmer Inc, Waters Corp, Bio-Rad Laboratories Inc, LifeCell International Pvt Ltd, Zentech SA, Trivitron Healthcare, Masimo Corp, Natus Medical Inc, Baebies Inc, and MRC Holland BV.

The List of Companies - Newborn Screening Market

  1. LifeCell International Pvt Ltd
  2. Zentech SA
  3. Trivitron Healthcare Pvt Ltd
  4. PerkinElmer Inc
  5. Waters Corp
  6. Bio-Rad Laboratories Inc.
  7. Masimo Corp
  8. Natus Medical Inc.
  9. Baebies Inc
  10. MRC Holland BV
  11. Medtronic Plc

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