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市场调查报告书
商品编码
1820376
2025 年至 2033 年新生儿筛检市场规模、份额、趋势及预测(按产品、技术、检测类型和地区)Newborn Screening Market Size, Share, Trends and Forecast by Product, Technology, Test Type, and Region, 2025-2033 |
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2024年,全球新生儿筛检市场规模达10.893亿美元。展望未来, IMARC Group预测,到2033年,该市场规模将达到18.181亿美元,2025年至2033年的复合年增长率为5.9%。目前,北美占据市场主导地位,2024年的市占率将超过33.2%。这得归功于人们日益增强的对新生儿重症早期发现意识、医疗技术的进步(旨在提高筛检结果的准确性)以及政府的积极倡议。
随着诊断技术的进步以及对新生儿疾病早期识别认识的提高,新生儿筛检市场正在蓬勃发展。世界各国政府已实施了全面的新生儿筛检计划,涵盖代谢、遗传和内分泌疾病,这进一步增加了对这些疾病的先进筛检试剂盒和系统的需求。串联质谱和酶联免疫吸附测定领域的进一步发展提高了检测所需的灵敏度和特异性,从而提高了其整体应用率。先天性畸形和遗传性代谢疾病发生率的上升使得早期诊断至关重要,这使得早期诊断成为公共卫生政策的重中之重。
美国已成为新生儿筛检的重要区域市场。这得归功于人们对早期疾病检测及其在预防终身併发症方面作用的认识日益加深。政府强制推行的全面新生儿筛检计画在推动新生儿筛检应用方面发挥了关键作用。串联质谱和新一代定序等技术进步提高了检测遗传、代谢和感染性疾病的准确性和速度,促进了筛检的广泛应用。遗传性疾病和代谢性疾病盛行率的上升进一步刺激了需求。公共和私人资金的增加支持了先进筛检方法的研究和实施。此外,非侵入性筛检技术的发展提供了更安全、更有效率的检测选择。此外,医疗保健提供者和政策制定者强调早期诊断和治疗的长期成本节约,这进一步推动了筛检的发展。
提高对早期疾病检测的认识
家长们越来越意识到早期疾病检测的重要性,因为它有助于提高治疗效果、改善儿童生活品质并提供及时干预,这是推动新生儿筛检市场发展的主要驱动力之一。此外,先天性疾病发生率的上升也是另一个重要的成长诱因。此外,据报道,在美国,每1,000名儿童中约有2至3名患有脑性麻痹。
有利的政府倡议
监管机构推出的政策通常涵盖全面的疾病种类,并确保有效解决潜在的健康问题,这正在推动全球新生儿筛检市场的发展。例如,2022年6月,加拿大曼尼托巴省政府机构宣布扩大其新生儿筛检计划,旨在将脊髓性肌肉萎缩症及其他疾病的筛检范围扩大到其他疾病。此外,各政府部门也强制要求新生儿出院前进行筛检,对新生儿筛检市场的整体成长产生了正面影响。
医疗科技的进步
主要参与者正在推进医疗技术,以改进新生儿筛检方法,这是另一个重要的成长驱动因素。此外,新兴的筛检技术鼓励医疗保健提供者提供和采用这些服务,从而推动全球市场的发展。例如,2021年6月,德州卫生服务部推出了新生儿脊髓性肌肉萎缩症 (SMA) 筛检。为此,Trivitron Healthcare 于2022年在印度AMTZ园区建立了一个卓越中心 (CoE),该中心拥有最先进的研发和製造设施,用于基因组学、新生儿筛检、代谢组学和分子诊断。此外,2023年1月,Masimo宣布推出其全新的先进婴儿监护系统,使照顾者能够即时监测婴儿的资料。
The global newborn screening market size was valued at USD 1,089.3 Million in 2024. Looking forward, IMARC Group estimates the market to reach USD 1,818.1 Million by 2033, exhibiting a CAGR of 5.9% from 2025-2033. North America currently dominates the market, holding a market share of over 33.2% in 2024. This is due to the increasing awareness among individuals toward early detection of severe diseases in newborns, improvements in medical technology for more accurate outcomes, and favorable government initiatives.
The newborn screening market is escalating due to the advent of technological advances in diagnostics and awareness regarding early identification of neonatal diseases. Governments around the world have undertaken programs for comprehensive screening at birth - metabolic, genetic, and endocrine disorders - which further increases the demand for advanced screening kits and systems for these disorders. Further extensions in the field of tandem mass spectrometry and enzyme-linked immunoassays have increased the sensitivity and specificity required by the tests and thus improved their overall adoption. The rising incidence of congenital anomalies and inherited metabolic disorders makes early diagnosis highly imperative, making this system a top priority in public health policy.
The United States has emerged as a key regional market for newborn screening. This is due to growing awareness about early disease detection and its role in preventing lifelong complications. Government initiatives mandating comprehensive newborn screening programs have been pivotal in driving adoption. Advances in technology, such as tandem mass spectrometry and next-generation sequencing, enhance the accuracy and speed of detecting genetic, metabolic, and infectious conditions, encouraging widespread use. The rising prevalence of genetic disorders and metabolic conditions further fuels demand. Increased public and private funding supports research and the implementation of advanced screening methods. Additionally, the development of non-invasive screening techniques offers safer and more efficient testing options. Moreover, healthcare providers and policymakers emphasize the long-term cost savings of early diagnosis and treatment, creating further momentum.
Increasing awareness about early disease detection
The growing awareness among parents toward the critical importance of early disease detection, as it helps in enhancing treatment outcomes, improving quality of life for the child, offering timely intervention represents one of the primary drivers bolstering the newborn screening market. Besides this, the rising occurrence of congenital diseases is also acting as another significant growth-inducing factor. Moreover, according to reports, about two to three children out of every 1000 children have cerebral palsy in the United States.
Favorable government initiatives
The launch of policies by regulatory authorities that often cover a comprehensive panel of disorders and ensure that potential health issues are addressed efficiently is bolstering the global newborn screening market. For example, in June 2022, government bodies in Manitoba, Canada, announced the expansion of their newborn screening program with an aim to extend screening for spinal muscular atrophy, along with other diseases. Moreover, various government authorities have also made newborn screening compulsory before getting discharged from the hospital, thereby positively impacting the overall newborn screening market growth.
Improvements in medical technology
Key players are advancing their medical technologies to improve newborn screening methods, which is acting as another significant growth-inducing factor. Moreover, emerging screening technologies encourage healthcare providers to offer and adopt these services, thereby fueling the global market. For example, in June 2021, the Texas Department of State Health Services introduced newborn screening for Spinal Muscular Atrophy (SMA). In line with this, in 2022, Trivitron Healthcare developed a Centre of Excellence (CoE) with state-of-the-art R&D and manufacturing facilities at AMTZ Campus in India for genomics, newborn screening, metabolomics, and molecular diagnostics. Furthermore, in January 2023, Masimo announced the launch of its new state-of-the-art baby monitoring system that allows caretakers to monitor the data of babies in real-time.
Instrument stand as the largest component in 2024, holding around 77.6% of the market. Instruments play a crucial role in the screening process for sample collection, analysis, result interpretation, etc. In addition to this, they comprise a wide array of technologies, such as deoxyribonucleic acid (DNA) analyzers, automated screening platforms, mass spectrometry systems, etc. Moreover, the rising investments by key healthcare companies in diagnostics tests that require instruments are expected to bolster the market growth in this segmentation. For instance, in March 2023, GC Labs announced the launch of its new test for the diagnosis of Inborn Errors of Metabolism (IEM) among newborns with the integration of novel disease detection methods.
Tandem mass spectrometry leads the market with around 23.8% of the newborn screening market share in 2024. Tandem mass spectrometry refers to an analytical technique that is employed in newborn screening to identify several metabolic disorders. In line with this, it provides improved accuracy and speed. Numerous technological advancements in the medical field enhance tandem mass spectrometry, which will continue to drive the market growth in this segmentation. For example, in April 2023, Waters Corporation announced the development of its new Xevo TQ Absolute IVD Mass Spectrometer for clinical applications.
Dry blood spot test leads the market with around 46.5% of market share in 2024. A dry blood spot test refers to a non-invasive screening technique that generally involves collecting a small amount of blood from the heel of a newborn onto a special filter paper. The dried blood sample is then analyzed for the presence of specific markers associated with several disorders. The test is widely preferred among newborn screening programs, as it provides ease of transportation, convenience of sample collection, and the ability to simultaneously screen for various conditions. Besides this, the elevating number of initiatives by government bodies is acting as another significant growth-inducing factor in this segmentation.
In 2024, North America accounted for the largest market share of over 33.2%. The increasing prevalence of congenital disabilities in North America is augmenting the need for newborn screening. Moreover, the implementation of stringent regulations by government bodies across the region is also acting as another significant growth-inducing factor. For example, according to the March of Dimes (MoD) report of 2021, before leaving the hospital, every baby in the United States went through the screening process. Apart from this, the elevating focus of key players on preventive healthcare is inflating the popularity of advanced technologies, which is expected to bolster the North America newborn screening market over the foreseeable future.
United States Newborn Screening Market Analysis
In 2024, the United States accounts for 86.80% of the newborn screening market in North America. Most insurance plans across the United States are covering newborn screening tests, which is contributing to its accessibility. This is providing an impetus to the market growth. In line with this, awareness campaigns and healthcare initiatives across the United States are continuously growing to improve early diagnosis, particularly among parents and healthcare providers. This is further fueling the market growth. According to reports, each year, approximately 8,000 to 10,000 newborns across the United States are diagnosed with cerebral palsy. Moreover, 764,000 number of children are diagnosed with cerebral palsy in the United States of America. In addition to this, the adoption of advanced diagnostic tools such as tandem mass spectrometry across the region is fueling the newborn screening market. Furthermore, newborn screening is being mandated by law in all the states situated across the United States of America for several diseases thereby leading to high screening coverage. This, in turn, is impelling the market growth.
Asia Pacific Newborn Screening Market Analysis
Several countries located across the Asia-Pacific region have established their nationwide newborn screening programs while others are in the process of expanding their programs. This is providing an impetus to the market growth. In line with this, healthcare systems particularly in urban areas across this region are propelling the reach of newborn screening programs. According to the National Bureau of Statistics of China, by the end of 2023, the national population totaled 1,409.67 Million, with urban permanent residents accounting for 932.67 Million. Additionally, the rising incidences of genetic disorders across this region are escalating the growing demand for early detection methods. This, in turn, is impelling the market growth. Furthermore, there is an increasing awareness among healthcare providers and the general public regarding the importance of newborn screening, proliferating its adoption and implementation.
Europe Newborn Screening Market Analysis
Many European countries are implementing national screening programs, ensuring that almost all newborns are being tested. This, in turn, is impelling the market growth. According to the British Medical Association, one in every 1000 children residing across the United Kingdom are diagnosed with autism spectrum disorder. Moreover, according to reports, in England and Wales, with an annual birth rate of approximately 700,000, there could be up to 1,700 new cases of cerebral palsy diagnosed in children each year. In line with this, European Union regulations and directives are supporting newborn screening, ensuring its adoption and standardization. This is providing an impetus to the market growth. Additionally, the use of high-throughput technologies across the European region, such as dry blood spot screening and tandem mass spectrometry, is continuously increasing. Owing to this, the market growth is augmenting. Furthermore, NGOs and healthcare agencies in Europe are actively advocating for the expansion of the scope of newborn screening.
Latin America Newborn Screening Market Analysis
Latin American countries are following newborn screening programs thereby ensuring that the newborns are being tested. This is providing an impetus to the market growth. According to the National Institutes of Health (NIH), in Brazil, there are approximately 4 Million pediatric pneumonia cases reported annually. In line with this, there is a growing awareness about the importance of early detection of diseases among infants which is being driven by healthcare NGOs and international organizations. This, in turn, is impelling the market growth.
Middle East and Africa Newborn Screening Market Analysis
Newborn screening is increasingly becoming mandatory across the region so that the list of disorders screened can be expanded. According to a survey, a total of 613 children diagnosed with cerebral palsy were identified, with a higher prevalence among males. Moreover, the median age at which children at risk for cerebral palsy were identified was 9 weeks. In addition to this, governments across the region are investing in healthcare infrastructure, which includes expanding newborn programs. This, in turn, is impelling the market growth.
Companies are investing in cutting-edge technologies, such as next-generation sequencing (NGS) and mass spectrometry, to enhance the accuracy and efficiency of screening processes. These advancements enable early detection of a broader range of disorders, meeting growing healthcare demands. Moreover, key players are introducing comprehensive screening panels and user-friendly devices tailored to healthcare providers' needs. These expanded offerings increase market appeal and address diverse customer requirements. Besides, strategic partnerships with healthcare institutions, research organizations, and government agencies allow companies to drive innovation and expand their market presence. Collaborations also facilitate better adoption of screening programs globally.