![]() |
市场调查报告书
商品编码
1825970
2025年无创产前检测全球市场报告Non-invasive Prenatal Testing Global Market Report 2025 |
||||||
近年来,非侵入性产前检测市场快速扩张,市场规模从2024年的54.8亿美元成长至2025年的62.7亿美元,复合年增长率达14.5%。预测期内的增长可归因于准确性的提高、风险的降低、孕妇年龄的增长、意识的提升以及临床指南的完善。
预计未来几年,非侵入性产前检测市场将快速成长,到2029年将达到108.6亿美元,复合年增长率为14.7%。预测期内的增长归因于检测服务的扩展、可近性的提高、孕妇年龄的增长、胎儿异常检测、远端医疗和数位健康。预测期内的主要趋势包括检测范围的扩大、NIPT的广泛应用、技术进步以及非侵入性胎儿非整倍体诊断 (NIFAD)。
非侵入性产前检测 (NIPT) 是一种采集母体血液并进行分析,以检测发育中胎儿潜在异常的程序。非侵入性产前检测套组和设备用于在怀孕早期识别基因异常,主要是染色体异常。
非侵入性产前检测的主要类别包括耗材和设备。耗材是指在使用过程中消耗的产品。设备包括NGS系统、PCR仪、微阵列、超音波设备、离心机、紫外线系统、培养箱及显微镜等设备。耗材包括检测试剂套件、试剂和一次性耗材。这些应用涉及三体性、微缺失、遗传学、Rh因子等的检测,通常用于医院和诊断实验室。
2025 年春季美国突然提高关税以及由此引发的贸易摩擦对医疗保健产业产生了重大影响,尤其是基本医疗设备、诊断设备和药品的供应。医院和医疗保健提供者正努力应对进口手术器械、诊断影像系统以及注射器和导管等消耗品成本的上涨,其中许多产品的国内替代品有限。这些不断上涨的成本使医疗保健预算捉襟见肘,导致一些医疗机构推迟设备升级或将增加的费用转嫁给患者。此外,原料和零件的关税扰乱了关键药品和医疗设备的生产,造成供应链延迟。作为应对措施,该行业正在采用多样化的筹资策略,尽可能扩大本地生产,并游说对关键医疗产品免关税。
本研究报告是商业研究公司 (The Business Research Company) 新报告系列的一部分,该系列提供无创产前检测市场统计数据,例如全球市场规模、区域份额、竞争对手的市场份额、详细的无创产前检测细分市场、市场趋势和机会,以及您在无创产前检测行业取得成功所需的数据。这份非侵入性产前检测市场研究报告对该行业的现状和未来趋势进行了详细分析,为您提供所需的一切观点。
未来五年14.7%的成长率预测比我们先前的预测略有下降,下降了0.2%。这一下降主要源自于美国与其他国家之间关税的影响。贸易摩擦可能导致新加坡和比利时开发的定序试剂套件和生物资讯软体价格上涨、产前检测延迟以及妇产科 (OB/GYN) 费用增加,阻碍美国无细胞DNA筛检的普及。由于互惠关税以及贸易紧张局势和限制加剧对全球经济和贸易的负面影响,贸易摩擦的影响可能会更加广泛。
唐氏症的高发生率是推动非侵入性产前检测 (NIPT) 市场成长的关键因素,特别是当母亲老化成为胎儿健康日益受到关注的因素时。唐氏症是一种由细胞分裂错误引起的染色体异常,导致多余的 21 号染色体,这会影响胎儿的认知和身体发育。 NIPT筛检测试提供了一种安全、非侵入性的唐氏症检测方法,不会对母亲或胎儿造成伤害,也不会有流产的风险。此测试可以检测出 99% 以上的唐氏症。在美国,国家唐氏症协会和疾病管制与预防中心报告称,每 700 名婴儿中就有 1 名患有唐氏症,而 80% 的唐氏症婴儿出生于高龄母亲。高龄产妇带来的风险增加正在推动 NIPT 市场的成长。
高龄产妇的趋势预计将推动非侵入性产前检测 (NIPT) 市场的成长。教育追求、职业发展、经济稳定、个人选择、晚婚、避孕方法的改进以及社会变革等因素,促使女性在计划生育方面做出更明智的决定。随着女性延迟生育,染色体异常的风险也随之增加,越来越多的孕妇选择 NIPT 来监测怀孕健康。例如,美国疾病管制与预防中心2023年6月发布的报告指出,35至39岁女性的临时生育率将增加2%,从2021年的每千名女性生育53.7个孩子增加到2022年的每千名女性生育54.9个孩子。同样,30多岁后期女性的生育率在2021年至2022年间也增加了2%。对于40至44岁年龄组,临时生育率增加了4%,从2021年的每千名女性生育12个孩子增加到2022年的12.5个孩子。这是自1985年(3.8)以来该年龄层的生育率首次持续增加。此外,从 2021 年到 2022 年,该年龄层的出生人数增加了 6%。 45-49 岁女性(包括 50 岁及以上)的临时生育率也从 2021 年的每 1,000 名女性 0.9 人增加到 2022 年的每 1,000 名女性 1.1 人,这是自 2015 年以来的首次变化。从 2021 年到 2022 年,该年龄层的出生人数跃升了 12%。随着母亲年龄的不断上升,预计在预测期内对非侵入性产前检测的需求将相应增加。
新一代定序技术的整合显着提升了研究人员的能力,使其在生物系统领域拥有更广泛的应用和更高水准的研究。次世代定序仪能够同时对数千至数百万个DNA分子定序,优化基因组和DNA检测结果,同时降低时间和成本。 Illumina、Eurofins、Natera、罗氏和安诺优达等领先公司已将该技术应用于非侵入性产前检测。中国食品药物监督管理总局(CFDA)已核准安诺优达NextSeq 550AR新一代定序系统获得医疗设备产品註册。
非侵入性产前检测市场受到各种国际和国家机构的严格监管。例如,美国食品药物管理局(FDA) 颁发临床实验室开发测试 (LDT) 和临床实验室改进法案 (CLIA) 认证。製造商必须获得体外诊断产品的上市前通知 (510(k))。 LDT 和 CLIA 认证是基于临床试验期间进行的测试数量。例如,对于发病率为千分之一的 21 三体症候群(唐氏症),至少需要 100,000 个样本才能满足 510(k) 要求。 510(k) 上市前通知确保新产品与其他合法销售的设备一样安全有效,製造商必须在销售新产品之前註册此类通知。
2024年1月,美国临床基因检测公司Natera以4,250万美元收购了Invitae的生殖健康资产。此次收购将增强Natera在非侵入性产前检测和携带者筛检是生殖保健的重要组成部分。 Invitae是一家提供非侵入性产前检测服务的美国生技公司。
非侵入性产前检测市场的主要参与者包括 F. Hoffmann-La Roche AG、Illumina Inc.、Laboratory Corporation of America Holdings、Natera Inc.、PerkinElmer Inc.、Quest Diagnostics Inc.、Agilent Technologies Inc.、BGI Diagnosis Co Ltd.、Berry Genomics Co.、LifeCGenetics Ltd.、Ann. Gene Technology Co Ltd.、CentGen Inc.、Council Inc.、Eurofins Genoma Group、Eurofins Scientific Inc.、Next Biosciences Inc.、Premaita Health Inc.、Ariosa Diagnostics Inc.、北京基因组研究所、Yurgen Health Inc.、GE Healthcare Technology Inc.、飞利浦、赛默飞尔浦、赛默飞世科技公司、GE Healthcare Technology Inc。 Labs, Inc. 以及 Progenity, Inc.。
2024年,非侵入性产前检测市场最大的地区是北美。西欧是非侵入性产前检测市场的第二大地区。非侵入性产前检测市场报告涵盖以下地区:亚太地区、西欧、东欧、北美、南美、中东和非洲。
非侵入性产前检测市场报告涵盖的国家有澳洲、巴西、中国、法国、德国、印度、印尼、日本、俄罗斯、韩国、英国、美国、加拿大、义大利和西班牙。
非侵入性产前检测市场包括超音波检测、母血胎儿细胞检测、母血浆游离DNA检测和生化筛检的收益。市场价值包括服务提供者销售或包含在服务产品中的相关商品的价值。仅包括营业单位之间交易或销售给最终消费者的商品和服务。
Non-invasive prenatal testing (NIPT) is a procedure where maternal blood is drawn and analyzed to detect potential abnormalities in the developing fetus. Non-invasive prenatal testing kits and equipment serve the purpose of identifying genetic irregularities, primarily chromosome defects, during the first trimester of pregnancy.
The key categories of non-invasive prenatal testing encompass consumables and instruments. Consumables refer to products that are used and depleted during their application. Instruments include NGS systems, PCR instruments, microarrays, ultrasound devices, and other equipment like centrifuges, UV systems, incubators, and microscopes. Various consumables comprise assay kits and reagents, as well as disposables. These applications pertain to the detection of conditions such as trisomy, microdeletion, genetics, and the Rh factor, and are typically employed by hospitals and diagnostic laboratories.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.
The non-invasive prenatal testing market research report is one of a series of new reports from The Business Research Company that provides non-invasive prenatal testing market statistics, including non-invasive prenatal testing industry global market size, regional shares, competitors with a non-invasive prenatal testing market share, detailed non-invasive prenatal testing market segments, market trends and opportunities, and any further data you may need to thrive in the non-invasive prenatal testing industry. This non-invasive prenatal testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The non-invasive prenatal testing market size has grown rapidly in recent years. It will grow from $5.48 billion in 2024 to $6.27 billion in 2025 at a compound annual growth rate (CAGR) of 14.5%. The growth in the historic period can be attributed to improved accuracy, reduced risk, increased maternal age, growing awareness, clinical guidelines.
The non-invasive prenatal testing market size is expected to see rapid growth in the next few years. It will grow to $10.86 billion in 2029 at a compound annual growth rate (CAGR) of 14.7%. The growth in the forecast period can be attributed to expanding test offerings, wider accessibility, rising maternal age, fetal anomaly detection, telemedicine and digital health. Major trends in the forecast period include expanded test panels, wider adoption of nipt, technological advancements, non-invasive fetal aneuploidy diagnosis (nifad).
The forecast of 14.7% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. adoption of cell-free DNA screening by inflating prices of sequencing kits and bioinformatics software developed in Singapore and Belgium, resulting in delayed prenatal diagnoses and higher Obstetrics and Gynecology(OB/GYN) costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The high incidence rate of Down syndrome is a significant factor propelling the growth of the non-invasive prenatal testing (NIPT) market, especially with the increasing trend of older maternal age, which raises concerns about fetal well-being. Down syndrome, a chromosomal condition resulting from an error in cell division, leads to an extra chromosome 21 and can impact the cognitive and physical development of the fetus. NIPT screening tests offer a safe and non-invasive means of detecting Down syndrome, posing no harm to the mother or baby and carrying no risk of miscarriage. These tests can identify over 99% of Down syndrome cases. In the USA, the National Down Syndrome Society and the Centers for Disease Control and Prevention report that 1 in every 700 babies is born with Down syndrome, and 80% of children with Down syndrome are born to older mothers. The increased risk associated with advanced maternal age is a driving force behind the growth of the NIPT market.
The growing trend of increasing maternal age is expected to drive the growth of the non-invasive prenatal testing (NIPT) market. Factors such as pursuing education, career advancement, financial stability, personal choice, delayed marriage, improved contraception, and societal shifts are contributing to women making more informed decisions about family planning. As women delay childbirth, the risk of chromosomal abnormalities increases, leading more expectant mothers to choose NIPT to monitor the health of their pregnancies. For example, a report from the Centers for Disease Control and Prevention published in June 2023 highlighted a 2% increase in the provisional birth rate for women aged 35 to 39, from 53.7 births per 1,000 women in 2021 to 54.9 in 2022. Similarly, the number of births to women in their late 30s rose by 2% from 2021 to 2022. In the 40-44 age group, the provisional birth rate increased by 4%, reaching 12.5 births per 1,000 women in 2022, up from 12.0 in 2021. This age group's birth rate has shown nearly continuous growth since 1985 (3.8). Additionally, the number of births in this age group increased by 6% from 2021 to 2022. The provisional birth rate for women aged 45-49 (including those aged 50 and older) also rose to 1.1 births per 1,000 women in 2022, up from 0.9 in 2021, marking the first change in this rate since 2015. The number of births in this group surged by 12% from 2021 to 2022. As maternal age continues to rise, the demand for non-invasive prenatal testing is expected to grow accordingly in the forecast period.
The integration of next-generation sequencing technology has significantly enhanced the capabilities of researchers, enabling them to conduct a wide range of applications and study biological systems at a higher level. Next-generation sequencing allows for the simultaneous sequencing of thousands to millions of DNA molecules, reducing both time and cost while optimizing results for genome and DNA testing. Major companies like Illumina, Eurofins, Natera, Roche, and Annoroad have adopted this technology for non-invasive prenatal testing. The China Food and Drug Administration (CFDA) has approved the medical instrument product registration for Annoroad's NGS instrument NextSeq 550AR.
The non-invasive prenatal testing market is subject to strict regulation by various international and country-specific agencies. For instance, the US Food and Drug Administration (FDA) issues certifications for Laboratory Developed Tests (LDTs) and Clinical Laboratory Improvement Amendments (CLIA). Manufacturers must obtain a 510(k) premarket notification for in vitro diagnostic tests, with LDTs and CLIA certification based on the number of tests conducted during clinical trials. For instance, for trisomy 21 (Down syndrome), with an incidence rate of 1/1000, at least 100,000 samples would need to be tested to meet the requirements of a 510(k). A 510(k) premarket notification ensures that the new product is as safe and effective as other legally-marketed devices, and manufacturers must register such notifications before commercially marketing new products.
In January 2024, Natera, Inc., a US-based clinical genetic testing company, acquired reproductive health assets from Invitae for $42.5 million. This acquisition allows Natera to strengthen its offerings in non-invasive prenatal and carrier screening, which are key components of reproductive health. Invitae is a US-based biotechnology company that provides non-invasive prenatal testing services.
Major companies operating in the non-invasive prenatal testing market include F. Hoffmann-La Roche AG, Illumina Inc., Laboratory Corporation of America Holdings, Natera Inc., PerkinElmer Inc., Quest Diagnostics Inc., Agilent Technologies Inc., BGI Diagnosis Co Ltd., Berry Genomics Co, LifeCodexx AG, Myriad Genetics Inc., NIPD Genetics Co Ltd., Sequenom Inc., Annoroad Gene Technology Co Ltd., Centogene AG, Counsyl Inc., EUROFINS Genoma Group, Eurofins Scientific SE, Next Biosciences, Premaitha Health PLC, Ariosa Diagnostics Inc., Beijing Genomics Institute, Yourgene Health PLC, GE Healthcare Technologies Inc., Koninklijke Philips NV, Thermo Fisher Scientific Inc., Pacific Biosciences of California Inc., QIAGEN NV, MedGenome Labs Ltd., Progenity Inc.
North America was the largest region in the non-invasive prenatal testing market in 2024. Western Europe was the second largest region in the non-invasive prenatal testing market. The regions covered in the non-invasive prenatal testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa
The countries covered in the non-invasive prenatal testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain
The non-invasive prenatal testing market includes revenue earned by ultrasound detection, fetal cells in maternal blood tests, cell-free DNA in maternal plasma tests, and biochemical screening tests. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Non-invasive Prenatal Testing Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on non-invasive prenatal testing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for non-invasive prenatal testing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The non-invasive prenatal testing market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.