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市場調查報告書
商品編碼
1825970
2025年無創產前檢測全球市場報告Non-invasive Prenatal Testing Global Market Report 2025 |
近年來,非侵入性產前檢測市場快速擴張,市場規模從2024年的54.8億美元成長至2025年的62.7億美元,複合年成長率達14.5%。預測期內的成長可歸因於準確性的提高、風險的降低、孕婦年齡的成長、意識的提升以及臨床指南的完善。
預計未來幾年,非侵入性產前檢測市場將快速成長,到2029年將達到108.6億美元,複合年成長率為14.7%。預測期內的成長歸因於檢測服務的擴展、可近性的提高、孕婦年齡的成長、胎兒異常檢測、遠端醫療和數位健康。預測期內的主要趨勢包括檢測範圍的擴大、NIPT的廣泛應用、技術進步以及非侵入性胎兒非整倍體診斷 (NIFAD)。
非侵入性產前檢測 (NIPT) 是一種採集母體血液並進行分析,以檢測發育中胎兒潛在異常的程序。非侵入性產前檢測套組和設備用於在懷孕早期識別基因異常,主要是染色體異常。
非侵入性產前檢測的主要類別包括耗材和設備。耗材是指在使用過程中消耗的產品。設備包括NGS系統、PCR儀、微陣列、超音波設備、離心機、紫外線系統、培養箱及顯微鏡等設備。耗材包括檢測試劑套件、試劑和一次性耗材。這些應用涉及三體性、微缺失、遺傳學、Rh因子等的檢測,通常用於醫院和診斷實驗室。
2025 年春季美國突然提高關稅以及由此引發的貿易摩擦對醫療保健產業產生了重大影響,尤其是基本醫療設備、診斷設備和藥品的供應。醫院和醫療保健提供者正努力應對進口手術器械、診斷影像系統以及注射器和導管等消耗品成本的上漲,其中許多產品的國內替代品有限。這些不斷上漲的成本使醫療保健預算捉襟見肘,導致一些醫療機構推遲設備升級或將增加的費用轉嫁給患者。此外,原料和零件的關稅擾亂了關鍵藥品和醫療設備的生產,造成供應鏈延遲。作為應對措施,該行業正在採用多樣化的籌資策略,盡可能擴大本地生產,並遊說對關鍵醫療產品免關稅。
本研究報告是商業研究公司 (The Business Research Company) 新報告系列的一部分,該系列提供無創產前檢測市場統計數據,例如全球市場規模、區域佔有率、競爭對手的市場佔有率、詳細的無創產前檢測細分市場、市場趨勢和機遇,以及您在無創產前檢測行業取得成功所需的數據。這份非侵入性產前檢測市場研究報告對該行業的現狀和未來趨勢進行了詳細分析,為您提供所需的一切觀點。
未來五年14.7%的成長率預測比我們先前的預測略有下降,下降了0.2%。這一下降主要源自於美國與其他國家之間關稅的影響。貿易摩擦可能導致新加坡和比利時開發的定序試劑套件和生物資訊軟體價格上漲、產前檢測延遲以及婦產科 (OB/GYN) 費用增加,阻礙美國無細胞DNA篩檢的普及。由於互惠關稅以及貿易緊張局勢和限制加劇對全球經濟和貿易的負面影響,貿易摩擦的影響可能會更加廣泛。
唐氏症的高發生率是推動非侵入性產前檢測 (NIPT) 市場成長的關鍵因素,特別是當母親老化成為胎兒健康日益受到關注的因素時。唐氏症是一種由細胞分裂錯誤引起的染色體異常,導致多餘的 21 號染色體,這會影響胎兒的認知和身體發育。 NIPT篩檢測試提供了一種安全、非侵入性的唐氏症檢測方法,不會對母親或胎兒造成傷害,也不會有流產的風險。此測試可以檢測出 99% 以上的唐氏症。在美國,國家唐氏症協會和疾病管制與預防中心報告稱,每 700 名嬰兒中就有 1 名患有唐氏症,而 80% 的唐氏症嬰兒出生於高齡母親。高齡產婦帶來的風險增加正在推動 NIPT 市場的成長。
高齡產婦的趨勢預計將推動非侵入性產前檢測 (NIPT) 市場的成長。教育追求、職業發展、經濟穩定、個人選擇、晚婚、避孕方法的改進以及社會變革等因素,促使女性在計劃生育方面做出更明智的決定。隨著女性延遲生育,染色體異常的風險也隨之增加,越來越多的孕婦選擇 NIPT 來監測懷孕健康。例如,美國疾病管制與預防中心2023年6月發布的報告指出,35至39歲女性的臨時生育率將增加2%,從2021年的每千名女性生育53.7個孩子增加到2022年的每千名女性生育54.9個孩子。同樣,30多歲後期女性的生育率在2021年至2022年間也增加了2%。對於40至44歲年齡層,臨時生育率增加了4%,從2021年的每千名女性生育12個孩子增加到2022年的12.5個孩子。這是自1985年(3.8)以來該年齡層的生育率首次持續增加。此外,從 2021 年到 2022 年,該年齡層的出生人數增加了 6%。 45-49 歲女性(包括 50 歲及以上)的臨時生育率也從 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,這是自 2015 年以來的首次變化。從 2021 年到 2022 年,該年齡層的出生人數躍升了 12%。隨著母親年齡的不斷上升,預計在預測期內對非侵入性產前檢測的需求將相應增加。
新一代定序技術的整合顯著提升了研究人員的能力,使其在生物系統領域擁有更廣泛的應用和更高水準的研究。次世代定序儀能夠同時對數千至數百萬個DNA分子定序,最佳化基因組和DNA檢測結果,同時降低時間和成本。 Illumina、Eurofins、Natera、羅氏和安諾優達等領先公司已將該技術應用於非侵入性產前檢測。中國食品藥物監督管理總局(CFDA)已核准安諾優達NextSeq 550AR新一代定序系統獲得醫療設備產品註冊。
非侵入性產前檢測市場受到各種國際和國家機構的嚴格監管。例如,美國食品藥物管理局(FDA) 頒發臨床實驗室開發測試 (LDT) 和臨床實驗室改進法案 (CLIA) 認證。製造商必須獲得體外診斷產品的上市前通知 (510(k))。 LDT 和 CLIA 認證是基於臨床試驗期間進行的測試數量。例如,對於發病率為千分之一的 21 三體症候群(唐氏症),至少需要 100,000 個樣本才能滿足 510(k) 要求。 510(k) 上市前通知確保新產品與其他合法銷售的設備一樣安全有效,製造商必須在銷售新產品之前註冊此類通知。
2024年1月,美國臨床基因檢測公司Natera以4,250萬美元收購了Invitae的生殖健康資產。此次收購將增強Natera在非侵入性產前檢測和攜帶者篩檢是生殖保健的重要組成部分。 Invitae是一家提供非侵入性產前檢測服務的美國生技公司。
非侵入性產前檢測市場的主要參與者包括 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.、北京基因組研究所、Yurgen Health Inc.、GE Healthcare Technology Inc.、飛利浦、賽默飛爾浦、賽默飛世科技公司、GE Healthcare Technology Inc。 Labs, Inc. 以及 Progenity, Inc.。
2024年,非侵入性產前檢測市場最大的地區是北美。西歐是非侵入性產前檢測市場的第二大地區。非侵入性產前檢測市場報告涵蓋以下地區:亞太地區、西歐、東歐、北美、南美、中東和非洲。
非侵入性產前檢測市場報告涵蓋的國家有澳洲、巴西、中國、法國、德國、印度、印尼、日本、俄羅斯、韓國、英國、美國、加拿大、義大利和西班牙。
非侵入性產前檢測市場包括超音波檢測、母血胎兒細胞檢測、母血漿遊離DNA檢測和生化篩檢的收益。市場價值包括服務提供者銷售或包含在服務產品中的相關商品的價值。僅包括營業單位之間交易或銷售給最終消費者的商品和服務。
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.