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市場調查報告書
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1372910

新生兒篩檢市場 - 2018-2028 年全球產業規模、佔有率、趨勢、機會和預測，按技術、測試類型、最終用戶和地區、競爭細分

Newborn Screening Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented by Technology, By Test Type, By End User, and By Region, Competition
出版日期: | 出版商: TechSci Research | 英文 170 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2022 年，全球新生兒篩檢市場價值為8.0107 億美元，預計到2028 年，預測期內將出現令人印象深刻的成長，年複合成長率為7.37%。新生兒篩檢是一項公共衛生計劃，涉及對新生兒進行系統檢測，以了解新生兒是否存在健康問題。出生後不久就會出現一系列遺傳、代謝和先天性疾病。新生兒篩檢的主要目標是在生命早期（通常在症狀出現之前）識別出面臨某些嚴重或危及生命疾病風險的嬰兒，以便能夠及時啟動適當的醫療干涉和治療。新生兒篩檢通常是政府衛生機構管理的公共衛生計劃的一部分。它作為出生後不久的常規醫療保健的一部分提供給所有新生兒。新生兒篩檢組中包含的特定疾病和篩檢時間可能因地區和國家而異。當地醫療保健政策和資源影響新生兒篩檢計劃的範圍。新生兒遺傳和代謝疾病盛行率的增加是重要的促進因素。透過新生兒篩檢進行早期發現可以及時干涉並更好地管理這些情況。

主要市場促進因素

市場概況
預測期 2024-2028
2022 年市場規模 80107萬美元
2028 年市場規模 12364.6億美元
2023-2028 年年複合成長率 7.37%
成長最快的細分市場 醫院
最大的市場 北美洲

技術進步

新一代定序 (NGS) 透過同時分析與各種遺傳和代謝疾病相關的多個基因，徹底改變了新生兒篩檢。它可以進行更全面的篩檢，包括檢測以前難以識別的罕見和新穎的基因突變。 NGS 也能夠診斷具有複雜遺傳基礎的疾病，例如脊髓性肌肉萎縮症 (SMA) 和某些形式的智力障礙。串聯質譜 (MS/MS) 技術已成為分析新生兒代謝紊亂的標準工具。它可以同時測量單一血液樣本中的多種代謝物，使其高效且經濟高效。 MS/MS 擴大了可篩檢的疾病範圍，包括胺基酸疾病和脂肪酸氧化疾病。多重測定可以同時測量單一樣品中的多種生物標記或分析物。這些測定用於檢測各種代謝和遺傳疾病，包括溶小體貯積症和原發性免疫缺陷。 DBS（乾血斑（DBS））技術的進步提高了濾紙上採集的血液樣本的穩定性和靈敏度。

DBS 可以輕鬆採集、運輸和儲存血液樣本，使其成為新生兒篩檢的實用選擇。生物資訊工具和軟體在解釋 NGS 和其他先進篩選方法產生的複雜資料方面發揮著至關重要的作用。這些工具有助於識別新生兒基因組中致病的突變和變異。 POCT（即時護理測試）設備專為特定的新生兒篩檢測試而開發，可在床邊快速得出結果。例如，POCT 脈搏血氧測定法用於在出生後不久篩檢嚴重先天性心臟病 (CCHD)。實驗室設備的小型化和自動化提高了篩選測試的效率和通量。自動化系統可以處理更多的樣品，同時保持準確性並減少人為錯誤。生物標記發現的進展導致了與各種疾病相關的新標記的鑑定。這些生物標記用於開發新的篩檢方法並擴大新生兒篩檢的範圍。遠距醫療和數位健康平台可以與醫療保健提供者和專家有效共享篩檢結果。數據與電子健康記錄 (EHR) 的整合促進了受影響嬰兒的資訊無縫流動和後續護理。品質控制措施和標準提高了新生兒篩檢測試的可靠性，確保結果準確。這項因素將有助於全球新生兒篩檢市場的發展。

消費者對綜合篩檢的需求不斷增加

如今，準父母和家庭可以獲得大量有關醫療保健和醫學檢測的資訊。資訊獲取的增加提高了人們對新生兒綜合篩檢益處的認知。父母通常希望確保新生兒有最好的開始，並重視及早發現潛在的健康問題。全面篩檢可以更全面地評估新生兒的健康狀況，讓父母更安心。許多私人醫療保健提供者和診斷中心提供全面的新生兒篩檢套餐。與標準公共衛生篩檢計劃相比，這些套餐通常包括更廣泛的測試。有些家長喜歡在同一時間在一處進行所有必要的篩檢測試的便利性。全面的篩檢套餐可以提供這種便利。有些家庭可能有遺傳或代謝疾病史，這增加了他們對全面篩檢以評估新生兒風險的興趣。全面的篩檢可以讓父母更放心，因為他們知道他們的新生兒已經針對各種情況進行了徹底的評估。

在日益全球化的世界中，家庭可能來自不同的背景和地區，採用不同的篩檢方案。全面篩檢有助於解決篩檢實踐中的潛在差距或差異。社群媒體平台和線上育兒社群在傳播新生兒篩檢訊息和影響父母選擇方面發揮作用。其他家長分享的正面經驗可以鼓勵全面篩檢。技術和醫學研究的進步使全面的新生兒篩檢變得更加可行和方便，從而滿足了消費者的需求。一些家長可能會尋求客製化篩檢小組，以符合他們的特定問題或遺傳史，從而推動對個人化篩檢選項的需求。這項因素將加快全球新生兒篩檢市場的需求。

遺傳和代謝疾病的發生率上升

新生兒篩檢通常可以在症狀出現之前及早發現遺傳和代謝疾病。早期介入和治療可以預防或減輕這些病症的嚴重程度，從而改善受影響嬰兒的長期健康結果。許多遺傳和代謝疾病如果未被發現和治療，可能會導致嚴重的健康併發症、發育遲緩，甚至死亡。新生兒篩檢透過早期醫療管理有助於降低與這些疾病相關的死亡率和發病率。透過新生兒篩檢及時診斷和介入可以顯著改善受影響嬰兒及其家人的生活品質。早期治療可以防止不可逆轉的損害並支持更好的長期結果。透過新生兒篩檢識別受影響的嬰兒也具有更廣泛的公共衛生影響。它有助於透過促進知情的計劃生育決策來防止某些遺傳性疾病在家庭和人群中的傳播。

遺傳和代謝疾病的發生率因人群和地區而異，但由於人口結構變化、血緣關係增加和其他遺傳風險因素等因素，某些疾病變得更加普遍。篩檢技術的進步擴大了可以有效率、準確地篩選的條件範圍。這使得在新生兒篩檢小組中涵蓋更多疾病成為可能。隨著醫療保健專業人員和家長對新生兒篩檢益處的認知不斷提高，對這些服務的需求也不斷增加。教育和宣傳工作強調了早期發現的重要性。在許多國家和地區，新生兒篩檢是法律強制規定的，或是標準醫療保健實踐的一部分。這些規定有助於提高篩檢率和需求。國際衛生組織和計劃推動了新生兒篩檢計畫的擴大，特別是在遺傳和代謝疾病負擔可能較高的低收入和中等收入國家。精準醫學和基因組學的興起凸顯了早期基因檢測和診斷的重要性，進一步強調了新生兒篩檢的需求。這項因素將加速全球新生兒篩檢市場的需求。

主要市場挑戰

教育和意識

許多父母和照顧者可能沒有完全意識到新生兒篩檢的重要性，或者可能對篩檢的目的和好處有誤解。缺乏認知可能會導致錯失早期發現和介入的機會。包括產科醫生、兒科醫生和助產士在內的醫療保健專業人員在向父母通報新生兒篩檢方面發揮著至關重要的作用。然而，並非所有醫療保健提供者都能掌握最新資訊或在產前和產後護理就診期間優先討論新生兒篩檢。在多元文化和多語言社會中，語言和文化障礙可能會阻礙新生兒篩檢的有效溝通。確保不同人群能夠獲取和理解資訊是一項挑戰。不同的國家和地區有不同的與新生兒篩檢相關的醫療保健系統、政策和實踐。這可能導致意識和獲得篩檢服務的差異。在一些低收入和中等收入國家，資源限制可能會限制新生兒篩檢教育和宣傳活動的能力。這可能會導致訊息傳播不充分。在新生兒中篩檢的一些遺傳和代謝疾病可能人們知之甚少或帶有恥辱感。這可能導致家長不願意參與篩檢或後續測試。

罕見疾病和變異性

罕見疾病涵蓋範圍廣泛，每種疾病都有其獨特的遺傳和臨床特徵。這種異質性使得開發能夠有效檢測所有罕見疾病的標準化篩檢測試變得具有挑戰性。對於許多罕見疾病，可用的流行病學資料和臨床研究有限。資訊的缺乏可能會阻礙有效篩檢方案的發展。根據定義，罕見疾病在一般人群中的盛行率較低。這意味著篩檢計畫必須對許多新生兒進行測試，以識別少數受影響的個體，這可能會佔用大量資源。罕見疾病的起病和臨床表現通常各不相同。一些受影響的嬰兒可能直到晚年才會表現出症狀，這使得透過新生兒篩檢進行早期發現更具挑戰性。對於一些罕見疾病，有效的治療方法可能有限或沒有。如果沒有可行的治療方案，早期發現可能無法總是帶來更好的結果。導致罕見疾病的基因突變在個體之間可能存在很大差異。開發能夠檢測所有可能的遺傳變異的篩檢測試是一項複雜的任務。平衡罕見疾病篩檢試驗的敏感度和特異性是很困難的。高敏感性可能會導致更多的假陽性，而高特異性可能會導致偽陰性。

主要市場趨勢

私人測試的興起

一些父母願意支付更廣泛的新生兒篩檢費用，其中包括比公共衛生計劃通常提供的更廣泛的遺傳和代謝疾病。個人化醫療的趨勢影響了新生兒篩檢。父母可以根據他們的家族病史或遺傳傾向尋求客製化的篩檢選項。私人醫療保健提供者和診斷中心經常投資最新的篩檢技術和方法，這些技術和方法可以提供更全面、更準確的結果。私人檢測設施可以提供更快的篩檢結果週轉時間，讓家長安心，並在需要時進行早期介入。有些家庭重視私人檢測中心提供的隱私和保密性，尤其是在遺傳資訊方面。私人測試使家長對篩檢過程有更多的控制權和自主權，包括測試的選擇和測試的時間。私人檢測中心可以提供額外的服務，例如遺傳諮詢、計劃生育建議以及為有特定病症的嬰兒的家庭提供持續支持。出國旅行或搬遷的家庭可能會選擇私人檢測，以確保護理的連續性和一致的篩檢做法，特別是如果他們來自篩檢方案不同的地區。

細分市場洞察

技術洞察

2022 年，全球新生兒篩檢市場將由脈搏血氧儀細分市場主導，預計未來幾年將繼續擴大。脈搏血氧測定法是一種非侵入性且相對簡單的測試，可測量新生兒血液中的氧飽和度。這種篩檢有助於及早發現患有嚴重先天性心臟病 (CCHD) 的新生兒，以便及時介入和治療。脈搏血氧測定是一種無痛、非侵入性的過程，可以快速、輕鬆地進行。它不需要抽血或其他侵入性方法，因此嬰兒及其父母具有良好的耐受性。許多國家和地區已將脈搏血氧飽和度篩檢作為新生兒篩檢指南的一部分，促進了其在 CCHD 檢測中的廣泛應用。許多醫療保健組織和專業協會建議在新生兒篩檢方案中使用脈搏血氧儀，這可能會導致其廣泛採用。

測試類型見解

2022 年，全球新生兒篩檢市場將由乾血斑 (DBS) 細分市場主導，預計未來幾年將繼續擴大。 DBS 是一種非侵入性且便捷的新生兒血液採樣方法。它包括簡單的足跟採血以獲得幾滴血液，然後將其吸收到濾紙上。與傳統的靜脈抽血相比，這種微創方法對嬰兒的耐受性良好，對嬰兒和父母的創傷較小。 DBS樣品穩定，可以長期保存，可以輕鬆地將樣品運送到集中實驗室進行檢測。這使其成為一個實用的選擇，特別是在先進醫療設施有限的地區。與靜脈抽血等其他樣本採集方法相比，它們具有成本效益。使用濾紙作為收集介質價格低廉，並且樣品收集的簡單性降低了勞動力和設備成本。

最終使用者見解

2022年，全球新生兒篩檢市場最大佔有率由診斷中心領域主導，預計未來幾年將持續擴大。診斷中心通常擁有訓練有素的專業人員，他們裝備精良，可以執行各種篩檢測試。他們擁有準確處理和分析新生兒篩檢樣本所需的專業知識。診斷中心通常投資最先進的新生兒篩檢設備和技術。這包括用於生化、遺傳和代謝檢測的先進儀器，可以提高篩檢的準確性和效率。一些診斷中心提供私人和公共服務。這意味著雖然公共醫療系統可能會將新生兒轉介到這些中心，但喜歡私人檢測的父母也可以付費使用這些服務。

區域洞察

到2022 年，北美地區將在全球新生兒篩檢市場中佔據主導地位。由於政府立法、強大的醫療基礎設施、該地區出生異常的高盛行率以及該地區營運商在新生兒篩檢技術方面的新技術進步，地區。預計美國將在北美地區擁有最大的市場佔有率。這是由於對複雜系統的需求不斷擴大以及新生兒疾病發生率的上升。對嬰兒出生第二天濾紙上收集的血點中的診斷標記進行研究是美國每個新生兒出生後進行檢查的方式。

目錄

第 1 章：產品概述

  • 市場定義
  • 市場範圍
    • 涵蓋的市場
    • 研究年份
    • 主要市場區隔

第 2 章：研究方法

  • 研究目的
  • 基線方法
  • 主要產業夥伴
  • 主要協會和二手資料來源
  • 預測方法
  • 數據三角測量與驗證
  • 假設和限制

第 3 章：執行摘要

  • 市場概況
  • 主要市場細分概述
  • 主要市場參與者概述
  • 重點地區/國家概況
  • 市場促進因素、挑戰、趨勢概述

第 4 章：COVID-19 對全球新生兒篩檢市場的影響

第 5 章：客戶之聲

第 6 章：全球新生兒篩檢市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依技術（串聯質譜、脈搏血氧測定、酵素測定、DNA 測定和其他技術）
    • 依測試類型（乾血斑、聽力篩檢、嚴重先天性心臟病 (CCHD) 和其他測試類型）
    • 按最終使用者（醫院、診斷中心和其他最終使用者），
    • 按地區
    • 按公司分類 (2022)
  • 市場地圖

第 7 章：亞太地區新生兒篩檢市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依技術
    • 按測試類型
    • 按最終用戶
    • 按國家/地區
  • 亞太地區：國家分析
    • 中國新生兒篩檢
    • 印度新生兒篩檢
    • 澳洲新生兒篩檢
    • 日本新生兒篩檢
    • 韓國新生兒篩檢

第 8 章：歐洲新生兒篩檢市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依技術
    • 按測試類型
    • 按最終用戶
    • 按國家/地區
  • 歐洲：國家分析
    • 法國
    • 德國
    • 西班牙
    • 義大利
    • 英國

第 9 章：北美新生兒篩檢市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依技術
    • 按測試類型
    • 按最終用戶
    • 按國家/地區
  • 北美：國家分析
    • 美國
    • 墨西哥
    • 加拿大

第 10 章：南美洲新生兒篩檢市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依技術
    • 按測試類型
    • 按最終用戶
    • 按國家/地區
  • 南美洲：國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第 11 章：中東和非洲新生兒篩檢市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依技術
    • 按測試類型
    • 按最終用戶
    • 按國家/地區
  • MEA：國家分析
    • 南非新生兒篩檢
    • 沙烏地阿拉伯新生兒篩檢
    • 阿拉伯聯合大公國新生兒篩檢

第 12 章：市場動態

  • 促進要素
  • 挑戰

第 13 章：市場趨勢與發展

  • 最近的發展
  • 產品發布
  • 併購

第 14 章：全球新生兒篩檢市場：SWOT 分析

第 15 章：波特的五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的力量
  • 客戶的力量
  • 替代產品的威脅

第 16 章：大環境分析

第17章：競爭格局

  • 商業概覽
  • 公司概況
  • 產品與服務
  • 財務（上市公司）
  • 最近的發展
  • 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：策略建議

第 19 章：關於我們與免責聲明

簡介目錄
Product Code: 16285

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 Period2024-2028
Market Size 2022USD 801.07 Million
Market Size 2028USD 1236.46 Billion
CAGR 2023-20287.37%
Fastest Growing SegmentHospitals
Largest MarketNorth 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

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