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到 2030 年新生兒篩檢市場預測：按產品、測試、技術、最終用戶和地區分類的全球分析

Newborn Screening Market Forecasts to 2030 - Global Analysis By Product, Test (Hearing Screening Test, Dried Blood Spot Test, Critical Congenital Heart Defect Test and Other Tests), Technology, End User and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3個工作天內

價格

根據 Stratistics MRC 的數據，2023 年全球新生兒篩檢市場規模為 11.5 億美元，預計到 2030 年將達到 22.9 億美元，預測期內複合年成長率為 10.3%。

新生兒篩檢是一項重要的公共衛生工作，旨在對嬰幼兒出生後立即篩檢嚴重但可治療的疾病。這項測試通常透過血液樣本進行，有助於及早識別遺傳、代謝和先天性疾病，從而實現快速干涉和改善結果。篩檢過程因地區而異，但通常包括苯酮尿症、甲狀腺機能低下症和鐮狀細胞疾病的檢查。早期發現可以及時進行醫療干預，以預防或盡量減少潛在的發育問題，並確保新生兒健康的開始。

根據美國疾病預防控制中心的數據，2015年至2017年美國新生兒疾病盛行率為每10,000名活產兒中有34例。預計每年約有 12,900 名新生兒被診斷​​出患有這種疾病。

促生長因素：遺傳病患病率上升

基因檢測技術的進步使得多種先天性疾病的早期檢測成為可能，增加了對新生兒篩檢計畫的需求。及時識別可以及時介入和治療，改善受影響兒童的長期結果。隨著醫療保健系統優先考慮全面篩檢舉措，人們越來越認知到早期檢測在遺傳疾病管理中的重要性，這有助於擴大新生兒篩檢市場。

成長抑制因素：道德與法律問題

在新生兒篩檢中，倫理問題圍繞著同意、隱私以及對家庭的潛在心理影響等問題。法律限制包括因司法管轄區而異的法規、資料保護法以及需要製定有關遺傳資訊儲存和使用的明確指南。父母可能面臨為嬰兒做出資訊決定的困境。侵犯隱私和濫用基因資料引發了對保密的擔憂。因此，這個因素阻礙了市場的擴張。

機會：開發和採用即時檢測解決方案

即時檢測解決方案的開發和普及提供了及時、便捷的診斷能力，使醫療保健專業人員能夠快速評估新生兒的各種狀況。轉向即時檢測將提高可及性、減少週轉時間並提高整體篩檢效率。這一趨勢不僅滿足了對早期準確診斷日益成長的需求，而且有助於改善新生兒醫療保健結果並加速新生兒篩檢的進步。

威脅：恥辱和歧視

恥辱和歧視是新生兒篩檢計畫的重大威脅，父母因擔心被貼上標籤和受到社會評判而不敢參與。有受影響嬰幼兒的家庭可能面臨社會恥辱、孤立和對孩子病情的誤解。這可能會導致情緒困擾並阻止人們公開討論篩檢過程。歧視也可能導致獲得支持服務的機會有限，從而加重受影響家庭的負擔。

COVID-19 的影響

COVID-19 大流行擾亂了醫療保健系統，推遲了常規篩檢，並將資源轉移到與大流行相關的優先事項上，從而影響了新生兒篩檢市場。獲得新生兒篩檢服務的機會有限，可能導致某些疾病的早期發現延遲。此外，這場大流行凸顯了彈性醫療基礎設施的重要性，以確保面對全球健康危機時包括新生兒篩檢在內的基本服務的連續性。此外，後大流行時代刺激了新生兒篩檢市場的進步，有助於兒童醫療保健結果的整體改善。

預計在預測期內，乾血斑細分市場規模最大

乾血斑片段被認為具有良好的生長，因為它是一種侵入性較小的方法。將少量血液收集在濾紙上、乾燥並分析各種代謝、遺傳和內分泌疾病。這種經濟有效且簡單的篩檢方法能夠及早發現苯酮尿症和甲狀腺機能低下症症等疾病。 DBS 檢測有助於及時干預，有助於改善受影響新生兒的結局，同時為全民篩檢計畫提供有效且易於使用的手段。

預計臨床測試領域在預測期內複合年成長率最高

預計臨床測試領域在預測期內複合年成長率最高。新生兒篩檢透過早期檢測兒童遺傳性疾病，在臨床實驗室中發揮至關重要的作用。及時的結果有助於及時進行醫療干預，防止不可逆轉的損害並改善結果。作為預防醫學的基石，它展示了臨床實驗室在透過高效、準確的篩檢過程促進可治療疾病的早期管理和保護新生兒健康方面的重要作用。

比最大的地區

由於人口密度高、出生率高以及先天性疾病發生率迅速增加，預計亞太地區在預測期內將佔據最大的市場佔有率。倫理考量、文化敏感度和法律規範的差異影響該地區篩檢舉措的實施。基礎設施和醫療保健規劃的改善、新的擴張機會的可用性等因素預計將在預測期內推動產業需求發揮重要作用。

複合年成長率最高的地區

由於先天性疾病和意識計劃的日益流行，預計北美在預測期內將呈現最高的複合年成長率。美國在該地區佔有很大的市場佔有率。在美國，所有新生兒在出生後都要篩檢，這種篩檢是透過分析出生第二天濾紙上收集的血斑上的診斷標記來進行的。此外，該地區新服務和產品的推出預計將對市場產生重大影響。

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  • 公司簡介
    • 其他市場公司的綜合分析（最多 3 家公司）
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  • 區域分割
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    • 根據產品系列、地理分佈和策略聯盟對主要企業基準化分析

目錄

第1章執行摘要

第2章 前言

  • 概述
  • 相關利益者
  • 調查範圍
  • 調查方法
    • 資料探勘
    • 資料分析
    • 資料檢驗
    • 研究途徑
  • 調查來源
    • 主要調查來源
    • 二次調查來源
    • 先決條件

第3章市場趨勢分析

  • 促進因素
  • 抑制因素
  • 機會
  • 威脅
  • 產品分析
  • 技術分析
  • 最終用戶分析
  • 新興市場
  • 新型冠狀病毒感染疾病（COVID-19）的影響

第4章波特五力分析

  • 供應商的議價能力
  • 買方議價能力
  • 替代品的威脅
  • 新進入者的威脅
  • 公司之間的競爭關係

第5章全球新生兒篩檢市場：按產品

  • 用具
    • 搖床
    • 疾病篩檢設備
    • 孵化器
  • 消耗品
    • 色譜管柱和篩檢卡
    • 檢測套件和試劑
  • 聽力篩檢設備
    • 配件
    • 裝置
  • 脈搏血氧儀

第6章 全球新生兒篩檢市場：通過測試

  • 聽力篩檢測試
  • 乾血斑試驗
  • 嚴重先天性心臟疾病(CCHD) 檢測
  • 其他測試

第7章全球新生兒篩檢市場：依技術分類

  • 凝膠電泳
  • 串聯式質譜法
  • 基於酵素的測定
  • DNA檢測
  • 螢光
  • 其他技術

第8章全球新生兒篩檢市場：依最終用戶分類

  • 醫院
  • 臨床實驗室

第9章全球新生兒篩檢市場：按地區

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳洲
    • 紐西蘭
    • 韓國
    • 其他亞太地區
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地區
  • 中東和非洲
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 卡達
    • 南非
    • 其他中東和非洲

第10章 主要進展

  • 合約、夥伴關係、協作和合資企業
  • 收購和合併
  • 新產品發布
  • 業務擴展
  • 其他關鍵策略

第11章 公司簡介

  • Agilent Technologies Inc.
  • Ab Sciex LLC
  • GE Healthcare
  • Covidien Plc
  • Bio-Rad Laboratories Inc.
  • Natus Medical Incorporated
  • PerkinElmer India Pvt. Limited
  • Rady Children's Institute for Genomic Medicine
  • Waters Corporation
  • Trivitron Healthcare
  • Masimo Corporation
  • Zivak Technologies
  • MP Biomedicals
  • DRG International
  • Regis Technologies
  • Parseq Lab
  • Zentech
  • Danaher Corporation
  • Hill-Rom Holdings Inc.
  • Thermo Fisher Scientific
Product Code: SMRC24629

According to Stratistics MRC, the Global Newborn Screening Market is accounted for $1.15 billion in 2023 and is expected to reach $2.29 billion by 2030 growing at a CAGR of 10.3% during the forecast period. Newborn screening is a vital public health initiative that involves testing infants for serious, yet treatable, conditions shortly after birth. Typically conducted through a blood sample, it helps identify genetic, metabolic, and congenital disorders early on, allowing for prompt intervention and improved outcomes. The screening process varies by region but often includes tests for conditions like phenylketonuria, congenital hypothyroidism, and sickle cell disease. Early detection enables timely medical intervention, preventing or minimizing potential developmental issues, ensuring a healthier start for newborns.

According to the US CDC, during 2015-2017, the prevalence of newborn disorders was 34 per 10,000 live births in the US. Approximately 12,900 infants are expected to be identified each year with a disorder.

Market Dynamics:

Driver:

Rising prevalence of genetic disorders

Advances in genetic testing technologies have enabled early detection of various congenital conditions, prompting higher demand for newborn screening programs. Timely identification allows for prompt intervention and treatment, improving long-term outcomes for affected infants. This rising awareness of the importance of early detection in managing genetic disorders contributes to the expansion of the newborn screening market as healthcare systems prioritize comprehensive screening initiatives.

Restraint:

Ethical and legal concerns

In the newborn screening, ethical concerns revolve around issues such as consent, privacy, and the potential psychological impact on families. Legal constraints include varying regulations across jurisdictions, data protection laws, and the need for clear guidelines on the storage and use of genetic information. Parents may grapple with the dilemma of making informed decisions for their infants. Privacy breaches and misuse of genetic data raise concerns about confidentiality. Therefore, this element hinders the market expansion.

Opportunity:

Development & adoption of point-of-care testing solutions

The development and widespread adoption of point-of-care testing solutions offer timely and convenient diagnostic capabilities, enabling healthcare professionals to quickly assess newborns for various conditions. The shift towards point-of-care testing enhances accessibility, reduces turnaround times, and improves overall screening efficiency. This trend not only meets the growing demand for early and accurate diagnoses but also contributes to better healthcare outcomes for newborns, fostering advancements in the newborn screening.

Threat:

Stigma and discrimination

Stigma and discrimination pose significant threats to newborn screening programs, deterring parents from participating due to fear of labeling or communal judgment. Families with affected infants may face societal bias, isolation, and misconceptions about their child's condition. This can lead to emotional distress and hinder open discussions about the screening process. Discrimination may also result in limited access to support services, exacerbating the burden on affected families.

COVID-19 Impact

The COVID-19 pandemic has affected the newborn screening market by disrupting healthcare systems, delaying routine screenings, and diverting resources to pandemic-related priorities. Access to newborn screening services has been limited, potentially leading to delays in early detection of certain disorders. Additionally, the pandemic has underscored the importance of resilient healthcare infrastructure to ensure the continuity of essential services, including newborn screening, in the face of global health crises. Moreover, the post-pandemic era has spurred advancements in the newborn screening market and contributed to the overall improvement of pediatric healthcare outcomes.

The dried blood spot segment is expected to be the largest during the forecast period

The dried blood spot segment is estimated to have a lucrative growth, due to its minimally invasive methods. Small blood drops are collected on filter paper, dried, and then analyzed for various metabolic, genetic, and endocrine disorders. This cost-effective and convenient screening approach allows for early detection of conditions such as phenylketonuria and hypothyroidism. DBS testing facilitates timely intervention, contributing to improved outcomes for affected newborns while providing an efficient and accessible means for population-wide screening programs.

The clinical laboratories segment is expected to have the highest CAGR during the forecast period

The clinical laboratories segment is anticipated to witness the highest CAGR growth during the forecast period. Newborn screening plays a pivotal role in clinical laboratories by detecting inherited disorders early in a child's life. Timely results enable prompt medical interventions, preventing irreversible damage and improving outcomes. As a cornerstone of preventive medicine, it facilitates the early management of treatable conditions, showcasing the indispensable role of clinical laboratories in safeguarding the health of newborns through efficient and accurate screening processes.

Region with largest share:

Asia Pacific is projected to hold the largest market share during the forecast period owing to the high population density, higher birth rate, and soaring prevalence of congenital diseases. Ethical considerations, cultural sensitivities, and variations in regulatory frameworks influence the implementation of screening initiatives in the region. Factors such as improving infrastructure and healthcare plans and the availability of new opportunities for expansion are expected to play a major role in driving industry demand over the forecast period.

Region with highest CAGR:

North America is projected to have the highest CAGR over the forecast period, owing to the growing prevalence of congenital disorders and awareness programmes. United States has the major share the region's market. In the United States, every newborn is screened post-birth, and this screening is performed by the analysis of diagnostic markers in blood spots collected on filter paper on the second day of an infant's life. Further, the launch of new services and products in the region is expected to have a significant impact on the market.

Key players in the market:

Some of the key players profiled in the Newborn Screening Market include Agilent Technologies Inc., Ab Sciex LLC, GE Healthcare, Covidien Plc, Bio-Rad Laboratories Inc., Natus Medical Incorporated, PerkinElmer India Pvt. Limited, Rady Children's Institute for Genomic Medicine, Waters Corporation, Trivitron Healthcare, Masimo Corporation, Zivak Technologies, MP Biomedicals, DRG International, Regis Technologies, Parseq Lab, Zentech, Danaher Corporation, Hill-Rom Holdings Inc. and Thermo Fisher Scientific.

Key Developments:

In April 2023, Thermo Fisher Scientific launched the first of 37 CE-IVD-marked real-time PCR assay kits, mostly for infectious diseases, that it plans to roll out this year, providing users of its QuantStudio Dx series of instruments with a menu of company-branded test kits for the first time.

In August 2022, Trivitron Healthcare launched a Centre of Excellence (CoE) with state-of-the-art research and development and manufacturing facilities at AMTZ Campus, Vishakhapatnam, India, for metabolomics, genomics, newborn screening, and molecular diagnostics.

In June 2022, Rady Children's Institute for Genomic Medicine launched a program to advance and evaluate the scalability of a diagnostic and precision medicine guidance tool called BeginNGS (pronounced 'beginnings') to screen newborns for approximately 400 genetic diseases that have known treatment options using rapid whole genome sequencing.

Products Covered:

  • Instruments
  • Consumables
  • Hearing Screening Instruments
  • Pulse oximeters

Tests Covered:

  • Hearing Screening Test
  • Dried Blood Spot Test
  • Critical Congenital Heart Defect (CCHD) Test
  • Other Tests

Technologies Covered:

  • Gel Electrophoresis
  • Tandem Mass Spectrometry
  • Enzyme Based Assays
  • DNA Assays
  • Fluorescence
  • Other Technologies

End Users Covered:

  • Hospitals
  • Clinical Laboratories

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Product Analysis
  • 3.7 Technology Analysis
  • 3.8 End User Analysis
  • 3.9 Emerging Markets
  • 3.10 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Newborn Screening Market, By Product

  • 5.1 Introduction
  • 5.2 Instruments
    • 5.2.1 Shakers
    • 5.2.2 Disorder Screening Instruments
    • 5.2.3 Incubator
  • 5.3 Consumables
    • 5.3.1 Columns & Screening Cards
    • 5.3.2 Assay kits & Reagents
  • 5.4 Hearing Screening Instruments
    • 5.4.1 Accessories
    • 5.4.2 Devices
  • 5.5 Pulse Oximeters

6 Global Newborn Screening Market, By Test

  • 6.1 Introduction
  • 6.2 Hearing Screening Test
  • 6.3 Dried Blood Spot Test
  • 6.4 Critical Congenital Heart Defect (CCHD) Test
  • 6.5 Other Tests

7 Global Newborn Screening Market, By Technology

  • 7.1 Introduction
  • 7.2 Gel Electrophoresis
  • 7.3 Tandem Mass Spectrometry
  • 7.4 Enzyme Based Assays
  • 7.5 DNA Assays
  • 7.6 Fluorescence
  • 7.7 Other Technologies

8 Global Newborn Screening Market, By End User

  • 8.1 Introduction
  • 8.2 Hospitals
  • 8.3 Clinical Laboratories

9 Global Newborn Screening Market, By Geography

  • 9.1 Introduction
  • 9.2 North America
    • 9.2.1 US
    • 9.2.2 Canada
    • 9.2.3 Mexico
  • 9.3 Europe
    • 9.3.1 Germany
    • 9.3.2 UK
    • 9.3.3 Italy
    • 9.3.4 France
    • 9.3.5 Spain
    • 9.3.6 Rest of Europe
  • 9.4 Asia Pacific
    • 9.4.1 Japan
    • 9.4.2 China
    • 9.4.3 India
    • 9.4.4 Australia
    • 9.4.5 New Zealand
    • 9.4.6 South Korea
    • 9.4.7 Rest of Asia Pacific
  • 9.5 South America
    • 9.5.1 Argentina
    • 9.5.2 Brazil
    • 9.5.3 Chile
    • 9.5.4 Rest of South America
  • 9.6 Middle East & Africa
    • 9.6.1 Saudi Arabia
    • 9.6.2 UAE
    • 9.6.3 Qatar
    • 9.6.4 South Africa
    • 9.6.5 Rest of Middle East & Africa

10 Key Developments

  • 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 10.2 Acquisitions & Mergers
  • 10.3 New Product Launch
  • 10.4 Expansions
  • 10.5 Other Key Strategies

11 Company Profiling

  • 11.1 Agilent Technologies Inc.
  • 11.2 Ab Sciex LLC
  • 11.3 GE Healthcare
  • 11.4 Covidien Plc
  • 11.5 Bio-Rad Laboratories Inc.
  • 11.6 Natus Medical Incorporated
  • 11.7 PerkinElmer India Pvt. Limited
  • 11.8 Rady Children's Institute for Genomic Medicine
  • 11.9 Waters Corporation
  • 11.10 Trivitron Healthcare
  • 11.11 Masimo Corporation
  • 11.12 Zivak Technologies
  • 11.13 MP Biomedicals
  • 11.14 DRG International
  • 11.15 Regis Technologies
  • 11.16 Parseq Lab
  • 11.17 Zentech
  • 11.18 Danaher Corporation
  • 11.19 Hill-Rom Holdings Inc.
  • 11.20 Thermo Fisher Scientific

List of Tables

  • Table 1 Global Newborn Screening Market Outlook, By Region (2021-2030) ($MN)
  • Table 2 Global Newborn Screening Market Outlook, By Product (2021-2030) ($MN)
  • Table 3 Global Newborn Screening Market Outlook, By Instruments (2021-2030) ($MN)
  • Table 4 Global Newborn Screening Market Outlook, By Shakers (2021-2030) ($MN)
  • Table 5 Global Newborn Screening Market Outlook, By Disorder Screening Instruments (2021-2030) ($MN)
  • Table 6 Global Newborn Screening Market Outlook, By Incubator (2021-2030) ($MN)
  • Table 7 Global Newborn Screening Market Outlook, By Consumables (2021-2030) ($MN)
  • Table 8 Global Newborn Screening Market Outlook, By Columns & Screening Cards (2021-2030) ($MN)
  • Table 9 Global Newborn Screening Market Outlook, By Assay kits & Reagents (2021-2030) ($MN)
  • Table 10 Global Newborn Screening Market Outlook, By Hearing Screening Instruments (2021-2030) ($MN)
  • Table 11 Global Newborn Screening Market Outlook, By Accessories (2021-2030) ($MN)
  • Table 12 Global Newborn Screening Market Outlook, By Devices (2021-2030) ($MN)
  • Table 13 Global Newborn Screening Market Outlook, By Pulse Oximeters (2021-2030) ($MN)
  • Table 14 Global Newborn Screening Market Outlook, By Test (2021-2030) ($MN)
  • Table 15 Global Newborn Screening Market Outlook, By Hearing Screening Test (2021-2030) ($MN)
  • Table 16 Global Newborn Screening Market Outlook, By Dried Blood Spot Test (2021-2030) ($MN)
  • Table 17 Global Newborn Screening Market Outlook, By Critical Congenital Heart Defect (CCHD) Test (2021-2030) ($MN)
  • Table 18 Global Newborn Screening Market Outlook, By Other Tests (2021-2030) ($MN)
  • Table 19 Global Newborn Screening Market Outlook, By Technology (2021-2030) ($MN)
  • Table 20 Global Newborn Screening Market Outlook, By Gel Electrophoresis (2021-2030) ($MN)
  • Table 21 Global Newborn Screening Market Outlook, By Tandem Mass Spectrometry (2021-2030) ($MN)
  • Table 22 Global Newborn Screening Market Outlook, By Enzyme Based Assays (2021-2030) ($MN)
  • Table 23 Global Newborn Screening Market Outlook, By DNA Assays (2021-2030) ($MN)
  • Table 24 Global Newborn Screening Market Outlook, By Fluorescence (2021-2030) ($MN)
  • Table 25 Global Newborn Screening Market Outlook, By Other Technologies (2021-2030) ($MN)
  • Table 26 Global Newborn Screening Market Outlook, By End User (2021-2030) ($MN)
  • Table 27 Global Newborn Screening Market Outlook, By Hospitals (2021-2030) ($MN)
  • Table 28 Global Newborn Screening Market Outlook, By Clinical Laboratories (2021-2030) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.