新生児スクリーニングの市場規模および予測（2020年～2030年）、世界および地域シェア、動向、成長機会分析レポートの対象範囲製品タイプ別（試薬およびアッセイキット、機器）、技術別（タンデム質量分析（TMS）、分子アッセイ、免疫アッセイおよび酵素アッセイ、パルスオキシメトリースクリーニング技術、その他）、検査タイプ別（乾燥血液スポット検査、聴覚スクリーニング検査、重症先天性心疾患（CCHD）検査、その他]、エンドユーザー（病院・診療所、診断研究所）、地域（北米、欧州、アジア太平洋、中東・アフリカ、中南米）

Newborn Screening Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Product Type (Reagents and Assay Kits, and Instruments), Technology [Tandem Mass Spectrometry (TMS), Molecular Assays, Immunoassays and Enzymatic Assays, Pulse Oximetry Screening Technology, and Others], Test Type [Dry Blood Spot Test, Hearing Screen Test, Critical Congenital Heart Diseases (CCHD) Test, and Others], End User (Hospitals and Clinics, and Diagnostic Laboratories), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

世界の新生児スクリーニング市場は、2022年の12億600万米ドルから2030年には24億8400万米ドルに達すると予測されている。2022年から2030年までの年平均成長率は9.4%と推定される。市場を牽引する主な要因とし... もっと見る

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世界の新生児スクリーニング市場は、2022年の12億600万米ドルから2030年には24億8400万米ドルに達すると予測されている。2022年から2030年までの年平均成長率は9.4%と推定される。

市場を牽引する主な要因としては、先天性疾患の負担増と新生児疾患の有病率の増加が挙げられる。しかし、新生児スクリーニングの政策や手順が世界的に統一されていないことや、偽陽性・偽陰性の結果が市場成長の妨げとなっている。

新生児スクリーニング市場の市場機会

病状の遺伝的原因に関する知識の深まりや医療技術の進歩に伴い、新生児の包括的な遺伝子スクリーニングの需要が高まっている。その結果、新生児スクリーニング市場の企業は、革新的で費用対効果の高いスクリーニング・ソリューションを開発している。米国FDAは2017年、特定の種類の急性リンパ芽球性白血病の小児患者に使用するためのKymriah遺伝子治療を認可した。この治療では、キメラ抗原受容体をコードする新しい遺伝子が患者のT細胞に挿入され、変化したT細胞を刺激して白血病細胞を追いかけて破壊する。イエスカルタとジンテグロは、大細胞型B細胞リンパ腫とβ-サラセミアに対して認可された遺伝子治療の2つの例である。さらに、生まれながらにして病気に対する遺伝的素因を特定する能力を付与する技術の出現は、個別化医療への道を開き、精密医療という広範な傾向と一致する。

妊娠中の遺伝性疾患のスクリーニングは、妊娠に関連する問題の早期発見にも重点を置いている。次世代シーケンサーは、すべての染色体における異数体（ダウン症候群やトリソミー21など）や部分的な染色体異常（重複や欠失）の検出において95％以上の感度で新生児の出生前スクリーニングを支援する。蛍光in-situハイブリダイゼーション(FISH)は、鎌状赤血球貧血のような単発性疾患を検出するために使用されます。母体血漿を用いた無細胞胎児DNAアプローチのような非侵襲的手順は、遺伝子検査における最近の進歩である。胚DNAはその大きさの違いから母体DNA片と区別することができる。蛍光プローブを用いたリアルタイムPCR、ショットガンシーケンス（SolexaまたはIllumina）、あるいは巨大なターゲットパラレルシーケンスを用いて、胎児の病状に関連するDNAを調べることができる。これにより、この種の遺伝子スクリーニングがさらに研究されれば、医師は特定の薬理療法（薬理遺伝学）による早期の分子的介入を行ったり、細胞、組織、臓器を物理的、化学的に変化させたりすることができるようになる。このように、乳児の遺伝性疾患スクリーニング方法の進歩は、新生児スクリーニング市場全体にとって計り知れない可能性を秘めている。

新生児スクリーニング市場を阻害する要因

国によってスクリーニングされる疾患のリストが異なるため、新生児スクリーニングの政策や実施方法が世界的に統一されていない。包括的な疾患のスクリーニングを行う国もあれば、限られた疾患に焦点を当てる国もある。この違いは、スクリーニング検査や技術を開発する企業にとって障壁となり、特定の市場に合わせて製品を変更する必要があるため、規模の経済が制限される。さらに、標準化されたプロトコルがないため、品質管理やデータ収集に一貫性がない。これはスクリーニング結果の不正確さや、地域間のデータ比較の困難さにつながり、研究者や医療提供者にとって、調査対象地域で実施されているスクリーニングプログラムの有効性を評価することを困難にしている。さらに、普遍的な基準が存在しないため、新生児スクリーニング市場で事業を展開する企業にとっては規制の状況が複雑になる。統一性の欠如はまた、国際的な共同研究やデータ共有の妨げとなり、新生児スクリーニングの研究や技術開発の可能性を制限する。このように、新生児スクリーニングの政策と手順が統一されていないことが、新生児スクリーニング市場の進展を制限している。

新生児スクリーニング市場セグメント別概要

新生児スクリーニング市場は、製品タイプ別に試薬・アッセイキットと機器に区分される。2022年には、試薬およびアッセイキットセグメントがより大きな市場シェアを占め、今後数年間で最も速い速度で成長すると予測されている。新生児スクリーニング用のさまざまな試薬およびアッセイキットは、DNAベースのアッセイ、免疫アッセイ、酵素アッセイに分類される。市場の様々な企業が、新生児スクリーニングに特化した様々な試薬やアッセイキットを開発している。まず、Labsystems Diagnostics社は、新生児のフェニルアラニンレベルが上昇すると知的障害を引き起こす可能性があるため、フェニルアラニン含有量に基づいて新生児のフェニルケトン尿症（PKU）を検出するための蛍光マイクロプレートベースのアッセイを発売した。当社が提供する試薬キットはすべて、手動モジュラーシステムまたは全自動ハンズオフシステムである。

新生児スクリーニング市場は、技術別にタンデム質量分析（TMS）、分子アッセイ、免疫アッセイ、酵素アッセイ、パルスオキシメトリー・スクリーニング技術、その他の技術に区分される。2022年には、パルスオキシメトリースクリーニング技術セグメントが市場で最大のシェアを占めた。さらに、イムノアッセイおよび酵素アッセイ分野は、今後数年間で最も急速に成長すると予想されている。先天性心疾患（CCHD）は、最も一般的な先天性障害の1つで、管依存性の先天性心疾患である。出生前や出生後に発見されることもあるが、新生児期や乳児期に未診断・未治療の場合、生命を脅かすこともある。パルスオキシメトリーによるスクリーニングは、乳児の重篤なCCHDを発見するために用いられます。痛みを伴わず、非侵襲的で、費用対効果の高い乳児スクリーニング法です。パルスオキシメーターによるスクリーニングでは、血液中のヘモグロビンが酸素で飽和している割合を測定します。

新生児スクリーニング市場は、検査タイプ別に、乾燥血液スポット検査、聴覚スクリーン検査、重症先天性心疾患検査、その他の検査に区分される。2022年には、血液スポット検査部門が市場で最大のシェアを占めた。同セグメントの新生児スクリーニング市場は、2022〜2030年に大幅なCAGRで成長すると推定される。

新生児スクリーニング市場は、エンドユーザー別に病院、診療所、診断研究所に区分される。2022年には、病院・診療所セグメントがより大きな市場シェアを占めている。しかし、病院・診療所セグメントは、2022-2030年にCAGRで成長すると推定される。医療提供者は、病院の部屋または新生児・保育所エリアで新生児スクリーニング検査を実施する。病院・診療所セグメントは、これらの施設が新生児スクリーニングのために最大限の患者数を受け入れていることから、今後数年間は新生児スクリーニング市場でより大きなシェアを占めると予測されている。より良い施設、さまざまな治療オプションの利用可能性、一つ屋根の下での優れた看護ケアは、さまざまな診断および治療手順のためにこれらの施設に患者を引き付ける。

新生児スクリーニング市場地理的概観

北米の新生児スクリーニング市場は、近年著しい成長を遂げている。先天性障害を特定し管理するための早期スクリーニングの重要性に対する両親や医療専門家の意識の高まりに伴い、新生児スクリーニングサービスに対する需要が大幅に増加している。さらに、医療技術の向上は新生児スクリーニングの能力を高める上で極めて重要であり、検査室の自動化はスクリーニングの精度、スピード、費用対効果を高めている。これによって医療専門家は、より広範な遺伝・代謝疾患をカバーする徹底した新生児スクリーニング・パネルを提供できるようになった。有利な法律や規制措置も北米の新生児スクリーニング市場に利益をもたらしている。多くの州や州が新生児スクリーニングの義務化プログラムを実施しており、すべての乳児が出生直後にスクリーニングを受けられるようになっている。例えば、米国では各州が公衆衛生プログラムとして新生児スクリーニングを実施しており、年間約400万人の乳児がこのプログラムの下で出産時にはあまり見られない病気のスクリーニングを受けている。テキサス州保健福祉局は2021年6月、脊髄性筋萎縮症（SMA）の新生児スクリーニングを開始した。

新生児スクリーニング市場に関する報告書を作成する際に参照した主な一次および二次情報源としては、世界銀行データ、国民保健サービス（NHS）、FDA（食品医薬品局）、EMA（欧州医薬品庁）、WHO（世界保健機関）などがある。

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TABLE OF CONTENTS

1. Introduction
1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation
2. Executive Summary
2.1 Key Insights
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. Newborn Screening Market Landscape
4.1 Overview
4.2 PEST Analysis
4.2.1 Global PEST Analysis
5. Newborn Screening Market - Key Industry Dynamics
5.1 Key Market Drivers
5.1.1 Surging Government Funding for Newborn Screening
5.1.2 Rising Burden of Congenital Diseases
5.1.3 Increasing Prevalence of Newborn Disorders
5.2 Key Market Restraints
5.2.1 Lack of Uniformity in Newborn Screening Policies and Practices
5.3 Key Market Opportunities
5.3.1 Genetic Screening of Newborns
5.4 Future Trends
5.4.1 Integration of Machine Learning and Artificial Intelligence in Screening
5.5 Impact Analysis:
6. Newborn Screening Market - Global Market Analysis
6.1 Newborn Screening Market Revenue (US$ Mn), 2022 – 2030
7. Global Newborn Screening Market – Revenue and Forecast to 2030 – by Product Type
7.1 Overview
7.2 Newborn Screening Market Revenue Share, by Product Type, 2022 & 2030 (%)
7.3 Reagents and Assay Kits
7.3.1 Overview
7.3.2 Reagents and Assay Kits: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
7.3.2.1 Global Newborn Screening Market, by Reagents and Assay Kits, 2020–2030 (US$ Million)
7.4 Instruments
7.4.1 Overview
7.4.2 Instruments: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
7.4.2.1 Global Newborn Screening Market, by Instruments, 2020–2030 (US$ Million)
8. Global Newborn Screening Market – Revenue and Forecast to 2030 – by Technology
8.1 Overview
8.2 Newborn Screening Market Revenue Share, by Technology 2022 & 2030 (%)
8.3 Tandem Mass Spectrometry (TMS)
8.3.1 Overview
8.3.2 Tandem Mass Spectrometry (TMS): Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
8.4 Molecular Assays
8.4.1 Overview
8.4.2 Molecular Assays: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
8.5 Immunoassays and Enzymatic Assays
8.5.1 Overview
8.5.2 Immunoassays and Enzymatic Assays: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
8.6 Pulse Oximetry Screening Technology
8.6.1 Overview
8.6.2 Pulse Oximetry Screening Technology: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
8.7 Other Technologies
8.7.1 Overview
8.7.2 Other Technologies: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
9. Global Newborn Screening Market – Revenue and Forecast to 2030 – by Test Type
9.1 Overview
9.2 Newborn Screening Market Revenue Share, by Test Type 2022 & 2030 (%)
9.3 Dry Blood Spot Test
9.3.1 Overview
9.3.2 Dry Blood Spot Test: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
9.4 Hearing Screen Test
9.4.1 Overview
9.4.2 Hearing Screen Test: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
9.5 Critical Congenital Heart Diseases (CCHD) Test
9.5.1 Overview
9.5.2 Critical Congenital Heart Diseases (CCHD) Test: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
9.6 Other Test Types
9.6.1 Overview
9.6.2 Other Test Types: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
10. Global Newborn Screening Market – Revenue and Forecast to 2030 – by End User
10.1 Overview
10.2 Newborn Screening Market Revenue Share, by End User, 2022 & 2030 (%)
10.3 Hospitals and Clinics
10.3.1 Overview
10.3.2 Hospitals and Clinics: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
10.4 Diagnostic Laboratories
10.4.1 Overview
10.4.2 Diagnostic Laboratories: Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
11. Newborn Screening Market - Geographical Analysis
11.1 North America Newborn Screening Market, Revenue and Forecast To 2030
11.1.1 Overview
11.1.2 North America Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.1.3 North America: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.1.3.1 North America: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.1.3.2 North America: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.1.4 North America: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.1.5 North America: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.1.6 North America: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.1.6.1 North America Newborn Screening Market, by Country
11.1.6.2 US
11.1.6.2.1 US Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.1.6.2.2 US: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.1.6.2.2.1 US: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.1.6.2.2.2 US: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.1.6.2.3 US: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.1.6.2.4 US: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.1.6.2.5 US: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.1.6.3 Canada
11.1.6.3.1 Canada Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.1.6.3.2 Canada: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.1.6.3.2.1 Canada: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.1.6.3.2.2 Canada: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.1.6.3.3 Canada: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.1.6.3.4 Canada: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.1.6.3.5 Canada: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.1.6.4 Mexico
11.1.6.4.1 Mexico Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.1.6.4.2 Mexico: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.1.6.4.2.1 Mexico: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.1.6.4.2.2 Mexico: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.1.6.4.3 Mexico: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.1.6.4.4 Mexico: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.1.6.4.5 Mexico: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.2 Europe Newborn Screening Market, Revenue and Forecast to 2030
11.2.1 Overview
11.2.2 Europe Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.2.3 Europe: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.2.3.1 Europe: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.2.3.2 Europe: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.2.4 Europe: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.2.5 Europe: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.2.6 Europe: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.2.6.1 Europe Newborn Screening Market, by Country
11.2.6.2 UK
11.2.6.2.1 UK Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.2.6.2.2 UK: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.2.6.2.2.1 UK: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.2.6.2.2.2 UK: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.2.6.2.3 UK: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.2.6.2.4 UK: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.2.6.2.5 UK: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.2.6.3 Germany
11.2.6.3.1 Germany Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.2.6.3.2 Germany: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.2.6.3.2.1 Germany: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.2.6.3.2.2 Germany: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.2.6.3.3 Germany: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.2.6.3.4 Germany: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.2.6.3.5 Germany: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.2.6.4 France
11.2.6.4.1 France Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.2.6.4.2 France: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.2.6.4.2.1 France: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.2.6.4.2.2 France: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.2.6.4.3 France: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.2.6.4.4 France: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.2.6.4.5 France: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.2.6.5 Italy
11.2.6.5.1 Italy Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.2.6.5.2 Italy: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.2.6.5.2.1 Italy: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.2.6.5.2.2 Italy: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.2.6.5.3 Italy: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.2.6.5.4 Italy: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.2.6.5.5 Italy: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.2.6.6 Spain
11.2.6.6.1 Spain Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.2.6.6.2 Spain: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.2.6.6.2.1 Spain: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.2.6.6.2.2 Spain: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.2.6.6.3 Spain: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.2.6.6.4 Spain: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.2.6.6.5 Spain: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.2.6.7 Rest of Europe
11.2.6.7.1 Rest of Europe Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.2.6.7.2 Rest of Europe: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.2.6.7.2.1 Rest of Europe: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.2.6.7.2.2 Rest of Europe: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.2.6.7.3 Rest of Europe: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.2.6.7.4 Rest of Europe: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.2.6.7.5 Rest of Europe: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.3 Asia Pacific Newborn Screening Market, Revenue and Forecast to 2030
11.3.1 Overview
11.3.2 Asia Pacific Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.3.3 Asia Pacific: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.3.3.1 Asia Pacific: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.3.3.2 Asia Pacific: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.3.4 Asia Pacific: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.3.5 Asia Pacific: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.3.6 Asia Pacific: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.3.6.1 Asia Pacific Newborn Screening Market, by Country
11.3.6.2 China
11.3.6.2.1 China Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.3.6.2.2 China: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.3.6.2.2.1 China: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.3.6.2.2.2 China: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.3.6.2.3 China: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.3.6.2.4 China: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.3.6.2.5 China: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.3.6.3 Japan
11.3.6.3.1 Japan Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.3.6.3.2 Japan: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.3.6.3.2.1 Japan: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.3.6.3.2.2 Japan: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.3.6.3.3 Japan: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.3.6.3.4 Japan: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.3.6.3.5 Japan: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.3.6.4 India
11.3.6.4.1 India Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.3.6.4.2 India: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.3.6.4.2.1 India: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.3.6.4.2.2 India: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.3.6.4.3 India: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.3.6.4.4 India: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.3.6.4.5 India: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.3.6.5 Australia
11.3.6.5.1 Australia Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.3.6.5.2 Australia: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.3.6.5.2.1 Australia: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.3.6.5.2.2 Australia: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.3.6.5.3 Australia: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.3.6.5.4 Australia: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.3.6.5.5 Australia: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.3.6.6 South Korea
11.3.6.6.1 South Korea Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.3.6.6.2 South Korea: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.3.6.6.2.1 South Korea: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.3.6.6.2.2 South Korea: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.3.6.6.3 South Korea: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.3.6.6.4 South Korea: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.3.6.6.5 South Korea: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.3.6.7 Rest of Asia Pacific
11.3.6.7.1 Rest of Asia Pacific Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.3.6.7.2 Rest of Asia Pacific: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.3.6.7.2.1 Rest of Asia Pacific: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.3.6.7.2.2 Rest of Asia Pacific: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.3.6.7.3 Rest of Asia Pacific: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.3.6.7.4 Rest of Asia Pacific: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.3.6.7.5 Rest of Asia Pacific: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.4 Middle East & Africa Newborn Screening Market, Revenue and Forecast to 2030
11.4.1 Overview
11.4.2 Middle East & Africa Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.4.3 Middle East & Africa: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.4.3.1 Middle East & Africa: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.4.3.2 Middle East & Africa: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.4.4 Middle East & Africa: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.4.5 Middle East & Africa: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.4.6 Middle East & Africa: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.4.6.1 Middle East & Africa Newborn Screening Market, by Country
11.4.6.2 Saudi Arabia
11.4.6.2.1 Saudi Arabia Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.4.6.2.2 Saudi Arabia: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.4.6.2.2.1 Saudi Arabia: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.4.6.2.2.2 Saudi Arabia: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.4.6.2.3 Saudi Arabia: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.4.6.2.4 Saudi Arabia: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.4.6.2.5 Saudi Arabia: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.4.6.3 UAE
11.4.6.3.1 UAE Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.4.6.3.2 UAE: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.4.6.3.2.1 UAE: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.4.6.3.2.2 UAE: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.4.6.3.3 UAE: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.4.6.3.4 UAE: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.4.6.3.5 UAE: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.4.6.4 South Africa
11.4.6.4.1 South Africa Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.4.6.4.2 South Africa: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.4.6.4.2.1 South Africa: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.4.6.4.2.2 South Africa: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.4.6.4.3 South Africa: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.4.6.4.4 South Africa: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.4.6.4.5 South Africa: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.4.6.5 Rest of Middle East & Africa
11.4.6.5.1 Rest of Middle East & Africa Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.4.6.5.2 Rest of Middle East & Africa: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.4.6.5.2.1 Rest of Middle East & Africa: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.4.6.5.2.2 Rest of Middle East & Africa: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.4.6.5.3 Rest of Middle East & Africa: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.4.6.5.4 Rest of Middle East & Africa: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.4.6.5.5 Rest of Middle East & Africa: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.5 South & Central America Newborn Screening Market, Revenue and Forecast to 2030
11.5.1 Overview
11.5.2 South & Central America Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.5.3 South & Central America: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.5.3.1 South & Central America: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.5.3.2 South & Central America: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.5.4 South & Central America: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.5.5 South & Central America: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.5.6 South & Central America: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.5.6.1 South & Central America Newborn Screening Market, by Country
11.5.6.2 Brazil
11.5.6.2.1 Brazil Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.5.6.2.2 Brazil: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.5.6.2.2.1 Brazil: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.5.6.2.2.2 Brazil: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.5.6.2.3 Brazil: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.5.6.2.4 Brazil: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.5.6.2.5 Brazil: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.5.6.3 Argentina
11.5.6.3.1 Argentina Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.5.6.3.2 Argentina: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.5.6.3.2.1 Argentina: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.5.6.3.2.2 Argentina: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.5.6.3.3 Argentina: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.5.6.3.4 Argentina: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.5.6.3.5 Argentina: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
11.5.6.4 Rest of South & Central America
11.5.6.4.1 Rest of South & Central America Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
11.5.6.4.2 Rest of South & Central America: Newborn Screening Market, by Product Type, 2020–2030 (US$ Million)
11.5.6.4.2.1 Rest of South & Central America: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020–2030 (US$ Million)
11.5.6.4.2.2 Rest of South & Central America: Newborn Screening Market, For Instruments by Product Type, 2020–2030 (US$ Million)
11.5.6.4.3 Rest of South & Central America: Newborn Screening Market, by Technology, 2020–2030 (US$ Million)
11.5.6.4.4 Rest of South & Central America: Newborn Screening Market, by Test Type, 2020–2030 (US$ Million)
11.5.6.4.5 Rest of South & Central America: Newborn Screening Market, by End User, 2020–2030 (US$ Million)
12. Newborn Screening Market–Industry Landscape
12.1 Overview
12.2 Growth Strategies in Newborn Screening Market
12.3 Organic Growth Strategies
12.3.1 Overview
12.4 Inorganic Growth Strategies
12.4.1 Overview
13. Company Profiles
13.1 LifeCell International Pvt Ltd
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Zentech SA
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Trivitron Healthcare Pvt Ltd
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 PerkinElmer Inc
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 Waters Corp
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 Bio-Rad Laboratories Inc
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 Masimo Corp
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 Natus Medical Inc.
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 Baebies Inc
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 MRC Holland BV
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
13.10.6 Key Developments
13.11 Medtronic Plc
13.11.1 Key Facts
13.11.2 Business Description
13.11.3 Products and Services
13.11.4 Financial Overview
13.11.5 SWOT Analysis
13.11.6 Key Developments
14. Appendix
14.1 About Us
14.2 Glossary of Terms

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Table of Contents

Summary

The global newborn screening market is expected to reach US$ 2.484 billion in 2030 from US$ 1.206 billion in 2022. The market is estimated to grow with a CAGR of 9.4% from 2022 to 2030.

The key factors driving the market include rising burden of congenital diseases and increasing prevalence of newborn disorders. However, lack of uniformity of newborn screening policies and procedures across the world and false positive and false negative results hinders the market growth.

Market Opportunities of Newborn Screening Market

The demand for comprehensive genetic screening of newborns is rising with the deepening knowledge about the genetic causes of medical conditions and advancements in healthcare technologies. As a result, companies in the newborn screening market are developing innovative, cost-effective screening solutions. The US FDA licensed the Kymriah gene therapy in 2017 for use in pediatric patients with a particular kind of acute lymphoblastic leukemia. During this therapy, a new gene that codes for a chimeric antigen receptor is inserted into the patient's T cells, stimulating the altered T cells to go after and destroy the leukemic cells. Yescarta and Zynteglo are two more examples of authorized gene treatments for large B-cell lymphoma and beta-thalassemia. Further, the emergence of technologies conferring an ability to identify genetic predispositions to diseases at birth pave the way for personalized healthcare, aligning with the broader trend of precision medicine.

Screening for genetic diseases during pregnancy also focuses on the early detection of pregnancy-related problems. Next-generation sequencing aids in the prenatal screening of neonates with a sensitivity of above 95% for detecting aneuploidies (such as Down syndrome and Trisomy 21) or partial chromosomal abnormalities (duplications or deletions) in all chromosomes. Fluorescence in-situ hybridization (FISH) is employed to detect monogenic illnesses such as sickle cell anemia; it also aids in an effective preimplantation genetic diagnosis. Noninvasive procedures such as the cell-free fetal DNA approach using maternal plasma are the recent advancements in genetic tests. The embryonic DNA can be distinguished from maternal DNA pieces based on differences in their sizes. Real-time PCR with fluorescent probes, shotgun sequencing (Solexa or Illumina), or huge targeted parallel sequencing can be used to examine DNA associated with fetal medical conditions. This would allow doctors to provide early molecular interventions with certain pharmacological therapies (pharmacogenetics) and to transform cells, tissues, and organs physically and chemically if this type of genetic screening is further researched. Thus, advancements in methods for screening infants for genetic disorders hold immense potential for the overall newborn screening market.

Factors Hampering Newborn Screening Market

Variations regarding the list of conditions screened for in different countries result in non-uniformity in newborn screening policies and practices worldwide. A few nations screen for a comprehensive range of disorders, while others focus on a limited set. This difference creates barriers for companies developing screening tests and technologies, as they need to modify their products to specific markets, limiting economies of scale. Moreover, the lack of standardized protocols can result in inconsistent quality control and data collection practices. This leads to inaccuracies in screening results and difficulties in comparing data between regions, making it challenging for researchers and healthcare providers to assess the effectiveness of screening programs implemented in localities understudy. Additionally, the absence of universal standards complicates the regulatory landscape for companies operating in the newborn screening market, as they need to focus on complying with a complex web of regulations for seeking approvals in different countries, which can be time-consuming and expensive. The lack of uniformity can also hinder international collaborations and data sharing, limiting the potential of newborn screening research and technology development. Thus, the lack of uniformity in newborn screening policies and procedures limits the progress of the newborn screening market.

Newborn Screening Market: Segmental Overview

The newborn screening market, by product type, is segmented into reagents and assay kits and instruments. In 2022, the reagents and assay kits segment held a larger market share and is expected to grow at the fastest rate in the coming years. Different reagents and assay kits for newborn screening are categorized into DNA-based assays, immunoassays, and enzymatic assays. Various companies in the market have developed a range of reagents and assay kits specifically for neonatal screening. Firstly, Labsystems Diagnostics launched a fluorometric microplate-based assay for detecting phenylketonuria (PKU) in newborns based on phenylalanine content, as increasing the phenylalanine level in the baby can cause intellectual disability. All the reagent kits offered by the Company are manual modular systems or fully automated hands-off systems.

The newborn screening market, by technology, is segmented into tandem mass spectrometry (TMS), molecular assays, immunoassays and enzymatic assays, pulse oximetry screening technology, and other technologies. In 2022, the pulse oximetry screening technology segment held the largest share of the market. Moreover, the immunoassays and enzymatic assays segment is expected to grow fastest during the coming years. Congenital heart disease (CCHD), one of the most common congenital disabilities, is a duct-dependent congenital heart disease. It may be detected during the prenatal and postnatal period, while it can be life-threatening if it goes undiagnosed and untreated in the neonatal period or infancy. Pulse oximetry screening is used to detect critical CCHD in infants. It is a painless, noninvasive, and cost-effective method of screening infants. The pulse oximeter screening determines the percentage of hemoglobin in the blood saturated with oxygen.

The newborn screening market, by test type, is segmented into dry blood spot tests, hearing screen tests, critical congenital heart disease tests, and other tests. In 2022, the blood spot test segment held the largest share of the market. The newborn screening market for the same segment is estimated to grow at a significant CAGR during 2022 -2030.

The newborn screening market, by end-user, is segmented into hospitals, clinics, and diagnostic laboratories. In 2022, the hospitals and clinics segment held a larger market share. However, the hospitals and clinics segment is estimated to grow at a CAGR during 2022-2030. healthcare provider performs newborn screening tests in a room or a newborn/nursery area at hospitals. The hospitals and clinics segment is projected to hold a larger share of the newborn screening market in the coming years as these facilities receive maximum patient footfall for newborn baby screening. Better facilities, and the availability of different treatment options and good nursing care under one roof attract patients toward these facilities for different diagnostic and therapeutic procedure.

Newborn Screening Market: Geographical Overview

The newborn screening market in North America has experienced significant growth in recent years. The demand for newborn screening services has increased significantly with the surging awareness among parents and healthcare professionals about the importance of early screening for identifying and managing congenital disorders. Additionally, improvements in medical technology have been crucial in enhancing newborn screening capabilities—laboratory automation has boosted screening accuracy, speed, and cost-effectiveness. This has made it possible for medical professionals to give thorough newborn screening panels that cover a larger spectrum of genetic and metabolic disorders. Favorable legislation and regulatory measures also benefit the newborn screening market in North America. Many states and provinces have implemented mandatory newborn screening programs, ensuring all infants are screened shortly after birth. For instance, every state in the US offers newborn screening as a public health program; yearly, ~4 million babies are screened under this program for illnesses that aren't often present at the time of delivery. The Texas Department of Health and Human Services began screening newborns for Spinal Muscular Atrophy (SMA) in June 2021.

A few of the major primary and secondary sources referred to while preparing the report on the newborn screening market are the World Bank Data, National Health Service (NHS), FDA (Food and Drug Administration), EMA (European Medicines Agency), and WHO (World Health Organization).

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Summary

Table of Contents

ご注文は、お電話またはWEBから承ります。お見積もりの作成もお気軽にご相談ください。

本レポートと同分野（医療機器）の最新刊レポート

The Insight Partners社の医療機器分野での最新刊レポート

本レポートと同じKEY WORD（reagents）の最新刊レポート

よくあるご質問

The Insight Partners社はどのような調査会社ですか?

調査レポートの納品までの日数はどの程度ですか?

注文の手続きはどのようになっていますか?

お支払方法の方法はどのようになっていますか?

データリソース社はどのような会社ですか?