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1439978

全球新生兒篩檢市場：洞察、競爭格局、市場預測：2030 年

Newborn Screening - Market Insights, Competitive Landscape, and Market Forecast - 2030

出版日期: 2024年02月01日 | 出版商:

DelveInsight | 英文 150 Pages | 商品交期: 2-10個工作天內

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簡介目錄圖表

2023年全球新生兒篩檢市場規模為10.0642億美元。預計到 2030 年，該市場將達到 14.2209 億美元，2024 年至 2030 年的預測期內複合年增長率為 6.03%。新生兒篩檢的需求主要針對先天性心臟病(CHD)、下絨毛膜、室間隔缺損、馬蹄內翻足、唐氏症、肺動脈瓣關閉不全和狹窄、唇裂和顎裂以及房室間隔缺損。這是由於新生兒篩檢的增加所致。先天性疾病，例如間隔缺損。此外，先進和創新技術的採用增加、政府對新生兒篩檢和篩檢技術開發的支持力度加大、出生率提高、妊娠期併發症增加、產品上市和批准增加等。促進了新生兒篩檢市場的整體成長。預測期為2024年至2030年。

受多種因素影響，新生兒篩檢市場的產品需求正在成長，其中關鍵因素之一是各種先天性疾病的盛行率不斷增加。例如，根據世界衛生組織 (WHO) 2023 年的數據，全球每年估計有 6% 的嬰兒出生時患有先天缺陷。此外，每 10 個患有嚴重先天性疾病的兒童中有 9 個出生在低收入和中等收入國家。先天性疾病可能導致長期殘疾，對個人、家庭、醫療系統和社會帶來沉重負擔。

據同一來源稱，全球每年估計有 24 萬名新生兒在出生後 28 天內因先天缺陷而死亡。先天性疾病可導致另外 17 萬名 1 個月至 5 歲的兒童死亡。因此，醫生應不時進行適當的診斷和篩檢測試，例如孕前篩檢、妊娠篩檢和新生兒篩檢，以降低盛行率和死亡率。世界各地先天性疾病的增加增加了對新生兒篩檢的需求。

本報告檢視了全球新生兒篩檢市場，並提供了市場概述，包括按類型、測試類型、技術、最終用戶、地區以及參與市場的公司概況劃分的趨勢。

Natus Medical Incorporated
Trivitron Healthcare
Medtronic
Bio-Rad Laboratories, Inc.
PerkinElmer
GE HealthCare
Masimo
Agilent Technologies, Inc.
DH Tech. Dev. Pte. Ltd.
Zentech.
Demant A/S
Waters Corporation
Baxter
Thermo Fisher Scientific Inc.
MP BIOMEDICALS
Integrated DNA Technologies, Inc.
LifeCell International Pvt. Ltd.
Labsystems Diagnostics Oy
Zivak
RECIPE Chemicals + Instruments GmbH

第8章KOL瀏覽量

第 9 章專案方法

第 10 章關於 DelveInsight

第 11 章免責聲明與聯絡我們

簡介目錄圖表

Product Code: DIMDCL0659

Newborn Screening Market By Type (Instruments And Kits), By Test Type (Dried Blood Spot, Hearing Screening, Critical Congenital Heart Defect, And Others), By Technology (Tandem Mass Spectrometry, Pulse Oximetry, Enzyme-Based Assays, Dna Assays, And Others), By End-User (Hospitals & Clinics, Diagnostic Centers, And Others), and by geography is expected to grow at a steady CAGR forecast till 2030 owing to the increasing prevalence of various congenital diseases in newborns and the increasing advancements in technologies used in newborn screening

The global newborn screening market was valued at USD 1,006.42 million in 2023, growing at a CAGR of 6.03% during the forecast period from 2024 to 2030 to reach USD 1,422.09 million by 2030. The demand for newborn screening is primarily being boosted by the increasing figures of newborn congenital diseases such as congenital heart defects (CHD), hypospadias, ventricular septal defect, clubfoot, down syndrome, pulmonary valve atresia and stenosis, cleft lip with cleft palate, atrioventricular septal defect, and others. Further, the rising adoption of advanced and innovative technologies, increasing government support for newborn screening and developments in screening technology, high birth rate, increasing complications in pregnancy, and increasing product launches and approval among others are thereby contributing to the overall growth of the newborn screening market during the forecast period from 2024-2030.

Newborn Screening Market Dynamics:

The newborn screening market is witnessing a growth in product demand owing to various factors, one of the key factors being the increase in the prevalence of various congenital diseases. For instance, according to World Health Organization (WHO) 2023, an estimated 6% of babies worldwide are born with a congenital disorder every year. Also, nine of ten children born with a serious congenital disorder are in low- and middle-income countries. Congenital disorders can contribute to long-term disability, which takes a significant toll on individuals, families, healthcare systems, and societies.

As per the same source, an estimated 240,000 newborns die worldwide within 28 days of birth every year due to congenital disorders. The congenital disorders can further cause 170,000 deaths of children between the ages of 1 month and 5 years. Thus, to reduce the figures of prevalence and mortality proper diagnosis and screening tests such as preconception screening, peri-conception screening, and neonatal screening should be performed by physicians from time to time as they can provide a proper health analysis of newborns in determining various birth defects or diseases. Thus, the increasing number of congenital diseases across the globe will increase the demand for newborn screening.

Government policies and programs also help to foster a favorable environment for market expansion. The WHO recommended the newborn screening program to protect children's health worldwide. The Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) of the US Department of Health and Human Services, the Japan Society of Obstetrics and Gynecology (JSOG), the United Kingdom (PEACH), and advocacy organizations like the March of Dimes have all taken various policies and initiatives under this program.

In addition, the increasing launches and approvals of various screening devices and kits will increase the demand for newborn screening in the market. For instance, in September 2020, PerkinElmer, Inc., announced that the EONIS(TM) screening assay for newborns that simultaneously tests for SMA (spinal muscular atrophy), SCID (severe combined immunodeficiency), and XLA (X-linked agammaglobulinemia) received CE-IVD approval. This IVD RT-PCR assay integrates into PerkinElmer's entire newborn screening workflow to provide labs with a complete, single-source solution encompassing everything from the sample to the solution.

Therefore, the above-mentioned factors are contributing to the growth of the newborn screening market during the forecast period from 2024-2030.

However, false-positive tests, Lack of uniformity of newborn screening policies and procedures across the world, and others may restrict the newborn screening market growth.

The newborn screening market experienced significant growth during the COVID-19 pandemic. In the initial period, the market suffered a temporary setback as lockdown restrictions were enforced as a necessary step to curb the spread of COVID-19. However, the demand for newborn screening testing kits and instruments increased during the pandemic owing to the sudden increase in the number of pregnancy cases. According to UNICEF 2020, globally, an estimated 116 million babies were born under the shadow of the COVID-19 pandemic, and almost a quarter of them which is approximately 29 million were born in South Asia. Countries in South Asia with the expected highest numbers of births in the nine months since the COVID-19 pandemic declaration were India (20 million), Pakistan (5 million), Bangladesh (2.4 million), and Afghanistan (1 million). The increasing number of pregnancy cases increased the demand for newborn screening, due to which various key players in the market accelerated the manufacturing of newborn screening kits, reagents, and instruments. Henceforth, the afore-said factors propelled the demand for newborn screening during the pandemic and are estimated to grow similarly during the forecast period.

Newborn Screening Market Segment Analysis:

Newborn Screening by Type (Instruments and Kits), Test Type (Dried Blood Spot, Hearing Screening, Critical Congenital Heart Defect, and Others), Technology (Tandem Mass Spectrometry, Pulse Oximetry, Enzyme Based Assays, DNA Assays, and Others), End-User (Hospitals & Clinics, Diagnostic Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the test type segment of the newborn screening market, the dried blood spot category is expected to amass significant revenue share in the year 2023. This can be ascribed to the advantages and applications offered by the segment.

Heel sticks or dried blood spot tests (DBS) refer to the collection of blood from a newborn's heel within 24-48 hours of birth on the screening card for the diagnosis of more than 50 conditions. These screening cards are identified by specific codes but don't include any other personal data. The test can be used to identify many different metabolic conditions, including autism, lymphomas, leukemia, and many others. In North America, the testing card is free as part of a strategy to encourage more procedures.

Moreover, the benefits of DBS sampling include its low volume demands (roughly 30 to 100 L per spot), ease of sample collection using a finger or heel stick with little training needed, and sample stability and portability. Dried blood spot analysis has the benefit of only requiring a portable small sample size. Therefore, the prevalence of newborn diseases is driving market expansion.

The increasing strategic activities such as approvals, launches, and acquisitions related to the segment will also drive the market of dried blood spot test type segment. For instance, in July 2020, PerkinElmer Inc. launched a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP/DELFIA platform, enabling the processing of up to 5,000 samples per day. The DBS assay runs on PerkinElmer's GSP analyzer and, combined with the universal TRF (time-resolved fluorescence) of the DELFIA platform, screens more than 30% of all newborn babies worldwide, spanning 32 countries.

Therefore, the advantages and applications offered by dried blood spots are predicted to contribute to the increasing demand for this test type thereby driving the growth of the overall newborn screening market during the forecast period.

North America is expected to dominate the overall Newborn Screening Market:

Among all the regions, North America is estimated to account for the largest share of the global newborn screening market in the year 2023. Owing to the rising prevalence of various newborn congenital diseases such as congenital heart defects (CHD), hypospadias, ventricular septal defect, clubfoot, down syndrome, pulmonary valve atresia and stenosis, cleft lip with cleft palate, atrioventricular septal defect, and others, will increase demand of newborn screening the North America market. Also, the growing birth rate, an increasing number of pregnancy complications, and increasing government support are driving the North America newborn screening market and are expected to witness positive growth. Furthermore, high disposable income, sophisticated healthcare infrastructure, regulatory approval for new products, and high awareness also helped the market growth in this region.

The Centers for Disease Control and Prevention (CDC) 2022, it was stated that congenital heart defects (CHDs) affect about 40,000 births per year in the United States. About 1 in 4 babies with a CHD have a critical CHD. Infants with critical CHDs generally need surgery or other procedures in their first year of life. Further, the source also estimated that birth defects affect one in every 33 babies (about 3% of all babies) born in the United States each year.

The aforesaid source stated that about 1 in every 593 births per year suffers from clubfoot, 1 in every 707 births yearly suffers from Down syndrome, and 1 in every 1,687 births every year suffers from cleft palate, in the US.

Thus, the increasing number of congenital diseases in the region will increase the demand for various kits and instruments used in newborn screening, thereby driving the overall market of newborn screening in North America.

Further, 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. Newborn screening programs are run on a state basis within the United States; therefore, it has been observed that there is a lack of uniformity among the testing panels of many states.

Coupled with the factors mentioned above, strategic activities such as product launches and approvals, mergers, acquisitions, partnerships, and others also help in boosting regional product demand. For instance, in September 2022, PerkinElmer Inc. received the US Food and Drug Administration (FDA) authorization for the marketing of the EONIS(TM) SCID-SMA assay kit for in vitro diagnostic (IVD) to be used for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns. This is the first FDA-authorized assay for SMA screening in newborns in the United States and is part of the Company's broader EONIS(TM) Platform. Thus, such strategic steps help to increase the demand for Newborn Screening, thereby driving the North America newborn screening market forward during the forecast period.

Newborn Screening Market Key Players:

Some of the key market players operating in the newborn screening market include Natus Medical Incorporated, Trivitron Healthcare, Medtronic, Bio-Rad Laboratories, Inc., PerkinElmer, GE HealthCare, Masimo, Agilent Technologies, Inc., DH Tech. Dev. Pte. Ltd., Zentech, Demant A/S, Waters Corporation, Baxter, Thermo Fisher Scientific Inc., MP BIOMEDICALS, Integrated DNA Technologies, Inc., LifeCell International Pvt. Ltd., Labsystems Diagnostics Oy, Zivak, RECIPE Chemicals + Instruments GmbH, and others.

Recent Developmental Activities in the Newborn Screening Market:

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 2021, the Texas Health and Human Services launched newborn screening for Spinal Muscular Atrophy (SMA).

Key Takeaways from the Newborn Screening Market Report Study

Market size analysis for current newborn screening market size (2023), and market forecast for 5 years (2024-2030)

Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years

Key companies dominating the global newborn screening market.

Various opportunities available for the other competitor in the newborn screening market space.

What are the top-performing segments in 2023? How these segments will perform in 2030.

Which are the top-performing regions and countries in the current newborn screening market scenario?

Which are the regions and countries where companies should have concentrated on opportunities for newborn screening market growth in the coming future?

Target Audience who can be benefited from this Newborn Screening Market Report Study

Newborn screening products providers

Research organizations and consulting companies

Newborn screening-related organizations, associations, forums, and other alliances

Government and corporate offices

Start-up companies, venture capitalists, and private equity firms

Distributors and Traders dealing in newborn screening

Various End-users who want to know more about the newborn screening market and the latest technological developments in the newborn screening market.

Frequently Asked Questions for the Newborn Screening Market:

1. What is newborn screening?

Newborn screening is a preventive screening test used to identify diseases by detecting congenital or inborn metabolic abnormalities. An infant's healthy development can be aided by early detection and appropriate diagnostic and therapeutic standards.

2. What is the market for global newborn screening?

The global newborn screening market was valued at USD 1,006.42 million in 2023, growing at a CAGR of 6.03% during the forecast period from 2024 to 2030 to reach USD 1,422.09 million by 2030.

3. What are the drivers for the global newborn screening market?

The demand for newborn screening is primarily being heightened by the increasing prevalence of various congenital diseases in newborns. In addition, the advancements in technologies used in newborn screening, increasing launches and approvals of various diagnosis kits, high birth rate, and rising funding from government sectors for newborn screening, among others are thereby contributing to the overall growth of the newborn screening market during the forecast period from 2024-2030.

4. Who are the key players operating in the global newborn screening market?

5. Which region has the highest share in the newborn screening market?

North America is expected to dominate the overall newborn screening market during the forecast period from 2024-2030. With factors such as the fast adoption of non-invasive techniques for newborn screening, favorable health reimbursement, and an increase in the number of preterm births, the North American newborn screening market is expected to witness positive growth. Furthermore, high disposable income, sophisticated healthcare infrastructure, regulatory approval for new devices and kits, and high awareness about congenital diseases also helped the market growth in this region.

1.Newborn Screening Market Report Introduction

2. Newborn Screening Market Executive Summary

2.1. Scope of the Study
2.2. Market at Glance
2.3. Competitive Assessment

3. Regulatory Analysis

3.1. The United States
3.2. Europe
3.3. Japan
3.4. China

4. Newborn Screening Market Key Factors Analysis

4.1. Newborn Screening Market Drivers
- 4.1.1. Rising prevalence of congenital diseases in newborns
- 4.1.2. Rising funding from government sectors for newborn screening
- 4.1.3. Growing neonatal population base
- 4.1.4. Technological advancements in diagnostic imaging and medical software
4.2. Newborn Screening Market Restraints and Challenges
- 4.2.1. False-positive tests
- 4.2.2. Lack of uniformity of newborn screening policies and procedures across the world
4.3. Newborn Screening Market Opportunities
- 4.3.1. Increasing Demand for Next-Generation Sequencing in Newborn Screening

5. Newborn Screening Market Porter's Five Forces Analysis

5.1. Bargaining Power of Suppliers
5.2. Bargaining Power of Consumers
5.3. Threat of New Entrants
5.4. Threat of Substitutes
5.5. Competitive Rivalry

6. Newborn Screening Market Layout

6.1. By Type
- 6.1.1. Instruments
- 6.1.2. Kits
6.2. By Test Type
- 6.2.1. Dried Blood Spot
- 6.2.2. Hearing Screening
- 6.2.3. Critical Congenital Heart Defect (CCHD)
- 6.2.4. Others
6.3. By Technology
- 6.3.1. Tandem Mass Spectrometry
- 6.3.2. Pulse Oximetry
- 6.3.3. Enzyme Based Assays
- 6.3.4. DNA Assays
- 6.3.5. Others
6.4. By End-User
- 6.4.1. Hospitals & Clinics
- 6.4.2. Diagnostic Centers
- 6.4.3. Others
6.5. By Geography
- 6.5.1. North America Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.1.1. United States Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.1.2. Canada Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.1.3. Mexico Newborn Screening Market Size in USD million (2021-2030)
- 6.5.2. Europe Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.2.1. France Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.2.2. Germany Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.2.3. United Kingdom Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.2.4. Italy Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.2.5. Spain Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.2.6. Rest of Europe Newborn Screening Market Size in USD million (2021-2030)
- 6.5.3. Asia-Pacific Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.3.1. China Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.3.2. Japan Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.3.3. India Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.3.4. Australia Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.3.5. South Korea Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.3.6. Rest of the Asia-Pacific Newborn Screening Market Size in USD million (2021-2030)
- 6.5.4. Rest of the World (RoW) Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.4.1. Middle East Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.4.2. Africa Newborn Screening Market Size in USD million (2021-2030)
  - 6.5.4.3. South America Newborn Screening Market Size in USD million (2021-2030)

7. Newborn Screening Market Company and Product Profiles

7.1. Natus Medical Incorporated
- 7.1.1. Company Overview
- 7.1.2. Company Snapshot
- 7.1.3. Financial Overview
- 7.1.4. Product Listing
- 7.1.5. Entropy
7.2. Trivitron Healthcare
- 7.2.1. Company Overview
- 7.2.2. Company Snapshot
- 7.2.3. Financial Overview
- 7.2.4. Product Listing
- 7.2.5. Entropy
7.3. Medtronic
- 7.3.1. Company Overview
- 7.3.2. Company Snapshot
- 7.3.3. Financial Overview
- 7.3.4. Product Listing
- 7.3.5. Entropy
7.4. Bio-Rad Laboratories, Inc.
- 7.4.1. Company Overview
- 7.4.2. Company Snapshot
- 7.4.3. Financial Overview
- 7.4.4. Product Listing
- 7.4.5. Entropy
7.5. PerkinElmer
- 7.5.1. Company Overview
- 7.5.2. Company Snapshot
- 7.5.3. Financial Overview
- 7.5.4. Product Listing
- 7.5.5. Entropy
7.6. GE HealthCare
- 7.6.1. Company Overview
- 7.6.2. Company Snapshot
- 7.6.3. Financial Overview
- 7.6.4. Product Listing
- 7.6.5. Entropy
7.7. Masimo
- 7.7.1. Company Overview
- 7.7.2. Company Snapshot
- 7.7.3. Financial Overview
- 7.7.4. Product Listing
- 7.7.5. Entropy
7.8. Agilent Technologies, Inc.
- 7.8.1. Company Overview
- 7.8.2. Company Snapshot
- 7.8.3. Financial Overview
- 7.8.4. Product Listing
- 7.8.5. Entropy
7.9. DH Tech. Dev. Pte. Ltd.
- 7.9.1. Company Overview
- 7.9.2. Company Snapshot
- 7.9.3. Financial Overview
- 7.9.4. Product Listing
- 7.9.5. Entropy
7.10. Zentech.
- 7.10.1. Company Overview
- 7.10.2. Company Snapshot
- 7.10.3. Financial Overview
- 7.10.4. Product Listing
- 7.10.5. Entropy
7.11. Demant A/S
- 7.11.1. Company Overview
- 7.11.2. Company Snapshot
- 7.11.3. Financial Overview
- 7.11.4. Product Listing
- 7.11.5. Entropy
7.12. Waters Corporation
- 7.12.1. Company Overview
- 7.12.2. Company Snapshot
- 7.12.3. Financial Overview
- 7.12.4. Product Listing
- 7.12.5. Entropy
7.13. Baxter
- 7.13.1. Company Overview
- 7.13.2. Company Snapshot
- 7.13.3. Financial Overview
- 7.13.4. Product Listing
- 7.13.5. Entropy
7.14. Thermo Fisher Scientific Inc.
- 7.14.1. Company Overview
- 7.14.2. Company Snapshot
- 7.14.3. Financial Overview
- 7.14.4. Product Listing
- 7.14.5. Entropy
7.15. MP BIOMEDICALS
- 7.15.1. Company Overview
- 7.15.2. Company Snapshot
- 7.15.3. Financial Overview
- 7.15.4. Product Listing
- 7.15.5. Entropy
7.16. Integrated DNA Technologies, Inc.
- 7.16.1. Company Overview
- 7.16.2. Company Snapshot
- 7.16.3. Financial Overview
- 7.16.4. Product Listing
- 7.16.5. Entropy
7.17. LifeCell International Pvt. Ltd.
- 7.17.1. Company Overview
- 7.17.2. Company Snapshot
- 7.17.3. Financial Overview
- 7.17.4. Product Listing
- 7.17.5. Entropy
7.18. Labsystems Diagnostics Oy
- 7.18.1. Company Overview
- 7.18.2. Company Snapshot
- 7.18.3. Financial Overview
- 7.18.4. Product Listing
- 7.18.5. Entropy
7.19. Zivak
- 7.19.1. Company Overview
- 7.19.2. Company Snapshot
- 7.19.3. Financial Overview
- 7.19.4. Product Listing
- 7.19.5. Entropy
7.20. RECIPE Chemicals + Instruments GmbH
- 7.20.1. Company Overview
- 7.20.2. Company Snapshot
- 7.20.3. Financial Overview
- 7.20.4. Product Listing
- 7.20.5. Entropy