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Global Newborn Screening Market Report and Forecast 2023-2031

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  • 147 Pages
  • May 2023
  • Region: Global
  • Expert Market Research
  • ID: 5797897
The global newborn screening market size attained a value of USD 1.10 billion in 2022. The market is likely to grow at a CAGR of 9.30% during the forecast period of 2023-2031, likely to attain a value of USD 2.46 billion by 2031.

Newborn Screening Market: Introduction

Newborn screening is a comprehensive public health program aimed at the early identification of congenital disorders in newborns. These screenings involve simple tests performed within the first few days of a baby's life to detect specific conditions that may lead to severe health issues or even death if not addressed promptly. Early detection and intervention enable healthcare providers to initiate appropriate treatment and management plans to improve outcomes and quality of life for affected infants.

Applications of Newborn Screening:

Newborn screening typically tests for a range of genetic, metabolic, and endocrine disorders, as well as certain blood and hearing conditions. The specific conditions tested vary by country and region, but some commonly screened disorders include:

  • Phenylketonuria (PKU): A metabolic disorder that results in the body's inability to break down the amino acid phenylalanine, leading to intellectual disabilities and other complications if left untreated
  • Cystic Fibrosis (CF): A genetic disorder affecting the respiratory and digestive systems, causing thick mucus build-up in the lungs and pancreas
  • Sickle Cell Disease (SCD): A group of inherited red blood cell disorders characterized by misshapen, "sickle-shaped" cells that can cause severe pain, organ damage, and other complications
  • Congenital Hypothyroidism (CH): A condition in which the thyroid gland does not produce enough thyroid hormone, leading to developmental delays and growth problems if left untreated
  • Hearing loss: Early detection of hearing loss allows for early intervention, which can significantly improve language and communication skills in affected children
Benefits of Newborn screening include the following:
Newborn screening offers numerous benefits, including:
  • Early detection: Identifying disorders early allows for prompt treatment and management, which can help prevent or minimize severe health issues and improve overall outcomes
  • Improved quality of life: Early intervention can lead to better management of symptoms, allowing affected children to lead healthier, more fulfilling lives
  • Cost-effectiveness: By detecting and treating disorders early, newborn screening can reduce long-term healthcare costs associated with managing complications and disabilities that may arise if left undiagnosed and untreated
  • Reduction in infant mortality: Early detection and treatment can reduce the risk of death from certain disorders, improving overall infant survival rates
  • Family support and planning: Identification of genetic disorders in a newborn can help inform family planning decisions, allowing parents to make informed choices about future pregnancies
In summary, Newborn screening is a vital public health initiative that offers numerous benefits to infants, families, and society as a whole. Early detection and intervention for a range of disorders can improve the quality of life and long-term outcomes for affected children, reducing healthcare costs and promoting overall health and well-being.

Newborn Screening Market Segmentations

The market can be categorised into product type, technology, test type, disease type, end user, and major region.

Market Breakup by Product Type

  • Instruments
  • Reagents and Assay Kits

Market Breakup by Technology

  • Tandem Mass Spectrometry
  • Pulse Oximetry
  • Enzyme Based Assays
  • DNA Assays
  • Electrophoresis
  • Others

Market Breakup by Test Type

  • Dry Blood Spot Test
  • Critical Congenital Heart Disease (CCHD)
  • Hearing Screen
  • Others

Market Breakup by Diseases Type

  • Critical Congenital Heart Diseases
  • Newborn Hearing Loss
  • Sickle Cell Disease
  • Phenylketonuria (PKU)
  • Cystic Fibrosis (CF)
  • Maple Syrup Urine Disease
  • Others

Market Breakup by End User

  • Clinical Laboratory
  • Hospitals
  • Diagnostic Centre’s
  • Others

Market Breakup by Region

North America

  • United States of America
  • Canada


  • United Kingdom
  • Germany
  • France
  • Italy
  • Others

Asia Pacific

  • China
  • Japan
  • India
  • Australia
  • Others

Latin America

  • Brazil
  • Argentina
  • Mexico
  • Others

Middle East and Africa

  • Saudi Arabia
  • United Arab Emirates
  • Nigeria
  • South Africa
  • Others

Newborn Screening Market Scenario

The newborn screening market has been experiencing significant growth in recent years due to several factors, including advancements in technology, increasing awareness about the benefits of early detection, and government initiatives to support the widespread implementation of screening programs.

Technological advancements have played a crucial role in the expansion of the newborn screening market. The introduction of advanced screening techniques, such as tandem mass spectrometry and next-generation sequencing, has increased the accuracy, speed, and range of conditions that can be detected. These technological innovations have made it possible to screen for a larger number of disorders, including rare conditions, with a high degree of precision.

Raising awareness about the importance of newborn screening has also contributed to market growth. Educational campaigns and initiatives by healthcare organizations, non-profit organizations, and governments have emphasized the benefits of early detection and intervention for various disorders. This increased awareness has led to a higher demand for newborn screening services, as parents and healthcare providers recognize the value of these tests in promoting infant health and well-being.

Government initiatives have played a key role in expanding the newborn screening market. Many countries have implemented mandatory newborn screening programs, ensuring that all newborns receive the necessary tests as a standard part of their postnatal care. These programs have increased the demand for screening services and have made newborn screening more accessible and affordable for all families.

Despite the overall growth in the newborn screening market, there are still challenges to address. One of the main challenges is the disparity in the availability and accessibility of newborn screening services between high-income and low-income countries. In resource-limited settings, inadequate healthcare infrastructure, lack of trained professionals, and financial constraints can hinder the implementation of comprehensive newborn screening programs. Efforts are being made to bridge this gap through global partnerships and collaborations, aiming to improve access to screening services for all newborns, regardless of their location or socioeconomic background.

Overall, the newborn screening market is expected to continue its growth trajectory in the coming years, driven by ongoing technological advancements, increased awareness, and government support. However, addressing the challenges faced by low-income countries will be crucial to ensuring equitable access to these life-saving services for all newborns worldwide.

Key Players in the Global Newborn Screening Market

The report gives an in-depth analysis of the key players involved in the newborn screening market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows:
  • PerkinElmer Inc
  • Demant A/S
  • Natus Medical Incorporated
  • Bio-Rad Laboratories
  • Luminex Corporation
  • F. Hoffmann-La Roche Ltd
  • Thermo Fisher Scientific Inc
  • Bruker
  • Danaher
  • Medtronic
  • Chromsystems Instruments & Chemicals GmbH
  • Trivitron Healthcare
  • Baebies Inc

Table of Contents

1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage - Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Newborn Screening Market Overview
3.1 Global Newborn Screening Market Historical Value (2016-2022)
3.2 Global Newborn Screening Market Forecast Value (2023-2031)
4 Global Newborn Screening Market Landscape
4.1 Global Newborn Screening Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Newborn Screening Product Landscape
4.2.1 Analysis by Product Type
4.2.2 Analysis by Technology
4.2.3 Analysis by End User
5 Global Newborn Screening Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Newborn Screening Market Segmentation
6.1 Global Newborn Screening Market by Product Type
6.1.1 Market Overview
6.1.2 Instruments
6.1.3 Reagent’s & Assay Kits
6.2 Global Newborn Screening Market by Technology
6.2.1 Market Overview
6.2.2 Tandem Mass Spectrometry
6.2.3 Pulse Oximetry
6.2.4 Enzyme Based Assays
6.2.5 DNA Assays
6.2.6 Electrophoresis
6.2.7 Others
6.3 Global Newborn Screening Market by Test Type
6.3.1 Market Overview
6.3.2 Dry Blood Spot Test
6.3.3 Critical Congenital Heart Disease (CCHD)
6.3.4 Hearing Screen
6.3.5 Others
6.4 Global Newborn Screening Market by Diseases Type
6.4.1 Market Overview
6.4.2 Critical Congenital Heart Diseases
6.4.3 New-born Hearing Loss
6.4.4 Sickle Cell Disease
6.4.5 Phenylketonuria (PKU)
6.4.6 Cystic Fibrosis (CF)
6.4.7 Maple Syrup Urine Disease
6.4.8 Others
6.5 Global Newborn Screening Market by End User
6.5.1 Market Overview
6.5.2 Clinical Laboratory
6.5.3 Hospitals
6.5.4 Diagnostic Centre’s
6.5.5 Others
6.6 Global Newborn Screening Market by Region
6.6.1 Market Overview
6.6.2 North America
6.6.3 Europe
6.6.4 Asia Pacific
6.6.5 Latin America
6.6.6 Middle East and Africa
7 North America Newborn Screening Market
7.1 Market Share by Country
7.2 United States of America
7.3 Canada
8 Europe Newborn Screening Market
8.1 Market Share by Country
8.2 United Kingdom
8.3 Germany
8.4 France
8.5 Italy
8.6 Others
9 Asia Pacific Newborn Screening Market
9.1 Market Share by Country
9.2 China
9.3 Japan
9.4 India
9.6 Australia
9.7 Others
10 Latin America Newborn Screening Market
10.1 Market Share by Country
10.2 Brazil
10.3 Argentina
10.4 Mexico
10.5 Others
11 Middle East and Africa Newborn Screening Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.4 Nigeria
11.5 South Africa
11.6 Others
12 Patent Analysis
12.1 Analysis by Type of Patent
12.2 Analysis by Publication year
12.3 Analysis by Issuing Authority
12.4 Analysis by Patent Age
12.5 Analysis by CPC Analysis
12.6 Analysis by Patent Valuation
12.7 Analysis by Key Players
13 Grants Analysis
13.1 Analysis by year
13.2 Analysis by Amount Awarded
13.3 Analysis by Issuing Authority
13.4 Analysis by Grant Application
13.5 Analysis by Funding Institute
13.6 Analysis by NIH Departments
13.7 Analysis by Recipient Organization
14 Funding Analysis
14.1 Analysis by Funding Instances
14.2 Analysis by Type of Funding
14.3 Analysis by Funding Amount
14.4 Analysis by Leading Players
14.5 Analysis by Leading Investors
14.6 Analysis by Geography
15 Partnership and Collaborations Analysis
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Supplier Landscape
16.1 PerkinElmer Inc.
16.1.1 Financial Analysis
16.1.2 Product Portfolio
16.1.3 Demographic Reach and Achievements
16.1.4 Mergers and Acquisitions
16.1.5 Certifications
16.2 Demant A/S
16.2.1 Financial Analysis
16.2.2 Product Portfolio
16.2.3 Demographic Reach and Achievements
16.2.4 Mergers and Acquisitions
16.2.5 Certifications
16.3 Natus Medical Incorporated
16.3.1 Financial Analysis
16.3.2 Product Portfolio
16.3.3 Demographic Reach and Achievements
16.3.4 Mergers and Acquisitions
16.3.5 Certifications
16.4 Bio-Rad Laboratories
16.4.1 Financial Analysis
16.4.2 Product Portfolio
16.4.3 Demographic Reach and Achievements
16.4.4 Mergers and Acquisitions
16.4.5 Certifications
16.5 Luminex Corporation
16.5.1 Financial Analysis
16.5.2 Product Portfolio
16.5.3 Demographic Reach and Achievements
16.5.4 Mergers and Acquisitions
16.5.5 Certifications
16.6 F. Hoffmann-La Roche Ltd.
16.6.1 Financial Analysis
16.6.2 Product Portfolio
16.6.3 Demographic Reach and Achievements
16.6.4 Mergers and Acquisitions
16.6.5 Certifications
16.7 Thermo Fisher Scientific Inc.
16.7.1 Financial Analysis
16.7.2 Product Portfolio
16.7.3 Demographic Reach and Achievements
16.7.4 Mergers and Acquisitions
16.7.5 Certifications
16.8 Bruker
16.8.1 Financial Analysis
16.8.2 Product Portfolio
16.8.3 Demographic Reach and Achievements
16.8.4 Mergers and Acquisitions
16.8.5 Certifications
16.9 Danaher
16.9.1 Financial Analysis
16.9.2 Product Portfolio
16.9.3 Demographic Reach and Achievements
16.9.4 Mergers and Acquisitions
16.9.5 Certifications
16.10 Medtronic
16.10.1 Financial Analysis
16.10.2 Product Portfolio
16.10.3 Demographic Reach and Achievements
16.10.4 Mergers and Acquisitions
16.10.5 Certifications
16.11 Chromsystems Instruments & Chemicals GmbH
16.11.1 Financial Analysis
16.11.2 Product Portfolio
16.11.3 Demographic Reach and Achievements
16.11.4 Mergers and Acquisitions
16.11.5 Certifications
16.12 Trivitron Healthcare
16.12.1 Financial Analysis
16.12.2 Product Portfolio
16.12.3 Demographic Reach and Achievements
16.12.4 Mergers and Acquisitions
16.12.5 Certifications
16.13 Baebies Inc
16.13.1 Financial Analysis
16.13.2 Product Portfolio
16.13.3 Demographic Reach and Achievements
16.13.4 Mergers and Acquisitions
16.13.5 Certifications
17 Global Newborn Screening Market - Distribution Model (Additional Insight)
17.1 Overview
17.2 Potential Distributors
17.3 Key Parameters for Distribution Partner Assessment
18 Key Opinion Leaders (KOL) Insights (Additional Insight)
19 Company Competitiveness Analysis (Additional Insight)
19.1 Very Small Companies
19.2 Small Companies
19.3 Mid-Sized Companies
19.4 Large Companies
19.5 Very Large Companies
20 Payment Methods (Additional Insight)
20.1 Government Funded
20.2 Private Insurance
20.3 Out-of-Pocket

Companies Mentioned

  • Perkinelmer Inc.
  • Demant A/S
  • Natus Medical Incorporated
  • Bio-Rad Laboratories
  • Luminex Corporation
  • F. Hoffmann-La Roche Ltd.
  • Thermo Fisher Scientific Inc.
  • Bruker
  • Danaher
  • Medtronic
  • Chromsystems Instruments & Chemicals GmbH
  • Trivitron Healthcare
  • Baebies Inc



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