Report Overview

Newborn screening is a process of detecting disorders/ diseases in newborn babies by using specialized devices, consumables, instruments, etc. These screening procedures help to diagnose diseases in newborns. The increasing cases of newborn diseases have been propelling the newborn screening market growth.

Global Newborn Screening Market- Industry Trends & Forecast Report 2027

Global newborn screening market was worth USD 812.1 million in 2020. The data gathered in the study suggest that the market is further projected to reach USD 1,479.4 million by 2027, at a CAGR of 9.3% during the forecast period (2021-2027). The rising prevalence of newborn disorders, such as congenital diseases, and neonatal diseases, along with increasing healthcare budgets across the globe, are driving the market growth. The global newborn screening market is also expected to grow due to technical advancements in the field of medical science and carious diagnostic screening procedures for the early detection of disorders. Furthermore, the government and non-governmental organizations are taking up initiatives to improve mother-child care, which is doubling the number of newborn screening programs around the world. Additionally, favorable reimbursement policies in several countries are also expected to fuel the growth of the global newborn screening market in the coming years.

Source: Blue Weave Consulting

Global Newborn Screening Market Overview

Newborn screening is a process of detecting disorders/ diseases in newborn babies by using specialized devices, consumables, instruments, etc. These screening procedures help to diagnose diseases in newborns. The increasing cases of newborn diseases have been propelling the newborn screening market growth. Government support coupled with non-governmental organizations’ initiatives for mother & child care has pushed the newborn screening market growth to the optimum level. The global newborn screening market is being driven due to high concerns for the early detection of diseases/disorders in newborns.  

Global Newborn Screening Market Trend

Growth Drivers

Rising Prevalence of Newborn Disorders

The global newborn screening market is experiencing rapid growth as frequent cases of infant-related disorders are being recorded. With the rising newborn diseases, many key players have raised awareness and support for using advanced screening instruments for early diagnosis. Hearing, metabolic, and hormonal disorders and critical congenital heart diseases are a few major disorders prevalent in newborns. The early diagnosis of such diseases can help the doctors to treat them effectively. WHO (World Health Organization) in its report published in 2020 claimed that children dying within the first 28 days of birth, have suffered from diseases due to lack of quality care at the time of birth or skilled care and treatment immediately post-birth.

High Birth Rates in Emerging Market

Following the high-natality rates in some countries like India, China, Brazil, etc. the risk for newborn diseases has also increased, which in turn has created lucrative opportunities for the global newborn screening market. According to the UN, India records 25 million births each year which is nearly one-fifth of the global annual childbirths. The high birth rate and the accessible newborn screening procedures in public hospitals indicate an increasing demand for products and consumables. Moreover, countries like China have mandated Congenital Hypothyroidism (CH), Phenylketonuria (PKU), and a hearing test by including them under national screening programs.

Market Restraints

Poor Healthcare Facilities and Infrastructure

One of the major concerns across the global newborn screening market is related to poor healthcare infrastructure & scarcity of skilled professionals. The coronavirus outbreak has depicted several shortcomings in healthcare systems even in emerging economies. Moreover, many countries have recorded falling GDP due to the global economic crisis, which has ultimately caused lower spending on healthcare. Moreover, inaccuracy and low precision of the devices, coupled with the scarcity of skilled professionals, are further restraining the market growth. However, several market players are also developing new models to enhance the precision and accuracy of the kits and instruments. 

Impact of COVID-19

The COVID-19-induced pandemic has affected practically every industry around the world. Due to the high infection rates and severe impact on public health systems, several countries had to enforce nationwide lockdowns, which significantly impacted industrial supply chains, trade, and related services. The pandemic, on the other hand, had a negligible influence on the global newborn screening market. Soon after the outbreak of the pandemic, strict restrictions were put in place to monitor infant health and safeguard neonates against COVID-19. Many diagnostic laboratories and government agencies have also sought to raise health awareness among parents.

Global Newborn Screening Market by Product Type

Based on the product type, the global newborn screening market is divided into two categories namely consumables, & instruments.  Consumables are further classified into assay kits & reagents, and other consumables. On the other hand, the instrument section is divided into three sections, namely pulse oximeter, newborn hearing screening, which comprises different devices and accessories, and other instruments. The consumables segment accounts for the largest market share due to the constant demand for consumables in newborn screening. Also, increasing newborn disease prevalence and rising health concerns for infants across the globe are the major driving factors that support the growth of consumables.

 Source: Blue Weave Consulting

Global Newborn Screening Market by Test Type

Based on the test type, the global newborn screening market is divided into four main categories- dried blood spot, hearing screening, critical congenital heart defect (CCHD), and other test types. Different test types are used for different purposes. Due to the wide acceptance of dry blood spot tests for screening disorders, and its ability to diagnose metabolic, hormonal, and genetic disorders in the newborn, the dried blood spot segment dominates the market. A dried blood spot is also called a heel-stick as the blood is collected from the heel of a newborn.

Global Newborn Screening Market by Technique

Based on techniques, the global newborn screening market is divided into the following segments- tandem mass spectrometry, pulse oximetry, enzyme-based assays, DNA assays, and other technologies.  Among these, the enzyme-based assays, also known as immune assays, dominate the global newborn screening market. This is due to the wide acceptance of these assays for screening disorders in newborns. This screening procedure implies enzyme-linked immunosorbent assays (ELISA), which help to detect antigens or antibodies by producing a color change. This test is used to detect any disorder that might have been transferred from mother to child during pregnancy.

Global Newborn Screening Market by End-User

Based on end-users, the global newborn screening market is fragmented into diagnostics centers, hospitals, and other end users. Hospitals dominate the newborn screening industry since hospitals are where most babies are born. Moreover, hospitals can also detect and diagnose any complications that might have transferred from mother to child immediately after the child's birth. Diagnostic centres, on the other hand, are only equipped to provide screening facilities related to different disorders. They provide pathological and radiological testing, along with a doctor to analyze, and verify the reports.

Global Newborn Screening Market Regional Insights

Based on regions, the global newborn screening market is segmented into North America, Europe, Asia-Pacific, South America, Middle East, and Africa.  Among these regions, North America owns the largest market share due to the growing prevalence of congenital disorders and mandatory testing in all the states of the nation. Additionally, the rising demand for advanced screening systems due to the increasing incidence of newborn disorders, favorable reimbursement policies, and a presence of key players in the region have fueled the global newborn screening market in North America. Additionally, the Asia Pacific is anticipated to witness the fastest growth. This can be attributed to high natality rates, increasing screening rates, and rising awareness regarding the early diagnosis of severe disorders in infants. 

Competitive Landscape

The global newborn screening market is a concentrated market, with several key players and a diverse range of products. Manufacturers are continually focusing on innovation to produce neonatal genetic screening technologies and kits for the early detection of diseases in newborns. This is expected to further drive the global newborn screening market. Some of the key players in the market are Natus Medical Incorporated, AB Sciex, Masimo Corporation, GE Healthcare, Medtronic Inc., Bio-Rad Laboratories Inc., PerkinElmer Inc., ZenTech SA, Demant A/S, Waters Corporation, Trivitron Healthcare, Thermo Fisher Scientific, Hill-Rom Holdings, Inc., and other prominent players.

Recent Developments

• In January 2021, NIPD Genetics announced the launch of an expanded neonatal genetic screening test for newborns, infants, and children by the name Orean.

• In September 2020, American global corporation, PerkinElmer, attained approval for EONIS screening assay. The approval will allow the company to integrate its newborn test for SCID (severe combined immunodeficiency), SMA (spinal muscular atrophy), and XLA (X-linked agammaglobulinemia) in newborns.

 

Scope of the Report:

Attribute	Details
Years Considered	Historical data – 2017-2020
	Base Year – 2020
	Forecast – 2021 – 2027
Facts Covered	Revenue in USD Million
Market Coverage	The U.S., Canada, Germany, Italy, U.K., France, Spain, Rest of Europe, Japan, China, India, South Korea, Australia, Rest of Asia-Pacific, Brazil, Mexico, Argentina, etc.
Product/Service Segmentation	By Product, By Type, By Test, By Technique, By End-User, and By Region
Key Players	AB Sciex, Bio-Rad Laboratories Inc., GE Healthcare, Masimo Corporation, Medtronic Inc., Natus Medical Incorporated, PerkinElmer Inc., Trivitron Healthcare, ZenTech SA, Demant A/S, Waters Corporation, Thermo Fisher Scientific, Hill-Rom Holdings, Inc., and other prominent players.

 

By Product Type

• Consumables
  • Assay Kits & Reagents
  • Other Consumables
• Instruments
  • Pulse Oximeter
  • Newborn Hearing Screening
    • • • Accessories
        • Devices
  • Other Instruments

By Test Type

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

By Technology

• Tandem Mass Spectrometry
• Pulse Oximetry
• Enzyme Based Assays
• DNA Assays
• Other Technologies

By End-User

• Hospitals
• Diagnostic Centers
• Other End Users

By Region

• North America
• Europe
• The Asia-Pacific
• Latin America
• Middle East and Africa

1.    Research Framework

1.1. Research Objective

1.2. Fiber Reinforcement Type Overview

1.3. Market Segmentation

2.    Research Methodology

2.1. Qualitative Research

2.1.1.   Primary & Secondary Research

2.2. Quantitative Research

2.3. Market Breakdown & Data Triangulation

2.3.1.   Primary & Secondary Research End-User

2.3.2.   Secondary Research

2.3.3.   Primary Research

2.4. Breakdown of Primary Research Respondents, By Region

2.5. Assumption & Limitation

3.    Executive Summary

4.    Global Newborn Screening Market Insights

4.1. Industry Value Chain Analysis

4.2. DROC Analysis

4.2.1.   Growth Drivers

4.2.2.   Restraints

4.2.3.   Opportunities

4.2.4.   Challenges

4.3. Recent Development/Technological Advancements

4.4. Porter’s Five Forces Analysis

4.4.1.   Bargaining End-User of Suppliers

4.4.2.   Bargaining End-User of Buyers

4.4.3.   Threat of New Entrants

4.4.4.   Threat of Substitutes

4.4.5.   Intensity of Rivalry

5.    Global Newborn Screening Market Overview

5.1. Market Size & Forecast by Value, 2017-2027

5.1.1.   By Value (USD Million)        

5.2. Market Share & Forecast

5.2.1.   By Product Type

5.2.1.1.       Consumables

5.2.1.1.1.           Assay Kits & Reagents

5.2.1.1.2.           Other Consumables

5.2.1.2.       Instruments

5.2.1.2.1.           Pulse Oximeter

5.2.1.2.2.           Newborn Hearing Screening

5.2.1.2.2.1.1.1.     Accessories

5.2.1.2.2.1.1.2.     Devices

5.2.1.2.3.           Other Instruments

5.2.2.   By Test Type

5.2.2.1.       Dried Blood Spot

5.2.2.2.       Hearing Screening

5.2.2.3.       Critical Congenital Heart Defect (CCHD)

5.2.2.4.       Other Test Types

5.2.3.   By Technology

5.2.3.1.       Tandem Mass Spectrometry

5.2.3.2.       Pulse Oximetry

5.2.3.3.       Enzyme Based Assays

5.2.3.4.       DNA Assays

5.2.3.5.       Other Technologies

5.2.4.   By End-User

5.2.4.1.       Hospitals

5.2.4.2.       Diagnostic Centres

5.2.4.3.       Other End Users

5.2.5.   By Region

5.2.5.1.       North America

5.2.5.2.       Europe

5.2.5.3.       The Asia-Pacific

5.2.5.4.       Latin America

5.2.5.5.       The Middle East and Africa

6.    North America Newborn Screening Market  

6.1. Market Size & Forecast by Value, 2017-2027

6.1.1.   By Value (USD Million)

6.2. Market Share & Forecast

6.2.1.   By Product Type

6.2.2.   By Test Type

6.2.3.   By Technology Type

6.2.4.   By End-User

6.2.5.   By Country

6.2.5.1.     United States

6.2.5.2.     Canada

7.    Europe Newborn Screening Market

7.1. Market Size & Forecast by Value, 2017-2027

7.1.1.   By Value (USD Million)

7.2. Market Share & Forecast

7.2.1.   By Product Type

7.2.2.   By Test Type

7.2.3.   By Technology Type

7.2.4.   By End-User

7.2.5.   By Country

7.2.5.1.       France

7.2.5.2.       Germany

7.2.5.3.       Italy

7.2.5.4.       Spain

7.2.5.5.       Russia

7.2.5.6.       United Kingdom

7.2.5.7.       Rest of Europe

8.    The Asia-Pacific Newborn Screening Market

8.1. Market Size & Forecast by Value, 2017-2027

8.1.1.   By Value (USD Million)

8.2. Market Share & Forecast

8.2.1.   By Product Type

8.2.2.   By Test Type

8.2.3.   By Technology Type

8.2.4.   By End-User

8.2.5.   By Country

8.2.5.1.     Japan

8.2.5.2.     China

8.2.5.3.     India

8.2.5.4.     South Korea

8.2.5.5.     Australia

8.2.5.6.     Rest of APAC

9.    Latin America Newborn Screening Market

9.1. Market Size & Forecast by Value, 2017-2027

9.1.1.   By Value (USD Million)

9.2. Market Share & Forecast

9.2.1.   By Product Type

9.2.2.   By Test Type

9.2.3.   By Technology Type

9.2.4.   By End-User

9.2.5.   By Country

9.2.5.1.     Brazil

9.2.5.2.     Mexico

9.2.5.3.     Argentina

9.2.5.4.     Rest of Latin America

10. The Middle East & Africa Newborn Screening Market

10.1.     Market Size & Forecast by Value, 2017-2027

10.1.1.                By Value (USD Million)

10.2.     Market Share & Forecast

10.2.1.                By Product Type

10.2.2.                By Test Type

10.2.3.                By Technology Type

10.2.4.                By End-User

10.2.5.                By Country

10.2.5.1.    South Africa

10.2.5.2.    Saudi Arabia

10.2.5.3.    UAE

10.2.5.4.    Rest of MEA

11.Competitive Landscape

11.1.     Company Market Share Analysis, 2020

11.2.     Competitive Benchmarking, By Product Type Offerings

11.3.     List of Key Players and their Offerings

12.Impact of Covid-19 across Industry

13.Company Profile (Company Overview, Financial Matrix, Key Product Type landscape, Key Personnel, Key Competitors, Contact Address, and Strategic Outlook)

13.1.     AB Sciex

13.2.     Bio-Rad Laboratories Inc.

13.3.     GE Healthcare

13.4.     Masimo Corporation

13.5.     Medtronic Inc.

13.6.     Natus Medical Incorporated

13.7.     PerkinElmer Inc.

13.8.     Trivitron Healthcare

13.9.     ZenTech SA

13.10.  Demant A/S

13.11.  Waters Corporation

13.12.  Thermo Fisher Scientific

13.13.  Hill-Rom Holdings, Inc.

13.14.  And Other Prominent Players

 

14.Key Strategic Recommendations

 

*Financial details of unlisted companies will be available as per data availability in final deliverable

**The segmentation and the companies are subjected to modifications based on in-depth secondary for the final deliverable

List of Figures.

Fig: Global Newborn Screening Segmentation

Fig: Global Newborn Screening Market Value Chain Analysis

Fig: Company Market Share Analysis, 2020

Fig: Global Newborn Screening Market Size, By Value (USD Million), 2017-2027

Fig: Global Newborn Screening Market Share, By Product Type, By Value, 2017-2027

Fig: Global Newborn Screening Market Share, By Test Type, By Value, 2017-2027

Fig: Global Newborn Screening Market Share, By Technology, By Value, 2017-2027

Fig: Global Newborn Screening Market Share, By End-User, By Value, 2017-2027

Fig: Global Newborn Screening Market Share, By Region, By Value, 2017-2027

Fig: North America Newborn Screening Market Size, By Product Type (USD Million), 2017-2027

Fig: North America Newborn Screening Market Share, By Test Type, By Value, 2017-2027

Fig: North America Newborn Screening Market Share, By Technology, By Value, 2017-2027

Fig: North America   Newborn Screening Market Share, By End-User, By Value, 2017-2027

Fig: North America Newborn Screening Market Share, By Country, By Value, 2017-2027

Fig: Europe Newborn Screening Market Size, By Product Type (USD Million), 2017-2027

Fig: Europe Newborn Screening Market Share, By Test Type, By Value, 2017-2027

Fig: Europe Newborn Screening Market Share, By Technology, By Value, 2017-2027

Fig: Europe Newborn Screening Market Share, By End-User, By Value, 2017-2027

Fig: Europe Newborn Screening Market Share, By Country, By Value, 2017-2027

Fig: The Asia-Pacific Newborn Screening Market Size, By Product Type (USD Million), 2017-2027

Fig: The Asia-Pacific Newborn Screening Market Share, By Test Type, By Value, 2017-2027

Fig: The Asia-Pacific Newborn Screening Market Share, By Technology, By Value, 2017-2027

Fig: The Asia-Pacific Newborn Screening Market Share, By End-User, By Value, 2017-2027

Fig: The Asia-Pacific Newborn Screening Market Share, By Country, By Value, 2017-2027

Fig: Latin America Newborn Screening Market Size, By Product Type (USD Million), 2017-2027

Fig: Latin America Newborn Screening Market Share, By Test Type, By Value, 2017-2027

Fig: Latin America Newborn Screening Market Share, By Technology, By Value, 2017-2027

Fig: Latin America Newborn Screening Market Share, By End-User, By Value, 2017-2027

Fig: Latin America Newborn Screening Market Share, By Country, By Value, 2017-2027

Fig: The Middle East & Africa Newborn Screening Market Size, By Product Type (USD Million), 2017-2027

Fig: The Middle East & Africa Newborn Screening Market Share, By Test Type, By Value, 2017-2027

Fig: The Middle East & Africa Newborn Screening Market Share, By Technology, By Value, 2017-2027

Fig: The Middle East & Africa Newborn Screening Market Share, By End-User, By Value, 2017-2027

Fig: The Middle East & Africa Newborn Screening Market Share, By Country, By Value, 2017-2027

 

List of Tables:

Table: Global Newborn Screening Size, By Product Type, By Value, 2017-2027

Table: Global Newborn Screening Market Size, By Test Type, By Value, 2017-2027

Table: Global Newborn Screening Market Size, By Technology, By Value, 2017-2027

Table: Global Newborn Screening Market Size, By End-User, By Value, 2017-2027

Table: Global Newborn Screening Market Size, By Region, By Value, 2017-2027

Table: North America Newborn Screening Market Size, By Product Type, By Value, 2017-2027

Table: North America Newborn Screening Market Size, By Test Type, By Value, 2017-2027

Table: North America Newborn Screening Market Size, By Technology, By Value, 2017-2027

Table: North America Newborn Screening Market Size, By End-User, By Value, 2017-2027

Table: North America Newborn Screening Market Size, By Country, By Value, 2017-2027

Table: Europe Newborn Screening Market Size, By Product Type, By Value, 2017-2027

Table: Europe Newborn Screening Market Size, By Test Type, By Value, 2017-2027

Table: Europe Newborn Screening Market Size, By Technology, By Value, 2017-2027

Table: Europe Newborn Screening Market Size, By End-User, By Value, 2017-2027

Table: Europe Newborn Screening Market Size, By Country, By Value, 2017-2027

Table: The Asia-Pacific Newborn Screening Market Size, By Product Type, By Value, 2017-2027

Table: The Asia-Pacific Newborn Screening Market Size, By Test Type, By Value, 2017-2027

Table: The Asia-Pacific Newborn Screening Market Size, By Technology, By Value, 2017-2027

Table: The Asia-Pacific Newborn Screening Market Size, By End-User, By Value, 2017-2027

Table: The Asia-Pacific Newborn Screening Market Size, By Country, By Value, 2017-2027

Table: Latin America Newborn Screening Market Size, By Product Type, By Value, 2017-2027

Table: Latin America Newborn Screening Market Size, By Test Type, By Value, 2017-2027

Table: Latin America Newborn Screening Market Size, By Technology, By Value, 2017-2027

Table: Latin America Newborn Screening Market Size, By End-User, By Value, 2017-2027

Table: Latin America Newborn Screening Market Size, By Country, By Value, 2017-2027

Table: The Middle East & Africa Newborn Screening Market Size, By Product Type, By Value, 2017-2027

Table: The Middle East & Africa Newborn Screening Market Size, By Test Type, By Value, 2017-2027

Table: The Middle East & Africa Newborn Screening Market Size, By Technology, By Value, 2017-2027

Table: The Middle East & Africa Newborn Screening Market Size, By End-User, By Value, 2017-2027

Table: The Middle East & Africa Newborn Screening Market Size, By Country, By Value, 2017-2027 

Table: AB Sciex Financial Analysis

Table:  AB Sciex Business Overview

Table: Bio-Rad Laboratories Inc. Financial Analysis

Table: Bio-Rad Laboratories Inc. Business Overview

Table: GE Healthcare Financial Analysis

Table: GE Healthcare Business Overview

Table: Masimo Corporation Financial Analysis

Table: Masimo Corporation Business Overview

Table:  Medtronic Inc. Financial Analysis

Table: Medtronic Inc. Business Overview

Table: Natus Medical Incorporated Financial Analysis

Table: Natus Medical Incorporated Business Overview

Table: PerkinElmer Inc Financial Analysis

Table: PerkinElmer Inc Business Overview

Table: Trivitron Healthcare Financial Analysis

Table: Trivitron Healthcare Business Overview

Table: ZenTech SA Financial Analysis

Table: ZenTech SA Business Overview

Table: Demant A/S Financial Analysis

Table: Demant A/S Business Overview

Table: Waters Corporation Financial Analysis

Table: Waters Corporation Business Overview

Table: Thermo Fisher Scientific Financial Analysis

Table: Thermo Fisher Scientific Business Overview

Table: Hill-Rom Holdings, Inc. Financial Analysis

Table: Hill-Rom Holdings, Inc. Business Overview