Newborn Screening Market

Newborn Screening Market by Product (Instrument, Consumables), Test Type (Dried Blood Spot, Hearing Screening, CCHD),Technology (Tandem Mass Spectrometry, Immunoassay, Enzyme Assay, Molecular, Pulse Oximetry),End User (Hospitals) - Global Forecast to 2026

Report Code: MD 2549 Feb, 2021, by marketsandmarkets.com

[177 Pages Report] The global newborn screening market size is projected to reach USD 1.3 billion by 2026 from USD 0.9 billion in 2021, at a CAGR of 8.3% during the forecast period. Growth in this market is majorly driven by the increasing prevalence of newborn disorders, favourable reimbursement polcies. However, the availability of refurbished products are expected to restrain the growth of this market to certain extent during the forecast period.

Newborn Screening Market

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Covid -19 Impact on the Newborn Screening Market

While COVID-19 has impacted many sectors of the medical devices and diagnostics industry, it has had a limited impact on the newborn screening market. Legislation in important markets has already emphasized the need for newborn screening; stringent regulations have been implemented to oversee newborn health and protect babies from COVID-19 or exposure to similar diseases. Many screening laboratories and government organizations provide health awareness to parents.

On the other hand, the supply and sales operations of major companies in the market, such as Natus (US), PerkinElmer (US), and Masimo (US), were affected during Q2 2020 due to COVID-19. However, operations resumed in Q3 as countries ended lockdowns and permitted the transportation of medical goods

Global Newborn screening Market Dynamics

Driver: growing prevalence of newborn disorders

The prevalence of newborn diseases has risen in recent years, prompting providers to raise awareness and support the demand for advanced screening instruments. Hearing, metabolic, and hormonal disorders and critical congenital heart disease are the major newborn disorders; most are treatable if diagnosed early.

  • According to the US CDC, during 2015–2017, the prevalence of newborn disorders was 34 per 10,000 live births in the US. Approximately 12,900 infants are expected to be identified each year with a disorder. Moreover, according to the same source, the most prevalent disorders are hearing loss (16.5 per 10,000), congenital hypothyroidism (6.0 per 10,000), sickle-cell disease (4.9 per 10,000), and cystic fibrosis (1.8 per 10,000).
  • According to the Indian Pediatric Academy, the prevalence of congenital heart disease in children is 9 per 1,000 births. Each year, more than 200,000 children are born with congenital heart disease.
  • According to BabysFirstTest.org, an organization supported by the US Health Resources and Services Administration (HRSA), critical congenital heart disease is estimated to affect two out of every 1,000 babies born each year in the US.

Opportunity: Emerging Markets

India, China, and Brazil provide significant opportunities to players in this market due to their high birth rates and increasing disposable income. According to the UN Children’s Fund, India records 25 million births every year, or nearly one-fifth of the global annual childbirths. The high birth rate and the availability of newborn screening in public hospitals indicates a strong demand for market products and consumables.

On the other hand, China has achieved great progress in newborn screening during the past 35 years. Moreover, by 2017, the overall uptake rate for CH and PKU screening crossed 96%. Also, each year, nearly 17 million infants undergo screening for CH and PKU. Currently, CH/PKU and hearing loss are included as national screening programs, mandatory for all newborns in China. By 2017, more than 150 NBS labs in China offered screening programs for CAH and G6PD. There are also ~100 NBS labs screening for IMDs by using tandem mass spectrometry technology. The strong newborn screening infrastructure in China indicates the potential for market growth.

Consuables segment accounted for the largest share of the newborn screening market by product in 2019

Based on the product, the newborn screening market is segmented into consumables and instruments. In 2019, consumables accounted for the largest share of the newborn screening market. The large share of this market segment is mainly due to the constant requirement for consumables in newborn screening. The increasing newborn disease prevalence, and increasing newborn screening rate across the globe are the major driving factors that supports the growth of consumables.

Immunoassays & enzymatic assays accounted for the largest share of the newborn screening market by technology in 2019

Based on technology, the newborn screening market is segmented into immunoassays & enzymatic assays, tandem mass spectrometry, molecular assays, hearing screening technologies, pulse oximetry, and other technologies. In 2019, the immunoassays & enzymatic assays segment dominated this market. This is mainly due to the wide usage of these assays to screen for disorders in newborns.

Newborn Screening Market  by Region

North America accounted for the largest share of the newborn screening market in 2019

The newborn screening market, by region, has been segmented into North America, Europe, the Asia Pacific, and the Rest of the world (RoW). North America is the largest market for newborn screening, followed by Europe. Growth in the North American market can be attributed to the availability of newborn screening programs, favorable reimbursement policies, and a strong market player presence.

The Asia Pacific is expected to register the highest CAGR during the forecast period. Growth in this region is driven by the large newborn pool, increasing screening rate, and rising awareness regarding early diagnosis.

Key Market Players

Prominent players in the newborn screening market are PerkinElmer (US), Natus Medical (US), Bio-Rad Laboratories (US), Danaher Corporation (US), and Medtronic (Ireland). Others include Chromsystems Instruments & Chemicals GmbH (Germany), Trivitron Healthcare (India), Baebies (US), Parseq Lab (Russia), Recipe Chemicals+Instruments (Germany), and Demant A/S (Denmark).

Scope of the report

Report Metric

Details

Market Size Available for Years

2019–2026

Base Year Considered

2019

Forecast Period

2021–2026

Forecast Units

Value (USD)

Segments Covered

Product, test, technology, end user and region

Geographies Covered

North America (US and Canada), Europe (Germany, France, UK, Italy, Spain, and the RoE), APAC (Japan, China, Australia, and the RoAPAC), and the RoW

Companies Covered

Major 10 players covered, including:
PerkinElmer (US), Demant A/S (Denmark), Natus Medical (US), Bio-Rad Laboratories (US), Danaher Corporation (US), and Medtronic (Ireland), Chromsystems Instruments & Chemicals GmbH (Germany), Trivitron Healthcare (India), Baebies (US), and Recipe Chemicals+Instruments (Germany)

This research report categorizes the newborn screening market into the following segments and subsegments:

By Product

  • Consumables
    • Assay kits & reagents
    • Other consumables ( columns and screening cards)
  • instruments
    • Disorder screening instruments
      • Fully-automated instruments
      • Other instruments (sei-automated instrumetns, shakers, incubatorea and etc.)
  • Hearing screening instruements
    • Accessories
    • Devices
  • Pulse oximeters

By Test

  • Dry blood spot tests
  • Hearing screening tets
  • CCHD screening tets

By technology

  • Immune assays & enzymatic assays
  • Tandem mass spectrometry
  • Molecular assays
  • Hearing sceening technologies
  • Pulse oximetry
  • Other Technologies (Flouroscence, gel electrophoresis and etc.)

By End user

  • Clinical Laboratories
  • Hospitals

By Region

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • Australia
    • Rest of Asia Pacific
  • Rest of the World

Recent Developments:

  • In September 2020,  PerkinElmer (US) recevied CE-IVD approval for EONIS screening assay used to screen SMA (spinal muscular atrophy), SCID (severe combined immunodeficiency), and XLA (X-linked agammaglobulinemia) in newborns
  • In December 2019, PerkinElmer (US) received US FDA approval for GSP Neonatal Creatine Kinase –MM (CK-MM) kit for screening newborns affected by Duchenne muscular dystrophy (DMD)
  • In October 2019, Demant A/S (Denmark) has lancuehd its easyScreen BERAphone, a hearing screening device, at the 64th International Congress of Hearing Aid Acousticians in Nuremberg, Germany
  • In January 2018, Demant A/S (Denmark) has launched GSI Novus, a handheld newborn hearing screener  

Frequently Asked Questions (FAQ):

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TABLE OF CONTENTS

1 INTRODUCTION (Page No. - 25)
    1.1 OBJECTIVES OF THE STUDY
    1.2 MARKET DEFINITION
    1.3 INCLUSIONS & EXCLUSIONS
    1.4 MARKET SCOPE
           1.4.1 MARKETS COVERED
           1.4.2 YEARS CONSIDERED FOR THE STUDY
    1.5 CURRENCY
    1.6 LIMITATIONS
    1.7 STAKEHOLDERS
    1.8 SUMMARY OF CHANGES
    1.9 LIMITATIONS OF THE CURRENT EDITION

2 RESEARCH METHODOLOGY (Page No. - 29)
    2.1 RESEARCH DATA
           FIGURE 1 RESEARCH DESIGN
           2.1.1 SECONDARY DATA
                    2.1.1.1 Secondary sources
           2.1.2 PRIMARY DATA
                    2.1.2.1 Key data from primary sources
           FIGURE 2 BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION, AND REGION
    2.2 MARKET SIZE ESTIMATION
           2.2.1 BOTTOM-UP APPROACH
           FIGURE 3 MARKET SIZE ESTIMATION: BOTTOM-UP APPROACH
           FIGURE 4 MARKET SIZE ESTIMATION: PATIENT-BASED METHODOLOGY
           2.2.2 TOP-DOWN APPROACH
           FIGURE 5 MARKET SIZE ESTIMATION: TOP-DOWN APPROACH
           2.2.3 GROWTH FORECAST
    2.3 MARKET BREAKDOWN AND DATA TRIANGULATION
           FIGURE 6 DATA TRIANGULATION METHODOLOGY
    2.4 ASSUMPTIONS FOR THE STUDY

3 EXECUTIVE SUMMARY (Page No. - 36)
           FIGURE 7 NEWBORN SCREENING MARKET, BY PRODUCT, 2021 VS. 2026
           FIGURE 8 NEWBORN SCREENING INSTRUMENTS MARKET, BY TYPE, 2021 VS. 2026
           FIGURE 9 NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2021 VS. 2026
           FIGURE 10 NEWBORN SCREENING MARKET, BY TEST, 2021 VS. 2026
           FIGURE 11 NEWBORN SCREENING MARKET, BY END USER, 2021 VS. 2026
           FIGURE 12 GEOGRAPHIC SNAPSHOT OF THE NEWBORN SCREENING MARKET

4 PREMIUM INSIGHTS (Page No. - 40)
    4.1 NEWBORN SCREENING MARKET OVERVIEW
           FIGURE 13 FAVORABLE GOVERNMENT POLICIES AND AVAILABILITY OF NEWBORN SCREENING PROGRAMS TO SUPPORT THE NEWBORN SCREENING MARKET
    4.2 NEWBORN SCREENING MARKET, BY PRODUCT, 2021 VS. 2026 (USD MILLION)
           FIGURE 14 CONSUMABLES ACCOUNTED FOR THE LARGEST MARKET SHARE IN 2019
    4.3 NORTH AMERICAN NEWBORN SCREENING MARKET, BY PRODUCT AND COUNTRY
           FIGURE 15 US DOMINATES THE NEWBORN SCREENING MARKET
    4.4 NEWBORN SCREENING MARKET: GEOGRAPHIC SNAPSHOT
           FIGURE 16 CHINA TO REGISTER THE HIGHEST GROWTH DURING THE FORECAST PERIOD

5 MARKET OVERVIEW (Page No. - 42)
    5.1 INTRODUCTION
    5.2 MARKET DYNAMICS
           FIGURE 17 NEWBORN SCREENING MARKET: DRIVERS, OPPORTUNITIES, AND CHALLENGES
           5.2.1 DRIVERS
                    5.2.1.1 Rising prevalence of newborn disorders
                    5.2.1.2 Newborn screening programs and legislation
                    5.2.1.3 Favorable reimbursement policies
           5.2.2 OPPORTUNITIES
                    5.2.2.1 Growth potential of emerging economies
           5.2.3 CHALLENGES
                    5.2.3.1 Availability of refurbished products
    5.3 COVID-19 IMPACT ON NEWBORN SCREENING
    5.4 PRICING ANALYSIS
    5.5 PATENT ANALYSIS
    5.6 TRADE ANALYSIS
           5.6.1 TRADE ANALYSIS FOR SPECTROMETERS
           TABLE 1 EXPORT DATA FOR SPECTROMETERS, SPECTROPHOTOMETERS AND SPECTROGRAPHS USING OPTICAL RADIATIONS, SUCH AS UV, VISIBLE, IR, BY COUNTRY, 2016—2020 (USD MILLION)
           TABLE 2 IMPORT DATA FOR SPECTROMETERS, SPECTROPHOTOMETERS AND SPECTROGRAPHS USING OPTICAL RADIATIONS, SUCH AS UV, VISIBLE, IR, BY COUNTRY, 2016—2020 (USD MILLION)
    5.7 VALUE CHAIN ANALYSIS
           FIGURE 18 VALUE CHAIN ANALYSIS: MAJOR VALUE ADDED DURING THE MANUFACTURING AND ASSEMBLY PHASES
    5.8 SUPPLY CHAIN ANALYSIS
           FIGURE 19 DIRECT DISTRIBUTION—THE PREFERRED STRATEGY FOR PROMINENT COMPANIES
    5.9 ECOSYSTEM ANALYSIS
    5.1 TECHNOLOGY ANALYSIS
    5.11 PESTLE ANALYSIS
    5.12 REGULATORY LANDSCAPE
           FIGURE 20 510(K) APPROVAL PROCESS
    5.13 PORTER’S FIVE ANALYSIS
           FIGURE 21 NEWBORN SCREENING MARKET, PORTER’S FIVE ANALYSIS

6 NEWBORN SCREENING MARKET, BY PRODUCT (Page No. - 53)
    6.1 INTRODUCTION
           TABLE 3 NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
    6.2 CONSUMABLES
           TABLE 4 NEWBORN SCREENING CONSUMABLES MARKET, BY TYPE, 2019–2026 (USD MILLION)
           6.2.1 ASSAY KITS & REAGENTS
                    6.2.1.1 Assay kits & reagents hold the largest share of the consumables market
           TABLE 5 ASSAY KITS & REAGENTS MARKET, BY REGION, 2019–2026 (USD MILLION)
           6.2.2 OTHER CONSUMABLES
           TABLE 6 OTHER NEWBORN SCREENING CONSUMABLES MARKET, BY REGION, 2019–2026 (USD MILLION)

           TABLE 7 NEWBORN SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           6.3.1 NEWBORN DISORDER SCREENING INSTRUMENTS
           TABLE 8 NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 9 NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY REGION, 2019–2026 (USD MILLION)
                    6.3.1.1 Fully automated instruments
                               6.3.1.1.1 Fully automated instruments dominate the disorder screening instruments market
           TABLE 10 FULLY AUTOMATED INSTRUMENTS MARKET, BY REGION, 2019–2026 (USD MILLION)
                    6.3.1.2 Other instruments
           TABLE 11 OTHER NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY REGION, 2019–2026 (USD MILLION)
           6.3.2 NEWBORN HEARING SCREENING INSTRUMENTS
           TABLE 12 NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 13 NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY REGION, 2019–2026 (USD MILLION)
                    6.3.2.1 Accessories
                               6.3.2.1.1 The accessories segment dominates the hearing screening instruments market
           TABLE 14 ACCESSORIES MARKET, BY REGION, 2019–2026 (USD MILLION)
                    6.3.2.2 Devices
                               6.3.2.2.1 Government recommendations ensure sustained demand for hearing screening devices
           TABLE 15 DEVICES MARKET, BY REGION, 2019–2026 (USD MILLION)
           6.3.3 PULSE OXIMETERS
                    6.3.3.1 The high prevalence of CCHD and recommendations for pulse oximetry testing drive the market growth
           TABLE 16 PULSE OXIMETERS MARKET, BY REGION, 2019–2026 (USD MILLION)

7 NEWBORN SCREENING MARKET, BY TEST (Page No. - 62)
    7.1 INTRODUCTION
           TABLE 17 NEWBORN SCREENING MARKET, BY TEST, 2018–2026 (USD MILLION)
    7.2 DRY BLOOD SPOT TESTS
           7.2.1 DRY BLOOD SPOT TESTS DOMINATE THE NEWBORN SCREENING MARKET
           TABLE 18 NEWBORN DRY BLOOD SPOT TESTS MARKET, BY REGION, 2019–2026 (USD MILLION)
    7.3 HEARING SCREENING TESTS
           7.3.1 RECOMMENDATIONS FROM GOVERNMENT ORGANIZATIONS TO SUPPORT THE MARKET GROWTH
           TABLE 19 NEWBORN HEARING SCREENING TESTS MARKET, BY REGION, 2018–2026 (USD MILLION)
    7.4 CRITICAL CONGENITAL HEART DEFECT SCREENING TESTS
           7.4.1 APAC TO SHOW RISING DEMAND FOR CCHD SCREENING TESTS
           TABLE 20 NEWBORN CCHD SCREENING TESTS MARKET, BY REGION, 2019–2026 (USD MILLION)

8 NEWBORN SCREENING MARKET, BY TECHNOLOGY (Page No. - 66)
    8.1 INTRODUCTION
           TABLE 21 NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
    8.2 IMMUNOASSAYS & ENZYMATIC ASSAYS
           8.2.1 ENZYMATIC AND IMMUNOASSAYS DOMINATE THE NEWBORN SCREENING MARKET, BY TECHNOLOGY
           TABLE 22 NEWBORN SCREENING MARKET FOR IMMUNOASSAYS & ENZYMATIC ASSAYS, BY REGION, 2019–2026 (USD MILLION)
    8.3 TANDEM MASS SPECTROMETRY
           8.3.1 NORTH AMERICA HOLDS THE LARGEST SHARE OF THE TANDEM MASS SPECTROMETRY MARKET
           TABLE 23 NEWBORN SCREENING MARKET FOR TANDEM MASS SPECTROMETRY, BY REGION, 2018–2026 (USD MILLION)
    8.4 MOLECULAR ASSAYS
           8.4.1 RISING NUMBER OF SEVERE COMBINED IMMUNODEFICIENCY CASES IN NEWBORNS TO SUPPORT THE MARKET GROWTH
           TABLE 24 NEWBORN SCREENING MARKET FOR MOLECULAR ASSAYS, BY REGION, 2018–2026 (USD MILLION)
    8.5 HEARING SCREENING TECHNOLOGIES
           8.5.1 APAC EXPECTED TO REGISTER HIGHEST GROWTH RATE IN THIS MARKET
           TABLE 25 NEWBORN SCREENING MARKET FOR HEARING SCREENING TECHNOLOGIES, BY REGION, 2018–2026 (USD MILLION)
    8.6 PULSE OXIMETRY
           8.6.1 INCREASING PREVALENCE OF CCHD TO SUPPORT THE MARKET GROWTH
           TABLE 26 NEWBORN SCREENING MARKET FOR PULSE OXIMETRY, BY REGION, 2018–2026 (USD MILLION)
    8.7 OTHER TECHNOLOGIES
           TABLE 27 OTHER NEWBORN SCREENING TECHNOLOGIES MARKET, BY REGION,2018–2026 (USD MILLION)

9 NEWBORN SCREENING MARKET, BY END USER (Page No. - 72)
    9.1 INTRODUCTION
           TABLE 28 NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
    9.2 CLINICAL LABORATORIES
           9.2.1 PRESENCE OF SKILLED PROFESSIONAL AND ROBUST INFRASTRUCTURE TO SUPPORT THE MARKET GROWTH
           TABLE 29 NEWBORN SCREENING MARKET FOR CLINICAL LABORATORIES, BY REGION, 2018–2026 (USD MILLION)
    9.3 HOSPITALS
           9.3.1 NORTH AMERICA DOMINATES THE HOSPITALS SEGMENT
           TABLE 30 NEWBORN SCREENING MARKET FOR HOSPITALS, BY REGION, 2018–2026 (USD MILLION)

10 NEWBORN SCREENING MARKET, BY REGION (Page No. - 75)
     10.1 INTRODUCTION
           TABLE 31 NEWBORN SCREENING MARKET, BY REGION, 2019–2026 (USD MILLION)
     10.2 NORTH AMERICA
           FIGURE 22 NORTH AMERICA: NEWBORN SCREENING MARKET SNAPSHOT
           TABLE 32 NORTH AMERICA: NEWBORN SCREENING MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           TABLE 33 NORTH AMERICA: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 34 NORTH AMERICA: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 35 NORTH AMERICA: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 36 NORTH AMERICA: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 37 NORTH AMERICA: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 38 NORTH AMERICA: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 39 NORTH AMERICA: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 40 NORTH AMERICA: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.2.1 US
                        10.2.1.1 Availability of reimbursement in the country is expected to support the market growth
           TABLE 41 US: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 42 US: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 43 US: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 44 US: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 45 US: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 46 US: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 47 US: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 48 US: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.2.2 CANADA
                        10.2.2.1 Investments for newborn screening in Canada to support market growth
           TABLE 49 CANADA: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 50 CANADA: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 51 CANADA: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 52 CANADA: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 53 CANADA: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 54 CANADA: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 55 CANADA: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 56 CANADA: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
     10.3 EUROPE
           TABLE 57 EUROPE: NEWBORN SCREENING MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           TABLE 58 EUROPE: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 59 EUROPE: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 60 EUROPE: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 61 EUROPE: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 62 EUROPE: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 63 EUROPE: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 64 EUROPE: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 65 EUROPE: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.1 GERMANY
                        10.3.1.1 Germany holds the largest share of the European newborn screening market
           TABLE 66 GERMANY: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 67 GERMANY: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 68 GERMANY: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 69 GERMANY: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 70 GERMANY: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 71 GERMANY: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 72 GERMANY: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 73 GERMANY: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.2 FRANCE
                        10.3.2.1 France accounted for the second-largest market share in Europe
           TABLE 74 FRANCE: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 75 FRANCE: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 76 FRANCE: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 77 FRANCE: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 78 FRANCE: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 79 FRANCE: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 80 FRANCE: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 81 FRANCE: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.3 UK
                        10.3.3.1 Favorable initiatives and reimbursement scenario indicate strong prospects for market growth
           TABLE 82 UK: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 83 UK: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 84 UK: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 85 UK: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 86 UK: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 87 UK: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 88 UK: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 89 UK: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.4 SPAIN
                        10.3.4.1 Availability of health insurance to support the market growth in the country
           TABLE 90 SPAIN: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 91 SPAIN: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 92 SPAIN: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 93 SPAIN: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 94 SPAIN: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 95 SPAIN: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 96 SPAIN: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 97 SPAIN: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.5 ITALY
                        10.3.5.1 Amendments by the Italian government support newborn screening in the country
           TABLE 98 ITALY: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 99 ITALY: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 100 ITALY: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 101 ITALY: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 102 ITALY: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 103 ITALY: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 104 ITALY: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 105 ITALY: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.6 REST OF EUROPE
           TABLE 106 ROE: HEALTH EXPENDITURE (% OF GDP), 2010–2017
           TABLE 107 ROE: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 108 ROE: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 109 ROE: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 110 ROE: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 111 ROE: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 112 ROE: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 113 ROE: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 114 ROE: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
     10.4 ASIA PACIFIC
           TABLE 115 ASIA PACIFIC: NEWBORN SCREENING MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           TABLE 116 ASIA PACIFIC: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 117 ASIA PACIFIC: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 118 ASIA PACIFIC: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 119 ASIA PACIFIC: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 120 ASIA PACIFIC: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 121 ASIA PACIFIC: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 122 ASIA PACIFIC: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 123 ASIA PACIFIC: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.1 CHINA
                        10.4.1.1 China dominates the newborn screening market in the APAC
           TABLE 124 CHINA: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 125 CHINA: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 126 CHINA: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 127 CHINA: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 128 CHINA: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 129 CHINA: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 130 CHINA: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 131 CHINA: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.2 JAPAN
                        10.4.2.1 Rising testing volumes and growing healthcare expenditure drive the market
           TABLE 132 JAPAN: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 133 JAPAN: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 134 JAPAN: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 135 JAPAN: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 136 JAPAN: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 137 JAPAN: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 138 JAPAN: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 139 JAPAN: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.3 AUSTRALIA
                        10.4.3.1 Favorable government policies in the country drive thegrowth of the market
           TABLE 140 AUSTRALIA: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 141 AUSTRALIA: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 142 AUSTRALIA: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 143 AUSTRALIA: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 144 AUSTRALIA: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 145 AUSTRALIA: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 146 AUSTRALIA: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 147 AUSTRALIA: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.4 REST OF ASIA PACIFIC
           TABLE 148 ROAPAC: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 149 ROAPAC: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 150 ROAPAC: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 151 ROAPAC: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 152 ROAPAC: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 153 ROAPAC: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 154 ROAPAC: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 155 ROAPAC: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)
     10.5 REST OF THE WORLD
           TABLE 156 ROW: NEWBORN SCREENING MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 157 ROW: NEWBORN SCREENING MARKET FOR CONSUMABLES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 158 ROW: NEWBORN SCREENING MARKET FOR INSTRUMENTS, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 159 ROW: NEWBORN DISORDER SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 160 ROW: NEWBORN HEARING SCREENING INSTRUMENTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 161 ROW: NEWBORN SCREENING MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
           TABLE 162 ROW: NEWBORN SCREENING MARKET, BY TEST, 2019–2026 (USD MILLION)
           TABLE 163 ROW: NEWBORN SCREENING MARKET, BY END USER, 2019–2026 (USD MILLION)

11 COMPETITIVE LANDSCAPE (Page No. - 126)
     11.1 OVERVIEW
           FIGURE 23 KEY DEVELOPMENTS IN THE NEWBORN SCREENING MARKET, JANUARY 2017–NOVEMBER 2020
           FIGURE 24 MARKET EVOLUTION FRAMEWORK: JANUARY 2017 TO JANUARY 2021
     11.2 MARKET SHARE ANALYSIS
           FIGURE 25 NEWBORN SCREENING MARKET SHARE ANALYSIS, 2019
     11.3 COMPANY EVALUATION MATRIX
             11.3.1 STARS
             11.3.2 EMERGING LEADERS
             11.3.3 PERVASIVE PLAYERS
             11.3.4 PARTICIPANTS
           FIGURE 26 VENDOR DIVE: NEWBORN SCREENING MARKET
     11.4 COMPETITIVE LEADERSHIP MAPPING (START-UPS)
             11.4.1 PROGRESSIVE COMPANIES
             11.4.2 STARTING BLOCKS
             11.4.3 RESPONSIVE COMPANIES
             11.4.4 DYNAMIC COMPANIES
           FIGURE 27 VENDOR DIVE MATRIX FOR START-UPS: NEWBORN SCREENING MARKET
     11.5 COMPETITIVE SCENARIO
             11.5.1 PRODUCT LAUNCHES & APPROVALS
           TABLE 164 NEWBORN SCREENING MARKET: PRODUCT LAUNCHES & APPROVALS, 2017–2021
             11.5.2 DEALS
           TABLE 165 NEWBORN SCREENING MARKET: DEALS 2017–2021
             11.5.3 OTHER DEVELOPMENTS
           TABLE 166 NEWBORN SCREENING MARKET: OTHER DEVELOPMENTS, 2017–2021
           FIGURE 28 PRODUCT BENCHMARKING
           FIGURE 29 GEOGRAPHIC ASSESSMENT

12 COMPANY PROFILES (Page No. - 136)
     12.1 MAJOR PLAYERS
(Business Overview, Products Offered, Recent Developments, and MnM View)* 
             12.1.1 PERKINELMER
           FIGURE 30 PERKINELMER: COMPANY SNAPSHOT (2019)
             12.1.2 DEMANT
           FIGURE 31 DEMANT A/S: COMPANY SNAPSHOT (2019)
             12.1.3 NATUS MEDICAL
           FIGURE 32 NATUS MEDICAL: COMPANY SNAPSHOT (2019)
             12.1.4 MASIMO
           FIGURE 33 MASIMO: COMPANY SNAPSHOT (2019)
             12.1.5 AB SCIEX
           FIGURE 34 DANAHER CORPORATION: COMPANY SNAPSHOT (2019)
             12.1.6 MEDTRONIC
           FIGURE 35 MEDTRONIC: COMPANY SNAPSHOT (2019)
             12.1.7 BAEBIES
             12.1.8 INTELLIGENT HEARING SYSTEMS CORP.
             12.1.9 WELCH ALLYN
           FIGURE 36 HILL-ROM HOLDINGS: COMPANY SNAPSHOT (2019)
             12.1.10 WATERS CORPORATION
             12.1.11 THERMO FISHER SCIENTIFIC
             12.1.12 TRIVITRON HEALTHCARE
     12.2 START-UPS/SME PLAYERS
             12.2.1 BIO-RAD LABORATORIES
           FIGURE 37 BIO-RAD LABORATORIES: COMPANY SNAPSHOT (2019)
             12.2.2 CHROMSYSTEMS INSTRUMENTS & CHEMICALS
             12.2.3 PARSEQ LAB
             12.2.4 RECIPE CHEMICALS + INSTRUMENTS GMBH
             12.2.5 ZIVAK TECHNOLOGIES
             12.2.6 CAMAG
             12.2.7 OTODYNAMICS
             12.2.8 ZENTECH
             12.2.9 VIVOSONIC
             12.2.10 MP BIOMEDICALS
             12.2.11 CENTOGENE
             12.2.12 DRG INTERNATIONAL
             12.2.13 REGIS TECHNOLOGIES
* Business Overview, Products Offered, Recent Developments, and MnM View might not be captured in case of unlisted companies. 

13 APPENDIX (Page No. - 168)
     13.1 INSIGHTS FROM INDUSTRY EXPERTS
     13.2 DISCUSSION GUIDE
     13.3 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL
     13.4 AVAILABLE CUSTOMIZATIONS
     13.5 RELATED REPORTS
     13.6 AUTHOR DETAILS 
      

The study involved four major activities in estimating the current size of the newborn screening market. Exhaustive secondary research was done to collect information on the market and its different subsegments. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation procedures were used to estimate the market size of the segments and subsegments.

Secondary Research

In the secondary research process, various secondary sources such as annual reports, press releases & investor presentations of companies, white papers, certified publications, articles by recognized authors, gold-standard & silver-standard websites, regulatory bodies, and databases (such as D&B Hoovers, Bloomberg Business, and Factiva) were referred to identify and collect information for this study.

Primary Research

Several stakeholders, such as newborn screening product manufacturers, vendors, and distributors; researchers; and doctors from hospitals and research laboraotories, were consulted for this report. The demand side of this market is characterized by significant use of newborn screening products due to the increasing prevalence of newborn disease, and the growing newborn screening rate across the globe. The supply side is characterized by advancements in technology and a shift towards advanced devices. Various primary sources from both the supply and demand sides of the market were interviewed to obtain qualitative and quantitative information. The following is a breakdown of the primary respondents:

Newborn Screening Market  Size, and Share

To know about the assumptions considered for the study, download the pdf brochure

Market Size Estimation

Both top-down and bottom-up approaches were used to estimate and validate the total size of the newborn screening market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

  • The key players in the industry and markets have been identified through extensive secondary research
  • The industry’s supply chain and market size, in terms of value, have been determined through primary and secondary research processes
  • All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources

Data Triangulation

After arriving at the overall market size-using the market size estimation processes-the market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics of each market segment and subsegment, the data triangulation, and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides in the newborn screening industry.

Report Objectives

  • To define, describe, and forecast the newborn screening market by product, test, technology, end user and region
  • To forecast the revenue of the market segments with respect to four main regional segments, namely, North America, Europe, Asia Pacific, and the Rest of the World (RoW)
  • To identify the micromarkets with respect to drivers, industry-specific challenges, opportunities, and challenges affecting the growth of the market
  • To analyze market segments and subsegments with respect to individual growth trends, prospects, and contributions to the overall market
  • To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
  • To profile the key players and comprehensively analyze their market shares and core competencies in terms of market developments and growth strategies
  • To track and analyze competitive developments such as partnerships, agreements, collaborations, acquisitions, product launches, and research and development activities in the newborn screening market.
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