North America Newborn Screening Market Forecast to 2030 - Regional Analysis - by Product Type (Reagents and Assay Kits, and Instruments), Technology, Test Type, and End User (Hospitals and Clinics, and Diagnostic Laboratories)

List of Tables

The North America newborn screening market was valued at US$ 521.55 million in 2022 and is expected to reach US$ 1,082.30 million by 2030; it is estimated to grow at a CAGR of 9.6% from 2022 to 2030.

Surging Government Funding for Newborn Screening Fuels the North America Newborn Screening Market

Governments of different countries are increasingly allocating funds for newborn screening programs. These programs help reduce long-term healthcare costs for children and their parents as congenital and genetic disorders could result in severe health complications and extensive medical interventions if left undetected. By identifying and addressing health issues in infancy, governments can enhance the health and well-being of their citizens. Thus, newborn screening aligns with broader public health objectives to improve overall population health and reduce the burden on healthcare systems.

Government funding promotes equity in healthcare access, ensuring that newborn screening services are available to all, regardless of socioeconomic status. This inclusivity is essential for early disease detection and intervention, as it prevents disparities in healthcare outcomes among different demographic groups. As governments continue to prioritize newborn screening through increased funding and policy support, the newborn screening market has been experiencing sustainable growth worldwide.

North America Newborn Screening Market Overview

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

The rising prevalence of genetic abnormalities and congenital problems has highlighted the significance of newborn screening. The National Institutes of Health has given a researcher from the University at Buffalo a highly competitive R01 grant to lead an international project developed as an effort to significantly increase the accuracy of newborn screening for three rare, frequently fatal genetic diseases. Further, the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the NIH funds the US$ 3.8 million five-year award. Thus, the newborn screening market in North America is increasing with increased awareness, technological advancements, supportive policies, and growing congenital disorder prevalence.

North America Newborn Screening Market Revenue and Forecast to 2030 (US$ Million)

North America Newborn Screening Market Segmentation

The North America newborn screening market is segmented based on product type, technology, test type, end user, and country.

Based on product type, the North America newborn screening market is bifurcated into reagents and assay kits, and instruments. The reagents and assay kits segment held a larger North America newborn screening market share in 2022. The reagents and assay segment kits is subsegmented into DNA-based assays, and immunoassays and enzymatic assays. Instruments segment is subsegmented into newborn disorder screening instruments, pulse oximeters, newborn hearing screening instruments, and other instruments.

In terms of technology, the North America newborn screening market is categorized into tandem mass spectrometry (TMS), molecular assays, immunoassays and enzymatic assay, pulse oximetry screening technology, and other technologies. The pulse oximetry screening technology segment held the largest North America newborn screening market share in 2022.

Based on test type, the North America newborn screening market is categorized into dry blood spot test, hearing screen test, critical congenital heart diseases (CCHD) test, and other test types. The dry blood spot test segment held the largest North America newborn screening market share in 2022.

By end user, the North America newborn screening market is segmented into hospitals and clinics and diagnostic laboratories. The hospitals and clinics segment held a larger North America newborn screening market share in 2022.

Based on country, the North America newborn screening market is categorized into the US, Canada, and Mexico. The US dominated the North America newborn screening market in 2022.

Baebies Inc, Bio-Rad Laboratories Inc, Masimo Corp, Medtronic Plc, Natus Medical Inc, PerkinElmer Inc, and Waters Corp are some of the leading companies operating in the North America newborn screening market.

Product Code: BMIRE00029603

Table of Content

1. Introduction

1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation

2. Executive Summary

2.1 Key Insights

3. Research Methodology

3.1 Coverage
3.2 Secondary Research
3.3 Primary Research

4. North America Newborn Screening Market - Key Industry Dynamics

4.1 Key Market Drivers
- 4.1.1 Surging Government Funding for Newborn Screening
- 4.1.2 Rising Burden of Congenital Diseases
- 4.1.3 Increasing Prevalence of Newborn Disorders
4.2 Key Market Restraints
- 4.2.1 Lack of Uniformity in Newborn Screening Policies and Practices
4.3 Key Market Opportunities
- 4.3.1 Genetic Screening of Newborns
4.4 Future Trends
- 4.4.1 Integration of Machine Learning and Artificial Intelligence in Screening
4.5 Impact Analysis:

5. Newborn Screening Market - North America Market Analysis

5.1 North America Newborn Screening Market Revenue (US$ Mn), 2022 - 2030

6. North America Newborn Screening Market - Revenue and Forecast to 2030 - by Product Type

6.1 Overview
6.2 North America Newborn Screening Market Revenue Share, by Product Type, 2022 & 2030 (%)
6.3 Reagents and Assay Kits
- 6.3.1 Overview
- 6.3.2 Reagents and Assay Kits: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
  - 6.3.2.1 North America Newborn Screening Market, by Reagents and Assay Kits, 2020-2030 (US$ Million)
6.4 Instruments
- 6.4.1 Overview
- 6.4.2 Instruments: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
  - 6.4.2.1 North America Newborn Screening Market, by Instruments, 2020-2030 (US$ Million)

7. North America Newborn Screening Market - Revenue and Forecast to 2030 - by Technology

7.1 Overview
7.2 North America Newborn Screening Market Revenue Share, by Technology 2022 & 2030 (%)
7.3 Tandem Mass Spectrometry (TMS)
- 7.3.1 Overview
- 7.3.2 Tandem Mass Spectrometry (TMS): North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
7.4 Molecular Assays
- 7.4.1 Overview
- 7.4.2 Molecular Assays: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
7.5 Immunoassays and Enzymatic Assays
- 7.5.1 Overview
- 7.5.2 Immunoassays and Enzymatic Assays: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
7.6 Pulse Oximetry Screening Technology
- 7.6.1 Overview
- 7.6.2 Pulse Oximetry Screening Technology: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
7.7 Other Technologies
- 7.7.1 Overview
- 7.7.2 Other Technologies: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)

8. North America Newborn Screening Market - Revenue and Forecast to 2030 - by Test Type

8.1 Overview
8.2 North America Newborn Screening Market Revenue Share, by Test Type 2022 & 2030 (%)
8.3 Dry Blood Spot Test
- 8.3.1 Overview
- 8.3.2 Dry Blood Spot Test: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
8.4 Hearing Screen Test
- 8.4.1 Overview
- 8.4.2 Hearing Screen Test: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
8.5 Critical Congenital Heart Diseases (CCHD) Test
- 8.5.1 Overview
- 8.5.2 Critical Congenital Heart Diseases (CCHD) Test: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
8.6 Other Test Types
- 8.6.1 Overview
- 8.6.2 Other Test Types: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)

9. North America Newborn Screening Market - Revenue and Forecast to 2030 - by End User

9.1 Overview
9.2 North America Newborn Screening Market Revenue Share, by End User, 2022 & 2030 (%)
9.3 Hospitals and Clinics
- 9.3.1 Overview
- 9.3.2 Hospitals and Clinics: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)
9.4 Diagnostic Laboratories
- 9.4.1 Overview
- 9.4.2 Diagnostic Laboratories: North America Newborn Screening Market - Revenue and Forecast to 2030 (US$ Million)

10. North America Newborn Screening Market - Country Analysis

10.1 North America Newborn Screening Market, Revenue and Forecast To 2030
- 10.1.1 North America Newborn Screening Market, by Country
  - 10.1.1.1 US
    - 10.1.1.1.1 US Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
    - 10.1.1.1.2 US: Newborn Screening Market, by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.1.2.1 US: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.1.2.2 US: Newborn Screening Market, For Instruments by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.1.3 US: Newborn Screening Market, by Technology, 2020-2030 (US$ Million)
    - 10.1.1.1.4 US: Newborn Screening Market, by Test Type, 2020-2030 (US$ Million)
    - 10.1.1.1.5 US: Newborn Screening Market, by End User, 2020-2030 (US$ Million)
  - 10.1.1.2 Canada
    - 10.1.1.2.1 Canada Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
    - 10.1.1.2.2 Canada: Newborn Screening Market, by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.2.2.1 Canada: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.2.2.2 Canada: Newborn Screening Market, For Instruments by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.2.3 Canada: Newborn Screening Market, by Technology, 2020-2030 (US$ Million)
    - 10.1.1.2.4 Canada: Newborn Screening Market, by Test Type, 2020-2030 (US$ Million)
    - 10.1.1.2.5 Canada: Newborn Screening Market, by End User, 2020-2030 (US$ Million)
  - 10.1.1.3 Mexico
    - 10.1.1.3.1 Mexico Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
    - 10.1.1.3.2 Mexico: Newborn Screening Market, by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.3.2.1 Mexico: Newborn Screening Market, For Reagents and Assay Kits by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.3.2.2 Mexico: Newborn Screening Market, For Instruments by Product Type, 2020-2030 (US$ Million)
    - 10.1.1.3.3 Mexico: Newborn Screening Market, by Technology, 2020-2030 (US$ Million)
    - 10.1.1.3.4 Mexico: Newborn Screening Market, by Test Type, 2020-2030 (US$ Million)
    - 10.1.1.3.5 Mexico: Newborn Screening Market, by End User, 2020-2030 (US$ Million)

11. North America Newborn Screening Market-Industry Landscape

11.1 Overview
11.2 Growth Strategies in Newborn Screening Market
11.3 Organic Growth Strategies
- 11.3.1 Overview
11.4 Inorganic Growth Strategies
- 11.4.1 Overview

12. Company Profiles

12.1 PerkinElmer Inc
- 12.1.1 Key Facts
- 12.1.2 Business Description
- 12.1.3 Products and Services
- 12.1.4 Financial Overview
- 12.1.5 SWOT Analysis
- 12.1.6 Key Developments
12.2 Waters Corp
- 12.2.1 Key Facts
- 12.2.2 Business Description
- 12.2.3 Products and Services
- 12.2.4 Financial Overview
- 12.2.5 SWOT Analysis
- 12.2.6 Key Developments
12.3 Bio-Rad Laboratories Inc
- 12.3.1 Key Facts
- 12.3.2 Business Description
- 12.3.3 Products and Services
- 12.3.4 Financial Overview
- 12.3.5 SWOT Analysis
- 12.3.6 Key Developments
12.4 Masimo Corp
- 12.4.1 Key Facts
- 12.4.2 Business Description
- 12.4.3 Products and Services
- 12.4.4 Financial Overview
- 12.4.5 SWOT Analysis
- 12.4.6 Key Developments
12.5 Natus Medical Inc.
- 12.5.1 Key Facts
- 12.5.2 Business Description
- 12.5.3 Products and Services
- 12.5.4 Financial Overview
- 12.5.5 SWOT Analysis
- 12.5.6 Key Developments
12.6 Baebies Inc
- 12.6.1 Key Facts
- 12.6.2 Business Description
- 12.6.3 Products and Services
- 12.6.4 Financial Overview
- 12.6.5 SWOT Analysis
- 12.6.6 Key Developments
12.7 Medtronic Plc
- 12.7.1 Key Facts
- 12.7.2 Business Description
- 12.7.3 Products and Services
- 12.7.4 Financial Overview
- 12.7.5 SWOT Analysis
- 12.7.6 Key Developments

13. Appendix

13.1 About Us
13.2 Glossary of Terms