Newborn Screening Market by Product (Reagents & Assay Kits and Instruments); Test Type (Dry Blood Spot Test, Hearing Screen Test, and Critical Congenital Heart Diseases (CCHD) Test); Technology (Electrophoresis, Immunoassays & Enzymatic Assays, Tandem Mass Spectrometry (TMS), DNA-Based Assays, Pulse Oximetry Screening Technology, and Hearing Screen Technology); End User (Hospitals, Diagnostic Centers, and Others): Global Market Size Estimates and Forecast (2022-2030)

Code: BMIRE00026480 | Pages: 100 | Industry: Medical Device | Date: Sep 2022 | Type: Global

The market crossed the US$ 1.24 billion mark in 2022 and is expected to hit US$ 2.34 billion by 2030, recording a CAGR of 8.1% during the forecast period

The newborn screening market has been significantly growing with the rise in government support

According to the World Health Organization (WHO), India's total population was 1,378.4 Mn in 2020, second in Asian counties after China. The birth rate of a newborn in India is approximately 17.377 births per 1,000 people annually. In 2021, or India, 67,385 babies are born daily, which is one-sixth of the world's childbirths. Owing to high birth rates, government agencies in Brazil, China, India, and others are implementing newborn screening programs. For instance, In India, the government and policymakers recognized the importance of newborn screening, resulting in the program's implementation in Kerala, Goa, and Chandigarh. In 2018, the Indian Council of Medical Research (ICMR) task force recommended newborn screening of congenital hypothyroidism (CH) and congenital adrenal hyperplasia (CAH) as CH is the most typical cause of preventable intellectual disability and CAH contributes greatly to both morbidity and death.

Within the report, the market is segmented into product, test type, technology, end-user, and geography. By product, the market is segmented into reagents & assay kits and instruments. Instruments are sub-segmented into newborn disorder screening instruments, pulse oximeters market, and newborn hearing screening instruments. Based on test type, the market is segmented into dry blood spot tests, hearing screen tests, and critical congenital heart diseases (CCHD) tests. Based on technology, the market is segmented into electrophoresis, immunoassays & enzymatic assays, tandem mass spectrometry (TMS), DNA-based assays, pulse oximetry screening technology, and hearing screen technology. Based on the end user, the market is segmented into hospitals, diagnostic centers, and others. Geographically, the market is sub-segmented into North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa.

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Surging cases of infant disorders are stimulating the newborn screening demand that will empower the market's growth

In recent years, the prevalence of infant diseases has multiplied, resulting in a sharp incline in mortality rates. Hormonal disorders, hearing impairment, and metabolic disorders are some most common conditions affecting newborns across prominent regions, which are mostly treatable. According to the Centers for Disease Control & Prevention (CDC), congenital disabilities affect one in every 33 babies across the United States or 3% of all infants. Furthermore, as per the Indian Academy of Pediatrics (IAP) estimations, congenital hearing loss impacts 30 per 100,000 children. Therefore, demand for effective diagnostic solutions has intensified, prompting key healthcare providers to invest in advanced newborn screening approaches, generating increased demand.

The rising technology adoption is one of the major factors accelerating market growth

Based on technology, immunoassay and enzymatic assay-based newborn screening is poised to acquire precedence. This technology is widely adopted to ascertain various circumstances amongst newborns. For instance, using conventional radioimmunoassay, ELISA-based is widely deployed to screen newborns for cystic fibrosis. Similarly, monoclonal antibody immunoassay tests identify hemoglobin variants for neonatal screening.

Recent strategic developments in the newborn screening market

The newborn screening market has undergone several significant developments, and a few of these have been mentioned below:

  • In Jan 2022, PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced that it will be providing the newborn screening assay for Parent Project Muscular Dystrophy’s (PPMD’s) Newborn Screening Pilot for Duchenne Muscular Dystrophy (Duchenne)


  • In September 2020, PerkinElmer received CE-IVD approval for the EONIS screening assay, which is used to screen SCID (severe combined immunodeficiency), SMA (spinal muscular atrophy), and XLA (X-linked agammaglobulinemia) in newborns


  • In May 2021, Baebies was awarded US$ 2.7 million in a Phase-II B SBIR grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) which supports validation, clinical evaluation, and FDA submission of a rapid test panel for near-patient heparin monitoring

The newborn screening market is driven by several players by implementing strategic activities such as investments, new launches, mergers & acquisitions, and partnerships. PerkinElmer, Demant A/S, Natus Medical, Bio-Rad Laboratories, Danaher Corporation, Medtronic, Chromsystems Instruments & Chemicals GmbH, Trivitron Healthcare, Baebies, and Recipe Chemicals+Instruments are among the prominent players operating in the market.

The target audience for the report:

  • Government bodies, such as regulating authorities and policymakers
  • Venture capitalists, private equity firms, and start-up companies
  • End users
  • Research institutes, organizations, and consulting companies

Scope of the report:

In this report, the market has been segmented based on:

  • Product:
    • Reagents and Assay Kits
    • Instruments
  • Newborn Disorder Screening Instruments
  • Pulse Oximeters Market
  • Newborn Hearing Screening Instruments
  • Test Type:
    • Dry Blood Spot Test
    • Hearing Screen Test
    • Critical Congenital Heart Diseases (CCHD) Test
  • Technology:
    • Electrophoresis
    • Immunoassays and Enzymatic Assays
    • Tandem Mass Spectrometry (TMS)
    • DNA-Based Assays
    • Pulse Oximetry Screening Technology
    • Hearing Screen Technology Military & Defense
  • End User:
    • Hospitals
    • Diagnostic Centers
    • Others
  • Region:
    • North America
    • Europe
    • Asia Pacific
    • South & Central America
    • Middle East & Africa
  • Companies Profiled:
    • PerkinElmer
    • Demant A/S
    • Natus Medical
    • Bio-Rad Laboratories
    • Danaher Corporation
    • Medtronic
    • Chromsystems Instruments & Chemicals GmbH
    • Trivitron Healthcare
    • Baebies
    • Recipe Chemicals+Instruments

Companies profiled:
- PerkinElmer
- Demant A/S
- Natus Medical
- Bio-Rad Laboratories
- Danaher Corporation
- Medtronic
- Chromsystems Instruments & Chemicals GmbH
- Trivitron Healthcare
- Baebies
- Recipe Chemicals+Instruments

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