Prenatal and Newborn Genetic Testing Market Scope 2031
The prenatal and newborn genetic testing market size in 2021 stood at US$ 5.72 billion and is projected to reach US$ 21.44 billion by 2031. The market is expected to register a CAGR of 14.5% in 2023–2031. Digital microfluidics for newborn screening is likely to remain key prenatal and newborn genetic testing market trends.
Prenatal and Newborn Genetic Testing Market Analysis
Developing technology capabilities, rising acceptance and awareness of genetic testing for prenatal and neonatal screening, and an increased emphasis on individualized healthcare are some factors that are expanding the market growth. The future of the market is shaped by the crucial role that genetic testing solutions play in improving early diagnosis, well-informed decision-making, and better healthcare outcomes for both pregnant women and babies. Increasing numbers of diagnostic companies operating in the prenatal and newborn screening domain, along with rising public and private investments, are anticipated to augment the market's expansion during the forecast period.
Prenatal and Newborn Genetic Testing Market Overview
Prenatal genetic testing is performed during pregnancy to diagnose diseases or detect specific genetic abnormalities before 8 to 10 weeks of gestation. Most prenatal genetic tests use a blood sample from the mother for the conduction of various screens. Growing demand for prenatal & newborn genetic testing for identifying genetic abnormalities, as well as the presence of public and private-public organizations such as Genomic Health Inc. and the National Human Genome Research Institute, is supporting the growth of the market. The American Association for Clinical Chemistry (AACC) recognizes newborn screening as a critical factor for improving children’s health. As an effort toward the management of genetic diseases in infants, the AACC endorses public-private efforts to maintain, improve, and expand newborn screening programs. In addition, the increase in maternal age, leading to pregnancy complications, is fueling the demand for prenatal genetic testing globally.
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Prenatal and Newborn Genetic Testing Market: Strategic Insights
Market Size Value in US$ 4,034.4 Million in 2018 Market Size Value by US$ 11,204.7 Million by 2027 Growth rate CAGR of 12.2% from 2019-2027 Forecast Period 2019-2027 Base Year 2019
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Prenatal and Newborn Genetic Testing Market: Strategic Insights
| Market Size Value in | US$ 4,034.4 Million in 2018 |
| Market Size Value by | US$ 11,204.7 Million by 2027 |
| Growth rate | CAGR of 12.2% from 2019-2027 |
| Forecast Period | 2019-2027 |
| Base Year | 2019 |
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Prenatal and Newborn Genetic Testing Market Drivers and Opportunities
High Prevalence of Genetic Diseases in Infants Drives the Market Growth
The fetuses in the womb are impacted by various genetic diseases. The way in which these genetic diseases are inherited helps to determine the risk that they pose on pregnancy and the risk of its recurrence. The risk of having genetic diseases in newborn is high in several cases, such as when the parents have another child with a genetic disease, a family history of a genetic disorder, or if either of a parent has a chromosomal abnormality. There is a substantial prevalence of genetic diseases among infants, and these diseases are also responsible for infant mortality globally. Down syndrome is the most common form of intellectual disability in the world. It remains the most common chromosomal condition diagnosed in the US, affecting about 1 in every 700 babies. According to the Centers for Disease Control and Prevention (CDC) data, ~6,000 babies born annually in the US have Down syndrome. The World Health Organization estimates that 240,000 newborns worldwide succumb to death yearly within 28 days of birth due to these diseases. An additional 170,000 children die between the ages of 1 month and 5 years due to congenital diseases. Thus, the prevalence of genetic diseases among infants increases the demand for prenatal and newborn genetic tests, thereby driving the growth of the market.
Government Support to Encourage Prenatal and Newborn Testing to Favor Market Growth
With the advancing field of genomic science, genetic and genomic tests are becoming more customary in various clinical and healthcare institutes. Governments and healthcare regulatory bodies across the world are comprehending the importance of genetic tests and the benefits that these tests offer. To ensure the health of newborns, various initiatives are taken by government worldwide that require babies to undergo newborn screening. The California Newborn Screening (NBS) Program is a public health program that screens all newborns for several serious but treatable genetic disorders. Similarly, in India, the Department of Biotechnology launched the UMMID Initiative (The Unique Methods of Management and Treatment of Inherited Disorders) in 2019. It is designed to promote the babies' genetic screening in the nation. Thus, the increase in support from the government to promote the use of prenatal and new genetic tests across the world is expected to contribute to the market's growth in the future.
Prenatal and Newborn Genetic Testing Market Report Segmentation Analysis
Key segments that contributed to the derivation of the prenatal and newborn genetic testing market analysis are product, disease indication, and end user.
- Based on product, the prenatal and newborn genetic testing market is divided into diagnostic and screening. The screening segment held the largest market share in 2023 and is anticipated to register the highest CAGR during the forecast period.
- By disease indication, the market is segmented into cystic fibrosis, sickle cell anaemia, down syndrome, phenylketonuria, and other diseases. The down syndrome segment held the largest share of the market in 2023. In addition, cystic fibrosis segment is projected to register the highest CAGR during the forecast period.
- Based on end user, the prenatal and newborn genetic testing market is divided into hospitals & clinics, diagnostic centers, and other end users. The hospitals & clinics segment held the largest market share in 2023. In addition, the diagnostic centers segment is anticipated to register the highest CAGR during the forecast period.
Prenatal and Newborn Genetic Testing Market Share Analysis by Geography
The geographic scope of the prenatal and newborn genetic testing market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South & Central America.
North America has dominated the prenatal and newborn genetic testing market. North America market is expanding due to a number of factors, including the increase in the prevalence of genetic diseases among infants, supportive government initiatives as well as initiatives undertaken by various organizations to facilitate the use of prenatal and newborn testing, and increasing birth rate. As per the CDC, birth defects affect one in every 33 babies born annually in the US. Moreover, the demand for the market in the region is anticipated to grow significantly during the forecast period owing to regulatory mandates for performance of prenatal and newborn tests, increasing focus on advanced method integration in healthcare, and the launch of non-invasive tests for diagnosis of prenatal and genetic tests in the region. Asia Pacific is anticipated to grow with the highest CAGR in the coming years.
Prenatal and Newborn Genetic Testing Market Report Scope
Prenatal and Newborn Genetic Testing Market News and Recent Developments
The prenatal and newborn genetic testing market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. The following is a list of developments in the market for prenatal and newborn genetic testing and strategies:
- PerkinElmer Inc. received the US Food and Drug Administration authorization for the marketing of the EONIS SCID-SMA assay kit for in vitro diagnostic (IVD) use by certified laboratories for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns. This is the first FDA-authorized assay for SMA screening in newborns in the US, and it is part of the company’s broader EONIS Platform. (Source: PerkinElmer Inc., Press Release, 2022)
- LifeCell International launched 'Genome-Scope' - a premier Genetic Diagnostic Test for newborns that assesses for thousands of early childhood onset disorders. (Source: LifeCell International Private Limited, Press Release, 2020)
Prenatal and Newborn Genetic Testing Market Report Coverage and Deliverables
The “Prenatal and Newborn Genetic Testing Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:
- Market size and forecast at global, regional, and country levels for all the key market segments covered under the scope.
- Market dynamics such as drivers, restraints, and key opportunities
- Key future trends
- Detailed PEST/Porter’s Five Forces and SWOT analysis
- Global and regional market analysis covering key market trends, major players, regulations, and recent market developments
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Product , Disease , End User and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
US, Canada, Mexico, UK, Germany, Spain, Italy, France, India, China, Japan, South Korea, Australia, UAE, Saudi Arabia, South Africa, Brazil, Argentina
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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