North America Genetic Testing Services Market Report (2021-2031) by Scope, Segmentation, Dynamics, and Competitive Analysis

The North America genetic testing services market size is expected to reach US$ 5,892.93 million by 2031 from US$ 1,808.02 million in 2023. The market is estimated to record a CAGR of 15.9% from 2023 to 2031.

Executive Summary and North America Genetic Testing Services Market Analysis:

The genetic testing services market in North America is experiencing significant growth, driven by technological advancements, increasing demand for personalized medicine, and a growing focus on preventive healthcare. The United States, in particular, is a key contributor to this market, with widespread adoption of genetic testing for cancer diagnosis, prenatal screening, and hereditary diseases. The presence of leading companies such as 23andMe, Illumina, and LabCorp further accelerates market expansion through innovation and improved testing technologies. Additionally, government support for genomics research and increasing healthcare investments are expected to fuel the market’s growth in the region, making it a global leader.

North America Genetic Testing Services Market Strategic Insights

Get more information on this report Request Free Sample PDF

North America Genetic Testing Services Market Segmentation Analysis

Key segments that contributed to the derivation of the genetic testing services market analysis are service type, disease, and service provider.

• By service type, the genetic testing services market is segmented into predictive testing, carrier testing, prenatal testing, newborn screening, diagnostic genetic testing, and others. The predictive testing segment held the largest share of the market in 2023. 
• By disease, the genetic testing services market is segmented into cancer, cardiovascular diseases, metabolic diseases, and other diseases. The cancer segment held the largest share of the market in 2023.
• By service provider, the genetic testing services market is segmented into hospital-based laboratories, diagnostic laboratories, and other service provider. The hospital-based laboratories segment held the largest share of the market in 2023.

North America Genetic Testing Services Market Outlook

The prevalence of genetic diseases is rising across the world and impacting the health of people at a severe level. Genetic diseases show many symptoms that are uncommon and are mostly non-curable. Most of the genetic diseases are rare and are developed due to the mutation in the genetic makeup of the people. According to The World Health Organization (WHO) 2021, 10 out of every 1,000 people are affected by single-gene diseases, signifying that 70 million and 80 million people worldwide are living with any one type of single-gene disease. As per the Global Genes, ~7,000 known rare diseases and disorders have been identified worldwide, and more are being discovered every year.

According to the University of Sheffield research, ~300 million people are living with genetic diseases around the world. In 2022, a report by MJH Life Sciences (US) estimated that 300,000 newborns worldwide are born with sickle cell disease every year, accounting for ∼5% of the global population. Also, as per the study titled "Sickle Cell Disease," published in August 2023, 1 in 500 African Americans is affected by sickle cell disease, and ∼1 in 12 African Americans carry the autosomal recessive mutation.  

Thus, the rising prevalence of genetic diseases fuels the demand for genetic testing, which in turn drives genetic testing services market growth.

North America Genetic Testing Services Market Country Insights

Based on country, the North America genetic testing services market comprises the US, Canada, and Mexico. The US held the largest share in 2023.

According to the Centers for Disease Control and Prevention (CDC), ~1,603,844 new cancer cases were diagnosed in 2020, with 602,347 cancer deaths in the US. For every 100,000 individuals, 403 new cancer cases were reported. In the US, 1,958,310 new cancer cases and 609,820 cancer deaths are projected to occur in 2023. Additionally, as per the International Agency for Research on Cancer, new cancer incidences were projected to reach 30.2 million by 2040. Cancer is the second highest death-causing disease worldwide, after heart disease. Several types of cancers are inherited from one generation to another generation due to genes. Genetic tests help in providing information on risk factors associated with the development of cancers among individuals with a family history of cancers. Thus, genetic testing is extensively applicable to study its pattern for prevention, treatment, and drug discovery.

As per the estimates of the US Government Accountability Office published in October 2021, ~25 to 30 million people suffer from rare diseases in the country; nearly 50% of patients with rare diseases are children. Rare diseases are often the result of a genetic mutation; it is estimated that 80% of rare diseases are genetic.

Genetic testing has been an essential part of the healthcare industry in the US for the last few decades. With the increased adoption of genetic testing, there has been a need to look after the quality of the tests being conducted across the US. Regulation of genetic testing laboratories has been undertaken by the Clinical Laboratory Improvement Amendments (CLIA), which extends federal regulation over nearly all US clinical laboratories. CLIA requires laboratories to participate in quality control and quality assurance schemes and requires laboratory inspections. Also, the quality of genetic testing kits that the clinical laboratory purchases from an external provider is regulated by the US FDA.

The demand for genetic testing in the US is expected to witness growth since the service encompasses a broad range of applications, such as cancer, autoimmune diseases, and infectious diseases. In the US, the products for genetic testing of pediatric as well as rare diseases have increased significantly. For instance, in July 2021, Avellino Labs launched AvaGen, the genetic eye test, in the US. The test is designed to determine the risk of keratoconus and other corneal dystrophies in patients. In February 2020, the US FDA authorized the marketing of the first genetic test to detect a condition known as Fragile X Syndrome, which is one of the common causes of inherited developmental delay and intellectual disability among people. Thus, innovation in product design, improvement in quality, and strong distribution partnerships help to retain a competitive edge in the market.

Therefore, the presence of regulatory policies associated with the use and the sale of genetic testing products, the rising cases of rare and genetic diseases in the US, and the development of innovative genetic testing products are anticipated to fuel the growth of the genetic testing services market during the forecast period.

North America Genetic Testing Services Market Report Highlights

North America Genetic Testing Services Market Company Profiles

Some of the key players operating in the market include Eurofins Scientific SE; Exact Sciences Corp; Laboratory Corp of America Holdings; 23andMe Holding Co; Ambry Genetics Corp; Quest Diagnostics Inc; Illumina Inc; F. Hoffmann-La Roche Ltd; NeoGenomics Inc; Centogene NV; Ancestry Genomics Inc; Gene By Gene Ltd; SIVOTEC BioInformatics LLC; Progenesis; Fulgent Genetics, Inc; VERITAS INTERCONTINENTAL; and GeneDx, LLC. among others. These players are adopting various strategies such as expansion, product innovation, and mergers and acquisitions to provide innovative products to their consumers and increase their market share.

North America Genetic Testing Services Market Research Methodology :

The following methodology has been followed for the collection and analysis of data presented in this report:

• Secondary Research

The research process begins with comprehensive secondary research, utilizing both internal and external sources to gather qualitative and quantitative data for each market. Commonly referenced secondary research sources include, but are not limited to:

• Company websites, annual reports, financial statements, broker analyses, and investor presentations.
• Industry trade journals and other relevant publications.
• Government documents, statistical databases, and market reports.
• News articles, press releases, and webcasts specific to companies operating in the market.

Note: All financial data included in the Company Profiles section has been standardized to USD. For companies reporting in other currencies, figures have been converted to USD using the relevant exchange rates for the corresponding year.

• Primary Research

Business Market Insights’ conducts a significant number of primary interviews each year with industry stakeholders and experts to validate its data analysis, and gain valuable insights. These research interviews are designed to:

• Validate and refine findings from secondary research.
• Enhance the expertise and market understanding of the analysis team.
• Gain insights into market size, trends, growth patterns, competitive dynamics, and future prospects.

Primary research is conducted via email interactions and telephone interviews, encompassing various markets, categories, segments, and sub-segments across different regions. Participants typically include:

• Industry stakeholders: Vice Presidents, business development managers, market intelligence managers, and national sales managers
• External experts: Valuation specialists, research analysts, and key opinion leaders with industry-specific expertise

North America Genetic Testing Services Market Country and Regional Insights