North America Genetic Testing Industry Overview
|Study Period:||2018 - 2028|
*Disclaimer: Major Players sorted in no particular order
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North America Genetic Testing Market Analysis
The North American genetic testing market is poised to witness a CAGR of 9.8% over the forecast period.
The COVID-19 pandemic left a significant impact on the growth of the genetic testing market. According to the study published in Prenatal Diagnosis in March 2021, the COVID-19 pandemic influenced pregnant women's decisions about prenatal genetic testing. Patients' access to and use of prenatal genetic tests may have been impacted by the pandemic. According to a study published in January 2021 by a group of researchers from the United States, there was an urgent need for the development of approaches that can reduce the serious challenges affecting patients with rare and undiagnosed diseases and families. The challenges include diagnostic and/or prognostic uncertainty coupled with medical complexity leading to poor health outcomes. In addition, clinical trials focused on rare diseases had also been affected by the COVID-19 pandemic. The pandemic created several challenges for clinical trials. The challenges associated with finding, recruiting, and retaining patients with rare diseases majorly impacted clinical trials. The genetic testing market was severely impacted by the COVID-19 outbreak but has recovered in the two years to show strong growth in the post pandemic era.
The market is growing constantly owing to factors, like increasing demand for personalized genetic testing services in the region and the rise in the prevalence of chronic and genetic disorders. According to the CDC, most clinics and hospitals have restricted in-person delivery of non-essential healthcare services, including genetic counseling, to minimize coronavirus transmission. Hence, though the market studied had slowed down due to the pandemic, the situation is expected to improve gradually.
According to the World Federation of Hemophilia 2021 Report, there were about 14,816 patiens with hemophilia (hemophilia A - 11,790 and hemophilia B - 3,026) in the United States in 2020 and 3,924 patients with hemophilia in Canada in 2020 (hemophilia A - 3,223 and hemophilia B - 701) . Such a high number of hemophilia cases in these regions is expected to drive the growth of the market due to the higher adoption of therapies for hemophilia. Thus, increasing genetic diseases in the region is driving the need for genetic testing.
The increasing product approvals by the USFDA and subsequent launches are anticipated to drive the market's growth in North America. For instance, in October 2021, F. Hoffmann-La Roche Ltd launched AVENIO Tumor Tissue CGP Kit, a comprehensive genomic profiling kit to make tailored cancer research more accessible. Thus, given the growing cancer incidence and strategies taken ahead by key players in the region, the genetic testing market is expected to grow significantly over the forecast period in North America.
North America Genetic Testing Industry Segments
As per the scope of the report, a genetic test is performed to identify the presence of a gene, with a particular sequence in the genome. The gene can be either identified directly through sequencing or can be identified indirectly through various methods. These genetic tests are carried out to assess the risk of an individual developing a certain disease.
The North American genetic testing market is segmented by type (carrier testing, diagnostic testing, newborn screening, predictive and presymptomatic testing, prenatal testing, and other types), disease (Alzheimer's disease, cancer, cystic fibrosis, sickle cell anemia, Duchenne muscular dystrophy, thalassemia, Huntington's disease, and rare diseases), technology (cytogenetic testing, biochemical testing, and molecular testing), and country (United States, Canada, and Mexico). The report offers the value (in USD million) for the above segments.
|Predictive and Presymptomatic Testing|
|Sickle Cell Anemia|
|Duchenne Muscular Dystrophy|
North America Genetic Testing Market Trends
Predictive and Presymptomatic Testing is Expected to be the Major Contributor to the Market over the Forecast Period
Predictive and presymptomatic testing is utilized for the detection of gene mutations that are related to disorders appearing after birth, frequently in the later stages of life. Such tests can be of assistance to individuals having a family member with a genetic disorder, even though they are free from any features of the disorder while testing. Thus, the rising incidences of cancer and growing awareness about the diseases are expected to lead to more such tests, which, in turn, is anticipated to drive the market.
Resources and technological advancement have played a great role in genetic counseling. As per the Proceeding National Academy of Science of North America in 2021, around 2.7 billion people (36% of the total world population) worldwide are the carrier of at least one mutation that causes AR-IRD (autosomal recessive (AR)-inherited retinal diseases (IRDs). Moreover, modern technologies and the latest innovations concerning genetic disorders are boosting the market's growth of the predictive and presymptomatic testing market.
As per the National Breast Cancer Foundation Inc., in 2021, an estimated 276,480 new cases of proliferating breast cancer were diagnosed in women in the United States. About 65% of breast cancer cases are diagnosed at a localized stage, in which 5-year survival is 98%. Additionally, North America is ranked highest in breast cancer treatment due to the occurrence of breast cancer cases in women. Furthermore, the high technological investment in the region with growing healthcare facilities with advanced infrastructure is fuelling the market's growth.
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United States is Expected to Winess Significant Growth over the Forecast Period
The United States is expected to witness significant growth in the genetic testing market currently, owing to factors like increasing demand for personalized genetic testing services in the region and the rise in the prevalence of chronic and genetic disorders. According to the CDC, most clinics and hospitals have restricted in-person delivery of non-essential healthcare services, including genetic counseling, to minimize the transmission of coronavirus. Hence, though the market studied slowed down due to the pandemic, the situation is expected to improve gradually.
The increasing product approvals by the USFDA and subsequent launches are anticipated to drive the market's growth in North America. For instance, in June 2021, Eurofins acquired DNA Diagnostics Center to extend its genetic testing capabilities and join the consumer testing industry. Thus, due to the growing cancer incidence and strategies taken by key players in the United States, the genetic testing market is expected to grow significantly over the forecast period.
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North America Genetic Testing Market Competitor Analysis
The competitive landscape includes an analysis of a few international and local companies that hold market shares and are well known. These include 23&Me Inc., Abbott Laboratories, Ariosa Diagnostics Inc., Danaher Corporation (Cepheid Inc.), Illumina Inc., DiaSorin Spa (Luminex Corporation), Biorad Laboratories Inc., PerkinElmer Inc., Quest Diagnostics Incorporated, and F Hoffmann-La Roche Ltd.
North America Genetic Testing Market Top Players
F Hoffmann-La Roche Ltd
Danaher Corporation (Cepheid Inc.)
*Disclaimer: Major Players sorted in no particular order
North America Genetic Testing Market Recent Developments
- September 2022: Invitae, a United States-based company, announced a collaboration with Simons Searchlight, an international research program, with the goal of accelerating research and improving lives for people with rare genetic neurodevelopmental disorders. This is intended to help improve treatment, with the goal of ultimately finding a cure for these rare diseases.
- June 2022: Prenetics Group Limited introduced a novel, non-invasive, at-home screening test - ColoClear by Circle (ColoClear), for detecting early signs of colorectal cancer.
North America Genetic Testing Market Report - Table of Contents
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Emphasis on Early Disease Detection and Prevention
4.2.2 Growing Demand for Personalized Medicine
4.2.3 Increasing Application of Genetic Testing in Oncology
4.3 Market Restraints
4.3.1 High Costs of Genetic Testing
4.3.2 Potentially Adverse Personal or Societal Consequences
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. Market Segmentation (Market Size by Value - USD million)
5.1 By Type
5.1.1 Carrier Testing
5.1.2 Diagnostic Testing
5.1.3 Newborn Screening
5.1.4 Predictive and Presymptomatic Testing
5.1.5 Prenatal Testing
5.1.6 Other Types
5.2 By Diseases
5.2.1 Alzheimer's Disease
5.2.3 Cystic Fibrosis
5.2.4 Sickle Cell Anemia
5.2.5 Duchenne Muscular Dystrophy
5.2.7 Huntington's Disease
5.2.8 Rare Diseases
5.3 By Technology
5.3.1 Cytogenetic Testing
5.3.2 Biochemical Testing
5.3.3 Molecular Testing
5.4 By Country
5.4.1 United States
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
6.1 Company Profiles
6.1.1 23&Me Inc.
6.1.2 Abbott Laboratories
6.1.3 Ariosa Diagnostics Inc.
6.1.4 Danaher Corporation (Cepheid Inc.)
6.1.5 Illumina Inc.
6.1.6 DiaSorin Spa (Luminex Corporation)
6.1.7 Biorad Laboratories Inc.
6.1.8 PerkinElmer Inc.
6.1.9 Quest Diagnostics Incorporated
6.1.10 F Hoffmann-La Roche Ltd
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
North America Genetic Testing Market Research FAQs
What is the study period of this market?
The North America Genetic Testing Market is studied from 2018 - 2028.
What is the growth rate of North America Genetic Testing Market?
The North America Genetic Testing Market is growing at a CAGR of 9.8% over the next 5 years.
Who are the key players in North America Genetic Testing Market?
Abbott Laboratories, Illumina Inc., 23&Me Inc., F Hoffmann-La Roche Ltd, Danaher Corporation (Cepheid Inc.) are the major companies operating in North America Genetic Testing Market.
North America Genetic Testing Industry Report
In-depth industry statistics and market share insights of the North America Genetic Testing Market sector for 2020, 2021, and 2022. The North America Genetic Testing Market research report provides a comprehensive outlook of the market size and an industry growth forecast for 2023 to 2028. Available to download is a free sample file of the North America Genetic Testing Market report PDF.