U.S. Carrier Screening Market Outlook to 2028
Description
U.S. Carrier Screening Market Overview
The U.S. Carrier Screening Market is valued at USD 720 million, based on a five-year historical analysis, driven by the increasing awareness of genetic disorders, advancements in screening technologies, and rising demand for early detection in at-risk populations. The market has seen significant growth due to the expansion of testing options and the broader acceptance of genetic screening as part of routine prenatal care.
Major metropolitan areas such as New York, Los Angeles, and Chicago are key drivers of this market, benefiting from the high concentration of advanced healthcare facilities, fertility clinics, and specialized genetic counseling centers. In rural areas, the demand for carrier screening is growing as healthcare access improves, particularly through telemedicine, enabling broader reach of genetic services across underserved regions.
The Genetic Information Nondiscrimination Act (GINA) remains a vital law governing the use of genetic information in the U.S. healthcare system. Enacted to protect individuals from discrimination based on their genetic data, GINA ensures that genetic information cannot be used by employers or insurers to make decisions.
U.S. Carrier Screening Market Segmentation
By Type of Test: The market is segmented into expanded carrier screening, targeted carrier screening, and single gene testing. Expanded carrier screening dominates the market due to its ability to test for multiple genetic conditions at once, offering broader insights for potential genetic risks. Targeted carrier screening, focusing on specific populations with known genetic risks, also holds a significant share, while single gene testing is seeing growth in cases with family histories of specific disorders.
By Technology: The market is segmented by technology into next-generation sequencing (NGS), polymerase chain reaction (PCR), and microarray technology. NGS holds the largest market share due to its accuracy, cost-effectiveness, and ability to sequence large portions of the genome. PCR remains popular for targeted gene tests, while microarray technology is used for more specialized applications, particularly in research settings.
U.S. Carrier Screening Market Competitive Landscape
The U.S. Carrier Screening Market is highly competitive, with several key players continuously innovating and expanding their test offerings. Major players include Myriad Genetics, Invitae, Natera, Quest Diagnostics, and Labcorp. These companies are investing in the development of comprehensive carrier screening panels, partnering with healthcare providers, and utilizing advanced technologies such as next-generation sequencing to maintain a competitive edge.
Company Name
Establishment Year
Headquarters
No. of Employees
Revenue (USD)
Key Products
Sustainability Initiatives
Geographical Reach
Technology Adoption
Partnerships
Myriad Genetics
1991
Salt Lake City, UT
Invitae
2010
San Francisco, CA
Natera
2004
San Carlos, CA
Quest Diagnostics
1967
Secaucus, NJ
Labcorp
1978
Burlington, NC
U.S. Carrier Screening Industry Analysis
Growth Drivers
Increasing Prevalence of Genetic Disorders: The rising prevalence of genetic disorders in the U.S. has significantly driven the demand for carrier screening. In 2023, the CDC reported over 12,000 infants born annually with a genetic or metabolic condition detected through newborn screening. This high number underscores the need for genetic carrier testing to identify potential hereditary risks. According to the National Institutes of Health (NIH), cystic fibrosis and sickle cell anemia are among the most common genetic disorders in the U.S., with cystic fibrosis affecting 30,000 individuals. The increasing incidence of these disorders makes carrier screening essential for early detection and treatment strategies.
Growing Adoption of Expanded Carrier Screening Panels: In 2024, expanded carrier screening panels, which test for hundreds of genetic conditions, have seen widespread adoption due to their comprehensive coverage. NIH data confirms that more than 7,000 rare diseases affect over 25 million people in the U.S. Expanded carrier panels provide a broader scope of testing, allowing healthcare professionals to detect multiple genetic conditions in one screening. The American College of Obstetricians and Gynecologists recommends that expanded panels be offered to all individuals planning pregnancies, reflecting the growing demand for more inclusive carrier testing.
Rising Demand for Personalized Medicine: Personalized medicine is gaining momentum in the U.S., with a notable impact on carrier screening. The FDA reports an increase in the use of genomic information to tailor medical treatments based on an individual’s genetic makeup. Genetic tests like carrier screenings are vital for identifying hereditary conditions that can affect treatment plans. In 2022, the Precision Medicine Initiative, launched by the National Institutes of Health, accelerated the use of genetic data in healthcare, particularly for rare diseases. This growing reliance on tailored medical approaches increases the demand for carrier screening to personalize treatments.
Market Challenges
Ethical and Privacy Concerns in Genetic Testing: Privacy issues surrounding genetic data remain a significant challenge in carrier screening. In 2024, the Genetic Information Nondiscrimination Act (GINA) continues to address these concerns by preventing the misuse of genetic information. However, ethical dilemmas persist regarding the ownership of genetic data, with majority of Americans expressing concerns about the security of their genetic information, according to a 2022 survey by the Pew Research Center. GINA and other federal guidelines aim to alleviate these concerns, but the debate over data protection and privacy in genetic testing is ongoing. Source: GINA
Regulatory Scrutiny (FDA regulations, Genetic Information Nondiscrimination Act): The U.S. carrier screening market faces rigorous regulatory scrutiny, particularly from the FDA and under GINA. As of 2023, the FDA introduced tighter regulations on genetic testing kits to ensure accuracy and safety. The Genetic Information Nondiscrimination Act remains a cornerstone law, protecting individuals from discrimination based on their genetic data. Nonetheless, compliance with these regulations adds complexity to the carrier screening industry, as companies must navigate stringent guidelines to avoid legal and ethical pitfalls, making the regulatory environment a significant market challenge.
U.S. Carrier Screening Market Future Outlook
The U.S. Carrier Screening Market is expected to grow steadily over the next five years, driven by increased awareness of genetic conditions, advancements in screening technologies, and rising demand for personalized healthcare solutions. With a growing focus on preventative care, carrier screening will become an integral part of family planning and prenatal care.
Future Market Opportunities
Expansion in Direct-to-Consumer Genetic Testing: Direct-to-consumer genetic testing presents a growing opportunity in the U.S. carrier screening market. A 2023 report from the U.S. Census Bureau revealed that more than 14 million people have already used genetic testing services like 23and Me globally. As these services become more affordable and widely accepted, they offer a pathway for consumers to access carrier screening without physician referrals, increasing market penetration. This shift toward consumer-driven testing provides an untapped avenue for growth, especially among health-conscious individuals seeking early genetic insights.
Integration with Telemedicine Platforms: Telemedicine has expanded dramatically in the U.S., particularly following the COVID-19 pandemic. The U.S. Department of Health and Human Services (HHS) reported a 38-fold increase in telemedicine visits from 2019 to 2023. This rise presents an opportunity for the integration of genetic counseling and carrier screening services through digital platforms. Offering genetic screening via telemedicine reduces geographical barriers, improves patient convenience, and allows for timely consultations with genetic counselors, particularly in underserved regions where healthcare access is limited.
Please Note: It will take 5-7 business days to complete the report upon order confirmation
The U.S. Carrier Screening Market is valued at USD 720 million, based on a five-year historical analysis, driven by the increasing awareness of genetic disorders, advancements in screening technologies, and rising demand for early detection in at-risk populations. The market has seen significant growth due to the expansion of testing options and the broader acceptance of genetic screening as part of routine prenatal care.
Major metropolitan areas such as New York, Los Angeles, and Chicago are key drivers of this market, benefiting from the high concentration of advanced healthcare facilities, fertility clinics, and specialized genetic counseling centers. In rural areas, the demand for carrier screening is growing as healthcare access improves, particularly through telemedicine, enabling broader reach of genetic services across underserved regions.
The Genetic Information Nondiscrimination Act (GINA) remains a vital law governing the use of genetic information in the U.S. healthcare system. Enacted to protect individuals from discrimination based on their genetic data, GINA ensures that genetic information cannot be used by employers or insurers to make decisions.
U.S. Carrier Screening Market Segmentation
By Type of Test: The market is segmented into expanded carrier screening, targeted carrier screening, and single gene testing. Expanded carrier screening dominates the market due to its ability to test for multiple genetic conditions at once, offering broader insights for potential genetic risks. Targeted carrier screening, focusing on specific populations with known genetic risks, also holds a significant share, while single gene testing is seeing growth in cases with family histories of specific disorders.
By Technology: The market is segmented by technology into next-generation sequencing (NGS), polymerase chain reaction (PCR), and microarray technology. NGS holds the largest market share due to its accuracy, cost-effectiveness, and ability to sequence large portions of the genome. PCR remains popular for targeted gene tests, while microarray technology is used for more specialized applications, particularly in research settings.
U.S. Carrier Screening Market Competitive Landscape
The U.S. Carrier Screening Market is highly competitive, with several key players continuously innovating and expanding their test offerings. Major players include Myriad Genetics, Invitae, Natera, Quest Diagnostics, and Labcorp. These companies are investing in the development of comprehensive carrier screening panels, partnering with healthcare providers, and utilizing advanced technologies such as next-generation sequencing to maintain a competitive edge.
Company Name
Establishment Year
Headquarters
No. of Employees
Revenue (USD)
Key Products
Sustainability Initiatives
Geographical Reach
Technology Adoption
Partnerships
Myriad Genetics
1991
Salt Lake City, UT
Invitae
2010
San Francisco, CA
Natera
2004
San Carlos, CA
Quest Diagnostics
1967
Secaucus, NJ
Labcorp
1978
Burlington, NC
U.S. Carrier Screening Industry Analysis
Growth Drivers
Increasing Prevalence of Genetic Disorders: The rising prevalence of genetic disorders in the U.S. has significantly driven the demand for carrier screening. In 2023, the CDC reported over 12,000 infants born annually with a genetic or metabolic condition detected through newborn screening. This high number underscores the need for genetic carrier testing to identify potential hereditary risks. According to the National Institutes of Health (NIH), cystic fibrosis and sickle cell anemia are among the most common genetic disorders in the U.S., with cystic fibrosis affecting 30,000 individuals. The increasing incidence of these disorders makes carrier screening essential for early detection and treatment strategies.
Growing Adoption of Expanded Carrier Screening Panels: In 2024, expanded carrier screening panels, which test for hundreds of genetic conditions, have seen widespread adoption due to their comprehensive coverage. NIH data confirms that more than 7,000 rare diseases affect over 25 million people in the U.S. Expanded carrier panels provide a broader scope of testing, allowing healthcare professionals to detect multiple genetic conditions in one screening. The American College of Obstetricians and Gynecologists recommends that expanded panels be offered to all individuals planning pregnancies, reflecting the growing demand for more inclusive carrier testing.
Rising Demand for Personalized Medicine: Personalized medicine is gaining momentum in the U.S., with a notable impact on carrier screening. The FDA reports an increase in the use of genomic information to tailor medical treatments based on an individual’s genetic makeup. Genetic tests like carrier screenings are vital for identifying hereditary conditions that can affect treatment plans. In 2022, the Precision Medicine Initiative, launched by the National Institutes of Health, accelerated the use of genetic data in healthcare, particularly for rare diseases. This growing reliance on tailored medical approaches increases the demand for carrier screening to personalize treatments.
Market Challenges
Ethical and Privacy Concerns in Genetic Testing: Privacy issues surrounding genetic data remain a significant challenge in carrier screening. In 2024, the Genetic Information Nondiscrimination Act (GINA) continues to address these concerns by preventing the misuse of genetic information. However, ethical dilemmas persist regarding the ownership of genetic data, with majority of Americans expressing concerns about the security of their genetic information, according to a 2022 survey by the Pew Research Center. GINA and other federal guidelines aim to alleviate these concerns, but the debate over data protection and privacy in genetic testing is ongoing. Source: GINA
Regulatory Scrutiny (FDA regulations, Genetic Information Nondiscrimination Act): The U.S. carrier screening market faces rigorous regulatory scrutiny, particularly from the FDA and under GINA. As of 2023, the FDA introduced tighter regulations on genetic testing kits to ensure accuracy and safety. The Genetic Information Nondiscrimination Act remains a cornerstone law, protecting individuals from discrimination based on their genetic data. Nonetheless, compliance with these regulations adds complexity to the carrier screening industry, as companies must navigate stringent guidelines to avoid legal and ethical pitfalls, making the regulatory environment a significant market challenge.
U.S. Carrier Screening Market Future Outlook
The U.S. Carrier Screening Market is expected to grow steadily over the next five years, driven by increased awareness of genetic conditions, advancements in screening technologies, and rising demand for personalized healthcare solutions. With a growing focus on preventative care, carrier screening will become an integral part of family planning and prenatal care.
Future Market Opportunities
Expansion in Direct-to-Consumer Genetic Testing: Direct-to-consumer genetic testing presents a growing opportunity in the U.S. carrier screening market. A 2023 report from the U.S. Census Bureau revealed that more than 14 million people have already used genetic testing services like 23and Me globally. As these services become more affordable and widely accepted, they offer a pathway for consumers to access carrier screening without physician referrals, increasing market penetration. This shift toward consumer-driven testing provides an untapped avenue for growth, especially among health-conscious individuals seeking early genetic insights.
Integration with Telemedicine Platforms: Telemedicine has expanded dramatically in the U.S., particularly following the COVID-19 pandemic. The U.S. Department of Health and Human Services (HHS) reported a 38-fold increase in telemedicine visits from 2019 to 2023. This rise presents an opportunity for the integration of genetic counseling and carrier screening services through digital platforms. Offering genetic screening via telemedicine reduces geographical barriers, improves patient convenience, and allows for timely consultations with genetic counselors, particularly in underserved regions where healthcare access is limited.
Please Note: It will take 5-7 business days to complete the report upon order confirmation
Table of Contents
86 Pages
- U.S. Carrier Screening Market Overview
- 1.1. Definition and Scope
- 1.2. Market Taxonomy
- 1.3. Market Growth Rate (CAGR, YoY growth analysis)
- 1.4. Market Segmentation Overview
- U.S. Carrier Screening Market Size (In USD Bn)
- 2.1. Historical Market Size
- 2.2. Year-On-Year Growth Analysis
- 2.3. Key Market Developments and Milestones (Technological innovations, regulatory approvals)
- U.S. Carrier Screening Market Analysis
- 3.1. Growth Drivers
- 3.1.1. Increasing Prevalence of Genetic Disorders
- 3.1.2. Growing Adoption of Expanded Carrier Screening Panels
- 3.1.3. Rising Demand for Personalized Medicine
- 3.1.4. Technological Advancements in Genetic Testing (NGS, PCR, Microarray)
- 3.2. Market Challenges
- 3.2.1. Ethical and Privacy Concerns in Genetic Testing
- 3.2.2. Regulatory Scrutiny (FDA regulations, Genetic Information Nondiscrimination Act)
- 3.2.3. High Costs of Carrier Screening Tests
- 3.2.4. Limited Genetic Counseling Access
- 3.3. Opportunities
- 3.3.1. Expansion in Direct-to-Consumer Genetic Testing
- 3.3.2. Integration with Telemedicine Platforms
- 3.3.3. Growth in Carrier Screening for Fertility Treatments
- 3.3.4. Rising Awareness of Genetic Screening in Underserved Areas
- 3.4. Trends
- 3.4.1. Shift Toward Preconception and Prenatal Genetic Testing
- 3.4.2. Increasing Use of AI and Data Analytics in Carrier Screening
- 3.4.3. Adoption of Non-Invasive Prenatal Testing (NIPT)
- 3.5. Government Regulation
- 3.5.1. FDA Oversight on Genetic Testing Products
- 3.5.2. Impact of the Genetic Information Nondiscrimination Act (GINA)
- 3.5.3. State-Level Guidelines for Carrier Screening
- 3.6. SWOT Analysis
- 3.7. Stake Ecosystem (Hospitals, Diagnostic Labs, Genetic Counselors, and Consumers)
- 3.8. Porter’s Five Forces
- 3.9. Competition Ecosystem
- U.S. Carrier Screening Market Segmentation
- 4.1. By Type of Test
- 4.1.1. Expanded Carrier Screening
- 4.1.2. Targeted Carrier Screening
- 4.1.3. Single Gene Testing
- 4.2. By Technology
- 4.2.1. Next-Generation Sequencing (NGS)
- 4.2.2. Polymerase Chain Reaction (PCR)
- 4.2.3. Microarray
- 4.3. By Application
- 4.3.1. Prenatal Screening
- 4.3.2. Fertility Screening
- 4.3.3. Genetic Counseling
- 4.4. By End-User
- 4.4.1. Hospitals
- 4.4.2. Diagnostic Laboratories
- 4.4.3. Research Institutions
- 4.5. By Distribution Channel
- 4.5.1. Direct-to-Consumer
- 4.5.2. Hospital-Based Labs
- 4.5.3. Physician-Ordered Tests
- U.S. Carrier Screening Market Competitive Analysis
- 5.1. Detailed Profiles of Major Companies (Key Metrics: No. of Employees, Revenue, Key Products, Technology Adoption)
- 5.1.1. Myriad Genetics
- 5.1.2. Invitae
- 5.1.3. Natera
- 5.1.4. Quest Diagnostics
- 5.1.5. Labcorp
- 5.1.6. Fulgent Genetics
- 5.1.7. Ambry Genetics
- 5.1.8. 23andMe
- 5.1.9. Counsyl
- 5.1.10. Sema4
- 5.1.11. GeneDx
- 5.1.12. GenPath
- 5.1.13. Good Start Genetics
- 5.1.14. NxGen MDx
- 5.1.15. CooperGenomics
- 5.2. Cross Comparison Parameters (No. of Employees, Revenue, Headquarters, Inception Year, Geographical Reach, Technology Adoption, Product Portfolio, Partnerships)
- 5.3. Market Share Analysis
- 5.4. Strategic Initiatives (Product Launches, Collaborations, Market Expansion)
- 5.5. Mergers and Acquisitions
- 5.6. Investment Analysis (Private Equity Investments, Venture Capital Funding)
- U.S. Carrier Screening Market Regulatory Framework
- 6.1. Compliance with Genetic Testing Standards (FDA, CMS)
- 6.2. Data Privacy and Security Regulations (HIPAA, GINA)
- 6.3. Certification Processes (CLIA, CAP Accreditation)
- U.S. Carrier Screening Market Future Size (In USD Bn)
- 7.1. Future Market Size Projections
- 7.2. Key Factors Driving Future Market Growth (Technological Advancements, Regulatory Approvals)
- U.S. Carrier Screening Market Future Segmentation
- 8.1. By Type of Test
- 8.2. By Technology
- 8.3. By Application
- 8.4. By End-User
- 8.5. By Distribution Channel
- U.S. Carrier Screening Market Analyst's Recommendations
- 9.1. TAM/SAM/SOM Analysis
- 9.2. Strategic Recommendations for Market Players (Key Entry Points, Partnerships)
- 9.3. White Space Opportunity Analysis
- 9.4. Innovation and R&D Focus Areas
- Disclaimer
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