U.S. Next Generation Sequencing Market (By Technology: Whole Exome Sequencing, Targeted Sequencing & Resequencing; By Product: Platforms, Consumables; By Application; By Workflow; By End-use) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. next generation sequencing market size was estimated at USD 3.41 billion in 2023 and it is expected to surpass around USD 21.4 billion by 2033, poised to grow at a CAGR of 20.16% from 2024 to 2033.

Key Pointers

• By Technology, the targeted sequencing and resequencing segment held the largest revenue share of 72% in 2023.
• By Product, the consumables segment accounted for the larger revenue share in 2023 and it is anticipated to grow at the fastest CAGR of 21.08% from 2024 to 2033.
• By Product, the platforms segment is expected to witness significant growth from 2024 to 2033.
• By Workflow, the sequencing segment registered the maximum market share of 58% in 2023.
• By Application, the oncology segment claimed the largest market share of 27% in 2023.
• By End-use, the academic research held the largest market share of 51% in 2023.
• By End-use, the clinical research segment is expected to grow at the highest CAGR of 22.88% from 2024 to 2033.

U.S. Next Generation Sequencing Market Overview

The landscape of healthcare is continually evolving, with advancements in technology playing a pivotal role in shaping the future of medical diagnostics and treatments. Next Generation Sequencing (NGS) has emerged as a transformative tool in the field of genomics, revolutionizing our understanding of genetic diseases, personalized medicine, and precision healthcare.

U.S. Next Generation Sequencing Market Growth Factors

The growth of the U.S. next generation sequencing (NGS) market is propelled the technological advancements play a pivotal role, with ongoing innovations enhancing the accuracy, throughput, and cost-effectiveness of sequencing processes. This has widened the scope of NGS applications across various sectors, including clinical diagnostics, oncology research, and agricultural genomics. Furthermore, the increasing demand for precision medicine has spurred the adoption of NGS in clinical settings, driving market expansion. Moreover, robust research and development initiatives, coupled with investments from government bodies, academic institutions, and pharmaceutical companies, contribute to the market's growth trajectory. Additionally, the declining cost of sequencing has democratized access to NGS technologies, fostering widespread adoption and market penetration.

U.S. Next Generation Sequencing Market Trends:

• Rapid Technological Advancements: Continuous innovation in NGS technologies is driving the development of faster, more accurate, and cost-effective sequencing platforms, expanding the utility of NGS across diverse applications.
• Growing Demand for Precision Medicine: There is an increasing emphasis on personalized medicine, with NGS playing a crucial role in genomic-based diagnostics and targeted therapies, driving demand for NGS technologies in clinical settings.
• Expansion of Clinical Applications: NGS is increasingly being integrated into routine clinical practice for diagnosing genetic disorders, oncology profiling, pharmacogenomics, and non-invasive prenatal testing, driving market growth in the clinical diagnostics segment.
• Shift towards Whole Genome Sequencing (WGS) and Whole Exome Sequencing (WES): There is a growing preference for comprehensive genomic analysis through WGS and WES, enabling researchers and clinicians to uncover rare variants, identify disease-causing mutations, and facilitate personalized treatment strategies.
• Integration of NGS in Oncology Research: NGS is playing a pivotal role in oncology research, facilitating tumor profiling, identification of actionable mutations, monitoring of treatment response, and the development of targeted therapies and immunotherapies.
• Rising Adoption in Agriculture and Animal Genomics: The agricultural and animal genomics sectors are increasingly leveraging NGS technologies for crop improvement, livestock breeding, disease surveillance, and biodiversity conservation, driving market expansion beyond healthcare.
• Advancements in Bioinformatics and Data Analysis: With the exponential growth of sequencing data, there is a heightened focus on developing advanced bioinformatics tools and computational algorithms for data analysis, interpretation, and visualization, driving innovation in data analytics.

U.S. Next Generation Sequencing Market Challenges:

• Data Analysis and Interpretation: The vast amount of sequencing data generated by NGS technologies presents challenges in data analysis, storage, and interpretation, requiring sophisticated bioinformatics tools and computational resources to extract meaningful insights.
• Regulatory Complexity: Navigating the evolving regulatory landscape governing NGS-based diagnostics and clinical applications poses challenges for market players, including compliance with FDA regulations, obtaining regulatory approvals, and ensuring adherence to quality standards.
• Reimbursement Uncertainty: The lack of standardized reimbursement policies for NGS-based tests and services presents a barrier to widespread adoption, particularly in clinical settings, leading to uncertainty regarding reimbursement eligibility and reimbursement rates.
• Cost Constraints: Despite declining sequencing costs, the overall cost of NGS remains a concern for healthcare providers and research institutions, particularly for comprehensive genomic analysis such as whole genome sequencing (WGS) and whole exome sequencing (WES), limiting accessibility and adoption.
• Data Privacy and Security: Safeguarding patient privacy and protecting sensitive genomic data from unauthorized access, breaches, and misuse present significant challenges, necessitating robust data privacy and security measures to ensure compliance with regulatory requirements and ethical standards.

Technology Insights

The segment focusing on targeted sequencing and resequencing dominated the revenue share in 2023, accounting for 72%, and is poised to experience the highest CAGR throughout the forecast period. These technologies are predominantly utilized in clinical applications such as cancer diagnostics, prenatal testing, and genetic disease screening. Their ability to precisely analyze specific genomic areas renders them highly suitable for clinical use, thus fueling their widespread adoption within the healthcare sector. Furthermore, ongoing advancements in targeted sequencing and resequencing technologies have bolstered sequencing throughput, enabling researchers to analyze larger sample numbers concurrently. This enhanced throughput facilitates more efficient study designs and expedites research progress.

On the other hand, the whole genome sequencing (WGS) segment is projected to undergo significant expansion by 2033, driven by the escalating adoption of precision medicine and personalized healthcare. Recent progress in WGS technology has enabled the comprehensive sequencing of an individual's entire genome, offering valuable insights into genetic variations and potential disease susceptibilities. Consequently, targeted therapies and personalized treatment strategies have emerged, promising improved patient outcomes and reduced healthcare expenditures. Moreover, the declining costs of WGS and the growing accessibility of sequencing services have democratized its usage among researchers and clinicians, further propelling the growth of this segment.

Product Insights

The consumables segment accounted for the larger revenue share in 2023 and it is anticipated to grow at the fastest CAGR of 21.08% over the forecast period. The dominance can be attributed to the high demand for sequencing reagents, kits, and other consumables required for NGS procedures. As NGS technologies are more widely adopted in research and clinical settings, the demand for consumables is expected to continue to increase. In addition, advancements in sequencing technologies are resulting in new applications and workflows, which is further driving the demand for new and innovative consumables.

The platforms segment is expected to witness significant growth from 2024 to 2033, due to the increasing demand for better and more advanced sequencing platforms. Several companies are investing heavily in the development of new and innovative platforms that can provide faster and more accurate sequencing results. For instance, in April 2022, Thermo Fisher Scientific introduced the Ion Torrent Genexus Dx Integrated Sequencer. It is a CE-IVD marked and automated NGS platform designed to provide results within a single day. These trends are expected to continue in the coming years, driving further growth in the platform product segment.

Workflow Insights

In 2023, the sequencing segment commanded the largest market share at 58%. The sequencing workflow encompasses a comprehensive process essential for obtaining precise and dependable results. It involves multiple stages, including sample preparation, sequencing, and data analysis. As the demand for NGS-based research and clinical applications continues to surge, the market for sequencing workflow is anticipated to witness further growth in the forthcoming years.

Meanwhile, the NGS data analysis segment is poised to exhibit the highest CAGR over the forecast period, driven by the escalating need for efficient and accurate analysis of genomic data. With NGS technology gaining traction across diverse applications such as drug discovery, clinical diagnostics, and personalized medicine, the demand for NGS data analysis is expected to soar. Furthermore, the availability of advanced software and tools tailored for NGS data analysis is also bolstering the expansion of this segment.

Application Insights

In 2023, the oncology segment claimed the largest market share of 27%, propelled by the escalating prevalence of cancer nationwide. NGS technology has heralded a paradigm shift in cancer diagnosis and treatment by enabling more precise and thorough genomic analysis of tumors, paving the way for personalized and targeted therapeutic interventions. Furthermore, ongoing research and development endeavors in the oncology sphere are fostering increased demand for NGS applications within this domain.

Concurrently, the consumer genomics segment is poised to witness the highest CAGR of 22.78% during the forecast period. There is a burgeoning interest among consumers in uncovering insights about their genetic composition, ancestry, and susceptibility to specific health conditions. Direct-to-consumer (DTC) genetic testing companies are offering affordable and user-friendly NGS-based DNA testing kits, empowering consumers with valuable information about their genetic traits, ancestral origins, and potential health vulnerabilities. This surge in consumer curiosity is anticipated to drive the demand for consumer genomics applications.

End-use Insights

In 2023, academic research held the largest market share of 51%. Academic institutions are at the forefront of genomic research and innovation. Researchers in academia are driven by interest and the purpose of knowledge, leading them to explore diverse areas of genomics using NGS technology. Their pioneering work drives the development of new sequencing methodologies, data analysis techniques, and applications, shaping the direction of the entire field. Government funding agencies, private foundations, and research grants often support academic research. These funding sources provide financial support for purchasing NGS equipment, reagents, and computational resources necessary for conducting genomic studies. The availability of funding enables academic researchers to invest in NGS technology and infrastructure, contributing to the growth of the market.

The clinical research segment is expected to grow at the highest CAGR of 22.88% from 2024 to 2033. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) have approved several NGS-based tests and assays for clinical use, particularly in oncology and infectious diseases. The establishment of regulatory frameworks and guidelines for NGS-based diagnostics has increased confidence in the reliability and accuracy of genomic testing, facilitating the adoption of NGS technology in clinical research. As regulatory approvals for NGS-based tests continue to expand across different therapeutic areas, the demand for NGS in clinical research is expected to grow.

U.S. Next Generation Sequencing Market Key Companies

• Illumina, Inc
• QIAGEN
• Thermo Fisher Scientific, Inc
• BGI
• Pacific Biosciences
• Bio Rad Laboratories
• Oxford Nanopore Technologies, Inc
• F. Hoffmann-La Roche AG
• Agilent Technologies, Inc
• Eurofins Scientific

Recent Developments

• In January 2024, Illumina announced a collaboration with Janssen Research & Development, LLC. The collaboration's primary objective is to develop a molecular residual disease assay. This assay, a WGS multi-cancer research solution, is designed to identify circulating tumor DNA, enhancing our understanding of disease persistence or recurrence following clinical intervention.
• In May 2023, Thermo Fisher Scientific Inc. and Pfizer joined forces to expand access to next-generation sequencing (NGS) testing for lung and breast cancer patients across more than 30 countries spanning Africa, Latin America, Asia, and the Middle East. By facilitating local access to NGS testing, the collaboration aims to expedite the analysis of relevant genes. This, in turn, empowers healthcare professionals to make more informed decisions regarding personalized therapy for patients.
• In April 2023, Agilent Technologies Inc. introduced a new NGS assay tailored for comprehensive genomic profiling, aimed at advancing precision oncology.

U.S. Next Generation Sequencing Market Segmentations:

By Technology

• Whole Genome Sequencing
• Whole Exome Sequencing
• Targeted Sequencing & Resequencing
  • DNA-based
  • RNA-based
• Others

By Product

• Platforms
  • Sequencing
  • Data Analysis
• Consumables
  • Sample Preparation
  • Target Enrichment
  • Others

By Application

• Oncology
  • Diagnostics and Screening
    • Oncology Screening
      • Sporadic Cancer
      • Inherited Cancer
    • Companion Diagnostics
    • Other Diagnostics
  • Research Studies
• Clinical Investigation
  • Infectious Diseases
  • Inherited Diseases
  • Idiopathic Diseases
  • Non-Communicable/Other Diseases
• Reproductive Health
  • NIPT
    • Aneuploidy
    • Microdeletions
  • PGT
  • Newborn Genetic Screening
  • Single Gene Analysis
• HLA Typing/Immune System Monitoring
• Metagenomics, Epidemiology & Drug Development
• Agrigenomics & Forensics
• Consumer Genomics

By Workflow

• Pre-sequencing
  • Library Preparation
    • NGS Library Preparation Kits
    • Semi-automated Library Preparation
    • Automated Library Preparation
  • Others
• Sequencing
• NGS Data Analysis
  • NGS Primary Data Analysis
  • NGS Secondary Data Analysis
  • NGS Tertiary Data Analysis

By End-use

• Academic Research
• Clinical Research
• Hospitals & Clinics
• Pharma & Biotech Entities
• Other Users