USA NGS Market Outlook to 2030

Region:North America

Author(s):Sanjana

Product Code:KROD3896

Published On

October 2024

Total pages

97

About the Report

USA NGS Market Overview

  • The USA NGS (NGS) market is valued at USD 3 billion, based on a five-year historical analysis. The significant growth of this market is driven by technological advancements in sequencing platforms, the reduced cost of genome sequencing, and the increasing adoption of NGS in clinical diagnostics, particularly in oncology and genetic disorders. The integration of NGS with artificial intelligence for data analysis has further fueled its adoption across various sectors, including personalized medicine and drug discovery.
  • In the USA, dominant cities driving the NGS market include Boston and San Francisco, due to their well-established biotechnology and pharmaceutical industries. These cities house some of the largest research institutes and NGS service providers, contributing to their market dominance. Additionally, the presence of top-tier universities and government-backed research initiatives in these regions bolsters the NGS adoption rates, positioning them as key hubs for genomic research and precision medicine.
  • Automation is revolutionizing NGS workflows, enabling laboratories to sequence more genomes faster and with less manual intervention. By 2023, more than 50% of NGS facilities in the U.S. have adopted automated workflows, leading to a significant reduction in turnaround times for genetic testing. This trend is expected to drive further adoption of NGS in both clinical and research settings.

USA NGS Market Size

USA NGS Market Segmentation

By Technology: The USA NGS market is segmented by technology into Sequencing by Synthesis (SBS), Ion Semiconductor Sequencing, Single-Molecule Real-Time (SMRT) Sequencing, and Nanopore Sequencing. Sequencing by Synthesis (SBS) holds the dominant share due to its widespread use in high-throughput sequencing, especially in clinical and research applications. The technology's accuracy, scalability, and cost-effectiveness have made it the preferred choice for large-scale genome sequencing projects and clinical diagnostics.

USA NGS Market Share

By Application: By application, the NGS market is segmented into Clinical Diagnostics, Oncology, Drug Discovery, and Agricultural and Animal Research. Oncology applications dominate the market due to the increasing use of NGS in cancer diagnostics and the development of targeted therapies. NGS enables the identification of genetic mutations and biomarkers, allowing for personalized cancer treatment and early detection, which are key growth drivers in this segment.

USA NGS Market Segmentation

USA NGS Market Competitive Landscape

The USA NGS market is dominated by key players who have established strong research and development capabilities, extensive product portfolios, and strategic partnerships within the industry. These companies are investing in expanding their NGS platforms and services to meet the growing demand for high-throughput sequencing in clinical diagnostics and research.

Company Name

Establishment Year

Headquarters

Revenue

R&D Expenditure

Global Presence

Product Portfolio

Strategic Partnerships

No. of Employees

Illumina Inc.

1998

San Diego, CA

Thermo Fisher Scientific Inc.

1956

Waltham, MA

Pacific Biosciences of California

2004

Menlo Park, CA

Oxford Nanopore Technologies Ltd.

2005

Oxford, UK

BGI Genomics

1999

Shenzhen, China

USA NGS Market Analysis

Growth Drivers

  • Increasing Adoption of NGS in Clinical Diagnostics: The growing demand for NGS (NGS) in clinical diagnostics is driven by its ability to detect genetic mutations with precision. NGS is playing a critical role in diagnosing rare diseases, with over 100,000 genetic conditions being screened using this technology. This adoption is encouraged by the US government's increased investment in precision medicine programs, which aim to treat conditions with a genetic basis, supporting the continued expansion of NGS in diagnostics.
  • Growing Use in Oncology Research: The use of NGS in oncology research has risen significantly as researchers focus on cancer genomics. There are over 7,000 known rare diseases, affecting approximately 2-6% of the global population, which translates to more than 150 million people worldwide. Government initiatives such as the Cancer Moonshot Program have dedicated over $1.8 billion in funding to cancer genomics, enabling researchers to explore personalized treatment plans. The development of NGS-based companion diagnostics is further accelerating the use of this technology in oncology.
  • Reduced Cost of Genome Sequencing: The cost of whole-genome sequencing has drastically dropped from over $1 million per genome in 2001 to approximately $600 in 2023, making NGS more accessible. This significant reduction is driven by advancements in automation and computing power, allowing more labs to utilize NGS for routine diagnostics and research. The National Institutes of Health (NIH) has also continued to invest in lowering sequencing costs, fostering increased adoption across healthcare sectors.

Challenges

  • Data Storage and Interpretation Challenges: Sequence Read Archive (SRA) had grown significantly, from about 3.6 petabytes in 2015 to an estimated 36 petabytes by the end of 2020. Managing this vast amount of data requires significant investment in data storage infrastructure and specialized expertise to interpret complex genomic information. Regulatory bodies such as the FDA have also highlighted challenges in ensuring the accuracy and consistency of data interpretation across various platforms.
  • Regulatory and Ethical Issues in Genomic Sequencing: Genomic sequencing, particularly in clinical settings, raises significant regulatory and ethical concerns. xT CDx- a 648-gene NGS panel approved in 2021 as a companion diagnostic to identify microsatellite instability status in colorectal cancer patients. The U.S. Department of Health and Human Services (HHS) is working to align NGS regulations with HIPAA guidelines to ensure the privacy of genomic data while allowing for clinical advancements.

USA NGS Future Market Outlook

Over the next five years, the USA NGS market is expected to show significant growth driven by the increased adoption of precision medicine, advancements in genomic technologies, and a growing number of research initiatives focused on personalized healthcare. Additionally, the decreasing cost of sequencing and the expansion of NGS applications into non-healthcare sectors, such as agriculture and environmental science, will further propel market expansion. Regulatory support for NGS-based diagnostics will also play a critical role in the sustained growth of the market.

Market Opportunities

  • Rising Demand for Liquid Biopsy Solutions: The demand for liquid biopsy, a minimally invasive alternative to traditional tissue biopsy, is rapidly increasing, driven by its ability to detect genetic mutations in circulating tumor DNA (ctDNA). By 2024, it is expected that over 300,000 patients in the U.S. will undergo liquid biopsies, particularly in cancer treatment. Major medical institutions are increasingly adopting NGS-based liquid biopsy solutions to monitor cancer progression and tailor personalized treatment.
  • Increasing Investment in Precision Medicine: The U.S. government has allocated over $1.5 billion to precision medicine initiatives, with NGS at the core of these programs. This investment is expected to support the development of personalized treatment plans, especially for cancer and rare genetic diseases. By 2024, over 150 academic and research institutions in the U.S. will utilize NGS in precision medicine studies.

Scope of the Report

Segments

Sub-Segments

By Technology

Sequencing by Synthesis (SBS)

Ion Semiconductor Sequencing

SMRT Sequencing, Nanopore Sequencing

By Product Type

NGS Instruments

NGS Kits & Reagents

NGS Data Analysis Tools & Software

NGS Services

By Application

Clinical Diagnostics

Oncology

Drug Discovery

Agricultural and Animal Research

By End User

Hospitals and Diagnostic Labs

Academic and Research Institutes

Pharmaceutical & Biotechnology Companies

CROs

By Region

North-East

Midwest

South

West

Products

Key Target Audience

  • NGS Equipment and Software Providers

  • Precision Medicine Companies

  • Genomics and Data Analytics Companies

  • Genetic Testing Companies

  • Pharmaceutical & Biotechnology Companies

  • Government and Regulatory Bodies (FDA, CDC)

  • Investment and Private Equity Firms

Companies

Major Players Mentioned in the Report

  • Illumina Inc.

  • Thermo Fisher Scientific Inc.

  • Pacific Biosciences of California, Inc.

  • Oxford Nanopore Technologies Ltd.

  • BGI Genomics

  • Agilent Technologies

  • Qiagen N.V.

  • F. Hoffmann-La Roche Ltd.

  • PerkinElmer Inc.

  • Bio-Rad Laboratories, Inc.

  • Genapsys, Inc.

  • Macrogen, Inc.

  • 10x Genomics, Inc.

  • Eurofins Scientific

  • Natera, Inc.

Table of Contents

1. USA NGS Market Overview

1.1. Definition and Scope
1.2. Market Taxonomy
1.3. Market Growth Rate
1.4. Market Segmentation Overview

2. USA NGS Market Size (In USD Bn)

2.1. Historical Market Size
2.2. Year-On-Year Growth Analysis
2.3. Key Market Developments and Milestones

3. USA NGS Market Analysis

3.1. Growth Drivers
3.1.1. Increasing Adoption of NGS in Clinical Diagnostics
3.1.2. Growing Use in Oncology Research
3.1.3. Reduced Cost of Genome Sequencing
3.1.4. Expanding Research in Genetic Disorders
3.2. Market Challenges
3.2.1. Data Storage and Interpretation Challenges
3.2.2. Regulatory and Ethical Issues in Genomic Sequencing
3.2.3. High Initial Setup and Operational Costs
3.3. Opportunities
3.3.1. Rising Demand for Liquid Biopsy Solutions
3.3.2. Increasing Investment in Precision Medicine
3.3.3. Collaboration with Biopharmaceutical Companies for Drug Development
3.4. Trends
3.4.1. Automation of NGS Workflows for Higher Efficiency
3.4.2. Integration of Artificial Intelligence for Data Analysis
3.4.3. Increased Focus on Personalized and Precision Medicine
3.5. Government Regulation
3.5.1. FDA Regulatory Framework for NGS Diagnostic Tests
3.5.2. CLIA Certification Requirements for Clinical Laboratories
3.5.3. HIPAA Compliance for Handling Genomic Data
3.6. SWOT Analysis
3.7. Stake Ecosystem
3.8. Porters Five Forces
3.9. Competition Ecosystem

4. USA NGS Market Segmentation

4.1. By Technology (In Value %) 4.1.1. Sequencing by Synthesis (SBS)
4.1.2. Ion Semiconductor Sequencing
4.1.3. Single-Molecule Real-Time (SMRT) Sequencing
4.1.4. Nanopore Sequencing
4.2. By Product Type (In Value %) 4.2.1. NGS Instruments
4.2.2. NGS Kits & Reagents
4.2.3. NGS Data Analysis Tools & Software
4.2.4. NGS Services
4.3. By Application (In Value %) 4.3.1. Clinical Diagnostics
4.3.2. Oncology
4.3.3. Drug Discovery
4.3.4. Agricultural and Animal Research
4.4. By End User (In Value %) 4.4.1. Hospitals and Diagnostic Labs
4.4.2. Academic and Research Institutes
4.4.3. Pharmaceutical & Biotechnology Companies
4.4.4. Contract Research Organizations (CROs)
4.5. By Region (In Value %) 4.5.1. North-East
4.5.2. Midwest
4.5.3. South
4.5.4. West

5. USA NGS Market Competitive Analysis

5.1. Detailed Profiles of Major Companies
5.1.1. Illumina Inc.
5.1.2. Thermo Fisher Scientific Inc.
5.1.3. Pacific Biosciences of California, Inc.
5.1.4. Oxford Nanopore Technologies Ltd.
5.1.5. Agilent Technologies
5.1.6. Qiagen N.V.
5.1.7. BGI Genomics
5.1.8. F. Hoffmann-La Roche Ltd.
5.1.9. PerkinElmer Inc.
5.1.10. Bio-Rad Laboratories, Inc.
5.1.11. Genapsys, Inc.
5.1.12. Macrogen, Inc.
5.1.13. 10x Genomics, Inc.
5.1.14. Eurofins Scientific
5.1.15. Natera, Inc.
5.2. Cross Comparison Parameters
5.2.1. Number of Employees
5.2.2. Headquarters
5.2.3. Inception Year
5.2.4. Revenue
5.2.5. R&D Expenditure
5.2.6. Product Portfolio
5.2.7. Global Presence
5.2.8. Strategic Partnerships
5.3. Market Share Analysis
5.4. Strategic Initiatives
5.5. Mergers and Acquisitions
5.6. Investment Analysis
5.7. Venture Capital Funding
5.8. Government Grants
5.9. Private Equity Investments

6. USA NGS Market Regulatory Framework

6.1. Regulatory Approvals for NGS Diagnostics (FDA, EMA)
6.2. Compliance Requirements for Clinical NGS Labs
6.3. Certification and Accreditation Processes
6.4. Data Privacy Regulations

7. USA NGS Future Market Size (In USD Bn)

7.1. Future Market Size Projections
7.2. Key Factors Driving Future Market Growth

8. USA NGS Future Market Segmentation

8.1. By Technology (In Value %)
8.2. By Product Type (In Value %)
8.3. By Application (In Value %)
8.4. By End User (In Value %)
8.5. By Region (In Value %)

9. USA NGS Market Analysts Recommendations

9.1. TAM/SAM/SOM Analysis
9.2. Customer Cohort Analysis
9.3. Marketing Initiatives
9.4. White Space Opportunity Analysis

Disclaimer Contact Us

Research Methodology

Step 1: Identification of Key Variables

The initial phase of the research involves the identification of key variables influencing the USA NGS market, such as technological advancements, regulatory frameworks, and market demand. This phase is conducted through desk research and the utilization of proprietary databases to map the market ecosystem.

Step 2: Market Analysis and Construction

In this phase, historical market data is analyzed, including market penetration, application areas, and revenue generation. This helps in building a clear understanding of market trends and identifying key drivers and restraints that influence market dynamics.

Step 3: Hypothesis Validation and Expert Consultation

Market hypotheses regarding growth factors and challenges are developed and validated through interviews with industry experts. These interviews provide insights into operational and financial aspects of the NGS industry, offering real-world data to refine market estimates.

Step 4: Research Synthesis and Final Output

The final phase includes synthesizing data collected from primary and secondary research, validating the results with key industry player, and compiling a comprehensive market report. This phase ensures the accuracy and completeness of the data presented in the final report.

Frequently Asked Questions

01. How big is the USA NGS Market?

The USA NGS market is valued at USD 3 billion, driven by advancements in sequencing technologies and increased adoption in clinical diagnostics and personalized medicine.

02. What are the challenges in the USA NGS Market?

Key challenges of USA NGS Market include high initial setup costs, data management and storage complexities, and the need for skilled professionals to handle the technology and interpret sequencing results.

03. Who are the major players in the USA NGS Market?

Major players of USA NGS Market include Illumina Inc., Thermo Fisher Scientific Inc., Pacific Biosciences, Oxford Nanopore Technologies, and BGI Genomics, which dominate the market due to their extensive product portfolios and strategic collaborations.

04. What are the growth drivers of the USA NGS Market?

The USA NGS market is driven by technological advancements in sequencing platforms, reduced costs of genome sequencing, and increasing adoption in clinical diagnostics, particularly in oncology.

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