Next Generation Sequencing Markets (Systems, Consumables, Services, Competitive Analysis, Trends, Platforms)

 
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Published Sep 7, 2016 | 533 Pages | Pub ID: KLI15104387

Next Generation Sequencing Markets (Systems, Consumables, Services, Competitive Analysis, Trends, Platforms)


What is the next generation sequencing market size for both medical devices and NGS, and how are those sequencing markets distributed across the healthcare industry's disease markets? Who are the top competitors in the NGS market?  How will next generation sequencing fit into the diagnostics industry in the future.  Kalorama Information's report, Next Generation Sequencing Markets (Systems, Consumables, Services, Competitive Analysis, Trends, Platforms), provides answers to these questions and others.

The next generation sequencing market is already one of healthcare's larger markets, estimated  at$5.3 billion-dollars in 2017.  This estimate the ngs market size includes both sequencing medical devices plus consumables, and also service revenue such as from extended sequencing instrument service contracts. The NGS market is a growing one.  

Clinical applications of DNA sequencing are being developed and commercialized. Evidence of the promise and current excitement with DNA sequencing can be seen with many recent events. Next Generation Sequencing Markets examines the segments of the dna sequencing market, including sequencing devices plus consumables and also service revenue such as from extended instrument service contracts.

Sequencing Market Analysis includes:


  • Worldwide Sequencing Market Product Revenues (Instruments and Consumables), 2015-2020
  • Sequencing Market, Worldwide, 2015 and 2020 (Instrument Revenue, Consumables Revenue, Services Revenue, Total Market)
  • Market Share of Sequencing Market, By Company (Instruments, Consumables, Services Relating to Supporting Products)
  • Sequencing Market by Geographical Region, Worldwide, 2015 and 2020 (North America, Europe, Asia, Rest of World, Total Market)
  • Next Generation Sequencing System Ownership by Country, Percentage (United States, China, Germany, UK, South Korea, Spain, Canada, France, Australia, Netherlands, Italy, Taiwan, Brazil, Japan, India, Sweden, Belgium, Denmark, Switzerland, Singapore, Saudi Arabia, Others)
  • Next Generation Sequencing System Ownership by Brand (HiSeq2000, Genome Analyser, Roche 454, ABI SOLiD, Ion Torrent, MiSeq, Ion Proton, Pacific Biosciences, Oxford Nanopore MinION, Polonator, NextSeq)
  • Percent of End Users (Academic & Government versus Commercial, Non-Profit & Hospital), 2014, 2015, and 2018 (projected)
  • Research Sequencing Market – Types of Sequencing: Targeted or Whole Exome Sequencing versus de novo or Whole Genome Sequencing (2015)
  • Clinical Sequencing Market by Disease Category, 2015, Percentage (Genetic Testing/Inherited Disorders, Other Disorders)
  • Clinical Sequencing Market by Disease Category, 2020, Percentage (Oncology, Genetic Testing/Inherited Disorders, Infectious Disease, Other Disorders)
  • Investments in Next Generation Sequencing Companies, 2015 and First Half of 2016
Growth in the research market and also in clinical applications of next generation sequencing – as demonstrated by the rapid growth of the market leader and the market as a whole – is being driven by several factors.  

Next Generation Sequencing Market Drivers include:


  • Advances in Technology
  • Increasing Number of Clinical Applications for Next Generation Sequencing
  • Cancer Diagnostic Market Drivers
  • Genetic Analysis [Inherited Disorders, Prenatal and Postnatal Diagnostics] Market Drivers
  • Infectious Disease Diagnostic Market Drivers
DNA sequencing has successfully penetrated the research market. The sequencing market is expected to continue to grow, despite funding issues and other challenges. DNA sequencing is also penetrating the clinical diagnostic market. The sequencing field has entered an exciting time where it is now becoming possible to realize some of the potential benefits long dreamed about by researchers and companies in this field, though improvements in sequencing technology are still needed in order to make sequencing-based diagnostic tests widely available and used by all physicians.

DNA sequencing has become a competitive field with companies developing or offering newer, proprietary nucleic acid sequencing technologies. Next Generation Sequencing Markets discusses new medical devices, among these Massively Parallel Signature Sequencing (MPSS), Pyrosequencing, 454 Technology, Sequencing by Synthesis (SBS), Supported Oligonucleotide Ligation and Detection (SOLiD), Ion Torrent Sequencing, Single Molecule Real Time (SMRT) Sequencing, DNA Nano Ball Sequencing, and Nanopore Sequencing.  

New Next Generation Sequencing Technology including:


  • Current and Emerging Sequencing Technologies and Platforms
  • Selected Companies Developing/Marketing Products for NGS Sample or Library Preparation
  • Selected Companies Developing/Marketing NGS Information Technology Solutions
  • Selected Companies Developing NGS Sample-to-Answer (Sample-to-Insight) Platforms
  • Selected Companies Developing Rapid NGS Assays or Platforms
Most currently available clinical tests based on next generation sequencing are laboratory developed tests (LDTs). The first next generation sequencing system and in vitro diagnostic tests have been cleared by the FDA, and more will follow. The next generation sequencing clinical diagnostic market is poised for continued rapid growth over the next several years.

Next generation sequencing is increasingly being used in the field of personalized medicine and companion diagnostics. For example, in oncology, pharmaceutical companies are developing and commercializing a growing number of targeted therapies. This has generated a need for assays that detect the presence or absence of increasingly more genetic markers, all from a small sample of tissue. In other words, multiplexed assays and/or panels are needed. This, in turn, has led to increased interest in technologies such as next-generation sequencing, which can be used to interrogate a large number of genes in a single assay. The report covers NGS applications in cancer diagnostics, including NGS-based tests for oncology and liquid biopsies; genetic analysis – inherited disorders, prenatal and postnatal diagnostics; infectious disease diagnostics; human leukocyte antigen (HLA) testing; and other diagnostic applications of sequencing, including in the direct-to-consumer genetic testing industry. 

Next Generation Sequencing in the Medical Device and Diagnostics Industry:


  • Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Oncology
  • Selected Companies Developing and/or Marketing Liquid Biopsy Assays
  • Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Genetic Analysis [Inherited Disorders, Prenatal and Postnatal Diagnostics]
  • Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Infectious Diseases
  • Selected Companies Offering Products/Services for Applications of DNA Sequencing in Human Leukocyte Antigen (HLA) Testing
  • Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Other Diagnostic Applications
Collaborations are an essential part of the growing sequencing market. The impact of deals in the sequencing marketplace is discussed in detail in this report:
  • Selected Investment and Financing Agreements in Next Generation Sequencing Companies [Includes IT Companies in NGS]
  • Selected Acquisitions of Next Generation Sequencing Companies [Includes IT Companies in NGS]
  • Selected Agreements between Next Generation Sequencing Companies and Diagnostic Companies or Clinical Laboratories [Includes IT Companies in NGS]
  • Examples of Diagnostic Companies and Clinical Laboratories That Have Made Agreements in Next Generation Sequencing
  • Selected Agreements between Next Generation Sequencing Companies and Pharmaceutical or Biopharmaceutical Companies [Includes Contract Research Organizations Providing Services to Pharma Companies]
  • Selected Pharmaceutical and Biopharmaceutical Companies Using or Active in Next Generation Sequencing
  • Selected Company Agreements between Two Next Generation Sequencing Companies [Includes IT Companies in NGS]
  • Selected Other Next-Generation Sequencing Company Agreements in Next Generation Sequencing [Includes IT Companies in NGS]
  • Selected Next Generation Sequencing Company Agreements with Academic or Other Non-Profit Organizations [Includes IT Companies in NGS]
Profiles of companies in Next Generation Sequencing Markets (Systems, Consumables, Services, Competitive Analysis, Trends, Platforms) reflect the wide range next generation sequencing products, including sample preparation, sequencing, and data analysis. 

NGS Company Profiles include:


  • 10x Genomics, Inc.
  • 23andMe, Inc.
  • Abbott Laboratories
  • ACT Genomics Co., Ltd.
  • Adaptive Biotechnologies Corporation
  • Admera Health
  • Advanced Biological Laboratories (ABL), S.A.
  • Agilent Technologies Inc.
  • AltheaDx, Inc.
  • Ambry Genetics Corp.
  • Aperiomics, Inc.
  • Asuragen, Inc.
  • Athena Diagnostics, Inc. (A Quest Diagnostics Business)
  • Base4 Innovation Ltd
  • Beckman Coulter, Inc. (Subsidiary of Danaher Corporation)
  • Becton, Dickinson and Company (BD)
  • BGI
  • Bina Technologies, Inc. (Part of Roche Sequencing)
  • BioDiscovery, Inc.
  • Biomatters Ltd.
  • bioMérieux S.A.
  • bioTheranostics, Inc.
  • Cancer Genetics, Inc.
  • CareDx, Inc.
  • Caris Life Sciences
  • CLC bio (A QIAGEN Company)
  • Color Genomics, Inc.
  • Complete Genomics (A BGI Company)
  • Courtagen Life Sciences, Inc.
  • Cynvenio Biosystems, Inc.
  • DNA Electronics Ltd.
  • Eurofins Genomics
  • Exosome Diagnostics, Inc.
  • Foundation Medicine, Inc.
  • GATC Biotech AG
  • GenapSys, Inc.
  • GenDx
  • GENEWIZ Inc.
  • Genia Technologies, Inc. (Part of Roche Sequencing)
  • Genomic Health, Inc.
  • Genoptix (A Novartis Company)
  • GnuBIO, Inc. (A Bio-Rad Company)
  • GRAIL
  • Guardant Health, Inc.
  • Helix
  • HTG Molecular Diagnostics
  • Human Longevity, Inc.
  • Illumina, Inc.
  • Inivata Ltd.
  • Invitae Corporation
  • Invivoscribe Technologies, Inc.
  • Laboratory Corporation of America (LabCorp)
  • Lasergen, Inc.
  • MolecularMD Corporation
  • Myriad Genetics, Inc.
  • NANTOMICS (Member of the NantWorks ecosystem of companies)
  • Natera, Inc.
  • NeoGenomics, Inc./NeoGenomics Laboratories
  • N-of-One, Inc.
  • OncoDNA S.A.
  • Oncospire Genomics
  • Oxford Nanopore Technologies Ltd.
  • Pacific Biosciences of California, Inc.
  • Pathway Genomics Corporation
  • Personal Genome Diagnostics, Inc.
  • Personalis, Inc.
  • QIAGEN N.V.
  • Quest Diagnostics
  • RainDance Technologies, Inc.
  • Roche
  • Siemens Healthcare Diagnostics
  • Stratos Genomics Inc.
  • Sysmex Corporation
  • Thermo Fisher Scientific, Inc.
Technology advances in genome sequencing knowledge, and in DNA sequencing technology/platforms, will continue to fuel the growth of diagnostic applications of next generation sequencing in clinical laboratories and companies with CLIA-certified laboratories, and also in IVD companies that sell kits to clinical labs.


What's Creating the Interest in Next Generation Sequencing?


The promise of DNA sequencing has attracted many companies, researchers, investors, and others. The sequencing market is now large, and is growing rapidly. Kalorama Information estimates that this market is growing at a CAGR of double digits.   Clinical applications of DNA sequencing are being developed and commercialized. Evidence of the promise and current excitement with DNA sequencing can be seen with many recent events. In January 2015, Roche and Foundation Medicine announced an agreement that is worth up to $1.2 billion. Roche agreed to acquire a majority interest in Foundation Medicine for approximately $780 million.  Companies are raising money: Just since the beginning of 2015, companies discussed in this report have raised over $3 billion in investments.

Are Pharmaceutical Companies Involved in the NGS Market?


Companies in the pharmaceutical industry have recognized the potential benefits of next generation sequencing as a research and development tool. Over twelve agreements with pharmaceutical companies since the beginning of 2016 are discussed in this report.   In March 2015, Illumina announced a collaboration with Merck Serono to develop a universal next-generation sequencing-based oncology

What Stage of Clinical Use of NGS Are We At?


It's happening and it's growing.   While next generation sequencing has been used for some clinical applications for a while, this is becoming more widespread and some next generation sequencing companies are starting to develop and commercialize kits that can be produced and sold to clinical laboratories following the traditional in vitro diagnostic (IVD) model. Illumina’s MiSeqDx was the first cleared in vitro diagnostic next generation sequencing system. MiSeqDx is also CE marked, and FDA-cleared tests are currently available on this platform. Illumina is
continuing to develop products for the IVD market. In August 2014, Illumina announced collaborative strategic partnerships with AstraZeneca, Janssen, and Sanofi to develop a next-generation sequencing based test for use during clinical trials, and eventually resulting in a multi-gene panel to be used to select therapies.   Both of these announcements included comments regarding regulatory approval as well as commercialization.

What's the Regulatory Status of NGS in Clinical Settings?


The path to development of FDA approved or cleared tests will become better understood when the FDA issues guidances regarding regulation of next generation sequencing based tests. An important step in this processes occurred


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      •   Worldwide Sequencing Market Product Revenues (Instruments and Consumables), 2015 and 2020 (millions USD)
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        •   Current and Emerging Sequencing Technologies and Platforms
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      •   Selected Companies Developing/Marketing Products for NGS Sample or Library Preparation

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      •   Selected Companies Developing/Marketing NGS Information Technology Solutions

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      •   Selected Companies Developing NGS Sample-to-Answer (Sample-to-Insight) Platforms

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      •   Selected Companies Developing Rapid NGS Assays or Platforms

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        •   Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Oncology

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        •   Selected Companies Developing and/or Marketing Liquid Biopsy Assays

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        •   Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Genetic Analysis [Inherited Disorders, Prenatal and Postnatal Diagnostics]

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        •   Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Infectious Diseases

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        •   Selected Companies Offering Products/Services for Applications of DNA Sequencing in Human Leukocyte Antigen (HLA) Testing

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        •   Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Other Diagnostic Applications
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      •   Selected Investment and Financing Agreements in Next Generation Sequencing Companies [Includes IT Companies in NGS]

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      •   Selected Acquisitions of Next Generation Sequencing Companies [Includes IT Companies in NGS]

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        •   Selected Agreements between Next Generation Sequencing Companies and Diagnostic Companies or Clinical Laboratories [Includes IT Companies in NGS]
        •   Examples of Diagnostic Companies and Clinical Laboratories That Have Made Agreements in Next Generation Sequencing

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        •   Selected Agreements between Next Generation Sequencing Companies and Pharmaceutical or Biopharmaceutical Companies [Includes Contract Research Organizations Providing Services to Pharma Companies]
        •   Selected Pharmaceutical and Biopharmaceutical Companies Using or Active in Next Generation Sequencing

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        •   Selected Company Agreements between Two Next Generation Sequencing Companies [Includes IT Companies in NGS]

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        •   Selected Other Next-Generation Sequencing Company Agreements in Next Generation Sequencing [Includes IT Companies in NGS]

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      •   Selected Next Generation Sequencing Company Agreements with Academic or Other Non-Profit Organizations [Includes IT Companies in NGS]

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      •   Sequencing Market, Worldwide, 2015 and 2020
      •   Market Share of Sequencing Market, By Company (Instruments, Consumables, Services Relating to Supporting Products)

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      •   Sequencing Market by Geographical Region, Worldwide, 2015 and 2020 (North America, Europe, Asia, Rest of World, Total Market) (in millions USD)
      •   Next Generation Sequencing System Ownership by Country, Percentage (United States, China, Germany, UK, South Korea, Spain, Canada, France, Australia, Netherlands, Italy, Taiwan, Brazil, Japan, India, Sweden, Belgium, Denmark, Switzerland, Singapore, Saudi Arabia, Others)

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      •   Next Generation Sequencing System Ownership by Brand (HiSeq2000, Genome Analyser, Roche 454, ABI SOLiD, Ion Torrent, MiSeq, Ion Proton, Pacific Biosciences, Oxford Nanopore MinION, Polonator, NextSeq)

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      •   Percent of End Users (Academic & Government versus Commercial, Non-Profit & Hospital), 2014, 2015, and 2018 (projected)

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      •   Research Sequencing Market - Types of Sequencing: Targeted or Whole Exome Sequencing versus de novo or Whole Genome Sequencing (2015)

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      •   Clinical Sequencing Market by Disease Category, 2015, Percentage
      •   Clinical Sequencing Market by Disease Category, 2020, Percentage

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      •   Investments in Next Generation Sequencing Companies, 2015 and First Half of 2016 (in millions USD)

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