Biomarkers: Technologies and Global Markets

Report Scope:
 
BCC Research’s new report, Biomarkers: Technologies and Global Markets, provides a comprehensive analysis of the biomarkers market in a global context, including market forecasts and sales through 2025. The report analyzes the market, segmenting it into various product offerings (i.e., instruments, consumables [reagents, kits and panels], services and software). Segmentation also provides analysis by popular technology type (genomics, proteomics and metabolomics, imaging and bioinformatics).
 
This study surveys the biomarker market by therapeutic area (cancer, cardiovascular and metabolic diseases, infectious diseases, neurodegenerative diseases, autoimmune diseases and others. End users include academic institutes, pharma and biotechnology companies, clinical research organizations, hospitals and diagnostics. Geographic regions include North America, Europe and Emerging markets. Emerging markets include countries like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America, etc.
 
This report features new product developments and patents that are boosting global growth in this market.
 
This report provides comprehensive profiles of market players in the industry. The industry structure chapter focuses on changing market trends, market players and leading products. This chapter also covers mergers and acquisitions and other collaborations or partnerships that are expected to shape the industry.
 
Strengths, weaknesses, threats and opportunities are expected to play a role in the diagnostic biomarkers market. These are evaluated in detail.
 
The scope of the report excludes in vitro diagnostic products and regulatory aspects. Digital biomarkers are not covered in this report.
 
Report Includes:
 
- 48 data tables and 25 additional tables
- An updated review and current landscape of the global biomarkers market
- Analyses of the global market trends, with data from 2018-2020, and projections of compound annual growth rates (CAGRs) through 2025
- Estimation of market size and market potential for global biomarkers market, and corresponding market share analysis by product type, technology type, therapeutic area, end user and geographic region for each market segment
- Latest information on market opportunities and drivers, industry structure, regulatory frameworks, clinical trials and technological updates which are affecting the overall market growth
- Identification of the leading biotechnology companies poised to introduce products during the forecast period, their impact on the face of the competitive environment and research priorities
- Encompassing details of major types of biomarkers and their use in clinical trial assessment, drug discovery and development, and therapeutics
- Review of patents issued for biomarker technologies and deep dive of the patent data by year, technology type, application, company, assignee and applicant country
- Profile description of the of major market players, including Abbott Laboratories Ltd., Bayer AG, Bio-Rad Laboratories Inc., Canon Medical Corp., and Luminex Corp.

Summary:
 
Biomarkers, the biological indicators of health and disease, have come a long way, from being used as simple measurements of clinical diagnosis, to becoming essential tools in the clinical space and drug discovery and development. The utility of biomarkers has been expanding over the last couple of decades, due to the potential for predicting disease diagnosis and prognosis, treatment response, pharmacokinetics of drugs and monitoring therapy. During the COVID-19 pandemic, boosted R&D for novel diagnostics led to the approval of many biomarker-based diagnostic tests for early and rapid detection of the SARS-CoV-2 virus.
 
Pharmaceutical and biopharmaceutical drug developers struggle to overcome escalating cost barriers and high drug attrition rates in late-stage clinical trials. Biomarkers are promising tools to address drug development challenges. offering the prediction of drug toxicity and efficacy in early stages. The 21st Century Act allowed the Food and Drug Administration (FDA) to publish guidelines for Biomarker Qualification for use in drug development programs, paving the way for biomarker inclusion into drug development through either the drug approval process or the Biomarker Qualification Program.
 
Biomarkers are extremely useful in clinical trials, increasingly used to identify populations for a study, monitor therapeutic response and identify side effects. There is an emerging market of clinical research organizations (CROs) carrying out clinical trial recruitment and other services, while expanding technical expertise in bioanalytical and biomarker development. This enables pharmaceutical clients access to biomarker discovery and development.
 
The global biomarkers market is growing at a significant pace, driven by an explosion of publications and clinical trials. Enhanced analytical methods and the development of new, sophisticated and sensitive multiplex methods in gene expression analysis, proteomics, metabolomics and transcriptomics bring huge momentum to this market. The development of multi-biomarker assays, novel immunoassays and multi-modal imaging and mass spectrometry methods further drive market growth.
 
Collaborations and strategic partnerships, mergers and acquisitions and other deals between private and public players are on the rise. Companies are strengthening technical know-how and expanding product portfolios in order to offer enhanced services and new offerings to the biomarker research community. Precision medicine, particularly in the field of cancer, has contributed tremendously to an interest in biomarkers, with growing adoption of biomarkers in companion diagnostics and selecting targeted patient populations for high-value drugs. Other therapeutic areas, such as cardiovascular, neurodegenerative and autoimmune diseases are getting noticeable attention in biomarker research.
 
Challenges for this market, remain in the form of disparity in biomarker definitions at an international level and lack of any defined regulatory guidance for use in R&D. There is still a need to develop sensitive and robust methods of analysis for low concentration analytes via methods that can be validated. Lack of skilled manpower and the high cost of technology are other challenging factors.
 
Positive approaches in biomarker research, effective dialogue and collaborations between all stakeholders is expected to address challenges and take this market forward in coming years.

 Chapter 1 Introduction
 Study Goals and Objectives
 Reasons for Doing This Study
 Scope of Report
 Information Sources
 Methodology
 Geographic Breakdown
 Analysts Credentials
 BCC Custom Research
 Related BCC Research Reports
 Chapter 2 Summary and Highlights
 Key Highlights
 Chapter 3 Market and Technology Background
 Definitions of Biomarkers
 Classification of Biomarkers
 Examples of Biomarkers
 Surrogate Biomarkers/Endpoints
 Types of Biomarkers
 Molecular Biomarkers
 Imaging Biomarkers
 Biomarker Discovery, Verification and Validation
 Biomarker Discovery and Development
 Biomarker Verification
 Biomarker Validation
 Clinical Implementation
 Biomarker Qualification
 Technologies Used in Biomarker Analysis
 Genomics
 Proteomics
 Metabolomics
 Imaging
 Bioinformatics
 Applications of Biomarkers
 Diagnostics, Therapeutics and Disease Monitoring
 Drug Discovery and Development
 Clinical Trials
 Personalized Medicine
 Chapter 4 Market Breakdown by Product Type
 Market by Biomarker Product Type
 Market Overview
 Market Revenue
 Market Share
 Market for Biomarker Products by Region
 Market Shares
 Instruments
 Consumables
 Services
 Software
 Chapter 5 Market Breakdown by Technology Type
 Biomarker Market by Technology Type
 Market Overview
 Market Revenue
 Market Share
 Genomics
 Proteomics
 Metabolomics
 Imaging
 Bioinformatics
 Chapter 6 Market Breakdown by Therapeutic Area
 Market by Therapeutic Area
 Market Overview
 Market Revenue
 Market Share
 Cancer
 Cardiovascular and Metabolic Diseases
 Infectious Diseases
 Neurodegenerative Diseases
 Autoimmune Diseases
 Other Diseases
 Chapter 7 Market Breakdown by End User
 Market by Biomarker End User
 Market Overview
 Market Revenue
 Market Share
 Academic Institutes
 Pharma and Biotechnology Companies
 Clinical Research Organizations (CROs)
 Hospitals and Diagnostics
 Chapter 8 Industry Structure
 Industry Trends
 Collaborations and Partnerships
 License Agreements
 Mergers and Acquisitions
 Leading Manufacturers/Suppliers of Biomarkers Technologies
 Genomics
 Proteomics
 Metabolomics
 Imaging
 Bioinformatics
 Chapter 9 Clinical Trials
 Clinical Trials by Therapeutic Area
 Clinical Trials by Study Status
 Clinical Trials by Study Phase
 Clinical Trials of Studies including Children
 Clinical Trials by Country
 Clinical Trials by Sponsor
 Chapter 10 Patent Analysis
 Patents on Biomarkers
 Case Studies
 Case Study: Association for Molecular Pathology v. Myriad Genetics Inc.
 Case Study: Roche Molecular Systems Inc. v. Cepheid
 Patent Analysis
 Patents by Year
 Patents by Type
 Patents by Application
 Patents by Company
 Patents, by Country
 Patents by Type of Assignee
 Chapter 11 Analysis of Market Opportunities
 Strengths of the Biomarker Market
 Rising Incidence of Diseases
 Drug Development Costs and Failures
 Advances in Omics and Imaging Technologies
 Support from Regulatory Agencies
 Collaborations and Partnerships
 Challenges in the Biomarker Market
 Technological Challenges
 Regulatory Challenges
 Requirement of Skilled Labor
 High Development Cost of Biomarkers
 Reimbursement Challenges
 Opportunities in the Biomarker Market
 Emerging Markets
 Personalized Medicine
 Innovation in Technology
 Funding and Research Initiatives
 Threats to the Biomarker Market
 Competition
 Regulatory and Reimbursement Challenges
 COVID-19 Pandemic
 Chapter 12 Company Profiles
 10X GENOMICS
 ABBOTT LABORATORIES LTD.
 ABCAM PLC
 AGILENT TECHNOLOGIES INC.
 BAYER AG
 BECKMAN COULTER LIFE SCIENCES
 BECTON DICKINSON & CO.
 BIOLEGEND
 BIO-RAD LABORATORIES INC.
 BIO-TECHNE CORP.
 BRUKER CORP.
 CANON MEDICAL SYSTEMS CORP.
 CEPHEID
 CREATIVE PROTEOMICS
 CUBRESA INC.
 CYTIVA
 DANAHER CORP.
 FUJIFILM VISUAL SONICS INC.
 GE HEALTHCARE
 F HOFFMANN-LA ROCHE AG
 ILLUMINA INC.
 INTEGRATED DNA TECHNOLOGIES (IDT)
 JEOL LTD.
 KONINKLIJKE PHILIPS N.V.
 LANTHEUS MEDICAL IMAGING INC.
 LECO CORP.
 LEICA BIOSYSTEMS
 LUMINEX CORP.
 METABOLON INC.
 MILLIPORE SIGMA
 MOLECULAR DEVICES
 OXFORD NANOPORE TECHNOLOGIES LTD.
 PACIFIC BIOSCIENCES INC.
 PERKINELMER INC.
 PROMEGA CORP.
 QIAGEN N.V.
 QUANTERIX CORP.
 SCIEX
 SIEMENS HEALTHINEER AG
 SHIMADZU CORP.
 THERMO FISHER SCIENTIFIC INC.
 WATERS CORP.
 Chapter 13 Appendix: Abbreviations/Acronyms


List Of Tables

 Summary Table : Global Market for Biomarkers, by Technology, Through 2025
 Table 1 : Different Categories of Biomarkers
 Table 2 : Examples of Biomarkers
 Table 3 : Different Types of ELISAs
 Table 4 : Global Market for Biomarkers, by Product Type, Through 2025
 Table 5 : Global Market Shares of Biomarkers, by Product Type, 2019
 Table 6 : Global Market for Biomarkers, by Region, Through 2025
 Table 7 : Global Market Shares of Biomarkers, by Region, 2019
 Table 8 : Global Market for Biomarker Instruments, by Region, Through 2025
 Table 9 : Global Market for Biomarker Consumables, by Region, Through 2025
 Table 10 : Global Market for Biomarker Services, by Region, Through 2025
 Table 11 : Global Market for Biomarker Software, by Region, Through 2025
 Table 12 : Global Market for Biomarkers, by Technology Type, Through 2025
 Table 13 : Global Market Shares of Biomarkers, by Technology Type, 2019
 Table 14 : Global Market for Genomics Biomarkers, by Region, Through 2025
 Table 15 : Global Market for Proteomics Biomarkers, by Region, Through 2025
 Table 16 : Global Market for Metabolomics Biomarkers, by Region, Through 2025
 Table 17 : Global Market for Imaging Biomarkers, by Region, Through 2025
 Table 18 : Global Market for Bioinformatics in Biomarkers, by Region, Through 2025
 Table 19 : Global Market for Biomarkers, by Therapeutic Area, Through 2025
 Table 20 : Global Market Shares of Biomarkers, by Therapeutic Area, 2019
 Table 21 : Global Market for Cancer Biomarkers, by Region, Through 2025
 Table 22 : Global Market for Cardiovascular and Metabolic Disease Biomarkers, by Region, Through 2025
 Table 23 : Global and U.S. Prevalence, Common Infectious Diseases
 Table 24 : Global Market for Infectious Disease Biomarkers, by Region, Through 2025
 Table 25 : Global Market for Neurodegenerative Disease Biomarkers, by Region, Through 2025
 Table 26 : Global Market for Autoimmune Disease Biomarkers, by Region, Through 2025
 Table 27 : Biomarkers for Other Diseases
 Table 28 : Global Market for Biomarkers for Other Diseases, by Region, Through 2025
 Table 29 : Global Market for Biomarkers, by End User, Through 2025
 Table 30 : Global Market Shares of Biomarkers, by End User, 2019
 Table 31 : Global Market for Biomarkers in Academic Institutes, by Region, Through 2025
 Table 32 : Global Market for Biomarkers in Pharma and Biotechnology, by Region, Through 2025
 Table 33 : Global Market for Biomarkers in CROs, by Region, Through 2025
 Table 34 : Global Market for Biomarkers in Hospitals and Diagnostics, by Region, Through 2025
 Table 35 : Alliances in Global Biomarker Market, by Year, 2018-2020
 Table 36 : Biomarker-Focused Consortia, 2002-2017
 Table 37 : Collaborations/Partnerships in the Global Biomarker Market, 2018-January 2021
 Table 38 : Licensing Agreements in the Global Biomarker Market, 2018-January 2021
 Table 39 : Mergers and Acquisitions in the Global Biomarker Market, 2018-January 2021
 Table 40 : Leading Manufacturers/Suppliers of Genomic Technologies, 2019
 Table 41 : Global Market Shares of Leading Manufacturers/Suppliers of Genomic Technologies, 2019
 Table 42 : Leading Manufacturers/Suppliers of Proteomic Technologies, 2019
 Table 43 : Global Market Shares of Leading Manufacturers/Suppliers of Proteomics Technologies, 2019
 Table 44 : Leading Manufacturers/Suppliers, Metabolomic Technologies, 2019
 Table 45 : Global Market Shares of Leading Manufacturers/Suppliers of Metabolomic Technologies, 2019
 Table 46 : Leading Manufacturers/Suppliers, Imaging Technologies, 2019
 Table 47 : Global Market Shares of Leading Manufacturers/Suppliers of Imaging Technologies, 2019
 Table 48 : Leading Manufacturers/Suppliers of Bioinformatics Technologies, 2019
 Table 49 : Global Market Shares of Leading Manufacturers/Suppliers of Bioinformatics Technologies, 2019
 Table 50 : Clinical Trials in Biomarkers, by Therapeutic Area, 2018-2020
 Table 51 : Clinical Trials in Biomarkers, by Study Status, 2018-2020
 Table 52 : Clinical Trials in Biomarkers, by Phase of the Study, 2018-2020
 Table 53 : Clinical Trials in Biomarkers, Studies including Children, 2018-2020
 Table 54 : Clinical Trials in Biomarkers, by Country, 2018-2020
 Table 55 : Clinical Trials in Biomarkers, by Sponsor, 2018-2020
 Table 56 : Representative Patents in Biomarkers, 2018-December 15, 2020
 Table 57 : Patents Issued for Biomarkers, by Year, 2018-December 15, 2020
 Table 58 : Patents Issued for Biomarkers, by Type, 2018-December 15, 2020
 Table 59 : Patents Issued for Biomarkers, by Application, 2018-December 15, 2020
 Table 60 : Patents Issued for Biomarkers, by Company, 2018-December 15, 2020
 Table 61 : Patents Issued for Biomarkers, by Country, 2018-December 15, 2020
 Table 62 : Patents Issued for Biomarkers, by Type of Assignee, 2018-December 15, 2020
 Table 63 : Biomarkers with Letters of Support from the EMA, 2018-2020
 Table 64 : Companion Diagnostics and Approved Drugs, 2017-2020
 Table 65 : FoundationOne CDx Approved Indications
 Table 66 : Abbott Laboratories: Biomarker Clinical Trials
 Table 67 : Bayer: Biomarker Clinical Trials
 Table 68 : Bio-Rad Laboratories: Biomarker Clinical Trials
 Table 69 : GE Healthcare: Biomarker Clinical Trials
 Table 70 : F Hoffmann-La Roche: Biomarker Clinical Trials
 Table 71 : Millipore-Sigma: Biomarker Clinical Trials
 Table 72 : Abbreviations in Biomarker Technologies and Global Markets Report


List Of Figures

Summary Figure : Global Market for Biomarkers, by Technology, 2018-2025
Figure 1 : Different Categories of Biomarkers
Figure 2 : Molecular and Imaging Biomarkers
Figure 3 : Biomarker Discovery, Verification and Validation
Figure 4 : Biomarker Qualification Process
Figure 5 : Global Market for Biomarkers, by Product Type, 2018-2025
Figure 6 : Global Market Shares of Biomarkers, by Product Type, 2019
Figure 7 : Global Market for Biomarkers, by Region, 2018-2025
Figure 8 : Global Market Shares of Biomarkers, by Region, 2019
Figure 9 : Global Market for Biomarker Instruments, by Region, 2018-2025
Figure 10 : Global Market for Biomarker Consumables, by Region, 2018-2025
Figure 11 : Global Market for Biomarker Services, by Region, 2018-2025
Figure 12 : Global Market for Biomarker Software, by Region, 2018-2025
Figure 13 : Global Market for Biomarkers, by Technology Type, 2018-2025
Figure 14 : Global Market Shares of Biomarkers, by Technology Type, 2019
Figure 15 : Global Market for Genomics Biomarkers, by Region, 2018-2025
Figure 16 : Global Market for Proteomics Biomarkers, by Region, 2018-2025
Figure 17 : Global Market for Metabolomics Biomarkers, by Region, 2018-2025
Figure 18 : Global Market for Imaging Biomarkers, by Region, 2018-2025
Figure 19 : Global Market for Bioinformatics in Biomarkers, by Region, 2018-2025
Figure 20 : Global Market for Biomarkers, by Therapeutic Area, 2018-2025
Figure 21 : Global Market Shares of Biomarkers, by Therapeutic Area, 2019
Figure 22 : Global Market for Cancer Biomarkers, by Region, 2018-2025
Figure 23 : Global Market for Cardiovascular and Metabolic Disease Biomarkers, by Region, 2018-2025
Figure 24 : Global Market for Infectious Disease Biomarkers, by Region, 2018-2025
Figure 25 : Global Market for Neurodegenerative Disease Biomarkers, by Region, 2018-2025
Figure 26 : Global Market for Autoimmune Disease Biomarkers, by Region, 2018-2025
Figure 27 : Global Market for Biomarkers for Other Diseases, by Region, 2018-2025
Figure 28 : Global Market for Biomarkers, by End User, 2018-2025
Figure 29 : Global Market Shares of Biomarkers, by End User, 2019
Figure 30 : Global Market for Biomarkers in Academic Institutes, by Region, 2018-2025
Figure 31 : Global Market for Biomarkers in Pharma and Biotechnology, by Region, 2018-2025
Figure 32 : Global Market for Biomarkers in CROs, by Region, 2018-2025
Figure 33 : Global Market for Biomarkers in Hospitals and Diagnostics, by Region, 2018-2025
Figure 34 : Global Market Shares of Leading Manufacturers/Suppliers of Genomic Technologies, 2019
Figure 35 : Global Market Shares of Leading Manufacturers/Suppliers of Proteomics Technologies, 2019
Figure 36 : Global Market Shares of Leading Manufacturers/Suppliers of Metabolomic Technologies, 2019
Figure 37 : Global Market Shares of Leading Manufacturers/Suppliers of Imaging Technologies, 2019
Figure 38 : Global Market Shares of Leading Manufacturers/Suppliers of Bioinformatic Technologies, 2019
Figure 39 : Clinical Trials in Biomarkers, by Therapeutic Area, 2018-2020
Figure 40 : Clinical Trials in Biomarkers, by Study Status, 2018-2020
Figure 41 : Clinical Trials in Biomarkers, by Phase of the Study, 2018-2020
Figure 42 : Clinical Trials in Biomarkers, Studies including Children, 2018-2020
Figure 43 : Patents Issued for Biomarkers, by Year, 2018-December 15, 2020
Figure 44 : Patents Issued for Biomarkers, by Type, 2018-December 15, 2020
Figure 45 : Patents Issued for Biomarkers, by Application, 2018-December 15, 2020
Figure 46 : Patents Issued for Biomarkers, by Country, 2018-December 15, 2020
Figure 47 : Patents Issued for Biomarkers, by Type of Assignee, 2018-December 15, 2020
Figure 48 : Global Market for Biomarker SWOT Analysis

Companies Mentioned
10X GENOMICS
ABCAM PLC
AGILENT TECHNOLOGIES INC.
BAYER AG
BECKMAN COULTER LIFE SCIENCES
BECTON DICKINSON & CO.
BIO-RAD LABORATORIES INC.
BIO-TECHNE CORP.
BIOLEGEND
BRUKER CORP.
CANON MEDICAL SYSTEMS CORP.
CEPHEID
CYTIVA
DANAHER CORP.
GE HEALTHCARE
ILLUMINA INC.
Integrated DNA Technologies (IDT)
JEOL LTD.
KONINKLIJKE PHILIPS N.V.
LANTHEUS MEDICAL IMAGING INC.
LECO CORP.
LUMINEX CORP.
METABOLON INC.
MILLIPORE SIGMA
MOLECULAR DEVICES
OXFORD NANOPORE TECHNOLOGIES LTD.
PERKINELMER INC.
PROMEGA CORP.
QIAGEN N.V.
QUANTERIX CORP.
Sciex
SHIMADZU CORP.
THERMO FISHER SCIENTIFIC INC.
WATERS CORP.


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