Labeling and Linkage Agents for Immunoassays and Gene Probes

Product Code BCC00048
Publication Date October 2011
Publisher BCC Research
Product Type Report
Pages 132
ISBN Number not applicable
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Labeling and Linkage Agents for Immunoassays and Gene Probes

INTRODUCTION

OBJECTIVES AND GOAL OF THE STUDY

This study provides the reader with a detailed analysis of the current application and consumption and future growth potential of immunoagents, gene probes, and molecular diagnostics. This study also analyzes the recent technological developments, future industry trends, and emerging business opportunities. Such information will facilitate the investment decisions and strategic planning for business managers.

Immunoassays are used to determine antibody or antigen levels in a variety of disease situations. Gene probes explore the DNA makeup of microorganisms causing infection and of the gene structure of cellular mutations involved in cancer diabetes, coronary disease, etc. Molecular diagnostics is an emerging science that studies cellular biomarkers that are related to gene expression and that also develops assays to serve as companion diagnostic tests to allow physicians to better structure treatment of diseases.

Major objectives of this study are to:

  • Assess the technology developments and how they will impact this industry.
  • Identify the driving forces for demand.
  • Make available the most current and reliable information on consumption of probes and related biomolecules in enzyme immunoassays.
  • Estimate a global supply and demand scenario broken down by applications and regions.
  • Project the growth rate in demand.
  • Estimate the projected demand and supply by applications and regions through 2016.
  • Profile major companies involved in this business and their market shares.

REASONS FOR DOING THE STUDY

The segment of the diagnostic industry using immunoassays, gene probes, and molecular diagnostics has developed rapidly as scientific understanding of these systems has advanced in the past decade. This industry is undergoing rapid changes driven by the ongoing progress in biotechnology and medicine. This area is now experiencing major research and development (R&D) initiatives, which are leading to the development of new products, and to improvements in the sensitivities and performance of existing immunoassay products. This has direct impact on the demand, consumption, and future growth of the labeling and immunoagents, gene probes, and the developing market of molecular diagnostics.

This report provides a current and comprehensive global report on the scientific fields that make up diagnostic tests. This study provides a comprehensive analysis of the underlying influences brought about by rapid developments in diagnostic products, changes in governmental regulations, and the evolving economies of countries such as China, India, the Pacific Rim, Australia, Brazil, Russia, and the Middle East.

This study also looks at major global players in this field and provides an insight into their performance; in addition, it anticipates involvement in future technological trends and potential investment opportunities in the field.

SCOPE OF STUDY

The Scope of this study is to outline the international supply and demand for compounds used in immunoassays and in probes, including gene probes, and related chemicals employed in diagnostic tests and in the detection of various antigens/analytes. This study excludes separation and purification applications, which use some of these technologies.

The industries studied in this report are:

  • In vitro diagnostics
  • Research and development laboratories
  • Point-of-Care Testing
  • Doctor's office
  • Private medical laboratories
  • Hospitaal bedside
  • Home
  • Molecular diagnostic testing
  • In vivo diagnostics
  • Immunoassay testing
  • Monoclonal antibody therapy
  • Blood banks
  • Food Safety testing
  • Bioterrorism detection

The large number of biochemical/chemical materials covered in this report is mainly due to the diversity of the immunological tests involved.

The immunological biochemical products covered include:

  • Proteins
  • Antibodies and antigens
  • Cellular components
  • Nucleic acids DNA, RNA
  • Cellular receptors
  • Gene structures
  • Mutated genes involved in diseases

TARGETED AUDIENCE

This study will be of great interest to those involved with the reagents industry, either as manufacturers and suppliers of reagents or as manufacturers of diagnostics/detection tests. It will also be of interest to end users of diagnostics/detection tests as well as to government and regulatory bodies involved in setting standards and tests that use the immunoassay, gene probe, and molecular diagnostic technologies. Research scientists interested in pursuing diagnostics and molecular detections using immunoassays and gene probes also will find this study of value.

Identifying overall market trends, product opportunities, emerging geographies, merger and acquisition (M&A) opportunities, and insights that provide guidance for sales growth or defensive moves is vital for a variety of readers:

  • Established companies in the industry will benefit from the contents, for corporate strategizing, sales and marketing, business development, and research and development.
  • Emerging companies in this medical diagnostic segment must understand specific opportunities for out-licensing that originate from the elements of differentiation of their product or technology as compared to leading, competitive, and emerging diagnostic tests. Market forecasts can support investment provided a thorough and detailed substantiation is provided for the market forecast.
  • Investment firms evaluating candidates for venture capital or hedged investments will gain insights as to the opportunity and risks that are being encountered in the industry in a product- and company-specific analysis.
  • Equity analysts are provided with detailed forecasts for the next 5 years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run. The readers are likely to hold positions in strategic planning, new business development, marketing, product management, sales, including purchasing agents, regulatory officers or analysts/investment advisors. These decision-makers will be better able to plan production, to develop new products, and to find new customers. Planners and marketers will gain insight for company and product positioning. Purchasers will locate new and additional suppliers.

Managers from several related industries will also find valuable information in the report. Distributors, test formulators, traders, and even test laboratory professionals can benefit from a better understanding of the tag/linkage business and how it influences competition in their own industries.

METHODOLOGY

In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts, and leading researchers in the field. The overall immunology market is comprised of a variety of fast-growing and independent segments. For completeness, the current and forecasted markets are comprised of the total market opportunity for each respective segment. Within each subsection there is a detailed forecast for each driving mechanism or relevant area of growth.

Information to prepare this report was obtained from participating and emerging companies in the immunoagent, gene probe, and molecular diagnostics areas. Information was gained from scientific publications like Nature Biotech, Genetic and Engineering News, Journal of Experimental Medicine, European Journal of Immunology, Immunology, Clinical and Diagnostic Laboratory Immunology, Immunobiology, Nature Immunology, and others.

Other information was from the World Health Organization (WHO) and other government agencies, literature searches, annual reports, 10-Ks, and others. Population estimates are based on those reported by the international database of the U.S. Census Bureau.

Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain or from government sources.

Major factors impacting the immunoassay, gene probe, and molecular diagnostic supply and demand are discussed. Government regulations, technology developments, patents and international trade are addressed.

ANALYST CREDENTIALS

Jackson Highsmith is a life sciences research consultant with more than 16 years of research experience. Jackson has been consulting with specialty pharmaceuticals and large pharmaceutical industry players since 2007. Prior to that, he worked at a large research consultancy where he focused on in-depth research; he also has worked at a large pharmaceutical company in a wide range of medical therapeutics in early and mid-stage drug development.

Contents

  • CHAPTER ONE: INTRODUCTION
    • OBJECTIVES AND GOAL OF THE STUDY
    • REASONS FOR DOING THE STUDY
    • SCOPE OF THE STUDY
    • TARGETED AUDIENCE
    • METHODOLOGY
    • ANALYST CREDENTIALS
    • RELATED REPORTS
    • BCC ONLINE SERVICES
    • DISCLAIMER
  • CHAPTER TWO: SUMMARY
    • SUMMARY TABLE MARKETS FOR IMMUNOAGENTS, PROBES AND
    • MOLECULAR DIAGNOSTICS, THROUGH 2016 ($ MILLIONS)
    • SUMMARY FIGURE MARKETS FOR IMMUNOAGENTS, PROBES
    • AND MOLECULAR DIAGNOSTICS, 2009-2016 ($ MILLIONS)
    • SUMMARY (CONTINUED)
  • CHAPTER THREE: TECHNOLOGY OVERVIEW
    • IMMUNOASSAY TECHNOLOGY
    • QUALITATIVE AND QUANTITATIVE IMMUNOASSAYS
    • APPLICATIONS FOR IMMUNOASSAY TECHNIQUES
    • COMPARISON OF IMMUNOASSAYS WITH CONVENTIONAL
    • METHODS
    • HIGH SENSITIVITY
    • HIGH ACCURACY
    • SPEED
    • COST FACTORS
    • METHODS OF IMMUNOASSAYS
    • IMMUNOPRECIPITATION
    • PARTICLE IMMUNOASSAYS
    • RADIOIMMUNOASSAY (RIA)
    • Immunoradiometric Assays
    • IMMUNONEPHELOMETRY
    • ENZYME IMMUNOASSAY (EIA)
    • Enzyme-Linked Immunosorbent Assays (ELISA)
    • FLUORESCENT IMMUNOASSAY (FIA)
    • Fluorescence Polarization (FP): A Variation of FIA
    • CHEMILUMINESCENT ASSAY (CLIA)
    • IMMUNOASSAY TECHNIQUES
    • MONOCLONAL-POLYCLONAL (MOAB-POAB) SANDWICH
    • IMMUNOASSAY
    • COMPETITIVE INHIBITION IMMUNOASSAY
    • ANTIGEN-DOWN IMMUNOASSAY
    • RAPID IMMUNOASSAYS
    • GENE PROBE TECHNOLOGY (NUCLEIC ACID ASSAYS)
    • DNA PROBES UTILIZED FOR ASSESSING TUMOR GENES IN
    • PATIENT SPECIMENS
    • TABLE 1 COMMONLY USED CHEMILUMINESCENT COMPOUNDS
    • GENE PROBES
    • MOLECULAR BEACONS
    • TABLE 2 COMMON MOLECULAR BEACON AND QUENCHER
    • COMBINATIONS
    • DETECTION OF BACTERIAL CONTAMINATION IN FOODS
    • CHIP-BASED NUCLEIC ACID ASSAY
    • REPORTER GENE ASSAY
    • TABLE 3 FDA APPROVED NUCLEIC ACID TEST USING DNA PROBE
    • TECHNOLOGIES
    • TABLE 3 (CONTINUED)
    • TABLE 3 (CONTINUED)
    • TABLE 3 (CONTINUED)
  • CHAPTER FOUR: OVERVIEW OF PROBES AND RELATED CHEMICALS
    • RADIOACTIVE COMPOUNDS
    • TABLE 4 PROPERTIES OF RADIOACTIVE ISOTOPES USED IN
    • RADIOACTIVE LABELED PROBES
    • ENZYMES/ENZYME SUBSTRATES
    • FLUORESCENT COMPOUNDS
    • CHEMILUMINESCENCE COMPOUNDS
    • GENE PROBES
    • CONSTRUCTION OF GENE PROBES
    • PROBE LABELING
    • RADIOACTIVE PROBES USED IN DIAGNOSTIC IMAGING
    • TABLE 5 RADIONUCLIDES COMMONLY USED FOR DIAGNOSTIC
    • IMAGING
    • TABLE 6 USE OF RADIOACTIVE PROBES - THYROID IMAGING
    • TABLE 7 ADDITIONAL USE OF ISOTOPES IN THYROID SCANNING
    • TABLE 8 RADIO-LABELED ANTIBODIES FOR DIAGNOSIS OF
    • SPECIFIC CANCE8S
    • TABLE 8 (CONTINUED)
    • TABLE 9 USE OF RADIOACTIVE PROBES IN DIAGNOSIS OF
    • THYROIDISM
    • TABLE 10 USE OF RADIOACTIVE PROBES - RADIOCARDIOGRAPHY
    • TABLE 11 USE OF RADIOACTIVE PROBES - TUMOR IMAGING
    • TABLE 12 USE OF RADIOACTIVE PROBES - CANCER TREATMENT
    • TABLE 13 USE OF RADIOACTIVE PROBES - DETERMINATION OF
    • CIRCULATION RED CELL MASS/PLASMA VOLUME
    • TABLE 14 USE OF RADIOACTIVE PROBES - DETERMINATION OF
    • BLOOD FLOW
    • TABLE 15 USE OF RADIOACTIVE PROBES - STOMACH IMAGING
    • TABLE 16 USE OF RADIOACTIVE PROBES - TREATMENT OF
    • LEUKEMIAS
    • TABLE 17 USE OF RADIOACTIVE PROBES - STUDY OF
    • GASTROINTESTINAL PROTEIN LOSS
    • TABLE 18 USE OF RADIOACTIVE PROBES - SCANNING
    • LUNGS/BRAIN
    • TABLE 19 USE OF RADIOACTIVE PROBES - MYOCARDIAL
    • STUDIES
    • TABLE 19 (CONTINUED)
    • TABLE 20 USE OF RADIOACTIVE PROBES - HEART IMAGING
    • TABLE 21 USE OF RADIOACTIVE PROBES - CEREBRAL
    • PERFUSION IMAGING
    • TABLE 22 USE OF RADIOACTIVE PROBES - BONE IMAGING
    • TABLE 23 USE OF RADIOACTIVE PROBES - LUNG IMAGING
    • TABLE 23 (CONTINUED)
    • HEPATOBILIARY IMAGING
    • RETICULOENDOTHELIAL SYSTEM
    • TABLE 24 USE OF RADIOACTIVE PROBES - RENAL IMAGING
    • TABLE 25 USE OF RADIOACTIVE PROBES - MALIGNANT AND
    • INFLAMMATORY REGIONS
    • TABLE 26 USE OF RADIOACTIVE PROBES - AUTORADIOGRAPHY
    • TRENDS IN RADIOLABELED ANTIBODY THERAPY
    • RADIOPHARMACEUTICAL MARKET
    • ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) ASSAY
    • PROCEDURES
    • TABLE 27 COMMON TYPES OF ELISA ASSAY
    • A CAPTURE EIA IS DESIGNED TO DETECT A SPECIFIC
    • TYPE OF ANTIBODY, SUCH AS IGG OR IGM
    • TABLE 28 ENZYMES AND SUBSTRATES USED IN ELISA ASSAYS
    • FLUORESCENCE COMPOUNDS
    • TABLE 29 COMMONLY USED FLUOROPHORES IN FIA
    • TABLE 29 (CONTINUED)
    • TABLE 30 FLUOROPHORES AND THEIR APPLICATIONS
    • TABLE 30 (CONTINUED)
    • TABLE 31 FLUOROPHORES AND THEIR APPLICATIONS
    • FLUORESCENT DOT IMAGING
    • MOLECULAR IMAGING AND OPTICAL IMAGING
    • OPTICAL IMAGING
    • TABLE 32 RADIO-PROBES USED IN MOLECULAR IMAGING
    • CHEMILUMINESCENT COMPOUNDS
    • TABLE 33 COMMONLY USED CHEMILUMINESCENT COMPOUNDS
    • TABLE 34 BLOTTING METHODS DEVELOPED FOR
    • BIOMOLECULAR SPECIES
    • FLOW CYTOMETRY
    • CLINICAL APPLICATIONS OF FLOW CYTOMETER
    • TABLE 35 FLUOROCHROME DYES USED IN MOLECULAR
    • DIAGNOSTICS AND MOLECULAR PROBES
    • TABLE 35 (CONTINUED)
    • TABLE 35 (CONTINUED)
    • TABLE 35 (CONTINUED)
  • CHAPTER FIVE: MARKETS FOR IMMUNOAGENTS, AND MOLECULAR
    • DIAGNOSTICS BY APPLICATION SECTORS
    • CHANGES IN THE GLOBAL MARKETS FOR IMMUNOGENIC
    • PROBES
    • TABLE 36 LIST OF FDA-APPROVED DRUGS THAT HAVE
    • BIOMARKER INFORMATION INCLUDED IN THEIR LABELING
    • TABLE 36 (CONTINUED)
    • TABLE 36 (CONTINUED)
    • TABLE 36 (CONTINUED)
    • TABLE 36 (CONTINUED)
    • TABLE 36 (CONTINUED)
    • CHANGES IN THE GLOBAL MARKETS ...(CONTINUED)
    • TABLE 37 GLOBAL MARKET FOR IMMUNOAGENTS, PROBES, AND
    • MOLECULAR DIAGNOSTICS BY APPLICATION SECTORS,
    • THROUGH 2016 ($ MILLIONS)
    • TABLE 38 DIAGNOSTIC CATEGORIES FOR FAILED DRUG
    • CLINICAL TRIALS IN PERIOD 2008-2016
    • TABLE 39 GLOBAL MARKET BY MATERIALS FOR PROBES IN
    • IMMUNOASSAYS, THROUGH 2016 ($ MILLIONS)
    • TABLE 40 GLOBAL MARKET BY MATERIALS FOR PROBES IN
    • IMMUNOASSAYS INCLUDING MOLECULAR ANTIBODY
    • THERAPY, THROUGH 2016 ($ MILLIONS
    • TABLE 41 REGIONAL SHARE OF THE MARKET FOR
    • IMMUNOAGENTS, PROBES, AND MOLECULAR DIAGNOSTICS,
    • THROUGH 2016 ($ MILLIONS)
    • POINT-OF-CARE TESTS
    • REQUIREMENTS FOR POC DEVICES
    • Requirements for POC Devices (Continued)
    • TABLE 42 FDA CRITERIA FOR CATEGORIZING POTENTIAL POC
    • TEST
    • TABLE 43 TYPES OF POC TESTS WITH AUTOMATIC WAIVED
    • STATUS
    • TABLE 44 GLOBAL REVENUES FROM POC TESTING, THROUGH
    • 2016 ($ MILLIONS)
    • TABLE 45 GLOBAL MARKET FOR IN VITRO DIAGNOSTICS POC
    • TESTS BY APPLICATION SECTORS, THROUGH 2016 ($
    • MILLIONS)
    • TABLE 46 GLOBAL DISTRIBUTION OF IN VITRO DIAGNOSTICS
    • POC TESTS BY REGION, 2010 ($ MILLIONS)
    • MOLECULAR DIAGNOSTICS TESTS
    • Molecular Diagnostics tests (Continued)
    • MOLECULAR DIAGNOSTICS REVENUE PROJECTIONS
    • TABLE 47 GLOBAL REVENUES FROM MOLECULAR DIAGNOSTICS
    • TESTS, THROUGH 2016 ($ MILLIONS)
    • FDA-APPROVED MDX TESTS
    • TABLE 48 CURRENT FDA APPROVED MOLECULAR DIAGNOSTICS
    • TESTS
    • TABLE 48 (CONTINUED)
    • TABLE 48 (CONTINUED)
    • TABLE 48 (CONTINUED)
    • TABLE 48 (CONTINUED)
    • TABLE 48 (CONTINUED)
    • TABLE 48 (CONTINUED)
    • TABLE 49 MOLECULAR DIAGNOSTICS SYSTEMS CURRENT IN
    • COMMERCE 2011
    • TABLE 49 (CONTINUED)
    • TABLE 49 (CONTINUED)
    • TABLE 49 (CONTINUED)
    • INFECTIOUS DISEASE TESTING
    • TABLE 50 FDA-APPROVED INFECTIOUS DISEASE TESTS
    • TABLE 50 (CONTINUED)
    • TABLE 50 (CONTINUED)
    • TABLE 50 (CONTINUED)
    • TABLE 50 (CONTINUED)
    • NEXT-GENERATION MOLECULAR DIAGNOSTICS
    • U.S. PATENTS FOR MOLECULAR DIAGNOSTICS
    • TABLE 51 NUMBER OF U.S. PATENTS ISSUED FOR MOLECULAR
    • DIAGNOSTICS DURING THE PERIOD, THROUGH 2010
    • TABLE 51 (CONTINUED)
    • TABLE 52 NUMBER OF U.S. PATENTS ISSUED TO UNIVERSITIES
    • DURING THE PERIOD, THROUGH 2010
    • THE RISE OF COMPANION DIAGNOSTICS
    • The Rise of Companion Diagnostics (Continued)
    • The Rise of Companion Diagnostics (Continued)
    • BLOOD BANK IMMUNE TESTING
    • FOOD TESTING IMMUNOASSAYS
    • FORENSIC, BIOTERRORISM, AND PATERNITY MARKETS
    • FORENSICS
    • PATERNITY AND MATERNITY TESTING
    • BIOTERRORISM
    • MERGERS AND ACQUISITIONS
    • TABLE 53 PHARMACEUTICAL AND BIOTECHNOLOGY MERGERS
    • AND ACQUISITIONS IN 2010
    • TABLE 53 (CONTINUED)
    • TABLE 54 MAJOR ACQUISITIONS IN
    • BIOPHARMACOLOGY/BIOTECHNOLOGY IN 2009
    • TABLE 55 MAJOR MERGER AND ACQUISITION ACTIVITY IN
    • BIOTECH INDUSTRY DURING THE PERIOD 2005 THROUGH 2008
    • WORLDWIDE IMMUNOASSAY AND MOLECULAR DIAGNOSTICS
    • ACTIVITY
    • TABLE 56 DISTRIBUTION OF GLOBAL REVENUES FOR
    • IMMUNOASSAYS, GENE PROBES, AND MOLECULAR
    • DIAGNOSTICS, 2010
    • JAPAN
    • CHINA
    • RUSSIA
    • BRAZIL
  • CHAPTER SIX: COMPANY PROFILES
    • MARKET SHARE OF MAJOR COMPANIES
    • TABLE 57 MARKET SHARE OF MAJOR COMPANIES IN THE
    • IMMUNOASSAY AND MOLECULAR DIAGNOSTICS AREAS, 2010
    • ABBOTT LABORATORIES
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • IMMUNOASSAY
    • TABLE 58 REPRESENTATIVE IMMUNOASSAY PRODUCTS AND
    • AUTOMATED SYSTEMS (ARCHITECT SERIES) FOR THEIR
    • ANALYSIS
    • GENE PROBE AND MOLECULAR DIAGNOSTICS
    • AFFYMETRIX
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • BECKMAN-COULTER
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • BIOMÉRIEUX
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • TABLE 59 BIOMÉRIEUX BIOMARKERS
    • BIO-RAD LABORATORIES
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • GE HEALTHCARE LIFE SCIENCES
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • GENENTECH, INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • TABLE 60 GENENTECH PRODUCTS IN PRODUCTION
    • GEN-PROBE INCORPORATED
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • TABLE 61 GEN-PROBE STANDARDIZED ANTIBODIES
    • LIFE TECHNOLOGIES
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • TABLE 62 LIFE TECHNOLOGIES' CELL-LIGHT MOLECULAR
    • SIGNALING DYES
    • TABLE 62 (CONTINUED)
    • MILLIPORE CORPORATION (MERCK KGAA)
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • QIAGEN, INC
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • ROCHE DIAGNOSTICS
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • TABLE 63 ROCHE DIAGNOSTIC TESTS
    • SIGMA-ALDRICH, USA
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICE
    • TABLE 64 MAJOR PRODUCT OFFERINGS OF SIGMA-ALDRICH
    • THERMO FISHER LIFE SCIENCES
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • TABLE 65 CUSTOMIZED ANTIBODY PRODUCTION PROCESS OF
    • THERMO FISHER LIFE SCIENCES