Abstract
REPORT HIGHLIGHTS
THIS REPORT CONTAINS:
- An overview of the technological developments in the market for labeling
and linkage agents for immunoassays and gene probes
- Analyses of global market trends, with data from 2009 and 2010, estimates
for 2011, and projections of compound annual growth rates (CAGRs) through 2016
- The most current and reliable information on consumption of probes and
related chemicals in enzyme immunoassay
- Estimates of the global supply-and-demand scenario broken down by
applications and regions
- Comprehensive profiles of major companies involved in the industry and
their market shares.
REPORT SCOPE
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.
Table of Contents
Chapter- 1: INTRODUCTION - Complimentary
- 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- 2: SUMMARY
- Table 0 : MARKETS FOR IMMUNOAGENTS, PROBES AND MOLECULAR DIAGNOSTICS,
THROUGH 2016
- Figure 0 : MARKETS FOR IMMUNOAGENTS, PROBES AND MOLECULAR DIAGNOSTICS,
2009-2016
Chapter- 3: TECHNOLOGY OVERVIEW
- IMMUNOASSAY TECHNOLOGY
- QUALITATIVE AND QUANTITATIVE IMMUNOASSAYS
- APPLICATIONS FOR IMMUNOASSAY TECHNIQUES
- COMPARISON OF IMMUNOASSAYS WITH CONVENTIONAL METHODS
- METHODS OF IMMUNOASSAYS
- IMMUNOASSAY TECHNIQUES
- GENE PROBE TECHNOLOGY (NUCLEIC ACID ASSAYS)
- DNA PROBES UTILIZED FOR ASSESSING TUMOR GENES IN PATIENT SPECIMENS
- GENE PROBES
- MOLECULAR BEACONS
- 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
Chapter- 4: OVERVIEW OF PROBES AND RELATED CHEMICALS
- RADIOACTIVE COMPOUNDS
- ENZYMES/ENZYME SUBSTRATES
- FLUORESCENT COMPOUNDS
- CHEMILUMINESCENCE COMPOUNDS
- GENE PROBES
- ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) ASSAY PROCEDURES
- MOLECULAR IMAGING AND OPTICAL IMAGING
- OPTICAL IMAGING
- CHEMILUMINESCENT COMPOUNDS
- FLOW CYTOMETRY
Chapter- 5: MARKETS FOR IMMUNOAGENTS, AND MOLECULAR DIAGNOSTICS BY APPLICATION SECTORS
- CHANGES IN THE GLOBAL MARKETS FOR IMMUNOGENIC PROBES
- POINT-OF-CARE TESTS
- INFECTIOUS DISEASE TESTING
- FORENSIC, BIOTERRORISM, AND PATERNITY MARKETS
- MERGERS AND ACQUISITIONS
- WORLDWIDE IMMUNOASSAY AND MOLECULAR DIAGNOSTICS ACTIVITY
- Table 56 : DISTRIBUTION OF GLOBAL REVENUES FOR IMMUNOASSAYS, GENE
PROBES, AND MOLECULAR DIAGNOSTICS, 2010
Chapter- 6: COMPANY PROFILES
- MARKET SHARE OF MAJOR COMPANIES
- ABBOTT LABORATORIES
- AFFYMETRIX
- BECKMAN-COULTER
- BIOMERIEUX
- BIO-RAD LABORATORIES
- GE HEALTHCARE LIFE SCIENCES
- GENENTECH, INC.
- GEN-PROBE INCORPORATED
- LIFE TECHNOLOGIES
- MILLIPORE CORPORATION (MERCK KGAA)
- QIAGEN, INC.
- ROCHE DIAGNOSTICS
- SIGMA-ALDRICH, USA
- THERMO FISHER LIFE SCIENCES
List of Tables
- Summary Table : MARKETS FOR IMMUNOAGENTS, PROBES AND MOLECULAR
DIAGNOSTICS, THROUGH 2016
- Table 1 : COMMONLY USED CHEMILUMINESCENT COMPOUNDS
- Table 2 : COMMON MOLECULAR BEACON AND QUENCHER COMBINATIONS
- Table 3 : FDA APPROVED NUCLEIC ACID TEST USING DNA PROBE TECHNOLOGIES
- Table 4 : PROPERTIES OF RADIOACTIVE ISOTOPES USED IN RADIOACTIVE LABELED
PROBES
- 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 9 : USE OF RADIOACTIVE PROBES IN DIAGNOSIS OF THYROIDISM
- Table 10 : USE OF RADIOACTIVE PROBES - RADIO-CARDIOGRAPHY
- 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 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 24 : USE OF RADIOACTIVE PROBES - RENAL IMAGING
- Table 25 : USE OF RADIOACTIVE PROBES - MALIGNANT AND INFLAMMATORY REGIONS
- Table 26 : USE OF RADIOACTIVE PROBES - AUTORADIOGRAPHY
- Table 27 : COMMON TYPES OF ELISA ASSAY
- Table 28 : ENZYMES AND SUBSTRATES USED IN ELISA ASSAYS
- Table 29 : COMMONLY USED FLUOROPHORES IN FIA
- Table 30 : FLUOROPHORES AND THEIR APPLICATIONS
- Table 31 : FLUOROPHORES AND THEIR APPLICATIONS
- Table 32 : RADIO-PROBES USED IN MOLECULAR IMAGING
- Table 33 : COMMONLY USED CHEMILUMINESCENT COMPOUNDS
- Table 34 : BLOTTING METHODS DEVELOPED FOR BIOMOLECULAR SPECIES
- Table 35 : FLUOROCHROME DYES USED IN MOLECULAR DIAGNOSTICS AND MOLECULAR
PROBES
- Table 36 : LIST OF FDA-APPROVED DRUGS THAT HAVE BIOMARKER INFORMATION
INCLUDED IN THEIR LABELING
- Table 37 : GLOBAL MARKET FOR IMMUNOAGENTS, PROBES, AND MOLECULAR
DIAGNOSTICS BY APPLICATION SECTORS, THROUGH 2016
- 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
- Table 40 : GLOBAL MARKET BY MATERIALS FOR PROBES IN IMMUNOASSAYS INCLUDING
MOLECULAR ANTIBODY THERAPY, THROUGH 2016
- Table 41 : REGIONAL SHARE OF THE MARKET FOR IMMUNOAGENTS, PROBES, AND
MOLECULAR DIAGNOSTICS, THROUGH 2016
- 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
- Table 45 : GLOBAL MARKET FOR IN VITRO DIAGNOSTICS POC TESTS BY APPLICATION
SECTORS, THROUGH 2016
- Table 46 : GLOBAL DISTRIBUTION OF IN VITRO DIAGNOSTICS POC TESTS BY
REGION, 2010
- Table 47 : GLOBAL REVENUES FROM MOLECULAR DIAGNOSTICS TESTS, THROUGH 2016
- Table 48 : CURRENT FDA APPROVED MOLECULAR DIAGNOSTICS TESTS
- Table 49 : MOLECULAR DIAGNOSTICS SYSTEMS CURRENT IN COMMERCE 2011
- Table 50 : FDA-APPROVED INFECTIOUS DISEASE TESTS
- Table 51 : NUMBER OF U.S. PATENTS ISSUED FOR MOLECULAR DIAGNOSTICS DURING
THE PERIOD, THROUGH 2010
- Table 52 : NUMBER OF U.S. PATENTS ISSUED TO UNIVERSITIES DURING THE
PERIOD, THROUGH 2010
- Table 53 : PHARMACEUTICAL AND BIOTECHNOLOGY MERGERS AND ACQUISITIONS IN
2010
- 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
- Table 56 : DISTRIBUTION OF GLOBAL REVENUES FOR IMMUNOASSAYS, GENE PROBES,
AND MOLECULAR DIAGNOSTICS, 2010
- Table 57 : MARKET SHARE OF MAJOR COMPANIES IN THE IMMUNOASSAY AND
MOLECULAR DIAGNOSTICS AREAS, 2010
- Table 58 : REPRESENTATIVE IMMUNOASSAY PRODUCTS AND AUTOMATED SYSTEMS
(ARCHITECT SERIES) FOR THEIR ANALYSIS
- Table 59 : BIOMERIEUX BIOMARKERS
- Table 60 : GENENTECH PRODUCTS IN PRODUCTION
- Table 61 : GEN-PROBE STANDARDIZED ANTIBODIES
- Table 62 : LIFE TECHNOLOGIES' CELL-LIGHT MOLECULAR SIGNALING DYES
- Table 63 : ROCHE DIAGNOSTIC TESTS
- Table 64 : MAJOR PRODUCT OFFERINGS OF SIGMA-ALDRICH
- Table 65 : CUSTOMIZED ANTIBODY PRODUCTION PROCESS OF THERMO FISHER LIFE
SCIENCES
List of Figures
- Summary Figure : MARKETS FOR IMMUNOAGENTS, PROBES AND MOLECULAR
DIAGNOSTICS, 2009-2016
