ReportsnReports - Labeling and Linkage Agents for Immunoassays and Gene Probes

Labeling and Linkage Agents for Immunoassays and Gene Probes 

The segment of the diagnostic industry using immunoassays and gene probes is relatively young and undergoing rapid changes spurred on by the rapid progress in biotechnology and medicine. This area is now experiencing major R&D initiatives, resulting in the development of the number of new products, and in improvement of sensitivities and performance of several existing products. This has a direct impact on the demand, consumption and future growth of the labeling and linking agents that go into products. There is therefore a need for an up to date, comprehensive global report on reagents that make up diagnostic tests.

SCOPE OF STUDY

This important report:

• Assesses technological developments and how they will impact the industry
• Identifies the driving forces for demand
• Makes available the most current and reliable information on consumption of probes and related chemicals in enzyme immunoassay
• Estimates the global supply and demand scenario broken down by applications and regions
• Assesses the growth rate in demand
• Projects demand and supply by applications and regions up to 2010
• Profiles major companies involved in this business and their market shares.

METHODOLOGY

Information was gathered using both primary and secondary sources. Background information was brought together from a multitude of secondary sources, and complementary and supplementary information was developed with telephone interviews.

Specific analysis includes value chain assessment, strategic positioning maps and life cycle evaluations of both markets and technologies. Technical and regulatory analysis yielded valuable information that facilitated the understanding of the direction and magnitude of market demand for various product segments. The key elements impacting market demand were determined so that specific demand forecasts could be developed for each product.

As might be expected, the diversity of materials used in research applications is far greater than that of commercial areas. This makes forecasting for the segment particularly difficult. However, we have identified the larger volume items and discussed them at length. Market demand forecasts (unit volume and dollar values), are developed for each of the larger volume reagents, and the total demand is determined. Major factors impacting the label/linker supply and demand are discussed. We have examined government regulations, technology developments, patents and international trade. European and Japanese suppliers and markets are also discussed and trade figures are provided.

Finally, we arrived at conclusions to facilitate the formation of specific plans of action by industry participants. Although the study is not geared toward any particular supplier, the analysis and conclusions are detailed in a manner that each will find valuable.

CREDENTIALS OF ANALYSTS

The study has been carried out by a team of chemical engineering consultants led by Senior Consultant Mr. N. S. Venkataraman, a chemical engineer with over 30 years of experience in various functions relating to chemical, pharmaceutical and allied industries. Other team members include D. Panneerselvam, Mr. T. K. Parija, Ms. P. Govindanayagi and Ms. K. Geetha. All the members of the team are practicing chemical engineers or chemists with extensive experience as business consultants in the chemical and allied industries.

The project manager for this study was Dr. Yatin B. Thakore, with over 15 years of industry experience in chemical and allied fields.


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
CREDENTIALS OF ANALYSTS
RELATED BCC REPORTS
BCC ONLINE SERVICES
DISCLAIMER

Chapter- 2: SUMMARY
Table 0 : MARKETS FOR LABELS AND PROBES BY APPLICATION AREA, THROUGH 2010
Figure 0 : MARKETS FOR LABELS AND PROBES BY APPLICATION AREA, 2003-2010

Chapter- 3: TECHNOLOGY OVERVIEW 
IMMUNOASSAY TECHNOLOGY
GENE PROBE TECHNOLOGY (NUCLEIC ACID ASSAYS)
EXAMPLES OF TECHNOLOGY DEVELOPMENTS
HISTORIC MILESTONES IN TECHNOLOGY DEVELOPMENT

Chapter- 4: OVERVIEW OF PROBES AND RELATED CHEMICALS
RADIOACTIVE COMPOUNDS
ENZYMES/ENZYME SUBSTRATES
FLUORESCEIN COMPOUNDS
CHEMILUMINESCENCE COMPOUNDS
GENE PROBES
EXAMPLES OF RADIOACTIVE COMPOUNDS AND THEIR APPLICATIONS
ENZYME PROBES
FLUORESCENCE COMPOUNDS
CHEMILUMINESCENT COMPOUNDS
Table 34 : COMMONLY USED CHEMILUMINESCENT COMPOUNDS

Chapter- 5: MARKETS FOR PROBES BY APPLICATION SECTORS
GLOBAL MARKET FOR PROBES
Table 35 : GLOBAL MARKET FOR PROBES IN IMMUNOASSAYS BY APPLICATION SECTORS, THROUGH 2010
Table 36 : GLOBAL MARKET BY MATERIALS FOR PROBES IN IMMUNOASSAYS, THROUGH 2010
Figure 1 : GLOBAL MARKET BY MATERIALS FOR PROBES IN IMMUNOASSAYS, 2003-2010
Table 37 : REGIONAL SHARE OF THE MARKET FOR PROBES IN IMMUNOASSAYS, THROUGH 2010
Figure 2 : REGIONAL SHARE OF MARKETS FOR PROBES IN IMMUNOASSAYS, 2005
Table L2 :

Chapter- 6: MARKET FOR PROBES─BY MATERIALS
FLUORESCENT COMPOUNDS
RADIOACTIVE COMPOUNDS
CHEMILUMINESCENT COMPOUNDS
ENZYME/ENZYME SUBSTRATE
GENE PROBES
Table 68 : MARKET FOR GENE PROBES, THROUGH 2010
Table 69 : MARKETS FOR GENE PROBES BY APPLICATION SECTORS, THROUGH 2010
Figure 9 : MARKETS FOR GENE PROBES BY APPLICATION SECTORS, 2003- 2010

Chapter- 7: REGULATIONS AFFECTING THE INDUSTRY 
REGULATIONS AFFECTING RADIOACTIVE MATERIALS
NUCLEAR REGULATORY COMMISSION (NRC) REGULATIONS
PRESENT RULES AND REGULATIONS
SAFETY STANDARDS
MEDICAL USE POLICY STATEMENT
ADVISORY COMMITTEE
REGULATIONS RELATING TO STORAGE OF RADIO ISOTOPES
SINK DISPOSAL
EXEMPTION TO SMALL QUANTITY ISOTOPES
EUROPEAN REGULATIONS ON WASTE DISPOSAL
PERMITS FOR THE IMPORT OF MEDICAL RADIOISOTOPES IN AUSTRALIA

Chapter- 8: GLOBAL HEALTHCARE AND INDUSTRY TRENDS
WORLD POPULATION AND DISEASE PROFILE
DISEASE PROFILE
DRIVING FACTORS OF TESTING IN DEVELOPING COUNTRIES
DRIVING FACTORS IN DEVELOPED COUNTRIES
CONSTRAINTS FOR GROWTH
THE STAKEHOLDERS
TECHNOLOGY FACTORS
FACTORS INFLUENCING GROWTH
GROWTH IN CONSUMPTION
PATTERN OF USE
HALF LIFE AND LIMITED AVAILABILITY IN SOME COUNTRIES
ENVIRONMENTAL ISSUES
COST ISSUES
SUBSTITUTION FOR RADIOISOTOPES
FUTURE FOR CHEMILUMINESCENT PROBES
FUTURE FOR ENZYME-BASED ASSAYS
FUTURE FOR FLUORESCENT PROBES
FUTURE FOR GENE PROBES

Chapter- 9: PROBES─TECHNOLOGY AND PATENTS 
FLUORESCENT COMPOUNDS
CHEMILUMINESCENT COMPOUNDS
RADIOACTIVE COMPOUNDS
ENZYMES/ENZYME SUBSTRATES
IMMUNOASSAYS
GENE PROBES
PATENT ANALYSIS
Table 74 : PATENT ANALYSIS FOR SELECTED ORGANIZATIONS

Chapter- 10: PROFILE OF MAJOR PLAYERSMARKET SHARE OF MAJOR PLAYERS
ABBOTT LABORATORIES
AMERSHAM BIOSCIENCES, USA
BACHEM AG
BIOFX LABORATORIES
BIO-NUCLEONICS INC.
BIO-RAD, USA
BIOTIUM, USA
BIOVECTRA DCL, USA
BIOZYME LABORATORIES
CARBOMER INC.
DIAGNOSTIC CHEMICALS LIMITED, USA
DUTCH DIAGNOSTICS
HYTEST LTD.
INSTITUTE OF ISOTOPE CO. LTD., HUNGARY
INTERNATIONAL MUREX TECHNOLOGIES CORPORATION / MUREX DIAGNOSTICS CORP.
LUMIGEN, INC
MDS NORDION
MORAVEK BIOCHEMICALS, USA
PERKINELMER LIFE SCIENCE, INC.
RESEARCH PRODUCTS INTERNATIONAL CORP., USA
SIGMA ALDRICH, USA
THERATASE, PLC
TOYOBO ENZYMES
VECTOR LABS
ZYMED LABORATORIES, INC., USA

List of Tables

Summary Table : MARKETS FOR LABELS AND PROBES BY APPLICATION AREA, THROUGH 2010
Table 1 : IMMUNOASSAYS: HISTORICAL TIMELINE
Table 2 : GENE PROBES: HISTORICAL TIMELINE
Table 3 : RADIOACTIVE COMPOUNDS: HISTORICAL TIMELINE
Table 4 : COMMONLY USED RADIOACTIVE ISOTOPES
Table 5 : RADIONUCLIDES FOR DIAGNOSTIC IMAGING
Table 6 : RADIONUCLIDES: POSITRON EMITTERS
Table 7 : USE OF RADIOACTIVE PROBES: THYROID IMAGING
Table 8 : USE OF RADIOACTIVE PROBES: AUTORADIOGRAPHY
Table 9 : USE OF RADIOACTIVE PROBES: IN DIAGNOSIS AND THERAPY
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 BLOOD CELL SURVIVAL TIME
Table 14 : USE OF RADIOACTIVE PROBES: DETERMINATION OF CIRCULATION RED CELL MASS/PLASMA VOLUME
Table 15 : USE OF RADIOACTIVE PROBES: DETERMINATION OF BLOOD FLOW
Table 16 : USE OF RADIOACTIVE PROBES: STOMACH IMAGING
Table 17 : USE OF RADIOACTIVE PROBES: EXCRETION STUDY
Table 18 : USE OF RADIOACTIVE PROBES: TREATMENT OF LEUKEMIAS
Table 19 : USE OF RADIOACTIVE PROBES: STUDY OF GASTROINTESTINAL PROTEIN LOSS
Table 20 : USE OF RADIOACTIVE PROBES: SCANNING LUNGS/BRAIN
Table 21 : USE OF RADIOACTIVE PROBES: MYOCARDIAL STUDIES
Table 22 : USE OF RADIOACTIVE PROBES: HEART IMAGING
Table 23 : USE OF RADIOACTIVE PROBES: BRAIN IMAGING
Table 24 : USE OF RADIOACTIVE PROBES: BRAIN PERFUSION IMAGING
Table 25 : USE OF RADIOACTIVE PROBES: BONE IMAGING
Table 26 : USE OF RADIOACTIVE PROBES: LUNG IMAGING
Table 27 : USE OF RADIOACTIVE PROBES: RENAL IMAGING
Table 28 : USE OF RADIOACTIVE PROBES: MALIGNANT AND INFLAMMATORY REGIONS
Table 29 : COMMONLY USED TYPE OF EIAS
Table 30 : COMMONLY USED ENZYMES IN EIAS
Table 31 : APPLICATIONS OF ENZYMES IN IMMUNOASSAY
Table 32 : COMMONLY USED FLUOROPHORES IN FIA
Table 33 : FLUOROPHORES AND THEIR APPLICATIONS
Table 34 : COMMONLY USED CHEMILUMINESCENT COMPOUNDS
Table 35 : GLOBAL MARKET FOR PROBES IN IMMUNOASSAYS BY APPLICATION SECTORS, THROUGH 2010
Table 36 : GLOBAL MARKET BY MATERIALS FOR PROBES IN IMMUNOASSAYS, THROUGH 2010
Table 37 : REGIONAL SHARE OF THE MARKET FOR PROBES IN IMMUNOASSAYS, THROUGH 2010
Table 38 : GLOBAL MARKET FOR PROBES FOR IN VITRO DIAGNOSTICS BY APPLICATION SECTORS, THROUGH 2010
Table 39 : GLOBAL MARKET FOR PROBES FOR IN VITRO DIAGNOSTICS BY REGION, THROUGH 2010
Table 40 : GLOBAL MARKET FOR PROBES FOR IN VITRO DIAGNOSTICS BY REAGENTS, THROUGH 2010
Table 41 : GLOBAL MARKET FOR PROBES FOR IN VITRO DIAGNOSTICS MEDICAL LABS, THROUGH 2010
Table 42 : GLOBAL MARKET FOR PROBES FOR IN VITRO DIAGNOSTICS HOSPITAL TESTING, THROUGH 2010
Table 43 : GLOBAL MARKET FOR PROBES FOR IN VITRO DIAGNOSTICS DOCTOR'S OFFICE, THROUGH 2010
Table 44 : GLOBAL MARKET FOR PROBES FOR IN VITRO DIAGNOSTICS HOME TESTING, THROUGH 2010
Table 45 : GLOBAL MARKET FOR PROBES FOR IN VIVO DIAGNOSTICS, THROUGH 2010
Table 46 : GLOBAL MARKET FOR PROBES IN THE DENTAL AREA, THROUGH 2010
Table 47 : GLOBAL MARKET FOR PROBES IN BLOOD BANKS, THROUGH 2010
Table 48 : GLOBAL MARKET FOR PROBES IN FOOD TESTING, THROUGH 2010
Table 49 : GLOBAL MARKET FOR PROBES IN RESEARCH LABORATORIES, THROUGH 2010
Table 50 : MARKET FOR PROBES IN FORENSIC AND PATERNITY, THROUGH 2010
Table 51 : GLOBAL MARKET FOR PROBES IN FORENSIC AND PATERNITY, THROUGH 2010
Table 52 : MARKET FOR PROBES IN ENVIRONMENTAL TESTING, THROUGH 2010
Table 53 : GLOBAL MARKET FOR PROBES IN ENVIRONMENTAL TESTING, THROUGH 2010
Table 54 : APPLICATIONS OF SPECIFIC FLUORESCENT COMPOUNDS
Table 55 : MARKET FOR FLUORESCENT COMPOUNDS BY MATERIAL TYPES, THROUGH 2010
Table 56 : MARKETS OF FLUORESCENT COMPOUNDS BY APPLICATION SECTORS, THROUGH 2010
Table 57 : MARKET FOR RADIOACTIVE COMPOUNDS BY MATERIAL TYPES, THROUGH 2010
Table 58 : RADIOPHARMACEUTICALS CURRENTLY USED
Table 59 : MARKETS FOR RADIOACTIVE COMPOUNDS BY APPLICATION SECTORS, THROUGH 2010
Table 60 : TYPES OF CHEMILUMINESCENT ASSAY
Table 61 : TYPES OF LUMINESCENT REACTIONS
Table 62 : MARKET FOR CHEMILUMINESCENT COMPOUNDS BY MATERIAL TYPES, THROUGH 2010
Table 63 : APPLICATIONS OF SELECTED CHEMILUMINESCENT COMPOUNDS
Table 64 : MARKETS OF CHEMILUMINESCENT COMPOUNDS BY APPLICATION SECTORS, THROUGH 2010
Table 65 : MARKET FOR ENZYMES AND THEIR SUBSTRATES BY TYPE, THROUGH 2010
Table 66 : SELECTED ENZYME IMMUNOASSAY APPLICATIONS
Table 67 : MARKETS FOR ENZYMES AND THEIR SUBSTRATES BY APPLICATION SECTORS, THROUGH 2010
Table 68 : MARKET FOR GENE PROBES, THROUGH 2010
Table 69 : MARKETS FOR GENE PROBES BY APPLICATION SECTORS, THROUGH 2010
Table 70 : HISTORICAL TIMELINE OF REGULATIONS AFFECTING THE HANDLING OF RADIOISOTOPES IN THE U.S.
Table 71 : HIGHLIGHTS OF DEVELOPMENTS IN NRC REGULATIONS
Table 72 : HOSPITAL BED STATISTICS FOR SELECTED COUNTRIES, 2004
Table 73 : DEVELOPMENTS IN RADIOLABELED COMPOUNDS
Table 74 : PATENT ANALYSIS FOR SELECTED ORGANIZATIONS
Table 75 : MARKET SHARE OF MAJOR PLAYERS IN MEDICAL DIAGNOSTICS
Table 76 : REPRESENTATIVE ASSAY PRODUCTS OF ABBOTT
Table 77 : SOME IMPORTANT COLLABORATION EFFORTS AT ABBOTT
Table 78 : MAJOR MILESTONES FOR BACHEM
Table 79 : BACHEM UNITS
Table 80 : BACHEM COLLABORATIONS
Table 81 : PRODUCT RANGE AND APPLICATION OF BIOVECTRA DCL
Table 82 : REPRESENTATIVE PRODUCTS OF HYTEST
Table 83 : REPRESENTATIVE PRODUCTS OF LUMIGEN
Table 84 : REPRESENTATIVE COLLABORATION EFFORTS OF MDS
Table 85 : MILESTONES FOR SIGMA ALDRICH
Table 86 : REPRESENTATIVE PRODUCTS OF TOYOBO
Table 87 : REPRESENTATIVE PRODUCTS OF VECTOR LABS

List of Figures

Summary Figure : MARKETS FOR LABELS AND PROBES BY APPLICATION AREA, 2003-2010
Figure 1 : GLOBAL MARKET BY MATERIALS FOR PROBES IN IMMUNOASSAYS, 2003-2010
Figure 2 : REGIONAL SHARE OF MARKETS FOR PROBES IN IMMUNOASSAYS, 2005
Figure 3 : GLOBAL MARKET FOR PROBES FOR IN VITRO DIAGNOSTICS BY APPLICATION SECTORS, 2003-2010
Figure 4 : GLOBAL MARKET FOR PROBES FOR IN VIVO DIAGNOSTICS, 2003-2010
Figure 5 : MARKETS OF FLUORESCENT COMPOUNDS BY APPLICATION SECTORS, 2003-2010
Figure 6 : MARKETS FOR RADIOACTIVE COMPOUNDS BY APPLICATION SECTORS, 2003-2010
Figure 7 : MARKETS OF CHEMILUMINESCENT COMPOUNDS BY APPLICATION SECTORS, 2003-2010
Figure 8 : MARKETS FOR ENZYMES AND THEIR SUBSTRATES BY APPLICATION SECTORS, 2003-2010
Figure 9 : MARKETS FOR GENE PROBES BY APPLICATION SECTORS, 2003- 2010


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