| Publications by Biophoenix' Principals |
| European Market for Nonisotopic Immunoassay Products | |
|---|---|
.gif) | |
| Publisher: | Frost & Sullivan Inc |
| Year of publication: | 1994 |
| Type of publication: | Market report |
| Publisher's reference (if any): | E1861 |
| Author(s): | Sreten Bogdanovic |
| Approximate page count: | 300 |
| Price when published: | $3,400 |
Remarks:
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EUROPEAN MARKET FOR NONISOTOPIC
IMMUNOASSAY PRODUCTS
FROST & SULLIVAN (1994)
(E1861)
CONTENTS
Page
TABLE OF CONTENTS TOC.1
LIST OF TABLES TOC.8
EXECUTIVE SUMMARY ES.1
CHAPTER 1 INTRODUCTION, SCOPE, METHODOLOGY, AND DEFINITIONS
1.1 INTRODUCTION 1.1
1.2 OBJECTIVES AND SCOPE OF THIS REPORT 1.4
1.2.1 Major objectives 1.4
1.2.2 Scope of this report 1.5
1.3 METHODOLOGY 1.10
1.4 ABBREVIATIONS AND DEFINITIONS 1.11
1.5 OUTLINE OF THE REPORT 1.20
1.6 CURRENCY EXCHANGE RATES 1.28
CHAPTER 2 TECHNOLOGY AND MARKET NEEDS
2.1 INTRODUCTION: MARKET NEEDS 2.1
2.2 TECHNOLOGICAL BASIS OF IMMUNOASSAYS 2.3
2.2.1 General characteristics of immunoassays 2.3
2.2.2 Labelling 2.5
2.2.3 Bound-free separation 2.6
2.2.4 Competitive immunoassays 2.8
2.2.5 Immunometric immunoassays 2.8
2.2.6 Monoclonal antibodies 2.11
2.2.6.1 Comparison with conventional antisera 2.11
2.2.6.2 Antigenic determinants 2.11
2.2.6.3 Monoclonal antibody preparation 2.12
2.2.6.4 Advantages of monoclonal antibodies 2.12
2.2.6.5 Future developments 2.14
2.2.7 Homogeneous immunoassays 2.14
2.2.8 Standardisation of immunoassays 2.15
2.2.9 Matrix effects 2.18
2.2.10 Sensitivities and detection limits 2.19
2.2.11 Types of instrumentation 2.20
2.2.11.1 Introduction 2.20
2.2.11.2 Nephelometers 2.21
2.2.11.3 Spectrophotometers 2.21
2.2.11.4 Fluorimeters 2.22
2.2.11.5 Luminometers 2.22
2.2.12 Automation 2.22
2.2.13 Immunoassay systems 2.27
2.3 APPLICATIONS 2.29
2.3.1 Introduction 2.29
2.3.2 Thyroid function testing 2.29
2.3.3 Reproductive endocrinology 2.31
2.3.4 Other endocrinological applications 2.32
2.3.5 Cancer 2.33
2.3.5.1 Clinical background 2.33
2.3.5.2 Clinical utility of tumour markers 2.34
2.3.5.3 Other oncology applications 2.35
2.3.6 Haematology 2.36
2.3.7 Immune function testing 2.36
2.3.8 Infectious disease 2.36
2.3.9 Therapeutic drug monitoring 2.37
2.3.9.1 Introduction to TDM 2.37
2.3.9.2 Benefits of TDM 2.38
2.3.9.3 Problems associated with TDM 2.39
2.3.10 Drugs-of-abuse screening 2.40
2.3.11 Non-medical immunoassays 2.41
2.3.11.1 Introduction 2.41
2.3.11.2 Veterinary diagnostics 2.42
2.3.11.3 Plant diagnostics 2.43
2.3.11.4 Pesticide residues and toxins 2.44
CHAPTER 3 PRODUCTS AND MARKET SATISFACTION
3.1 INTRODUCTION: MARKET SATISFACTION 3.1
3.2 MAJOR IMMUNOASSAY ANALYTES 3.2
3.2.1 Introduction 3.2
3.2.2 Thyroid function testing 3.2
3.2.2.1 T3 and T4 assays 3.3
3.2.2.2 TSH assays 3.5
3.2.2.3 The Measurement of free thyroid hormones 3.6
3.2.2.3.1 Equilibrium dialysis 3.6
3.2.2.3.2 Commercial kit methods 3.6
3.2.2.3.3 The labelled analogue debate 3.7
3.2.2.3.4 Solid phase antigen free
hormone methods 3.8
3.2.4 Reproductive endocrinology 3.9
3.2.5 Other endocrine applications 3.10
3.2.5.1 Adrenocorticotrophic hormone (ACTH)
and cortisol 3.10
3.2.5.2 Renin, angiotensin, and aldosterone 3.11
3.2.5.3 GH (growth hormone) 3.11
3.2.5.4 Parathormone (PTH) and osteocalcin 3.11
3.2.6 Tumour markers 3.12
3.2.6.1 Breast tumour markers 3.12
3.2.6.2 Gastrointestinal tumour markers 3.14
3.2.6.3 Lung tumour markers 3.17
3.2.6.4 Serum markers for haematogenous
malignancies 3.17
3.2.6.5 Thyroid tumour markers 3.18
3.3.6.6 Urinary tract tumour markers 3.18
3.2.6.7 Ovarian and related tumour markers 3.19
3.2.6.8 Tumour markers with mixed specificities 3.21
3.2.6.9 Other cancer-related immunoassays 3.25
3.2.6.10 Oncogenic viruses and oncogenes 3.27
3.2.7 Haematology 3.29
3.2.8 Immune function 3.30
3.2.8.1 Allergy 3.30
3.2.8.2 Autoimmunity 3.31
3.2.8.3 Immunodeficiency 3.38
3.2.9 Infectious diseases 3.39
3.2.9.1 Range and uses of available tests 3.39
3.2.9.2 Bacterial pathogens 3.41
3.2.9.2.1 Bacteroides species 3.41
3.2.9.2.2 Campylobacter 3.41
3.2.9.2.3 Chlamydia 3.42
3.2.9.2.4 Clostridia 3.43
3.2.9.2.5 Escherichia coli 3.43
3.2.9.2.6 Gonorrhoea 3.44
3.2.9.2.7 Hemophilus influenzae 3.44
3.2.9.2.8 Legionella 3.45
3.2.9.2.9 Leptospirosis 3.45
3.2.9.2.10 Listeria 3.46
3.2.9.2.11 Lyme disease 3.46
3.2.9.2.12 Mycobacteria 3.47
3.2.9.2.13 Mycoplasmas 3.47
3.2.9.2.14 Neisseria meningitidis 3.48
3.2.9.2.15 Salmonellae 3.48
3.2.9.2.16 Shigellae 3.49
3.2.9.2.17 Staphylococcus aureus 3.49
3.2.9.2.18 Streptococcus 3.49
3.2.9.2.19 Treponema pallidum 3.50
3.2.9.3 Viral pathogens 3.51
3.2.9.3.1 Adenovirus 3.51
3.2.9.3.2 Cytomegalovirus 3.52
3.2.9.3.3 Epstein Barr virus 3.52
3.2.9.3.4 Herpes simplex 3.53
3.2.9.3.5 Human immunodeficiency virus 3.53
3.2.9.3.6 Hepatitis 3.55
3.2.9.3.7 Parainfluenza virus 3.55
3.2.9.3.8 Respiratory syncytial virus 3.56
3.2.9.3.9 Rotavirus 3.56
3.2.9.3.10 Rubella 3.57
3.2.9.3.11 Varicella-zoster virus 3.57
3.2.9.4 Parasitic pathogens 3.58
3.2.9.4.1 Entamoeba histolytica 3.58
3.2.9.4.2 Leishmaniasis 3.58
3.2.9.4.3 Plasmodium 3.59
3.2.9.4.4 Pneumocystis carinii 3.59
3.2.9.4.5 Trichomonas vaginalis 3.59
3.2.9.5 Fungal pathogens 3.60
3.2.9.5.1 Aspergillus species 3.60
3.2.9.5.2 Coccidioides immitis 3.60
3.2.9.5.3 Cryptococcus neoformans 3.60
3.2.9.5.4 Histoplasma capsulatum 3.61
3.2.9.5.5 Yeast pathogens 3.61
3.3 COMMERCIAL IMMUNOASSAY FORMATS 3.61
3.3.1 Kits and systems 3.61
3.3.2 Commercial radioimmunoassays 3.65
3.3.3 Commercial enzyme immunoassays 3.65
3.3.3.1 Introduction 3.65
3.3.3.2 Reagents 3.66
3.3.3.3 Instrumentation 3.68
3.3.4 Commercial fluoroimmunoassays 3.72
3.3.4.1 Introduction 3.72
3.3.4.2 Reagents 3.74
3.3.4.3 Instrumentation 3.75
3.3.5 Commercial luminescent immunoassays 3.78
3.3.5.1 Introduction 3.78
3.3.5.2 Reagents 3.78
3.3.5.3 Instruments 3.80
3.3.6 Commercial nephelometric immunoassays 3.82
3.3.6.1 Introduction 3.82
3.3.6.2 Reagents 3.82
3.3.6.3 Instruments 3.84
3.4 SECOND GENERATION (SEMI-AUTOMATED) SYSTEMS 3.88
3.4.1 Third party instruments 3.88
3.4.2 Semi-automated modular systems 3.90
3.5 THIRD AND FOURTH GENERATION (FULLY AUTOMATED)
IMMUNOASSAY SYSTEMS 3.91
3.6 AUTOMATED SYSTEMS FOR HOMOGENEOUS IMMUNOASSAY 3.105
CHAPTER 4 THE MARKET - ANALYSES AND GROWTH FORECASTS
4.1 INTRODUCTION 4.1
4.2 OVERVIEW OF EUROPEAN HEALTHCARE SYSTEMS 4.1
4.3 OVERVIEW OF THE EUROPEAN REGULATORY CLIMATE 4.3
4.4 REGULATORY IMPACT OF EEC MARKET HARMONISATION 4.5
4.4.1 New regulatory framework 4.5
4.4.2 Diagnostics industry implications 4.8
4.5 OVERVIEW OF THE NIA PRODUCT MARKET 4.9
4.6 OVERVIEW OF END-USERS OF NIA PRODUCTS 4.12
4.6.1 Introduction to our end-user
segmentation model 4.12
4.6.2 Specific end-user segments 4.15
4.7 REVIEW OF NATIONAL MARKETS 4.18
4.7.1 Belgium 4.18
4.7.1.1 Overall regulatory climate 4.18
4.7.1.2 Health service structure 4.19
4.7.1.3 Clinical laboratories 4.19
4.7.2 France 4.20
4.7.2.1 Overall regulatory climate 4.20
4.7.2.2 Health service structure 4.21
4.7.2.3 Clinical laboratories 4.22
4.7.3 Germany 4.25
4.7.3.1 Overall regulatory climate 4.25
4.7.3.2 Health service structure 4.26
4.7.3.3 Clinical laboratories 4.27
4.7.4 Italy 4.29
4.7.4.1 Overall regulatory climate 4.29
4.7.4.2 Health service structure 4.29
4.7.4.3 Clinical laboratories 4.30
4.7.5 The Netherlands 4.33
4.7.5.1 Overall regulatory climate 4.33
4.7.5.2 Health service structure 4.34
4.7.5.3 Clinical laboratories 4.35
4.7.6 Spain 4.36
4.7.6.1 Overall regulatory climate 4.36
4.7.6.2 Health service structure 4.37
4.7.6.3 Clinical laboratories 4.38
4.7.7 United Kingdom 4.40
4.7.7.1 Overall regulatory climate 4.40
4.7.7.2 Health Service Structure 4.41
4.7.7.3 Clinical laboratories 4.42
4.8 DEMOGRAPHIC SUMMARY 4.44
4.9 WORLD IN VITRO DIAGNOSTIC MARKET IN PERSPECTIVE 4.52
4.10 MARKET FORECASTS 4.53
4.10.1 Introduction 4.53
4.10.2 NIA and RIA 4.56
4.10.3 Infectious disease tests 4.56
4.10.4 Endocrinology 4.57
4.10.5 TDM and DOA testing 4.57
4.10.6 Tumour markers 4.58
4.10.7 Immune function testing 4.59
4.10.8 Other tests 4.60
4.10.9 Forecasts for nonisotopic immunoassay types 4.60
CHAPTER 5 THE INDUSTRY - COMPANY PROFILES
5.1 INTRODUCTION 5.1
5.2 ABBOTT 5.4
5.3 ARES-SERONO 5.5
5.4 BAXTER HEALTHCARE 5.6
5.5 BECTON DICKINSON AND COMPANY 5.7
5.6 BEHRING 5.9
5.7 bioMERIEUX 5.11
5.8 BIOMERICA 5.12
5.9 BIOWHITTAKER 5.13
5.10 BOEHRINGER MANNHEIM GmbH 5.15
5.11 CAMBRIDGE LIFE SCIENCES 5.18
5.12 CIBA-CORNING 5.19
5.13 CENTOCOR DIAGNOSTICS 5.20
5.14 CIS BIOINDUSTRIES 5.23
5.15 DIAGNOSTIC PRODUCTS 5.24
5.16 EASTMAN KODAK (AMERLITE DIAGNOSTICS) 5.26
5.17 HYBRITECH INCORPORATED 5.28
5.18 IDS (IMMUNODIAGNOSTIC SYSTEMS LIMITED) 5.31
5.19 MAST IMMUNOSYSTEMS 5.32
5.20 PHARMACIA 5.34
5.21 QUIDEL 5.36
5.22 ROCHE DIAGNOSTIC SYSTEMS 5.37
5.23 SANOFI-DIAGNOSTICS PASTEUR 5.40
5.24 SORIN BIOMEDICA 5.41
5.25 SYVA CORPORATION 5.43
CHAPTER 6 TRENDS AND OPPORTUNITIES - TOWARDS THE FUTURE
6.1 INTRODUCTION 6.1
6.2 TECHNOLOGY TRENDS 6.3
6.2.1 Solid phases 6.3
6.2.2 Antibody configurations 6.3
6.2.3 Labels 6.4
6.2.4 User-friendliness 6.5
6.3 PRODUCT TRENDS 6.6
6.3.1 Automation in immunoassays 6.6
6.3.2 Open and closed automated systems 6.7
6.4 MARKET TRENDS 6.8
6.5 TOWARDS THE FUTURE 6.12
6.5.1 DNA diagnostics 6.12
6.5.2 Monoclonal antibodies and DNA probes 6.14
6.5.3 Immunosensors 6.16
6.6 CURRENT AND EMERGING OPPORTUNITIES 6.21
6.6.1 Market opportunities 6.21
6.6.2 Product and technology opportunities 6.22
APPENDIX 1 SCHEDULE OF COMPANIES MENTIONED A1.1
APPENDIX 2 SCHEDULE OF TRADE SHOWS AND EXHIBITIONS A2.1
APPENDIX 3 COMPANY INDEX A3.1
LIST OF TABLES
TABLE 1.1 EXCHANGE RATES USED IN THIS REPORT 1.29
TABLE 3.1 STRATEGIES FOR THYROID TESTING 3.4
TABLE 3.2 EXAMPLES OF TYPICAL ANIMAL ALLERGENS 3.32
TABLE 3.3 EXAMPLES OF TYPICAL INSECT ALLERGENS 3.32
TABLE 3.4 EXAMPLES OF TYPICAL FOOD ALLERGENS 3.33
TABLE 3.5 EXAMPLES OF TYPICAL FUNGAL ALLERGENS 3.33
TABLE 3.6 EXAMPLES OF TYPICAL TREE ALLERGENS 3.34
TABLE 3.7 EXAMPLES OF TYPICAL WEED ALLERGENS 3.34
TABLE 3.8 EXAMPLES OF TYPICAL GRASS ALLERGENS 3.35
TABLE 3.9 SOME ORGAN-SPECIFIC AUTOANTIGENS 3.36
TABLE 3.10 NON ORGAN-SPECIFIC AUTOANTIGENS 3.37
TABLE 3.11 KEY NON-ISOTOPIC IMMUNOASSAY ANALYTES 3.64
TABLE 3.12 COLOURIMETRIC IMMUNOASSAY REAGENTS 3.69
TABLE 3.13 PHOTOMETRIC ENZYME IMMUNOASSAY INSTRUMENTATION 3.73
TABLE 3.14 FLUORIMETRIC IMMUNOASSAYS 3.77
TABLE 3.15 CHEMILUMINOMETRIC IMMUNOASSAYS 3.81
TABLE 3.16 NEPHELOMETRIC INSTRUMENTS AND SYSTEMS 3.86
TABLE 3.17 TEST MENUS OF BECKMAN AND BEHRING
NEPHELOMETRIC IMMUNOASSAY SYSTEMS 3.87
TABLE 3.18 ANAGEN AN2000 3.93
TABLE 3.19 ABBOTT AxSYM 3.93
TABLE 3.20 ABBOTT IMx 3.94
TABLE 3.21 BAXTER-DADE STRATUS II 3.94
TABLE 3.22 BECTON DICKINSON AFFINITY 3.95
TABLE 3.23 BIOMERIEUX VIDAS 3.95
TABLE 3.24 BIOTROL S7000 3.96
TABLE 3.25 BOEHRINGER MANNHEIM ES600/700 3.96
TABLE 3.26 BOEHRINGER MANNHEIM ES300 3.97
TABLE 3.27 BYK SANGTEC S300 3.97
TABLE 3.28 CIBA-CORNING ACS:180 3.98
TABLE 3.29 CIS BIOINDUSTRIES CISPACK 4200 3.98
TABLE 3.30 DIAGNOSTIC PRODUCTS IMMULITE 3.99
TABLE 3.31 MERCK MAGIA 7000 3.99
TABLE 3.32 MITSUI QUARTUS 3.100
TABLE 3.33 PHARMACIA AutoDELFIA 3.100
TABLE 3.34 ROCHE COBAS CORE 3.101
TABLE 3.35 SANOFI ACCESS 3.101
TABLE 3.36 POLAROID-BEHRING OPUS 3.102
TABLE 3.37 SERONO SR1 3.102
TABLE 3.38 TECHNICON IMMUNO-1 3.103
TABLE 3.39 TOSOH (EUROGENETICS) AIA-600 3.103
TABLE 3.40 TOSOH (EUROGENETICS) AIA-1200 3.104
TABLE 4.1 HOSPITALS AND LABORATORIES IN BELGIUM 4.24
TABLE 4.2 HOSPITALS AND LABORATORIES IN FRANCE 4.24
TABLE 4.3 HOSPITALS AND LABORATORIES IN GERMANY 4.32
TABLE 4.4 HOSPITALS AND LABORATORIES IN ITALY 4.32
TABLE 4.5 HOSPITALS AND LABORATORIES IN THE NETHERLANDS 4.39
TABLE 4.6 HOSPITALS AND LABORATORIES IN SPAIN 4.39
TABLE 4.7 HOSPITALS AND LABORATORIES IN
THE UNITED KINGDOM 4.45
TABLE 4.8 GENERAL DATA ON THE COUNTRIES
SURVEYED IN THIS REPORT 4.46
TABLE 4.9 WORLD IVD MARKET BY TEST CATEGORY 4.47
TABLE 4.10 WORLD IVD TEST MARKET BY REGION 4.47
TABLE 4.11 WORLD IMMUNOASSAY MARKET BY APPLICATION GROUP 4.47
TABLE 4.12 WORLD IMMUNOASSAY MARKET BY LABEL/TEST METHOD 4.48
TABLE 4.13 EUROPEAN IVD MARKET BY REGION 4.48
TABLE 4.14 EUROPEAN IMMUNOASSAY MARKET
BY LABEL/TEST METHOD 4.49
TABLE 4.15 EUROPEAN IMMUNOASSAY MARKET BY
APPLICATION GROUP 4.49
TABLE 4.16 EUROPEAN NIA MARKET BY TEST METHOD 4.50
TABLE 4.17 EUROPEAN NIA MARKET BY APPLICATION GROUP 4.50
TABLE 4.18 EUROPEAN NIA MARKET BY REGION 4.51
TABLE 4.19 EUROPEAN MARKET FOR ALL IMMUNOASSAY
PRODUCTS BY REGION, 1992-1998 4.62
TABLE 4.20 EUROPEAN MARKET FOR ALL RIA SYSTEMS
BY REGION, 1992-1998 4.62
TABLE 4.21 EUROPEAN NIA MARKET BY REGION, 1992-1998 4.63
TABLE 4.22 EUROPEAN MARKET FOR HIV/AIDS NIA TESTS
BY REGION, 1992-1998 4.63
TABLE 4.23 EUROPEAN MARKET FOR HEPATITIS NIA TESTS
BY REGION, 1992-1998 4.64
TABLE 4.24 EUROPEAN MARKET FOR NIA TORCH TESTS
BY REGION, 1992-1998 4.64
TABLE 4.25 EUROPEAN MARKET FOR OTHER NIA INFECTIOUS
DISEASE TESTS BY REGION, 1992-1998 4.65
TABLE 4.26 EUROPEAN MARKET FOR THYROID NIA TESTS
BY REGION, 1992-1998 4.65
TABLE 4.27 EUROPEAN MARKET FOR FERTILITY-RELATED
NIA TESTS BY REGION, 1992-1998 4.66
TABLE 4.28 EUROPEAN MARKET FOR OTHER ENDOCRINE
NIA TESTS BY REGION, 1992-1998 4.66
TABLE 4.29 EUROPEAN MARKET FOR TDM AND DOA NIA
TESTS BY REGION, 1992-1998 4.67
TABLE 4.30 EUROPEAN MARKET FOR CANCER-RELATED
NIA TESTS BY REGION, 1992-1998 4.67
TABLE 4.31 EUROPEAN MARKET FOR ALLERGY-RELATED
NIA TESTS BY REGION, 1992-1998 4.68
TABLE 4.32 EUROPEAN MARKET FOR AUTOANTIBODY NIA
TESTS BY REGION, 1992-1998 4.68
TABLE 4.33 EUROPEAN MARKET FOR OTHER NIA TESTS
BY REGION, 1992-1998 4.69
TABLE 4.34 EUROPEAN MARKET FOR RAPID-TYPE NIA
TEST SYSTEMS BY REGION, 1992-1998 4.69
TABLE 4.35 EUROPEAN MARKET FOR NIA BLOOD BANKING
TEST SYSTEMS BY REGION, 1992-1998 4.70
TABLE 4.36 EUROPEAN MARKET FOR NEPHELOMETRY/
TURBIDIMETRY TESTS BY REGION, 1992-1998 4.70
TABLE 4.37 EUROPEAN MARKET FOR HIGH-VOLUME
RANDOM-ACCESS NIA SYSTEMS BY REGION, 1992-1998 4.71
TABLE 4.38 EUROPEAN MARKET FOR LOW-VOLUME
RANDOM-ACCESS NIA SYSTEMS BY REGION, 1992-1998 4.71
TABLE 4.39 EUROPEAN MARKET FOR FULLY AUTOMATED
NIA SYSTEMS BY REGION, 1992-1998 4.72
TABLE 4.40 EUROPEAN MARKET FOR SEMI-AUTOMATED
NIA SYSTEMS BY REGION, 1992-1998 4.72
TABLE 4.41 EUROPEAN MARKET FOR MANUAL NIA
SYSTEMS BY REGION, 1992-1998 4.73
TABLE 4.42 EUROPEAN NIA MARKET BY APPLICATION
AND COUNTRY IN 1992 4.74
TABLE 4.43 EUROPEAN NIA MARKET BY APPLICATION
AND COUNTRY IN 1998 4.75
TABLE 4.44 EUROPEAN NIA MARKET BY TEST TYPE
AND COUNTRY IN 1992 4.76
TABLE 4.45 EUROPEAN NIA MARKET BY TEST TYPE
AND COUNTRY IN 1998 4.76
TABLE 5.1 EUROPEAN MARKET FOR NONISOTOPIC
IMMUNOASSAY PRODUCTS: COMPANY
MARKET SHARE SUMMARY 5.2
TABLE 5.2 EUROPEAN MARKET FOR NONISOTOPIC
IMMUNOASSAY PRODUCTS: COMPANY
MARKET SHARES BY COUNTRY IN 1992 5.3
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