| Publications by Biophoenix' Principals |
| European Market for Allergy and Autoimmunity Testing Products | |
|---|---|
 | |
| Publisher: | Frost & Sullivan Inc |
| Year of publication: | 1992 |
| Type of publication: | Market report |
| Publisher's reference (if any): | E1721 |
| Author(s): | Sreten Bogdanovic |
| Approximate page count: | 300 |
| Price when published: | $3,400 |
Remarks:
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EUROPEAN MARKET FOR ALLERGY AND
AUTOIMMUNITY TESTING PRODUCTS
FROST & SULLIVAN (1992)
(E1721)
TABLE OF CONTENTS
PAGE
TABLE OF CONTENTS ToC.1
LIST OF TABLES LoT.1
EXECUTIVE SUMMARY ES.1
CHAPTER 1 INTRODUCTION, SCOPE, AND METHODOLOGY
1.1 INTRODUCTION 1.1
1.1.1 The immune system 1.1
1.1.2 Allergic disorders 1.2
1.1.3 Autoimmune disorders 1.2
1.1.4 Overview of the market 1.3
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
1.2.3 Structure of this Report 1.7
1.3 RESEARCH METHODOLOGY 1.15
1.4 ABBREVIATIONS AND DEFINITIONS 1.18
1.5 EXCHANGE RATES USED IN COMPILING THIS REPORT 1.24
CHAPTER 2 TECHNOLOGY AND MARKET NEEDS
2.1 INTRODUCTION: MARKET NEEDS 2.1
2.2 THE NATURE OF THE IMMUNE SYSTEM 2.3
2.3 COMPONENTS OF THE IMMUNE SYSTEM 2.4
2.3.1 Immunoglobulins 2.4
2.3.2 Complement proteins 2.6
2.3.3 HLA proteins 2.6
2.3.4 Lymphocytes 2.8
2.3.5 Phagocytes 2.10
2.3.6 Other granulocytes 2.12
2.3.7 Killer cells 2.13
2.4 THE IMMUNE RESPONSE 2.14
2.4.1 Direct cellular interactions 2.16
2.4.2 Interactions mediated by cytokines 2.18
2.4.3 Immune-system mediated inflammation 2.19
2.5 ALLERGY 2.20
2.5.1 Introduction and terminology 2.20
2.5.2 Role of IgE in health 2.21
2.5.3 Role of IgE in atopy 2.23
2.5.4 Role of IgE in parasitic disorders 2.24
2.5.5 Spectrum of atopic disease 2.25
2.5.5.1 General considerations 2.25
2.5.5.2 Atopic or allergic rhinitis (hay fever) 2.27
2.5.5.3 Atopic asthma 2.28
2.5.5.4 Atopic eczema/dermatitis 2.30
2.5.5.5 Food allergy 2.32
2.5.5.6 Urticaria (hives) and angioedema 2.34
2.5.5.7 Anaphylaxis 2.35
2.5.6 Treatment of atopic diseases 2.37
2.5.6.1 General considerations 2.37
2.5.6.2 Prophylactic treatments 2.37
2.5.6.3 Treatment with drugs 2.38
2.6 AUTOIMMUNITY 2.40
2.6.1 Introduction and terminology 2.40
2.6.2 Immunological tolerance 2.42
2.6.3 Autoimmunity and tolerance breakdown 2.43
2.6.4 Factors predisposing to autoimmune disease 2.45
2.6.4.1 Effects of age and sex 2.45
2.6.4.2 Genetic factors 2.45
2.6.4.3 HLA haplotype 2.46
2.6.5 Pathological mechanisms in autoimmune disease 2.47
2.6.6 Organ-specific autoimmune diseases 2.49
2.6.6.1 Addison's disease 2.49
2.6.6.2 Ear disorders 2.50
2.6.6.3 Eye disorders 2.51
2.6.6.4 Infertility 2.52
2.6.6.5 Diabetes mellitus 2.54
2.6.6.6 Pernicious anaemia 2.56
2.6.6.7 Thyroid disorders 2.58
2.6.6.7.1 Hashimoto's thyroiditis 2.59
2.6.6.7.2 Graves' disease 2.60
2.6.6.7.3 Primary myxoedema 2.62
2.6.6.8 Vitiligo 2.63
2.6.7 Intermediate group of autoimmune diseases 2.63
2.6.7.1 Chronic active hepatitis 2.64
2.6.7.2 Goodpasture's syndrome 2.65
2.6.7.3 Haemolytic anaemia 2.65
2.6.7.4 Idiopathic thrombocytopenic purpura 2.66
2.6.7.5 Multiple sclerosis 2.66
2.6.7.6 Myasthenia gravis 2.68
2.6.7.7 Primary biliary cirrhosis 2.69
2.6.7.8 Sj”gren's syndrome 2.70
2.6.7.9 Ulcerative colitis 2.71
2.6.7.10 Vesicobullous skin disorders 2.72
2.6.8 Non organ-specific autoimmune diseases 2.73
2.6.8.1 Discoid lupus erythematosus 2.74
2.6.8.2 Mixed connective tissue disease 2.74
2.6.8.3 Polymyositis-dermatomyositis 2.74
2.6.8.4 Primary anti-phospholipid syndrome 2.75
2.6.8.5 Rheumatoid arthritis 2.76
2.6.8.6 Scleroderma 2.78
2.6.8.7 Systemic lupus erythematosus 2.80
2.6.8.8 Autoimmune vasculitides 2.83
2.6.9 `Hyperimmune' disorders 2.84
2.6.9.1 Coeliac disease 2.84
2.6.9.2 Allergic rhinitis/asthma 2.86
2.6.9.3 Infectious and parasitic disorders 2.86
2.6.10 Treatment of autoimmune diseases 2.87
2.7 TECHNOLOGY OVERVIEW 2.88
2.7.1 Provocative tests 2.89
2.7.2 Skin tests 2.90
2.7.3 Immunoassays 2.92
2.7.3.1 Total and allergen-specific IgE 2.93
2.7.3.2 Autoantibodies and inflammatory markers 2.94
2.7.4 Immunofluorescence 2.95
2.7.4.1 Organ specific and intermediate
autoantibodies 2.96
2.7.4.2 Non organ specific (nuclear)
autoantibodies 2.96
2.7.4.3 Anti-neutrophil cytoplasmic
autoantibodies (ANCA) 2.97
2.7.5 Flow cytometry 2.98
2.7.6 Other diagnostic technologies 2.100
2.7.6.1 Functional autoantibody assays 2.100
2.7.6.2 Ouchterlony double immunodiffusion 2.101
2.7.6.3 Counter-current immunoelectrophoresis 2.101
2.7.6.4 Western blot assays 2.102
2.7.6.5 Agglutination-based assays 2.102
2.7.6.6 Traditional assays for rheumatoid factor 2.103
2.7.6.7 Older immunological tests 2.104
CHAPTER 3 PRODUCTS AND MARKET SATISFACTION
3.1 INTRODUCTION: MARKET SATISFACTION 3.1
3.2 PROVOCATIVE TESTS 3.3
3.3 SKIN TESTING 3.4
3.3.1 Overview 3.4
3.3.2 Skin testing products and reagents 3.4
3.3.3 Which assay? 3.5
3.4 TOTAL SERUM IgE 3.6
3.4.1 Clinical utility 3.6
3.4.2 Review of commercial immunoassays 3.7
3.4.2.1 Introduction 3.7
3.4.2.2 Radioimmunoassays 3.8
3.4.2.3 Enzyme immunoassays 3.9
3.4.2.4 Fluoroimmunoassays 3.9
3.4.2.5 Luminescent immunoassays 3.10
3.4.2.6 Automated immunoassay systems 3.11
3.4.3 Commercial kits for total IgE 3.14
3.5 ALLERGEN-SPECIFIC IgE 3.17
3.5.1 Clinical utility 3.17
3.5.2 Measurement 3.23
3.5.3 Commercial specific IgE methods 3.24
3.5.3.1 Pharmacia EAST/RAST 3.25
3.5.3.2 Pharmacia CAP system 3.26
3.5.3.3 Abbott Laboratories MATRIX Aero 3.27
3.5.3.4 Diagnostic Products Corporation's
AlaSTAT/AlaTOP 3.3
3.5.3.5 Ciba-Corning Magic-Lite 3.31
3.5.3.6 Other specific IgE systems 3.32
3.6 ALLERGEN-SPECIFIC IgG 3.35
3.6.1 Clinical significance 3.35
3.6.2 Measurement of allergen-specific IgG 3.38
3.6.3 Survey of commercial methods for specific IgG 3.38
3.7 TESTS IN AUTOIMMUNITY 3.39
3.8 TRADITIONAL TESTS FOR AUTOANTIBODIES 3.43
3.8.1 Indirect immunofluorescence 3.43
3.8.2 Functional assays 3.43
3.8.3 Immunological assays 3.44
3.8.3.1 Ouchterlony double diffusion 3.44
3.8.3.2 Western blot assay 3.44
3.8.4 Specialised assays 3.44
3.8.4.1 Rheumatoid factor 3.44
3.8.4.2 Sperm autoantibodies 3.44
3.9 IMMUNOASSAYS FOR AUTOANTIBODIES 3.49
3.9.1 Advantages and disadvantages 3.49
3.9.2 ANA/ENA autoantibody kits 3.49
3.9.3 Cardiolipin and pyruvate dehydrogenase
autoantibody kits 3.51
3.9.4 Organ-specific autoantibody kits 3.51
3.9.5 Miscellaneous autoimmunity-related antibodies 3.52
3.10 INFLAMMATORY MARKERS 3.52
3.10.1 Histamine 3.52
3.10.2 Ascorbic acid 3.63
3.10.3 Myeloperoxidase (MPO) 3.63
3.10.4 Eosinophil cationic protein (ECP) 3.64
3.10.5 Platelet-activating factor (PAF) 3.64
3.10.6 Eicosanoids 3.64
3.10.7 Cytokines and their receptors 3.65
3.10.8 sCD23 3.66
3.10.9 Neopterin 3.67
3.10.10 sCD14 3.68
3.11 FLOW CYTOMETRY PRODUCTS 3.68
3.12 REAGENTS FOR HLA-DR TYPING 3.69
CHAPTER 4 THE MARKET - ANALYSES AND GROWTH FORECASTS
4.1 INTRODUCTION 4.1
4.2 OVERVIEW OF NATIONAL MARKETS 4.1
4.2.1 Belgium 4.1
4.2.1.1 Overall regulatory climate 4.1
4.2.1.2 Health service structure. 4.2
4.2.1.3 Clinical laboratories. 4.2
4.2.2 France 4.4
4.2.2.1 Overall regulatory climate 4.4
4.2.2.2 Health service structure 4.5
4.2.2.3 Clinical laboratories 4.5
4.2.3 Germany 4.8
4.2.3.1 Overall regulatory climate 4.8
4.2.3.2 Health service structure 4.10
4.2.3.3 Clinical laboratories 4.11
4.2.4 Italy 4.12
4.2.4.1 Overall regulatory climate 4.12
4.2.4.2 Health service structure 4.13
4.2.4.3 Clinical laboratories 4.14
4.2.5 The Netherlands 4.17
4.2.5.1 Overall regulatory climate 4.17
4.2.5.2 Health service structure 4.18
4.2.5.3 Clinical laboratories 4.20
4.2.6 Spain 4.21
4.2.6.1 Overall regulatory climate 4.21
4.2.6.2 Health service structure 4.21
4.2.6.3 Clinical laboratories 4.23
4.2.7 United Kingdom 4.25
4.2.7.1 Overall regulatory climate 4.25
4.2.7.2 Health service structure 4.25
4.2.7.3 Clinical laboratories 4.27
4.3 DEMOGRAPHIC SUMMARY 4.29
4.4 WORLD IN VITRO DIAGNOSTIC MARKET IN PERSPECTIVE 4.31
4.5 MARKET FORECASTS 4.32
4.5.1 Products covered 4.32
4.5.2 Countries covered 4.33
4.5.3 Product pricing 4.33
4.5.4 Forecasts for allergy products 4.34
4.5.5 Forecasts for autoimmunity products 4.41
4.6 OVERVIEW OF MARKET AND FORECASTS 4.45
CHAPTER 5 THE INDUSTRY - COMPANY PROFILES
5.1 INTRODUCTION 5.1
5.2 ABBOTT 5.6
5.3 BIOHYTECH 5.7
5.4 BIOLAB 5.8
5.5 BIOMERIEUX 5.10
5.6 BIOMERICA 5.11
5.7 BIOWHITTAKER 5.13
5.8 CAMBRIDGE LIFE SCIENCES 5.15
5.9 CIBA-CORNING 5.16
5.10 DIAGNOSTIC PRODUCTS 5.18
5.11 HYCOR BIOMEDICAL 5.19
5.12 IDS (IMMUNODIAGNOSTIC SYSTEMS LIMITED) 5.21
5.13 IMMUNOVISION 5.22
5.14 IMMUNOTECH 5.23
5.15 LABORATORIOS LETI 5.25
5.16 MAST IMMUNOSYSTEMS 5.26
5.17 PHARMACIA 5.28
5.18 QUIDEL 5.30
5.19 SANOFI-DIAGNOSTICS PASTEUR 5.32
5.20 SORIN BIOMEDICA 5.33
5.21 T CELL SCIENCES 5.35
5.22 THE BINDING SITE 5.36
5.23 VENTREX LABORATORIES 5.38
CHAPTER 6 TRENDS AND OPPORTUNITIES - TOWARDS THE FUTURE
6.1 INTRODUCTION 6.1
6.2 TECHNOLOGY TRENDS 6.2
6.2.1 The adoption of immunoassays 6.2
6.2.2 The adoption of nonisotopic immunoassays 6.4
6.3 PRODUCT TRENDS 6.5
6.3.1 Automation in allergy and other immunoassays 6.5
6.3.2 Self-contained automated systems 6.6
6.4 MARKET TRENDS 6.7
6.5 TOWARDS THE FUTURE 6.8
6.5.1 Political and economic factors 6.8
6.5.2 Scientific and technical factors 6.10
6.5.2.1 Molecular genetics 6.10
6.5.2.2 Combinatorial chemistry 6.11
6.6 CURRENT AND EMERGING OPPORTUNITIES 6.12
6.6.1 Which solid phase? 6.12
6.6.2 Which antibody configuration? 6.13
6.6.3 Which label? 6.14
6.6.4 How user-friendly? 6.14
6.6.5 Which analytes? 6.16
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 AND FIGURES
(Excluding the Executive Summary)
PAGE
TABLES
TABLE 1.1 CURRENCY EXCHANGE RATES USED
IN COMPILING THIS REPORT 1.24
TABLE 3.1 SUMMARY OF COMMERCIAL NONISOTOPIC
IMMUNOASSAY SYSTEMS 3.13
TABLE 3.2 TOTAL IgE IMMUNOASSAY KITS 3.15
TABLE 3.3 EXAMPLES OF TYPICAL ANIMAL ALLERGENS 3.18
TABLE 3.4 EXAMPLES OF TYPICAL INSECT ALLERGENS 3.18
TABLE 3.5 EXAMPLES OF TYPICAL FOOD ALLERGENS 3.19
TABLE 3.6 EXAMPLES OF TYPICAL FUNGAL ALLERGENS 3.19
TABLE 3.7 EXAMPLES OF TYPICAL TREE ALLERGENS 3.20
TABLE 3.8 EXAMPLES OF TYPICAL WEED ALLERGENS 3.20
TABLE 3.9 EXAMPLES OF TYPICAL GRASS ALLERGENS 3.21
TABLE 3.10 TYPICAL ALLERGEN PANELS 3.21
TABLE 3.11 SUMMARY OF COMMERCIAL SPECIFIC IgE METHODS 3.36
TABLE 3.12 ORGAN-SPECIFIC AUTOANTIGENS, BY ANTIGEN 3.40
TABLE 3.13 ORGAN-SPECIFIC AUTOANTIGENS, BY DISEASE 3.41
TABLE 3.14 NON ORGAN-SPECIFIC AUTOANTIGENS 3.42
TABLE 3.15 COMMERCIAL IMMUNOFLUORESCENCE
KITS FOR AUTOANTIBODIES 3.45
TABLE 3.16 FUNCTIONAL ASSAYS FOR AUTOANTIBODIES 3.46
TABLE 3.17 MISCELLANEOUS COMMERCIAL AUTOANTIBODY ASSAYS 3.47
TABLE 3.18 COMMERCIAL IMMUNOASSAY KITS FOR
ANA/ENA AND RELATED AUTOANTIBODIES 3.53
TABLE 3.19 COMMERCIAL IMMUNOASSAY KITS FOR CARDIOLIPIN
AND PYRUVATE DEHYDROGENASE AUTOANTIBODIES 3.56
TABLE 3.20 COMMERCIAL IMMUNOASSAY KITS FOR ORGAN-
SPECIFIC AUTOANTIBODIES 3.57
TABLE 3.21 COMMERCIAL IMMUNOASSAY KITS FOR MISCELLANEOUS
AUTOIMMUNITY-RELATED ANTIBODIES 3.58
TABLE 3.22 IMMUNOASSAYS FOR INFLAMMATORY MARKERS 3.60
TABLE 3.23 SUPPLIERS OF FLOW CYTOMETRY PRODUCTS 3.70
TABLE 3.24 HLA SPECIFICITIES 3.71
TABLE 3.25 SUPPLIERS OF PRODUCTS FOR HLA TYPING 3.72
TABLE 4.1 HOSPITALS AND LABORATORIES IN BELGIUM 4.7
TABLE 4.2 HOSPITALS AND LABORATORIES IN FRANCE 4.7
TABLE 4.3 HOSPITALS AND LABORATORIES IN GERMANY 4.16
TABLE 4.4 HOSPITALS AND LABORATORIES IN ITALY 4.16
TABLE 4.5 HOSPITALS AND LABORATORIES IN THE NETHERLANDS 4.24
TABLE 4.6 HOSPITALS AND LABORATORIES IN SPAIN 4.24
TABLE 4.7 HOSPITALS AND LABORATORIES IN THE UNITED KINGDOM 4.30
TABLE 4.8 GENERAL DATA ON THE COUNTRIES
SURVEYED IN THIS REPORT 4.36
TABLE 4.9 WORLD IN VITRO DIAGNOSTIC MARKET 4.37
TABLE 4.10 COST OF ALLERGY AND AUTOIMMUNITY TESTS 4.38
TABLE 4.11 TOTAL IgE ASSAYS, 1991-1997 4.40
TABLE 4.12 SPECIFIC IgE ASSAYS, 1991-1997 4.40
TABLE 4.13 SPECIFIC IgG ASSAYS, 1991-1997 4.46
TABLE 4.14 ORGAN-SPECIFIC AUTOANTIBODY ASSAYS, 1991-1997 4.46
TABLE 4.15 NON-ORGAN SPECIFIC AUTOANTIBODY
ASSAYS, 1991-1997 4.47
TABLE 4.16 CYTOKINE AND RELATED ASSAYS, 1991-1997 4.47
TABLE 4.17 FLOW CYTOMETRY MARKER ANTIBODIES, 1991-1997 4.48
TABLE 4.18 MISCELLANEOUS TESTS, 1991-1997 4.48
TABLE 4.19 ALLERGY/AUTOIMMUNITY MARKET SUMMARY, 1991-1997 4.49
TABLE 4.20 MARKET BY GEOGRAPHICAL AREA
AND PRODUCT GROUP (1991) 4.50
TABLE 4.21 MARKET BY GEOGRAPHICAL AREA AND
PRODUCT GROUP (1997) 4.50
TABLE 5.1 LEADING MANUFACTURERS OF IMMUNOASSAY KITS 5.3
TABLE 5.2 LEADING MANUFACTURERS OF OTHER
CLINICAL IMMUNOLOGY REAGENTS 5.4
TABLE 5.3 LEADING MANUFACTURERS OF FLOW CYTOMETRY REAGENTS 5.4
TABLE 5.4 OVERALL SUPPLIER RANKINGS 5.5
FIGURES
FIGURE 4.1 ALLERGY/AUTOIMMUNITY TESTING PRODUCT
MARKET SHARE BY COUNTRY IN 1991 4.51
FIGURE 4.2 ALLERGY/AUTOIMMUNITY TESTING PRODUCT
MARKET SHARE BY PRODUCT GROUP IN 1991 4.52
FIGURE 4.3 ALLERGY/AUTOIMMUNITY TESTING PRODUCT
MARKET SHARE BY MANUFACTURER IN 1991 4.53
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