World In Vitro Diagnostics Market

  • April 2011
  • -
  • Freedonia



Global demand to increase 6.1% annually through 2014

The Freedonia Group projects world demand for in vitro diagnostic (IVD) products increasing 6.1 percent annually to nearly $68 billion in 2014. Based on the advanced nature of medical delivery systems and widespread insurance coverage for primary health care procedures, the developed countries combined will absorb more than two-thirds of this total. Demand in the developing countries as a whole will expand faster as medical delivery systems are expanded and upgraded and the availability and accessibility of basic health care services improve.

Nucleic acid testing to be fastest growing type

Clinical chemistry and immunoassay will remain the top two IVD methodologies, the former based on sales of personal blood glucose monitors and test strips and the latter due to the penetration of high value-added chemiluminescent products into infectious disease and drug testing markets. Nucleic acid testing products will post the fastest growth in global demand gains among all IVD products based on throughput, accuracy and speed advantages, especially in the detection of infectious diseases and cancer markers. Because of increasing blood glucose monitoring among diabetic patients, endocrine condition testing will remain the largest IVD application through 2014 and beyond. Due to their ability to quantify heart attack and embolism risk prior to occurrence, hemostasis tests for D-dimer and other cardiac parameters will provide the best growth opportunities among IVD blood testing products. Demand for nucleic acid diagnostics will expand at a strong pace as next- generation PCR (polymerase chain reaction) and microarray technologies penetrate applications involving the analysis and characterization of complex infections and tumors. DNA-based forensic, genetic and identity testing will comprise the fastest growing IVD application through 2014 as the vast potential of law enforcement and genetic screening markets begins to translate into significant revenues. Among other IVD products, cellular analysis and anatomical pathology reagents and instruments will post the best global sales gains. Cellular analysis techniques will continue to dominate cervical cancer testing and penetrate additional cancer diagnostic applications. Anatomical pathology will remain the leading IVD technique for biopsy-based cancer and infectious disease detection.

Most IVD products to benefit from evolving trends

Evolving epidemiological trends and patient care approaches will impact favorably on worldwide growth opportunities for most types of IVD products. The market for clinical chemistry reagents and instruments will benefit from an increasing number of diabetic patients engaging in self-blood glucose monitoring and the expanding use of general health screening in routine patient examinations. The widening availability of chemiluminescent tests with inherent sensitivity and selectivity advantages will broaden applications for immunoassays in therapeutic drug monitoring, drugs of abuse detection and infectious disease testing.

Study coverage

World In Vitro Diagnostics presents historical demand data (1999, 2004 and 2009) plus forecasts for 2014 and 2019 by IVD product (reagents and consumables, instruments and systems), application (e.g., clinical chemistry, immunodiagnostics, nucleic acid testing), world region, and for 32 countries. The study also considers market environment factors, evaluates company market share and profiles 24 US industry competitors, including Abbott Laboratories, Beckman Coulter, Becton Dickinson, Johnson & Johnson, Roche Holding and Siemens Healthcare Diagnostics

Table Of Contents


TABLE OF CONTENTS

INTRODUCTION xii

I. EXECUTIVE SUMMARY 1

II. MARKET ENVIRONMENT 4

General 4
Economic Factors 6
Recent Economic Trends 6
World Economic Outlook 8
World Demographic Patterns 12
Total Population 13
Population 65 Years and Older 15
World Health Care Trends 16
World Health Expenditures 18
Hospital Beds 22
Physicians 24
Patient Activity 26
Hospital Admissions 27
Surgical Procedures 28
Outpatient Consultations 30
IVD Testing Volume 32
Regulation 34

III. PRODUCT OVERVIEW 37

General 37
Demand by Region 38
Shipments by Region 42
World Trade 44
Demand by Product Group 46
IVD Reagents and Consumables 49
IVD Instruments 51
Clinical Chemistry Products 52
Demand by Region 53
Demand by Product 56
Reagents and Test Kits 57
Standards and Controls 62
Instruments and Systems 64
Demand by Application 64
Producers 65
Immunoassay Products 66
Demand by Region 67
Demand by Product 69
Reagents and Test Kits 70
Instruments and Systems 74
Demand by Application 76
Producers 77
Diabetes Testing 80
Demand by Region 80
Demand by Product 82
Reagents 83
Instruments 86
Producers 88
Blood Testing Products 88
Demand by Region 89
Demand by Product 90
Reagents and Consumables 91
Instruments and Systems 96
Demand by Application 99
Producers 101
Hematology Products 101
Blood Banking Products 103
Hemostasis Products 104
Molecular Diagnostic Products 106
Demand by Region 107
Demand by Product 109
Reagents and Consumables 110
Instruments and Systems 119
Demand by Application 123
Producers 125
Pathology Products 126
Demand by Region 126
Demand by Product 128
Reagents and Consumables 129
Instruments and Systems 130
Demand by Application 131
Producers 132
Cellular Analysis Products 132
Demand by Region 132
Demand by Product 134
Reagents and Consumables 136
Instruments and Systems 138
Demand by Application 142
Producers 142
Microbiology Products 144
Demand by Region 144
Demand by Product 146
Reagents and Consumables 146
Instruments and Systems 148
Demand by Application 149
Producers 151

IV. NORTH AMERICA 152

Market Environment 152
IVD Product Demand 155
United States 156
Canada 162
Mexico 168

V. WESTERN EUROPE 173

Market Environment 173
IVD Product Demand 176
France 178
Germany 183
Italy 188
Spain 194
United Kingdom 199
Other Western Europe 205

VI. ASIA/PACIFIC 212

Market Environment 212
IVD Product Demand 216
Australia 218
China 223
India 228
Japan 235
Other Asia/Pacific 241

VII. OTHER REGIONS 248

Central and South America 248
Brazil 255
Other Central and South America 260
Eastern Europe 267
Russia 273
Other Eastern Europe 277
Africa/Mideast 282

VIII. INDUSTRY STRUCTURE 289

General 289
Market Share 291
Competitive Strategies 297
Mergers and Acquisitions 299
Licensing and Related Agreements 304
Product Development 312
Marketing and Distribution 314
Manufacturing 316
Company Profiles 318
Abbott Laboratories 319
AcroMetrix, see Life Technologies
Affymetrix Incorporated 326
Alere Incorporated 328
ARKRAY Incorporated 333
Bayer AG 337
BBInternational, see Alere
Beckman Coulter Incorporated 340
Becton, Dickinson and Company 350
Biocare Diagnostics Limited 357
Bioline Group, see Meridian Bioscience
bioMerieux SA 358
Bio-Rad Laboratories Incorporated 364
Concateno, see Alere
Danaher Corporation 369
DiaMed, see Bio-Rad Laboratories
DxS, see QIAGEN
Eurogentec, see Kaneka
First Check Diagnostics, see Alere
Gen-Probe Incorporated 372
GTI Diagnostics, see Gen-Probe
Hologic Incorporated 378
Johnson and Johnson 381
Kaneka Corporation 387
Leica Microsystems, see Danaher
Life Technologies Corporation 390
LifeScan, see Johnson and Johnson
Matritech, see Alere
Meridian Bioscience Incorporated 395
MP Biomedicals LLC 399
Olympus Corporation 400
Ortho-Clinical Diagnostics, see Johnson and Johnson
Oxoid, see Thermo Fisher Scientific
Primus, see Trinity Biotech
Prodesse, see Gen-Probe
QIAGEN NV 402
Radiometer Medical ApS, see Danaher
Remel, see Thermo Fisher Scientific
Roche Holding Limited 407
SABiosciences, see QIAGEN
Siemens AG 415
SPD Swiss Precision Diagnostics, see Alere
Sysmex Corporation 423
Tepnel Life Sciences, see Gen-Probe
Thermo Fisher Scientific Incorporated 430
Third Wave Technologies, see Hologic
Trinity Biotech plc 435
Ventana Medical Systems, see Roche Holding
Veridex, see Johnson and Johnson
VircoBA, see Johnson and Johnson

LIST OF TABLES
SECTION I -- EXECUTIVE SUMMARY

Summary Table 3

SECTION II -- MARKET ENVIRONMENT

1 World Macroeconomic Indicators 5
2 World Gross Domestic Product by Region 12
3 World Population by Region 14
4 World Population 65 Years and Older by Region 16
5 World Health Care Indicators 17
6 World Health Expenditures by Region 21
7 World Number of Acute Care Hospital Beds by Region 24
8 World Number of Practicing Physicians by Region 26
9 World Number of Acute Care Hospital Admissions by Region 28
10 World Number of Surgical Procedures by Region 30
11 World Number of Outpatient Consultations by Region 32
12 World Number of IVD Tests by Region 34

SECTION III -- PRODUCT OVERVIEW

1 World In Vitro Diagnostic (IVD) Product Demand by Region 41
2 World IVD Product Shipments by Region 44
3 World IVD Product Net Exports by Region 46
4 World IVD Product Demand by Technology and Type 48
5 World Clinical Chemistry Product Demand by Region 55
6 World Clinical Chemistry Product Demand by Type 56
7 World Clinical Chemistry Product Demand by Application 65
8 World Immunoassay Product Demand by Region 68
9 World Immunoassay Product Demand by Type 69
10 World Immunoassay Product Demand by Application 77
11 World Diabetes Testing Product Demand by Region 82
12 World Diabetes Testing Product Demand by Type 83
13 World Blood Testing Product Demand by Region 90
14 World Blood Testing Product Demand by Type 91
15 World Blood Testing Product Demand by Application 101
16 World Molecular Diagnostic Product Demand by Region 109
17 World Molecular Diagnostic Product Demand by Type 110
18 World Molecular Diagnostic Product Demand by Application 125
19 World Pathology Product Demand by Region 128
20 World Pathology Product Demand by Type 129
21 World Pathology Product Demand by Application 131
22 World Cellular Analysis Product Demand by Region 133
23 World Cellular Analysis Product Demand by Type 136
24 World Cellular Analysis Product Demand by Application 142
25 World Microbiology Product Demand by Region 145
26 World Microbiology Product Demand by Type 146
27 World Microbiology Product Demand by Application 150

SECTION IV -- NORTH AMERICA

1 North America: Health Care Indicators 154
2 North America: IVD Product Demand 156
3 United States: Health Care Indicators 159
4 United States: IVD Product Demand 162
5 Canada: Health Care Indicators 165
6 Canada: IVD Product Demand 167
7 Mexico: Health Care Indicators 170
8 Mexico: IVD Product Demand 172

SECTION V -- WESTERN EUROPE

1 Western Europe: Health Care Indicators 175
2 Western Europe: IVD Product Demand 177
3 France: Health Care Indicators 180
4 France: IVD Product Demand 182
5 Germany: Health Care Indicators 185
6 Germany: IVD Product Demand 187
7 Italy: Health Care Indicators 191
8 Italy: IVD Product Demand 193
9 Spain: Health Care Indicators 196
10 Spain: IVD Product Demand 198
11 United Kingdom: Health Care Indicators 202
12 United Kingdom: IVD Product Demand 204
13 Other Western Europe: Health Care Indicators 208
14 Other Western Europe: IVD Product Demand
by Technology and Type 210
15 Other Western Europe: IVD Product Demand by Country 211

SECTION VI -- ASIA/PACIFIC

1 Asia/Pacific: Health Care Indicators 215
2 Asia/Pacific: IVD Product Demand 217
3 Australia: Health Care Indicators 221
4 Australia: IVD Product Demand 223
5 China: Health Care Indicators 226
6 China: IVD Product Demand 228
7 India: Health Care Indicators 232
8 India: IVD Product Demand 234
9 Japan: Health Care Indicators 238
10 Japan: IVD Product Demand 240
11 Other Asia/Pacific: Health Care Indicators 244
12 Other Asia/Pacific: IVD Product Demand
by Technology and Type 246
13 Other Asia/Pacific: IVD Product Demand by Country 247

SECTION VII -- OTHER REGIONS

1 Central and South America: Health Care Indicators 251
2 Central and South America: IVD Product Demand 254
3 Brazil: Health Care Indicators 258
4 Brazil: IVD Product Demand 260
5 Other Central and South America: Health Care Indicators 264
6 Other Central and South America: IVD Product Demand
by Technology and Type 266
7 Other Central and South America: IVD Product Demand
by Country 267
8 Eastern Europe: Health Care Indicators 270
9 Eastern Europe: IVD Product Demand 272
10 Russia: Health Care Indicators 275
11 Russia: IVD Product Demand 277
12 Other Eastern Europe: Health Care Indicators 279
13 Other Eastern Europe: IVD Product Demand
by Technology and Type 281
14 Other Eastern Europe: IVD Product Demand by Country 282
15 Africa/Mideast: Health Care Indicators 285
16 Africa/Mideast: IVD Product Demand by Technology and Type 287
17 Africa/Mideast: IVD Product Demand by Country 288
SECTION VIII -- INDUSTRY STRUCTURE
1 World IVD Product Sales by Company, 2010 290
2 Selected Acquisitions and Divestitures 301
3 Selected Cooperative Agreements 306

LIST OF CHARTS


SECTION II -- MARKET ENVIRONMENT
1 World Health Expenditures, 2010 22
SECTION III -- PRODUCT OVERVIEW
1 World IVD Product Demand by Region, 2010 42
2 World IVD Product Demand by Technology, 2010 49
SECTION VIII -- INDUSTRY STRUCTURE
1 World IVD Products Market Share by Company, 2010 292

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