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World In Vitro Diagnostics

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.


PRESS RELEASE

World Demand for In Vitro Diagnostic Products to Reach $61.8 Billion in 2015

World demand for in vitro diagnostic (IVD) products will increase 7.1 percent annually to $61.8 billion in 2015. Based on the advanced nature of medical delivery systems and the widespread health insurance coverage of residents, the developed countries combined will absorb about three-fourths of the total. Demand in the developing countries as a whole will advance faster as medical delivery systems are expanded and upgraded and the accessibility of basic patient testing services improves. Molecular diagnostic products will post the fastest growth in global demand among all IVD products based on throughput, accuracy and speed advantages, especially in the detection of infectious diseases and cancer markers. These and other trends are presented in World In Vitro Diagnostic Products, a new study from The Freedonia Group, Inc., a Cleveland-based industry market research firm.

The US will remain the largest market for IVD products, absorbing nearly 36 percent of global demand in 2015, or $22 billion. The country will maintain this leading position because of aging demographic patterns, a high health care spending intensity, the favorable receptiveness of medical providers to new reagents and instruments, and overall trends promoting the use of patient tests to detect diseases in early, more treatable stages. Western Europe, Japan and other developed economies will also continue to provide a high and diverse volume of IVD testing. However, tighter insurance-imposed cost controls will keep per capita demand for related reagents and instruments below US levels.

Developing world demand for IVD products will rise much faster than developed world demand as countries upgrade and expand health care systems. These improvements will boost the volume of patient tests, especially in China and other emerging economies. Nonetheless, the ongoing constraints on health care spending and less advanced nature of medical delivery systems in most developing countries will keep IVD product demand largely in low cost reagents and instruments for basic health screening.

INTRODUCTION
I. EXECUTIVE SUMMARY
II. MARKET ENVIRONMENT
General
Economic Factors
Recent Economic Trends
World Economic Outlook
World Demographic Patterns
Total Population
Population 65 Years & Older
World Health Care Trends
World Health Expenditures
Hospital Beds
Physicians
Patient Activity
Hospital Admissions
Surgical Procedures
Outpatient Consultations
IVD Testing Volume
Regulation
III. PRODUCT OVERVIEW
General
Demand by Region
Shipments by Region
World Trade
Demand by Product Group
IVD Reagents & Consumables
IVD Instruments
Clinical Chemistry Products
Demand by Region
Demand by Product
Reagents & Test Kits
Standards & Controls
Instruments & Systems
Demand by Application
Producers
Immunoassay Products
Demand by Region
Demand by Product
Reagents & Test Kits
Instruments & Systems
Demand by Application
Producers
Diabetes Testing
Demand by Region
Demand by Product
Reagents
Instruments
Producers
Blood Testing Products
Demand by Region
Demand by Product
Reagents & Consumables
Instruments & Systems
Demand by Application
Producers
Hematology Products
Blood Banking Products
Hemostasis Products
Molecular Diagnostic Products
Demand by Region
Demand by Product
Reagents & Consumables
Instruments & Systems
Demand by Application
Producers
Pathology Products
Demand by Region
Demand by Product
Reagents & Consumables
Instruments & Systems
Demand by Application
Producers
Cellular Analysis Products
Demand by Region
Demand by Product
Reagents & Consumables
Instruments & Systems
Demand by Application
Producers
Microbiology Products
Demand by Region
Demand by Product
Reagents & Consumables
Instruments & Systems
Demand by Application
Producers
IV. NORTH AMERICA
Market Environment
IVD Product Demand
United States
Canada
Mexico
V. WESTERN EUROPE
Market Environment
IVD Product Demand
France
Germany
Italy
Spain
United Kingdom
Other Western Europe
VI. ASIA/PACIFIC
Market Environment
IVD Product Demand
Australia
China
India
Japan
Other Asia/Pacific
VII. OTHER REGIONS
Central & South America
Brazil
Other Central & South America
Eastern Europe
Russia
Other Eastern Europe
Africa/Mideast
VIII. INDUSTRY STRUCTURE
General
Market Share
Competitive Strategies
Mergers & Acquisitions
Licensing & Related Agreements
Product Development
Marketing & Distribution
Manufacturing
Company Profiles
Abbott Laboratories
AcroMetrix, see Life Technologies
Affymetrix Incorporated
Alere Incorporated
ARKRAY Incorporated
Bayer AG
BBInternational, see Alere
Beckman Coulter Incorporated
(continued on next page)
Becton, Dickinson and Company
Biocare Diagnostics Limited
Bioline Group, see Meridian Bioscience
bioMerieux SA
Bio-Rad Laboratories Incorporated
Concateno, see Alere
Danaher Corporation
DiaMed, see Bio-Rad Laboratories
DxS, see QIAGEN
Eurogentec, see Kaneka
First Check Diagnostics, see Alere
Gen-Probe Incorporated
GTI Diagnostics, see Gen-Probe
Hologic Incorporated
Johnson & Johnson
Kaneka Corporation
Leica Microsystems, see Danaher
Life Technologies Corporation
LifeScan, see Johnson & Johnson
Matritech, see Alere
Meridian Bioscience Incorporated
MP Biomedicals LLC
Olympus Corporation
Ortho-Clinical Diagnostics, see Johnson & Johnson
Oxoid, see Thermo Fisher Scientific
Primus, see Trinity Biotech
Prodesse, see Gen-Probe
QIAGEN NV
Radiometer Medical ApS, see Danaher
Remel, see Thermo Fisher Scientific
Roche Holding Limited
SABiosciences, see QIAGEN
Siemens AG
SPD Swiss Precision Diagnostics, see Alere
Sysmex Corporation
Tepnel Life Sciences, see Gen-Probe
Thermo Fisher Scientific Incorporated
Third Wave Technologies, see Hologic
Trinity Biotech plc
Ventana Medical Systems, see Roche Holding
Veridex, see Johnson & Johnson
VircoBA, see Johnson & Johnson
LIST OF TABLES
SECTION I -- EXECUTIVE SUMMARY
Summary Table
SECTION II -- MARKET ENVIRONMENT
1 World Macroeconomic Indicators
2 World Gross Domestic Product by Region
3 World Population by Region
4 World Population 65 Years & Older by Region
5 World Health Care Indicators
6 World Health Expenditures by Region
7 World Number of Acute Care Hospital Beds by Region
8 World Number of Practicing Physicians by Region
9 World Number of Acute Care Hospital Admissions by Region
10 World Number of Surgical Procedures by Region
11 World Number of Outpatient Consultations by Region
12 World Number of IVD Tests by Region
SECTION III -- PRODUCT OVERVIEW
1 World In Vitro Diagnostic (IVD) Product Demand by Region
2 World IVD Product Shipments by Region
3 World IVD Product Net Exports by Region
4 World IVD Product Demand by Technology & Type
5 World Clinical Chemistry Product Demand by Region
6 World Clinical Chemistry Product Demand by Type
7 World Clinical Chemistry Product Demand by Application
8 World Immunoassay Product Demand by Region
9 World Immunoassay Product Demand by Type
10 World Immunoassay Product Demand by Application
11 World Diabetes Testing Product Demand by Region
12 World Diabetes Testing Product Demand by Type
13 World Blood Testing Product Demand by Region
14 World Blood Testing Product Demand by Type
15 World Blood Testing Product Demand by Application
16 World Molecular Diagnostic Product Demand by Region
17 World Molecular Diagnostic Product Demand by Type
18 World Molecular Diagnostic Product Demand by Application
19 World Pathology Product Demand by Region
20 World Pathology Product Demand by Type
21 World Pathology Product Demand by Application
22 World Cellular Analysis Product Demand by Region
23 World Cellular Analysis Product Demand by Type
24 World Cellular Analysis Product Demand by Application
25 World Microbiology Product Demand by Region
26 World Microbiology Product Demand by Type
27 World Microbiology Product Demand by Application
SECTION IV -- NORTH AMERICA
1 North America: Health Care Indicators
2 North America: IVD Product Demand
3 United States: Health Care Indicators
4 United States: IVD Product Demand
5 Canada: Health Care Indicators
6 Canada: IVD Product Demand
7 Mexico: Health Care Indicators
8 Mexico: IVD Product Demand
SECTION V -- WESTERN EUROPE
1 Western Europe: Health Care Indicators
2 Western Europe: IVD Product Demand
3 France: Health Care Indicators
4 France: IVD Product Demand
5 Germany: Health Care Indicators
6 Germany: IVD Product Demand
7 Italy: Health Care Indicators
8 Italy: IVD Product Demand
9 Spain: Health Care Indicators
10 Spain: IVD Product Demand
11 United Kingdom: Health Care Indicators
12 United Kingdom: IVD Product Demand
13 Other Western Europe: Health Care Indicators
14 Other Western Europe: IVD Product Demand by Technology & Type
15 Other Western Europe: IVD Product Demand by Country
SECTION VI -- ASIA/PACIFIC
1 Asia/Pacific: Health Care Indicators
2 Asia/Pacific: IVD Product Demand
3 Australia: Health Care Indicators
4 Australia: IVD Product Demand
5 China: Health Care Indicators
6 China: IVD Product Demand
7 India: Health Care Indicators
8 India: IVD Product Demand
9 Japan: Health Care Indicators
10 Japan: IVD Product Demand
11 Other Asia/Pacific: Health Care Indicators
12 Other Asia/Pacific: IVD Product Demand by Technology & Type
13 Other Asia/Pacific: IVD Product Demand by Country
SECTION VII -- OTHER REGIONS
1 Central & South America: Health Care Indicators
2 Central & South America: IVD Product Demand
3 Brazil: Health Care Indicators
4 Brazil: IVD Product Demand
5 Other Central & South America: Health Care Indicators
6 Other Central & South America: IVD Product Demand by Technology & Type
7 Other Central & South America: IVD Product Demand by Country
8 Eastern Europe: Health Care Indicators
9 Eastern Europe: IVD Product Demand
10 Russia: Health Care Indicators
11 Russia: IVD Product Demand
12 Other Eastern Europe: Health Care Indicators
13 Other Eastern Europe: IVD Product Demand by Technology & Type
14 Other Eastern Europe: IVD Product Demand by Country
15 Africa/Mideast: Health Care Indicators
16 Africa/Mideast: IVD Product Demand by Technology & Type
17 Africa/Mideast: IVD Product Demand by Country
SECTION VIII -- INDUSTRY STRUCTURE
1 World IVD Product Sales by Company, 2010
2 Selected Acquisitions & Divestitures
3 Selected Cooperative Agreements
LIST OF CHARTS
SECTION II -- MARKET ENVIRONMENT
1 World Health Expenditures, 2010
SECTION III -- PRODUCT OVERVIEW
1 World IVD Product Demand by Region, 2010
2 World IVD Product Demand by Technology, 2010
SECTION VIII -- INDUSTRY STRUCTURE
1 World IVD Products Market Share by Company, 2010

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