Point of Care Diagnostics

• The global point-of-care (POC) diagnostics market reached $13.4 billion in 2010 and is expected to reach $13.8 billion in 2011. It will further grow to $16.5 billion in 2016 for a compound annual growth rate (CAGR) of 3.7% between 2011 and 2016.
• The glucose monitoring segment of the POC market reached $7.6 billion in 2010 and is expected to decrease falling to $7.5 billion in 2011. It will grow to $7.6 billion in 2016 for a CAGR of 0.3% between 2011 and 2016.
• The blood chemistry and electrolyte segment of the POC market reached $2.2 billion in 2010 and is expected to reach $2.3 billion in 2011. It will further grow to $2.8 billion in 2016 for a CAGR of 4.8% between 2011 and 2016.

The market for point-of-care (POC) diagnostics can be broken down into 10 segments: glucose monitoring, blood chemistry and electrolyte, pregnancy and fertility, cardiac markers, drug and alcohol, infectious disease, cholesterol, hemoglobin/hemostasis, urine chemistry and tumor marker.

The fastest-growing segment, cardiac markers, is projected to increase at a CAGR of 14.4 percent, rising from $1 billion in 2011 to $2 billion in 2016.

The infectious disease and tumor marker segments have the next highest projected growth rates, with both expected to increase at CAGRs of more than 10 percent.

Globally, the diagnostic testing business is a multibillion-dollar industry with intense competition and areas of high growth, BCC researchers note. The United States is the world’s largest single market for diagnostic testing. This study focuses on POC testing, one of the most active segments within the diagnostic industry. POC testing is growing in both home use and near-patient applications. Both segments are included in this market study.

POC testing includes any screening or diagnostic test that is performed outside the main hospital laboratory. Over the last decade, more diagnostic tests have been performed at patients’ bedsides in hospitals, in physicians’ office laboratories, outpatient clinics, emergency rooms, and intensive-critical-care units. The wider availability of POC testing has revolutionized the continuum of the patient-care process by providing laboratory results rapidly and efficiently at these locations. The trend toward greater POC testing is driven by the faster diagnostic benefits it provides, according to BCC Research.

Several other reasons have emerged for the high demand of POC testing, including staff shortages, older populations, long-term cost savings and rural locations without conventional laboratory services.
 

STUDY GOALS AND OBJECTIVES

The goal of this study on the point-of-care (POC) industry is to describe this flourishing near-patient testing market.  This report provides a complete review and analysis of the current POC markets, and forecasts the market through 2016 in constant dollars.  In addition, it provides an examination and description of select products, current and emerging technologies, and company profiles.

The study also covers issues regarding regulation of POC testing, international developments, and patents for POC testing technologies.

REASONS FOR DOING THE STUDY

Over the last few decades, there has been a strong trend toward POC testing due to an increasing demand for near-patient testing that provides rapid results.  More tests are being performed at the hospital patient’s bedside, in physicians’ office laboratories, outpatient clinics, emergency rooms, and intensive-care units.  Critical-care instruments combining selected important chemistry, hematology, and hemostasis parameters have entered the market for POC testing in the emergency and operating rooms.

The wider availability of POC testing has revolutionized the continuum of the patient-care process by providing laboratory results rapidly and efficiently at these locations.  The trend toward greater POC testing is driven by the faster diagnostic benefits it provides.

Several reasons have emerged for this demand of POC testing, including staff shortages, older populations, long-term cost savings, faster diagnosis and care, and rural locations without conventional laboratory services.  This study will address these areas and others.

SCOPE OF REPORT

This study will describe the market for POC diagnostics at the global level.  It focuses on the accelerating growth in this important diagnostic market segment and the key industry players.  Specifically, the report:

• Describes the POC industry
• Estimates the current and future market size
• Provides breakdowns for U.S. markets
• Describes product segments and the continuous updating of POC products
• Analyzes market influences in the industry and predicts the changes that will shape the future  POC  market
• Discusses trends within the market and provides a future outlook
• Reviews business activities of market leaders
• Lists patents for POC technologies

DEFINING POC

For the purpose of this study, POC testing includes those tests that are used outside the traditional laboratory.  This can be a range of users, including patients, physicians, outpatient clinics, community health centers, and pharmacies.  Tests included in this report are those that do not require any specialized training to perform, are performed easily, and whose results are produced in a minimal time frame.  Some other terms often used to describe POC include:

• Waived tests
• Rapid tests
• Near patient testing
• Bedside testing
• Outpatient testing

METHODOLOGY

The information for this BCC report was obtained through primary and secondary data-collection methods.  Primary methods included interviews with key representatives in the industry such as product development managers, clinical specialists, government departments, and other key representatives involved in the diagnostic industry.

Secondary methods included published literature, investment reports, company literature, and various business journals that focus on diagnostic products and technologies.

Market data for this report pertains to the worldwide market, with specific U.S. data included.  All information is displayed using U.S. dollars at the manufacturers’ level.  The base year of the report is 2011, with historical data provided for 2009 and 2010 and forecast data provided through 2016.  Historical, base year, and forecast data are provided for each of the ten market segments in the report.  Compound annual growth rates (CAGRs) are determined through a compilation of data, including past trends, future trends, demographics, incidence of disease, products in research and development, current product growth, and trends in government regulations.  Competitor market share estimates are provided for each market segment for the 2011 base year.

ANALYST CREDENTIALS

Melissa Elder is an experienced healthcare market analyst specializing in prescription and over-the-counter pharmaceuticals, medical devices, and emerging healthcare technologies.  Ms. Elder has nearly 20 years of experience in the healthcare industry, specializing in market research for the past 14 years.  This experience has given her substantial insight into pharmaceutical market analysis.  Her work in the medical community, including emergency room medical training and healthcare information system coordination, has enhanced her ability to provide insight into many healthcare markets.

Table Of Contents

Chapter- 1: INTRODUCTION - Complimentary 4
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
DEFINING POC
METHODOLOGY
ANALYST CREDENTIALS
RELATED REPORTS
BCC ON-LINE SERVICES
DISCLAIMER

Chapter- 2: SUMMARY 3
OVERVIEW
MAJOR FINDINGS
Table: FORECAST OF THE GLOBAL POC MARKET BY TEST TYPE, THROUGH 2016
Figure: FORECAST OF THE GLOBAL POC MARKET BY TEST TYPE, 2009-2016

Chapter- 3: INDUSTRY OVERVIEW 30
WHAT IS POC TESTING?
OVERVIEW OF POC MARKET
POC AS PART OF CLINICAL DIAGNOSTICS INDUSTRY STRUCTURE
MEDICAL BENEFITS DERIVED FROM IMMEDIATE DIAGNOSTIC TESTING
POC TESTING SITES
POC PRODUCT SEGMENTS
COMMONLY PERFORMED POC TESTS
SIGNIFICANCE OF CLIA IN THE UNITED STATES
OTHER REGULATORY AGENCIES
INITIATIVE FOR HIV/AIDS TESTING
DRIVING FORCES OF THE POC MARKET
NEW ATTENTION TO DRUGS OF ABUSE

Chapter- 4: THE POC MARKET 89
MARKET OVERVIEW
COMPETITOR MARKET SHARE
MARKET STRUCTURE
MARKET COMPONENTS

Chapter- 5: TECHNOLOGY APPLICATIONS 13
BIOSENSORS
ELECTRODES
CONTINUOUS TESTING
RAPID HIV TESTS
DRUG TESTING
PATENT ANALYSIS

Chapter- 6: WORLDWIDE POC MARKET 9
MARKET SIZE
GLOBAL MARKET SHARES
PRESENCE OF MANUFACTURERS IN THE WORLDWIDE MARKET
Table: MARKET SHARE OF MAJOR POC MARKET PARTICIPANTS, 2011
Figure: MARKET SHARE MAJOR POC MARKET PARTICIPANTS, 2011

Chapter- 7: PROFILES OF MAJOR MARKET PARTICIPANTS 33
OVERVIEW OF MARKET PARTICIPANTS
COMPANY PROFILES

Chapter- 8: APPENDIX 5
KEY SOURCES OF INFORMATION

List of Tables

Summary Table : FORECAST OF THE GLOBAL POC MARKET BY TEST TYPE, THROUGH 2016
Table 1 : SELECTED KEY STATISTICS FOR POC TESTING SITES
Table 2 : NUMBER OF HOSPITALS FOR SELECTED COUNTRIES, 2009
Table 3 : NUMBER OF U.S. HEALTHCARE FACILITIES BY TYPE, 2009*
Table 4 : SELECTED POC TESTS – CLIA WAIVED
Table 5 : PERTINENT PARAMETERS OF GMP REGULATIONS AFFECTING IN VITRO DIAGNOSTICS
Table 6 : HEALTH EXPENDITURES AS PERCENTAGE OF GDP BY COUNTRY: 1980-2008
Table 7 : HOSPITAL USAGE STATISTICS, AVERAGE, 2000-2010
Table 8 : WORLD HEALTH ORGANIZATION RANKING OF HEALTHCARE SYSTEMS, TOP 50, 2000
Table 9 : STATISTICS OF SELECTED DISEASES IN THE GLOBAL POPULATION, 2009-2010 ESTIMATES
Table 10 : BIRTH RATES AND BIRTHS BY COUNTRY, 2010 ESTIMATES
Table 11 : GLOBAL POPULATION AND ANNUAL GROWTH BY SELECTED AGE GROUP AND SELECTED YEARS, THROUGH 2030
Table 12 : GLOBAL POPULATION BY SELECTED COUNTRY, THROUGH 2015
Table 13 : GLOBAL FORECAST FOR THE POC MARKET, THROUGH 2016
Table 14 : MARKET SHARE OF MAJOR POC MARKET PARTICIPANTS, 2011
Table 15 : FORECAST OF THE GLOBAL POC BLOOD GAS/ELECTROLYTE TESTING MARKET, THROUGH 2016
Table 16 : RELATIVE MARKET SHARE OF POC BLOOD CHEMISTRY ANALYZER MANUFACTURERS, 2011
Table 17 : NOVA BIOCHEMICAL POC STAT PROFILE PHOX SERIES BY AVAILABLE TESTS
Table 18 : NOVA BIOCHEMICAL POC STAT PROFILE CCX SERIES BY AVAILABLE TESTS
Table 19 : FORECAST OF THE GLOBAL POC CARDIAC MARKER TESTING MARKET, THROUGH 2016
Table 20 : RELATIVE MARKET SHARE OF POC CARDIAC MARKER MANUFACTURERS, 2011
Table 21 : FORECAST OF THE GLOBAL CHOLESTEROL POC RAPID TEST MARKET, THROUGH 2016
Table 22 : RELATIVE MARKET SHARE OF CHOLESTEROL POC RAPID TEST MANUFACTURERS, 2011
Table 23 : RECENT (2010-2011) CLIA-WAIVED APPROVED CHOLESTEROL TESTS
Table 24 : FORECAST OF THE GLOBAL DRUG AND ALCOHOL POC RAPID TEST MARKET, THROUGH 2016
Table 25 : RELATIVE MARKET SHARE OF DRUG AND ALCOHOL POC RAPID TEST MANUFACTURERS, 2011
Table 26 : RECENT (2010-2011) CLIA-WAIVED APPROVED POC DRUG AND ALCOHOL SCREENING TESTS
Table 27 : FORECAST OF THE GLOBAL POC GLUCOSE METER MARKET, THROUGH 2016
Table 28 : MARKET SHARE FOR THE GLOBAL POC GLUCOSE METER MARKET BY COMPONENT, 2011
Table 29 : RELATIVE MARKET SHARE FOR GLUCOSE METERS AND SUPPLIES MANUFACTURERS, 2011
Table 30 : RECENT (2010-2011) CLIA-WAIVED APPROVED BLOOD GLUCOSE METERS
Table 31 : SELECTED LISTING OF RETAILERS SELLING HOME DIAGNOSTIC’S METERS
Table 32 : SELECT LISTING OF BLOOD GLUCOSE MONITORS CAPABLE OF INTERACTING WITH COMPUTER SOFTWARE
Table 33 : RECENT (2010-2011) CLIA-WAIVED APPROVED STREP A TESTS
Table 34 : RECENT (2010-2011) CLIA-WAIVED APPROVED INFLUENZA TESTS
Table 35 : RECENT (2010–2011) CLIA-WAIVED APPROVED RSV TESTS
Table 36 : RECENT (2010-2011) CLIA-WAIVED APPROVED HIV TESTS
Table 37 : RECENT (2010-2011) CLIA-WAIVED APPROVED INFECTIOUS MONONUCLEOSIS TESTS
Table 38 : RECENT (2010–2011) CLIA-WAIVED APPROVED H. PYLORI TESTS
Table 39 : FORECAST OF THE GLOBAL INFECTIOUS DISEASE POC RAPID TEST MARKET, THROUGH 2016
Table 40 : MARKET SHARE FOR THE GLOBAL POC INFECTIOUS DISEASE MARKET BY TEST TYPE, 2011
Table 41 : RELATIVE MARKET SHARE OF INFECTIOUS DISEASE POC RAPID TEST MANUFACTURERS, 2011
Table 42 : FORECAST OF THE GLOBAL PREGNANCY/FERTILITY POC RAPID TEST MARKET, THROUGH 2016
Table 43 : MARKET SHARE FOR THE GLOBAL POC PREGNANCY/FERTILITY MARKET BY TEST TYPE, 2011
Table 44 : RELATIVE MARKET SHARE OF PREGNANCY/FERTILITY POC RAPID TEST MANUFACTURERS, 2011
Table 45 : RECENT (2010-2011) CLIA-WAIVED APPROVED PREGNANCY TESTS
Table 46 : FORECAST OF THE GLOBAL HEMOGLOBIN/HEMOSTASIS POC RAPID TEST MARKET, THROUGH 2016
Table 47 : RELATIVE MARKET SHARE OF HEMOGLOBIN/HEMOSTASIS POC RAPID TEST MANUFACTURERS, 2011
Table 48 : RECENT (2010-2011) CLIA-WAIVED APPROVED HEMATOLOGY TESTS
Table 49 : FORECAST OF THE GLOBAL TUMOR MARKER POC RAPID TEST MARKET, THROUGH 2016
Table 50 : RELATIVE MARKET SHARE OF TUMOR MARKER POC RAPID TEST MANUFACTURERS, 2011
Table 51 : RECENT (2010-2011) CLIA-WAIVED APPROVED FECAL OCCULT BLOOD TESTS
Table 52 : RECENT (2010-2011) CLIA-WAIVED APPROVED BLADDER TESTS
Table 53 : FORECAST OF THE GLOBAL POC URINE CHEMISTRY ANALYZER MARKET, THROUGH 2016
Table 54 : RELATIVE MARKET SHARE OF POC URINE CHEMISTRY ANALYZER MANUFACTURERS, 2011
Table 55 : RECENT (2010-2011) CLIA-WAIVED APPROVED URINE CHEMISTRY ANALYZERS
Table 56 : RECENT (2010-2011) CLIA-WAIVED APPROVED VAGINAL PH TESTS
Table 57 : RECENT (2010-2011) CLIA-WAIVED APPROVED TSH TESTS
Table 58 : RECENT (2010-2011) CLIA-WAIVED APPROVED MALE REPRODUCTIVE TESTS
Table 59 : RESULTS OF U.S. PATENT SEARCH FOR POC CATEGORIES, JANUARY 2009 TO NOVEMBER 2011
Table 60 : U.S. PATENTS BY SUBJECT AREA, JANUARY 2009 TO NOVEMBER 2011
Table 61 : PATENT ASSIGNEES BY COUNTRY, JANUARY 2009 TO NOVEMBER 2011
Table 62 : GLOBAL FORECAST FOR THE POC MARKET, THROUGH 2016
Table 63 : POC GLOBAL MARKET SHARE BY REGION, 2011
Table 64 : MARKET SHARE OF MAJOR POC MARKET PARTICIPANTS, 2011
Table 65 : ABAXIS’ COMPANY REVENUES, 2006-2010*
Table 66 : ABBOTT’S COMPANY REVENUES, 2006-2010
Table 67 : ALERE’S COMPANY REVENUES, 2006-2010
Table 68 : BECKMAN COULTER’S COMPANY REVENUES, 2006-2010
Table 69 : BECTON DICKINSON’S COMPANY REVENUES, 2006-2011*
Table 70 : CHURCH & DWIGHT’S COMPANY REVENUES, 2006-2010
Table 71 : DANAHER’S COMPANY REVENUES, 2006-2010
Table 72 : QUEST’S COMPANY REVENUES, 2006-2010
Table 73 : ITC’S COMPANY SALES, 2008-2010
Table 74 : JOHNSON & JOHNSON’S COMPANY REVENUES, 2006-2010
Table 75 : NIPRO CORPORATION’S COMPANY REVENUES, 2006-2010*
Table 76 : ORASURE’S COMPANY REVENUES, 2006-2010
Table 77 : QUIDEL’S COMPANY REVENUES, 2006-2010
Table 78 : ROCHE GROUP’S REVENUES, 2006-2010
Table 79 : SEKISUI CHEMICAL CO’S REVENUES, 2006-2010
Table 80 : SIEMENS’ COMPANY REVENUES, 2006-2010
Table 81 : SPECTRAL’S COMPANY REVENUES, 2007-2010
Table 82 : TRINITY’S COMPANY REVENUES, 2006-2010

List of Figures

Summary Figure : FORECAST OF THE GLOBAL POC MARKET BY TEST TYPE, 2009-2016
Figure 1 : HEALTH EXPENDITURES AS PERCENT OF GDP BY COUNTRY, 1980-2008
Figure 2 : HOSPITAL USAGE STATISTICS
Figure 3 : BIRTH RATES AND BIRTHS BY COUNTRY, 2010 ESTIMATES
Figure 4 : GLOBAL POPULATION BY SELECTED AGE GROUP AND SELECTED YEARS, 2000–2030
Figure 5 : GLOBAL POPULATION BY SELECTED COUNTRY, 2010 AND PROJECTED 2015
Figure 6 : GLOBAL FORECAST FOR THE POC MARKET, 2009-2016
Figure 7 : DISTRIBUTION OF SALES FOR THE GLOBAL POC MARKET BY TEST TYPE, 2011
Figure 8 : MARKET SHARE MAJOR POC MARKET PARTICIPANTS, 2011
Figure 9 : DISTRIBUTION CHANNELS: POC DIAGNOSTIC DEVICES
Figure 10 : FORECAST OF THE GLOBAL POC BLOOD GAS/ELECTROLYTE TESTING MARKET, 2009-2016
Figure 11 : RELATIVE MARKET SHARE BLOOD GAS ANALYZER MANUFACTURERS, 2011
Figure 12 : FORECAST OF THE GLOBAL POC CARDIAC MARKER TESTING MARKET, 2009-2016
Figure 13 : RELATIVE MARKET SHARE OF POC CARDIAC MARKER MANUFACTURERS, 2011
Figure 14 : FORECAST OF THE GLOBAL CHOLESTEROL POC RAPID TEST MARKET, 2009-2016
Figure 15 : RELATIVE MARKET SHARE OF CHOLESTEROL POC RAPID TEST MANUFACTURERS, 2011
Figure 16 : FORECAST OF THE GLOBAL DRUG AND ALCOHOL POC RAPID TEST MARKET, THROUGH 2016
Figure 17 : RELATIVE MARKET SHARE OF DRUG AND ALCOHOL POC RAPID TEST MANUFACTURERS, 2011
Figure 18 : FORECAST OF THE GLOBAL POC GLUCOSE METER MARKET, 2009-2016
Figure 19 : MARKET SHARE FOR THE GLOBAL POC GLUCOSE METER MARKET BY COMPONENT, 2011
Figure 20 : RELATIVE MARKET SHARE FOR GLUCOSE METERS AND SUPPLIES MANUFACTURERS, 2011
Figure 21 : FORECAST OF THE GLOBAL INFECTIOUS DISEASE POC RAPID TEST MARKET, THROUGH 2016
Figure 22 : MARKET SHARE FOR THE GLOBAL POC INFECTIOUS DISEASE MARKET BY TEST TYPE, 2011
Figure 23 : RELATIVE MARKET SHARE OF INFECTIOUS DISEASE POC RAPID TEST MANUFACTURERS, 2011
Figure 24 : FORECAST OF THE GLOBAL INFECTIOUS DISEASE POC RAPID TEST MARKET, 2008-2016
Figure 25 : MARKET SHARE FOR THE GLOBAL POC PREGNANCY/FERTILITY MARKET BY TEST TYPE, 2011
Figure 26 : RELATIVE MARKET SHARE OF PREGNANCY/FERTILITY POC RAPID TEST MANUFACTURERS, 2011
Figure 27 : FORECAST OF THE GLOBAL HEMOGLOBIN/HEMOSTASIS POC RAPID TEST MARKET, THROUGH 2016
Figure 28 : RELATIVE MARKET SHARE OF HEMOGLOBIN/HEMOSTASIS POC RAPID TEST MANUFACTURERS, 2011
Figure 29 : FORECAST OF THE GLOBAL TUMOR MARKER POC RAPID TEST MARKET, THROUGH 2016
Figure 30 : RELATIVE MARKET SHARE OF TUMOR MARKER POC RAPID TEST MANUFACTURERS, 2011
Figure 31 : FORECAST OF THE GLOBAL POC URINE CHEMISTRY ANALYZER MARKET, 2009-2016
Figure 32 : RELATIVE MARKET SHARE OF POC URINE CHEMISTRY ANALYZER MANUFACTURERS, 2011
Figure 33 : U.S. PATENTS BY POC CATEGORIES, JANUARY 2009 TO NOVEMBER 2011
Figure 34 : U.S. PATENTS BY SUBJECT AREA, JANUARY 2009 TO NOVEMBER 2011
Figure 35 : GLOBAL FORECAST FOR THE POC MARKET, THROUGH 2016
Figure 36 : POC GLOBAL MARKET SHARE BY REGION, 2011
Figure 37 : NORTH AMERICAN POC MARKET SHARE BY COUNTRY, 2011
Figure 38 : EUROPEAN POC MARKET SHARE BY COUNTRY, 2011
Figure 39 : ASIAN POC MARKET SHARE BY COUNTRY, 2011
Figure 40 : MARKET SHARE MAJOR POC MARKET PARTICIPANTS, 2011
Figure 41 : ABAXIS’ COMPANY REVENUES, 2006-2010*
Figure 42 : ABBOTTS’ COMPANY REVENUES, 2006-2010
Figure 43 : ALERE’S COMPANY REVENUES 2006–2010
Figure 44 : BECKMAN COULTER’S COMPANY REVENUES, 2006-2010
Figure 45 : BECTON DICKINSON’S COMPANY REVENUES, 2006-2011*
Figure 46 : CHURCH & DWIGHT’S COMPANY REVENUES, 2006-2010
Figure 47 : DANAHER’S COMPANY REVENUES, 2006–2010
Figure 48 : QUEST’S COMPANY REVENUES, 2006-2010
Figure 49 : ITC’S COMPANY SALES, 2008-2010
Figure 50 : JOHNSON & JOHNSON’S COMPANY REVENUES, 2006-2010
Figure 51 : NIPRO CORPORATION’S COMPANY REVENUES, 2006-2010*
Figure 52 : ORASURE’S COMPANY REVENUES, 2006-2010
Figure 53 : QUIDEL’S COMPANY REVENUES, 2006-2010
Figure 54 : ROCHE GROUP’S REVENUES, 2006-2010
Figure 55 : SEKISUI CHEMICAL CO’S REVENUES, 2006-2010
Figure 56 : SIEMENS’ COMPANY REVENUES, 2006-2010
Figure 57 : SPECTRAL’S COMPANY REVENUES, 2007-2010
Figure 58 : TRINITY’S COMPANY REVENUES, 2006-2010