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Global Markets for Rapid Medical Diagnostic Kits

September 19, 2013

Reportbuyer.com just published a new market research report: Global Markets for Rapid Medical Diagnostic Kits.

London (PRWEB) September 19, 2013

STUDY GOALS AND OBJECTIVES

The current report focuses on the rapid medical diagnostic kit (MDK) portion of the overall MDK market. Within the MDK market there are rapid kits, which in this report are defined as non-automated tests that provide results in two hours or less, MDK that require more than two hours to complete and MDK that are analyzed and read with the use of automation.

The analysis of the rapid market will include an overview of the MDK global market and the position of rapid MDK within that market; a technology review with a description of the types of rapid tests currently used and emerging technologies that will affect the market in the future; rapid tests for use in the clinical, home and veterinary markets, and an overview of current regulations and economic concerns that impact the market.

REASONS FOR DOING THE STUDY

The increasing use of rapid tests enables the clinician and the patient to receive test results quickly, usually within 30 minutes, and enable the clinician to prescribe the appropriate medications to treat an identified problem. In the past, clinicians relied on out-of-office laboratories that often took days to weeks to process tests. This left the clinician to begin treatment protocols without a clear diagnosis.

Several factors are driving the rapid MDK market.

  • An extremely large aging population of 78 million so-called “Baby Boomers,” who will demand quicker diagnosis and treatment.
  • Increasing rates of various types of cancer and the need for rapid confirmatory tests.
  • Continued threat of bioterrorism through chemical/biological methods and the need for rapid detection and early treatment.
  • An ever-increasing at-risk population of individuals with diabetes, hepatitis and human papillomavirus (HPV).
  • A slowdown in HIV/AIDS diagnosed cases, but still large numbers of individuals who have the disease but are unaware of it.
  • A virtual epidemic of substance abuse.
  • Introduction of infectious diseases from global migrations of people.
  • Reintroduction of infectious diseases such as syphilis, tuberculosis and measles, thought to be vanquished.

This report will identify and examine these marketplace trends and forecast future market changes from 2012 through 2017.

The current veterinary rapid MDK marketplace is highly competitive with dominance by less than four companies, but expanded competition on a regional basis. Idexx is the acknowledged market leader, but loss of patent protection on key products and increasing competition, particularly in the area of heartworm diagnostic kits, will ensure a competitive market with various pricing strategies.

The clinical market includes rapid tests for infectious diseases, cancer markers, pregnancy, drugs of abuse and diabetes.

The home-use market continues to expand with tests for human immunodeficiency virus (HIV), hepatitis, drugs of abuse, pregnancy and diabetes. This report includes blood glucose monitors and test strips for diabetes testing.

SCOPE OF REPORT

The report concentrates on rapid MDK and their position in the overall MDK market. The report specifically excludes tests that involve automated testing or tests that require processing devices and semi-automated batch testing devices.

The rapid MDK market encapsulates current and potential products, related technologies, components and component suppliers, end markets, governmental and regulatory agencies, major companies competing in this market, relative market shares and the impact of the worldwide market status.

This study defines the MDK market and provides detailed information on the following.

  • Products that comprise the rapid MDK industry.
  • Emerging and current MDK technologies.
  • Analysis of these technologies and the effect on future market development.
  • Market structure and current market size, with forecasts by type of product and market region from 2012 to 2017.
  • The effect of external market forces, such as insurance, regulatory and economic issues and increased incidence of disease.

INTENDED AUDIENCE

This study of the competitive and evolving MDK industry will be beneficial to diagnostic industry participants holding marketing, management and technical development positions. It will also benefit readers who are suppliers to this industry. Additionally, investors, venture capitalists, insurance companies and those interested in diagnostic medical testing will find this report valuable.

METHODOLOGIES AND INFORMATION SOURCES

Sources for this report include information provided by company representatives, company websites and product literature, financial analyst reports, industry association members and industry sources.

The primary data collection methodology for this report focuses on information provided by industry personnel through Web-based sources or interviews, government agencies, industry observers and industry professional organizations. In addition to these primary data sources, secondary data research techniques include a literature search of medical, government and business sources.

All data collected were analyzed by BCC personnel to determine specific findings and to make forecasts. Growth forecasts are made in constant 2011 dollars based on the U.S. manufacturers’ (wholesale) price levels, unless otherwise noted.

ANALYST CREDENTIALS

Peggy S. Lehr is the BCC research analyst of this report. Ms. Lehr holds a BS in Journalism from the University of Colorado, Boulder, and a MS in Communication from the University of Denver. Ms. Lehr has been involved with the medical/nursing industry for more than 20 years, and she has worked within the publishing industry for both for-profit and not-for-profit organizations. Recent reports for BCC include seven healthcare reports and her latest report, PHM061B, on the global infectious disease market.

REPORT HIGHLIGHTS

This report provides:

  • An overview of the market for rapid medical diagnostic kits, with an intensive examination of the in vitro diagnostic kit segment of the medical device market.
  • Analyses of market trends, with data from 2011 and 2012, and projections of compound annual growth rates (CAGRs) through 2017.
  • Discussion of changes that have occurred over the last five years as the result of technological advances and regulatory implementations, and the impact those changes will have on the overall market and key market segments.
  • Examination of the effect on the market of inexpensive, automated testing devices, known as point-of-care (POC) instruments, which have replaced MDKs in smaller laboratories and physicians’ offices.
  • Emerging marketing practices, such as strategic alliances and acquisitions.
  • Coverage of the effect of external market forces, such as insurance and increased incidence of disease.

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

STUDY GOALS AND OBJECTIVES 2

REASONS FOR DOING THE STUDY 2

SCOPE OF REPORT 3

INTENDED AUDIENCE 3

METHODOLOGIES AND INFORMATION SOURCES 3

ANALYST CREDENTIALS 4

RELATED BCC REPORTS 4

BCC ONLINE SERVICES 4

DISCLAIMER 5

CHAPTER 2 SUMMARY 7

SUMMARY TABLE GLOBAL MARKET FOR RAPID MEDICAL DIAGNOSTIC KITS,

THROUGH 2017 ($ MILLIONS) 8

SUMMARY FIGURE GLOBAL MARKET FOR RAPID DIAGNOSTIC KITS BY REGION,

2012 AND 2017 (%) 9

CHAPTER 3 OVERVIEW OF MDK AND RAPID MDK MARKETS 11

COMPONENTS OF MDK 11

FIGURE 1 COMPONENTS OF AN MDK 11

ADVANTAGES OF RAPID MDK 12

MARKETS FOR RAPID MDK 12

CLINICAL TESTING 13

Clinical Diagnostic Testing 13

Monitoring 13

Screening 13

Confirmatory Testing 13

HOME USE 14

VETERINARY DIAGNOSIS 14

EXCLUSION OF RESEARCH MARKET IN THIS REPORT 14

INTERNAL AND EXTERNAL MARKET FORCES 14

INTERNAL MARKET FORCES 14

Trade Practices 14

Promotion 14

Pricing 15

Sales Tie-ins 15

Industry Channels of Distribution 15

Strategies in Consumer Advertising 15

EXTERNAL FORCES 16

TYPES OF RAPID MDK SCREENING 16

TABLE 1 CHARACTERISTICS OF TWO RAPID TESTING TECHNOLOGIES 17

RAPID MDK MARKET DRIVERS 17

GLOBALLY AGING POPULATION 17

SPREADING INFECTIOUS DISEASES 17

TRENDS CONTRIBUTING TO INCREASE IN INFECTIOUS DISEASE PROBLEMS 18

TABLE 2 SELECTED MAJOR GLOBAL INFECTIOUS DISEASES, 2006* 19

INFECTIOUS DISEASE TRANSMISSION 19

ANTIBIOTIC-RESISTANT ORGANISMS 20

IMPLICATIONS OF CLIMATE CHANGE ON INFECTIOUS DISEASES 20

CHRONIC DISEASE TREATMENT 20

TABLE 3 TOP 10 CAUSES OF DEATH BY INCOME GROUP, 2004* 21

RAPID MDK MARKET SIZE 21

TABLE 4 PROJECTED RAPID MDK MARKET BY END-USE SEGMENT, THROUGH 2017

($ MILLIONS) 22

ALTERNATIVE METHODS 22

TABLE 5 ALTERNATIVE METHODS TO MDKS AND AREAS OF PRIMARY USE 22

CULTURE 23

MICROSCOPY 23

BIOLOGICAL ASSAY 23

CHROMATOGRAPHIC SEPARATION 24

MERGERS AND ACQUISITIONS 24

TABLE 6 SELECTED MERGERS AND ACQUISITIONS IN THE RAPID MDK MARKET,

JANUARY 2007–FEBRUARY 2013 24

CHAPTER 4 THE TECHNOLOGICAL ASPECTS OF RAPID MDK 26

TABLE 7 MAJOR MDK APPLICATIONS BY TYPE OF TECHNOLOGY AND ITS USES 26

CHEMICAL ANALYSIS 26

ENZYMATIC ANALYSIS 27

IMMUNOLOGICAL ANALYSIS 27

ENZYME IMMUNOASSAY (EIA) 27

LATERAL FLOW TECHNIQUE 28

Components of a Lateral Flow Test 28

FLOW-THROUGH TECHNIQUE 28

Colloid Gold Technology 29

LATEX AGGLUTINATION (LA) 29

IMMUNOPRECIPITATION/AGGLUTINATION 30

TYPES OF RAPID MDKS FOR INFECTIOUS DISEASE TESTING 30

IMMUNODIAGNOSTIC KITS 30

DIPSTICKS 30

MICROBIAL AND RAPID MDK 30

MDK FEATURES AFFECTING MARKETABILITY 31

RELIABILITY AND ACCURACY 31

RANGE OF MEASUREMENT AND SENSITIVITY 31

STORAGE STABILITY 31

EASE OF USE 31

RAPID MDK MARKET SHARE BY TYPE 32

TABLE 8 MARKET SHARE FOR RAPID MDK, BY TEST TYPE (%) 32

TRENDS IN RAPID MDK MANUFACTURE 32

CLINICAL RAPID TESTING 32

VETERINARY RAPID TESTING 33

PAPER-BASED DIAGNOSTICS 33

CHAPTER 5 CLINICAL RAPID MDK APPLICATIONS 35

TABLE 9 PROJECTED GLOBAL MARKET FOR RAPID MDK IN CLINICAL SETTINGS BY

TEST, THROUGH 2017 ($ MILLIONS) 35

FIGURE 2 RAPID CLINICAL MDK MARKET BY CONDITION, 2012 AND 2017 (%) 36

INFECTIOUS DISEASE TESTING 37

BACTERIA 37

TABLE 10 SELECTED LISTING OF BACTERIA FOUND IN CLINICAL SPECIMENS, THE

DISEASES THEY CAUSE AND RAPID MDK MANUFACTURERS 38

FUNGI 38

VIRUSES 39

TABLE 11 SELECTED LISTING OF VIRUSES FOUND IN CLINICAL SPECIMENS, THE

DISEASES THEY CAUSE AND RAPID MDK MANUFACTURERS 39

PROTOZOA 39

IMPORTANCE OF TESTING 39

CLINICAL TESTING METHODS 40

INFECTIOUS DISEASE RAPID TESTS 40

GASTROINTESTINAL DISEASES (GAS) 40

TABLE 12 SELECTED LISTING OF RAPID MDK GASTROINTESTINAL TESTS, 2012 41

TABLE 13 SELECTED LISTING OF RAPID STREP TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 42

MONONUCLEOSIS 42

TABLE 14 SELECTED LISTING OF RAPID MONONUCLEOSIS TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 43

HEPATITIS 43

TABLE 15 RAPID MDK FOR HEPATITIS 44

TABLE 16 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR HEPATITIS TESTING,

THROUGH 2017 ($ MILLIONS) 45

HUMAN IMMUNODEFICIENCY VIRUS (HIV) 45

TESTING TYPES 45

TABLE 17 RAPID MDK FOR HIV TEST NAME, MANUFACTURER AND PROCESS TIME 46

TABLE 18 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR HIV TESTING,

THROUGH 2017 ($ MILLIONS) 46

H. PYLORI BLOOD TEST 47

TABLE 19 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR H. PYLORI TESTING,

THROUGH 2017 ($ MILLIONS) 47

TABLE 20 SELECTED LISTING OF RAPID H. PYLORI BLOOD TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 48

SEXUALLY TRANSMITTED DISEASES 48

IMPLICATIONS FOR WOMEN 48

SEXUALLY TRANSMITTED DISEASES IN THE U.S. 48

TABLE 21 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR SEXUALLY

TRANSMITTED DISEASES TESTING, THROUGH 2017 ($ MILLIONS) 49

TABLE 22 SELECTED LISTING OF RAPID MDK TESTS TO DETECT SEXUALLY

TRANSMITTED DISEASES, 2012 49

MALARIA 50

TABLE 23 PROJECTED MARKET FOR RAPID MALARIA MDK, THROUGH 2017 ($

MILLIONS) 50

MALARIA RAPID DETECTION PRODUCTS 50

TABLE 24 SELECTED LISTING OF RAPID MALARIA MDK TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 51

INFLUENZA A & B 51

TABLE 25 SELECTED LISTING OF RAPID INFLUENZA A, B TESTS BY DISEASE, TEST

NAME, MANUFACTURER AND PROCESS TIME, 2012 52

CARDIOVASCULAR DISEASE/CHOLESTEROL 52

TABLE 26 PROJECTED GLOBAL MARKET FOR CARDIOVASCULAR AND

CHOLESTEROL RAPID MDK, THROUGH 2017 ($ MILLIONS) 53

TABLE 27 SELECTED LISTING OF RAPID CARDIAC MARKER MDK, 2012 53

CHOLESTEROL 54

TABLE 28 SELECTED LISTING OF RAPID MDK CHOLESTEROL TESTS, 2012 54

DRUG/SUBSTANCE ABUSE TESTING 54

THERAPEUTIC MONITORING 54

DIAGNOSING OVERDOSES 55

DIFFERENTIAL DIAGNOSIS 55

DETECTING DRUG ABUSE 55

TABLE 29 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR SUBSTANCE ABUSE

TESTING, THROUGH 2017 ($ MILLIONS) 55

PRODUCTS FOR SUBSTANCE ABUSE TESTING 55

TABLE 30 RAPID MDK FOR SUBSTANCE ABUSE TESTING 56

PREGNANCY/OVULATION/HORMONAL CONDITIONS 57

HORMONAL CONDITIONS 57

Diagnostic Benefits of Hormone Analysis 57

TABLE 31 PROJECTED MARKET FOR RAPID CLINICAL PREGNANCY, OVULATION,

MENOPAUSE MDK, THROUGH 2017 ($ MILLIONS) 57

TYPES OF HORMONE MDK TESTS 57

Hypothalamus 58

Pituitary 58

Thyroid 58

Parathyroid 58

Adrenal Glands 58

Pancreas 59

Brain Peptides 59

HORMONE TESTING MARKET 59

TABLE 32 RAPID MDK FOR CLINICAL HORMONE TESTING 59

CLINICAL CONFIRMATION OF PREGNANCY 59

TABLE 33 RAPID MDK FOR PREGNANCY/OVULATION 60

TUMOR MARKERS 61

MARKET SIZE AND STRUCTURE 61

TABLE 34 PROJECTED GLOBAL MARKET FOR RAPID TUMOR MARKER MDK,

THROUGH 2017 ($ MILLIONS) 61

INCIDENCE OF NEW CANCER CASES ANNUALLY 61

Risk Factors 61

Detection Methods 62

TABLE 35 SELECTED LISTING OF RAPID CANCER MDK, 2012 63

OTHER TESTS 63

BLOOD/URINE CHEMISTRY 63

Market Size and Structure 63

TABLE 36 PROJECTED MARKET FOR OTHER RAPID MDK, THROUGH 2017 ($

MILLIONS) 64

TABLE 37 SELECTED LISTING OF RAPID BLOOD/URINE MDK TESTS, 2012 64

AUTOIMMUNE DISEASE 65

TABLE 38 SELECTED LISTING OF RAPID AUTOIMMUNE TESTS, 2012 65

BLOOD GLUCOSE TESTING IN CLINICAL SETTINGS 66

FECAL OCCULT BLOOD TEST 66

TABLE 39 SELECTED LISTING OF RAPID FECAL OCCULT BLOOD TESTS BY TEST

NAME, MANUFACTURER AND PROCESS TIME, 2012 67

REGIONAL ANALYSIS 67

TABLE 40 PROJECTED GLOBAL MARKET FOR RAPID CLINICAL MDK BY GEOGRAPHIC

REGION, THROUGH 2017 67

FIGURE 3 GLOBAL MARKET FOR RAPID CLINICAL MDK BY GEOGRAPHIC REGION,

2012 AND 2017 (%) 68

TABLE 41 PROJECTED GLOBAL RAPID CLINICAL MDK MARKET BY GEOGRAPHIC

REGION AND DISEASE CATEGORY, THROUGH 2017 ($ MILLIONS) 69

AMERICAS 69

TABLE 42 PROJECTED AMERICAS MARKET FOR RAPID CLINICAL MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 70

FIGURE 4 PROJECTED MARKET SHARE FOR RAPID CLINICAL MDK IN THE AMERICAS

BY REGION, 2012 AND 2017 (%) 70

EMRA 71

TABLE 43 PROJECTED EMRA MARKET FOR RAPID CLINICAL MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 71

FIGURE 5 PROJECTED MARKET SHARE FOR RAPID CLINICAL MDK IN THE EMRA BY

REGION, 2012 AND 2017 (%) 71

ASIA 73

TABLE 44 PROJECTED ASIAN MARKET FOR RAPID CLINICAL MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 73

FIGURE 6 PROJECTED MARKET SHARE FOR RAPID CLINICAL MDK IN ASIA BY

REGION, 2012 AND 2017 (%) 73

CHAPTER 6 HOME-USE TESTING MARKET 76

TABLE 45 PROJECTED HOME-USE RAPID MDK MARKET, THROUGH 2017 ($

MILLIONS) 76

ALLERGIES 77

ALLERGY TESTING PRODUCTS 77

TABLE 46 SELECTED LISTING OF RAPID HOME-USE MDK ALLERGY TESTS, 2012 77

BLOOD GLUCOSE MONITORING 77

DIABETES IN INDIA 78

BLOOD GLUCOSE MONITORING MARKET 78

FIGURE 7 GLOBAL HOME-USE BLOOD GLUCOSE MONITORING MARKET BY

MANUFACTURER, 2011 (%) 78

TABLE 47 PROJECTED GLOBAL MARKET FOR RAPID HOME-USE BLOOD GLUCOSE

MONITORING MDK, THROUGH 2017 ($ MILLIONS) 79

BLOOD GLUCOSE MONITORING PRODUCTS 79

TABLE 48 RAPID HOME-USE MDK FOR BLOOD GLUCOSE MONITORING 80

CHOLESTEROL 80

CHOLESTEROL MONITORING 81

TABLE 49 PROJECTED GLOBAL MARKET FOR RAPID HOME-USE RAPID

CHOLESTEROL MDK, THROUGH 2017 ($ MILLIONS) 81

CHOLESTEROL MONITORING PRODUCTS 81

TABLE 50 SELECTED LISTING OF RAPID HOME-USE MDK CHOLESTEROL TESTS,

2012 82

DRUG SCREENING 82

THE GROWTH OF THE HOME-USE DRUG SCREENING MDK MARKET 82

TABLE 51 PROJECTED GLOBAL MARKET FOR RAPID HOME-USE MDK FOR DRUG

SCREENING, THROUGH 2017 ($ MILLIONS) 83

DRUG SCREENING PRODUCTS 83

TABLE 52 SELECTED LISTING OF RAPID HOME-USE DRUG SCREENING TESTS BY

TEST NAME, MANUFACTURER AND PROCESS TIME, 2012 83

FECAL OCCULT BLOOD 85

FECAL OCCULT BLOOD TEST PRODUCTS 85

TABLE 53 SELECTED LISTING OF RAPID MDK HOME-USE FECAL OCCULT BLOOD

TESTS, 2012 86

PREGNANCY/OVULATION/MENOPAUSE 86

TABLE 54 PROJECTED GLOBAL MARKET FOR RAPID HOME-USE MDK FOR

PREGNANCY, OVULATION AND MENOPAUSE PRODUCTS, THROUGH 2017 ($

MILLIONS)

86

PREGNANCY/OVULATION/MENOPAUSE PRODUCTS 86

TABLE 55 SELECTED LISTING OF HOME-USE RAPID PREGNANCY, OVULATION AND

MENOPAUSE TESTS, 2012 87

INFECTIOUS DISEASES 87

HEPATITIS 88

TABLE 56 PROJECTED GLOBAL MARKET FOR HOME-USE RAPID HEPATITIS MDK,

THROUGH 2017 ($ MILLIONS) 88

Hepatitis Home-Use Test Products 88

TABLE 57 SELECTED LISTING OF RAPID HOME-USE MDK HEPATITIS C TESTS, 2012 88

H. PYLORI 89

TABLE 58 PROJECTED GLOBAL MARKET FOR HOME-USE H. PYLORI RAPID MDK,

THROUGH 2017 ($ MILLIONS) 89

H. pylori Home-Use Rapid Test MDK 89

TABLE 59 SELECTED LISTING OF HOME-USE RAPID MDK H. PYLORI TESTS, 2012 89

HUMAN IMMUNODEFICIENCY VIRUS (HIV) 90

HIV Rapid Home-Use Test 90

TABLE 60 SELECTED LISTING OF HOME-USE RAPID MDK HIV TESTS, 2012 90

REGIONAL ANALYSIS 90

TABLE 61 PROJECTED MARKET FOR RAPID HOME-USE MDK BY REGION, THROUGH

2017 ($ MILLIONS) 91

FIGURE 8 MARKET SHARE FOR RAPID HOME-USE MDK BY REGION, 2012 AND 2017

(%) 91

THE AMERICAS 92

Diabetes in North America 92

Diabetes in the Central and South America 92

TABLE 62 PROJECTED AMERICAS MARKET FOR RAPID HOME-USE MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 93

FIGURE 9 MARKET SHARE FOR RAPID HOME-USE MDK IN THE AMERICAS, 2012

AND 2017 (%) 93

TABLE 63 PROJECTED AMERICAS MARKET FOR RAPID HOME-USE MDK BY DISEASE,

THROUGH 2017 ($ MILLIONS) 94

EMRA 94

Blood Glucose Monitoring Reimbursement in Europe 94

Diabetes in Africa 95

Diabetes in Europe, Eastern Europe and Russia 95

Diabetes in the Middle East 95

Pregnancy Home-Use MDK in EMRA 96

MARKET IN THE EMRA BY REGION 96

TABLE 64 PROJECTED EMRA MARKET FOR RAPID HOME-USE MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 96

FIGURE 10 MARKET SHARE FOR RAPID HOME-USE MDK IN THE EMRA, 2012 AND

2017 (%) 96

TABLE 65 PROJECTED EMRA MARKET FOR RAPID HOME-USE MDK BY DISEASE,

THROUGH 2017 ($ MILLIONS) 98

ASIA 98

Diabetes in Japan 98

Diabetes in Southeast Asia 99

Diabetes in the Western Pacific Region 99

TABLE 66 PROJECTED ASIAN MARKET FOR RAPID HOME-USE MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 99

FIGURE 11 MARKET SHARE FOR RAPID HOME-USE MDK IN ASIA, 2012 AND 2017 (%) 99

TABLE 67 PROJECTED ASIAN MARKET FOR RAPID HOME-USE MDK BY DISEASE,

THROUGH 2017 ($ MILLIONS) 101

CHAPTER 7 VETERINARY RAPID MDK APPLICATIONS 103

THE VETERINARY PRACTITIONER AND CHANGING VETERINARY PRACTICE 103

VIRAL INFECTIOUS AGENTS 103

TABLE 68 MAJOR VIRAL INFECTIOUS AGENTS 104

BACTERIAL INFECTIOUS AGENTS 105

TABLE 69 MAJOR BACTERIAL INFECTIOUS AGENTS, THE DISEASES THEY CAUSE

AND THE AVAILABLE RAPID MDK 106

PARASITIC INFECTIOUS AGENTS 106

TABLE 70 MAJOR PARASITIC INFECTIOUS AGENTS 106

COMPANION ANIMALS 107

LEISHMANOSIS 107

BORDETELLA 107

CANINE CORONAVIRUS (CCV) 107

CANINE INFLUENZA VIRUS (CIV) 107

CANINE PARVOVIRUS TYPE 2 (CPV2) 107

FELINE IMMUNODEFICIENCY VIRUS (FIV) 108

FELINE LEUKEMIA VIRUS (FELV) 108

GIARDIA 108

HEARTWORM 108

DIAGNOSTIC METHODS FOR ANIMAL DISEASES 108

TABLE 71 DIAGNOSTIC METHODS FOR SELECTED VIRAL, BACTERIAL, PARASITIC

AND OTHER CONDITIONS OF COMPANION ANIMALS 108

LIVESTOCK ANIMALS 110

AVIAN INFLUENZA 110

BOVINE TUBERCULOSIS 111

BOVINE VIRAL DIARRHEA 111

FOOT AND MOUTH DISEASE 111

PORCINE REPRODUCTIVE, RESPIRATORY SYNDROME VIRUS (PRRSV) 111

JOHNE'S DISEASE 111

TABLE 72 DIAGNOSTIC METHODS FOR SELECTED VIRAL, BACTERIAL AND OTHER

CONDITIONS OF LIVESTOCK ANIMALS 112

VETERINARY RAPID MDK TECHNOLOGY 112

LATERAL FLOW IMMUNOASSAY 113

LATEX AGGLUTINATION (LA) 113

ENZYME IMMUNOASSAY (EIA) 113

VETERINARY RAPID MDK MARKET SIZE AND STRUCTURE 113

TABLE 73 PROJECTED GLOBAL VETERINARY RAPID MDK TESTING MARKET,

THROUGH 2017 ($ MILLIONS) 114

LEADING RAPID MDK KITS 114

TABLE 74 REVENUES FOR VETERINARY RAPID DIAGNOSTICS BY TYPE, THROUGH

2017 ($ MILLIONS) 115

MARKET SHARE BY PARTICIPANT 115

FIGURE 12 GLOBAL MARKET SHARE FOR MAJOR PARTICIPANTS IN THE COMPANION

INFECTIOUS DISEASE MDK MARKET, 2011 (%) 115

FIGURE 13 GLOBAL MARKET SHARE FOR MAJOR PARTICIPANTS IN THE LIVESTOCK

INFECTIOUS DISEASE MDK MARKET, 2011 (%) 116

REGIONAL ANALYSIS 117

TABLE 75 MAJOR COMPANION ANIMAL INFECTIOUS DISEASES, BY REGION 117

TABLE 76 PROJECTED MARKET FOR RAPID MDK FOR COMPANION AND LIVESTOCK

ANIMALS BY GEOGRAPHIC REGION, THROUGH 2017 ($ MILLIONS) 117

FIGURE 14 GLOBAL MARKET SHARE FOR RAPID MDK FOR COMPANION AND

LIVESTOCK ANIMALS BY REGION, 2012 AND 2017 (%) 117

REGIONAL MARKETS FOR RAPID INFECTIOUS DISEASE MDK FOR

COMPANION ANIMALS 118

FIGURE 15 PROJECTED REGIONAL MARKETS FOR RAPID INFECTIOUS DISEASE MDK

FOR COMPANION ANIMALS, 2012 AND 2017 (%) 119

REGIONAL MARKETS FOR RAPID INFECTIOUS DISEASE MDK FOR

LIVESTOCK ANIMALS 120

FIGURE 16 PROJECTED REGIONAL MARKETS FOR RAPID INFECTIOUS DISEASE MDK

FOR LIVESTOCK ANIMALS, 2012 AND 2017 (%) 120

AMERICAS 121

Heartworm in North America 121

Canine Influenza in North America 121

FeLV 121

TABLE 77 PROJECTED MARKET FOR RAPID MDK IN THE AMERICAS, THROUGH 2017

($ MILLIONS) 121

EMRA 122

Heartworm in EMRA 122

FeLV 122

TABLE 78 PROJECTED MARKET FOR RAPID MDK IN THE EMRA, THROUGH 2017 ($

MILLIONS) 122

ASIA 123

FeLV in Asia 123

MDK in China 123

Declining Japanese Market 123

TABLE 79 PROJECTED MARKET FOR RAPID MDK IN ASIA, THROUGH 2017 ($

MILLIONS) 123

VETERINARY RAPID MDK 124

TABLE 80 VETERINARY RAPID MDK BY ANIMAL TYPE, 2012 124

CHAPTER 8 EMERGING TECHNOLOGY/PATENTS/REGULATIONS 130

EMERGING TECHNOLOGIES 130

MICROFLUIDIC PAPER-BASED PRODUCTS 130

MALARIA 130

Fyodor Biotechnologies 130

Foundation for Innovative New Diagnostics 131

CHEMBIO DIAGNOSTICS 131

DPP Hepatitis-C (HCV) Test 131

DPP Tuberculosis 132

ROCHE DIAGNOSTICS 132

RECENTLY GRANTED PATENTS FOR RAPID DIAGNOSTIC TESTS 132

TABLE 81 SELECTED LISTING OF RECENTLY GRANTED PATENTS FOR RAPID

DIAGNOSTIC TESTS, 2008-2012 132

REGULATIONS 133

FDA REGULATION 133

510(K) CLEARANCE PATHWAY 133

PMA APPROVAL PATHWAY 133

BLA APPROVAL PATHWAY 134

CLINICAL STUDIES 134

POST-MARKET REGULATION 134

CLIA CLASSIFICATION 135

Selected CLIA Approved Rapid Tests 135

TABLE 82 CLIA-WAIVED TESTS 136

GOOD MANUFACTURING PRACTICE 137

TABLE 83 PERTINENT PARAMETERS OF GMP AFFECTING MDK 138

COST CONTAINMENT EFFORTS 138

United States 138

Diagnosis Related Groups (DRGs) 138

Medicare 138

Third-Party Payers 139

REGULATION OUTSIDE THE UNITED STATES 139

CHAPTER 9 HUMAN RAPID MDK COMPANY DIRECTORY 141

ABBOTT LABORATORIES 141

ACCUTECH, LLC 141

ALERE 141

ALFA SCIENTIFIC DESIGNS 142

ANI BIOTECH OY 142

AGAMATRIX 142

APEX BIOTECHNOLOGY 143

ARKRAY USA, INC. 143

ATLAS LINK BIOTECH CO, LTD. 143

BTNX, INC. 144

BECKMAN COULTER/DANAHER 144

BECTON DICKINSON 144

BIOCARE DIAGNOSTICS, LTD 145

BIOMERICA 145

BIOMERIEUX 145

CHEMATICS 146

CHEMBIO DIAGNOSTIC SYSTEMS 146

DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS, INC. 146

DIASORIN 147

ENZO LIFE SCIENCES 147

FIRST DIAGNOSTIC LLC 147

FIRSTVUE CORP. 147

GERMAINE LABORATORIES 148

GLUCO PLUS 148

HENRY SCHEIN, INC 148

HOME DIAGNOSTICS, INC. (SEE NIPRO DIAGNOSTICS) 149

IMMUNOSTICS, INC. 149

INBIOS INTERNATIONAL, INC. 149

IND DIAGNOSTIC, INC. 149

JANT PHARMACAL CORP. 150

LIFESCAN (JOHNSON & JOHNSON DIABETES CARE) 150

LIFESIGN 150

MEDMIRA, INC. 150

MERIDIAN BIOSCIENCE 151

NIPRO DIAGNOSTICS (FORMERLY HOME DIAGNOSTICS) 151

ORASURE TECHNOLOGIES 151

PHAMATECH 151

PRINCETON BIOMEDITECH 152

QUIDEL 152

REDWOOD TOXICOLOGY 152

REMEL (THERMOFISHER SCIENTIFIC) 152

ROCHE DIAGNOSTICS 153

RUNBIO BIOTECH CO., LTD 153

SA SCIENTIFIC, INC. 153

SCI INTERNATIONAL 153

SEIKISUI DIAGNOSTICS 154

SHANGHAI KEHUA BIO-ENGINEERING CO, LTD. 154

STANBIO LABORATORY 154

STANDARD DIAGNOSTICS 154

TAIDOC 155

TRINITY BIOTECH PLC 155

UCP BIOSCIENCES 155

CHAPTER 10 VETERINARY COMPANY DIRECTORY 157

AGROLABO SPA 157

ABAXIS 157

BIOGAL-GALED LABORATORIES 157

BIONOTE/ALERE 158

CHEMBIO (SEE HUMAN MDK) 158

DIACHEMIX, LLC 158

IDEXX LABORATORIES 158

HESKA 159

MEGACOR DIAGNOSTIK, GMBH 159

SA SCIENTIFIC (SEE HUMAN MDK MANUFACTURERS) 159

SHENZHEN LVSHIYUAN BIOTECHNOLOGY CO. LTD 159

ZOETIS (FORMERLY PFIZER ANIMAL HEALTH AND SYNBIOTICS) 160

LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR RAPID MEDICAL DIAGNOSTIC KITS,

THROUGH 2017 ($ MILLIONS) 8

TABLE 1 CHARACTERISTICS OF TWO RAPID TESTING TECHNOLOGIES 17

TABLE 2 SELECTED MAJOR GLOBAL INFECTIOUS DISEASES, 2006* 19

TABLE 3 TOP 10 CAUSES OF DEATH BY INCOME GROUP, 2004* 21

TABLE 4 PROJECTED RAPID MDK MARKET BY END-USE SEGMENT, THROUGH 2017 ($

MILLIONS) 22

TABLE 5 ALTERNATIVE METHODS TO MDKS AND AREAS OF PRIMARY USE 22

TABLE 6 SELECTED MERGERS AND ACQUISITIONS IN THE RAPID MDK MARKET,

JANUARY 2007–FEBRUARY 2013 24

TABLE 7 MAJOR MDK APPLICATIONS BY TYPE OF TECHNOLOGY AND ITS USES 26

TABLE 8 MARKET SHARE FOR RAPID MDK, BY TEST TYPE (%) 32

TABLE 9 PROJECTED GLOBAL MARKET FOR RAPID MDK IN CLINICAL SETTINGS BY

TEST, THROUGH 2017 ($ MILLIONS) 35

TABLE 10 SELECTED LISTING OF BACTERIA FOUND IN CLINICAL SPECIMENS, THE

DISEASES THEY CAUSE AND RAPID MDK MANUFACTURERS 38

TABLE 11 SELECTED LISTING OF VIRUSES FOUND IN CLINICAL SPECIMENS, THE

DISEASES THEY CAUSE AND RAPID MDK MANUFACTURERS 39

TABLE 12 SELECTED LISTING OF RAPID MDK GASTROINTESTINAL TESTS, 2012 41

TABLE 13 SELECTED LISTING OF RAPID STREP TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 42

TABLE 14 SELECTED LISTING OF RAPID MONONUCLEOSIS TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 43

TABLE 15 RAPID MDK FOR HEPATITIS 44

TABLE 16 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR HEPATITIS TESTING,

THROUGH 2017 ($ MILLIONS) 45

TABLE 17 RAPID MDK FOR HIV TEST NAME, MANUFACTURER AND PROCESS TIME 46

TABLE 18 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR HIV TESTING,

THROUGH 2017 ($ MILLIONS) 46

TABLE 19 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR H. PYLORI TESTING,

THROUGH 2017 ($ MILLIONS) 47

TABLE 20 SELECTED LISTING OF RAPID H. PYLORI BLOOD TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 48

TABLE 21 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR SEXUALLY

TRANSMITTED DISEASES TESTING, THROUGH 2017 ($ MILLIONS) 49

TABLE 22 SELECTED LISTING OF RAPID MDK TESTS TO DETECT SEXUALLY

TRANSMITTED DISEASES, 2012 49

TABLE 23 PROJECTED MARKET FOR RAPID MALARIA MDK, THROUGH 2017 ($

MILLIONS) 50

TABLE 24 SELECTED LISTING OF RAPID MALARIA MDK TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 51

TABLE 25 SELECTED LISTING OF RAPID INFLUENZA A, B TESTS BY DISEASE, TEST

NAME, MANUFACTURER AND PROCESS TIME, 2012 52

TABLE 26 PROJECTED GLOBAL MARKET FOR CARDIOVASCULAR AND CHOLESTEROL

RAPID MDK, THROUGH 2017 ($ MILLIONS) 53

TABLE 27 SELECTED LISTING OF RAPID CARDIAC MARKER MDK, 2012 53

TABLE 28 SELECTED LISTING OF RAPID MDK CHOLESTEROL TESTS, 2012 54

TABLE 29 PROJECTED GLOBAL MARKET FOR RAPID MDK FOR SUBSTANCE ABUSE

TESTING, THROUGH 2017 ($ MILLIONS) 55

TABLE 30 RAPID MDK FOR SUBSTANCE ABUSE TESTING 56

TABLE 31 PROJECTED MARKET FOR RAPID CLINICAL PREGNANCY, OVULATION,

MENOPAUSE MDK, THROUGH 2017 ($ MILLIONS) 57

TABLE 32 RAPID MDK FOR CLINICAL HORMONE TESTING 59

TABLE 33 RAPID MDK FOR PREGNANCY/OVULATION 60

TABLE 34 PROJECTED GLOBAL MARKET FOR RAPID TUMOR MARKER MDK, THROUGH

2017 ($ MILLIONS) 61

TABLE 35 SELECTED LISTING OF RAPID CANCER MDK, 2012 63

TABLE 36 PROJECTED MARKET FOR OTHER RAPID MDK, THROUGH 2017 ($ MILLIONS) 64

TABLE 37 SELECTED LISTING OF RAPID BLOOD/URINE MDK TESTS, 2012 64

TABLE 38 SELECTED LISTING OF RAPID AUTOIMMUNE TESTS, 2012 65

TABLE 39 SELECTED LISTING OF RAPID FECAL OCCULT BLOOD TESTS BY TEST NAME,

MANUFACTURER AND PROCESS TIME, 2012 67

TABLE 40 PROJECTED GLOBAL MARKET FOR RAPID CLINICAL MDK BY GEOGRAPHIC

REGION, THROUGH 2017 67

TABLE 41 PROJECTED GLOBAL RAPID CLINICAL MDK MARKET BY GEOGRAPHIC

REGION AND DISEASE CATEGORY, THROUGH 2017 ($ MILLIONS) 69

TABLE 42 PROJECTED AMERICAS MARKET FOR RAPID CLINICAL MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 70

TABLE 43 PROJECTED EMRA MARKET FOR RAPID CLINICAL MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 71

TABLE 44 PROJECTED ASIAN MARKET FOR RAPID CLINICAL MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 73

TABLE 45 PROJECTED HOME-USE RAPID MDK MARKET, THROUGH 2017 ($ MILLIONS) 76

TABLE 46 SELECTED LISTING OF RAPID HOME-USE MDK ALLERGY TESTS, 2012 77

TABLE 47 PROJECTED GLOBAL MARKET FOR RAPID HOME-USE BLOOD GLUCOSE

MONITORING MDK, THROUGH 2017 ($ MILLIONS) 79

TABLE 48 RAPID HOME-USE MDK FOR BLOOD GLUCOSE MONITORING 80

TABLE 49 PROJECTED GLOBAL MARKET FOR RAPID HOME-USE RAPID CHOLESTEROL

MDK, THROUGH 2017 ($ MILLIONS) 81

TABLE 50 SELECTED LISTING OF RAPID HOME-USE MDK CHOLESTEROL TESTS, 2012 82

TABLE 51 PROJECTED GLOBAL MARKET FOR RAPID HOME-USE MDK FOR DRUG

SCREENING, THROUGH 2017 ($ MILLIONS) 83

TABLE 52 SELECTED LISTING OF RAPID HOME-USE DRUG SCREENING TESTS BY

TEST NAME, MANUFACTURER AND PROCESS TIME, 2012 83

TABLE 53 SELECTED LISTING OF RAPID MDK HOME-USE FECAL OCCULT BLOOD

TESTS, 2012 86

TABLE 54 PROJECTED GLOBAL MARKET FOR RAPID HOME-USE MDK FOR

PREGNANCY, OVULATION AND MENOPAUSE PRODUCTS, THROUGH 2017 ($

MILLIONS)

86

TABLE 55 SELECTED LISTING OF HOME-USE RAPID PREGNANCY, OVULATION AND

MENOPAUSE TESTS, 2012 87

TABLE 56 PROJECTED GLOBAL MARKET FOR HOME-USE RAPID HEPATITIS MDK,

THROUGH 2017 ($ MILLIONS) 88

TABLE 57 SELECTED LISTING OF RAPID HOME-USE MDK HEPATITIS C TESTS, 2012 88

TABLE 58 PROJECTED GLOBAL MARKET FOR HOME-USE H. PYLORI RAPID MDK,

THROUGH 2017 ($ MILLIONS) 89

TABLE 59 SELECTED LISTING OF HOME-USE RAPID MDK H. PYLORI TESTS, 2012 89

TABLE 60 SELECTED LISTING OF HOME-USE RAPID MDK HIV TESTS, 2012 90

TABLE 61 PROJECTED MARKET FOR RAPID HOME-USE MDK BY REGION, THROUGH

2017 ($ MILLIONS) 91

TABLE 62 PROJECTED AMERICAS MARKET FOR RAPID HOME-USE MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 93

TABLE 63 PROJECTED AMERICAS MARKET FOR RAPID HOME-USE MDK BY DISEASE,

THROUGH 2017 ($ MILLIONS) 94

TABLE 64 PROJECTED EMRA MARKET FOR RAPID HOME-USE MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 96

TABLE 65 PROJECTED EMRA MARKET FOR RAPID HOME-USE MDK BY DISEASE,

THROUGH 2017 ($ MILLIONS) 98

TABLE 66 PROJECTED ASIAN MARKET FOR RAPID HOME-USE MDK BY REGION,

THROUGH 2017 ($ MILLIONS) 99

TABLE 67 PROJECTED ASIAN MARKET FOR RAPID HOME-USE MDK BY DISEASE,

THROUGH 2017 ($ MILLIONS) 101

TABLE 68 MAJOR VIRAL INFECTIOUS AGENTS 104

TABLE 69 MAJOR BACTERIAL INFECTIOUS AGENTS, THE DISEASES THEY CAUSE AND

THE AVAILABLE RAPID MDK 106

TABLE 70 MAJOR PARASITIC INFECTIOUS AGENTS 106

TABLE 71 DIAGNOSTIC METHODS FOR SELECTED VIRAL, BACTERIAL, PARASITIC AND

OTHER CONDITIONS OF COMPANION ANIMALS 108

TABLE 72 DIAGNOSTIC METHODS FOR SELECTED VIRAL, BACTERIAL AND OTHER

CONDITIONS OF LIVESTOCK ANIMALS 112

TABLE 73 PROJECTED GLOBAL VETERINARY RAPID MDK TESTING MARKET,

THROUGH 2017 ($ MILLIONS) 114

TABLE 74 REVENUES FOR VETERINARY RAPID DIAGNOSTICS BY TYPE, THROUGH

2017 ($ MILLIONS) 115

TABLE 75 MAJOR COMPANION ANIMAL INFECTIOUS DISEASES, BY REGION 117

TABLE 76 PROJECTED MARKET FOR RAPID MDK FOR COMPANION AND LIVESTOCK

ANIMALS BY GEOGRAPHIC REGION, THROUGH 2017 ($ MILLIONS) 117

TABLE 77 PROJECTED MARKET FOR RAPID MDK IN THE AMERICAS, THROUGH 2017

($ MILLIONS) 121

TABLE 78 PROJECTED MARKET FOR RAPID MDK IN THE EMRA, THROUGH 2017 ($

MILLIONS) 122

TABLE 79 PROJECTED MARKET FOR RAPID MDK IN ASIA, THROUGH 2017 ($

MILLIONS) 123

TABLE 80 VETERINARY RAPID MDK BY ANIMAL TYPE, 2012 124

TABLE 81 SELECTED LISTING OF RECENTLY GRANTED PATENTS FOR RAPID

DIAGNOSTIC TESTS, 2008-2012 132

TABLE 82 CLIA-WAIVED TESTS 136

TABLE 83 PERTINENT PARAMETERS OF GMP AFFECTING MDK 138

LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR RAPID DIAGNOSTIC KITS BY REGION, 2012

AND 2017 (%) 9

FIGURE 1 COMPONENTS OF AN MDK 11

FIGURE 2 RAPID CLINICAL MDK MARKET BY CONDITION, 2012 AND 2017 (%) 36

FIGURE 3 GLOBAL MARKET FOR RAPID CLINICAL MDK BY GEOGRAPHIC REGION,

2012 AND 2017 (%) 68

FIGURE 4 PROJECTED MARKET SHARE FOR RAPID CLINICAL MDK IN THE AMERICAS

BY REGION, 2012 AND 2017 (%) 70

FIGURE 5 PROJECTED MARKET SHARE FOR RAPID CLINICAL MDK IN THE EMRA BY

REGION, 2012 AND 2017 (%) 71

FIGURE 6 PROJECTED MARKET SHARE FOR RAPID CLINICAL MDK IN ASIA BY REGION,

2012 AND 2017 (%) 73

FIGURE 7 GLOBAL HOME-USE BLOOD GLUCOSE MONITORING MARKET BY

MANUFACTURER, 2011 (%) 78

FIGURE 8 MARKET SHARE FOR RAPID HOME-USE MDK BY REGION, 2012 AND 2017

(%) 91

FIGURE 9 MARKET SHARE FOR RAPID HOME-USE MDK IN THE AMERICAS, 2012 AND

2017 (%) 93

FIGURE 10 MARKET SHARE FOR RAPID HOME-USE MDK IN THE EMRA, 2012 AND

2017 (%) 96

FIGURE 11 MARKET SHARE FOR RAPID HOME-USE MDK IN ASIA, 2012 AND 2017 (%) 99

FIGURE 12 GLOBAL MARKET SHARE FOR MAJOR PARTICIPANTS IN THE COMPANION

INFECTIOUS DISEASE MDK MARKET, 2011 (%) 115

FIGURE 13 GLOBAL MARKET SHARE FOR MAJOR PARTICIPANTS IN THE LIVESTOCK

INFECTIOUS DISEASE MDK MARKET, 2011 (%) 116

FIGURE 14 GLOBAL MARKET SHARE FOR RAPID MDK FOR COMPANION AND

LIVESTOCK ANIMALS BY REGION, 2012 AND 2017 (%) 117

FIGURE 15 PROJECTED REGIONAL MARKETS FOR RAPID INFECTIOUS DISEASE MDK

FOR COMPANION ANIMALS, 2012 AND 2017 (%) 119

FIGURE 16 PROJECTED REGIONAL MARKETS FOR RAPID INFECTIOUS DISEASE MDK

FOR LIVESTOCK ANIMALS, 2012 AND 2017 (%) 120

Read the full report:

Global Markets for Rapid Medical Diagnostic Kits

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For more information:

Sarah Smith

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Email: query@reporbuyer.com

Tel: +44 208 816 85 48

Website: http://www.reportbuyer.com

For the original version on PRWeb visit: http://www.prweb.com/releases/2013/9/prweb11140671.htm


Source: prweb