Global Markets for Rapid Medical Diagnostic Kits

NEW YORK, July 2, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Markets for Rapid Medical Diagnostic Kits
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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 nonautomated 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 semiautomated 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

To order this report:
In_Vitro_Diagnostic Industry: Global Markets for Rapid Medical Diagnostic Kits


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