1. Market Research
  2. > Healthcare
  3. > Medical Device
  4. > In Vitro Diagnostics Market Trends
  5. > In Vitro Diagnostics: Technologies and Global Markets

In Vitro Diagnostics: Technologies and Global Markets

  • November 2015
  • -
  • BCC Research
  • -
  • 192 pages

This BCC Research report offers a comprehensive analysis of the global in-vitro diagnostic market, along with an in-depth study of the various IVD segments. Includes forecast through 2020.

Use this report to:

Identify emerging products and technologies and associated start-ups that are likely to accelerate the growth of the IVD industry through best practices in the research and development of IVDs.

Outline the global market for IVD products by segments such as region, diagnostics types, application, and industry end user.

Have a close look at the IVD industry and current trends affecting the market.

Assess technology patents and trends relating to IVD.

Highlights

The global market for in vitro diagnostics (IVD) products totaled $57.3 billion in 2014. The market is expected to grow from $60.3 billion in 2015 to $81.1 billion by 2020 at a compound annual growth rate (CAGR) of 6.1%.

North America leads the global IVD products market throughout the period, valued at $24.6 billion in 2014. The market should reach $29.4 billion in 2020 from $25.3 billion in 2015 increasing at a CAGR of 3.1%.

Asia is the fastest growing region of global IVD market with a CAGR of 12.9% from 2015 to 2020. The market is valued at $15.3 billion in 2015 and should reach $28.2 billion by 2020.

STUDY GOALS AND OBJECTIVES

along with an in-depth study of the various IVD segments (clinical chemistry, immunoassays, point-of-care diagnostics, molecular diagnostics, hematology, microbiology and tissue diagnostics); products (instruments, reagents and accessory products); end-user groups (central labs, critical care, OTC/self-testing and academia);
and the regional markets of North America, Europe, Asia and LAAM (Latin America/Africa/Middle East).

This report provides a complete review and analysis of the current trends in the IVD markets, along with industry growth drivers and restraints. Revenues are broken down by regions, segments, products and end users, and sales figures have been estimated for the five-year period from 2015 through 2020 in constant U.S. dollars.

In addition, it provides an examination and description of select products, current and emerging technologies, and company profiles. Applications for IVD are also discussed, with emphasis of the use of these types of tests in various disease sectors. Further, the report offers a view on IVD patents, regulatory aspects and emerging developments in the IVD market across the globe.

REASONS FOR DOING THIS STUDY

In vitro diagnostic tests performed on biological samples, such as blood, urine, saliva, spinal fluid and DNA, are a key component of health care delivery. The information provided by IVD tests enable medical care providers to manage several diseases through timely prevention, diagnosis and decision making, and by administering
patient-specific treatment modalities.

Due to recent rapid technological advances and automation, the range and complexity of diagnostic tests have overwhelmingly increased. This has made lab tests much easier to use and less error prone, with more precise and timelier results, thus transforming medical practice. As a result of these rapid innovations, disease detection
has been made possible much before the appearance of symptoms, along with the prediction of beneficial and adverse treatment outcomes. These developments have in turn enabled personalized treatment through the emergence of point-of-care (POC) tests and home-based testing in the form of blood glucose meters for diabetics,
pregnancy tests and cholesterol tests. These tests facilitate more rapid decision-making, especially for management of major chronic diseases such as diabetes, hypertension or cardiovascular conditions. Instead of a patient having to wait for test results and schedule his or her next visit, test values for key biochemical
parameters (such as, for example, HbA1c or lipid profiles), are generated the same day, allowing a doctor to make treatment decisions during the same visit. In addition, new tests have become less invasive, easier to perform and more patient friendly. Likewise, for critical care, POC tests enable doctors to make life-saving decisions within minutes, as opposed to waiting for hours for test data that was once available only from a
central lab.

Today, more than 4,000 different diagnostic tests have become available, and as more IVD tests become compatible with POC environments, health care providers should take advantage of the benefits of these evolving IVDs for effective treatment of life-threatening illnesses through optimization of healthcare delivery. IVDs have
already tremendously impacted cancer diagnosis and treatment globally by gaining deeper insights into genetic pathways of the disease enabled by human genome sequencing. As a result, identifying faulty genes, personalized risk predictions and tailored therapies have now become possible.

Big challenges need to be addressed, however, despite IVDs being at the top of global market attractiveness index. The regional and country-wise differences in regulatory aspects, market approvals and entry bottlenecks, affordability issues, reimbursement inadequacies, logistics and healthcare infrastructure may hold the market back. Due to these factors, the IVD companies need to look at each country’s market landscape and IVD requirements, and then tailor their entries, launch and marketing strategies to gain a strong foot hold. This BCC Research report, In Vitro Diagnostics: Technologies and Global Markets, will thereby provide a detailed analysis of these and other key factors governing the growth of IVD industry, and provide strategic insights and recommendations for those looking to expand their markets.

Table Of Contents

In Vitro Diagnostics: Technologies and Global Markets
IN VITRO DIAGNOSTICS: TECHNOLOGIES AND GLOBAL MARKETS
HLC186A
November 2015
Sangeetha Prabakar
Project Analyst
ISBN: 1-62296-178-1
BCC Research
49 Walnut Park, Building 2
ormation@bccresearch.com
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
CONTRIBUTION OF THE STUDY AND FOR WHOM 3
SCOPE OF REPORT 3
METHODOLOGY 4
ANALYST'S CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 5
BCC RESEARCH WEBSITE 5
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
INTRODUCTION 7
GLOBAL MARKET TRENDS 7
SUMMARY TABLE GLOBAL IVD MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL IVD MARKET BY REGION, 2013-2020 ($ MILLIONS) 9
CHAPTER 3 MARKET LANDSCAPE 11
MARKET OVERVIEW AND SEGMENTATION 11
FIGURE 1 MARKET SEGMENTATION 11
KEY FINDINGS 11
FACTORS INFLUENCING THE GLOBAL IVD MARKET 13
DRIVERS 13
Need for Disease Detection before Appearance of Symptoms 13
Need to Identify the Right Patients for Drug Therapy 13
Need for Faster Real-Time Tests that Enable Personalized Treatment 13
Point-of-Care Tests that Minimize Dependency on Lab Testing 14
Improving Healthcare Budgets Drive Demand for IVD in Emerging
Markets 14
Rising Aging Population and Global Incidence of Chronic Diseases 14
Discovery of New Biomarkers and Advances in Molecular Techniques 15
Public and Environmental Health Monitoring Requires the Use of IVDs
for Faster Diagnosis and Treatment 15
RESTRAINTS 16
Declining Reimbursement for IVDs in Europe Reduces Growth 16
U.S. Medical Device Tax Reduces Profits for Manufacturers 16
Stringent Regulatory Framework to Stifle the Growth of IVD Market 16
High RandD and Marketing Costs 17
Regulatory Disparities and the Expansion of Laboratory-developed
Tests 17
REGULATORY LANDSCAPE 18
IVD REGULATIONS IN NORTH AMERICA 18
U.S. 18
TABLE 1 TYPES OF DIAGNOSTIC TESTS AND HOW THEY ARE REGULATED 18
Canada 19
IVD REGULATIONS IN EUROPE 19
IVD REGULATIONS IN ASIA 20
Japan 20
China 20
India 21
Australia and New Zealand 21
Malaysia 22
Singapore 22
TABLE 2 CHANGES IN IVD REGULATIONS IN ASIA 23
IVD REGULATIONS IN LAAM 23
Brazil 23
Mexico 24
Israel 25
Saudi Arabia 25
South Africa 25
CHAPTER 4 GLOBAL IVD MARKET BY SUBCATEGORIES 28
INTRODUCTION 28
DESCRIPTION 28
IMMUNOCHEMISTRY 28
POC TESTING 28
MOLECULAR DIAGNOSTICS 28
HEMATOLOGY 28
CLINICAL MICROBIOLOGY 29
TISSUE DIAGNOSTICS 29
TRENDS IN IVD SEGMENTS 29
TABLE 3 GLOBAL IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 30
FIGURE 2 GLOBAL IVD MARKET BY SEGMENT, 2013-2020 ($ MILLIONS) 30
FIGURE 3 GLOBAL IVD MARKET SHARE BY SEGMENT, 2014 (%) 31
COMPETITIVE STRUCTURE 31
MARKET SHARE ANALYSIS 31
TABLE 4 MAJOR IVD MARKET COMPANIES, 2014 ($ MILLIONS) 32
FIGURE 4 MARKET SHARE OF MAJOR IVD MARKET COMPANIES, 2014 (%) 33
CHAPTER 5 GLOBAL IMMUNOCHEMISTRY MARKET 35
APPLICATIONS 37
BLOOD GAS, ELECTROLYTES AND METABOLITES (BGEM) 37
ENDOCRINE 37
INFECTIOUS DISEASES 37
CANCER 38
URINALYSIS 38
DIABETES 38
CARDIOLOGY 39
BLOOD SCREENING 39
OTHERS 40
TABLE 5 GLOBAL IMMUNOCHEMISTRY MARKET BY APPLICATION THROUGH 2020 ($
MILLIONS) 40
FIGURE 5 GLOBAL IMMUNOCHEMISTRY MARKET SHARE BY APPLICATION, 2014 (%) 40
TABLE 6 GLOBAL IMMUNOCHEMISTRY MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 42
FIGURE 6 GLOBAL IMMUNOCHEMISTRY MARKET BY REGION, 2013-2020 ($
MILLIONS) 42
CHAPTER 6 GLOBAL POC TESTING MARKET 44
APPLICATIONS 45
GLUCOSE TESTING 45
BGEM 46
CARDIAC MARKER TESTING 46
INFECTIOUS DISEASE TESTING 46
PREGNANCY AND FERTILITY TESTING 46
DRUG AND ALCOHOL ABUSE TESTING 47
HEMATOLOGY AND HEMOSTASIS TESTING 47
CHOLESTEROL TESTING 47
URINE CHEMISTRY TESTING 48
TUMOR MARKER TESTING 48
OTHER POC TESTING 48
TABLE 7 GLOBAL POC TESTING MARKET BY APPLICATION, THROUGH 2020 ($
MILLIONS) 49
FIGURE 7 GLOBAL POC TESTING MARKET BY APPLICATION, 2013-2020 ($ MILLIONS) 49
FIGURE 8 GLOBAL POC TESTING MARKET SHARE BY APPLICATION, 2014 (%) 49
TABLE 8 GLOBAL POC TESTING MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 51
FIGURE 9 GLOBAL POC TESTING MARKET BY REGION, 2013-2020 ($ MILLIONS) 51
CHAPTER 7 GLOBAL HEMATOLOGY MARKET 53
APPLICATIONS 55
ROUTINE HEMATOLOGY TESTS 55
HEMOSTASIS 56
TABLE 9 GLOBAL HEMATOLOGY MARKET BY APPLICATION, THROUGH 2020 ($
MILLIONS) 56
FIGURE 10 GLOBAL HEMATOLOGY MARKET BY APPLICATION, 2013-2020 ($
MILLIONS) 56
FIGURE 11 GLOBAL HEMATOLOGY MARKET SHARE BY APPLICATION, 2014 (%) 57
FIGURE 12 GLOBAL HEMATOLOGY MARKET SHARE BY TECHNIQUE, 2014 (%) 58
FIGURE 13 GLOBAL HEMATOLOGY MARKET SHARE BY TECHNIQUE, 2014 (%) 58
TABLE 10 GLOBAL HEMATOLOGY MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 59
FIGURE 14 GLOBAL HEMATOLOGY MARKET BY REGION, 2013-2020 ($ MILLIONS) 59
CHAPTER 8 GLOBAL MOLECULAR DIAGNOSTICS MARKET 61
APPLICATIONS 63
INFECTIOUS DISEASES 63
BLOOD SCREENING 63
ONCOLOGY 63
GENETIC TESTING 64
OTHERS (COMPANION DIAGNOSTICS, PRENATAL GENETIC TESTS AND
RARE DISEASES) 65
TABLE 11 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY APPLICATION THROUGH
2020 ($MILLIONS) 65
FIGURE 15 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY APPLICATION,
2013-2020 ($ MILLIONS) 65
FIGURE 16 GLOBAL MOLECULAR DIAGNOSTICS MARKET SHARE BY APPLICATION,
2014 (%) 66
FIGURE 17 GLOBAL INFECTIOUS DISEASE MOLECULAR DIAGNOSTICS MARKET
SHARE BY DISEASE, 2014 (%) 67
FIGURE 18 COMPANION DIAGNOSTIC TESTS BY YEAR APPROVED, 1994-2014 (NO.
OF TESTS) 68
TABLE 12 COMPANION DIAGNOSTIC TESTS MANUFACTURERS BY NUMBER OF
TESTS, 2013 69
TABLE 13 FDA-APPROVED NUCLEIC ACID BASED TESTS FOR GENETIC CONDITIONS 69
TABLE 14 FDA-APPROVED COMPANION DIAGNOSTIC TESTS 71
TABLE 15 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY REGION, THROUGH
2020 ($ MILLIONS) 73
FIGURE 19 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY REGION, 2013-2020 ($
MILLIONS) 73
CHAPTER 9 GLOBAL CLINICAL MICROBIOLOGY MARKET 75
APPLICATIONS 76
BLOOD CULTURE 76
GENERAL CULTURE (URINE/SALIVA/STOOL/SPUTUM/CSF AND OTHER BODY
FLUIDS) 77
IDENTIFICATION AND ANTIBIOTIC SUSCEPTIBILITY TESTING 77
TABLE 16 GLOBAL CLINICAL MICROBIOLOGY MARKET BY APPLICATION, THROUGH
2020 ($ MILLIONS) 77
FIGURE 20 GLOBAL CLINICAL MICROBIOLOGY MARKET BY APPLICATION, 2013-2020
($ MILLIONS) 77
FIGURE 21 GLOBAL CLINICAL MICROBIOLOGY MARKET SHARE BY APPLICATION,
2014 (%) 78
TABLE 17 GLOBAL CLINICAL MICROBIOLOGY MARKET BY REGION, THROUGH 2020
($ MILLIONS) 79
FIGURE 22 GLOBAL CLINICAL MICROBIOLOGY MARKET BY REGION, 2013-2020 ($
MILLIONS) 79
CHAPTER 10 GLOBAL TISSUE DIAGNOSTICS MARKET 81
APPLICATIONS 82
CANCER DIAGNOSIS 82
TISSUE TYPING 83
PATHOGEN DETECTION 83
TABLE 18 GLOBAL TISSUE DIAGNOSTICS MARKET BY APPLICATION, THROUGH
2020 ($ MILLIONS) 84
FIGURE 23 GLOBAL TISSUE DIAGNOSTICS MARKET BY APPLICATION, 2013-2020 ($
MILLIONS) 84
FIGURE 24 GLOBAL TISSUE DIAGNOSTICS MARKET SHARE BY APPLICATION, 2014
(%) 85
TABLE 19 GLOBAL TISSUE DIAGNOSTICS MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 85
FIGURE 25 GLOBAL TISSUE DIAGNOSTICS MARKET BY REGION, 2013-2020 ($
MILLIONS) 85
CHAPTER 11 GLOBAL IVD MARKET BY END USERS 88
INTRODUCTION 88
TRENDS 88
FIGURE 26 GLOBAL IVD MARKET SHARE BY END USER, 2014 (%) 89
CHAPTER 12 GLOBAL IVD MARKET PRODUCTS 91
INTRODUCTION 91
TRENDS 91
FIGURE 27 GLOBAL IVD MARKET SHARE BY PRODUCT TYPE, 2014 (%) 92
CHAPTER 13 REGIONAL ANALYSIS 95
INTRODUCTION 95
NORTH AMERICA 95
EUROPE 95
ASIA 96
LAAM 96
INTERNATIONAL HEALTH EXPENDITURE AND TRENDS 96
FIGURE 28 TOTAL HEALTH EXPENDITURE AS A PERCENTAGE OF GDP FOR THE TOP
INDUSTRIALIZED ECONOMIES, 2010 (%) 97
TABLE 20 GLOBAL IVD MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 98
FIGURE 29 GLOBAL IVD MARKET SHARE BY REGION, 2014 (%) 99
NORTH AMERICA 99
TABLE 21 NORTH AMERICA IVD MARKET BY COUNTRY, THROUGH 2020 ($
MILLIONS) 100
FIGURE 30 NORTH AMERICA IVD MARKET SHARE BY COUNTRY, 2014 (%) 100
TABLE 22 NORTH AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($
MILLIONS) 101
U.S. 101
TABLE 23 U.S. IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 102
CANADA 102
TABLE 24 CANADA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 102
EUROPE 103
WESTERN EUROPE (WE) 103
CENTRAL AND EASTERN EUROPE (CEE) 103
TABLE 25 EUROPE IVD MARKET BY COUNTRY, THROUGH 2020 ($ MILLIONS) 104
FIGURE 31 EUROPE IVD MARKET SHARE BY COUNTRY, 2014 (%) 104
FIGURE 32 WE IVD MARKET SHARE BY COUNTRY, 2014 (%) 105
FIGURE 33 CEE IVD MARKET SHARE BY COUNTRY, 2014 (%) 106
TABLE 26 EUROPE IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 107
WESTERN EUROPE 107
GERMANY 107
TABLE 27 GERMANY IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 108
FRANCE 108
TABLE 28 FRANCE IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 108
ITALY 109
TABLE 29 ITALY IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 109
SPAIN 109
TABLE 30 SPAIN IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 110
U.K. 110
TABLE 31 U.K. IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 110
OTHERS 111
TABLE 32 OTHERS IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 111
CENTRAL AND EASTERN EUROPE 112
TURKEY 112
TABLE 33 TURKEY IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 112
RUSSIA 112
TABLE 34 RUSSIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 113
POLAND 113
TABLE 35 POLAND IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 113
GREECE 114
TABLE 36 GREECE IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 114
CZECH REPUBLIC 114
TABLE 37 CZECH REPUBLIC IVD MARKET BY SEGMENT, THROUGH 2020 ($
MILLIONS) 115
OTHERS 115
TABLE 38 OTHERS IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 115
ASIA 116
TABLE 39 ASIA IVD MARKET BY COUNTRY, THROUGH 2020 ($ MILLIONS) 116
FIGURE 34 ASIA IVD MARKET SHARE BY COUNTRY, 2013-2020 (%) 116
TABLE 40 ASIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 118
JAPAN 118
TABLE 41 JAPAN IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 119
CHINA 119
TABLE 42 CHINA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 120
AUSTRALIA 120
TABLE 43 AUSTRALIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 121
INDIA 121
TABLE 44 INDIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 123
SOUTH KOREA 123
TABLE 45 SOUTH KOREA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 124
TAIWAN 124
TABLE 46 TAIWAN IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 125
REST OF ASIA 125
TABLE 47 REST OF ASIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 125
LATIN AMERICA, AFRICA AND MIDDLE EAST (LAAM) 126
TABLE 48 LAAM IVD MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 127
TABLE 49 LAAM IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 127
LATIN AMERICA 127
TABLE 50 LATIN AMERICA IVD MARKET BY COUNTRY, THROUGH 2020 ($ MILLIONS) 128
FIGURE 35 LATIN AMERICA IVD MARKET SHARE BY COUNTRY, 2014 (%) 128
TABLE 51 LATIN AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 129
BRAZIL 129
TABLE 52 BRAZIL IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 130
MEXICO 130
TABLE 53 MEXICO IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 131
REST OF LATIN AMERICA 131
TABLE 54 REST OF LATIN AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($
MILLIONS) 131
MIDDLE EAST AND AFRICA (MEA) 132
TABLE 55 MIDDLE EAST AND AFRICA IVD MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 133
FIGURE 36 MIDDLE EAST AND AFRICA IVD MARKET SHARE BY REGION, 2014 (%) 133
TABLE 56 MIDDLE EAST AND AFRICA IVD MARKET BY SEGMENT, THROUGH 2020 ($
MILLIONS) 134
CHAPTER 14 EMERGING GLOBAL TECHNOLOGY TRENDS AND DEVELOPMENTS 136
TRENDS 136
INDUSTRY DEVELOPMENTS 137
RAPID FINGER PRICK EBOLA TEST 137
ROCHE DIAGNOSTICS' ELECSYS HTLV-I/II 137
HIV COMBO ASSAY 138
BLOOD-BASED GENETIC ASSAY 138
PORTABLE MOLECULAR DIAGNOSTICS SYSTEM GENEXPERT OMNI 138
NEW INSTRUMENTS AND ASSAYS AT AACC 2015 138
INOVA DIAGNOSTICS' QUANTA FLASH ASSAYS 139
LEADCARE PLUS CLINICAL LEAD ANALYZER 139
DIAGNOSTIC TEST TO DIFFERENTIATE BETWEEN TYPES OF HIV
INFECTIONS 139
IMMUNOCHEMICAL POC TESTING IN FIVE MINUTES 140
ASSAYS FOR DETECTING FOODBORNE PATHOGENS 140
TEST TO DETECT PATHOGENIC C. DIFFICILE 140
MOLECULAR DIAGNOSTIC TESTS FOR ONCOLOGY 141
RAPID DIAGNOSTIC TEST FOR MALARIA 141
EMERGING APPROACHES TO DIAGNOSIS OF MALARIA 141
TABLE 57 EMERGING APPROACHES TO MALARIA DIAGNOSIS 142
MALARIA IVD TECHNOLOGIES IN DEVELOPMENT 142
TABLE 58 MALARIA DIAGNOSTIC TECHNOLOGIES UNDER DEVELOPMENT 143
TABLE 59 IVD PRODUCT APPROVALS, 2014-2015 144
ACADEMIC RESEARCH AND DEVELOPMENT 151
RAPID TECHNIQUE TO DETECT DISEASE-CAUSING DNA 151
SALIVA TEST TO PREDICT ALZHEIMER'S DISEASE 151
MOBILE DNA TEST FOR CHLAMYDIA 151
BLOOD TEST FOR VIRAL INFECTIONS 152
RAPID IVD FOR DENGUE 152
CHAPTER 15 TECHNOLOGY DEVELOPMENT OPPORTUNITIES IN IVD INDUSTRY 154
OPPORTUNITY AREAS 154
IVD FOR NEGLECTED INFECTIOUS DISEASES 154
PORTABLE DEVICES COMPATIBLE WITH SIMPLE DETECTION PLATFORMS 154
CHEMISTRY-BASED PORTABLE ANALYZERS 155
IMPROVED SAMPLE PRESERVATION TECHNOLOGIES 155
NEW DETECTION TECHNOLOGIES 156
ALTERNATIVE TECHNOLOGIES TO PCR 157
KEY BIOMARKERS FOR DISEASES OF THE DEVELOPING WORLD 158
FIGURE 37 BIOMARKER RELATED PUBLICATIONS, 2009-2014 (NO. OF
PUBLICATIONS) 158
FIGURE 38 BIOMARKER-BASED TESTS CLEARED BY 510(K), 2009-2014 (NO. OF
BIOMARKER-BASED TESTS) 160
TABLE 60 BIOMARKER-BASED TESTS RELEASED PER COMPANY, 2013 (NO. OF
TESTS) 160
FIGURE 39 BIOMARKERS IN FDA-CLEARED TESTS, 2010-2014 (NO. OF TESTS
CLEARED) 161
MICROFLUIDIC PLATFORM BASED POC TESTS FOR REMOTE SETTINGS 162
COMBINING MULTIPLE DETECTION TECHNOLOGIES INTO A SINGLE
INSTRUMENT 163
CHAPTER 16 FUNDING ANALYSIS AND INDUSTRY ACTIVITY 166
PUBLIC FUNDING 166
EUROPE 166
U.S. 166
FIGURE 40 NCI'S FUNDING SHARE FOR IVDS AND VARIOUS OTHER DISCIPLINES,
2014 (%) 167
SWISS-BASED SERI FUNDS EBOLA DIAGNOSTICS WORK BY FIND 168
EUROPEAN UNION AWARD FOR FABPULOUS BV FOR CARDIAC IVD 168
PRIVATE FUNDING 168
CANADIAN START-UP XAGENIC RECEIVES SERIES B VC FUNDING 168
BLOOD-BASED IVD FOR CANCER 169
OPTICS-BASED IVD 169
IVD FOR LIVER DISEASES 169
DNA-BASED IVD FOR PRENATAL AND CANCER TESTING 169
IVD FOR ORAL CANCER 170
IVD FOR BLADDER CANCER 170
TESTS FOR INFECTIOUS DISEASES AND CANCERS 170
TAIWAN-BASED MOLECULAR DIAGNOSTICS FIRM RECEIVES PRIVATE
FUNDING 171
MERGERS AND ACQUISITIONS 171
FIGURE 41 IVD MERGERS AND ACQUISITIONS, 2012-2015 (NO. OF DEALS) 172
FIGURE 42 SHARE OF MERGERS AND ACQUISITIONS BY CATEGORY, 2012-2015 (%) 172
TABLE 61 MERGERS AND ACQUISITIONS, 2012-JUNE 2015 173
CHAPTER 17 PATENT LANDSCAPE 181
FIGURE 43 PATENTS BY PUBLICATION DATE, 2012-JUNE 2015 (NUMBERS) 182
FIGURE 44 PATENTS BY SUBSEGMENT AND PUBLICATION DATE, 2012-JUNE 2015
(NUMBERS) 182
IMMUNOASSAYS 183
FIGURE 45 IMMUNOASSAYS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015
(NUMBERS) 184
CLINICAL CHEMISTRY 184
FIGURE 46 CLINICAL CHEMISTRY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE
2015 (NUMBERS) 185
POC TESTING 185
FIGURE 47 POCT PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 (NUMBERS) 186
MOLECULAR DIAGNOSTICS 187
FIGURE 48 MOLECULAR DIAGNOSTICS PATENT DISTRIBUTION BY SECTOR,
2011-JUNE 2015 (NUMBERS) 187
MICROBIOLOGY 188
FIGURE 49 MICROBIOLOGY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015*
(NUMBERS) 188
HEMATOLOGY 189
FIGURE 50 HEMATOLOGY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015
(NUMBERS) 189
TISSUE DIAGNOSTICS 190
FIGURE 51 TISSUE DIAGNOSTICS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE
2015 (NUMBERS) 190
CHAPTER 18 COMPANY PROFILES 193
ABBOTT DIAGNOSTICS INC. 193
GEOGRAPHIC REACH 193
GLOBAL REACH 193
SALES AND MARKETING 193
STRATEGY 194
ALERE SAN DIEGO INC. 194
GEOGRAPHIC REACH 194
SALES AND MARKETING 195
STRATEGY 195
BAYER DIABETES CARE (NOW PART OF PANASONIC HEALTHCARE) 195
BECKMAN COULTER (PART OF DANAHER) 196
GEOGRAPHIC REACH 196
OPERATIONS 196
SALES AND MARKETING 197
STRATEGY 197
BECTON DICKINSON 197
STRATEGY 198
BIOMERIEUX 198
GLOBAL REACH 198
SALES AND MARKETING 199
STRATEGY 199
BIORAD 199
SALES AND MARKETING 200
ELITECH GROUP 200
HOLOGIC INC. 200
SALES AND MARKETING 201
KEM-EN-TEC DIAGNOSTICS A/S 201
ORTHO CLINICAL DIAGNOSTICS 202
ROCHE DIAGNOSTICS CORP. 202
GEOGRAPHIC REACH 203
SALES AND MARKETING 203
FINANCIAL PERFORMANCE 203
STRATEGY 203
SIEMENS HEALTHCARE DIAGNOSTICS INC. 204
GEOGRAPHIC REACH 204
SALES AND MARKETING 204
STRATEGY 205
SYSMEX 205
THERMO FISHER SCIENTIFIC INC. 205
STRATEGY 206
TRANSASIA BIO-MEDICALS 206
WERFEN GROUP 207
CHAPTER 19 APPENDIX 209
LIST OF IVD MARKET PARTICIPANTS 209
LIST OF ABBREVIATIONS 210

LIST OF TABLES

SUMMARY TABLE GLOBAL IVD MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 8
TABLE 1 TYPES OF DIAGNOSTIC TESTS AND HOW THEY ARE REGULATED 18
TABLE 2 CHANGES IN IVD REGULATIONS IN ASIA 23
TABLE 3 GLOBAL IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 30
TABLE 4 MAJOR IVD MARKET COMPANIES, 2014 ($ MILLIONS) 32
TABLE 5 GLOBAL IMMUNOCHEMISTRY MARKET BY APPLICATION THROUGH 2020 ($
MILLIONS) 40
TABLE 6 GLOBAL IMMUNOCHEMISTRY MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 42
TABLE 7 GLOBAL POC TESTING MARKET BY APPLICATION, THROUGH 2020 ($
MILLIONS) 49
TABLE 8 GLOBAL POC TESTING MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 51
TABLE 9 GLOBAL HEMATOLOGY MARKET BY APPLICATION, THROUGH 2020 ($
MILLIONS) 56
TABLE 10 GLOBAL HEMATOLOGY MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 59
TABLE 11 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY APPLICATION THROUGH
2020 ($MILLIONS) 65
TABLE 12 COMPANION DIAGNOSTIC TESTS MANUFACTURERS BY NUMBER OF TESTS,
2013 69
TABLE 13 FDA-APPROVED NUCLEIC ACID BASED TESTS FOR GENETIC CONDITIONS 69
TABLE 14 FDA-APPROVED COMPANION DIAGNOSTIC TESTS 71
TABLE 15 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY REGION, THROUGH 2020
($ MILLIONS) 73
TABLE 16 GLOBAL CLINICAL MICROBIOLOGY MARKET BY APPLICATION, THROUGH
2020 ($ MILLIONS) 77
TABLE 17 GLOBAL CLINICAL MICROBIOLOGY MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 79
TABLE 18 GLOBAL TISSUE DIAGNOSTICS MARKET BY APPLICATION, THROUGH 2020
($ MILLIONS) 84
TABLE 19 GLOBAL TISSUE DIAGNOSTICS MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 85
TABLE 20 GLOBAL IVD MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 98
TABLE 21 NORTH AMERICA IVD MARKET BY COUNTRY, THROUGH 2020 ($ MILLIONS) 100
TABLE 22 NORTH AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 101
TABLE 23 U.S. IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 102
TABLE 24 CANADA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 102
TABLE 25 EUROPE IVD MARKET BY COUNTRY, THROUGH 2020 ($ MILLIONS) 104
TABLE 26 EUROPE IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 107
TABLE 27 GERMANY IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 108
TABLE 28 FRANCE IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 108
TABLE 29 ITALY IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 109
TABLE 30 SPAIN IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 110
TABLE 31 U.K. IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 110
TABLE 32 OTHERS IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 111
TABLE 33 TURKEY IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 112
TABLE 34 RUSSIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 113
TABLE 35 POLAND IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 113
TABLE 36 GREECE IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 114
TABLE 37 CZECH REPUBLIC IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 115
TABLE 38 OTHERS IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 115
TABLE 39 ASIA IVD MARKET BY COUNTRY, THROUGH 2020 ($ MILLIONS) 116
TABLE 40 ASIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 118
TABLE 41 JAPAN IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 119
TABLE 42 CHINA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 120
TABLE 43 AUSTRALIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 121
TABLE 44 INDIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 123
TABLE 45 SOUTH KOREA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 124
TABLE 46 TAIWAN IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 125
TABLE 47 REST OF ASIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 125
TABLE 48 LAAM IVD MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 127
TABLE 49 LAAM IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 127
TABLE 50 LATIN AMERICA IVD MARKET BY COUNTRY, THROUGH 2020 ($ MILLIONS) 128
TABLE 51 LATIN AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 129
TABLE 52 BRAZIL IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 130
TABLE 53 MEXICO IVD MARKET BY SEGMENT, THROUGH 2020 ($ MILLIONS) 131
TABLE 54 REST OF LATIN AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($
MILLIONS) 131
TABLE 55 MIDDLE EAST AND AFRICA IVD MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 133
TABLE 56 MIDDLE EAST AND AFRICA IVD MARKET BY SEGMENT, THROUGH 2020 ($
MILLIONS) 134
TABLE 57 EMERGING APPROACHES TO MALARIA DIAGNOSIS 142
TABLE 58 MALARIA DIAGNOSTIC TECHNOLOGIES UNDER DEVELOPMENT 143
TABLE 59 IVD PRODUCT APPROVALS, 2014-2015 144
TABLE 60 BIOMARKER-BASED TESTS RELEASED PER COMPANY, 2013 (NO. OF TESTS) 160
TABLE 61 MERGERS AND ACQUISITIONS, 2012-JUNE 2015 173

LIST OF FIGURES

SUMMARY FIGURE GLOBAL IVD MARKET BY REGION, 2013-2020 ($ MILLIONS) 9
FIGURE 1 MARKET SEGMENTATION 11
FIGURE 2 GLOBAL IVD MARKET BY SEGMENT, 2013-2020 ($ MILLIONS) 30
FIGURE 3 GLOBAL IVD MARKET SHARE BY SEGMENT, 2014 (%) 31
FIGURE 4 MARKET SHARE OF MAJOR IVD MARKET COMPANIES, 2014 (%) 33
FIGURE 5 GLOBAL IMMUNOCHEMISTRY MARKET SHARE BY APPLICATION, 2014 (%) 40
FIGURE 6 GLOBAL IMMUNOCHEMISTRY MARKET BY REGION, 2013-2020 ($ MILLIONS) 42
FIGURE 7 GLOBAL POC TESTING MARKET BY APPLICATION, 2013-2020 ($ MILLIONS) 49
FIGURE 8 GLOBAL POC TESTING MARKET SHARE BY APPLICATION, 2014 (%) 49
FIGURE 9 GLOBAL POC TESTING MARKET BY REGION, 2013-2020 ($ MILLIONS) 51
FIGURE 10 GLOBAL HEMATOLOGY MARKET BY APPLICATION, 2013-2020 ($ MILLIONS) 56
FIGURE 11 GLOBAL HEMATOLOGY MARKET SHARE BY APPLICATION, 2014 (%) 57
FIGURE 12 GLOBAL HEMATOLOGY MARKET SHARE BY TECHNIQUE, 2014 (%) 58
FIGURE 13 GLOBAL HEMATOLOGY MARKET SHARE BY TECHNIQUE, 2014 (%) 58
FIGURE 14 GLOBAL HEMATOLOGY MARKET BY REGION, 2013-2020 ($ MILLIONS) 59
FIGURE 15 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY APPLICATION, 2013-2020
($ MILLIONS) 65
FIGURE 16 GLOBAL MOLECULAR DIAGNOSTICS MARKET SHARE BY APPLICATION,
2014 (%) 66
FIGURE 17 GLOBAL INFECTIOUS DISEASE MOLECULAR DIAGNOSTICS MARKET
SHARE BY DISEASE, 2014 (%) 67
FIGURE 18 COMPANION DIAGNOSTIC TESTS BY YEAR APPROVED, 1994-2014 (NO.
OF TESTS) 68
FIGURE 19 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY REGION, 2013-2020 ($
MILLIONS) 73
FIGURE 20 GLOBAL CLINICAL MICROBIOLOGY MARKET BY APPLICATION, 2013-2020
($ MILLIONS) 77
FIGURE 21 GLOBAL CLINICAL MICROBIOLOGY MARKET SHARE BY APPLICATION,
2014 (%) 78
FIGURE 22 GLOBAL CLINICAL MICROBIOLOGY MARKET BY REGION, 2013-2020 ($
MILLIONS) 79
FIGURE 23 GLOBAL TISSUE DIAGNOSTICS MARKET BY APPLICATION, 2013-2020 ($
MILLIONS) 84
FIGURE 24 GLOBAL TISSUE DIAGNOSTICS MARKET SHARE BY APPLICATION, 2014 (%) 85
FIGURE 25 GLOBAL TISSUE DIAGNOSTICS MARKET BY REGION, 2013-2020 ($
MILLIONS) 85
FIGURE 26 GLOBAL IVD MARKET SHARE BY END USER, 2014 (%) 89
FIGURE 27 GLOBAL IVD MARKET SHARE BY PRODUCT TYPE, 2014 (%) 92
FIGURE 28 TOTAL HEALTH EXPENDITURE AS A PERCENTAGE OF GDP FOR THE TOP
INDUSTRIALIZED ECONOMIES, 2010 (%) 97
FIGURE 29 GLOBAL IVD MARKET SHARE BY REGION, 2014 (%) 99
FIGURE 30 NORTH AMERICA IVD MARKET SHARE BY COUNTRY, 2014 (%) 100
FIGURE 31 EUROPE IVD MARKET SHARE BY COUNTRY, 2014 (%) 104
FIGURE 32 WE IVD MARKET SHARE BY COUNTRY, 2014 (%) 105
FIGURE 33 CEE IVD MARKET SHARE BY COUNTRY, 2014 (%) 106
FIGURE 34 ASIA IVD MARKET SHARE BY COUNTRY, 2013-2020 (%) 116
FIGURE 35 LATIN AMERICA IVD MARKET SHARE BY COUNTRY, 2014 (%) 128
FIGURE 36 MIDDLE EAST AND AFRICA IVD MARKET SHARE BY REGION, 2014 (%) 133
FIGURE 37 BIOMARKER RELATED PUBLICATIONS, 2009-2014 (NO. OF PUBLICATIONS) 158
FIGURE 38 BIOMARKER-BASED TESTS CLEARED BY 510(K), 2009-2014 (NO. OF
BIOMARKER-BASED TESTS) 160
FIGURE 39 BIOMARKERS IN FDA-CLEARED TESTS, 2010-2014 (NO. OF TESTS
CLEARED) 161
FIGURE 40 NCI'S FUNDING SHARE FOR IVDS AND VARIOUS OTHER DISCIPLINES,
2014 (%) 167
FIGURE 41 IVD MERGERS AND ACQUISITIONS, 2012-2015 (NO. OF DEALS) 172
FIGURE 42 SHARE OF MERGERS AND ACQUISITIONS BY CATEGORY, 2012-2015 (%) 172
FIGURE 43 PATENTS BY PUBLICATION DATE, 2012-JUNE 2015 (NUMBERS) 182
FIGURE 44 PATENTS BY SUBSEGMENT AND PUBLICATION DATE, 2012-JUNE 2015
(NUMBERS) 182
FIGURE 45 IMMUNOASSAYS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015
(NUMBERS) 184
FIGURE 46 CLINICAL CHEMISTRY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE
2015 (NUMBERS) 185
FIGURE 47 POCT PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 (NUMBERS) 186
FIGURE 48 MOLECULAR DIAGNOSTICS PATENT DISTRIBUTION BY SECTOR,
2011-JUNE 2015 (NUMBERS) 187
FIGURE 49 MICROBIOLOGY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015*
(NUMBERS) 188
FIGURE 50 HEMATOLOGY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015
(NUMBERS) 189
FIGURE 51 TISSUE DIAGNOSTICS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE
2015 (NUMBERS) 190

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Ahmad

+1 718 618 4302

Purchase Reports From Reputable Market Research Publishers
2016 POC/Point-of-Care Testing Markets: Cancer Clinics, Ambulatory Centers, Surgery Centers, Nursing Homes, Birth Centers-- Volume and Sales Segment Forecasts, Emerging Technologies, Instrumentation Review, Competitive Strategies

2016 POC/Point-of-Care Testing Markets: Cancer Clinics, Ambulatory Centers, Surgery Centers, Nursing Homes, Birth Centers-- Volume and Sales Segment Forecasts, Emerging Technologies, Instrumentation Review, Competitive Strategies

  • $ 7500
  • Industry report
  • October 2016
  • by Venture Planning Group

This 1,007-page report provides a comprehensive analysis of the emerging POC market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, ...

Point of Care Diagnostics, BCC Research

Point of Care Diagnostics, BCC Research

  • $ 6650
  • Industry report
  • November 2016
  • by BCC Research

Use this report to: - Review business opportunities in the thriving near-patient testing market. - Learn about the impact of chronic diseases, growing and aging populations. - Receive information about ...

2016 World In Vitro Diagnostic Instrumentation Review

2016 World In Vitro Diagnostic Instrumentation Review

  • $ 6500
  • Industry report
  • October 2016
  • by Venture Planning Group

This new report from VPGMarketResearch.com reviews operating characteristics and features of major automated and semi-automated high-, medium-, and low-volume/POC in vitro diagnostic systems within the ...


ref:plp2015

Reportlinker.com © Copyright 2016. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.