In Vitro Diagnostics (IVD) Market Report – Research, Industry Analysis Reports and Market Demands

In Vitro Diagnostics (IVD) Global Market

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Table of Content

1 EXECUTIVE SUMMARY 36

2 INTRODUCTION 46

2.1 KEY TAKE AWAYS 46
2.2 REPORT DESCRIPTION 47
2.3 MARKETS COVERED 49
2.4 STAKEHOLDERS 52
2.5 RESEARCH METHODOLOGY 52
- 2.5.1 MARKET SIZE ESTIMATION 54
- 2.5.2 MARKET BREAKDOWN & DATA TRIANGULATION 56
- 2.5.3 SECONDARY SOURCES 57
- 2.5.4 KEY DATA POINTS FROM SECONDARY SOURCES 58
- 2.5.5 PRIMARY SOURCES 58
- 2.5.6 KEY DATA POINTS FROM PRIMARY SOURCES 59
- 2.5.7 ASSUMPTIONS 59

3 MARKET ANALYSIS 61

3.1 INTRODUCTION 61
3.2 MARKET SEGMENTATION 63
3.3 FACTORS INFLUENCING MARKET 65
- 3.3.1 DRIVERS AND OPPORTUNITIES 65
  - 3.3.1.1 Growing incidence of chronic and infectious diseases 65
  - 3.3.1.2 Increasing adoption of point-of-care testing 66
  - 3.3.1.3 Emergence of next generation molecular diagnostics 67
  - 3.3.1.4 Growing awareness of companion diagnostics and personalized
medicine 68
- 3.3.1.5 Emergence of minimally invasive and non invasive diagnostics 69
- 3.3.1.6 Rising number of clia-waived ivd tests 70
3.3.2 RESTRAINTS & THREATS 71
- 3.3.2.1 Rising incidence of product recalls 71
- 3.3.2.2 Lack of skilled laboratory technicians in developing nations 72
- 3.3.2.3 Inadequate reimbursement 73
- 3.3.2.4 Stringent regulatory framework 74
3.4 PORTER’S FIVE FORCE ANALYSIS 75
- 3.4.1 THREAT OF NEW ENTRANTS 76
- 3.4.2 THREAT OF SUBSTITUTES 77
- 3.4.3 BARGAINING POWER OF SUPPLIERS 78
- 3.4.4 BARGAINING POWER OF BUYERS 78
- 3.4.5 RIVALRY AMONG EXISTING COMPETITORS 79
3.5 REGULATORY AFFAIRS 80
3.6 TECHNOLOGICAL ADVANCEMENTS 85
3.7 FUNDING SCENARIO 87
3.8 SUPPLY CHAIN ANALYSIS 92
3.9 MARKET SHARE ANALYSIS BY IN-VITRO DIAGNOSTICS MAJOR

PLAYERS 95

3.9.1 MARKET SHARE ANALYSIS BY IMMUNOASSAY IN-VITRO DIAGNOSTICS MAJOR PLAYERS 99
3.9.2 MARKET SHARE ANALYSIS BY CLINICAL CHEMISTRY IN-VITRO DIAGNOSTICS MAJOR PLAYERS 101
3.9.3 MARKET SHARE ANALYSIS BY MOLECULAR DIAGNOSTICS

MAJOR PLAYERS 103

3.9.4 MARKET SHARE ANALYSIS BY CLINICAL MICROBIOLOGY IN-VITRO DIAGNOSTICS MAJOR PLAYERS 105
3.9.5 MARKET SHARE ANALYSIS BY HEMATOLOGY IN-VITRO DIAGNOSTICS MAJOR PLAYERS 107
3.9.6 MARKET SHARE ANALYSIS BY COAGULATION AND HEMOSTASIS

IN-VITRO DIAGNOSTICS MAJOR PLAYERS 109

4 IN-VITRO DIAGNOSTICS GLOBAL MARKET, BY TECHNOLOGY 111

4.1 INTRODUCTION 111
4.2 IMMUNOCHEMISTRY 114
- 4.2.1 ENZYME-LINKED IMMUNOSORBENT ASSAYS (ELISA) 118
  - 4.2.1.1 Chemiluminescence Immunoassays (CLIAS) 120
  - 4.2.1.2 Fluorescence Immunoassays (FIAS) 122
  - 4.2.1.3 Colorimetric Immunoassays (CIS) 123
- 4.2.2 RADIOIMMUNOASSAY (RIA) 124
- 4.2.3 ENZYME-LINKED IMMUNOSPOT (ELISPOT) ASSAY 126
- 4.2.4 RAPID TESTS 127
- 4.2.5 OTHER IMMUNOASSAY TECHNIQUES 129
4.3 CLINICAL CHEMISTRY 132
- 4.3.1 BASIC METABOLIC PROFILE 136
- 4.3.2 ELECTROLYTE PANEL 138
- 4.3.3 LIVER PANEL 140
- 4.3.4 LIPID PANEL 142
- 4.3.5 RENAL PANEL 144
- 4.3.6 THYROID FUNCTION PANEL 146
- 4.3.7 SPECIALTY CHEMICAL TESTS 148
4.4 MOLECULAR DIAGNOSTICS 150
- 4.4.1 PCR (POLYMERASE CHAIN REACTION) 154
- 4.4.2 ISOTHERMAL NUCLEIC ACID AMPLIFICATION TECHNOLOGY 157
- 4.4.3 MICROARRAY 159
- 4.4.4 HYBRIDIZATION 161
- 4.4.5 DNA SEQUENCING AND NEXT GENERATION SEQUENCING (NGS) 163
- 4.4.6 OTHER MDX TECHNOLOGIES 165
4.5 CLINICAL MICROBIOLOGY 167
4.6 HEMATOLOGY 169
4.7 COAGULATION AND HEMOSTASIS 171
4.8 OTHER IVD TECHNOLOGIES 174

5 IN-VITRO DIAGNOSTICS GLOBAL MARKET, BY APPLICATION 177

6 IN-VITRO DIAGNOSTICS GLOBAL MARKET, BY PRODUCT 207

6.1 INTRODUCTION 207
6.2 INSTRUMENTS 209
6.3 REAGENTS 212
6.4 SOFTWARES AND SERVICES 214

7 IN-VITRO DIAGNOSTICS MARKET, BY SAMPLE TYPE 217

7.1 INTRODUCTION 217
7.2 BLOOD 219
7.3 SALIVA 222
7.4 URINE 225
7.5 OTHERS 228

8 IN-VITRO DIAGNOSTICS GLOBAL MARKET, BY END USER 232

9 REGIONAL MARKET ANALYSIS 246

9.1 INTRODUCTION 246
9.2 NORTH AMERICA 249
- 9.2.1 U.S. 259
- 9.2.2 OTHERS 263
9.3 EUROPE 266
- 9.3.1 GERMANY 275
- 9.3.2 ITALY 279
- 9.3.3 FRANCE 282
- 9.3.4 OTHERS 285
9.4 ASIA PACIFIC 288
- 9.4.1 INDIA 298
- 9.4.2 CHINA 301
- 9.4.3 JAPAN 305
- 9.4.4 OTHERS 308
9.5 REST OF THE WORLD 311
- 9.5.1 BRAZIL 321
- 9.5.2 REST OF LATIN AMERICA 323
- 9.5.3 MIDDLE EAST AND OTHERS 327

10 COMPANY DEVELOPMENTS 330

10.1 INTRODUCTION 330
- 10.1.1 REGULATORY APPROVAL AS A MAJOR GROWTH STRATEGY OF

IN-VITRO DIAGNOSTICS MARKET PLAYERS 331

10.2 APPROVAL 331
10.3 NEW PRODUCT LAUNCH 351
10.4 AGREEMENTS PARTERNER SHIPS, COLLABORATIONS &

JOINT VENTURES 362

10.5 MERGERS AND ACQUISITIONS 369
10.6 BUSINESS EXPANSION 372

11 COMPANY PROFILES 373

Description

In-vitro diagnostic is a process in which reagents, instruments, and systems are intended for the diagnosis of disease or other conditions or for determining the state of health, to cure, mitigate, treat, or prevent disease. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments.
The in-vitro diagnostics market is segmented into Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoassay (RIA), Rapid tests, Enzyme-Linked Immunospot (Elispot) Assay and others are some of the immunoassay techniques in the IVD market. Basic Metabolic Panel, Electrolyte Panel, liver Panel, Lipid Profile, Renal Profile and Thyroid function panel and specialty chemical tests are some of the clinical chemistry technologies. Polymerase Chain Reaction (PCR), Isothermal Nucleic Acid Amplification Technology (INAAT), Microarray, Hybridization, DNA Sequencing & Next-Generation Sequencing and others are some of the molecular diagnostics market. Along with these, clinical microbiology, hematology, coagulation and hemostasis and others are the type of the IVD technologies in the market.
Among technologies in in-vitro diagnostics market, immunochemistry techniques accounted for the largest share in 2016 growing at mid range single digit CAGR and molecular diagnostics is expected to grow at high single digit CAGR from 2016-2023.
By application, the in-vitro diagnostics global market is segmented into oncology, diabetes, cardiology, nephrology, transplantation technology, genetic testing, autoimmune diseases, drug testing, infectious diseases and others. Infectious diseases held the largest revenue in 2016 and transplantation diagnostics application is expected to grow at double digit CAGR from 2016-2023.
By product type, the market is segmented into reagents, instruments, software and services. The reagents segment accounted for the largest revenue in 2016, and is expected to grow at mid range single digit CAGR from 2016 to 2023.
By sample type, the market is segmented into blood, urine, saliva and others. The blood segment accounted for the largest revenue in 2016, and is expected to grow at mid range single digit CAGR from 2016 to 2023.
By end-users, the market is segmented into laboratories, hospitals, academic, and home care. The hospitals end user segment accounted for the largest revenue in 2016, home healthcare is fastest growing segment during the forecasting period.
By geography, the market is segmented into North America, Europe, Asia-Pacific and Rest of World. North America holds the largest market share in 2016, followed by Europe and Asia. The APAC regions tend to be an emerging market with an opportunity for growth with a highest CAGR from 2016-2023 and are likely to be a destination of investment for new investors in the in-vitro diagnosis market.
Growing healthcare expenditure in the emerging markets, strong demand for technologically advanced testing methods for disease diagnosis, increasing adaptation of point of care testing, increasing incidences of chronic lifestyle diseases are some of the important driving factors for this market. It is also seen that there is an increase in the number of clinical laboratories with improved infrastructure in many developed countries which could further push the diagnostics market in these regions. However, Lack of proper reimbursement policies in the developing countries and stringent regulatory framework are the main factors hampering the growth of the IVD market.
The in-vitro diagnostics global market is a competitive and all the active players in this market are involved in innovating new and advanced products to maintain their market shares. The key players in the in-vitro diagnostics global market include Abbott Laboratories (U.S.), Becton Dickinson (U.S.), Bio-Rad laboratories (U.S.), BioMerieux (France), Danaher Corporation (U.S.), Hoffmann-la Roche (Switzerland), Siemens AG (Germany), Carlyle Group (Ortho Clinical Diagnostics) (U.S.), Johnson and Johnson (U.S.), Sysmex Corporation (Japan), ThermoFisher Scientific (U.S.), and Hologic Inc (U.S.).
The report provides an in depth market analysis of the above mentioned segments across the following regions:
• North America
• Europe
• Asia-Pacific
• Rest of the World (RoW)