In-Vitro Diagnostics (IVDs) Market : Current Scenario and Forecast (2019-2025): Emphasis on Product (Reagents, Instruments Services), Techniques (Immunoassay, Clinical Chemistry, SMBG, Molecular Diagnostics, Hematology, Microbiology, Point-of-Care, Hemostasis), Application (Infectious Disease, Diabetes, Oncology, Cardiology, Nephrology, Autoimmune Disease, Others), End-Users (Hospitals, Clinics & Labs, Home Care, Others), Usability (Disposable IVD Devices, Reusable IVD Devices) and Region/Country
- UNI4065899
- 399 Pages
- December 2019
- Healthcare
“Reagents dominated the product segment of the global In-Vitro Diagnostics market with 69.0% share in 2018”
Based on Product type the global in-vitro diagnostics market is segmented into reagents and Instruments Services. The market of the Reagents segment is expected to grow tremendously and is projected to dominate the market in 2025 due to its high demand in over-the-counter diagnostic tests, paired with rising demand of these for tests at non-medical facilities such as home.
“Immunoassay technique of In-Vitro Diagnostic dominated the market in 2018”
Based on techniques the global In-Vitro Diagnostics market is segmented into Immunoassay, Clinical Chemistry, SMBG, Molecular Diagnostics, Hematology, Microbiology, Point-of-Care and Hemostasis. The Immunoassay technique occupied the largest share of 24.7% in 2018 and is expected to maintain its dominance throughout the forecast period 2019-2025. However, Molecular Diagnostics and Point-of-Care testing techniques are expected to witness highest CAGR growth during the analyzed period, owing to increasing demand for such tests at home.
“In-Vitro Diagnostic technology was majorly applied for the treatment or diagnosis of Infectious Disease”
Infectious Diseases, Diabetes, Oncology, Cardiology, Nephrology, Autoimmune Diseases are the major applications of In-Vitro Diagnostics technology. In 2018, IVD was majorly used for the treatment and diagnosis of Infectious Diseases. The segment is expected to witness CAGR 4.89% during the forecast period 2019-2025 to generate revenue of US$ 33.73 billion by 2025. However, Oncology treatment using IVD is expected to grow at the highest rate during the analyzed period.
“Hospitals were the major end-users of In-Vitro Diagnostic technology in 2018”
Based on end-users, the global In-Vitro Diagnostics market is bifurcated into hospitals, clinics & labs, home care and other healthcare facilities. In 2018, hospital segment occupied ~47% share. However, use of the technology for home disease treatment is expected to witness highest CAGR growth dusting the forecast period 2019-2025. The growing elderly population and associated diseases would help the segment to witness such growth.
“Reusable IVD Devices are expected to dominate the usability segment of the global in-vitro diagnostics market during the analyzed period.”
In-Vitro Diagnostics market segmented based on usability include reusable and disposable IVD devices. The Reusable IVD Devices occupied the largest share and is expected to maintain its dominance throughout the forecast period 2019-2025.
“North America represents one of the largest markets of In-Vitro Diagnostics market globally in 2018”
For a deep-dive analysis of the industry and its adoption rate, detailed regional/country-level analysis was conducted for regions including North America (US, Canada, Rest of North America), Europe (Germany, France, Spain, Italy, UK and Rest of Europe), Asia-Pacific (China, Japan, India, Australia and Rest of Asia-Pacific) and Rest of the World (Brazil and Others). In 2018, North America dominated the market, however growing elderly population in Europe and Asia-Pacific would help the region to use more of in-vitro diagnostic technology for disease detection and treatment.
Competitive Landscape-Top 10 Market Players
Abbott Laboratories, Becton Dickinson and Company, Biomerieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, Johnson & Johnson, Roche, Siemens Healthineers AG, Sysmex Corporation and Thermo Fisher Scientific are some of the prominent players operating in the Global In-Vitro Diagnostics market industry. Several M&A’s along with partnerships have been undertaken by these players to facilitate costumers with hi-tech and innovative products in the In-Vitro Diagnostic sector.
Reasons to buy (The research report presents):
• Current and future market size from 2018 to 2025 in terms of value (US$)
• Combined analysis of deep-dive secondary research and input from primary research through Key Opinion Leaders of the industry
• Country-level details of the overall adoption of the In-Vitro Diagnostics market
• A quick review of overall industry performance at a glance
• In-depth analysis of key industry players
• A detailed analysis of regulatory framework, drivers, restraints, key trends and opportunities prevailing in the industry
• Examination of industry attractiveness with the help of Porter’s Five Forces analysis and start-ups
• The study comprehensively covers the market across different segments and sub-segments of the technology
• Region/country Covered: North America (US, Canada, Rest of North America), Europe (Germany, France, Spain, Italy, UK and Rest of Europe), Asia-Pacific (China, Japan, India, Australia and Rest of Asia-Pacific) and Rest of the World (Brazil and Others)
Customization Options:
The Global In-Vitro Diagnostics Market can be customized to the country level or any other market segment. Besides this, UMI understands that you may have your own business need, hence we also provide fully customized solutions to clients.
1.1 Market Definition 25
1.2 Objective of the Study 25
1.3 Limitation 26
1.4 Stakeholders 26
1.5 Currency used in the Report 26
1.6 Scope of the Global In-Vitro Diagnostics Market Study 27
2. RESEARCH METHODOLOGY 28
2.1 Research Methodology for Global In-Vitro Diagnostics Market Study 28
2.1.1 Main objective of the Global In-Vitro Diagnostics Market Study 29
3. COMPREHENSIVE ASSESSMENT OF THE VALUE OF DIAGNOSTIC TESTS 30
3.1 General Overview 30
3.2 Capturing the full spectrum of the value that a diagnostic test contributes 34
3.3 Ensuring that robust analyses underpin the value assessment 35
3.4 Accounting for variation in diagnostic test types in value assessment methods 37
3.5 Aligning on how to define and measure value drivers 38
3.5.1 Value Driver: Clinical Impact 38
3.5.2 Value Driver: Non-Clinical Patient Impact 40
3.5.3 Value Driver: Care Delivery Revenue and Cost Impact 41
3.5.4 Value Driver: Public/Population Impact 43
4. REFRAMING THE DIAGNOSTICS INDUSTRY 44
4.1 General Overview 44
4.2 The key to accountable adoption of in vitro diagnostic technologies 46
4.2.1 Drivers of diagnostic technology innovation and adoption: 47
4.2.2 Current Challenges for Diagnostic Innovation 47
4.2.2.1 Regulation 47
4.2.2.2 Evidence generation 48
4.2.2.3 Clinical needs 48
4.2.2.4 Commissioning 48
4.2.2.5 Adoption 48
4.2.3 Current needs 49
4.2.3.1 Three key questions for diagnostic innovation: 49
4.2.4 Developing an evidence ‘toolkit’ for diagnostic test research 50
4.3 Value of Diagnostics to Health Care and Health Status 52
5. COSTS AND BENEFITS OF DIAGNOSTIC TESTING 54
5.1 General Overview 54
5.2 Introduction and problem statement 54
5.2.1 Increasing healthcare costs 54
5.2.2 Underutilization of IVDs in clinical practice 54
5.3 Consequences for patient care 55
5.3.1 Conceptual interventions 56
5.3.1.1 Fostering prevention, screening, early diagnosis, and therapy 56
5.3.1.2 Promoting comprehensive disease management 57
5.3.1.3 Promoting stratified disease management 58
5.3.1.4 Targeted delivery of treatment alongside companion diagnostics 59
5.4 Consequences for policies: promoting a fee for outcomes 61
5.5 Analysis 62
5.6 Conclusion 64
6. RISK MITIGATION 65
6.1 General Overview 65
6.2 Supply Chain 66
6.3 Risk Assessment 67
6.4 Bulk, Custom and Contract Manufacturing 68
7. CURRENT AND FUTURE USE OF DIAGNOSTIC PRODUCTS 69
7.1 Primary Uses of Diagnostics 69
7.1.1 Predictive Applications/Screening/Early Disease Detection 69
7.1.2 Diagnostic 70
7.1.3 Secondary Risk Assessment – Prognostic 70
7.1.4 Drug Selection/Treatment Targeting 70
7.1.5 Disease/Condition Monitoring and Management 70
7.2 In Vitro Diagnostics: Overview of Future Trends and Directions 70
7.2.1 Predict Disease Before Symptoms Appear 71
7.2.2 Predict Beneficial and Adverse Treatment Effects 72
7.2.3 Enable Personalized “Real-Time” Treatment and Disease Management Regimens 73
7.2.4 Facilitate Point-of-care and Near-patient Testing 74
7.2.5 Enable Home Testing 74
7.2.6 Public Health, Environmental, Bioterrorism Applications 75
7.2.7 Technology and Testing System Integration 76
7.3 The importance of diagnostics 77
7.3.1 The role of diagnostics 77
7.3.2 Improving patient care 78
7.3.3 Reducing healthcare spending 78
7.3.4 Reasons In Vitro Diagnostics Are Superior 78
7.3.4.1 Quick Results 78
7.3.4.2 Multiple Tests at the Same Time 78
7.3.4.3 Customizable to Detect Different Chemicals 79
7.3.4.4 Ease of Recording the Data 79
7.3.4.5 Reliable Results That Can Be Quickly Repeated 79
8. EXECUTIVE SUMMARY 80
9. INDUSTRY PERFORMANCE 83
10. MARKET OVERVIEW 85
10.1 Introduction of In-Vitro Diagnostics Market 85
10.1.1 Essential Components or Attributes of Diagnostics 86
10.1.2 Main Categories of Diagnostics 87
10.1.3 Settings of Use 89
10.2 Market Dynamics 90
10.2.1 Market Drivers 90
10.2.1.1 Increasing prevalence of Chronic Diseases 90
10.2.1.2 Rising geriatric population 93
10.2.1.3 Increasing adoption of Point-of-Care Diagnosis 95
10.2.1.4 Technology Advancement in the In-vitro Diagnostics 96
10.2.2 Market Restraints 98
10.2.2.1 Stringent Government Regulations for the Manufacturing of IVD Products 98
10.2.2.2 Unfavourable Reimbursement Policies for In-vitro Diagnostics 99
10.2.3 Market Opportunities 100
10.2.3.1 Development of Condition-Specific Markers and Tests 100
10.2.3.2 Growing significance of Companion Diagnostics 101
10.2.4 Market Trends 104
10.2.4.1 Changing Reimbursement Models and Regulations 104
10.2.4.2 Investing in Unifying Technology 106
10.2.4.3 Consolidation and Automation of Labs 106
10.2.4.4 Shift to data-driven Healthcare 107
10.2.4.5 Consumer Lab Testing 108
10.2.4.6 Healthcare Convergence 108
11. REGULATIONS AND REIMBURSEMENT POLICY 110
11.1 United States 110
11.2 Europe 112
11.3 China 114
11.4 India 115
11.5 Japan 118
11.6 Australia 120
12. KEY MARKET INDICATORS 123
12.1 Demand Side Analysis 123
12.1.1 Key Facts on Aging Population 123
12.1.2 Health Conditions Associated with Aging 124
12.1.2.1 Some of the key facts about Cardiovascular Diseases (CVD) 124
12.2 Supply Side Analysis 125
12.2.1 Product Launches 126
12.2.2 Partnerships 141
12.2.3 Business Expansion and Investments 147
12.2.4 Mergers and Acquisitions 149
12.2.5 SWOT Analysis of In-Vitro Diagnostics Market 152
12.2.6 Value Chain Analysis of In-Vitro Diagnostics 153
13. ROLE OF IN-VITRO DIAGNOSTICS IN HEALTHCARE 154
13.1 General Overview 154
14. MARKET INSIGHT BY PRODUCT 158
14.1 General Overview 158
14.1.1 Reagents 160
14.1.2 Instruments Services 166
15. MARKET INSIGHT BY TECHNIQUES 171
15.1 General Overview 171
15.1.1 Immunoassay 173
15.1.2 Clinical Chemistry 174
15.1.3 Self-Monitoring of Blood Glucose (SMBG) 175
15.1.4 Molecular Diagnostics 177
15.1.5 Hematology 178
15.1.6 Microbiology 180
15.1.7 Point-of-Care 181
15.1.8 Hemostasis 183
16. MARKET INSIGHT BY APPLICATION 184
16.1 General Overview 184
16.1.1 Infectious Disease 185
16.1.2 Diabetes 187
16.1.3 Oncology 188
16.1.4 Cardiology 189
16.1.5 Nephrology 191
16.1.6 Autoimmune Disease 192
16.1.7 Others 194
17. MARKET INSIGHT BY END-USER 196
17.1 General Overview 196
17.1.1 Hospital In-Vitro Diagnostic 197
17.1.2 Clinics & Laboratory In-Vitro Diagnostic 199
17.1.3 Home Care In-Vitro Diagnostic Market 205
17.1.4 Others Healthcare Facility In-Vitro Diagnostic 209
18. MARKET INSIGHT BY USABILITY 210
18.1 General Overview 210
18.1.1 Disposable IVD Devices 211
18.1.2 Reusable IVD Devices 213
19. MARKET INSIGHT BY REGION 215
19.1 General Overview 215
19.2 North America IVD Market Insight 218
19.2.1 North America In-Vitro Diagnostics Market by Product 218
19.2.2 North America In-Vitro Diagnostics Market by Technique 219
19.2.3 North America In-Vitro Diagnostics Market by Application 220
19.2.4 North America In-Vitro Diagnostics Market by End-Users 220
19.2.5 North America In-Vitro Diagnostics Market by Usability 221
19.2.6 North America In-Vitro Diagnostics Market by Country 221
19.2.6.1 United States 222
19.2.6.1.1 Key Findings on Healthcare Spending in the US, 2017 222
19.2.6.1.2 US Health Spending by Type of Service or Product, 2017 223
19.2.6.1.3 Health Spending by Major Sources of Funds 224
19.2.6.1.4 United States In-Vitro Diagnostics Market by Product 225
19.2.6.1.5 United States In-Vitro Diagnostics Market by Technique 225
19.2.6.1.6 United States In-Vitro Diagnostics Market by Application 226
19.2.6.1.7 United States In-Vitro Diagnostics Market by End-Users 226
19.2.6.1.8 United States In-Vitro Diagnostics Market by Usability 227
19.2.6.2 Canada 227
19.2.6.2.1 Key Findings on Canada Healthcare Spending, 2018 229
19.2.6.2.2 Key Findings on Hospital sector Spending in Canada, 2017 229
19.2.6.2.3 Canada In-Vitro Diagnostics Market by Product 230
19.2.6.2.4 Canada In-Vitro Diagnostics Market by Technique 231
19.2.6.2.5 Canada In-Vitro Diagnostics Market by Application 231
19.2.6.2.6 Canada In-Vitro Diagnostics Market by End-Users 232
19.2.6.2.7 Canada In-Vitro Diagnostics Market by Usability 232
19.2.6.3 Rest of North America 233
19.2.6.3.1 Rest of NA In-Vitro Diagnostics Market by Product 234
19.2.6.3.2 Rest of NA In-Vitro Diagnostics Market by Technique 235
19.2.6.3.3 Rest of NA In-Vitro Diagnostics Market by Application 235
19.2.6.3.4 Rest of NA In-Vitro Diagnostics Market by End-Users 236
19.2.7 Rest of NA In-Vitro Diagnostics Market by Usability 236
19.3 Europe IVD Market Insight 237
19.3.1 Europe In-Vitro Diagnostics Market by Product 238
19.3.2 Europe In-Vitro Diagnostics Market by Technique 238
19.3.3 Europe In-Vitro Diagnostics Market by Application 239
19.3.4 Europe In-Vitro Diagnostics Market by End-Users 239
19.3.5 Europe In-Vitro Diagnostics Market by Usability 240
19.3.6 Europe In-Vitro Diagnostics Market by Country 240
19.3.6.1 Germany 241
19.3.6.1.1 Germany In-Vitro Diagnostics Market by Product 242
19.3.6.1.2 Germany In-Vitro Diagnostics Market by Technique 243
19.3.6.1.3 Germany In-Vitro Diagnostics Market by Application 243
19.3.6.1.4 Germany In-Vitro Diagnostics Market by End-Users 244
19.3.6.1.5 Germany In-Vitro Diagnostics Market by Usability 244
19.3.6.2 France 245
19.3.6.2.1 France In-Vitro Diagnostics Market by Product 246
19.3.6.2.2 France In-Vitro Diagnostics Market by Technique 246
19.3.6.2.3 France In-Vitro Diagnostics Market by Application 247
19.3.6.2.4 France In-Vitro Diagnostics Market by End-Users 247
19.3.6.2.5 France In-Vitro Diagnostics Market by Usability 248
19.3.6.3 Spain 248
19.3.6.3.1 Spain In-Vitro Diagnostics Market by Product 249
19.3.6.3.2 Spain In-Vitro Diagnostics Market by Technique 250
19.3.6.3.3 Spain In-Vitro Diagnostics Market by Application 250
19.3.6.3.4 Spain In-Vitro Diagnostics Market by End-Users 251
19.3.6.3.5 Spain In-Vitro Diagnostics Market by Usability 252
19.3.6.4 Italy 252
19.3.6.4.1 Italy In-Vitro Diagnostics Market by Product 253
19.3.6.4.2 Italy In-Vitro Diagnostics Market by Technique 254
19.3.6.4.3 Italy In-Vitro Diagnostics Market by Application 254
19.3.6.4.4 Italy In-Vitro Diagnostics Market by End-Users 255
19.3.6.4.5 Italy In-Vitro Diagnostics Market by Usability 255
19.3.6.5 United Kingdom 256
19.3.6.5.1 United Kingdom In-Vitro Diagnostics Market by Product 258
19.3.6.5.2 United Kingdom In-Vitro Diagnostics Market by Technique 258
19.3.6.5.3 United Kingdom In-Vitro Diagnostics Market by Application 259
19.3.6.5.4 United Kingdom In-Vitro Diagnostics Market by End-Users 259
19.3.6.5.5 United Kingdom In-Vitro Diagnostics Market by Usability 260
19.3.6.6 Rest of Europe 260
19.3.6.6.1 Rest of Europe In-Vitro Diagnostics Market by Product 262
19.3.6.6.2 Rest of Europe In-Vitro Diagnostics Market by Technique 262
19.3.6.6.3 Rest of Europe In-Vitro Diagnostics Market by Application 263
19.3.6.6.4 Rest of Europe In-Vitro Diagnostics Market by End-Users 263
19.3.6.6.5 Rest of Europe In-Vitro Diagnostics Market by Usability 264
19.4 Asia-Pacific In-Vitro Diagnostics Market Insight 264
19.4.1 Asia-Pacific In-Vitro Diagnostics Market by Product 266
19.4.2 Asia-Pacific In-Vitro Diagnostics Market by Technique 266
19.4.3 Asia-Pacific In-Vitro Diagnostics Market by Application 267
19.4.4 Asia-Pacific In-Vitro Diagnostics Market by End-Users 267
19.4.5 Asia-Pacific In-Vitro Diagnostics Market by Usability 268
19.4.6 Asia-Pacific In-Vitro Diagnostics Market by Country 268
19.4.6.1 China 269
19.4.6.1.1 IVD Product Registration in China 270
19.4.6.1.2 China IVD Type Testing Process 270
19.4.6.1.3 Clinical Trials for IVD Products in China 271
19.4.6.1.4 Reimbursement of IVD Products in China 271
19.4.6.1.5 China In-Vitro Diagnostics Market by Product 272
19.4.6.1.6 China In-Vitro Diagnostics Market by Technique 273
19.4.6.1.7 China In-Vitro Diagnostics Market by Application 273
19.4.6.1.8 China In-Vitro Diagnostics Market by End-Users 274
19.4.6.1.9 China In-Vitro Diagnostics Market by Usability 274
19.4.6.2 India 275
19.4.6.2.1 Notified Medical Devices 277
19.4.6.2.2 Non-Notified Medical Devices 278
19.4.6.2.3 India In-Vitro Diagnostics Market by Product 281
19.4.6.2.4 India In-Vitro Diagnostics Market by Technique 281
19.4.6.2.5 India In-Vitro Diagnostics Market by Application 282
19.4.6.2.6 India In-Vitro Diagnostics Market by End-Users 283
19.4.6.2.7 India In-Vitro Diagnostics Market by Usability 283
19.4.6.3 Japan 284
19.4.6.3.1 Classification of IVDs in Japan 284
19.4.6.3.2 Category of Approval Applications for IVD Reagents 284
19.4.6.3.3 Japan In-Vitro Diagnostics Market by Product 285
19.4.6.3.4 Japan In-Vitro Diagnostics Market by Technique 286
19.4.6.3.5 Japan In-Vitro Diagnostics Market by Application 286
19.4.6.3.6 Japan In-Vitro Diagnostics Market by End-Users 287
19.4.6.3.7 Japan In-Vitro Diagnostics Market by Usability 287
19.4.6.4 Australia 288
19.4.6.4.1 Australia In-Vitro Diagnostics Market by Product 290
19.4.6.4.2 Australia In-Vitro Diagnostics Market by Technique 290
19.4.6.4.3 Australia In-Vitro Diagnostics Market by Application 291
19.4.6.4.4 Australia In-Vitro Diagnostics Market by End-Users 292
19.4.6.4.5 Australia In-Vitro Diagnostics Market by Usability 292
19.4.6.5 Rest of Asia-Pacific Market Insight 293
19.4.6.5.1 Rest of APAC In-Vitro Diagnostics Market by Product 294
19.4.6.5.2 Rest of APAC In-Vitro Diagnostics Market by Technique 294
19.4.6.5.3 Rest of APAC In-Vitro Diagnostics Market by Application 295
19.4.6.5.4 Rest of APAC In-Vitro Diagnostics Market by End-Users 296
19.4.6.5.5 Rest of APAC In-Vitro Diagnostics Market by Usability 296
19.5 Rest of World Market Insight 297
19.5.1 Rest of World In-Vitro Diagnostics Market by Product 297
19.5.2 Rest of World In-Vitro Diagnostics Market by Technique 298
19.5.3 Rest of World In-Vitro Diagnostics Market by Application 298
19.5.4 Rest of World In-Vitro Diagnostics Market by End-Users 299
19.5.5 Rest of World In-Vitro Diagnostics Market by Usability 300
19.5.6 Rest of World In-Vitro Diagnostics Market by Country 300
19.5.6.1 Brazil 301
19.5.6.1.1 Brazil In-Vitro Diagnostics Market by Product 302
19.5.6.1.2 Brazil In-Vitro Diagnostics Market by Technique 303
19.5.6.1.3 Brazil In-Vitro Diagnostics Market by Application 303
19.5.6.1.4 Brazil In-Vitro Diagnostics Market by End-Users 304
19.5.6.1.5 Brazil In-Vitro Diagnostics Market by Usability 304
19.5.6.2 Other Rest of World 305
19.5.6.2.1 Other Rest of World In-Vitro Diagnostics Market by Product 305
19.5.6.2.2 Other Rest of World In-Vitro Diagnostics Market by Technique 306
19.5.6.2.3 Other Rest of World In-Vitro Diagnostics Market by Application 307
19.5.6.2.4 Other Rest of World In-Vitro Diagnostics Market by End-Users 307
19.5.6.2.5 Other Rest of World In-Vitro Diagnostics Market by Usability 308
20. COMPETITIVE SCENARIO 309
20.1 Porter’s Five forces analysis 309
20.1.1 Bargaining Power of Suppliers 309
20.1.2 Bargaining Power of Buyers 310
20.1.3 Threat of New Entrants 311
20.1.4 Threat of Substitutes 311
20.1.5 Industry Rivalry 312
20.2 Market Share Analysis, by Company 313
20.2.1 Global In-Vitro Diagnostic Market Share Analysis, by Company 2018 313
21. TOP COMPANY PROFILES 315
21.1 Abbott Laboratories 315
21.1.1 Key Facts 315
21.1.2 Business Description 315
21.1.3 Key Product/Services Offerings 316
21.1.4 Growth Strategy 316
21.1.5 SWOT Analysis 317
21.1.6 Key Financials 318
21.1.6.1 Revenue Split 319
21.1.7 Recent Developments 320
21.1.7.1 Product Launches 320
21.1.7.2 Partnership 322
21.1.7.3 Merger and Acquisition 323
21.2 Becton Dickinson 324
21.2.1 Key Facts 324
21.2.2 Business Description 324
21.2.3 Key Product/Services Offerings (AI Technology) 324
21.2.4 Growth Strategy 325
21.2.5 SWOT Analysis 326
21.2.6 Key Financials 327
21.2.6.1 Revenue Split 328
21.2.7 Recent Developments 328
21.2.7.1 Product Launch 328
21.2.7.2 Partnerships 330
21.2.7.3 Business Expansions and Investments 330
21.2.7.4 Merger & Acquisitions 330
21.3 Biomérieux SA 331
21.3.1 Key Facts 331
21.3.2 Business Description 331
21.3.3 Key Product/Services Offerings 332
21.3.4 Growth Strategy 332
21.3.5 SWOT Analysis 333
21.3.6 Key Financials 334
21.3.6.1 Revenue Split 335
21.3.7 Recent Developments 335
21.3.7.1 Product Launches 335
21.3.7.2 Partnerships 337
21.3.7.3 Mergers and Acquisitions 338
21.4 Bio-Rad Laboratories, Inc. 339
21.4.1 Key Facts 339
21.4.2 Business Description 339
21.4.3 Key Product/Services Offerings 339
21.4.4 Growth Strategy 341
21.4.5 SWOT Analysis 342
21.4.6 Key Financials 343
21.4.6.1 Revenue Split 344
21.4.7 Recent Developments 344
21.4.7.1 Product Launches 344
21.4.7.2 Mergers and Acquisitions 345
21.5 Danaher Corporation 346
21.5.1 Key Facts 346
21.5.2 Business Description 346
21.5.3 Key Product/Services Offerings 346
21.5.4 Growth Strategy 347
21.5.5 SWOT Analysis 348
21.5.6 Key Financials 349
21.5.6.1 Revenue Split 350
21.5.7 Recent Developments 350
21.5.7.1 Merger and Acquisitions 350
21.6 Johnson & Johnson 351
21.6.1 Key Facts 351
21.6.2 Business Description 351
21.6.3 Key Product/Services Offerings 352
21.6.4 Growth Strategy 352
21.6.5 SWOT Analysis 353
21.6.6 Key Financials 354
21.6.6.1 Revenue Split 355
21.7 Roche Holding AG 356
21.7.1 Key Facts 356
21.7.2 Business Description 356
21.7.3 Key Product/Services Offerings 357
21.7.4 Growth Strategy 357
21.7.5 SWOT Analysis 358
21.7.6 Key Financials 359
21.7.6.1 Revenue Split 360
21.7.7 Recent Developments 360
21.7.7.1 Product Launches 360
21.7.7.2 Partnership 362
21.7.7.3 Mergers and Acquisitions 362
21.8 Siemens Healthineers AG. 363
21.8.1 Key Facts 363
21.8.2 Business Description 363
21.8.3 Key Product/Services Offerings 364
21.8.4 Growth Strategy 364
21.8.5 SWOT Analysis 365
21.8.6 Key Financials 366
21.8.6.1 Revenue Split 367
21.8.7 Recent Developments 367
21.8.7.1 Product Launches 367
21.8.7.2 Partnership 368
21.8.7.3 Business Expansion and Investment 369
21.8.7.4 Merger and Acquisitions 369
21.9 Thermo Fisher Scientific 370
21.9.1 Key Facts 370
21.9.2 Business Description 370
21.9.3 Key Product/Services Offerings 371
21.9.4 Growth Strategy 373
21.9.5 SWOT Analysis 373
21.9.6 Key Financials 374
21.9.6.1 Revenue Split 375
21.9.7 Recent Developments 375
21.9.7.1 Product Launch 375
21.9.7.2 Partnerships 379
21.9.7.3 Business Expansion and Investment 382
21.9.7.4 Merger and Acquisition 383
21.10 Sysmex Corporation 385
21.10.1 Key Facts 385
21.10.2 Business Description 385
21.10.3 Key Product/Services Offerings 386
21.10.4 SWOT Analysis 386
21.10.5 Growth Strategy 387
21.10.6 Key Financials 388
21.10.6.1 Revenue Split 389
21.10.7 Recent Developments 389
21.10.7.1 Product Launches 389
21.10.7.2 Partnership 392
21.10.7.3 Business Expansion & Investments 394
21.10.7.4 Merger and Acquisitions 395
TABLE 2 Considerations in Demonstrating Value by Diagnostic Test Type 36
TABLE 3 Value Driver: Clinical Impact 37
TABLE 4 Value Driver: Non-Clinical Patient Impact 39
TABLE 5 Value Driver: Care Delivery Revenue and Cost Impact 40
TABLE 6 Value Driver: Public/Population Impact 42
TABLE 7 Overview of selected compounds and their companion diagnostics in and beyond the field of oncology 59
TABLE 8 Application of the outcome measures hierarchical tier system described by Porter to reinforcement interventions proposed as solutions to the shifting the burden archetype in the in-vitro diagnostics arena 60
TABLE 9 Risk from Raw Material Supply and In-House Manufacturing Capabilities of IVD Manufacturers 64
TABLE 10 Rapidly Expanding Areas of Scientific Inquiry 70
TABLE 11 Examples of Commonly Used in-vitro and in-vivo Diagnostics 85
TABLE 12 Categories and Examples of Diagnostic Products 87
TABLE 13 Number and distribution of persons aged 60 years or over by region, in 2017 and 2050 93
TABLE 14 Classification system for IVD’s medical devices based on risk 98
TABLE 15 Oncology CDx Market: Selected Tests Resulting from Partnerships, U.S., 2017 102
TABLE 16 IVD Market Regulatory Analysis, Selected Regions 104
TABLE 17 List of In-Vitro Diagnostics Devices along with their Risk Class 116
TABLE 18 Classes of IVD 119
TABLE 19 Recent Product Launches 125
TABLE 20 Partnerships 140
TABLE 21 Business Expansions and Investments 146
TABLE 22 Mergers and Acquisitions 148
TABLE 23 Products List for In-Vitro Diagnostics Reagents 163
TABLE 24 IVD Ancillary Reagents 164
TABLE 25 IVD Instruments Comparison Tailored for Clinical Labs 166
TABLE 26 Common Clinical Chemistry Tests 173
TABLE 27 FDA Approved In Vitro Molecular Diagnostic Devices 176
TABLE 28 Common Hematology Tests 178
TABLE 29 In-Vitro Diagnostic Medical Devices for Microbiology by Merck 179
TABLE 30 Clinical Laboratory Improvement Amendments (CLIA)-Waived Tests for Infectious Diseases 180
TABLE 31 General IVDs for Primary Health Care 200
TABLE 32 General IVDs for Health Care Facilities with Clinical Laboratories 201
TABLE 33 Countries with Shift in Average Life Expectancies in 2030 214
TABLE 34 Classification system for IVD’s medical devices based on risk 276
TABLE 35 Notified Medical Devices Under Drugs and Cosmetics Act 277
TABLE 36 Classification of IVD Reagents 283
TABLE 37 Classification and Type of Regulation 283
TABLE 38 Australia, Total Health Expenses, US$ Million, (2018-22) 288
TABLE 39 Abbott Laboratories Key Facts 314
TABLE 40 Product segmentation of Abbott Laboratories 315
TABLE 41 Abbott laboratories Growth Strategy 315
TABLE 42 Abbott Laboratories, Inc. Product Launches 319
TABLE 43 Abbott Laboratories, Inc. Partnership 321
TABLE 44 Abbott Laboratories, Inc. Merger and Acquisition 322
TABLE 45 Becton Dickinson Key Facts 323
TABLE 46 Becton Dickinson Growth Strategy 324
TABLE 47 Becton, Dickinson and Company Product Launch 327
TABLE 48 Becton, Dickinson and Company Partnerships 329
TABLE 49 Becton, Dickinson and Company Business Expansions and Investments 329
TABLE 50 Becton, Dickinson and Company Merger & Acquisitions 329
TABLE 51 Biomérieux SA Key Facts 330
TABLE 52 Product segmentation of Biomérieux SA 331
TABLE 53 Biomérieux SA Growth Strategy 331
TABLE 54 Biomérieux SA Product Launches 334
TABLE 55 Biomérieux SA Partnerships 336
TABLE 56 Biomérieux SA Mergers and Acquisitions 337
TABLE 57 Bio-Rad Laboratories, Inc. Key Facts 338
TABLE 58 Product segmentation of Bio-Rad Laboratories, Inc. 338
TABLE 59 Bio-Rad Laboratories, Inc. Growth Strategy 340
TABLE 60 Bio-Rad Laboratories, Inc. Product Launches 343
TABLE 61 Bio-Rad Laboratories, Inc. Merger and Acquisitions 344
TABLE 62 Danaher Corporation Key Facts 345
TABLE 63 Product segmentation of Danaher Corporation 345
TABLE 64 Danaher Corporation Growth Strategy 346
TABLE 65 Danaher Corporation Merger and Acquisitions 349
TABLE 66 Johnson & Johnson Key Facts 350
TABLE 67 Product segmentation of Johnson & Johnson 351
TABLE 68 Johnson & Johnson Growth Strategy 351
TABLE 69 Research & Development Expense, US$ million (2015-2017) 354
TABLE 70 Roche Key Facts 355
TABLE 71 Product segmentation of Roche 356
TABLE 72 Roche Growth Strategy 356
TABLE 73 Roche Product Launches 359
TABLE 74 Roche Partnership 361
TABLE 75 Roche Mergers and Acquisitions 361
TABLE 76 Siemens Healthcare AG Key Facts 362
TABLE 77 Product segmentation of Siemens Healthcare 363
TABLE 78 Siemens Healthcare Growth Strategy 363
TABLE 79 Siemens Healthineers Product Launches 366
TABLE 80 Siemens Healthineers Partnership 367
TABLE 81 Siemens Healthineers Business Expansion and Investment 368
TABLE 82 Siemens Healthineers Merger and Acquisitions 368
TABLE 83 Thermo Fisher Scientific Key Facts 369
TABLE 84 Product segmentation of Thermo Fisher Scientific 370
TABLE 85 Thermo Fisher Scientific Growth Strategy 372
TABLE 86 Thermo Fisher Scientific Product Launch 374
TABLE 87 Thermo Fisher Scientific Partnerships 378
TABLE 88 Thermo Fisher Scientific Business Expansion and Investments 381
TABLE 89 Thermo Fisher Scientific Merger and Acquisition 382
TABLE 90 Sysmex Corporation Key Facts 384
TABLE 91 Product segmentation of Sysmex Corporation 385
TABLE 92 Sysmex Corporation Growth Strategy 386
TABLE 93 Sysmex Corporation Product Launches 388
TABLE 94 Sysmex Corporation Partnership 391
TABLE 95 Sysmex Corporation Business Expansion & Investments 393
TABLE 96 Sysmex Corporation Merger and Acquisitions 394
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