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Molecular Diagonstics Market : Current Scenario and Forecast (2019-2025): Emphasis on Product (Reagents, Instruments Services), Techniques (Polymerase Chain Reaction (PCR), Transcription-Mediated Amplification (TMA), In Situ Hybridization, DNA Sequencing & Next-Generation Sequencing (NGS), Chips and Microarrays, Others), Application (Microbiology, Virology, Hospital Acquired Infections (HAI), Genetic Testing, Oncology, Pharmacogenetics, Human Leukocytes Antigen (HLA), Blood Screening, Others), End-Users (Hospitals, Clinics & Labs, Other Healthcare Facilities) and Region/Country

  • UNI4065900
  • 399 Pages
  • December 2019
  • Healthcare
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Global Molecular Diagnostics Market was valued at US$ 6,242.6 million in 2018 and is anticipated to reach US$ 9,546.2 million by 2025 displaying a reasonable CAGR of 6.3% over the forecast period (2019-2025). Molecular Diagnostics is the detection of genomic variants, aiming to facilitate detection, diagnosis, subclassification, prognosis, and monitoring response to therapy. The market of Molecular Diagnostics market is anticipated to grow enormously owing to factors such as rising geriatric population, increasing prevalence of chronic diseases, increasing adoption of Point-of-care diagnosis, advances in genomics and proteomics, and introduction of technologically advanced products. The growing incidence of infectious diseases and cancer is increasing the demand for molecular diagnostics techniques. The rapid advancements witnessed in the molecular biology technologies, development of molecular diagnostic technologies to automated processes, growing awareness about molecular diagnostics usage for the detection of different diseases in developing countries is boosting the overall market growth. The investment in unifying technology, consolidation and automation of labs, and shift to data-driven healthcare will mark as a trend in this industry. However, high prices of molecular diagnostics tests and unfavorable reimbursement policies will act as the major challenges in the growth of this market.

In this evolving environment, it is a business imperative for diagnostic manufacturers to understand, demonstrate, and clearly articulate how their offerings can lead not only to better patient outcomes but also create value for a variety of key stakeholders. There are many ways that diagnostic technologies can impact the quality and cost of care. Medical diagnostic tests and technologies are at the forefront of health care and personalized medicine. These technologies increasingly are a key component in ensuring that the right treatment gets to the right patient at the right time. Advances in life sciences and in test technologies are making diagnostics ever more central in the delivery of effective health care. It is well understood by health care stakeholders that diagnostics significantly affect clinical decision-making. Nevertheless, it is critical for diagnostic test developers to be able to demonstrate the value of their tests to a variety of stakeholders in the face of growing scrutiny and cost pressure directed at almost every health care sector

“Reagents are the majorly used product under the Molecular Diagnostics market, holding ~69% share in 2018”

Based on product type the global molecular diagnostics market is bifurcated into Instruments, Reagents and services and others. The market of the Reagents segment is expected to grow tremendously and is projected to dominate the market in 2025 due to the high demand for over-the-counter diagnostic tests, rise in adoption of these tests in nonmedical facilities, such as home.

“Polymerase chain reaction (PCR) is expected to dominate the technique segment during the analyzed period.”

Molecular diagnostics market, based on technique is segmented into Polymerase Chain Reaction (PCR), Transcription-Mediated Amplification (TMA), In Situ Hybridization, DNA Sequencing & Next-Generation Sequencing (NGS), Chips and Microarrays and others. The PCR segment occupied the largest share and is expected to maintain its dominance throughout the forecast period 2019-2025 owing to the increased usage and advancements in PCR techniques.

“Molecular Diagnostic techniques are majorly applied for Virology study, the segment generated revenue of US$ 2,243.9 million in 2018”

The molecular diagnostics market is applied in various medical fields including Microbiology, Virology, Hospital Acquired Infections (HAI), Genetic Testing, Oncology, Pharmacogenetics, Human Leukocytes Antigen (HLA), Blood Screening and others. In 2018, Virology segment dominated the market and is anticipated to dominate this segment in 2025. However, Oncology application segment is expected to witness highest CAGR growth during the forecast period 2019-2025.

“Amongst end-users’ type, hospitals are anticipated to dominate Global Molecular Diagnostics market by 2025.”

Hospitals, clinics & labs and others are the major end-users of the molecular diagnostic technology. In 2018, the application of the technology was dominated by Hospitals segment. The increased adoption in hospitals is driven by high procedure volume and extensive presence of ancillary support in terms of manpower and infrastructure. However, Clinics & labs application type is expected to witness reasonable CAGR growth during the analyzed period.

“North America dominated the market for molecular diagnostic technology in 2018, followed by Asia-Pacific and Europe”

For a deep-dive analysis of the industry, detailed regional/country-level analysis is conducted for markets including North America (US, Canada, Rest of US), Europe (Germany, France, Spain, Italy, UK, Rest of Europe), Asia-Pacific (China, Japan, India, Australia and Rest of Asia-Pacific) and Rest of World (Brazil and Other Rest of World). In 2018, North America generated revenue of US$ 2,964.9 million, however, Asia-Pacific is expected to witness highest CAGR of 6.74%b during the forecast period. The dominance of North America is majorly driven by the presence of a well-established diagnostic infrastructure, technological advancements, patient awareness and presence of advanced products in the field of molecular diagnostics.

Competitive Landscape-Top 10 Market Players

Abbott Laboratories, Becton Dickinson and Company, Biomerieux SA, Danaher Corporation, Hologic, Inc., Qiagen, Roche, Siemens Healthineers AG, Sysmex Corporation and Thermo Fisher Scientific are some of the prominent players operating in the Global Molecular 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.

Reasons to buy:

• 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 molecular 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

• Regions/countries Covered: North America (US, Canada, Rest of US), Europe (Germany, France, Spain, Italy, UK, Rest of Europe), Asia-Pacific (China, Japan, India, Australia and Rest of Asia-Pacific) and Rest of World (Brazil and Other Rest of World)

Customization Options:

UMI understands that you may have your own business need, hence we also provide fully customized solutions to clients. The Global Molecular Diagnostics Market can be customized to the country level or any other market segment.

1. MARKET INTRODUCTION

1.1 Market Definition 21

1.2 Objective of the Study 21

1.3 Limitation 22

1.4 Stakeholders 22

1.5 Currency used in the Report 22

1.6 Scope of the Global Molecular Diagnostics Market Study 23

2. RESEARCH METHODOLOGY 24

2.1 Research Methodology for Global Molecular Diagnostics (MDx) Market Study 24

2.1.1 Main objective of the Global Molecular Diagnostics Market Study 25

3. COMPREHENSIVE ASSESSMENT OF THE VALUE OF DIAGNOSTIC TESTS 26

3.1 General Overview 26

3.2 Capturing the full spectrum of the value that a diagnostic test contributes 29

3.3 Ensuring that robust analyses underpin the value assessment 31

3.4 Accounting for variation in diagnostic test types in value assessment methods 32

3.5 Aligning on how to define and measure value drivers 34

3.5.1 Value Driver: Clinical Impact 34

3.5.2 Value Driver: Non-Clinical Patient Impact 36

3.5.3 Value Driver: Care Delivery Revenue and Cost Impact 37

3.5.4 Value Driver: Public/Population Impact 39

4. REFRAMING THE DIAGNOSTICS INDUSTRY 41

4.1 General Overview 41

5. EXECUTIVE SUMMARY 44

6. INDUSTRY PERFORMANCE 47

7. RISK MITIGATION 48

7.1 General Overview 48

7.2 Supply Chain 49

7.3 Risk Assessment 50

7.4 Bulk, Custom and Contract Manufacturing 51

5. MARKET OVERVIEW 52

5.1 Introduction of Molecular Diagnostics Market 52

5.1.1 Essential Components or Attributes of Diagnostics 54

5.1.2 Main Categories of Diagnostics 55

5.1.3 Settings of Use 57

5.2 Current and Future Use of Diagnostic Products 58

5.2.1 Primary Uses of Diagnostics 58

5.2.1.1 Predictive Applications/Screening/Early Disease Detection 59

5.2.1.2 Diagnostic 59

5.2.1.3 Secondary Risk Assessment – Prognostic 60

5.2.1.4 Drug Selection/Treatment Targeting 60

5.2.1.5 Disease/Condition Monitoring and Management 60

5.2.2 Molecular Diagnostics: Overview of Future Trends and Directions 60

5.2.2.1 Predict Disease Before Symptoms Appear 60

5.2.2.2 Predict Beneficial and Adverse Treatment Effects 61

5.2.2.3 Enable Personalized “Real-Time” Treatment and Disease Management Regimens 63

5.2.2.4 Facilitate Point-of-care and Near-patient Testing 64

5.2.2.5 Enable Home Testing 64

5.2.2.6 Public Health, Environmental, Bioterrorism Applications 65

5.2.2.7 Technology and Testing System Integration 66

5.2.3 The Importance of Molecular Diagnostics 67

5.2.4 Market Drivers 68

5.2.4.1 Increasing Prevalence of Chronic Diseases 68

5.2.4.2 Rising Geriatric Population 70

5.2.4.3 Increasing adoption of Point-of-Care Diagnosis 71

5.2.4.4 Technology Advancement in the In-Vitro Diagnostics 73

5.2.4.5 Advances in Genomics and Proteomics 74

5.2.5 Market Restraints 75

5.2.5.1 Unfavorable Reimbursement Policies for In-Vitro Diagnostics 75

5.2.5.2 High Prices of Molecular Diagnostics Tests 76

5.2.6 Market Opportunities 76

5.2.6.1 Increasing Support from Governments and Key Players 76

5.2.6.2 Growing Significance of Companion Diagnostics 78

5.2.7 Market Trends 80

5.2.7.1 Changing Reimbursement Models and Regulations 80

5.2.7.2 Investing in Unifying Technology 81

5.2.7.3 Consolidation and Automation of Labs 82

5.2.7.4 Shift to Data-Driven Healthcare 83

5.2.7.5 Consumer Lab Testing 83

5.2.7.6 Healthcare Convergence 84

6. REGULATIONS AND REIMBURSEMENT POLICY 86

6.1 Regulation 86

6.1.1 United States 86

6.1.1.1 Approval/Clearance of Molecular Diagnostic Instruments 86

6.1.1.2 Recommendations for Submissions for Molecular Diagnostic Instruments with Combined Functions 88

6.1.1.2.1 New Instruments 88

6.1.1.2.2 Existing Approved/Cleared Instruments 88

6.1.1.2.3 Submission Information, Labeling, and Marketing 88

6.1.1.2.4 Promotion and Labeling Issues 89

6.1.1.2.5 Software/Hardware Changes 89

6.1.1.2.6 Third-Party Assay Developers 90

6.1.1.2.7 MDR Reporting 90

6.2 Reimbursement 91

7. KEY MARKET INDICATORS 96

7.1 Demand Side Analysis 96

7.1.1 Some of the Key Facts about Aging Population 97

7.1.2 Health Conditions Associated with Aging 98

7.1.2.1 Some of the key facts about Cardiovascular Diseases (CVD) as per WHO 99

7.2 Supply Side Analysis 100

7.2.1 Product Launches 102

7.2.2 Partnership 108

7.2.3 Business Expansions and Investments 112

7.2.4 Merger and Acquisition 114

7.3 SWOT Analysis of Molecular Diagnostics 116

7.4 Value Chain Analysis of Molecular Diagnostics 117

8. MARKET INSIGHT BY PRODUCT 118

8.1 General Overview 118

8.1.1 Reagents 120

8.1.2 Instruments Services 126

9. MARKET INSIGHT BY TECHNIQUE 131

9.1 General Overview 131

9.1.1 Polymerase chain reaction (PCR) 133

9.1.2 Transcription-Mediated Amplification (TMA) 136

9.1.3 In Situ Hybridization & FISH 137

9.1.4 DNA Sequencing & Next-Generation Sequencing (NGS) 138

9.1.5 Case Study: Next Generation Sequencing for Clinical Diagnostics 139

9.1.6 Chips and Microarrays 142

9.1.7 Others 144

10. MARKET INSIGHT BY APPLICATION 146

10.1 General Overview 146

10.1.1 Microbiology 147

10.1.2 Virology 148

10.1.3 Hospital Acquired Infections (HAI) 153

10.1.4 Genetic Testing 155

10.1.5 Oncology 156

10.1.6 Pharmacogenetics 160

10.1.7 Human Leukocyte Antigen (HLA Testing) 161

10.1.8 Blood Screening 163

10.1.9 Others 164

11. MARKET INSIGHT BY END USER 166

11.1 General Overview 166

11.1.1 Hospitals 167

11.1.2 Clinics & Laboratory 168

11.1.3 Others 173

12. MARKET INSIGHT BY REGION 175

12.1 General Overview 175

12.2 North America MDx Market Insight 177

12.2.1 North America Molecular Diagnostics Market by Product 178

12.2.2 North America Molecular Diagnostics Market by Technique 178

12.2.3 North America Molecular Diagnostics Market by Application 179

12.2.4 North America Molecular Diagnostics Market by End Users 179

12.2.5 North America Molecular Diagnostics Market by Country 180

12.2.5.1 United States 180

12.2.5.1.1 Key Findings on Healthcare Spending in the US, 2017 181

12.2.5.1.2 US Health Spending by Type of Service or Product, 2017 181

12.2.5.1.3 Health Spending by Major Sources of Funds 182

12.2.5.1.4 United States Molecular Diagnostics Market by Product 184

12.2.5.1.5 United States Molecular Diagnostics Market by Technique 184

12.2.5.1.6 United States Molecular Diagnostics Market by Application 185

12.2.5.1.7 United States Molecular Diagnostics Market by End Users 185

12.2.5.2 Canada 186

12.2.5.2.1 Key Findings on Canada Healthcare Spending, 2018 187

12.2.5.2.2 Key Findings on Hospital sector Spending in Canada, 2017 188

12.2.5.2.3 Canada Molecular Diagnostics Market by Product 189

12.2.5.2.4 Canada Molecular Diagnostics Market by Technique 190

12.2.5.2.5 Canada Molecular Diagnostics Market by Application 190

12.2.5.2.6 Canada Molecular Diagnostics Market by End Users 191

12.2.5.3 Rest of North America 191

12.2.5.3.1 Rest of NA Molecular Diagnostics Market by Product 192

12.2.5.3.2 Rest of NA Molecular Diagnostics Market by Technique 193

12.2.5.3.3 Rest of NA Molecular Diagnostics Market by Application 193

12.2.5.3.4 Rest of NA Molecular Diagnostics Market by End Users 194

12.3 Europe Molecular Diagnostics Market Insight 194

12.3.1 Europe Molecular Diagnostics Market by Product 195

12.3.2 Europe Molecular Diagnostics Market by Technique 196

12.3.3 Europe Molecular Diagnostics Market by Application 196

12.3.4 Europe Molecular Diagnostics Market by End Users 197

12.3.5 Europe Molecular Diagnostics Market by Country 197

12.3.5.1 Germany 198

12.3.5.1.1 Germany Molecular Diagnostics Market by Product 199

12.3.5.1.2 Germany Molecular Diagnostics Market by Technique 200

12.3.5.1.3 Germany Molecular Diagnostics Market by Application 200

12.3.5.1.4 Germany Molecular Diagnostics Market by End Users 201

12.3.5.2 France 201

12.3.5.2.1 France Molecular Diagnostics Market by Product 202

12.3.5.2.2 France Molecular Diagnostics Market by Technique 203

12.3.5.2.3 France Molecular Diagnostics Market by Application 203

12.3.5.2.4 France Molecular Diagnostics Market by End Users 204

12.3.5.3 Spain 204

12.3.5.3.1 Spain Molecular Diagnostics Market by Product 206

12.3.5.3.2 Spain Molecular Diagnostics Market by Technique 206

12.3.5.3.3 Spain Molecular Diagnostics Market by Application 207

12.3.5.3.4 Spain Molecular Diagnostics Market by End Users 207

12.3.5.4 Italy 208

12.3.5.4.1 Italy Molecular Diagnostics Market by Product 209

12.3.5.4.2 Italy Molecular Diagnostics Market by Technique 209

12.3.5.4.3 Italy Molecular Diagnostics Market by Application 210

12.3.5.4.4 Italy Molecular Diagnostics Market by End Users 210

12.3.5.5 United Kingdom 211

12.3.5.5.1 United Kingdom Molecular Diagnostics Market by Product 213

12.3.5.5.2 United Kingdom Molecular Diagnostics Market by Technique 213

12.3.5.5.3 United Kingdom Molecular Diagnostics Market by Application 214

12.3.5.5.4 United Kingdom Molecular Diagnostics Market by End Users 214

12.3.5.6 Rest of Europe 215

12.3.5.6.1 Rest of Europe Molecular Diagnostics Market by Product 216

12.3.5.6.2 Rest of Europe Molecular Diagnostics Market by Technique 217

12.3.5.6.3 Rest of Europe Molecular Diagnostics Market by Application 217

12.3.5.6.4 Rest of Europe Molecular Diagnostics Market by End Users 218

12.4 Asia-Pacific Molecular Diagnostics Market Insight 218

12.4.1 Asia-Pacific Molecular Diagnostics Market by Product 219

12.4.2 Asia-Pacific Molecular Diagnostics Market by Technique 220

12.4.3 Asia-Pacific Molecular Diagnostics Market by Application 220

12.4.4 Asia-Pacific Molecular Diagnostics Market by End Users 221

12.4.5 Asia-Pacific Molecular Diagnostics Market by Country 221

12.4.5.1 China 222

12.4.5.1.1 China In-Vitro Diagnostics Services Market 223

12.4.5.1.2 China Molecular Diagnostics Market by Product 223

12.4.5.1.3 China Molecular Diagnostics Market by Technique 224

12.4.5.1.4 China Molecular Diagnostics Market by Application 224

12.4.5.1.5 China Molecular Diagnostics Market by End Users 225

12.4.5.2 India 225

12.4.5.2.1 India Molecular Diagnostics Market by Product 227

12.4.5.2.2 India Molecular Diagnostics Market by Technique 228

12.4.5.2.3 India Molecular Diagnostics Market by Application 228

12.4.5.2.4 India Molecular Diagnostics Market by End Users 229

12.4.5.3 Japan 229

12.4.5.3.1 Japan Molecular Diagnostics Market by Product 231

12.4.5.3.2 Japan Molecular Diagnostics Market by Technique 232

12.4.5.3.3 Japan Molecular Diagnostics Market by Application 232

12.4.5.3.4 Japan Molecular Diagnostics Market by End Users 233

12.4.5.4 Australia 233

12.4.5.4.1 Australia Molecular Diagnostics Market by Product 235

12.4.5.4.2 Australia Molecular Diagnostics Market by Technique 236

12.4.5.4.3 Australia Molecular Diagnostics Market by Application 236

12.4.5.4.4 Australia Molecular Diagnostics Market by End Users 237

12.4.5.5 Rest of APAC Market Insight 237

12.4.5.5.1 Rest of APAC Molecular Diagnostics Market by Product 239

12.4.5.5.2 Rest of APAC Molecular Diagnostics Market by Technique 239

12.4.5.5.3 Rest of APAC Molecular Diagnostics Market by Application 240

12.4.5.5.4 Rest of APAC Molecular Diagnostics Market by End Users 240

12.5 Rest of World Market Insight 241

12.5.1 Rest of World Molecular Diagnostics Market by Product 242

12.5.2 Rest of World Molecular Diagnostics Market by Technique 242

12.5.3 Rest of World Molecular Diagnostics Market by Application 243

12.5.4 Rest of World Molecular Diagnostics Market by End Users 243

12.5.5 Rest of World Molecular Diagnostics Market by Country 244

12.5.5.1 Brazil 244

12.5.5.1.1 Brazil Molecular Diagnostics Market by Product 246

12.5.5.1.2 Brazil Molecular Diagnostics Market by Technique 246

12.5.5.1.3 Brazil Molecular Diagnostics Market by Application 247

12.5.5.1.4 Brazil Molecular Diagnostics Market by End Users 247

12.5.5.2 Other Rest of World 248

12.5.5.2.1 Other Rest of World Molecular Diagnostics Market by Product 248

12.5.5.2.2 Other Rest of World Molecular Diagnostics Market by Technique 249

12.5.5.2.3 Other Rest of World Molecular Diagnostics Market by Application 249

12.5.5.2.4 Other Rest of World Molecular Diagnostics Market by End Users 250

13. COMPETITIVE SCENARIO 251

13.1 Porter’s Five forces analysis 251

13.1.1 Bargaining Power of Suppliers 252

13.1.2 Bargaining Power of Buyers 252

13.1.3 Threat of New Entrants 253

13.1.4 Threat of Substitutes 254

13.1.5 Industry Rivalry 254

13.2 Market Share Analysis, by Company 255

13.2.1 Molecular Diagnostics Market Share Analysis by Company 2018 255

14. TOP COMPANY PROFILES 258

14.1 Abbott Laboratories 258

14.1.1 Key Facts 258

14.1.2 Business Description 258

14.1.3 Key Product/Services Offerings 259

14.1.4 Growth Strategy 259

14.1.5 SWOT Analysis 260

14.1.6 Key Financials 261

14.1.6.1 Revenue Split 262

14.1.7 Recent Developments 262

14.1.7.1 Product Launches 262

14.1.7.2 Partnership 263

14.1.7.3 Merger and Acquisition 263

14.2 Becton, Dickinson and Company 264

14.2.1 Key Facts 264

14.2.2 Business Description 264

14.2.3 Key Product/Services Offerings (AI Technology) 264

14.2.4 Growth Strategy 265

14.2.5 SWOT Analysis 266

14.2.6 Key Financials 267

14.2.6.1 Revenue Split 268

14.2.7 Recent Developments 268

14.2.7.1 Product Launches 268

14.2.7.2 Business Expansions and Investments 269

14.2.7.3 Merger & Acquisitions 270

14.3 Biomérieux SA 271

14.3.1 Key Facts 271

14.3.2 Business Description 271

14.3.3 Key Product/Services Offerings 272

14.3.4 Growth Strategy 272

14.3.5 SWOT Analysis 273

14.3.6 Key Financials 274

14.3.6.1 Revenue Split 275

14.3.7 Recent Developments 275

14.3.7.1 Product Launches 275

14.3.7.2 Partnerships 276

14.3.7.3 Mergers and Acquisitions 277

14.4 Hologic, Inc. 278

14.4.1 Key Facts 278

14.4.2 Business Description 278

14.4.3 Key Product/Services Offerings 279

14.4.4 Growth Strategy 281

14.4.5 SWOT Analysis 281

14.4.6 Key Financials 282

14.4.6.1 Revenue Split 283

14.4.7 Recent Developments 283

14.4.7.1 Product Launches 283

14.4.7.2 Partnerships 285

14.4.7.3 Business Expansion & Investment 286

14.4.7.4 Mergers and Acquisitions 286

14.5 Danaher Corporation 287

14.5.1 Key Facts 287

14.5.2 Business Description 287

14.5.3 Key Product/Services Offerings 287

14.5.4 Growth Strategy 288

14.5.5 SWOT Analysis 289

14.5.6 Key Financials 290

14.5.6.1 Revenue Split 291

14.5.7 Recent Developments 291

14.5.7.1 Merger and Acquisitions 291

14.6 Qiagen 292

14.6.1 Key Facts 292

14.6.2 Business Description 292

14.6.3 Key Product/Services Offerings 293

14.6.4 Growth Strategy 293

14.6.5 Key Milestones 294

14.6.6 SWOT Analysis 294

14.6.7 Key Financials 295

14.6.7.1 Revenue Split 296

14.6.8 Recent Developments 296

14.6.8.1 Product Launches 296

14.6.8.2 Partnerships 297

14.6.8.3 Business Expansions and Investment 299

14.6.8.4 Mergers and Acquisitions 300

14.7 Roche Holding AG 301

14.7.1 Key Facts 301

14.7.2 Business Description 301

14.7.3 Key Product/Services Offerings 302

14.7.4 Growth Strategy 302

14.7.5 SWOT Analysis 303

14.7.6 Key Financials 304

14.7.6.1 Revenue Split 305

14.7.7 Recent Developments 305

14.7.7.1 Product Launches 305

14.7.7.2 Partnership 307

14.7.7.3 Mergers and Acquisitions 307

14.8 Siemens Healthineers AG 308

14.8.1 Key Facts 308

14.8.2 Business Description 308

14.8.3 Key Product/Services Offerings 309

14.8.4 Growth Strategy 309

14.8.5 SWOT Analysis 310

14.8.6 Key Financials 311

14.8.6.1 Revenue Split 312

14.8.7 Recent Developments 312

14.8.7.1 Product Launches 312

14.8.7.2 Partnership 313

14.8.7.3 Business Expansion and Investment 313

14.8.7.4 Merger and Acquisitions 313

14.9 Thermo Fisher Scientific 314

14.9.1 Key Facts 314

14.9.2 Business Description 314

14.9.3 Key Product/Services Offerings 315

14.9.4 Growth Strategy 317

14.9.5 SWOT Analysis 317

14.9.6 Key Financials 318

14.9.6.1 Revenue Split 319

14.9.7 Recent Developments 319

14.9.7.1 Product Launch 319

14.9.7.2 Partnerships 322

14.9.7.3 Expansion and Investment 323

14.9.7.4 Merger and Acquisition 324

14.10 Sysmex Corporation 326

14.10.1 Key Facts 326

14.10.2 Business Description 326

14.10.3 Key Product/Services Offerings 326

14.10.4 Growth Strategy 327

14.10.5 SWOT Analysis 328

14.10.6 Key Financials 329

14.10.6.1 Revenue Split 330

14.10.7 Recent Developments 330

14.10.7.1 Product Launches 330

14.10.7.2 Partnership 331

14.10.7.3 Business Expansion & Investments 332

14.10.7.4 Merger and Acquisitions 333

TABLE 1 Principles for Effective Value Assessments 28

TABLE 2 Considerations in Demonstrating Value by Diagnostic Test Type 33

TABLE 3 Value Driver: Clinical Impact 34

TABLE 4 Value Driver: Non-Clinical Patient Impact 36

TABLE 5 Value Driver: Care Delivery Revenue and Cost Impact 38

TABLE 6 Value Driver: Public/Population Impact 39

TABLE 7 Risk from Raw Material Supply and In-House Manufacturing Capabilities of MDx Manufacturers 48

TABLE 8 Examples of Molecular Diagnostics across the Continuum of Care 53

TABLE 9 Categories and Examples of Diagnostic Products 56

TABLE 10 Rapidly Expanding Areas of Scientific Inquiry 61

TABLE 11 Number and distribution of persons aged 60 years or over by region, in 2017 and 2050 71

TABLE 12 Presently Used Proteomics Tools in Diseases Diagnostics 75

TABLE 13 Oncology CDx Market: Selected Tests Resulting from Partnerships, U.S., 2017 79

TABLE 14 MDx Market Regulatory Analysis, Selected Regions 81

TABLE 15 CEN/TS and ISO standards on the pre-examination process for Molecular Diagnostics that have emerged from SPIDIA 91

TABLE 16 Product Launches 102

TABLE 17 Partnership 108

TABLE 18 Business Expansions and Investments 112

TABLE 19 Merger and Acquisition 114

TABLE 20 Products List for In-Vitro Diagnostics Reagents 124

TABLE 21 IVD Ancillary Reagents 125

TABLE 22 IVD Market Regulatory Analysis, Selected Regions 127

TABLE 23 Overview of Next-Generation Sequencing Technologies 139

TABLE 24 Microarrays and Applications 143

TABLE 25 Global Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 147

TABLE 26 Standardised Molecular Protocols in Diagnostic Virology 149

TABLE 27 Examples of Molecular Diagnostics in Cancer 157

TABLE 28 General Molecular Diagnostics for Primary Health Care 169

TABLE 29 General Molecular Diagnostics for health care facilities with clinical laboratories 170

TABLE 30 Countries with Shift in Average Life Expectancies in 2030 175

TABLE 31 North America Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 179

TABLE 32 United States Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 185

TABLE 33 Canada Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 190

TABLE 34 Rest of NA Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 193

TABLE 35 Europe Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 196

TABLE 36 Germany Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 200

TABLE 37 France Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 203

TABLE 38 Spain Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 207

TABLE 39 Italy Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 210

TABLE 40 United Kingdom Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 214

TABLE 41 Rest of Europe Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 217

TABLE 42 Asia-Pacific Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 220

TABLE 43 China Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 224

TABLE 44 India Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 228

TABLE 45 Japan Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 232

TABLE 46 Australia, Total Health Expenses, US$ Million 235

TABLE 47 Australia Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 236

TABLE 48 Rest of APAC Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 240

TABLE 49 Rest of World Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 243

TABLE 50 Brazil Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 247

TABLE 51 Other Rest of World Molecular Diagnostics Market Size, by Application, 2018-25 (US$ Mn) 249

TABLE 52 Abbott Laboratories Key Facts 258

TABLE 53 Product segmentation of Abbott Laboratories 259

TABLE 54 Abbott laboratories Growth Strategy 259

TABLE 55 Abbott Laboratories, Inc. Product Launches 262

TABLE 56 Abbott Laboratories, Inc. Partnership 263

TABLE 57 Abbott Laboratories, Inc. Merger and Acquisition 263

TABLE 58 Becton, Dickinson and Company Key Facts 264

TABLE 59 Becton, Dickinson and Company Growth Strategy 264

TABLE 60 Becton, Dickinson and Company Growth Strategy 265

TABLE 61 Becton, Dickinson and Company Product Launches 268

TABLE 62 Becton, Dickinson and Company Business Expansions and Investments 269

TABLE 63 Becton, Dickinson and Company Merger & Acquisitions 270

TABLE 64 Biomérieux SA Key Facts 271

TABLE 65 Product segmentation of Biomérieux SA 272

TABLE 66 Biomérieux SA Growth Strategy 272

TABLE 67 Biomérieux SA Product Launches 275

TABLE 68 Biomérieux SA Partnerships 276

TABLE 69 Biomérieux SA Mergers and Acquisitions 277

TABLE 70 Hologic, Inc. Key Facts 278

TABLE 71 Hologic, Inc. Ownership Structure 278

TABLE 72 Product segmentation of Hologic, Inc. 279

TABLE 73 Hologic, Inc. Growth Strategy 281

TABLE 74 Hologic, Inc. Product Launches 283

TABLE 75 Hologic, Inc. Partnerships 285

TABLE 76 Hologic, Inc. Business Expansion & Investment 286

TABLE 77 Hologic, Inc. Merger and Acquisitions 286

TABLE 78 Danaher Corporation Key Facts 287

TABLE 79 Product Segmentation of Danaher Corporation 287

TABLE 80 Danaher Corporation Growth Strategy 288

TABLE 81 Danaher Corporation Merger and Acquisitions 291

TABLE 82 Qiagen Key Facts 292

TABLE 83 Qiagen. Ownership Structure 292

TABLE 84 Product Segmentation of Qiagen 293

TABLE 85 Qiagen Growth Strategy 293

TABLE 86 Qiagen Product Launches 296

TABLE 90 Roche Key Facts 301

TABLE 91 The product segmentation of Roche 302

TABLE 92 Roche Growth Strategy 302

TABLE 93 Roche Product Launches 305

TABLE 94 Roche Partnership 307

TABLE 95 Roche Mergers and Acquisitions 307

TABLE 96 Siemens Healthineers AG Key Facts 308

TABLE 97 Product Segmentation of Siemens Healthineers AG 309

TABLE 98 Siemens Healthineers AG Growth Strategy 309

TABLE 99 Siemens Healthineers AG Product Launches 312

TABLE 100 Siemens Healthineers AG Partnership 313

TABLE 101 Siemens Healthineers AG Business Expansion and Investment 313

TABLE 102 Siemens Healthineers AG Merger and Acquisitions 313

TABLE 103 Thermo Fisher Scientific Key Facts 314

TABLE 104 Product Segmentation of Thermo Fisher Scientific 315

TABLE 105 Thermo Fisher Scientific Growth Strategy 317

TABLE 106 Thermo Fisher Scientific Product Launch 319

TABLE 107 Thermo Fisher Scientific Partnerships 322

TABLE 108 Thermo Fisher Scientific Business Expansion and Investments 323

TABLE 109 Thermo Fisher Scientific Merger and Acquisition 324

TABLE 110 Sysmex Corporation Key Facts 326

TABLE 111 Product segmentation of Sysmex Corporation 326

TABLE 112 Sysmex Corporation Growth Strategy 327

TABLE 113 Sysmex Corporation Product Launches 330

TABLE 114 Sysmex Corporation Partnership 331

TABLE 115 Sysmex Corporation Business Expansion & Investments 332

TABLE 116 Sysmex Corporation Merger and Acquisitions 333

 
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