Point of Care Diagnostics (POCD) Market Report – Research, Industry Analysis Reports and Market Demands

Point of Care Diagnostics (POCD) Global Market

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Table of Content

1 EXECUTIVE SUMMARY 28

2 INTRODUCTION 34

2.1 KEY TAKEAWAYS 34
2.2 REPORT DESCRIPTION 35
2.3 MARKETS COVERED 36
2.4 STAKEHOLDERS 38
2.5 RESEARCH METHODOLOGY 38
- 2.5.1 MARKET SIZE ESTIMATION 40
- 2.5.2 MARKET CRACKDOWN AND DATA TRIANGULATION 42
- 2.5.4 SECONDARY SOURCES 43
- 2.5.5 PRIMARY SOURCES 43
- 2.5.6 KEY DATA POINTS FROM SECONDARY SOURCES 44
- 2.5.7 KEY DATA POINTS FROM PRIMARY SOURCES 45
- 2.5.8 ASSUMPTIONS 45

3 MARKET OVERVIEW 46

3.1 INTRODUCTION 46
3.2 MARKET SEGMENTATION 48
3.3 FACTORS INFLUENCING MARKET 50
3.4 MARKET DYNAMICS 51
- 3.4.1 DRIVERS AND OPPORTUNITIES 51
  - 3.4.1.1 Rapid rise in the aging population 51
  - 3.4.1.2 High prevalence of chronic and infectious diseases 51
  - 3.4.1.3 Lack of skilled laboratory technicians in emerging countries 52
  - 3.4.1.4 Rising number of clia-waived poc tests 53
  - 3.4.1.5 Rising awareness about point of care diagnostics in developing countries 54
  - 3.4.1.6 Technological advancements 55
- 3.4.2 RESTRAINTS AND THREATS 56
  - 3.4.2.1 Inconsistent reimbursement and high cost of devices 56
  - 3.4.2.2 Stringent regulatory requirements 56
  - 3.4.2.3 Rising incidence of product recalls 57
  - 3.4.2.4 Accuracy issues 58
3.5 REGULATORY AFFAIRS 59
- 3.5.1 U.S. 59
- 3.5.2 EUROPE 60
- 3.5.3 INDIA 62
- 3.5.4 CHINA 62
- 3.5.5 JAPAN 63
3.6 PORTER’S FIVE FORCE ANALYSIS 64
- 3.6.1 THREAT OF NEW ENTRANTS 65
- 3.6.2 THREAT OF SUBSTITUTES 66
- 3.6.3 BARGAINING POWER OF SUPPLIERS 66
- 3.6.4 BARGAINING POWER OF BUYERS 67
- 3.6.5 RIVALRY AMONG EXISTING COMPETITORS 68
3.7 MARKET SHARE ANALYSIS 69
- 3.7.1 MARKET SHARE ANALYSIS OF GLUCOSE MONITORING KITS 72
- 3.7.2 MARKET SHARE ANALYSIS OF CONTINUOUS GLUCOSE KITS 74
- 3.7.3 MARKET SHARE ANALYSIS OF COAGULATION TESTING KITS 76
- 3.7.4 MARKET SHARE ANALYSIS OF CARDIAC MARKERS 78
3.8 TECHNOLOGICAL ADVANCEMENTS 80
- 3.8.1 SMARTPHONE-BASED TECHNOLOGIES 80
- 3.8.2 NANOBIOSENSOR 81
- 3.8.3 SMART CONTACT LENSES 82
- 3.8.4 LIQUID BIOPSY 82
3.9 FUNDING SCENARIO 83
3.10 SUPPLY CHAIN ANALYSIS 88

4 POINT OF CARE DIAGNOSTICS GLOBAL MARKET, BY PRODUCTS 91

4.1 INTRODUCTION 91
4.2 GLUCOSE MONITORING KITS 94
- 4.2.1 SELF-GLUCOSE MONITORING KITS 97
- 4.2.2 CONTINUOUS GLUCOSE MONITORING KITS 99
4.3 INFECTIOUS DISEASES TESTING KITS 100
- 4.3.1 HIV TESTING KITS 104
- 4.3.2 HEPATITIS TESTING KITS 106
- 4.3.3 TROPICAL DISEASES TESTING KITS 108
- 4.3.4 TUBERCULOSIS TESTING KITS 110
- 4.3.5 HEALTHCARE-ASSOCIATED INFECTION TEST KITS 112
- 4.3.6 RESPIRATORY INFECTIONS TESTING KITS 114
- 4.3.7 OTHER INFECTIOUS DISEASE TESTING KITS. 117
- 4.3.8 EBOLA VIRUS DISEASE 117
- 4.3.9 SYPHILIS 118
4.4 COAGULATION MONITORING KITS 119
- 4.4.1 PROTHROMBIN TIME (PT/INR) TESTING KITS 124
- 4.4.2 ACTIVATED CLOTTING TIME (ACT/APTT) TESTING KITS 126
4.5 HEMATOLOGY TESTING KITS 128
4.6 PREGNANCY AND FERTILITY TESTING KITS 130
4.6.1.1 Pregnancy testing kit 133
4.6.1.2 Fertility testing kit 134

4.7 CARDIOMETABOLIC MONITORING KITS 136

4.7.1 CARDIAC MARKERS 139
4.7.2 BLOOD GAS ANALYZERS/ELECTROLYTES TESTING KITS 141
4.7.3 HBA1C TESTING KITS 143
4.7.4 LIPID TESTING KITS 145

4.8 TUMOR/CANCER MARKERS 146

4.9 URINALYSIS 148

4.10 CHOLESTEROL TESTING KITS 150

4.11 DRUGS-OF-ABUSE TESTING KITS 151

4.12 OTHERS 153

4.12.1 OPHTHALMIC TESTING KITS 153

4.13 GENETIC MARKERS/TESTING KITS 154

4.13.1 THERAPEUTIC DRUG MONITORING TESTS 155
4.13.2 BLOOD LACTATE TEST 156

4.14 FAECAL OCCULT BLOOD TESTING KITS 156

5 POINT OF CARE DIAGNOSTICS MARKET, BY TECHNOLOGY 159

5.1 INTRODUCTION 159
5.2 BIOSENSOR TECHNOLOGY 162
5.3 IMMUNOCHROMATOGRAPHIC/LATERAL FLOW TECHNOLOGY 164
5.4 POLYMERASE CHAIN REACTION (PCR) TECHNOLOGY 166
5.5 MICROFLUIDIC/LAB-ON-A–CHIP TECHNOLOGY 168
5.6 OTHER TECHNOLOGIES 171

6 POINT OF CARE DIAGNOSTICS MARKET, BY PRESCRIPTION MODE 174

6.1 INTRODUCTION 174
- 6.1.1 PRESCRIPTION BASED TESTING KITS 176
- 6.1.2 OVER THE COUNTER (OTC) TESTING KITS MARKET 177

7 POINT OF CARE DIAGNOSTICS MARKET, BY SAMPLE TYPE 180

7.1 INTRODUCTION 180
- 7.1.1 BLOOD 182
- 7.1.2 URINE 183
- 7.1.3 SALIVA 185
- 7.1.4 OTHER 187

8 POINT OF CARE DIAGNOSTICS GLOBAL MARKET, BY END USER 191

8.1 INTRODUCTION 191
8.2 CLINICS 192
8.3 HOSPITALS 193
8.4 HOME HEALTHCARE 195
8.5 OTHER END-USERS 197

9 REGIONAL MARKET ANALYSIS 200

9.1 INTRODUCTION 200
9.2 NORTH AMERICA 202
- 9.2.1 U.S. 215
- 9.2.2 OTHERS 218
9.3 EUROPE 221
9.4 GERMANY 234
- 9.4.1 ITALY 238
- 9.4.2 FRANCE 240
- 9.4.3 OTHERS 243
9.5 ASIA PACIFIC 246
- 9.5.1 JAPAN 259
- 9.5.2 CHINA 262
- 9.5.3 INDIA 265
- 9.5.4 OTHERS 268
9.6 REST OF THE WORLD 271
- 9.6.1 BRAZIL 284
- 9.6.2 REST OF LATIN AMERICA 287
- 9.6.3 MIDDLE EAST AND OTHERS 290

10 COMPANY DEVELOPMENTS 293

10.1 INTRODUCTION 293
10.2 APPROVALS 294
10.3 AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS 306
10.4 NEW PRODUCT LAUNCH 310
10.5 ACQUISITIONS 315
10.6 OTHER DEVELOPMENTS 316

11 MAJOR COMPANIES 319

Description

Point of care tests, also called near-patient testing or bedside testing, refers to the performance of diagnostic tests at or near the site where the patient is located and helps in obtaining accurate results in a very short period of time. It can be performed by non-laboratory personnel and the main benefit of POCT is to make tests more convenient and immediately to the patient that helps doctors/physician to receive the results quicker, enabling clinicians to support the timely diagnosis, monitoring, and treatment of patients. It can be performed by non-laboratory personnel and the results are used for clinical decision making. POCD is usually used in clinics, healthcare departments, hospitals, and patient’s homes. In hospitals, they are primarily performed in emergency departments, surgical suites, critical care units, and certain outpatient areas. POC tests can be performed by a wide variety of people can, including laboratory professionals, emergency first responders, radiologists, doctors, nurses, physician assistants, or other healthcare practitioners. They may even be done by patients, sometimes called "self-tests" or "home tests”. POCT has a range of complexity and procedures that vary from manual methodologies to automated analyzers. With the advancements in technology, POC testing analyzers are becoming smaller, faster, and more user-friendly and to achieve accuracy with increasingly smaller samples (body fluids). The point of care diagnostics global market is expected to grow at single digit CAGR to reach $26,331.1 million by 2023.
The Point of care diagnostics market is segmented based on their products, technology, prescription mode, sample types, end-users, and geography. The global POCD market by products is segmented into glucose monitoring kits, infectious diseases testing kits, coagulation monitoring kits, hematology testing kits, pregnancy and fertility testing kits, cardiometabolic testing kits, tumor/cancer markers, urinalysis kits, cholesterol testing kits, drugs-of-abuse testing kits and others. The glucose monitoring kits are further segmented into self-glucose monitoring and continuous glucose monitoring kits. The Infectious diseases kits are further divided into HIV testing kits, Hepatitis testing kits, Tropical diseases testing kits, tuberculosis testing kits, Healthcare–Associated infection testing kits, respiratory infections testing kits, and others. The coagulation monitoring testing kits are further segmented into Prothrombin Time(PT/INR) Testing Kits and Activated Clotting Time(ACT/APTT) Testing Kits. The Pregnancy and Fertility Testing Kits are further segmented into Pregnancy Testing Kits and Fertility Testing Kits. The Cardiometabolic Monitoring Kits further segmented into Cardiac Markers, Blood Gas/Electrolytes Testing Kits, HBA1C Testing Kits, and LIPID Testing Kits. By technology, the POCD market is divided into a biosensor,microfluidics/lab-on-a-chip technology, PCR technology, Immunochromatographic/lateral flow technology and others. Based on prescription mode, POCD market is segmented into prescription based tests and over the counter tests. By sample types, POCD market is divided into blood, urine, saliva and others. Based on end-users, POCD market is segmented into hospitals, home healthcare, clinics. Further, the POCD global market is separated by geographical regions into North America, Europe, Asia-pacific and Rest of the World.

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