Table of Content

1 INTRODUCTION 13
1.1 OBJECTIVES OF THE STUDY 13
1.2 MARKET DEFINITION 13
1.3 RESEARCH SCOPE 14
1.3.1 SEGMENTS COVERED 14
1.3.2 GEOGRAPHIC SCOPE 15
1.3.3 YEARS CONSIDERED FOR THE STUDY 15
1.4 CURRENCY USED FOR THE STUDY 15
1.5 MAJOR MARKET STAKEHOLDERS 16

2 RESEARCH METHODOLOGY 17
2.1 RESEARCH DATA 17
2.1.1 SECONDARY DATA 18
2.1.2 PRIMARY DATA 20
2.2 MARKET ESTIMATION METHODOLOGY 20
2.2.1 REVENUE MAPPING-BASED MARKET ESTIMATION 21
2.2.2 PROCEDURE-BASED MARKET ESTIMATION 22
2.2.3 PRIMARY DATA VALIDATION 22
2.3 COVID-19 IMPACT ASSESSMENT METHODOLOGY 23
2.3.1 COVID-19 HEALTH ASSESSMENT 24
2.3.2 COVID-19 ECONOMIC ASSESSMENT 26
2.3.3 COVID-19 IMPACT ON THE ECONOMY?SCENARIO ASSESSMENT 27
2.4 RESEARCH ASSUMPTIONS 30
2.5 RESEARCH LIMITATIONS 30

3 MARKET OVERVIEW 31
3.1 INTRODUCTION 31
3.2 MARKET DYNAMICS 31
3.3 REGULATORY OVERVIEW 32
3.3.1 US 32
3.3.2 EUROPE 34
3.3.3 CHINA 35
3.3.4 JAPAN 36
3.3.5 INDIA 37
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4 IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 38
4.1 INTRODUCTION 38
4.2 POLYMERASE CHAIN REACTION 39
4.2.1 RISING PUBLIC PREFERENCE FOR PERSONALIZED MEDICINE IS EXPECTED TO DRIVE THE MARKET FOR PCR OVER THE NEXT DECADE 39
4.3 NEXT-GENERATION SEQUENCING 40
4.3.1 ONGOING SHIFT OF NGS FROM A RESEARCH TOOL TO AN EFFECTIVE DIAGNOSTIC MODALITY?A KEY FACTOR DRIVING GROWTH 40
4.4 RAPID TESTS 42
4.4.1 PATIENT PREFERENCE FOR SELF-USE OR POC DIAGNOSTIC PLATFORMS TO DRIVE THE ADOPTION OF RAPID TESTS 42
4.5 ELISA 43
4.5.1 RISING USE OF IMMUNOASSAYS IN VARIOUS CLINICAL APPLICATIONS TO DRIVE GROWTH IN THIS MARKET 43
4.6 MICROARRAYS 45
4.6.1 GROWING APPLICATION OF MICROARRAYS IN CLINICAL DIAGNOSTICS SUPPORTS MARKET GROWTH 45
4.7 HEMATOLOGY 46
4.7.1 CONSOLIDATION OF DIAGNOSTIC LABS (MAINLY IN EUROPE) MAY RESTRAIN MARKET GROWTH TO AN EXTENT 46
4.8 MICROBIOLOGY 47
4.8.1 CONTINUOUS COMMERCIALIZATION OF AUTOMATED & COMPACT MICROBIOLOGY TEST PLATFORMS TO SUPPORT GROWTH 47
4.9 COAGULATION & HEMOSTASIS 49
4.9.1 CONCERNS RELATED TO PRODUCT STANDARDIZATION AND PREMIUM PRODUCT PRICING MAY RESTRAIN MARKET GROWTH 49
4.10 CLINICAL CHEMISTRY 50
4.10.1 CONTINUED DIGITIZATION & INTEGRATION OF DIAGNOSTIC TECHNOLOGIES TO DRIVE GROWTH IN THIS MARKET 50
4.11 URINALYSIS 51
4.11.1 REPLACEMENT OF TRADITIONAL PLATFORMS WITH AUTOMATED DEVICES TO DRIVE MARKET GROWTH 51
4.12 OTHER TECHNOLOGIES 53

5 IN VITRO DIAGNOSTICS MARKET, BY END USER 54
5.1 INTRODUCTION 54
5.2 HOSPITAL-BASED LABORATORIES 54
5.2.1 HOSPITAL-BASED LABORATORIES HAVE WITNESSED HIGH TEST VOLUMES AND DEMAND FOR SERVICES 54
5.3 REFERENCE LABORATORIES 56
5.3.1 GOVERNMENT FOCUS ON CONTAINMENT OF COVID-19 WILL ENSURE GREATER TESTING VOLUMES IN REFERENCE LABORATORIES 56
5.4 INDEPENDENT LABORATORIES 57
5.4.1 HIGH TESTING VOLUMES AND GOVERNMENT MANDATES HAVE ENSURED STRONG GROWTH IN THIS SEGMENT 57
5.5 POINT-OF-CARE & SELF-TESTING 58
5.5.1 PACE OF MARKET GROWTH TO INCREASE AS NEW AND INNOVATIVE TESTS ARE INTRODUCED IN THE MARKET 58
5.6 RESEARCH LABORATORIES & ACADEMIC INSTITUTES 60
5.6.1 INDUSTRY-ACADEMIA COLLABORATIONS ARE A KEY DRIVER FOR MARKET GROWTH 60
5.7 OTHER END USERS 61

6 IN VITRO DIAGNOSTICS MARKET, BY REGION 62
6.1 INTRODUCTION 62
6.2 US 63
6.2.1 SUPPORTIVE GOVERNMENT REGULATIONS FOR PRODUCT DEVELOPMENT MAKES THE US A MAJOR MARKET 63
6.3 GERMANY 64
6.3.1 STRONG TECHNOLOGICAL CAPABILITIES OF LOCAL PLAYERS IN THE FIELD OF POC TESTING TO DRIVE GROWTH IN THE COUNTRY 64
6.4 ITALY 66
6.4.1 INCREASING PREFERENCE FOR MOLECULAR DIAGNOSTICS-BASED TESTING PROCEDURES TO DRIVE GROWTH IN ITALY 66
6.5 FRANCE 67
6.5.1 LACK OF REIMBURSEMENTS FOR VARIOUS DIAGNOSTIC TESTS TO RESTRAIN THE MARKET IN FRANCE 67
6.6 SPAIN 69
6.6.1 GROWING DEMAND FOR PRENATAL GENETIC SCREENING TO DRIVE GROWTH IN SPAIN 69
6.7 UK 70
6.7.1 PREMIUM PRICING OF NOVEL PLATFORMS MAY RESTRICT MARKET GROWTH IN THE UK 70
6.8 JAPAN 72
6.8.1 RISING ADOPTION OF MOLECULAR DIAGNOSTICS AND OTHER NOVEL TECHNOLOGIES TO DRIVE GROWTH IN JAPAN 72
6.9 CHINA 73
6.9.1 THE DEMAND FOR IVD PRODUCTS IN CHINA WILL MAINLY BE DRIVEN BY SUPPORTIVE GOVERNMENT REGULATIONS 73
6.10 SOUTH KOREA 75
6.10.1 RISING INDUSTRY FOCUS ON ORGANIC GROWTH STRATEGIES TO PROPEL THE DEMAND FOR IVD PRODUCTS IN SOUTH KOREA 75
6.11 INDIA 76
6.11.1 THE IVD INDUSTRY IN INDIA IS ESTIMATED TO WITNESS SIGNIFICANT GROWTH DUE TO THE LARGE PATIENT POPULATION 76
6.12 BRAZIL 78
6.12.1 GROWTH OF THE IVD MARKET IN BRAZIL WILL MAJORLY BE DRIVEN BY SUPPORTIVE GOVERNMENT REGULATIONS 78
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6.13 REST OF THE AMERICAS 79
6.14 REST OF EUROPE 81
6.15 REST OF ASIA PACIFIC 82
6.16 MIDDLE EAST & AFRICA 84

7 COMPETITIVE LANDSCAPE 86
7.1 INTRODUCTION 86
7.2 MARKET SHARE ANALYSIS 86
7.3 COMPETITIVE SITUATION AND TRENDS 87
7.3.1 PRODUCT COMMERCIALIZATION AND UPGRADES 87
7.3.2 AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS 90
7.3.3 EXPANSIONS 91
7.4 AUTHOR DETAILS 92



List of Figures



FIGURE 1 IN VITRO DIAGNOSTICS: OVERALL INDUSTRY ECOSYSTEM 17
FIGURE 2 MAJOR SECONDARY SOURCES 19
FIGURE 3 BREAKDOWN OF PRIMARIES: IN VITRO DIAGNOSTICS MARKET 20
FIGURE 4 RESEARCH METHODOLOGY: HYPOTHESIS BUILDING 21
FIGURE 5 MARKET SIZE ESTIMATION: GLOBAL IN VITRO DIAGNOSTICS MARKET 23
FIGURE 6 COVID-19: THE GLOBAL PROPAGATION 24
FIGURE 7 COVID-19 PROPAGATION: SELECT COUNTRIES 25
FIGURE 8 COUNTRIES BEGIN WITH SIMILAR TRAJECTORIES BUT CURVES DEVIATE
BASED ON MEASURES TAKEN 25
FIGURE 9 REVISED GDP FORECASTS FOR SELECT G20 COUNTRIES IN 2020 26
FIGURE 10 CRITERIA IMPACTING THE GLOBAL ECONOMY 27
FIGURE 11 SCENARIO IN TERMS OF RECOVERY OF THE GLOBAL ECONOMY 28
FIGURE 12 IN VITRO DIAGNOSTICS MARKET: KEY SEGMENTS WITH COVID-19 IMPACT 29
FIGURE 13 US: REGULATORY PROCESS FOR IVD DEVICES 33
FIGURE 14 EUROPE: REGULATORY PROCESS FOR IVD DEVICES 35
FIGURE 15 JAPAN: REGULATORY PROCESS FOR IVD DEVICES 36
FIGURE 16 INDIA: REGULATORY PROCESS FOR IVD DEVICES 37
FIGURE 17 IN VITRO DIAGNOSTICS MARKET SHARE ANALYSIS: TOP 5 GLOBAL
PLAYERS (2019) 86

 

List of Tables



TABLE 1 IMPACT OF COVID-19 ON THE IN VITRO DIAGNOSTICS MARKET AND OVERALL MARKET DRIVERS, RESTRAINTS, OPPORTUNITIES, CHALLENGES 31
TABLE 2 US: CLASSIFICATION OF IN VITRO DIAGNOSTIC DEVICES 32
TABLE 3 EUROPE: CLASSIFICATION OF IVD DEVICES 34
TABLE 4 IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY, 2019–2025 (USD MILLION) 38
TABLE 5 IN VITRO DIAGNOSTICS MARKET FOR PCR, BY COUNTRY/REGION 2019–2025 (USD MILLION) 40
TABLE 6 IN VITRO DIAGNOSTICS MARKET FOR NGS, BY COUNTRY/REGION 2019–2025 (USD MILLION) 41
TABLE 7 IN VITRO DIAGNOSTICS MARKET FOR RAPID TESTS, BY COUNTRY/REGION 2019–2025 (USD MILLION) 43
TABLE 8 IN VITRO DIAGNOSTICS MARKET FOR ELISA, BY COUNTRY/REGION 2019–2025 (USD MILLION) 44
TABLE 9 IN VITRO DIAGNOSTICS MARKET FOR MICROARRAY, BY COUNTRY/REGION 2019–2025 (USD MILLION) 46
TABLE 10 IN VITRO DIAGNOSTICS MARKET FOR HEMATOLOGY, BY COUNTRY/REGION, 2019–2025 (USD MILLION) 47
TABLE 11 IN VITRO DIAGNOSTICS MARKET FOR MICROBIOLOGY, BY COUNTRY/REGION, 2019–2025 (USD MILLION) 48
TABLE 12 IN VITRO DIAGNOSTICS MARKET FOR COAGULATION AND HEMOSTASIS BY COUNTRY/REGION, 2019–2025 (USD MILLION) 49
TABLE 13 IN VITRO DIAGNOSTICS MARKET FOR CLINICAL CHEMISTRY, BY COUNTRY/REGION, 2019–2025 (USD MILLION) 50
TABLE 14 IN VITRO DIAGNOSTICS MARKET FOR URINALYSIS, BY COUNTRY/REGION 2019–2025 (USD MILLION) 52
TABLE 15 IN VITRO DIAGNOSTICS MARKET FOR OTHER TECHNOLOGIES BY COUNTRY/REGION, 2019–2025 (USD MILLION) 53
TABLE 16 GLOBAL IN VITRO DIAGNOSTIC MARKET, BY END USER, 2019-2025 (USD MILLION) 54
TABLE 17 IN VITRO DIAGNOSTICS MARKET FOR HOSPITAL-BASED LABORATORIES BY COUNTRY/REGION, 2019–2025 (USD MILLION) 55
TABLE 18 IN VITRO DIAGNOSTICS MARKET FOR REFERENCE LABORATORIES BY COUNTRY/REGION, 2019–2025 (USD MILLION) 56
TABLE 19 IN VITRO DIAGNOSTICS MARKET FOR INDEPENDENT LABORATORIES BY COUNTRY/REGION, 2019–2025 (USD MILLION) 58
TABLE 20 IN VITRO DIAGNOSTICS MARKET FOR POINT-OF-CARE & SELF TESTING BY COUNTRY/REGION, 2019–2025 (USD MILLION) 59
TABLE 21 IN VITRO DIAGNOSTICS MARKET FOR RESEARCH LABORATORIES & ACADEMIC INSTITUTES, BY COUNTRY/REGION, 2019–2025 (USD MILLION) 60
TABLE 22 IN VITRO DIAGNOSTICS MARKET FOR OTHER END USERS, BY COUNTRY/REGION, 2019–2025 (USD MILLION) 61
TABLE 23 IN VITRO DIAGNOSTICS MARKET, BY COUNTRY/REGION 2019–2025 (USD MILLION) 62
TABLE 24 US: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 63
TABLE 25 US: IN VITRO DIAGNOSTICS MARKET, BY END USER, 2019–2025 (USD MILLION) 64
TABLE 26 GERMANY: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 65
TABLE 27 GERMANY: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 65
TABLE 28 ITALY: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 66
TABLE 29 ITALY: IN VITRO DIAGNOSTICS MARKET, BY END USER, 2019–2025 (USD MILLION) 67
TABLE 30 FRANCE: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 68
TABLE 31 FRANCE: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 68
TABLE 32 SPAIN: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 69
TABLE 33 SPAIN: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 70
TABLE 34 UK: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 71
TABLE 35 UK: IN VITRO DIAGNOSTICS MARKET, BY END USER, 2019–2025 (USD MILLION) 71
TABLE 36 JAPAN: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 72
TABLE 37 JAPAN: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 73
TABLE 38 CHINA: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 74
TABLE 39 CHINA: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 74
TABLE 40 SOUTH KOREA: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 75
TABLE 41 SOUTH KOREA: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 76
TABLE 42 INDIA: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 77
TABLE 43 INDIA: IN VITRO DIAGNOSTICS MARKET, BY END USER, 2019–2025 (USD MILLION) 77
TABLE 44 BRAZIL: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 78
TABLE 45 BRAZIL: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 79
TABLE 46 REST OF AMERICAS: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 80
TABLE 47 REST OF AMERICAS: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 80
TABLE 48 REST OF EUROPE: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 81
TABLE 49 REST OF EUROPE: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 82
TABLE 50 REST OF ASIA PACIFIC: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 2019–2025 (USD MILLION) 83
TABLE 51 REST OF ASIA PACIFIC: IN VITRO DIAGNOSTICS MARKET, BY END USER 2019–2025 (USD MILLION) 83

TABLE 52 MIDDLE EAST AND AFRICA: IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY, 2019–2025 (USD MILLION) 84
TABLE 53 MIDDLE EAST AND AFRICA: IN VITRO DIAGNOSTICS MARKET, BY END USER, 2019–2025 (USD MILLION) 85
TABLE 54 PRODUCT COMMERCIALIZATION AND UPGRADES (DECEMBER 2019–APRIL 2020) 87
TABLE 55 AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS
(DECEMBER 2019–APRIL 2020) 90
TABLE 56 EXPANSIONS (DECEMBER 2019–APRIL 2020) 91