Table of Content

1 INTRODUCTION 14
1.1 OBJECTIVES OF THE STUDY 14
1.2 MARKET DEFINITION 14
1.3 MARKET SCOPE 15
1.3.1 MARKETS COVERED 15
1.3.2 YEARS COVERED FOR THE STUDY 15
1.4 CURRENCY 16
1.5 LIMITATIONS 16
1.6 STAKEHOLDERS 16

2 RESEARCH METHODOLOGY 17
2.1 RESEARCH DATA 17
2.1.1 SECONDARY SOURCES 18
2.1.1.1 Key data from secondary sources 18
2.1.2 PRIMARY SOURCES 19
2.1.2.1 Key data from primary sources 20
2.2 MARKET SIZE ESTIMATION 20
2.3 MARKET BREAKDOWN AND DATA TRIANGULATION 22
2.3.1.1 Key industry insights 23

3 EXECUTIVE SUMMARY 24
3.1 INTRODUCTION 24

4 PREMIUM INSIGHTS 28
4.1 MOLECULAR QUALITY CONTROLS: MARKET OVERVIEW 28
4.2 MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 29
4.3 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET, BY END USER (2018) 30

5 MARKET OVERVIEW 31
5.1 INTRODUCTION 31
5.1.1 DRIVERS 32
5.1.1.1 Increasing number of accredited clinical laboratories 32
5.1.1.2 Growing adoption of third-party quality controls 33
5.1.1.3 Rising demand for external quality assessment support 33
5.1.2 RESTRAINTS 34
5.1.2.1 Additional costs involved in quality control and budget constraints in hospitals and laboratories 34
5.1.2.2 Unfavorable reimbursement scenario for molecular tests 34
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5.1.3 OPPORTUNITIES 34
5.1.3.1 Rising demand for multi-analyte controls 34
5.1.4 CHALLENGES 35
5.1.4.1 Lack of mandatory regulations for clinical laboratory accreditation in several emerging countries 35
5.1.4.2 Complex regulatory frameworks 35

6 MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 36
6.1 INTRODUCTION 37
6.2 INDEPENDENT CONTROLS 37
6.2.1 WIDE RANGE OF APPLICATIONS AND REDUCTIONS IN OPERATIONAL COSTS HAVE BOOSTED THE USE OF INDEPENDENT CONTROLS 37
6.3 INSTRUMENT-SPECIFIC CONTROLS 39
6.3.1 PCR 40
6.3.1.1 PCR controls dominate the instrument-specific controls market 40
6.3.2 DNA SEQUENCING & NGS 41
6.3.2.1 Advancements in sequencing technologies form a positive growth factor for this market 41
6.3.3 OTHER TECHNOLOGIES 43

7 MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE 44
7.1 INTRODUCTION 45
7.2 SINGLE-ANALYTE CONTROLS 45
7.2.1 SIGNIFICANT USE OF SINGLEPLEX ASSAYS IN HOSPITALS?A KEY MARKET DRIVER 45
7.3 MULTI-ANALYTE CONTROLS 47
7.3.1 INCREASING PREFERENCE FOR MULTI-ANALYTE CONTROLS TO FUEL MARKET GROWTH 47

8 MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION 49
8.1 INTRODUCTION 50
8.2 INFECTIOUS DISEASES 51
8.2.1 DEMAND FOR INFECTIOUS DISEASE TESTING CONTROLS HAS GROWN STEADILY 51
8.3 ONCOLOGY 52
8.3.1 GROWING CANCER PREVALENCE AND TECHNOLOGICAL ADVANCEMENTS ARE KEY GROWTH DRIVERS IN THIS SEGMENT 52
8.4 GENETIC TESTING 53
8.4.1 ADVANCEMENTS IN GENETIC TESTING DRIVE THE MARKET 53
8.5 OTHER APPLICATIONS 55
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9 MOLECULAR QUALITY CONTROLS MARKET, BY END USER 56
9.1 INTRODUCTION 57
9.2 CLINICAL LABORATORIES 57
9.2.1 INCREASING NUMBER OF ACCREDITED CLINICAL LABORATORIES TO PROVIDE GROWTH OPPORTUNITIES IN THE COMING YEARS 57
9.3 HOSPITALS 59
9.3.1 GROWING PATIENT VOLUME DRIVING THE ADOPTION OF MOLECULAR QUALITY CONTROLS IN HOSPITAL-BASED LABORATORIES 59
9.4 IVD MANUFACTURERS AND CONTRACT RESEARCH ORGANIZATIONS 60
9.4.1 ADVANCEMENTS IN MOLECULAR TECHNOLOGIES DRIVING THE ADOPTION OF MOLECULAR QUALITY CONTROLS AMONG IVD MANUFACTURERS AND CONTRACT RESEARCH ORGANIZATIONS 60
9.5 ACADEMIC & RESEARCH INSTITUTES 61
9.5.1 INCREASING DEMAND FOR ENSURING THE ACCURACY OF DIAGNOSTIC TESTS TO SUPPORT THE GROWTH OF THIS END-USER SEGMENT 61
9.6 OTHER END USERS 63

10 MOLECULAR QUALITY CONTROLS MARKET, BY REGION 64
10.1 INTRODUCTION 65
10.2 NORTH AMERICA 66
10.2.1 US 70
10.2.1.1 Increasing CLIA accreditation for clinical laboratories driving the market for molecular quality controls in the US 70
10.2.2 CANADA 72
10.2.2.1 Government investments supporting the development of advanced diagnostic procedures for infectious diseases and cancer in Canada 72
10.3 EUROPE 75
10.3.1 GROWING DEMAND FOR EXTERNAL QUALITY CONTROL SUPPORT FROM END USERS WILL PROVIDE GROWTH OPPORTUNITIES 75
10.4 ASIA PACIFIC 77
10.4.1 STRATEGIC DEVELOPMENTS BY LEADING PLAYERS TO DRIVE THE MARKET FOR MOLECULAR QUALITY CONTROLS IN APAC 77
10.5 REST OF THE WORLD 81

11 COMPETITIVE LANDSCAPE 84
11.1 MARKET OVERVIEW 84
11.2 MARKET RANKING ANALYSIS, 2017 84
11.2.1 COMPETITIVE LEADERSHIP MAPPING 85
11.2.2 VISIONARY LEADERS 85
11.2.3 INNOVATORS 85
11.2.4 DYNAMIC DIFFERENTIATORS 85
11.2.5 EMERGING COMPANIES 85
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11.3 COMPETITIVE BENCHMARKING 87
11.3.1 STRENGTH OF PRODUCT PORTFOLIO (15 PLAYERS) 87
11.3.2 BUSINESS STRATEGY EXCELLENCE (15 PLAYERS) 88

12 COMPANY PROFILES 89
(Business Overview, Products Offered, Recent Developments, MnM View)*
12.1 SERACARE LIFE SCIENCES INC. 89
12.2 THERMO FISHER SCIENTIFIC 93
12.3 BIO-RAD LABORATORIES 98
12.4 MICROBIOLOGICS INC. 100
12.5 ZEPTOMETRIX 104
12.6 ROCHE DIAGNOSTICS 108
12.7 ABBOTT LABORATORIES 110
12.8 QUIDEL 112
12.9 QNOSTICS 114
12.10 MAINE MOLECULAR QUALITY CONTROLS INC. 117
*Business Overview, Products Offered, Recent Developments, MnM View might not be captured in case of unlisted companies.

13 APPENDIX 119
13.1 DISCUSSION GUIDE 119
13.2 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 122
13.3 AVAILABLE CUSTOMIZATIONS 124
13.4 RELATED REPORTS 124
13.5 AUTHOR DETAILS 125



List of Figures



FIGURE 1 RESEARCH DESIGN 17
FIGURE 2 PRIMARY SOURCES 19
FIGURE 3 BOTTOM-UP APPROACH 21
FIGURE 4 TOP-DOWN APPROACH 21
FIGURE 5 DATA TRIANGULATION METHODOLOGY 22
FIGURE 6 MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT, 2018 (USD MILLION) 24
FIGURE 7 MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE 2018 VS. 2024 (USD MILLION) 25
FIGURE 8 MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION, 2018 (USD MILLION) 26
FIGURE 9 MOLECULAR QUALITY CONTROLS MARKET, BY END USER, 2018 26
FIGURE 10 GEOGRAPHICAL SNAPSHOT OF THE MOLECULAR QUALITY CONTROLS MARKET 27
FIGURE 11 MOLECULAR QUALITY CONTROLS MARKET TO REGISTER A DOUBLE-DIGIT GROWTH RATE DURING THE FORECAST PERIOD 28
FIGURE 12 INDEPENDENT CONTROLS SEGMENT TO REGISTER THE HIGHEST GROWTH DURING THE FORECAST PERIOD (2018–2024) 29
FIGURE 13 CLINICAL LABORATORIES ACCOUNTED FOR THE LARGEST SHARE OF THE NORTH AMERICAN MOLECULAR QUALITY CONTROLS MARKET IN 2018 30
FIGURE 14 MOLECULAR QUALITY CONTROLS MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES 31
FIGURE 15 NUMBER OF LABORATORIES THAT RECEIVED CLIA ACCREDITATION BY ACCREDITATION ORGANIZATION (2018) 32
FIGURE 16 GEOGRAPHIC SNAPSHOT: APAC WILL BE THE FASTEST-GROWING REGIONAL SEGMENT IN THE MOLECULAR QUALITY CONTROLS MARKET DURING THE FORECAST PERIOD 65
FIGURE 17 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET SNAPSHOT 67
FIGURE 18 ASIA PACIFIC: MOLECULAR QUALITY CONTROLS MARKET SNAPSHOT 78
FIGURE 19 RANK OF COMPANIES IN THE GLOBAL MOLECULAR QUALITY CONTROLS
MARKET, 2017 84
FIGURE 20 MOLECULAR QUALITY CONTROLS MARKET (GLOBAL), COMPETITIVE LEADERSHIP MAPPING, 2017 86
FIGURE 21 THERMO FISHER SCIENTIFIC: COMPANY SNAPSHOT (2017) 93
FIGURE 22 BIO-RAD LABORATORIES: COMPANY SNAPSHOT (2017) 98
FIGURE 23 ROCHE DIAGNOSTICS: COMPANY SNAPSHOT (2017) 108
FIGURE 24 ABBOTT LABORATORIES: COMPANY SNAPSHOT (2017) 110
FIGURE 25 QUIDEL: COMPANY SNAPSHOT (2017) 112

 

List of Tables



TABLE 1 MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 2016–2024 (USD MILLION) 37
TABLE 2 INDEPENDENT CONTROLS MARKET, BY REGION, 2016–2024 (USD MILLION) 38
TABLE 3 NORTH AMERICA: INDEPENDENT CONTROLS MARKET, BY COUNTRY 2016–2024 (USD MILLION) 38
TABLE 4 INSTRUMENT-SPECIFIC CONTROLS MARKET, BY REGION 2016–2024 (USD MILLION) 39
TABLE 5 NORTH AMERICA: INSTRUMENT-SPECIFIC CONTROLS MARKET, BY COUNTRY, 2016–2024 (USD MILLION) 39
TABLE 6 INSTRUMENT-SPECIFIC CONTROLS MARKET, BY TECHNOLOGY 2016–2024 (USD MILLION) 40
TABLE 7 INSTRUMENT-SPECIFIC CONTROLS MARKET FOR PCR, BY REGION 2016–2024 (USD MILLION) 41
TABLE 8 NORTH AMERICA: INSTRUMENT-SPECIFIC CONTROLS MARKET FOR PCR BY COUNTRY, 2016–2024 (USD MILLION) 41
TABLE 9 INSTRUMENT-SPECIFIC CONTROLS MARKET FOR DNA SEQUENCING & NGS BY REGION, 2016–2024 (USD MILLION) 42
TABLE 10 NORTH AMERICA: INSTRUMENT-SPECIFIC CONTROLS MARKET FOR DNA SEQUENCING & NGS, BY COUNTRY, 2016–2024 (USD MILLION) 42
TABLE 11 INSTRUMENT-SPECIFIC CONTROLS MARKET FOR OTHER TECHNOLOGIES BY REGION, 2016–2024 (USD MILLION) 43
TABLE 12 NORTH AMERICA: INSTRUMENT-SPECIFIC CONTROLS MARKET FOR OTHER TECHNOLOGIES, BY COUNTRY, 2016–2024 (USD MILLION) 43
TABLE 13 MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE 2016–2024 (USD MILLION) 45
TABLE 14 SINGLE-ANALYTE CONTROLS MARKET, BY REGION, 2016–2024 (USD MILLION) 46
TABLE 15 NORTH AMERICA: SINGLE-ANALYTE CONTROLS MARKET, BY COUNTRY 2016–2024 (USD MILLION) 46
TABLE 16 MULTI-ANALYTE CONTROLS MARKET, BY REGION, 2016–2024 (USD MILLION) 47
TABLE 17 NORTH AMERICA: MULTI-ANALYTE CONTROLS MARKET, BY COUNTRY 2016–2024 (USD MILLION) 48
TABLE 18 MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION 2016–2024 (USD MILLION) 50
TABLE 19 MOLECULAR QUALITY CONTROLS MARKET FOR INFECTIOUS DISEASES BY REGION, 2016–2024 (USD MILLION) 51
TABLE 20 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR INFECTIOUS DISEASES, BY COUNTRY, 2016–2024 (USD MILLION) 52
TABLE 21 MOLECULAR QUALITY CONTROLS MARKET FOR ONCOLOGY, BY REGION 2016–2024 (USD MILLION) 52
TABLE 22 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR ONCOLOGY BY COUNTRY, 2016–2024 (USD MILLION) 53
TABLE 23 MOLECULAR QUALITY CONTROLS MARKET FOR GENETIC TESTING, BY REGION, 2016–2024 (USD MILLION) 54
TABLE 24 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR GENETIC TESTING, BY COUNTRY, 2016–2024 (USD MILLION) 54
TABLE 25 MOLECULAR QUALITY CONTROLS MARKET FOR OTHER APPLICATIONS, BY REGION, 2016–2024 (USD MILLION) 55
TABLE 26 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2016–2024 (USD MILLION) 55
TABLE 27 MOLECULAR QUALITY CONTROLS MARKET, BY END USER 2016–2024 (USD MILLION) 57
TABLE 28 MOLECULAR QUALITY CONTROLS MARKET FOR CLINICAL LABORATORIES BY REGION, 2016–2024 (USD MILLION) 58
TABLE 29 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR CLINICAL LABORATORIES, BY COUNTRY, 2016–2024 (USD MILLION) 58
TABLE 30 MOLECULAR QUALITY CONTROLS MARKET FOR HOSPITALS, BY REGION 2016–2024 (USD MILLION) 59
TABLE 31 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR HOSPITALS BY COUNTRY, 2016–2024 (USD MILLION) 60
TABLE 32 MOLECULAR QUALITY CONTROLS MARKET FOR IVD MANUFACTURERS AND CONTRACT RESEARCH ORGANIZATIONS, BY REGION, 2016–2024 (USD MILLION) 61
TABLE 33 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR IVD MANUFACTURERS AND CONTRACT RESEARCH ORGANIZATIONS BY COUNTRY, 2016–2024 (USD MILLION) 61
TABLE 34 MOLECULAR QUALITY CONTROLS MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY REGION, 2016–2024 (USD MILLION) 62
TABLE 35 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR ACADEMIC
& RESEARCH INSTITUTES, BY COUNTRY, 2016–2024 (USD MILLION) 62
TABLE 36 MOLECULAR QUALITY CONTROLS MARKET FOR OTHER END USERS, BY REGION, 2016–2024 (USD MILLION) 63
TABLE 37 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET FOR OTHER END USERS, BY COUNTRY, 2016–2024 (USD MILLION) 63
TABLE 38 MOLECULAR QUALITY CONTROLS MARKET, BY REGION 2016–2024 (USD MILLION) 66
TABLE 39 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET, BY COUNTRY 2016–2024 (USD MILLION) 68
TABLE 40 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 2016–2024 (USD MILLION) 68
TABLE 41 NORTH AMERICA: INSTRUMENT-SPECIFIC CONTROLS MARKET, BY TECHNOLOGY, 2016–2024 (USD MILLION) 68
TABLE 42 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE, 2016–2024 (USD MILLION) 69
TABLE 43 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION, 2016–2024 (USD MILLION) 69
TABLE 44 NORTH AMERICA: MOLECULAR QUALITY CONTROLS MARKET, BY END USER, 2016–2024 (USD MILLION) 69
TABLE 45 US: MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 2016–2024 (USD MILLION) 70
TABLE 46 US: INSTRUMENT-SPECIFIC CONTROLS MARKET, BY TECHNOLOGY 2016–2024 (USD MILLION) 71
TABLE 47 US: MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE 2016–2024 (USD MILLION) 71
TABLE 48 US: MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION 2016–2024 (USD MILLION) 71
TABLE 49 US: MOLECULAR QUALITY CONTROLS MARKET, BY END USER 2016–2024 (USD MILLION) 72
TABLE 50 CANADA: MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 2016–2024 (USD MILLION) 73
TABLE 51 CANADA: INSTRUMENT-SPECIFIC CONTROLS MARKET, BY TECHNOLOGY 2016–2024 (USD MILLION) 73
TABLE 52 CANADA: MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE 2016–2024 (USD MILLION) 73
TABLE 53 CANADA: MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION 2016–2024 (USD MILLION) 74
TABLE 54 CANADA: MOLECULAR QUALITY CONTROLS MARKET, BY END USER 2016–2024 (USD MILLION) 74
TABLE 55 EUROPE: MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 2016–2024 (USD MILLION) 75
TABLE 56 EUROPE: INSTRUMENT-SPECIFIC CONTROLS MARKET, BY TECHNOLOGY 2016–2024 (USD MILLION) 76
TABLE 57 EUROPE: MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE 2016–2024 (USD MILLION) 76
TABLE 58 EUROPE: MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION 2016–2024 (USD MILLION) 76
TABLE 59 EUROPE: MOLECULAR QUALITY CONTROLS MARKET, BY END USER 2016–2024 (USD MILLION) 77
TABLE 60 ASIA PACIFIC: MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 2016–2024 (USD MILLION) 79
TABLE 61 ASIA PACIFIC: INSTRUMENT-SPECIFIC CONTROLS MARKET, BY TECHNOLOGY, 2016–2024 (USD MILLION) 79
TABLE 62 ASIA PACIFIC: MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE, 2016–2024 (USD MILLION) 79
TABLE 63 ASIA PACIFIC: MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION 2016–2024 (USD MILLION) 80
TABLE 64 ASIA PACIFIC: MOLECULAR QUALITY CONTROLS MARKET, BY END USER 2016–2024 (USD MILLION) 80
TABLE 65 ROW: MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT 2016–2024 (USD MILLION) 81
TABLE 66 ROW: INSTRUMENT-SPECIFIC CONTROLS MARKET, BY TECHNOLOGY 2016–2024 (USD MILLION) 81
TABLE 67 ROW: MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE 2016–2024 (USD MILLION) 82
TABLE 68 ROW: MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION 2016–2024 (USD MILLION) 82
TABLE 69 ROW: MOLECULAR QUALITY CONTROLS MARKET, BY END USER 2016–2024 (USD MILLION) 83