In Vitro Diagnostics

In Vitro Diagnostics (IVD) Quality Control Market, by Source (Plasma, Whole Blood, Urine), Technology (Immunoassay, Hematology, Microbiology, Molecular Diagnostics), Manufacturer (Third-party, OEM), End Users (Hospitals, Lab) - Global Forecast to 2026

Report Code: MD 4180 Sep, 2021, by marketsandmarkets.com

[342 Pages Report] The global IVD quality control market is projected to reach USD 1.4 billion by 2026 from USD 1.1 billion in 2021, at a CAGR of 5.3% during the forecast period. IVD testing plays a significant role in clinical decision-making. The growth of the IVD quality control market is primarily driven by the rising number of accredited clinical laboratories, rising geriatric population, rising demand for external quality assessment programs, increasing adoption of and POC instruments in developed regions and increasing adoption of third-party quality controls. The rising focus on multi-analyte controls is also expected to offer significant growth opportunities for the market in the coming years. The use of quality control products is, however, not mandatory for all clinical laboratories in many countries. The lack of regulations for these products is expected to adversely affect the market growth.

In Vitro Diagnostics (IVD) Quality Control Market

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COVID-19 Impact on Global IVD Quality Control Market

The COVID-19 pandemic has impacted the overall IVD industry in both positive and negative ways. The demand for diagnostic tests that are not available over-the-counter (OTC) and can be carried out only under physician supervision observed a major decline in the previous year (2019). However, rapid diagnostic tests, POC tests, and IVD devices utilized in drug discovery have witnessed a significant demand. Several industry players are focusing on introducing rapid antigen tests to detect COVID-19. Regulatory authorities also have extended support to approve these tests to combat the pandemic. Thus, the IVD industry has experienced positive as well as negative effects, and key players have undertaken strategic decisions to cope with the situation. The increasing number of rapid diagnostic tests, POC tests, and IVD devices also increase the demand for control and calibrator kits to ensure the accuracy and precision of patients’ sample results.

Several companies changed their business model to sustain their market position and revenue during the pandemic. For instance, F. Hoffmann-La Roche experienced a 4% decline in its pharmaceutical business in 2020 compared to 2019. The company, therefore, focused on investing in R&D to introduce COVID-19 rapid diagnostic tests along with controls and calibrators, which boosted its revenue growth. Companies and laboratories are also focusing on ensuring the quality of their test results, which has also boosted the market growth.

IVD Quality Control Market Dynamics

Driver: Increasing number of accredited clinical laboratories

Globally, the number of laboratory tests has increased owing to the rising burden of various diseases worldwide. In order to meet this demand, there has been an increase in the number of laboratories in the public and the private sector. From December 2019, the demand for diagnostic testing has increased with the emergence of the COVID- 19 pandemic. In response to this pandemic and to increase laboratory testing capacities, many government bodies have set up new laboratories.

In most countries, clinical laboratories must secure accreditation from regulatory bodies to perform diagnostic tests. Moreover, accreditation to ISO 15189:2012 and other similar standards is becoming mandatory in various countries. During the accreditation process, authorities evaluate the quality system and competence of a laboratory based on specific standards. European countries such as Belgium, France, Hungary, Ireland, and Lithuania have mandatory accreditation for various laboratory tests, whereas countries such as Finland, the Netherlands, Sweden, Switzerland, and the UK have almost completed the accreditation of clinical laboratories.

Restraint: Additional costs and budget constraints in hospitals and laboratories

Setting up a QC process in a clinical laboratory requires significant investments. Laboratories also need to maintain dedicated personnel to manage the QC system. Moreover, QC procedures incur similar costs, regardless of the volume of tests performed. Hence, the cost of adopting QC procedures is very high for clinical laboratories working with low volumes of diagnostic tests. This, coupled with budgetary constraints in many hospitals and laboratories in developed and developing economies, is expected to result in the lower adoption of QC practices.

Moreover, the cost of data management solutions to manage QC data and QA services for the independent assessment of diagnostic tests further increases the total cost for end users. Even after implementing data management solutions, small hospitals and laboratories may be unable to bear the additional costs.

Opportunity: Rising demand for multi-analyte controls

Technological advancements have led to the development of a new range of multi-analyte and multi-instrument controls. These innovative controls consolidate multiple instrument-specific controls into a single control, thereby enabling clinical laboratories to cut costs and greatly reduce the time taken by QC procedures.

Multi-analyte controls are useful in screening and diagnostic procedures and can be used with multiple reagents and instruments. Currently, there are several multi-analyte controls available in the market, such as Liquichek Tumor Marker Control (Bio-Rad Laboratories), Acusera Infectious Disease (Serology) Controls (Randox Laboratories), AcroMetrix Multi-Analyte Controls—Transplant (Thermo Fisher Scientific), and ACCURUN 1 Series 4400 Multi-Analyte Positive Control (SeraCare Life Sciences). Earlier, laboratories had to maintain more than thirty individual controls to run QC procedures; however, with the evolution of multi-analyte controls, clinical laboratories offer accurate and precise test results using only one or two multi-analytes. Multi-analyte controls in the market for immunoassay testing help laboratories perform QC tests for fifty or more parameters—including cardiac and tumor markers, hormones, therapeutic drugs, kidney functions, and vitamins—in the same serum. In addition, these controls need not be changed with reagent lots and hence support long-term QC monitoring. The increasing preference for these controls is thus expected to offer significant growth opportunities for players in the IVD quality control market.

Challenge: Stringent product approval process

In the past few years, IVD companies have faced difficulties due to an increasingly complex regulatory process. For more than twenty years, the FDA has emphasized its regulatory authority over LDTs (laboratory-developed tests) and related products but has chosen to exercise enforcement discretion over such tests. In recent years, however, the FDA declared that added oversight of LDTs and related products are needed and that the agency plans to issue a guidance document on this. Assayed and unassayed QC materials are subject to the Quality System Regulation (QSR), 21 CFR, Part 820, and labeling regulation 21 CFR 809.10.

In the past few years, the FDA requirements, particularly with regard to 510(k) notifications, have increased, requiring more data and details than earlier. This change, resulting in unpredictable premarket submission requirements, is extremely unfavorable for IVD manufacturers that require 510(k) clearance.

North America is expected to account for the largest share of the IVD quality control market in 2020

In 2020, North America accounted for the largest share of the global IVD quality control market, followed by Europe. Recommendations for and approvals of quality control products from the FDA and the College of American Pathologists (CAP) and the presence of well-established distribution channels and leading companies in the US are driving the IVD quality control market in North America.

In Vitro Diagnostics (IVD) Quality Control Market by Region

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Key Market Players

The prominent players in the market include Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), and Abbott Laboratories (US). Other prominent payers in the market include Roche Diagnostics (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), Fortress Diagnostics (UK), SERO AS (US), Sysmex Corporation (Japan), Ortho-Clinical Diagnostics (US), Helena Laboratories Corporation (US), Quidel Corporation (US), Sun Diagnostics, LLC (US), Seegene Inc. (South Korea), ZeptoMetrix Corporation (US), Qnostics (UK), Bio-Techne Corporation (US), Microbiologics (US), Microbix Biosystems (Canada), Streck, Inc. (US), Alpha-Tec Systems (US), Maine Molecular Quality Controls, Inc. (US), and Grifols, S.A. (Spain).

Scope of Market

Report Metric

Details

Market size available for years

2019–2026

Base year considered

2020

Forecast period

2021–2026

Forecast units

Value (USD Billion)

Segments covered

By product, technology, manufacturer type, and end user

Geographies covered

North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa

Companies covered

Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), and Abbott Laboratories (US), Roche Diagnostics (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), Fortress Diagnostics (UK), SERO AS (US), Sysmex Corporation (Japan), Ortho-Clinical Diagnostics (US), Helena Laboratories Corporation (US), Quidel Corporation (US), Sun Diagnostics, LLC (US), Seegene Inc. (South Korea), ZeptoMetrix Corporation (US), Qnostics (UK), Bio-Techne Corporation (US), Microbiologics (US), Microbix Biosystems (Canada), Streck, Inc. (US), Alpha-Tec Systems (US), Maine Molecular Quality Controls, Inc. (US), and Grifols, S.A. (Spain). These players aim to secure higher market shares through strategies such as product launches, expansions, agreements, and acquisitions.

The study categorizes the IVD quality control market based on product, technology, manufacturer type, end user and regional and global level.

Global IVD quality control market, by product and service

  • Quality control products
    • Serum/ Plasma based controls
    • Whole blood based controls
    • Urine based controls
    • Other controls
  • Data Management Solutions
  • Quality Assurance Services

Global IVD quality control market, by technology

  • Immunochemistry
  • Clinical Chemistry
  • Molecular Diagnostics
  • Microbiology
  • Hematology
  • Coagulation/ Hemostasis
  • Other Technologies

Global IVD quality control market, by manufacturer type

  • Third-party controls
    • Independent controls
    • Instrument specific controls
  • Original Equipment Manufacturer controls

Global IVD quality control market, by end user

  • Hospitals
  • Clinical Laboratories
  • Academic and Research Institutes
  • Other End users

Global IVD quality control market, by region

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of APAC
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa

Recent Developments

  • In August 2021, Zeptometrix Corporation (US) announced the immediate availability of its ready-to-use NATSARS(COV2)-ERC for laboratory QC and test validation
  • In July 2021, Quidel Corporation (US) received the CE Mark for its innovative Savanna multiplex molecular analyzer and Savanna RVP4 Assay (Respiratory Viral Panel-4).
  • In June 2021, LGC SeraCare (US) expanded its line of SARS-CoV-2 molecular quality solutions to include AccuPlex SARS-CoV-2 Variant Panel 1.
  • In June 2021, Abbott Laboratories (US) received CE mark for its Panbio Rapid Antigen self-test. It helped the company expand its reach throughout Europe for fast, reliable COVID-19 testing

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TABLE OF CONTENTS

1 INTRODUCTION (Page No. - 36)
    1.1 OBJECTIVES OF THE STUDY
    1.2 MARKET DEFINITION
           1.2.1 INCLUSIONS & EXCLUSIONS OF THE STUDY
    1.3 MARKET SCOPE
           1.3.1 MARKETS COVERED
           1.3.2 YEARS CONSIDERED FOR THE STUDY
           1.3.3 CURRENCY
                    TABLE 1 EXCHANGE RATES UTILIZED FOR CONVERSION TO USD
    1.4 STAKEHOLDERS
    1.5 SUMMARY OF CHANGES

2 RESEARCH METHODOLOGY (Page No. - 41)
    2.1 RESEARCH DATA
                    FIGURE 1 RESEARCH DESIGN
           2.1.1 SECONDARY DATA
                    2.1.1.1 Key data from secondary sources
           2.1.2 PRIMARY DATA
                    FIGURE 2 PRIMARY SOURCES
                    2.1.2.1 Key data from primary sources
                    2.1.2.2 Key industry insights
                               FIGURE 3 BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION, AND REGION
                               FIGURE 4 BREAKDOWN OF PRIMARY INTERVIEWS: SUPPLY-SIDE AND DEMAND- SIDE PARTICIPANTS
    2.2 MARKET SIZE ESTIMATION
           FIGURE 5 SUPPLY-SIDE MARKET SIZE ESTIMATION: REVENUE SHARE ANALYSIS
           FIGURE 6 REVENUE SHARE ANALYSIS ILLUSTRATION: BIO-RAD LABORATORIES, INC.
           FIGURE 7 REVENUE ANALYSIS OF THE TOP FIVE COMPANIES: IVD QUALITY CONTROL MARKET (2020)
           FIGURE 8 CAGR PROJECTIONS FROM THE ANALYSIS OF DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES OF THE IVD QUALITY CONTROL MARKET (2021–2026)
           FIGURE 9 CAGR PROJECTIONS
           FIGURE 10 TOP-DOWN APPROACH
    2.3 MARKET BREAKDOWN & DATA TRIANGULATION
           FIGURE 11 MARKET DATA TRIANGULATION METHODOLOGY
    2.4 MARKET SHARE ANALYSIS
    2.5 ASSUMPTIONS FOR THE STUDY
    2.6 RISK ASSESSMENT
           TABLE 2 RISK ASSESSMENT: IVD QUALITY CONTROL MARKET
    2.7 LIMITATIONS
           2.7.1 METHODOLOGY-RELATED LIMITATIONS
           2.7.2 SCOPE-RELATED LIMITATIONS

3 EXECUTIVE SUMMARY (Page No. - 54)
    FIGURE 12 IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2021 VS. 2026 (USD MILLION)
    FIGURE 13 IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2021 VS. 2026 (USD MILLION)
    FIGURE 14 IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2021 VS. 2026 (USD MILLION)
    FIGURE 15 THIRD-PARTY CONTROLS MARKET, BY TYPE, 2021 VS. 2026 (USD MILLION)
    FIGURE 16 IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2021 VS. 2026 (USD MILLION)
    FIGURE 17 IVD QUALITY CONTROL MARKET, BY END USER, 2021 VS. 2026 (USD MILLION)
    FIGURE 18 IVD QUALITY CONTROL MARKET: GEOGRAPHIC SNAPSHOT

4 PREMIUM INSIGHTS (Page No. - 59)
    4.1 IVD QUALITY CONTROL MARKET OVERVIEW
           FIGURE 19 GROWING ADOPTION OF THIRD-PARTY CONTROLS AND INCREASING DEMAND FOR EXTERNAL QUALITY ASSESSMENT TO DRIVE MARKET GROWTH
    4.2 APAC: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY AND COUNTRY (2020)
           FIGURE 20 IMMUNOCHEMISTRY TO COMMAND THE LARGEST SHARE OF THE APAC IVD QUALITY CONTROL MARKET IN 2020
    4.3 IVD QUALITY CONTROL MARKET: GEOGRAPHIC MIX
           FIGURE 21 CHINA TO GROW AT THE HIGHEST CAGR DURING THE FORECAST PERIOD
    4.4 IVD QUALITY CONTROL MARKET: DEVELOPED VS DEVELOPING MARKETS
           FIGURE 22 DEVELOPING MARKETS TO REGISTER HIGHEST CAGR DURING THE FORECAST PERIOD

5 MARKET OVERVIEW (Page No. - 62)
    5.1 MARKET DYNAMICS
           FIGURE 23 IVD QUALITY CONTROL MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES
           5.1.1 MARKET DRIVERS
                    5.1.1.1 Increasing number of accredited clinical laboratories
                               FIGURE 24 US: NUMBER OF LABORATORIES WITH CLIA ACCREDITATION, BY ORGANIZATION (2018)
                    5.1.1.2 Growing adoption of third-party quality controls
                    5.1.1.3 Rising demand for external quality assessment support
                    5.1.1.4 Rising geriatric population and subsequent growth in the prevalence of chronic and infectious diseases
                               TABLE 3 ESTIMATED INCREASE IN THE GERIATRIC POPULATION, BY REGION (2019–2050)
                               FIGURE 25 ESTIMATED DIABETIC POPULATION, BY REGION, 2019 VS. 2030 VS. 2040
                               FIGURE 26 GLOBAL CANCER INCIDENCE, 2015–2040
                    5.1.1.5 Increasing adoption of POC instruments in developed regions
                               TABLE 4 MARKET DRIVERS: IMPACT ANALYSIS
           5.1.2 MARKET RESTRAINTS
                    5.1.2.1 Additional costs and budget constraints in hospitals and laboratories
                    5.1.2.2 Unfavorable reimbursement scenario for IVD tests
                               TABLE 5 MARKET RESTRAINTS: IMPACT ANALYSIS
           5.1.3 MARKET OPPORTUNITIES
                    5.1.3.1 Rising demand for multi-analyte controls
                               TABLE 6 MARKET OPPORTUNITIES: IMPACT ANALYSIS
           5.1.4 MARKET CHALLENGES
                    5.1.4.1 Stringent product approval process
                    5.1.4.2 Lack of regulations for clinical laboratory accreditation in several emerging countries
                               TABLE 7 MARKET CHALLENGES: IMPACT ANALYSIS
    5.2 INDUSTRY TRENDS
           5.2.1 LYOPHILIZED/FREEZE-DRIED CONTROLS
                    TABLE 8 LYOPHILIZED OR FREEZE-DRIED QUALITY CONTROLS OFFERED BY KEY MARKET PLAYERS
           5.2.2 TRENDS ON ANALYTE SOURCE: HUMAN VS. ANIMAL ORIGIN
           5.2.3 CONSOLIDATION OF LABORATORIES
    5.3 VALUE CHAIN ANALYSIS
           FIGURE 27 IVD QUALITY CONTROL MARKET: VALUE CHAIN ANALYSIS
    5.4 SUPPLY CHAIN ANALYSIS
           FIGURE 28 IVD QUALITY CONTROL MARKET: SUPPLY CHAIN ANALYSIS
    5.5 ECOSYSTEM MARKET MAP
           FIGURE 29 IVD QUALITY CONTROL MARKET: ECOSYSTEM MARKET MAP
    5.6 PORTER’S FIVE FORCES ANALYSIS
           5.6.1 THREAT FROM NEW ENTRANTS
           5.6.2 THREAT FROM SUBSTITUTES
           5.6.3 BARGAINING POWER OF SUPPLIERS
           5.6.4 BARGAINING POWER OF BUYERS
           5.6.5 INTENSITY OF COMPETITIVE RIVALRY
    5.7 REGULATORY ANALYSIS
           5.7.1 NORTH AMERICA
                    5.7.1.1 US
                               TABLE 9 US: CLASSIFICATION OF QUALITY CONTROL MATERIAL
                               TABLE 10 US: TIME, COST, AND COMPLEXITY OF REGISTRATION
                    5.7.1.2 Canada
                               TABLE 11 CANADA: CLASSIFICATION OF IVD PRODUCTS
                               TABLE 12 CANADA: TIME, COST, AND COMPLEXITY OF REGISTRATION
           5.7.2 EUROPE
                    TABLE 13 EUROPE: ACCREDITATION BODIES FOR MEDICAL LABORATORIES
                    TABLE 14 EUROPE: TIME, COST, AND COMPLEXITY OF REGISTRATION
           5.7.3 ASIA PACIFIC
                    5.7.3.1 Japan
                               TABLE 15 JAPAN: TIME, COST, AND COMPLEXITY OF REGISTRATION
                    5.7.3.2 China
                               TABLE 16 CHINA: TIME, COST, AND COMPLEXITY OF REGISTRATION
                    5.7.3.3 India
                               TABLE 17 INDIA: TIME, COST, AND COMPLEXITY OF REGISTRATION
    5.8 IMPACT OF COVID-19 ON THE IVD QUALITY CONTROL MARKET
           FIGURE 30 THERMO FISHER SCIENTIFIC INC.: COVID-19 IMPACT ON SEGMENTAL ANALYSIS
           FIGURE 31 ROCHE DIAGNOSTICS.: COVID-19 IMPACT ON SEGMENTAL ANALYSIS
           FIGURE 32 BIO-RAD LABORATORIES, INC.: COVID-19 IMPACT ON SEGMENTAL ANALYSIS
           FIGURE 33 ABBOTT LABORATORIES: COVID-19 IMPACT ON SEGMENTAL ANALYSIS
    5.9 PATENT ANALYSIS
           5.9.1 PATENT PUBLICATION TRENDS FOR IVD QUALITY CONTROLS
                    FIGURE 34 PATENT PUBLICATION TRENDS (2011–AUGUST 2021)
           5.9.2 INSIGHTS: JURISDICTION AND TOP APPLICANT ANALYSIS
                    FIGURE 35 TOP APPLICANTS AND OWNERS (COMPANIES/INSTITUTIONS) FOR IVD QUALITY CONTROL PATENTS (JANUARY 2011–AUGUST 2021)
                    FIGURE 36 TOP APPLICANT COUNTRIES/REGIONS FOR IVD QUALITY CONTROL PATENTS (JANUARY 2011–AUGUST 2021)
    5.10 TECHNOLOGY ANALYSIS
           5.10.1 KEY TECHNOLOGIES
                    5.10.1.1 Analyte extraction
                               5.10.1.1.1 Specimen pooling
                               5.10.1.1.2 Human monoclonals
                    5.10.1.2 Specimen processing
                               5.10.1.2.1 Inactivation
                               5.10.1.2.2 Dilution
                    5.10.1.3 Preservation
           5.10.2 ADJACENT TECHNOLOGIES
                    5.10.2.1 Sensor-based quality control
           5.10.3 COMPLEMENTARY TECHNOLOGIES
                    5.10.3.1 Storage
                    5.10.3.2 Transport
                    5.10.3.3 Temperature control
                    5.10.3.4 Temperature monitoring

6 IVD QUALITY CONTROL MARKET, BY PRODUCT AND SERVICE (Page No. - 91)
    6.1 INTRODUCTION
           TABLE 18 IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
    6.2 QUALITY CONTROL PRODUCTS
           TABLE 19 QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 20 QUALITY CONTROL PRODUCTS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           6.2.1 SERUM/PLASMA-BASED CONTROLS
                    6.2.1.1 Greater stability and accuracy of diagnostic test results to increase the demand for serum/plasma-based controls
                               TABLE 21 SERUM/PLASMA-BASED QUALITY CONTROLS OFFERED BY KEY MARKET PLAYERS
                               TABLE 22 SERUM/PLASMA-BASED QUALITY CONTROL PRODUCTS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           6.2.2 WHOLE BLOOD-BASED CONTROLS
                    6.2.2.1 Rising need to ensure high-quality clinical test results to drive the whole blood-based controls market
                               TABLE 23 WHOLE BLOOD-BASED QUALITY CONTROLS OFFERED BY KEY MARKET PLAYERS
                               TABLE 24 WHOLE BLOOD-BASED QUALITY CONTROL PRODUCTS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           6.2.3 URINE-BASED CONTROLS
                    6.2.3.1 The growing incidence of kidney diseases increase the need for urine-based controls
                               TABLE 25 URINE-BASED IVD CONTROLS OFFERED BY KEY MARKET PLAYERS
                               TABLE 26 URINE-BASED QUALITY CONTROL PRODUCTS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           6.2.4 OTHER CONTROLS
                    TABLE 27 OTHER CONTROLS OFFERED BY KEY MARKET PLAYERS
                    TABLE 28 OTHER QUALITY CONTROL PRODUCTS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
    6.3 DATA MANAGEMENT SOLUTIONS
           6.3.1 RISING FOCUS ON IMPROVING THE ANALYTICAL PERFORMANCE OF CLINICAL LABORATORIES TO SUPPORT MARKET GROWTH
                    TABLE 29 DATA MANAGEMENT SOLUTIONS OFFERED BY KEY MARKET PLAYERS
                    TABLE 30 DATA MANAGEMENT SOLUTIONS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
    6.4 QUALITY ASSURANCE SERVICES
           6.4.1 GROWING NEED FOR PERFORMANCE ASSESSMENT OF CLINICAL LABORATORIES TO INCREASE THE DEMAND FOR QUALITY ASSURANCE SERVICES
                    TABLE 31 QUALITY ASSURANCE SERVICES OFFERED BY KEY MARKET PLAYERS
                    TABLE 32 QUALITY ASSURANCE SERVICES MARKET, BY COUNTRY, 2019–2026 (USD MILLION)

7 IVD QUALITY CONTROL MARKET, BY TECHNOLOGY (Page No. - 106)
    7.1 INTRODUCTION
           TABLE 33 IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
    7.2 IMMUNOCHEMISTRY
           7.2.1 FOCUS ON MONITORING THE PRECISION OF IMMUNOASSAY TESTS TO DRIVE THE ADOPTION OF IMMUNOASSAY CONTROLS
                    TABLE 34 QUALITY CONTROLS FOR IMMUNOCHEMISTRY OFFERED BY KEY MARKET PLAYERS
                    TABLE 35 IVD QUALITY CONTROL MARKET FOR IMMUNOCHEMISTRY, BY COUNTRY, 2019–2026 (USD MILLION)
    7.3 CLINICAL CHEMISTRY
           7.3.1 RISING INCIDENCE OF LIFESTYLE DISEASES TO PROVIDE OPPORTUNITIES FOR MARKET GROWTH
                    TABLE 36 QUALITY CONTROLS FOR CLINICAL CHEMISTRY OFFERED BY KEY MARKET PLAYERS
                    TABLE 37 IVD QUALITY CONTROL MARKET FOR CLINICAL CHEMISTRY, BY COUNTRY, 2019–2026 (USD MILLION)
    7.4 MOLECULAR DIAGNOSTICS
           7.4.1 GROWING INCIDENCE OF INFECTIOUS DISEASES TO DRIVE THE DEMAND FOR MOLECULAR DIAGNOSTIC CONTROLS
                    TABLE 38 QUALITY CONTROLS FOR MOLECULAR DIAGNOSTICS OFFERED BY KEY MARKET PLAYERS
                    TABLE 39 IVD QUALITY CONTROL MARKET FOR MOLECULAR DIAGNOSTICS, BY COUNTRY, 2019–2026 (USD MILLION)
    7.5 MICROBIOLOGY
           7.5.1 INCREASING ADOPTION OF AUTOMATED CLINICAL MICROBIOLOGY TESTING INSTRUMENTS TO SUPPORT MARKET GROWTH
                    TABLE 40 QUALITY CONTROLS FOR MICROBIOLOGY OFFERED BY KEY MARKET PLAYERS
                    TABLE 41 IVD QUALITY CONTROL MARKET FOR MICROBIOLOGY, BY COUNTRY, 2019–2026 (USD MILLION)
    7.6 HEMATOLOGY
           7.6.1 NEED FOR ACCURACY IN HEMATOLOGICAL TEST RESULTS TO DRIVE RELIANCE ON HEMATOLOGY QUALITY CONTROLS
                    TABLE 42 QUALITY CONTROLS FOR HEMATOLOGY OFFERED BY KEY MARKET PLAYERS
                    TABLE 43 IVD QUALITY CONTROL MARKET FOR HEMATOLOGY, BY COUNTRY, 2019–2026 (USD MILLION)
    7.7 COAGULATION & HEMOSTASIS
           7.7.1 GROWING NUMBER OF CARDIOVASCULAR SURGERIES TO DRIVE THE NEED FOR COAGULATION & HEMOSTASIS TESTING
                    TABLE 44 QUALITY CONTROLS FOR COAGULATION & HEMOSTASIS OFFERED BY KEY MARKET PLAYERS
                    TABLE 45 IVD QUALITY CONTROL MARKET FOR COAGULATION & HEMOSTASIS, BY COUNTRY, 2019–2026 (USD MILLION)
    7.8 OTHER TECHNOLOGIES
           TABLE 46 QUALITY CONTROLS FOR OTHER TECHNOLOGIES OFFERED BY KEY MARKET PLAYERS
           TABLE 47 IVD QUALITY CONTROL MARKET FOR OTHER TECHNOLOGIES, BY COUNTRY, 2019–2026 (USD MILLION)

8 IVD QUALITY CONTROL MARKET, BY MANUFACTURER (Page No. - 122)
    8.1 INTRODUCTION
           TABLE 48 IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
    8.2 THIRD-PARTY CONTROLS
           TABLE 49 THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 50 THIRD-PARTY CONTROLS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           8.2.1 INDEPENDENT CONTROLS
                    8.2.1.1 Increased preference for independent controls to fuel market growth
                               TABLE 51 INDEPENDENT CONTROLS OFFERED BY KEY MARKET PLAYERS
                               TABLE 52 INDEPENDENT THIRD-PARTY CONTROLS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           8.2.2 INSTRUMENT-SPECIFIC CONTROLS
                    8.2.2.1 Usage limitations to subdue market growth rate in favor of independent controls
                               TABLE 53 INSTRUMENT-SPECIFIC CONTROLS OFFERED BY KEY MARKET PLAYERS
                               TABLE 54 INSTRUMENT-SPECIFIC THIRD-PARTY CONTROLS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
    8.3 ORIGINAL EQUIPMENT MANUFACTURER CONTROLS
           8.3.1 OEM CONTROLS TO WITNESS LOWER ADOPTION AS THEY ARE LESS SENSITIVE TO QC-RELATED ISSUES
                    TABLE 55 OEM CONTROLS OFFERED BY KEY MARKET PLAYERS
                    TABLE 56 ORIGINAL EQUIPMENT MANUFACTURER CONTROLS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)

9 IVD QUALITY CONTROL MARKET, BY END USER (Page No. - 131)
    9.1 INTRODUCTION
           TABLE 57 IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
    9.2 HOSPITALS
           9.2.1 HUGE VOLUME OF IVD PROCEDURES PERFORMED IN HOSPITALS TO DRIVE MARKET GROWTH
                    TABLE 58 IVD QUALITY CONTROL MARKET FOR HOSPITALS, BY COUNTRY, 2019–2026 (USD MILLION)
    9.3 CLINICAL LABORATORIES
           9.3.1 GROWING NUMBER OF ACCREDITED LABORATORIES TO DRIVE THE MARKET
                    TABLE 59 IVD QUALITY CONTROL MARKET FOR CLINICAL LABORATORIES, BY COUNTRY, 2019–2026 (USD MILLION)
    9.4 ACADEMIC AND RESEARCH INSTITUTES
           9.4.1 RISING FOCUS ON ACCURATE RESEARCH RESULTS TO DRIVE MARKET GROWTH
                    TABLE 60 IVD QUALITY CONTROL MARKET FOR ACADEMIC AND RESEARCH INSTITUTES, BY COUNTRY, 2019–2026 (USD MILLION)
    9.5 OTHER END USERS
           TABLE 61 IVD QUALITY CONTROL MARKET FOR OTHER END USERS, BY COUNTRY, 2019–2026 (USD MILLION)

10 IVD QUALITY CONTROL MARKET, BY REGION (Page No. - 138)
     10.1 INTRODUCTION
               TABLE 62 IVD QUALITY CONTROL MARKET, BY REGION, 2019–2026 (USD MILLION)
               TABLE 63 IVD QUALITY CONTROL MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
     10.2 NORTH AMERICA
               FIGURE 37 NORTH AMERICA: IVD QUALITY CONTROL MARKET SNAPSHOT
               TABLE 64 NORTH AMERICA: IVD QUALITY CONTROL MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
               TABLE 65 NORTH AMERICA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
               TABLE 66 NORTH AMERICA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
               TABLE 67 NORTH AMERICA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
               TABLE 68 NORTH AMERICA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
               TABLE 69 NORTH AMERICA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
               TABLE 70 NORTH AMERICA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.2.1 US
                       10.2.1.1 High healthcare expenditure in the country and the implementation of mandatory laboratory accreditation and quality assurance guidelines in laboratories to drive market growth in the US
                                   TABLE 71 US: KEY MACROINDICATORS
                                   TABLE 72 US: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 73 US: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 74 US: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 75 US: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 76 US: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 77 US: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.2.2 CANADA
                       10.2.2.1 Government initiatives to promote quality controls to drive market growth in Canada
                                   TABLE 78 CANADA: KEY MACROINDICATORS
                                   TABLE 79 CANADA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 80 CANADA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 81 CANADA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 82 CANADA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 83 CANADA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 84 CANADA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
     10.3 EUROPE
               TABLE 85 EUROPE: IVD QUALITY CONTROL MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
               TABLE 86 EUROPE: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
               TABLE 87 EUROPE: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
               TABLE 88 EUROPE: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
               TABLE 89 EUROPE: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
               TABLE 90 EUROPE: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
               TABLE 91 EUROPE: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.1 GERMANY
                       10.3.1.1 Increasing number of certified laboratories and the rising volume of high-quality tests performed by these laboratories to support market growth in Germany
                                   TABLE 92 GERMANY: KEY MACROINDICATORS
                                   TABLE 93 GERMANY: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 94 GERMANY: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 95 GERMANY: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 96 GERMANY: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 97 GERMANY: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 98 GERMANY: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.2 FRANCE
                       10.3.2.1 Increasing prevalence of infectious diseases and growing demand for early diagnosis to drive market growth
                                   TABLE 99 FRANCE: KEY MACROINDICATORS
                                   TABLE 100 FRANCE: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 101 FRANCE: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 102 FRANCE: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 103 FRANCE: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 104 FRANCE: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 105 FRANCE: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.3 UK
                       10.3.3.1 Growth in the life science industry and increased research to drive market growth in the UK
                                   TABLE 106 UK: KEY MACROINDICATORS
                                   TABLE 107 UK: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 108 UK: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 109 UK: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 110 UK: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 111 UK: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 112 UK: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.4 ITALY
                       10.3.4.1 Growing disease prevalence to drive the demand for better and more accurate disease diagnosis in Italy
                                   TABLE 113 ITALY: KEY MACROINDICATORS
                                   TABLE 114 ITALY: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 115 ITALY: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 116 ITALY: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 117 ITALY: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 118 ITALY: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 119 ITALY: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.5 SPAIN
                       10.3.5.1 Increasing demand for prenatal and genetic testing and rising focus on laboratory consolidation to support market growth in Spain
                                   TABLE 120 SPAIN: KEY MACROINDICATORS
                                   TABLE 121 SPAIN: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 122 SPAIN: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 123 SPAIN: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 124 SPAIN: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 125 SPAIN: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 126 SPAIN: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.6 RUSSIA
                       10.3.6.1 Increasing access to quality healthcare and growing incidence of lifestyle and infectious diseases to drive market growth in Russia
                                   TABLE 127 RUSSIA: KEY MACRO INDICATORS
                                   TABLE 128 RUSSIA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 129 RUSSIA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 130 RUSSIA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 131 RUSSIA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 132 RUSSIA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 133 RUSSIA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.3.7 REST OF EUROPE
                       TABLE 134 ROE: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                       TABLE 135 ROE: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                       TABLE 136 ROE: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                       TABLE 137 ROE: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                       TABLE 138 ROE: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                       TABLE 139 ROE: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
     10.4 ASIA PACIFIC
               FIGURE 38 ASIA PACIFIC: IVD QUALITY CONTROL MARKET SNAPSHOT
               TABLE 140 ASIA PACIFIC: IVD QUALITY CONTROL MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
               TABLE 141 ASIA PACIFIC: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
               TABLE 142 ASIA PACIFIC: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
               TABLE 143 ASIA PACIFIC: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
               TABLE 144 ASIA PACIFIC: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
               TABLE 145 ASIA PACIFIC: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
               TABLE 146 ASIA PACIFIC: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.1 JAPAN
                       10.4.1.1 Well-developed healthcare system and the rising demand for improvements in the quality of IVD test results to drive market growth in Japan
                                   TABLE 147 JAPAN: KEY MACROINDICATORS
                                   TABLE 148 JAPAN: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 149 JAPAN: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 150 JAPAN: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 151 JAPAN: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 152 JAPAN: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 153 JAPAN: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.2 CHINA
                       10.4.2.1 Growing access to modern healthcare and government support to boost the market growth in China
                                   TABLE 154 CHINA: KEY MACROINDICATORS
                                   TABLE 155 CHINA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 156 CHINA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 157 CHINA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 158 CHINA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 159 CHINA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 160 CHINA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.3 INDIA
                       10.4.3.1 Rising need to secure NABL accreditations to drive the demand for quality controls in India
                                   FIGURE 39 INDIA: INCREASING NUMBER OF LABS WITH NABL ACCREDITATIONS, 2012–2020
                                   TABLE 161 INDIA: KEY MACROINDICATORS
                                   TABLE 162 INDIA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 163 INDIA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 164 INDIA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 165 INDIA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 166 INDIA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 167 INDIA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.4 AUSTRALIA
                       10.4.4.1 Growing geriatric population has resulted in initiatives to enhance access to healthcare and improve infrastructure
                                   TABLE 168 AUSTRALIA: KEY MACROINDICATORS
                                   TABLE 169 AUSTRALIA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 170 AUSTRALIA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 171 AUSTRALIA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 172 AUSTRALIA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 173 AUSTRALIA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 174 AUSTRALIA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.5 SOUTH KOREA
                       10.4.5.1 Rising healthcare expenditure and the growing number of hospitals to drive the growth of the South Korean market
                                   TABLE 175 SOUTH KOREA: KEY MACROINDICATORS
                                   TABLE 176 SOUTH KOREA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 177 SOUTH KOREA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 178 SOUTH KOREA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 179 SOUTH KOREA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 180 SOUTH KOREA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 181 SOUTH KOREA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.4.6 REST OF ASIA PACIFIC
                       TABLE 182 ROAPAC: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                       TABLE 183 ROAPAC: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                       TABLE 184 ROAPAC: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                       TABLE 185 ROAPAC: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                       TABLE 186 ROAPAC: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                       TABLE 187 ROAPAC: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
     10.5 LATIN AMERICA
               TABLE 188 LATIN AMERICA: IVD QUALITY CONTROL MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
               TABLE 189 LATIN AMERICA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
               TABLE 190 LATIN AMERICA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
               TABLE 191 LATIN AMERICA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
               TABLE 192 LATIN AMERICA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
               TABLE 193 LATIN AMERICA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
               TABLE 194 LATIN AMERICA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.5.1 BRAZIL
                       10.5.1.1 Brazil dominates the Latin American IVD quality control market
                                   TABLE 195 BRAZIL: KEY MACROINDICATORS
                                   TABLE 196 BRAZIL: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 197 BRAZIL: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 198 BRAZIL: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 199 BRAZIL: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 200 BRAZIL: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 201 BRAZIL: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.5.2 MEXICO
                       10.5.2.1 Mexico is emerging as a prominent medical tourism hub
                                   TABLE 202 MEXICO: KEY MACROINDICATORS
                                   TABLE 203 MEXICO: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                                   TABLE 204 MEXICO: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 205 MEXICO: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                                   TABLE 206 MEXICO: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                                   TABLE 207 MEXICO: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                                   TABLE 208 MEXICO: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
             10.5.3 REST OF LATIN AMERICA
                       TABLE 209 ROLA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                       TABLE 210 ROLA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                       TABLE 211 ROLA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                       TABLE 212 ROLA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                       TABLE 213 ROLA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                       TABLE 214 ROLA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)
     10.6 MIDDLE EAST & AFRICA
             10.6.1 RISING CANCER INCIDENCE HAS ATTRACTED STAKEHOLDER ATTENTION TO REGIONAL MARKETS IN MEA
                       TABLE 215 MIDDLE EAST & AFRICA: IVD QUALITY CONTROL MARKET, BY PRODUCT & SERVICE, 2019–2026 (USD MILLION)
                       TABLE 216 MIDDLE EAST & AFRICA: IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                       TABLE 217 MIDDLE EAST & AFRICA: IVD QUALITY CONTROL MARKET, BY TECHNOLOGY, 2019–2026 (USD MILLION)
                       TABLE 218 MIDDLE EAST & AFRICA: IVD QUALITY CONTROL MARKET, BY MANUFACTURER, 2019–2026 (USD MILLION)
                       TABLE 219 MIDDLE EAST & AFRICA: THIRD-PARTY CONTROLS MARKET, BY TYPE, 2019–2026 (USD MILLION)
                       TABLE 220 MIDDLE EAST & AFRICA: IVD QUALITY CONTROL MARKET, BY END USER, 2019–2026 (USD MILLION)

11 COMPETITIVE LANDSCAPE (Page No. - 208)
     11.1 OVERVIEW
     11.2 KEY PLAYER STRATEGIES
     11.3 REVENUE SHARE ANALYSIS OF THE TOP MARKET PLAYERS
               FIGURE 40 REVENUE ANALYSIS OF THE TOP PLAYERS IN THE IVD QUALITY CONTROL MARKET
     11.4 MARKET SHARE ANALYSIS
               FIGURE 41 IVD QUALITY CONTROL MARKET SHARE, BY KEY PLAYER, 2020
     11.5 COMPANY EVALUATION QUADRANT
             11.5.1 STARS
             11.5.2 EMERGING LEADERS
             11.5.3 PERVASIVE PLAYERS
             11.5.4 PARTICIPANTS
                       FIGURE 42 IVD QUALITY CONTROL MARKET: COMPANY EVALUATION QUADRANT (2020)
     11.6 R&D EXPENDITURE
               FIGURE 43 IVD QUALITY CONTROL MARKET: R&D EXPENDITURE (IN USD MILLION), 2020
     11.7 COMPANY EVALUATION QUADRANT FOR START-UPS
             11.7.1 PROGRESSIVE COMPANIES
             11.7.2 DYNAMIC COMPANIES
             11.7.3 STARTING BLOCKS
             11.7.4 RESPONSIVE COMPANIES
                       FIGURE 44 IVD QUALITY CONTROL MARKET: COMPANY EVALUATION QUADRANT FOR START-UPS (2020)
     11.8 COMPANY PRODUCT FOOTPRINT
               TABLE 221 PRODUCT PORTFOLIO ANALYSIS: IVD QUALITY CONTROL MARKET
               FIGURE 45 TECHNOLOGY PORTFOLIO ANALYSIS: IVD QUALITY CONTROL MARKET
               TABLE 222 MANUFACTURER TYPE PORTFOLIO ANALYSIS: IVD QUALITY CONTROL MARKET
               TABLE 223 END-USER PORTFOLIO ANALYSIS: IVD QUALITY CONTROL MARKET
     11.9 GEOGRAPHIC FOOTPRINT OF THE MAJOR PLAYERS IN THE IVD QUALITY CONTROL MARKET
               TABLE 224 GEOGRAPHIC REVENUE MIX: IVD QUALITY CONTROL MARKET (2020)
     11.10 COMPETITIVE SCENARIO
               11.10.1 PRODUCT LAUNCHES
                                   TABLE 225 PRODUCT LAUNCHES
               11.10.2 DEALS
                                   TABLE 226 DEALS
               11.10.3 OTHER DEVELOPMENTS
                                   TABLE 227 OTHER DEVELOPMENTS

12 COMPANY PROFILES (Page No. - 225)
     12.1 KEY PLAYERS
(Business overview, Products and Services offered, Recent developments, SWOT analysis, MNM view)*
             12.1.1 BIO-RAD LABORATORIES, INC.
                       TABLE 228 BIO-RAD LABORATORIES, INC.: BUSINESS OVERVIEW
                       FIGURE 46 BIO-RAD LABORATORIES, INC.: COMPANY SNAPSHOT (2020)
             12.1.2 THERMO FISHER SCIENTIFIC, INC.
                       TABLE 229 THERMO FISHER SCIENTIFIC, INC.: BUSINESS OVERVIEW
                       FIGURE 47 THERMO FISHER SCIENTIFIC, INC.: COMPANY SNAPSHOT
             12.1.3 RANDOX LABORATORIES LTD.
                       TABLE 230 RANDOX LABORATORIES: BUSINESS OVERVIEW
             12.1.4 LGC LIMITED
                       TABLE 231 LGC LIMITED: BUSINESS OVERVIEW
                       FIGURE 48 LGC LIMITED: COMPANY SNAPSHOT
             12.1.5 ROCHE DIAGNOSTICS
                       TABLE 232 F. HOFFMANN-LA ROCHE AG: BUSINESS OVERVIEW
                       FIGURE 49 ROCHE DIAGNOSTICS: COMPANY SNAPSHOT (2020)
             12.1.6 ABBOTT LABORATORIES
                       TABLE 233 ABBOTT LABORATORIES: BUSINESS OVERVIEW
                       FIGURE 50 ABBOTT LABORATORIES: COMPANY SNAPSHOT (2020)
             12.1.7 SIEMENS HEALTHINEERS
                       TABLE 234 SIEMENS HEALTHINEERS: BUSINESS OVERVIEW
                       FIGURE 51 SIEMENS HEALTHINEERS: COMPANY SNAPSHOT (2020)
             12.1.8 QUIDEL CORPORATION
                       TABLE 235 QUIDEL CORPORATION: BUSINESS OVERVIEW
                       FIGURE 52 QUIDEL CORPORATION: COMPANY SNAPSHOT (2020)
             12.1.9 DANAHER CORPORATION
                       TABLE 236 DANAHER CORPORATION: BUSINESS OVERVIEW
                       FIGURE 53 DANAHER CORPORATION: COMPANY SNAPSHOT (2020)
             12.1.10 SYSMEX CORPORATION
                       TABLE 237 SYSMEX CORPORATION: BUSINESS OVERVIEW
                       FIGURE 54 SYSMEX CORPORATION: COMPANY SNAPSHOT (2020)
             12.1.11 ORTHO CLINICAL DIAGNOSTICS
                       TABLE 238 ORTHO CLINICAL DIAGNOSTICS: BUSINESS OVERVIEW
                       FIGURE 55 ORTHO CLINICAL DIAGNOSTICS HOLDINGS PLC: COMPANY SNAPSHOT (2020)
             12.1.12 BIO-TECHNE CORPORATION
                       TABLE 239 BIO-TECHNE CORPORATION: BUSINESS OVERVIEW
                       FIGURE 56 BIO-TECHNE CORPORATION: COMPANY SNAPSHOT (2020)
             12.1.13 SEEGENE INC.
                       TABLE 240 SEEGENE INC.: BUSINESS OVERVIEW
                       FIGURE 57 SEEGENE INC: COMPANY SNAPSHOT (2020)
             12.1.14 QNOSTICS
                       TABLE 241 QNOSTICS: BUSINESS OVERVIEW
             12.1.15 MICROBIOLOGICS, INC.
                       TABLE 242 MICROBIOLOGICS: BUSINESS OVERVIEW
             12.1.16 ZEPTOMETRIX CORPORATION
                       TABLE 243 ZEPTOMETRIX CORPORATION: BUSINESS OVERVIEW
             12.1.17 FORTRESS DIAGNOSTICS
                       TABLE 244 FORTRESS DIAGNOSTICS: BUSINESS OVERVIEW
             12.1.18 MICROBIX BIOSYSTEMS INC.
                       TABLE 245 MICROBIX BIOSYSTEMS: BUSINESS OVERVIEW
                       FIGURE 58 MICROBIX BIOSYSTEMS: COMPANY SNAPSHOT
             12.1.19 GRIFOLS, S.A.
                       TABLE 246 GRIFOLS, S.A.: BUSINESS OVERVIEW
                       FIGURE 59 GRIFOLS, S.A.: COMPANY SNAPSHOT
             12.1.20 ALPHA-TEC SYSTEMS, INC.
                       TABLE 247 ALPHA-TEC SYSTEMS, INC.: BUSINESS OVERVIEW
     12.2 OTHER PLAYERS
             12.2.1 HELENA LABORATORIES CORPORATION
                       TABLE 248 HELENA LABORATORIES CORPORATION: BUSINESS OVERVIEW
             12.2.2 STRECK, INC.
                       TABLE 249 STRECK: BUSINESS OVERVIEW
             12.2.3 MAINE MOLECULAR QUALITY CONTROLS, INC. (MMQCI)
                       TABLE 250 MAINE MOLECULAR QUALITY CONTROLS, INC.: BUSINESS OVERVIEW
             12.2.4 SUN DIAGNOSTICS, LLC
                       TABLE 251 SUN DIAGNOSTICS, LLC: BUSINESS OVERVIEW
             12.2.5 SERO AS
                       TABLE 252 SERO AS: BUSINESS OVERVIEW

*Business overview, Products and Services offered, Recent developments, SWOT analysis, MNM view might not be captured in case of unlisted companies.

13 APPENDIX (Page No. - 334)
     13.1 DISCUSSION GUIDE
     13.2 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL
     13.3 AVAILABLE CUSTOMIZATIONS
     13.4 RELATED REPORTS
     13.5 AUTHOR DETAILS

This study involved the extensive use of both primary and secondary sources. The research process involved the study of various factors affecting the industry to identify the segmentation types, industry trends, key players, competitive landscape, key market dynamics, and key player strategies.

Secondary Research

This research study involved comprehensive secondary sources; directories; databases such as Bloomberg Business, Factiva, and Dun & Bradstreet; white papers; annual reports; company house documents; investor presentations; and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the IVD quality control market. It was also used to obtain important information about the key players, market classification and segmentation according to industry trends to the bottom-most level, and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.

Primary Research

In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side and demand side are detailed below.

A breakdown of the primary respondents is provided below:

In Vitro Diagnostics (IVD) Quality Control Market  Size, and Share

To know about the assumptions considered for the study, download the pdf brochure

Market Size Estimation

The total size of the IVD quality control market was arrived at after data triangulation from different approaches. After each approach, the weighted average of all approaches was taken based on the level of assumptions used in each approach.

Data Triangulation

After arriving at the market size, the total market was divided into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The following figure shows the market validation, source structure, and data triangulation methodology implemented in the market engineering process.

Objectives of the Study

  • To validate the segmentation defined through the assessment of the product portfolios of the leading players in the market
  • To understand key industry trends and issues defining the growth objectives of market players
  • To gather both demand- and supply-side validation of the key factors affecting market growth, including market drivers, restraints, opportunities, and challenges
  • To validate assumptions for the market sizing and forecasting model used for this market study
  • To understand the market positions of the leading players in the IVD quality control market and their shares/rankings

Available Customizations

With the given market data, MarketsandMarkets offers customizations as per your company’s specific needs. The following customization options are available for the report:

Geographic Analysis

  • Further breakdown of the RoE IVD quality control market includes Switzerland, the Netherlands, and others.
  • Further breakdown of the Southeast Asia IVD quality control market includes Singapore, New Zealand, and others

Portfolio Assessment

  • Product Matrix, which gives a detailed comparison of the product portfolios of the top three companies
COVID-19

Get in-depth analysis of the COVID-19 impact on the In Vitro Diagnostics

Benchmarking the rapid strategy shifts of the Top 100 companies in the In Vitro Diagnostics

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