In Vitro Diagnostics (IVD) Quality Control Product Market by Product Type (Quality Controls (Whole Blood-based Controls, Serum/Plasma-based Controls, Urine-based Controls, Other IVD Quality Controls), Data Management Software, and Quality Assurance Services), by Application (Clinical Chemistry, Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis, Microbiology, and Others), by End User (Hospitals, Clinical Laboratories, Research & Academic Institutes, and Others), by Manufacturer Type [Instrument Manufacturer Controls and Independent Manufacturer Controls (Third-party Controls and Instrument Manufacturer Controls)] - Global Opportunity Analysis and Industry Forecast, 2014-2022

In Vitro Diagnostics (IVD) Quality Control Product Market by Product Type (Quality Controls (Whole Blood-based Controls, Serum/Plasma-based Controls,

Category : Medical Devices
Published On : December  2016
Pages : 170



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In-vitro diagnostics (IVD) quality controls (QC) are liquid or lyophilized samples or materials, which are used by laboratories to check the testing process to ensure reliability and accuracy of testing results. The regulatory bodies and accredited bodies insist on using quality controls for every test performed in laboratories. However, laboratories use quality controls for testing products when reagent batches are changed, analyzers/instruments are serviced, or test results seem incorrect.

The global IVD quality control products market was valued at $823 million in 2015, and is expected to reach $1,052 million by 2022, registering a CAGR of 3.5% from 2016 to 2022. The market is driven by factors such as increase in adoption of third party quality control products, upsurge in the number of laboratories and diagnostic centers worldwide, and stringent norms for using controls. However, poor reimbursement framework and lack of regulations on the use of controls in the emerging economies are projected to hamper the market growth during the analysis period.

The global IVD quality controls products market is segmented based on product type into quality controls, IVD quality control data management software, and IVD quality assurance services. In 2015, the quality controls segment accounted for the largest share in the global market, and is estimated to grow at the fastest CAGR of 3.7% during the analysis period. The market growth is attributed to upsurge in demand for third-party quality control products and services.

The IVD quality controls market is segmented based on application into clinical chemistry, immunochemistry, hematology, molecular diagnostics, coagulation, microbiology, and others. The molecular biology diagnostics segment is estimated to grow at the fastest CAGR of 5.3% during the analysis period. The end users of the market are hospitals, clinical laboratories, research & academic institutes, and others. The hospitals segment held the largest share in the global IVD quality control products market in 2015.

Based on manufacturer type, the market is segment into instrument manufacturer controls and independent manufacturer controls including third party controls and instrument specific controls. The independent manufacturer controls segment dominated the market in 2015, and is estimated to grow at the fastest CAGR during the forecast period, owing to the increase in demand for third party controls.

The global IVD quality control market is segmented on the basis of region into North America, Europe, Asia-Pacific, and LAMEA regions. North America dominated the global market in 2015 due to stringent mandates on the use of third party IVD quality control products by regulatory authorities. The Asia-Pacific and LAMEA regions are expected to provide lucrative opportunities to market players in the near future. Asia-Pacific is expected to be the fastest growing region by 2022, registering a CAGR of 4.9% during the forecast period.

KEY MARKET BENEFITS

  • In-depth analysis of the market is based on market estimations of key segments for the period of 2014–2022.
  • Comprehensive analyses of market dynamics, such as drivers, restraints, and opportunities impacting the market growth are provided in the report.
  • Exhaustive analysis of the market segments helps in understanding the prospects of IVD quality control products and variants in the future.
  • Competitive intelligence of leading manufacturers and distributors of IVD quality control products market helps in understanding the competitive scenario of geographies.
  • The profiles and strategies of key market players are provided in the report to understand the competitive outlook of the global market.

KEY MARKET SEGMENT

The global IVD quality control products market is segmented based on product type, application, end user, manufacturer type, and geography.

BY PRODUCT TYPE

  • Quality Controls
  • Whole Blood-based Controls
  • Serum/Plasma-based Controls
  • Urine-based Controls
  • Other IVD Quality Controls
  • Data Management Software
  • Quality Assurance Services

BY APPLICATION

  • Clinical Chemistry
  • Immunochemistry
  • Hematology
  • Molecular Diagnostics
  • Coagulation/Hemostasis
  • Microbiology
  • Others

BY END USER

  • Hospitals
  • Clinical Laboratories
  • Research and Academic Institutes
  • Others

BY MANUFACTURER TYPE

  • Instrument Manufacturer Controls
  • Independent Manufacturer Controls
  • Third-party Controls
  • Instrument Manufacturer Controls

BY GEOGRAPHY

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • Japan
    • China
    • India
    • Rest of Asia-Pacific
  • LAMEA
    • Latin America
    • Middle East
    • Africa

KEY PLAYERS

  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific, Inc.
  • Randox Laboratories Ltd.
  • Roche Diagnostics
  • Abbott Diagnostics
  • Helena Laboratories
  • Seracare Life Sciences, Inc.
  • Technopath Clinical Diagnostics
  • Sun Diagnostics, LLC.

The other players in the industry (profiles not included in the report) include

  • Zeptometrix Corporation
  • ISOLAB GmbH
  • Sysmex Corporation
  • Fortress Diagnostics
  • Meril Life Sciences Pvt. Ltd.
  • Multiplicom N.V.
  • Future Diagnostics Solutions B.V.
  • Surmodics, Inc.

CHAPTER 1 INTRODUCTION

1.1. REPORT DESCRIPTION
1.2. KEY BENEFITS
1.3. KEY MARKET SEGMENTS
1.4. RESEARCH METHODOLOGY

1.4.1. Secondary research
1.4.2. Primary research

1.5. ANALYST TOOLS AND MODELS

CHAPTER 2 EXECUTIVE SUMMARY

2.1. CXO PERSPECTIVE

CHAPTER 3 MARKET OVERVIEW

3.1. MARKET DEFINITION AND SCOPE
3.2. KEY FINDINGS

3.2.1. Top Investment Pockets
3.2.2. Top Winning Strategies

3.3. PORTERS FIVE FORCES ANALYSIS

3.3.1. Bargaining Power Of Suppliers
3.3.2. Bargaining Power Of Buyers
3.3.3. Threat Of New Entrants
3.3.4. Intensity Of Competitive Rivalry
3.3.5. Threat Of Substitutes

3.4. MARKET SHARE ANALYSIS, 2015
3.5. MARKET DYNAMICS
3.6. DRIVERS

3.6.1. Growing number of accredited clinical laboratories

3.6.1.1. Increasing mandates on the use of quality controls from regulatory and accreditation bodies
3.6.1.2. Increasing Adoption of Third-Party multi-analyte Quality Controls

3.6.2. Restraints

3.6.2.1. Stringent regulatory requirements for the approval and commercialization of IVD and their quality control Products
3.6.2.2. Inadequate reimbursement policies for IVD quality control

3.6.3. Opportunities

3.6.3.1. Developing economies offer lucarative growth opportunities

CHAPTER 4 IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE

4.1. OVERVIEW
4.2. QUALITY CONTROLS

4.2.1. Key market trends
4.2.2. Key growth factors and opportunities
4.2.3. Market size and forecast
4.2.4. Whole Blood-Based Controls

4.2.4.1 Market size and forecast

4.2.5. Serum/plasma-based Controls

4.2.5.1. Market size and forecast

4.2.6. Urine-based controls

4.2.6.1. Market size and forecast

4.2.7. Other source-based controls

4.2.7.1. Market size and forecast

4.3. DATA MANAGEMENT SOFTWARE

4.3.1. Key market trends
4.3.2. Key growth factors and opportunities
4.3.3. Market size and forecast

4.4. QUALITY ASSURANCE SERVICES

4.4.1. Key market trends
4.4.2. Key growth factors and opportunities
4.4.3. Market size and forecast

CHAPTER 5 IVD QUALITY CONTROL PRODUCTS MARKET, BY APPLICATION

5.1. OVERVIEW
5.2. CLINICAL CHEMISTRY

5.2.1. Market size and forecast

5.3. IMMUNOASSAY

5.3.1. Market size and forecast

5.4. HEMATOLOGY

5.4.1. Market size and forecast

5.5. MOLECULAR DIAGNOSTICS

5.5.1. Market size and forecast

5.6. COAGULATION/HEMOSTASIS

5.6.1. Market size and forecast

5.7. MICROBIOLOGY

5.7.1. Market size and forecast

CHAPTER 6 IVD QUALITY CONTROL PRODUCTS MARKET, BY MANUFACTURER TYPE

6.1. OVERVIEW

6.1.1. Market size and forecast

6.2. INSTRUMENT MANUFACTURER CONTROLS

6.2.1. Market size & forecast

6.3. INDEPENDENT MANUFACTURER CONTROLS

6.3.1. Market size & forecast
6.3.2. Third-party controls

6.3.2.1. Market Size & Forecast

6.3.3. Instrument-Specific Controls

6.3.3.1. Market Size & Forecast

CHAPTER 7 IVD QUALITY CONTROL PRODUCTS MARKET, BY END USER

7.1. OVERVIEW
7.2. CLINICAL LABORATORIES

7.2.1. Market size and forecast

7.3. HOSPITALS

7.3.1. Market size and forecast

7.4. RESEARCH AND ACADEMIC INSTITUTES

7.4.1. Market size and forecast

7.5. OTHERS

7.5.1. Market size and forecast

CHAPTER 8 IVD QUALITY CONTROL PRODUCTS MARKET, BY GEOGRAPHY

8.1. INTRODUCTION

8.1.1. Market size and forecast

8.2. NORTH AMERICA

8.2.1. Key market trends
8.2.2. Key growth factors and opportunities
8.2.3. Market size and forecast
8.2.4. U.S. market size and forecast
8.2.5. Canada market size and forecast
8.2.6. Mexico market size and forecast

8.3. EUROPE

8.3.1. Key market trends
8.3.2. Key growth factors and opportunities
8.3.3. Market size and forecast
8.3.4. Germany market size and forecast
8.3.5. France market size and forecast
8.3.6. UK: market size and forecast
8.3.7. Italy market size and forecast
8.3.8. Rest of Europe: market size and forecast

8.4. ASIA-PACIFIC

8.4.1. Key market trends
8.4.2. Key growth factors and opportunities
8.4.3. Market size and forecast
8.4.4. Japan market size and forecast
8.4.5. China market size and forecast
8.4.6. India market size and forecast
8.4.7. Rest of Asia-Pacific market size and forecast

8.5. LAMEA

8.5.1. Key market trends
8.5.2. Key growth factors and opportunities
8.5.3. Market size and forecast
8.5.4. Latin America market size and forecast
8.5.5. Middle East market size and forecast
8.5.6. Africa market size and forecast

CHAPTER 9 COMPANY PROFILES

9.1. SERACARE LIFE SCIENCES, INC.

9.1.1. Company overview
9.1.2. Operating business segments
9.1.3. Business performance
9.1.4. Key strategic moves and developments

9.2. TECHNOPATH DISTRIBUTION LTD.

9.2.1. Company overview
9.2.2. Operating business segments
9.2.3. Business performance
9.2.4. Key strategic moves and developments

9.3. BIO-RAD LABORATORIES INC.

9.3.1. Company overview
9.3.2. Business operating segments
9.3.3. Business performance
9.3.4. Key strategic moves and developments

9.4. ABBOTT LABORATORIES

9.4.1. Company overview
9.4.2. Operating business segments
9.4.3. Business performance

9.5. DANAHER CORPORATION

9.5.1. Company overview
9.5.2. Operating business segments
9.5.3. Business performance
9.5.4. Key strategic moves and developments

9.6. HELENA LABORATORIES CORPORATION

9.6.1. Company overview
9.6.2. Operating business segments
9.6.3. Business performance

9.7. ORTHO-CLINICAL DIAGNOSTICS, INC.

9.7.1. Company overview
9.7.2. Operating business segments
9.7.3. Business performance
9.7.4. Key strategic moves and developments

9.8. RANDOX LABORATORIES LTD.

9.8.1. Company overview
9.8.2. Operating business segments
9.8.3. Business performance
9.8.4. Key strategic moves and developments

9.9. F. HOFFMANN-LA ROCHE LTD.

9.9.1. Company overview
9.9.2. Operating business segments
9.9.3. Business performance
9.9.4. Key strategic moves and developments

9.10. SUN DIAGNOSTICS, LLC

9.10.1. Company overview
9.10.2. Operating business segments
9.10.3. Sun Diagnostics, LLC.: business segments
9.10.4. Business performance

LIST OF TABLES

TABLE 1. GLOBAL IVD QUALITY CONTROLS PRODUCTS MARKET, BY PRODUCT TYPE, 2014-2022 ($MILLION)
TABLE 2. GLOBAL IVD QUALITY CONTROLS MARKET, BY SOURCE TYPE, 2014-2022 ($MILLION)
TABLE 3. IVD QUALITY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 4. WHOLE BLOOD-BASED QUATILTY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 5. SERUM-BASED QUALITY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 6. URINE-BASED QUALITY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 7. OTHER SOURCE-BASED QUALITY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 8. IVD QUALITY CONTROLS DATA MANAGEMENT SOFTWARE MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 9. IVD QUALITY ASSURANCE SERVICES MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 10. GLOBAL IVD QUALITY CONTROLS MARKET, BY APPLICATION, 2014-2022 ($MILLION)
TABLE 11. CLINICAL CHEMISTRY QUATILTY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 12. IMMUNOCHEMISTRY QUATILTY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 13. HEMAOTOLOGY QUATILTY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 14. MOLECULAR DAIGNOSTICS QUATILTY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 15. MICROBIOLOGY QUATILTY CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 16. INSTRUMENT MANUFACTURER CONTROLS MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 19. GLOBAL IVD QUALITY CONTROL PRODUCTS MARKET, BY END USER, 2015-2022 ($MILLION)
TABLE 20. IVD QUALITY CONTROL PRODUCTS MARKET FOR CLINICAL LABORATORIES, BY GEOGRAPHY, 2015-2022 ($MILLION)
TABLE 21. IVD QUALITY CONTROL PRODUCTS MARKET FOR HOSPITALS, BY GEOGRAPHY, 2015-2022 ($MILLION)
TABLE 22. IVD QUALITY CONTROL PRODUCTS MARKET FOR RESEARCH AND ACADEMIC INSTITUTES, BY GEOGRAPHY, 2015-2022 ($MILLION)
TABLE 23. IVD QUALITY CONTROL PRODUCTS MARKET FOR OTHER END USERS, BY GEOGRAPHY, 2015-2022 ($MILLION)
TABLE 24. IVD QUALITY CONTROL PRODUCTS MARKET, BY GEOGRAPHY, 2015-2022 ($MILLION)
TABLE 25. NORTH AMERICA IVD QUALITY CONTROL PRODUCTS MARKET, BY COUNTRY, 2014-2022 ($MILLION)
TABLE 26. NORTH AMERICA IVD QUALITY CONTROL PRODUCTS MARKET, BY PRODUCT TYPE, 2014-2022 ($MILLION)
TABLE 27. NORTH AMERICA IVD QUALITY CONTROL PRODUCTS MARKET, BY APPLICATION, 2014-2022 ($MILLION)
TABLE 28. NORTH AMERICA IVD QUALITY CONTROL PRODUCTS MARKET, BY END USER, 2014-2022 ($MILLION)
TABLE 29. NORTH AMERICA IVD QUALITY CONTROL PRODUCTS MARKET, BY MANUFACTURER TYPE, 2014-2022 ($MILLION)
TABLE 30. EUROPE IVD QUALITY CONTROL PRODUCTS MARKET, BY COUNTRY, 2014-2022 ($MILLION)
TABLE 31. EUROPE IVD QUALITY CONTROL PRODUCTS MARKET, BY PRODUCT TYPE, 2014-2022 ($MILLION)
TABLE 32. EUROPE IVD QUALITY CONTROL PRODUCTS MARKET, BY APPLICATION, 2014-2022 ($MILLION)
TABLE 33. EUROPE IVD QUALITY CONTROL PRODUCTS MARKET, BY END USER, 2014-2022 ($MILLION)
TABLE 34. EUROPE IVD QUALITY CONTROL PRODUCTS MARKET, BY MANUFACTURER TYPE, 2014-2022 ($MILLION)
TABLE 35. ASIA-PACIFIC IVD QUALITY CONTROL PRODUCTS MARKET, BY COUNTRY, 2014-2022 ($MILLION)
TABLE 36. ASIA-PACIFIC IVD QUALITY CONTROL PRODUCTS MARKET, BY PRODUCT TYPE, 2014-2022 ($MILLION)
TABLE 37. ASIA-PACIFIC IVD QUALITY CONTROL PRODUCTS MARKET, BY APPLICATION, 2014-2022 ($MILLION)
TABLE 38. ASIA-PACIFIC IVD QUALITY CONTROL PRODUCTS MARKET, BY END USER, 2014-2022 ($MILLION)
TABLE 39. ASIA-PACIFIC IVD QUALITY CONTROL PRODUCTS MARKET, BY MANUFACTURER TYPE, 2014-2022 ($MILLION)
TABLE 40. LAMEA IVD QUALITY CONTROL PRODUCTS MARKET, BY REGION, 2014-2022 ($MILLION)
TABLE 41. LAMEA IVD QUALITY CONTROL PRODUCTS MARKET, BY PRODUCT TYPE, 2014-2022 ($MILLION)
TABLE 42. LAMEA IVD QUALITY CONTROL PRODUCTS MARKET, BY APPLICATION, 2014-2022 ($MILLION)
TABLE 43. LAMEA IVD QUALITY CONTROL PRODUCTS MARKET, BY END USER, 2014-2022 ($MILLION)
TABLE 44. LAMEA IVD QUALITY CONTROL PRODUCTS MARKET, BY MANUFACTURER TYPE, 2014-2022 ($MILLION)
TABLE 45. SERACARE LIFE SCIENCES, INC.: COMPANY SNAPSHOT
TABLE 46. SERACARE LIFE SCIENCES, INC.: BUSINESS SEGMENTS
TABLE 47. TECHNOPATH DISTRIBUTION LTD.: COMPANY SNAPSHOT
TABLE 48. TECHNOPATH DISTRIBUTION LTD: BUSINESS SEGMENTS
TABLE 49. BIO-RAD LABORATORIES INC.: COMPANY SNAPSHOT
TABLE 50. BIO-RAD LABORATORIES INC.: BUSINESS SEGMENTS
TABLE 51. ABBOTT: COMPANY SNAPSHOT
TABLE 52. ABBOTT: BUSINESS SEGMENTS
TABLE 53. DANAHER: COMPANY SNAPSHOT
TABLE 54. DANAHER: BUSINESS SEGMENTS
TABLE 55. HELENA LABORATORIES CORPORATION: COMPANY SNAPSHOT
TABLE 56. HELENA LABORATORIES CORPORATION: BUSINESS SEGMENTS
TABLE 57. ORTHO-CLINICAL DIAGNOSTICS: COMPANY SNAPSHOT
TABLE 58. ORTHO-CLINICAL DIAGNOSTICS, INC.: OPERATING SEGMENTS
TABLE 59. RANDOX LABORATORIES: COMPANY SNAPSHOT
TABLE 60. RANDOX LABORATORIES: OPERATING SEGMENTS
TABLE 61. ROCHE: OPERATING SEGMENTS
TABLE 62. SUN DIAGNOSTICS, LLC: COMPANY SNAPSHOT

LIST OF FIGURES

FIGURE 1. TOP INVESTMENT POCKETS
FIGURE 2. TOP WINNING STRATEGIES: PERCENTAGE DISTRIBUTION, 2014-2016
FIGURE 3. TOP WINNING STRATEGIES: NATURE AND TYPE 2014-2016
FIGURE 4. PORTERS FIVE FORCES ANALYSIS
FIGURE 5. MARKET SHARE ANALYSIS, 2015
FIGURE 6. TOP IMPACTING FACTORS: GLOBAL IVD QUALITY CONTROL PRODUCTS MARKET
FIGURE 7. MEDICAL DEVICE DEVELOPMENT AND APPROVAL PROCEDURE
FIGURE 8. U.S. IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 9. CANADA IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 10. MEXICO IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 11. GERMANY IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 12. FRANCE IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 13. UK IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 14. ITALY IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 15. REST OF EUROPE IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 16. JAPAN IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 17. CHINA IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 18. INDIA IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 19. REST OF ASIA-PACIFIC: IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 20. LATIN AMERICA IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 21. MIDDLE EAST IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 22. AFRICA IVD QUALITY CONTROL PRODUCTS MARKET, 2014-2022 ($MILLION)
FIGURE 23. BIO-RAD LABORATORIES INC.: BUSINESS PERFORMANCE
FIGURE 24. ABBOTT REVENUE, 2013-2015 ($MILLION)
FIGURE 25. ABBOTT REVENUE SHARE, BY OPERATING SEGMENT, 2015 (%)
FIGURE 26. ABBOTT REVENUE SHARE, BY GEOGRAPHY, 2015 (%)
FIGURE 27. DANAHER REVENUE, 2013-2015 ($MILLION)
FIGURE 28. DANAHER REVENUE SHARE, BY OPERATING SEGMENT, 2015 (%)
FIGURE 29. DANAHER REVENUE SHARE, BY GEOGRAPHY, 2015(%)
FIGURE 30. ROCHE: REVENUE, 2013-2015 ($MILLION)
FIGURE 31. ROCHE REVENUE SHARE, BY PRODUCT, 2015 (%)
FIGURE 32. ROCHE REVENUE SHARE, BY GEOGRAPHY, 2015 (%)

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