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
Whole Blood-based Controls
Other IVD Quality Controls
Data Management Software
Quality Assurance Services
By End User
Research and Academic Institutes
BY MANUFACTURER TYPE
Instrument Manufacturer Controls
Independent Manufacturer Controls
Instrument Manufacturer Controls
Rest of Europe
Rest of Asia-Pacific
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
3.6.1. Growing number of accredited clinical laboratories
22.214.171.124. Increasing mandates on the use of quality controls from regulatory and accreditation bodies
126.96.36.199. Increasing Adoption of Third-Party multi-analyte Quality Controls
188.8.131.52. Stringent regulatory requirements for the approval and commercialization of IVD and their quality control Products
184.108.40.206. Inadequate reimbursement policies for IVD quality control
220.127.116.11. Developing economies offer lucarative growth opportunities
CHAPTER 4 IVD QUALITY CONTROL PRODUCTS MARKET, BY TYPE
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
18.104.22.168 Market size and forecast
4.2.5. Serum/plasma-based Controls
22.214.171.124. Market size and forecast
4.2.6. Urine-based controls
126.96.36.199. Market size and forecast
4.2.7. Other source-based controls
188.8.131.52. 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
5.2. CLINICAL CHEMISTRY
5.2.1. Market size and forecast
5.3.1. Market size and forecast
5.4.1. Market size and forecast
5.5. MOLECULAR DIAGNOSTICS
5.5.1. Market size and forecast
5.6.1. Market size and forecast
5.7.1. Market size and forecast
CHAPTER 6 IVD QUALITY CONTROL PRODUCTS MARKET, BY MANUFACTURER TYPE
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
184.108.40.206. Market Size & Forecast
6.3.3. Instrument-Specific Controls
220.127.116.11. Market Size & Forecast
CHAPTER 7 IVD QUALITY CONTROL PRODUCTS MARKET, BY END USER
7.2. CLINICAL LABORATORIES
7.2.1. Market size and forecast
7.3.1. Market size and forecast
7.4. RESEARCH AND ACADEMIC INSTITUTES
7.4.1. Market size and forecast
7.5.1. Market size and forecast
CHAPTER 8 IVD QUALITY CONTROL PRODUCTS MARKET, BY GEOGRAPHY
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
8.3.1. 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
8.4.1. 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
8.5.1. 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
The IVD quality control products market is driven by factors such as increasing number of accredited laboratories, stringent mandates on the use of third party IVD quality control products, and increase in the number of IVD test volumes across the globe. Increase in adoption of multianalyte controls and focus of key players on expanding their market presence in emerging economies are anticipated to create new growth opportunities for market players. However, poor reimbursement scenario and lack of regulations regarding the use of controls in emerging economies are expected to hamper the market growth during the analysis period.
In 2015, the quality controls segment accounted for the largest market share in the global market due to the upsurge in demand for third-party quality controls. The serum/plasma based controls accounted for the largest share in the quality controls market in 2015, and is estimated to grow at the fastest CAGR of 4.1% from 2016 to 2022, owing to the increase in demand for products with long self-life and high stability. The immunochemistry application segment dominated the global market by application in 2015, owing to the rise in demand for high-sensitivity immunochemistry tests and increase in availability of multianalyte controls to test the accuracy of large immunoassay test menus.
Key findings of In Vitro Diagnostics (IVD) Quality Control Product Market:
In 2015, quality controls segment dominated the IVD quality control products market. It is projected to grow at a CAGR of 3.7% during the forecast period.
North America contributed the largest share in the global IVD quality control products market in 2015, and is projected to grow at a CAGR of 3.3% from 2016 to 2022.
The immunochemistry application segment holds the largest share in the global IVD quality control products market, and is projected to grow at a CAGR of 4.2% during the forecast period.
The U.S. was the major shareholder in the North American market in 2015.
The Japan was the major shareholder in the Asia-Pacific market in 2015 with around half of market share.
North America was the highest revenue contributor to the global market. Asia-Pacific is projected to be the fastest-growing region by 2022, registering a CAGR of 4.9% during the forecast period, due to increase in acceptance of third party IVD control products and spiraling number of accredited laboratories in the region.
The key players in the IVD quality control products market have focused on expanding their business operations in the emerging economies by adopting strategies such as new product launches and geographical expansion.
The major market players profiled in the report include Abbott Diagnostics, Bio-Rad Laboratories, Inc., Roche Diagnostics, Thermo Fisher Scientific, Inc., Randox Laboratories Ltd., Helena Laboratories, Seracare Life Sciences, Inc., Technopath Clinical Diagnostics, and Sun Diagnostics, LLC.
- 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.
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