USD 1.10 billion
IVD Quality Control Market Size, Share, Growth Analysis, By Product and Service(Quality control products, data management solutions, and quality assurance services.), By Application(Clinical Chemistry, immunochemistry/immunoassay, hematology, molecular diagnostics), By Manufacturer type(Third-party control manufacturers, and original equipment manufacturers), By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35H2068 |
Region:
Global |
Published Date: July, 2024
Pages:
219
|Tables:
93
|Figures:
76
IVD Quality Control Market Insights
IVD Quality Control Market size was valued at USD 1.11 Billion in 2023 and is poised to grow from USD 1.16 Billion in 2024 to USD 1.56 Billion by 2032, growing at a CAGR of 4.10% during the forecast period (2025-2032).
The growth of the global IVD quality control market is accredited to clinical laboratories, increasing geriatric population, increasing demand for external quality assessment programs, rising adoption of POC instruments in developed regions, and the increase in third-party quality control.
Increase in the global incidence of infectious illness, HIV, and malignancies that need innovative diagnostics for effective treatment and quality control for monitoring their performance. According to the Joint United Nations Program on HIV and AIDS, in 2019, an estimated 24.5 million HIV patients received antiretroviral medication. Fast diagnosis systems and rising demand for quality evolution support also propel the market growth.
The factors that hindered the global IVD quality control market include additional burdens associated with quality control on laboratories, unfavorable reimbursement scenario for IVD test, and lack of mandatory regulations for clinical laboratory accreditation in many emerging countries.
US IVD Quality Control Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
Hospital
Fastest Growth
Home Care
Growth Rate
4.10% CAGR
Global IVD Quality Control Market, 2022-2030 ($ Bn)
Country Share for North America Region- 2022 (%)
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IVD Quality Control Market Segmental Analysis
Global In Vitro Diagnostics (IVD) Quality Control market is segmented into product and service, application, manufacturer type, end user, and region. Based on product and service, the IVD Quality Control Market is segmented into quality control products, data management solutions, and quality assurance services. In terms of application, the global market is classified into clinical chemistry, immunochemistry/immunoassay, hematology, molecular diagnostics, coagulation and hemostasis, microbiology, and others. With respect to categorization by manufacturer type, the global IVD Quality Control Market is divided into third-party control manufacturers, and original equipment manufacturers. Based on end users, the global IVD Quality Control Market is segmented into hospitals, home care settings, clinical laboratories, and academic and research institutes.
IVD Quality Control Market Analysis by Application
The Immunochemistry segment is expected to dominate the global market during the forecast period. This segment is further expected to hold the largest share in the global market during the forecast period as it helps to determine the molecular mechanism of various antigens, antibodies, and their interaction that affects the immune system.
The growth of this segment is attributed to the prevalence of various autoimmune disorders, infections, chronic diseases, and the need for earlier diagnosis with greater accuracy and precision for better treatment.
The molecular diagnostics segment is projected to grow at the fastest rate during the forecast period due to increasing use of innovative tools such as Polymerase Chain Reaction and next generation sequencing. The growth of this segment is attributed to increasing prevalence of diseases, high research on cancer biomarkers, enhanced diagnosis infrastructure.
IVD Quality Control Market Analysis by End-user
Hospital segment accounted for the largest revenue share during the forecast period due to increasing admissions in hospitals and improved clinical diagnostic reliability of healthcare experts in determining treatment options. In hospitals, distinct departments are available for diagnostics services. Regular monitoring of the test and instrument is necessary, which would help the market to grow. In addition, rising demand for rapid diagnostics tests in the critical care department and significant number of IVD devices and reagent kits.
Home care segment is projected to grow at the fastest rate during the forecast period. The devices used in home care settings are self-testing kits, Point-of-Care equipment used for near patient bed testing, and IVD devices in assisted healthcare settings. Self-testing kits are beneficial for patients who require routine testing and reduce the hospital visit.
Global IVD Quality Control Market By End User, 2022 (%)
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IVD Quality Control Market Regional Insights
North America is expected to hold a large revenue share of the global IVD quality control market due to the presence of the U.S. FDA and many accredited diagnostic laboratories coupled with a strong QC regulation system. The U.S. FDA along with GHTF regulates the North America region for the IVD QC market, from the production to pre-and post-marketing surveillance.
The Asia Pacific region is projected to grow at the fastest rate during the forecast period due to the increasing number of product manufacturing companies. In addition, presence of regulatory authorities in the regions such as Ministry of Health, Labor and Welfare, Pharmaceuticals and Medical Devices Evaluation Agency, and Ministry of Agriculture and Fisheries and food, helps to drive the market
Global IVD Quality Control Market By Geography, 2022-2030
- Largest
- Fastest
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IVD Quality Control Market Dynamics
IVD Quality Control Market Driver
Increasing Authorized Clinical Laboratory Across the Globe
- Burden of various diseases are increased which result in increasing laboratory tests. So that there is an increase in the laboratories in the public and commercial sectors. In Dec2019, COVID-19 increased rapidly which led to high demand for diagnostic testing. Many government authorities have established additional laboratories in order to increase the capacity of laboratory testing. Hence drive the market growth.
IVD Quality Control Market Restraint
Additional Cost and Budget Constraints in Hospital and Laboratories
- In a hospital to set up a QC procedure there is a need for investment as well as expertise. In Clinical laboratories working with low volume QC procedures, adoption of QC procedures is costly. This coupled with budgetary constraints in many hospitals and laboratories decreases the adoption of QC procedures.
- The cost of data management to manage QC data and QA services for the independent assessment of diagnostic tests further increases the total cost for end users. So that small hospital and laboratory are unable to handle this cost burden.
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IVD Quality Control Market Competitive Landscape
The Global In Vitro Diagnostics Quality Control market is moderately competitive. Key players adopted various strategies such as merger & acquisitions, collaboration and others to strengthen their position in the global market. Companies focusing on new treatments to produce innovative products.
IVD Quality Control Market Top Player’s Company Profiles
- Bio-Rad Laboratories
- Abbott Laboratories
- Siemens Healthineers
- Thermo Fisher Scientific
- Roche Diagnostics
- Randox Laboratories
- Bio-Techne Corporation
- Ortho Clinical Diagnostics
- Streck
- Sysmex Corporation
- Technopath Clinical Diagnostics
- Helena Biosciences
- SeraCare Life Sciences
- Quidel Corporation
- ZeptoMetrix Corporation
- Merck KGaA
- Seracare Life Sciences
- Fortress Diagnostics
- Maine Molecular Quality Controls
- LGC Group
IVD Quality Control Key Market Trends
Increasing Adoption of Point-of-care Testing Devices
- Due to increasing prevalence of diseases, medical device companies are continuously focusing on the development of technologically advanced diagnostic devices. Hospitals and laboratories show a rising preference towards point-of-care testing devices to get accurate real time data. Hence the demand for point-of-care testing devices is increased that help to propel the market growth.
IVD Quality Control Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyzes the Data collected utilizing Primary Exploratory Research backed by the robust Secondary Desk research.
According to our analysis, the global IVD quality control market is witnessing a significant growth throughout the forecast period due to increasing population, accredited clinical laboratories across the globe. In addition, an extensive rise in research and development activities by several key market players to introduce more enhanced and improved devices for better diagnosis treatment is also anticipated to contribute to the global market in the coming years. High cost of QC producers is the major factor that hinders the market growth.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 1.11 Billion |
| Market size value in 2032 | USD 1.56 Billion |
| Growth Rate | 4.10% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on IVD Quality Control Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on IVD Quality Control Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the IVD Quality Control Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the IVD Quality Control Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the IVD Quality Control Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the IVD Quality Control Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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