In Vitro Diagnostics Quality Control Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2028

The global In Vitro Diagnostics Quality Control market size is expected to be worth around US$ 120.6 billion by 2028, according to a new report by Vision Research Reports.

The global In Vitro Diagnostics Quality Control market size was valued at US$ 960 million in 2020 and is anticipated to grow at a CAGR of 5.4% during forecast period 2021 to 2028.

Growth Factors

The growth is driven by the growing geriatric population and technological advancements in diagnostics that are supporting its adoption.

Technological advancements in terms of accuracy, portability, and cost-effectiveness are expected to be one of the high impact rendering drivers of this market. For instance, in June 2017, Agena Bioscience launched the MassARRAY system integrated with CHIP Prep Module in Europe. The system was marketed as a CE-IVD product under Directive 98/79/EC. Moreover, Real-Time Polymerase Chain Reaction (qPCR) is one of the fastest-growing application segments of the in vitro diagnostics (IVD) market.

The IVD market is highly competitive in nature. Consequently, manufacturers are required to improvise products in terms of specificity, accuracy, precision, speed, and other parameters, in order to gain an advantage over previously marketed products.

Report Highlights

The immunology application segment led the global market in 2020. Immunology includes the study of the molecular mechanism for understanding the function of the immune system. It majorly involves the mechanism of action of antigens, antibodies, and their interactions. Key applications of the immunochemistry include detection of infectious microorganisms, such as viruses, bacteria, and fungus, by detecting the presence of their toxins and coat antigens. A rise in the outbreaks of communicable and chronic diseases and the need for its early diagnosis are the key factors driving the demand for immunochemistry methods involving different types of Enzyme-Linked Immunosorbent Assay (ELISA).

Molecular diagnostics is anticipated to be the fastest-growing segment at a CAGR of 8.2% over the forecast period. It is a set of complex tests for a medical diagnosis for all major viral, bacterial, and parasitic infections. The introduction of advanced technologies, such as Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS), has helped overcome the drawbacks of traditional systems. Some of the key pathogens routinely diagnosed using multiplex PCR, but not limited to, are HIV, HSV (meningitis and encephalitis), H. influenza, S. pneumonia (respiratory tract infections), N. gonorrhea, C. trachoma (genital infections), G. Lombardia, C. parvum (diarrheal diseases), and Leishmaniaspp (Leishmaniasis).

Quality control in the laboratory is focused on ensuring that the results delivered to the patient are accurate. These checks are usually undertaken while installing an instrument, after servicing, changing reagent lots, and when the instrument readings are not in range. Authorities that regulate the quality of these IVDs include the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4). American Association for Laboratory Accreditation (A2LA) and Clinical Laboratory Improvement Amendments (CLIA) have enhanced the demand for IVD quality control.

Hospitals segment was the largest end-use segment in 2020 and is likely to retain the position in the future owing to a rising number of admissions and better reliability of healthcare professionals on clinical diagnosis for deciding treatment alternatives. Hospitals have a separate department for diagnostic services. The tests and instruments in this department need to be monitored regularly, which will augment the market growth. Moreover, third-party companies, such as Bio-Rad and Randox, entered into a collaboration with hospitals for providing reagents of QC. Other factors contributing toward its dominance include increasing demand for fast diagnostic tests in the critical care department and the presence of a large number of IVD instruments and reagent kits.

Home care is expected to be the fastest-growing end-use segment over the forecast period. Home care settings include a variety of devices, such as self-testing kits, Point-of-Care (POC) instruments used for near-patient bed testing, and IVD devices in assisted healthcare settings. Self-testing kits give ease of convenience for the patient who requires everyday testing and further reduces hospital visits. Home care products include blood glucose monitoring devices for diabetes patients, pregnancy detection kits/devices, urine analyzers, hemoglobin sensors, and hormone home tests. These devices pose a high risk due to their use by the layman. Pre- and post-marketing quality assurance and control are performed on these devices to ensure patient safety.

Key Players

Siemens Healthcare GmbH; Roche Diagnostics; Alere, Inc.; Abbott Laboratories, Inc.; Bio-Techne; Hologic, Inc. (Gen-Probe); Qiagen N.V.; Bio-Rad Laboratories, Inc.; Quidel Corp.; Becton, Dickinson, and Company (BD); bioMerieux, Inc.; Sysmex Corp.; Sero AS; and Thermo Fisher Scientific, Inc. 

Market Segmentation

  • Application Outlook 

    • Immunochemistry

    • Hematology

    • Clinical Chemistry

    • Molecular Diagnostics

    • Coagulation

    • Microbiology

    • Others

  • Type Outlook

    • Quality Control

      • Quality Controls, by Type

        • Plasma-based Control

        • Serum-based Control

        • Whole Blood-based Control

        • Others

      • Quality Controls, by Application

        • Immunochemistry

        • Hematology

        • Clinical Chemistry

        • Molecular Diagnostics

        • Coagulation

        • Microbiology

        • Others

    • Quality Assurance Services

      • Immunochemistry

      • Hematology

      • Clinical Chemistry

      • Molecular Diagnostics

      • Coagulation

      • Microbiology

      • Others

    • Data Management

      • Clinical Chemistry

      • Immunochemistry

      • Hematology

      • Molecular Diagnostics

      • Coagulation

      • Microbiology

      • Others

  • End-Use Outlook 

    • Hospitals

    • Laboratories

    • Home-care

    • Others

  • Regional Outlook

    • North America

      • The U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • France

      • Spain

      • Italy

      • Russia

    • Asia Pacific

      • Japan

      • China

      • India

      • South Korea

      • Singapore

      • Australia

    • Latin America

      • Brazil

      • Argentina

    • Middle East & Africa

      • South Africa

      • UAE

      • Saudi Arabia

The In Vitro Diagnostics Quality Control market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of In Vitro Diagnostics Quality Control market for the base year 2020 and the forecast between 2021 and 2028. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global In Vitro Diagnostics Quality Control market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the In Vitro Diagnostics Quality Control market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted In Vitro Diagnostics Quality Control market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the In Vitro Diagnostics Quality Control capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of In Vitro Diagnostics Quality Control by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global In Vitro Diagnostics Quality Control market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major In Vitro Diagnostics Quality Control market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of In Vitro Diagnostics Quality Control market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the In Vitro Diagnostics Quality Control industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The In Vitro Diagnostics Quality Control market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to In Vitro Diagnostics Quality Control market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of In Vitro Diagnostics Quality Control market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new In Vitro Diagnostics Quality Control market. These factors have benefited the growth of the global market for In Vitro Diagnostics Quality Control. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for In Vitro Diagnostics Quality Control. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of In Vitro Diagnostics Quality Control are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2020
  • Forecast Year 2021 to 2028

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 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 include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2028);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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