US dominated the North America IVD quality control market. In the coming years, the increasing number of IVD tests; the growing need to ensure the accuracy, reliability, and reproducibility of test results; and the use of third-party quality controls among clinical laboratories in this region will play a key role in the market growth.

IVD Quality Control Market in terms of revenue was estimated to be worth $1.3 billion in 2022 and is poised to reach $1.6 Billion by 2027, growing at a CAGR of 5.4% from 2022 to 2027 according to a new report by MarketsandMarkets™. The growth of the IVD quality control market is driven by the rising number of accredited clinical laboratories, rising geriatric population and subsequent growth in the prevalence of chronic and infectious diseases and increasing adoption of third-party quality controls. The rising focus on multi-analyte controls and Increasing investments from government bodies and private players in healthcare sectors in emerging economies is also expected to offer significant growth opportunities for the market in the coming years. Lack of regulations for clinical laboratory accreditation in several emerging countries could be the challenges faced by the market in upcoming years.

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The product & service segment holds the highest share of the total IVD quality control market during the forecast period.

The quality control products segment accounted for the largest share of the IVD quality control market in the base year 2021. The increasing number of accredited laboratories and mandates for the use of quality controls from regulatory bodies are driving the growth of the IVD quality control products market. The growth in the number of IVD tests performed, the increased number of accredited laboratories, and the implementation of mandates from regulatory bodies for ensuring the accuracy of diagnostic test results using QC materials are also some of the major factors influencing this market growth.

Immunochemistry accounted for the highest share of the technology segment of the global IVD quality control market

The immunochemistry segment accounted for the largest share of the IVD quality control market in 2021. The large share of the immunochemistry segment can be attributed to the growing use of immunoassay controls in diagnostics. However, the molecular diagnostics segment is estimated to grow at the highest CAGR of 7.9% during the forecast period, majorly due to the rising prevalence of infectious diseases such as tuberculosis, influenza, pneumonia, and COVID-19.

Third-party controls accounted for the largest share for the IVD quality control market

Based on manufacturer, the IVD quality control market is segmented into third-party controls and OEM controls. The third-party controls segment accounted for the largest share of the global IVD quality control market in 2021. The large share of this segment is mainly attributed to the increasing use of third-party quality controls due to their benefits, such as longer shelf-life and flexibility across different reagent lots, which helps reduce costs. Other benefits include unbiased independent assessment, consistent analyte-level stability, and clinically relevant levels.

Hospitals accounted for the highest share of the global IVD quality control market

The hospitals segment accounted for the largest share of the IVD quality control market in 2021, owing to the large volume of diagnostic tests carried out in hospitals. Clinical laboratories are estimated to be the fastest-growing end-user segment in this market. Amid the COVID-19 pandemic, manufacturers developed a diverse range of controls for clinical laboratories, hospitals, and research centers, as ensuring the accuracy of tests is vital to curb the spread of the outbreak.

Based on Region, North America to dominate the global IVD quality control market

In 2021, North America dominated the global IVD quality control market. Approvals of quality control products from the FDA and the College of American Pathologists (CAP) and the presence of leading companies in the US are driving the IVD quality control market in North America. In 2021, US dominated the North America IVD quality control market. In the coming years, the increasing number of IVD tests; the growing need to ensure the accuracy, reliability, and reproducibility of test results; and the use of third-party quality controls among clinical laboratories in this region will play a key role in the market growth.

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IVD Quality Control Market Dynamics:

Drivers:

1. Increasing number of accredited clinical laboratories
2. Growing adoption of third-party quality controls
3. Rising demand for external quality assessment support
4. Rising geriatric population and subsequent growth in the prevalence of chronic and infectious diseases
5. Increasing adoption of POC instruments in developed regions

Restraints:

1. Additional costs and budget constraints in hospitals and laboratories
2. Unfavorable reimbursement scenario for IVD tests

Opportunities:

1. Rising demand for multi-analyte controls

Challenges:

1. Stringent product approval process
2. Lack of regulations for clinical laboratory accreditation in several emerging countries

Key Market Players:

Some of the key 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).

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IVD Quality Control Market – Report Highlights

Refinement in the segments of the global IVD Quality Control market:

• The current edition of the report consists of an updated market overview, average selling price trends, value chain analysis, Porter’s Five Forces analysis, ecosystem map, pricing analysis, patent analysis, and new industry insights.
• The report also consists of the impact of recession on the global IVD Quality Control market.
• The competitive landscape chapter has been updated with the market evaluation framework and updated product portfolio matrix. The competitive landscape also includes the revenue share analysis of the top market players and an updated competitive situation and trends section.
• Competitive leadership mapping for SMEs/start-ups has also been updated for the IVD Quality Control market.

Updated financial information/product portfolio of players:

• The new edition of the report provides updated financial information in the IVD Quality Control market till 2021 for each listed company in a single diagram. This will easily help analyze the present status of profiled companies in terms of their financial strength, profitability, key revenue-generating region/country, business segment focus in terms of the highest revenue-generating segment, and investments in R&D.

Updated market developments of profiled players:

• Recent developments are important to understand market trends and the growth strategies adopted by players. The current edition of this report provides updated developments of profiled players from January 2019 to October 2022, indicating a continuation from the previous version. Product launches, expansions, acquisitions, agreements, partnerships, and collaborations have been the principal growth strategies adopted by market players within this period.

Recession Impact:

The impact of recession has been considered in the research methodology and market forecast for the years 2020 and 2021. It has also been analyzed in the product, application, end user and geographic segmentation. The market dynamics have also been updated taking into consideration the current scenario.

Research for this report involved the use of a large number of secondary and primary sources. Secondary sources include directories; databases such as Bloomberg Business, and Factiva; white papers; annual reports; company house documents; investor presentations; and SEC filings of companies. During the primary research process, in-depth interviews were conducted with various primary respondents, which include key opinion leaders, subject matter experts, directors, and C-level executives of distributors and suppliers, to obtain and verify critical qualitative and quantitative information. This primary data was collected mainly through questionnaires, emails, and telephonic interviews.

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