The Global In Vitro Diagnostics (IVD) Quality Control Market The market is projected to grow from USD 71.43 Billion in 2022 to USD 107.42 Billion by 2030, exhibiting a CAGR of 6.0% during the forecast.

In Vitro Diagnostics (IVD) Quality Control Market Overview:

A major factor contributing to the growth of the market is the increasing global prevalence of infectious diseases, HIV and cancer, which require new diagnostic methods for efficient treatment and quality control to monitor their performance. For example, according to the Joint United Nations Program on HIV and AIDS (UNAIDS), 24.5 million people living with HIV were receiving antiretroviral treatment worldwide in 2019. In addition, expansion of government participation in controlling the spread of infectious diseases and increasing demand for quality assessment support along with immediate diagnosis systems are expected to contribute to the growth of the global market during the forecast period.

The increase in the number of accredited clinical laboratories across the globe acts as one of the major factors driving the growth of in vitro diagnostics (IVD) quality control market. The increase in the geriatric population and subsequent growth in the prevalence of chronic and infectious diseases accelerate the market growth. The market is also affected by the rise in the number of accredited clinical laboratories and the rise in the use of point-of-care (POC) instruments in developed areas. Additionally, advancements in healthcare infrastructure, high disposable income, surge in healthcare expenditure and rise in healthcare expenditure positively affect the in vitro diagnostics (IVD) quality control market.

The rise in the prevalence of infectious diseases such as HIV and cancer is greatly contributing to the growth of the in vitro diagnostics quality control market. Infectious diseases are common and caused by the spread of pathogens such as viruses, bacteria, fungi, or parasites. The rise in infectious diseases, including HIV and cancer cases, necessitates novel diagnostic testing goods and services for effective treatment, which is driving up demand for in vitro diagnostics quality control that ensures the accuracy, performance, and quality of test equipment and findings.

Key Market Updates:

• In August 2021, Zeptometrix Corporation (USA) announced the immediate availability of ready-to-use NATSARS (COV2)-ERC for laboratory QC and test validation.
• In July 2021, Quidel Corporation (USA) received CE marking for its innovative Savanna multi-molecular analyzer and Savanna RVP4 assay (Respiratory Virus Panel-4).
• In June 2021, LGC SeraCare (USA) expanded its SARS-CoV-2 molecular quality solution line to include the AccuPlex SARS-CoV-2 Variant Panel 1.
• In June 2021, Abbott Laboratories (USA) received the CE mark for Panbio Rapid Antigen self-test. It has helped the company expand its reach across Europe for fast and reliable COVID-19 testing.

Major Market Segments Covered in In Vitro Diagnostics (IVD) Quality Control Market Industry Research:

Market Key Players:

• Siemens Healthcare GmbH
• Roche Diagnostics
• Alere Inc.
• Abbott Laboratories Inc.
• Bio-Techne
• Hologic Inc.
• Others

Key Vendors:

1.Roche Diagnostics: It is our great pleasure to be able to bring to you interesting developments on the role of diagnostics in building a healthy people. Roche has been a frontrunner of superior diagnostics technology in India, bringing to the country the world’s best tests in disease areas like blood safety, oncology, cardio-vascular, women’s health and fertility. While on the one hand, diagnostics plays a pivotal role in early detection and disease management, on the other hand, it addresses an important component of being healthy – preventive healthcare – through its screening solutions. It is our endeavour, as markets leaders of in-vitro diagnostics in India.

2.Alere Inc.:Alere is now Abbott! Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

3.Abbott Laboratories Inc.:Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

4.Bio-Techne:It is a leading developer and manufacturer of high-quality purified proteins and reagent solutions - notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, and cell and gene therapy workflow solutions including T-Cell activation technologies. Bio-Techne’s portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name, that offer researchers efficient and streamlined options for automated Western blot and multiplexed ELISA workflow. These reagent and protein analysis solutions are sold to biomedical researchers, as well as clinical research laboratories, and constitute the Protein Sciences Segment.

5.Hologic Inc.: An innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While we discover and develop groundbreaking products and services that benefit everyone, we are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives.

By Type:

• Quality Controls
• Data Management
• Quality Assurance Services
• Other

• Data Management: Data management is the process of collecting, storing, and analyzing data from IVD tests. This data can be used to track patient outcomes, identify trends, and improve the quality of care. Data management can be a complex process, and it is important to have a system in place that is secure, reliable, and easy to use.
• Quality Assurance Services: Quality assurance services are provided by third-party companies to help IVD laboratories comply with regulatory requirements and to improve the quality of their testing. These services can include audits, training, and consulting. Quality assurance services can be a valuable resource for IVD laboratories, and they can help to ensure that the laboratory is operating at a high level of quality.
• Other: There are a number of other services that are available to IVD laboratories, such as proficiency testing, instrument calibration, and reagent validation. These services can help to ensure that the laboratory is using accurate and reliable equipment and reagents.

By Application:

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

• Clinical chemistry: Clinical chemistry tests measure the levels of various substances in the blood, such as glucose, electrolytes, and enzymes. These tests can be used to diagnose diseases, monitor treatment, and assess overall health.
• Hematology: Hematology tests assess the blood count, including the number of red blood cells, white blood cells, and platelets. These tests can be used to diagnose anemia, leukemia, and other blood disorders.
• Immunoassay: Immunoassay tests detect the presence of antibodies or antigens in the blood. These tests can be used to diagnose allergies, infections, and autoimmune diseases.
• Molecular diagnostics: Molecular diagnostics tests detect the presence of genetic mutations or other changes in DNA. These tests can be used to diagnose cancer, inherited disorders, and infectious diseases.
• Microbiology: Microbiology tests identify and grow bacteria, viruses, and other microorganisms from clinical specimens. These tests can be used to diagnose infections and to determine the best course of treatment.
• Coagulation/Hemostasis: Coagulation/Hemostasis tests assess the ability of the blood to clot. These tests can be used to diagnose bleeding disorders and to monitor the effects of anticoagulant therapy.
• Others: There are a number of other types of IVD tests, such as urinalysis, tumor markers, and drug testing. These tests can be used to diagnose a wide range of conditions and to monitor treatment.

By End-User:

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

By Region:

North America led the global in vitro diagnostic quality control market in 2019 and is expected to maintain its leading position throughout the evaluation period, owing to surging demand for technologically superior multi-assay controls and stringent guidelines for the use of controls. The APAC region is estimated to be a rapidly developing region under the assessment timeline as it has enormous potential for this market due to the increasing number of product manufacturing companies. Besides, the Asia Pacific Federation of Clinical Biochemistry and Laboratory Medicine is strengthening the application of IVD. Therefore, increasing awareness of early and accurate diagnosis fuels product demand and ultimately fuels the IVD quality control market in the region. In addition, major regulatory authorities in the region such as the Ministry of Health, Labor and Welfare (MHLW), the Pharmaceutical and Medical Device Evaluation Agency (PMDA), and the Ministry of Agriculture, Fisheries, and Food will support the market growth.

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
  • Denmark
  • Finland
  • Iceland
  • Sweden
  • Norway
  • Belgium
  • The Netherlands
  • Luxembourg
• Germany
• France
• Italy
• Spain
• UK
• Nordic Countries
• Benelux Union
• Rest of Europe
• Asia-Pacific
  • Indonesia
  • Thailand
  • Malaysia
  • Singapore
  • Rest of Southeast Asia
• Japan
• China
• India
• Australia
• South Korea
• Southeast Asia
• Rest of Asia-Pacific
• The Middle East & Africa
• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest of the Middle East & Africa
• Latin America
• Brazil
• Argentina
• Rest of Latin America

Significant Market Dynamics:

Dynamics

The IVD quality control market is driven by the increasing demand for IVD tests and the growing regulatory requirements for IVD laboratories. The market is also expected to benefit from the development of new technologies, such as automation and artificial intelligence, which can improve the efficiency and accuracy of IVD testing.

Restraints

The IVD quality control market is restrained by the high cost of quality control materials and the lack of awareness of the importance of quality control among some IVD laboratories.

Trends

The key trends in the IVD quality control market are:

• Increasing demand for third-party quality controls: Third-party quality controls are becoming increasingly popular as they offer a number of advantages, such as increased accuracy, reduced risk of contamination, and lower cost.
• Growing focus on automation: Automation is becoming increasingly important in the IVD quality control market as it can help to improve efficiency and accuracy.
• Development of new technologies: The development of new technologies, such as artificial intelligence, is expected to revolutionize the IVD quality control market.

Drivers

The key drivers for the IVD quality control market are:

• Increasing demand for IVD tests: The demand for IVD tests is increasing due to the aging population, the rising prevalence of chronic diseases, and the increasing focus on preventive healthcare.
• Growing regulatory requirements: The regulatory requirements for IVD laboratories are becoming increasingly stringent, which is driving the demand for quality control materials and services.
• Increasing awareness of the importance of quality control: The awareness of the importance of quality control among IVD laboratories is increasing, which is driving the demand for quality control materials and services.

Challenges

The key challenges for the IVD quality control market are:

• High cost of quality control materials: The cost of quality control materials is high, which can be a barrier to entry for some IVD laboratories.
• Lack of awareness of the importance of quality control: The awareness of the importance of quality control among some IVD laboratories is low, which can lead to inaccurate test results.
• Lack of standardization: There is a lack of standardization in the IVD quality control market, which can make it difficult for laboratories to choose the right materials and services.

Opportunity

 The key opportunities in the market include:

• Increasing demand for IVD tests
• Growing regulatory requirements
• Increasing awareness of the importance of quality control
• Development of new technologies

In Vitro Diagnostics (IVD) Quality Control Market report scope:

Report Attribute	Details
Study Period	2017-2030
Base Year	2022
Estimated year	2023
Forecast period	2022-2030
Historic Period	2017-2022
Units	Value (USD Billion)
Growth Rate	CAGR of 6.0% from 2022 to 2030
By Type	Quality Controls Data Management Quality Assurance Services Other
By Application	Clinical Chemistry Hematology Immunoassay Molecular Diagnostics Microbiology Coagulation/Hemostasis Others
By End-User:	Hospitals Clinical/ Reference Laboratories Research and Academic Institutes Others
By Companies	Siemens Healthcare GmbH, Roche Diagnostics, Alere Inc., Abbott Laboratories Inc., Bio-Techne, Hologic Inc., And Others.
	North America US Canada Mexico Rest of North America Europe Germany France Italy Spain UK Nordic Countries Denmark Finland Iceland Sweden Norway Benelux Union Belgium The Netherlands Luxembourg Rest of Europe Asia-Pacific Japan China India Australia South Korea Southeast Asia Indonesia Thailand Malaysia Singapore Rest of Southeast Asia Rest of Asia-Pacific The Middle East & Africa Saudi Arabia UAE Egypt South Africa Rest of the Middle East & Africa Latin America Brazil Argentina Rest of Latin America
Reasons to Purchase this Report	Qualitative and quantitative analysis of the market based on segmentation involving both economic and non-economic factors; Provision of market value (USD Billion) data for each segment and sub-segment; Indicates the region and segment that is expected to witness the fastest growth and dominate the market; Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the market's dominance by region; Analysis by product/service type A competitive landscape that includes the market ranking of the top competitors, as well as new service/product launches, collaborations, business expansions, and acquisitions of companies featured during the previous five years Extensive company profiles with business overview, company insights, product benchmarking, and SWOT analysis for the leading market players The current and future market outlook of the industry in light of recent developments (which include growth opportunities and drivers as well as challenges and restraints of both emerging and developed regions) Includes in-depth analysis of the market from multiple perspectives using Porter's five forces analysis Provides market insight across the Value Chain Market dynamics situation, as well as development potential for the market in the coming years 6-month post-sale analyst assistance

Conclusion:
                  In conclusion, the IVD quality control market is driven by the increasing demand for accurate and reliable diagnostic testing, stringent regulatory requirements, and technological advancements in the field of diagnostics. As the importance of quality control in IVD continues to be recognized, the market is expected to witness sustained growth, with a focus on the development of advanced quality control products and comprehensive quality management solutions.