New York, United States: The Report on In Vitro Diagnostics (IVD) Quality Control Market by Decisive Markets Insights was released in the middle of Covid -19 after a thorough analysis of the top players and primary interviews with key industry figures. A market study from In Vitro Diagnostics (IVD) Quality Control Market examines the market size, segmentation, future trends, growth rate, drivers and challenges, as well as the sales channels and distributors.
The global In Vitro Diagnostics (IVD) Quality Control market gathered revenue around USD 1.0 Billion in 2020 and market is set to grow USD 2.9 Billion by the end of 2027 and is estimated to expand at a modest CAGR of 6.2% during the prediction period 2021 to 2027.
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The In Vitro Diagnostics (IVD) Quality Control testing plays a significant role in clinical decision-making. Over the years, In Vitro Diagnostics (IVD) Quality Control quality control products and procedures have become mandatory in accredited clinical or medical laboratories. The applications of In Vitro Diagnostics (IVD) Quality Control quality control products have also widened over the years, with a number of quality controls currently available in the market for clinical chemistry, immunochemistry, hematology, molecular diagnostics, coagulation, and microbiology. To ensure technological competitiveness, companies are continuously launching innovative and advanced quality control products in the market for a variety of applications.
The growth of the In Vitro Diagnostics Quality Control Market is primarily driven by the rising number of accredited clinical laboratories, rising geriatric population, rising demand for external quality assessment programs, increasing adoption of and POC instruments in developed regions and increasing adoption of third-party quality controls. The rising focus on multi-analyte controls is also expected to offer significant growth opportunities for the market in the coming years. The use of quality control products is, however, not mandatory for all clinical laboratories in many countries. The lack of regulations for these products is expected to adversely affect market growth.
IVD Quality Control Market Dynamics
Driver: Increasing number of accredited clinical laboratories
Globally, the number of laboratory tests has increased owing to the rising burden of various diseases worldwide. In order to meet this demand, there has been an increase in the number of laboratories in the public and the private sector. From December 2019, the demand for diagnostic testing has increased with the emergence of the COVID- 19 pandemic. In response to this pandemic and to increase laboratory testing capacities, many government bodies have set up new laboratories.
In most countries, clinical laboratories must secure accreditation from regulatory bodies to perform diagnostic tests. Moreover, accreditation to ISO 15189:2012 and other similar standards is becoming mandatory in various countries. During the accreditation process, authorities evaluate the quality system and competence of a laboratory based on specific standards. European countries such as Belgium, France, Hungary, Ireland, and Lithuania have mandatory accreditation for various laboratory tests, whereas countries such as Finland, the Netherlands, Sweden, Switzerland, and the UK have almost completed the accreditation of clinical laboratories.
Restraint: Additional costs and budget constraints in hospitals and laboratories
Setting up a QC process in a clinical laboratory requires significant investments. Laboratories also need to maintain dedicated personnel to manage the QC system. Moreover, QC procedures incur similar costs, regardless of the volume of tests performed. Hence, the cost of adopting QC procedures is very high for clinical laboratories working with low volumes of diagnostic tests. This, coupled with budgetary constraints in many hospitals and laboratories in developed and developing economies, is expected to result in the lower adoption of QC practices.
Moreover, the cost of data management solutions to manage QC data and QA services for the independent assessment of diagnostic tests further increases the total cost for end users. Even after implementing data management solutions, small hospitals and laboratories may be unable to bear the additional costs.
Opportunity: Rising demand for multi-analyte controls
Technological advancements have led to the development of a new range of multi-analyte and multi-instrument controls. These innovative controls consolidate multiple instrument-specific controls into a single control, thereby enabling clinical laboratories to cut costs and greatly reduce the time taken by QC procedures.
Multi-analyte controls are useful in screening and diagnostic procedures and can be used with multiple reagents and instruments. Currently, there are several multi-analyte controls available in the market, such as Liquichek Tumor Marker Control (Bio-Rad Laboratories), Acusera Infectious Disease (Serology) Controls (Randox Laboratories), AcroMetrix Multi-Analyte Controls—Transplant (Thermo Fisher Scientific), and ACCURUN 1 Series 4400 Multi-Analyte Positive Control (SeraCare Life Sciences). Earlier, laboratories had to maintain more than thirty individual controls to run QC procedures; however, with the evolution of multi-analyte controls, clinical laboratories offer accurate and precise test results using only one or two multi-analytes. Multi-analyte controls in the market for immunoassay testing help laboratories perform QC tests for fifty or more parameters—including cardiac and tumor markers, hormones, therapeutic drugs, kidney functions, and vitamins—in the same serum. In addition, these controls need not be changed with reagent lots and hence support long-term QC monitoring. The increasing preference for these controls is thus expected to offer significant growth opportunities for players in the IVD quality control market.
Challenge: Stringent product approval process
In the past few years, IVD companies have faced difficulties due to an increasingly complex regulatory process. For more than twenty years, the FDA has emphasized its regulatory authority over LDTs (laboratory-developed tests) and related products but has chosen to exercise enforcement discretion over such tests. In recent years, however, the FDA declared that added oversight of LDTs and related products are needed and that the agency plans to issue a guidance document on this. Assayed and unassayed QC materials are subject to the Quality System Regulation (QSR), 21 CFR, Part 820, and labeling regulation 21 CFR 809.10.
In the past few years, the FDA requirements, particularly with regard to 510(k) notifications, have increased, requiring more data and details than earlier. This change, resulting in unpredictable premarket submission requirements, is extremely unfavorable for IVD manufacturers that require 510(k) clearance.
North America is expected to account for the largest share of the IVD quality control market in 2020
In 2020, North America accounted for the largest share of the global IVD quality control market, followed by Europe. Recommendations for and approvals of quality control products from the FDA and the College of American Pathologists (CAP) and the presence of well-established distribution channels and leading companies in the US are driving the IVD quality control market in North America.
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COVID-19 Impact on In Vitro Diagnostics (IVD) Quality Control Sales
Businesses today are operating in a dynamic environment. Earlier focus primarily concentrated on keeping pace with changing consumer preferences. COVID-19 outbreak was unprecedented and exposed vulnerabilities of various industries. Pandemic-induces obstacles also were registered in the In Vitro Diagnostics (IVD) Quality Control market.
Sales plummeted as COVID-19 gradually tightened its noose worldwide. Supply-chain disruptions caused massive losses, while demand took nose-dive as consumers remained indoors with affected countries implementing either partial or complete lockdown.
Gradual recovery however is on the cards with the roll out of vaccinations. Nonetheless, consecutive waves of the virus compelled businesses to stay prepared for the worst. As government and healthcare organizations successfully implement steps to contain the spread of COVID-19, industries have begun operations, albeit at a slow and more cautious pace.
Against this backdrop, Nova one advisor’s study predicts gradual recovery for the In Vitro Diagnostics (IVD) Quality Control market 2021 onwards. This trend will however continue through the course of the report’s assessment period
This report provides detailed company profiles of the key market players. This research report also highlights the competitive landscape of the In Vitro Diagnostics (IVD) Quality Control market and ranks noticeable companies as per their occurrence in diverse regions across globe and crucial developments initiated by them in the market space. This research study also tracks and evaluates competitive developments, such as collaborations, partnerships, and agreements, mergers and acquisitions; novel product introductions and developments, promotion strategies and Research and Development (R&D) activities in the marketplace. The competitive profiling of these players includes business and financial overview, gross margin, production, sales, and recent developments which can aid in assessing competition in the market.
Some of the prominent players in the In Vitro Diagnostics (IVD) Quality Control market include:
Bio-Rad Laboratories, Inc., Randox Laboratories Ltd., Thermo Fisher Scientific, Inc., LGC Limited, and Abbott Laboratories. Roche Diagnostics, Siemens Healthineers, Danaher Corporation, Fortress Diagnostics, SERO AS, Sysmex Corporation, Ortho-Clinical Diagnostics, Helena Laboratories Corporation, Quidel Corporation, Sun Diagnostics, LLC, Seegene Inc., ZeptoMetrix Corporation, Qnostics, Bio-Techne Corporation, Microbiologics, Microbix Biosystems, Streck, Inc., Alpha-Tec Systems, Maine Molecular Quality Controls, Inc..
Unravelling the Critical Segments
This research report offers market revenue, sales volume, production assessment and prognoses by classifying it on the basis of various aspects including product type, application/end-user, and region. Further, this research study investigates market size, production, consumption and its development trends at global, regional, and country level for period 2017 to 2027 and covers subsequent region in its scope:
Global IVD quality control market, by product and service
- Quality control products
- Serum/ Plasma based controls
- Whole blood based controls
- Urine based controls
- Other controls
- Data Management Solutions
- Quality Assurance Services
Global IVD quality control market, by technology
- Clinical Chemistry
- Molecular Diagnostics
- Coagulation/ Hemostasis
- Other Technologies
Global IVD quality control market, by manufacturer type
- Third-party controls
- Independent controls
- Instrument specific controls
- Original Equipment Manufacturer controls
Global IVD quality control market, by end user
- Clinical Laboratories
- Academic and Research Institutes
- Other End users
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Why Buy this Report?
The purpose of Nova one advisor’s In Vitro Diagnostics (IVD) Quality Control market study is to provide stakeholders with a detailed picture of potential barriers and untapped opportunities. The report contains exclusive information to assist businesses in making informed decisions about how to maintain growth throughout the assessment period.
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