Industries Study Report: In Vitro Diagnostics and IVD Quality Control Industry

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What Are the Key Trends Shaping the In Vitro Diagnostics and IVD Quality Control Industry?

In Vitro Diagnostics And IVD Quality Control Industry Data Book - In Vitro Diagnostics & IVD Quality Control Market Size, Share, Trends Analysis, And Segment Forecasts, 2022 - 2030

The global In Vitro Diagnostics and IVD Quality Control Industry was estimated at USD 112.79 Billion in 2021 and is anticipated to increase at a significant CAGR of 0.2% from 2022 to 2030.

Grand View Research’s In Vitro Diagnostics and IVD quality control industry data book is a collection of market sizing & forecasts insights, regulatory & technology framework, pricing intelligence, volumetric analyses, competitive benchmarking analyses, macro-environmental analyses studies. Within the purview of the database, such information is systematically analyzed and provided in the form of summary presentations and detailed outlook reports on individual areas of research.

In Vitro Diagnostics Market Insights

The global in vitro diagnostics (IVD) market size was estimated at USD 111.67 Billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 0.2% from 2022 to 2030. The growth can be attributed to increasing adoption of IVD owing to a rise in the incidence of infectious and chronic diseases. The development of automated IVD systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnoses is expected to fuel market growth. The rising number of IVD products being launched by key players is also fueling market growth. For instance, in November 2023, ARUP Laboratories received a CE mark from EU-IVDR for AAV5 DetectCDx, a companion diagnostic to select the eligibility of severe hemophilia A-affected patients for BioMarin’s new gene therapy, Roctavian.

Favorable initiatives undertaken by government and non-government bodies to improve overall healthcare services are anticipated to increase market growth. In October 2023, the WHO published the Essential Diagnostics List (EDL), a comprehensive list of IVD products that helps countries make decisions regarding diagnostic tools. It provides evidence-based recommendations and ensures the accessibility of essential products for target people. Moreover, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to increase access to diagnostic tests across Africa. Such initiatives are expected to boost market growth.

A rise in the geriatric population and growth in knowledge regarding early testing have led to a surge in the number of regular check-ups, as a majority of deaths due to infections and chronic conditions occur in the population aged over 75 years. As per the Office for Budget Responsibility, UK, healthcare costs have risen exponentially, which can create economic pressure on nations with rapidly growing geriatric population. However, this expenditure is anticipated to translate positively for the IVD industry, driving market growth.

In Vitro Diagnostics Market-Number of Tests Performed, by Country, 2021 (%)

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IVD Quality Control Market Insights

The global in vitro diagnostics quality control market size was estimated at USD 1.12 Billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 2.0% from 2022 to 2030. An increasing number of accredited clinical laboratories worldwide and the presence of favorable regulatory bodies are expected to be the key factors driving the market growth. Due to the high prevalence rate of diseases, such as diabetes, cardiovascular diseases, and infectious diseases, diagnostic laboratories have gained demand. Many private as well as public laboratories are undergoing laboratory accreditation procedures to meet industry standards, improve their procedural volume, and attract more patients. Laboratories accredited by CLIA are eligible for reimbursement through Medicare and Medicaid Services.

The regulatory bodies monitoring quality control and regular quality check of in vitro diagnostics (IVD) devices and service providers include FDA for U.S.; Medicines and Healthcare Products Regulatory Agency (MHRA) for the UK; Therapeutic Goods Administration (TGA) for Australia; Central Drug Standard Control Organization (CDSCO) for India; Health Canada for Canada; European Medicines Agency (EMEA) for Europe; Ministry of Health, Labor & Welfare(MHLW) for Japan; Ministry of Health, Labor & Welfare (MHLW) for Brazil; and Ministry of Health for South Africa.

Moreover, Global Harmonization Task Force (GHTF) regulatory authorities, such as the U.S. FDA, are encouraging convergence of regulatory systems for medical devices, which is anticipated to encourage trade, while protecting public health through regulatory means. The American Clinical Laboratory Association states that more than 7.5 billion lab tests are performed in the U.S. annually and 80% of clinical decisions are taken after laboratory testing. According to the WHO, an estimated 537 million adults aged 20–79 years are suffering from diabetes. This represented 10.5% of the world’s population in this age group in 2021.

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In Vitro Diagnostics and IVD Quality Control Industry Data Book Competitive Landscape

Companies are focusing on expansions, development of innovative medical devices, and technological advances. Moreover, mergers and acquisitions for novel product development constitute some of the other strategic initiatives implemented by key players.

Key players operating in the In Vitro Diagnostics and IVD Quality Control Industry are:

Una Health Ltd.
Diachel Diagnostics S.A.
BHR Diagnostics Pvt. Ltd.
MD Doctors Direct GmbH
Axon Lab AG

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Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

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Analyzing the Impact of Recent Mergers and Deals in the In Vitro Diagnostics and IVD Quality Control Industry

In Vitro Diagnostics and IVD Quality Control Industry Data Book - In Vitro Diagnostics & IVD Quality Control Market Size, Share, Trends Analysis, And Segment Forecasts, 2022 - 2030

The global In Vitro Diagnostics and IVD Quality Control Industry was estimated at USD 112.79 Billion in 2021 and is anticipated to increase at a significant CAGR of 0.2% from 2022 to 2030.

Access the Global In Vitro Diagnostics And IVD Quality Control Industry Data Book, 2023 to 2030, compiled with details like market sizing information & forecasts, trade data, pricing intelligence, competitive benchmarking, macro-environmental analyses, and regulatory & technological framework studies

In Vitro Diagnostics Market Growth & Trends

The global in vitro diagnostics market size is expected to reach USD 101.58 billion by 2030, according to a new report by Grand View Research, Inc. It is estimated to register a CAGR of 0.2% over the forecast period driven by the increasing geriatric population, COVID-19 pandemic, and technological advancements in diagnostics that are supporting its adoption. Technological advancements in terms of portability, accuracy, and cost-effectiveness are projected to be one of the high-impact rendering drivers. Technological advancements were further accelerated by the launch of COVID-19 IVD diagnostics and enhanced the adoption of instruments and consumables for technologies, such as PCR. Competitors in the market are increasingly adopting agreement and partnership strategies to maintain a constant flow of business for manufacturers & diagnostics for users.

These agreements are also a result of the harsh price containment strategies for government laboratories, which lowers the price in government settings. For instance, in April 2021, the Italian subsidiary of Seegene, Inc. received a USD 108.25 million tenders for public procurement for the supply of extraction reagents, as well as 7.15 million SARS-CoV-2 diagnostic tests. However, it increases the multiparty nature and complexity of the supply chain. The high prevalence of cancer and Cardiovascular Diseases (CVDs) globally is anticipated to drive diagnostic innovation to facilitate early diagnosis and meet the constantly evolving needs of consumers. Novel technologies, such as plasmonic PCR, are anticipated to commercially enter the market during the forecast period, influencing the business of existing products adversely.

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IVD Quality Control Market Growth & Trends

The global in vitro diagnostics quality control market size is expected to reach USD 1.39 billion by 2030, registering a CAGR of 2.0% over the forecast period, according to a new report by Grand View Research, Inc. The continually evolving technology-oriented changes in the diagnostics field and the growing requirement to ensure patient safety necessitate the execution of quality assurance programs in several medical domains including point-of-care devices and radiology.The patients rely on self-testing in vitro diagnostics (IVD) devices for long-term disease management and hence it is important for such IVD devices to be checked for quality in terms of result reproducibility and validity to guarantee patient safety.

The rising number of certified clinical laboratories offering dependable IVD-based diagnostic services directly correlates with increased patient confidence, thus driving market growth. 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. lambardia, C. parvum (diarrheal diseases), and Leishmaniaspp (Leishmaniasis).In addition to assessments, amendments to the regulatory framework are made intermittently to enhance the present standards with the main objective of safeguarding the qualitative superiority of the diagnostic services rendered to patients.

Quality control in the laboratory is focused on ensuring that the results delivered to the patient are accurate. Control checks are usually undertaken while installing an instrument, after servicing, changing reagent lots, and when the instrument readings are not in range.Home care settings include a variety of devices, such as point-of-care (PoC) instruments used for near-patient bed testing, self-testing kits, and IVD devices in assisted healthcare settings. Self-testing kits giveease of convenience for patients who require everyday testing and further reduce hospital visits.

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Competitive Landscape

Key players operating in the In Vitro Diagnostics and IVD Quality Control industry are:

Quidel Corporation
Sysmex Corporation
Charles River Laboratories
Quest Diagnostics
Agilent Technologies

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Technological Advancements drives In Vitro Diagnostics and IVD Quality Control Industry

In Vitro Diagnostics and IVD Quality Control Industry Data Book - In Vitro Diagnostics & IVD Quality Control Market Size, Share, Trends Analysis, And Segment Forecasts, 2022 - 2030

Access the Global In Vitro Diagnostics and IVD Quality Control Industry Data Book, 2023 to 2030, compiled with details like trade data, pricing intelligence, and competitive benchmarking.

In Vitro Diagnostics Market Report Highlights

The global In Vitro Diagnostics Market size was estimated USD 111.67 Billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 0.2% from 2022 to 2030.

Molecular diagnostics is anticipated to grow at the fastest CAGR from 2023 to 2030 owing to the rising adoption and usage rate
Reagents held the largest market share owing to the surge in demand for genetic testing and enhanced availability of technologically advanced diagnostic tests in lower and middle-income countries with unmet clinical needs
The infectious diseases application segment held the largest market share owing to the large volume of testing for infectious diseases globally
North America dominated the global market in 2022 owing to the high demand for novel technologies, a large pool of key players, high prevalence of diseases, and advanced healthcare infrastructure

Order your copy of Free Sample of “In Vitro Diagnostics and IVD Quality Control Industry Data Book - In Vitro Diagnostics & IVD Quality Control Market Size, Share, Trends Analysis, And Segment Forecasts, 2022 - 2030” Data Book, published by Grand View Research

IVD Quality Control Market Size (USD Million), 2021 & 2030, and Market Attributes

IVD Quality Control Market Report Highlights

The global IVD Quality Control Market size was estimated at USD 1.12 Billion in 2021 and is anticipated to grow at a compound annual growth rate (CAGR) of 2.0% from 2022 to 2030.

In 2022, the clinical chemistry segment held the largest share of the market. The increasing demand for preventive medicine and the rapid transformation of clinical laboratories into highly automated and efficient businesses are some of the factors responsible for its high market share
The quality control segment dominated the market in 2022 and is estimated to grow at the highest CAGR over the forecast period. Quality control in the research laboratory is concentrated on certifying the results provided to the individuals are precise
The hospital segment held the largest share in 2022 due to the presence of highly advanced technology-based devices, such as Next Generation Sequencing (NGS), mass spectrophotometry, and microarrays, and the rising applications of the optimized quality-control procedures
North America was a major revenue contributor in the global market in 2022 due to the presence of over 150,000 registered diagnostics laboratories. The clinical laboratories are required to provide accurate results and maintain the accuracy standards to retain their license to operate
Many pharmaceutical companies are implementing the new draft guidance enforced by the U.S. FDA for data integrity on current Good Manufacturing Practices (cGMP)
It provides information in relation to establishing robust operating procedures and strong management systems, obtaining high-quality raw materials, investigating deviations, and maintaining reliable diagnostic laboratories

Go through the table of content of In Vitro Diagnostics and IVD Quality Control Industry Data Book to get a better understanding of the Coverage and Scope of the study

Competitive Landscape

Market participants are updating their range of testing options for qPCR instruments by undertaking R&D initiatives for the development of kits that target emerging diseases or by entering into agreements with other kit manufacturing companies.

Key players operating in the In Vitro Diagnostics and IVD Quality Control industry are:

Abbott
bioMérieux
Bio-Rad Laboratories
Becton, Dickinson and Company
Siemens Healthineers
Qiagen

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What Are the Key Trends Shaping the In Vitro Diagnostics and IVD Quality Control Industry?

Analyzing the Impact of Recent Mergers and Deals in the In Vitro Diagnostics and IVD Quality Control Industry

Technological Advancements drives In Vitro Diagnostics and IVD Quality Control Industry

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