Global In Vitro Diagnostics (IVD) Quality Control Market Outlook 2030

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  • Published Date:
    21 Sep 2021
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    Healthcare & Pharmaceuticals
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Impact Analysis on the Growth of Market

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The Research Report is Updated with 2020 Base Year, 2021 Estimated year and Forecast till 2030 with Market Insights.

With the dip in global production, the GDP has contracted in 2020 and impacted the market across the world. Upon placing a Sample Request, you will receive an updated report with 2020 as base year, 2021 as estimated year and forecast to 2030. This will have market drivers, recovery rate in the market, insights and competitive analysis.

Market Overview:

" In 2021, the global in vitro diagnostics market is estimated to be worth ~USD 85 billion and is expected to grow at a compound annual growth rate (CAGR) of ~5% from 2022 to 2030. This increase can be attributed to the increasing adoption of in vitro diagnostics (IVD) due to the increase in testing due to the pandemic. The development of automated in vitro diagnostic systems for laboratories and hospitals to provide efficient, accurate and error-free diagnosis is expected to drive market growth. The increasing number of in vitro diagnostic products released by major players has also contributed to the lucrative growth rate of the market. 

 Globally, the elderly population is growing faster than the younger population. In many countries, the increase in the elderly population can be attributed to the decline in fertility and low birth rates. According to United Nations estimates, there were approximately 962 million people over the age of 60 in the world in 2017. In addition, the population of 80 years and over is expected to increase from 137 million in 2017 to 425 million in 2050. With age, the immune system is affected, increasing the susceptibility to various diseases. Therefore, the large elderly population needs better medical care, especially chronic diseases. 


The COVID-19 outbreak caused by SARS-CoV-2 is affecting millions of people worldwide. The outbreak of the pandemic prompted the diagnostic industry to take action, racing to develop new rapid diagnostic kits to detect the coronavirus. Most tests are approved under the emergency use authorization (EUA) of a federal agency. 

The main detection method used to detect COVID-19 uses RT-PCR technology. Although traditional testing takes 5 to 6 hours to obtain results, PoC testing has significantly shortened the duration. The prevalence of various diseases such as cancer, autoimmune diseases, and inflammation is increasing globally, which is expected to drive the demand for in vitro diagnostic tests. For example, according to the American Cancer Society, about 1.7 million new cancer cases were reported in 2018, and about 609,640 people died of cancer.



The reagent segment occupies a dominant position in the in vitro diagnostic market, with the largest revenue share in 2020, at 64%. The growth of this sector can be attributed to the growing demand for fast, accurate and sensitive equipment. In addition, its widespread use in in vitro diagnostic tests, increased demand for self-diagnostics and care products, and an increase in the number of reagent-related R&D programs are expected to contribute to market growth. 


In the automation of the diagnostic process and the connection of reagents and samples, they are called analytical instruments. Commercial robots and kits are used in polymerase chain reaction (PCR) laboratories to help detect and quantify infectious microorganisms, blood antigens, and viral load. In addition, the increasing use of these systems to develop new tests that can detect infectious diseases is expected to drive market growth. 


For example, in February 2020, Sherlock Biosciences collaborated with Cepheid to develop a new CRISPR-based molecular test that can be used on the GeneXpert platform. The service part includes program interfaces for operating diagnostic instruments, performing analysis, and interpreting results. In vitro diagnostic software is used in many devices, such as instant analyzers, laboratory analyzers, and portable personal in vitro diagnostic instruments. In addition, the increasing use of in vitro diagnostic systems with analyzer software in diagnostic centers is expected to drive market growth.



The infectious disease sector dominates the market, with the largest revenue share in 2020 at 40%. This is attributed to the increasing incidence of infectious diseases such as SARS-CoV-2, HIV, AIDS, tuberculosis and pneumonia. In addition, the increase in infectious disease detection analysis developed by market participants for in vitro diagnostics is expected to drive the development of this segment. For example, in December 2018, 12 new trials of Siemens Healthineers for viral hepatitis and other diseases received pre-market approval from the US FDA. 


These tests are used in the Atellica solution, which provides test options for the detection, diagnosis and monitoring of hepatitis C. Cancer is a chronic disease and one of the leading causes of death in the world. The most common types of cancer are colorectal cancer, prostate cancer, breast cancer and lung cancer. The increase in cancer prevalence is expected to accelerate the demand for in vitro diagnostic tests. 


According to data from the National Cancer Institute, an estimated 1,735,350 new cancer cases will be diagnosed in 2018, of which 609,640 people will die from the disease in the United States. . Stress is expected to increase the risk of cardiovascular disease. In addition, diabetes can cause heart disease, leading to an increased demand for in vitro diagnostics in cardiology. The introduction of PoC devices for rapid and on-site diagnosis, especially in emergency situations, is expected to drive market development.



The hospital sector dominates the market and will have the largest revenue share in 2020 at 41%. This is due to the increase in the number of hospitalizations, as doctors need diagnosis and interpretation for additional treatment. Usually, the diagnostic center operates in cooperation with the hospital; therefore, the hospital has its own diagnostic settings. In addition, the continued development of medical infrastructure is expected to improve existing hospital facilities. 


Therefore, the demand for in vitro diagnostic tests in hospitals is increasing. Home care refers to supportive care or patient self-care provided by licensed healthcare professionals at home. Self-care equipment accounts for most of the home care field. It is more convenient and reduces the number of visits. Due to the increase in the elderly population and the increasing demand for in vitro diagnostic equipment for nursing care, the home care sector is expected to experience the fastest growth at a CAGR of 6% during the forecast period. 


Environment, laboratories, outpatient care services, schools and academic institutions, especially in emergencies and research institutions. These health institutions mainly conduct POC tests to monitor or detect diseases. The high adoption of these tests by the aforementioned organizations is expected to drive market growth due to lower costs and rapid results.



The immunoanalysis field dominates the market, accounting for the largest revenue share in 2020, at 29%. Since it is used to detect infectious microorganisms, such as fungi, it is expected to grow at a profitable rate in the next few years. bacterial. And viruses, by detecting their toxins. The increasing prevalence of chronic diseases (such as HIV) and the introduction of more precise instruments can be attributed to a larger market share.


 Clinical chemistry is the practical application of biochemistry, used to analyze body fluids for diagnosis and treatment purposes. Serum, plasma, and urine are the most commonly analyzed samples in pathology. The increasing use of approved blood gas analyzers to monitor respiratory conditions is expected to drive the growth of the in vitro diagnostics market. For example, in March 2020, Siemens Healthineers AG Rapidpoint 500e blood gas analyzer was approved by the US FDA, and the analyzer received the CE-IVD mark in August 2019. The microbiology field includes testing and analysis used to identify infectious microorganisms. It is expected that organizations will increase the use of fast and cost-effective diagnostic techniques to help combat antibiotic resistance and improve patient outcomes, which will drive market growth. For example, in April 2019, the University of Antwerp, Wellcome Trust and BioMérieux jointly launched Value-Dx, an Innovative Medicines Initiative (IMI) project initiated by six in vitro diagnostic companies to combat antibiotic resistance Sex.



North America has the largest revenue share in the IVD market in 2020, at 40%, and is expected to continue to dominate during the forecast period. This is due to the local presence of major market participants. In addition, the increasing prevalence of diseases and increased consumer awareness are driving the demand for improved diagnostic equipment. 


In the Asia-Pacific region, the market is expected to grow the fastest during the forecast period, with a compound annual growth rate of 6%. The Asia-Pacific region is composed of developing economies and advanced economies. It is expected that the increased awareness of healthcare in the region and the increase in patients seeking early diagnosis, as well as the high prevalence of chronic diseases, are expected to drive the development of the market.



The IVD market is price-sensitive, so participants have entered fierce competition in manufacturing profitable and efficient products. These companies are participating in acquisitions, partnerships, and mergers to strengthen their manufacturing capabilities, product portfolios, and provide competitive differentiation. In addition, the company is focusing on obtaining market approval for innovative products to diagnose different infectious diseases. For example, in 2019, Abbott&;s m-PIMA HIV-1/2 VL (a PoC virus diagnostic test) received pre qualification approval from the WHO. This product obtained CE mark approval in December 2018. Due to the difficulty of meeting high capital requirements, the presence of prominent participants in this market space significantly reduces the opportunities for new entrants to enter the market. Some of the major players in the IVD market include: Abbott DanaherbioMérieux SA Bio-Rad Laboratories, Inc. Becton, Dickinson and Company Siemens Healthineers QIAGEN Quidel CorporationF. Hoffmann-La Roche AG Sysmex Corporation Charles River Laboratories International, Inc. Search and Diagnostics Agilent Technologies



The report forecasts global, regional, and national revenue growth, and analyzes the latest industry trends in each sub-segment from 2022-2030. For the purpose of this research, Kenneth Research will report on the global IVD market based on products, technologies, applications, end-uses, and regions: Product Outlook (Revenue, USD million, 2022-2030) Reactive Instruments Services Insights Technology (Revenue, $ million, 2022-2030) ImmunoassayI nstruments Reagents Services Hematology Instruments Reagents Services Clinical Chemistry Instruments Reagents Services Outlook Clinical Chemistry Instruments Reagents Services Coagulation Instruments Reagents Services Microbiology Instruments, Outlook 2022-2030, Infections Reagents Services, Coagulation Instruments Reagents, Outlook Services Microbiology Instruments, Reagents, Outlook, Servicesnciology, Reagents, Outlook, Servicesnciology, revenues, revenues, OutlookInstrumentsInc hrology autoimmune disease drug testing other end use Outlook (income , USD million, 2022-2030) Hospital laboratory home care other. "

Geography Analysis:

The report further discusses the market opportunity, compound annual growth rate (CAGR) growth rate, competition, new technology innovations, market players analysis, government guidelines, export and import (EXIM) analysis, historical revenues, future forecasts etc. in the following regions and/or countries:

  • North America (U.S. & Canada) Market Size, Y-O-Y Growth, Market Players Analysis & Opportunity Outlook
  • Latin America (Brazil, Mexico, Argentina, Rest of Latin America) Market Size, Y-O-Y Growth & Market Players Analysis & Opportunity Outlook
  • Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC(Finland, Sweden, Norway, Denmark), Ireland, Switzerland, Austria, Poland, Turkey, Russia, Rest of Europe), Poland, Turkey, Russia, Rest of Europe) Market Size, Y-O-Y Growth Market Players Analys  & Opportunity Outlook
  • Asia-Pacific (China, India, Japan, South Korea, Singapore, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific) Market Size, Y-O-Y Growth & Market Players Analysis & Opportunity Outlook
  • Middle East and Africa  (Israel, GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, Rest of Middle East and Africa) Market Size, Y-O-Y Growth Market Players Analysis & Opportunity Outlook


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Bio-Rad Laboratories, Inc., Abbott Laboratories Inc., Thermo Fisher Scientific Inc., Helena Laboratories, Ortho Clinical Diagnostics, SERO AS, Siemens Healthineers, Sun Diagnostics and Roche Diagnostics

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