The In-Vitro Diagnostics (IVD) quality control market studied was anticipated to grow with a CAGR of nearly 3.5% during the forecast period. The major factors attributing to the growth of the market are a rise in the global prevalence of infectious diseases, HIV, and the cancers which necessitate novel diagnostic methods for efficient treatment and quality controls to monitor their performance. For instance, according to the Joint United Nations Programme on HIV and AIDS (UNAIDS), in 2019, 24.5 million people with HIV were accessing antiretroviral therapy globally. Additionally, increased participation of the government to control the outbreaks of infectious diseases and a rise in the 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.

Key Market Trends


Immunochemistry segment in the Application is Expected to Hold the Largest Market Share in the In Vitro Diagnostics Quality Controls Market

  • Immunochemistry diagnostics are anticipated to hold the largest market share in the IVD quality controls market due to their importance in identifying the molecular mechanism of various antigens, antibodies, and their interactions that impact the immune system. The increased demand for the segment is owing to a rise in the prevalence of various autoimmune disorders, infections, communicable and chronic diseases among all the age groups in recent years necessitating earlier diagnosis with more accuracy and precision for better treatment are fueling the growth of the market.
  • On the other hand, the molecular diagnostics segment is anticipated to witness the highest CAGR over the forecast period due to a rise in the adoption of advanced technologies such as Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS). Furthermore, an increased application of molecular diagnostics in the diagnosis of cancers with a rising global prevalence of cancer, increasing research on cancer biomarkers, advanced diagnosis infrastructure and other applications in detecting multiplex PCR, HIV, respiratory tract infections and genital infections propelling the global market revenue.



North America Dominates the Market and Expected to do Same in the Forecast Period.

North America is expected to dominate the overall In Vitro Diagnostics quality controls market, throughout the forecast period. The high adoption rate of advanced infrastructure, increased number of diagnostic centers and accredited clinical laboratories are factors estimated to fuel the market in the region. In North America, the United States holds the largest market share due to increased patient pool. For instance, as per U.S. Department of Health & Human Services report published in 2020, about 37,832 people in the U.S. were diagnosed with HIV in 2018 and 38,000 new HIV infections still occur in the United States and 6 dependent areas each year which results in rapid spread of various infectious diseases such as meningitis, urinary tract infections fueling the market contributing its outstanding share of the global market revenue during the forecast period.

Competitive Landscape


The In Vitro diagnostics quality controls market is moderately competitive and consists of several major players. Some of the companies are expanding their market position by adopting various strategies such as acquisitions and mergers, while others are developing new methods for the treatment and introducing new products to maintain their market share. For instance, in April 2019, Bruker expanded its portfolio for microbial identification, infection control, and molecular diagnostics of infectious diseases by introducing new assays, software and library extensions for its MALDI Biotyper, IR Biotyper, and Fluorocycler XT product lines which is expected to have a positive impact on the market. Some of the companies which are currently dominating the market are Bio-Rad Laboratories Inc F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc, bioMerieux Inc and ZeptoMetrix Corporation.

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