Molecular Quality Control Market: Information by Product (Independent and Instrument-Specific Control), Analyte (Single-Analyte and Multi-Analyte Control), and Region — Forecast till 2029

Apr 28, 2020   Market Overview Molecular quality control focuses on testing and reporting of irregularities in molecular diagnostic products, which influences the decision on whether to approve the product for laboratory use. From the last few years, the adoption of molecular diagnostics quality control testing procedures has been on the rise, especially for tests used in the diagnosis of infectious diseases. This can be attributed to the availability of quality control materials, rising clearance from regula...
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Report Description

Market Overview

Molecular quality control focuses on testing and reporting of irregularities in molecular diagnostic products, which influences the decision on whether to approve the product for laboratory use. From the last few years, the adoption of molecular diagnostics quality control testing procedures has been on the rise, especially for tests used in the diagnosis of infectious diseases. This can be attributed to the availability of quality control materials, rising clearance from regulatory agencies, published quality control protocols, and possible quantitative estimation with a limited number of analytes. Moreover, specialty quality controls are available for some of the multiplex tests, such as the cystic fibrosis test.

The global Molecular Quality Control market is expected to grow from the U.S.D 136 million in 2019 to the U.S.D 256 million by 2029, at a CAGR of 10.5% during the forecast period 2020-2029.

Molecular-Quality-Control-Market

Market Drivers

Third-Part Agencies Facilitating Independent Assessment to Drive the Market Growth 

The existence of third-party agencies for an independent assessment of the molecular diagnostic devices and laboratory services is expected to raise the current quality standards along with the adoption rate of molecular quality control, which is anticipated to drive the molecular quality control market demand. Third-party quality control service provider, such as Bio-Rad and Randox, entered into a collaboration with hospitals and various molecular diagnostic laboratories for providing resources required for QC services. The American Clinical Laboratory Association (ACLA) reported that more than 7.5 billion molecular diagnostic laboratory tests are performed in the U.S. every year, whereas 80% of clinical decisions are taken based on these laboratory testing.

The Increasing Number of Accredited Clinical Laboratories

Clinical laboratories have proved to be one of the most fundamental units in the healthcare sector’s current value chain. Clinical laboratory tests have not only helped in the identification of disease but also to further monitor the potency of treatment. Clinical laboratories across the world are, nowadays, seeking to become accredited nationally and internationally, primarily to assure more reliable and better laboratory services. Molecular diagnostic laboratories perform more complex tests and are subject to a higher level of regulatory oversight and must adhere to stringent regulatory requirements. Enactment of the Clinical Laboratory Improvement Amendments (CLIA) was the most significant factor overhauling the general regulatory structure of the laboratory industry in the United States. This has led to an increasing number of accredited clinical laboratories that perform molecular diagnostics testing, boosting the demand for molecular quality control systems.

Segment Overview

Cost-Effective and Easy-Detection Feature of Single-Analyte Quality Controls

Single-analyte quality controls have been used extensively in the market, owing to its cost advantage feature and easier detection of molecular changes in specific cell types. For instance, the introduction of a single-cell analysis tool, Rhapsody single-cell analysis system by Becton Dickinson, has enabled the assessment of a significant number of genes across ten thousands of single cells in parallel.

Qualitative and Quantitative Detection Ability of Multi-Analyte Quality Controls 

The multi-analyte quality controls segment is expected to grow at a fast pace due to the cost-effectiveness and time-saving feature for molecular quality control procedures. The multi-analyte testing platform also allows simultaneous quantitative or qualitative detection of a wide range of analytes from a single patient sample. It can screen biological samples expeditiously, accurately, and in an easy-to-use fashion. Randox Laboratories has developed a Biochip array technology (BAT) multi-analyte control system in 2018 and invested around the U.S.D 200 million on research and development of BAT. It comprised of an instrument platform and assay cartridges designed to detect a broad range of pathogens and molecular material in the sample. 

The Clinical Laboratory Segment to Hold the Largest Share Among Other End-Users 

By the end-user, the clinical laboratory segment holds the largest market share on account of the high requirement of molecular quality control, rising adoption of QC techniques, growing incidences of regulatory actions, and increasing expenditure on molecular diagnosis. Centers for Medicare & Medicaid Services have introduced Clinical Laboratory Improvement Amendments (CLIA), which has played a key role in bolstering the adoption rate of Molecular Quality Control procedures in clinical laboratories.

Intensive Research Activities Across Pertaining to Molecular Quality Control

The academic and research Institutes segment holds a significant market share, owing to large scale research activities underway across academic and research institutes. For instance, in 2018, Thermo Fisher Scientific partnered with Sichuan University in China to establish training centers for standardized pathology quality control, standardized pathological diagnosticians, and advanced laboratories.

Impact of COVID-19

The increasing volume of testing for COVID-19 is expected to spur the molecular quality control demand, especially if clinical testing goes beyond symptomatic patients. As the disease continues for a longer duration, the U.S. FDA has made molecular diagnostic tests available under an emergency use authorization (EUA), owing to accuracy and faster development time of molecular testing than serological tests. Roche and Thermo Fisher Scientific are among the molecular diagnostic vendors that have received EUAs for testing COVID-19 as these players have their quality control systems available.

Regional Overview

Geographically, the Molecular Quality Control market is segmented by North America, Europe, Asia-Pacific, South America, and the Middle East and Africa.

Molecular-Quality-Control-Market-Growth

The U.S and Canada’s Robust Health Infrastructure

North America leads the Molecular Quality Control market due to the well-established healthcare infrastructure both in the U.S and Canada, easy accessibility to technologically advanced diagnostic products, and the presence of a slew of leading molecular quality control products manufacturers. The high adoption rate of advanced technology, the burgeoning diagnostic centers, and accredited clinical laboratories are factors that are expected to fuel the regional market growth.

Alarming Rate of HIV Patients in the U.S.

In North America, the United States holds the largest market share due to increased patient pool suffering from cancer, genetic disorders, and infectious diseases. As per the 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. Besides, close to 38,000 new HIV infections occur in the United States each year, resulting in a rapid spread of various infectious diseases.

A Slew of Key Market Players Across the U.S.

The strong presence of key market players in the U.S. such as SeraCare Life Sciences Inc. (the U.S.), ZeptoMetrix Corporation (the U.S.), Bio-Rad Laboratories Inc. (the U.S.), Microbiologics Inc. (the U.S.), and Thermo Fisher Scientific (the U.S.), Maine Molecular Quality Control Inc. (the U.S.), Abbott Laboratories (the U.S.), Roche Diagnostics (Switzerland), Quidel Corporation (the U.S.) is expected to drive the market growth.

Asia-Pacific’s Awareness Regarding Early and Precise Diagnosis of Diseases

Asia-Pacific is expected to emerge as the fastest-growing region in terms of market share for the global Molecular Quality Control market. The growth can be attributed to the high demand for the accurate and high-quality diagnostics tests, rise in awareness for early and precise diagnosis of various diseases such as diabetes, cancer, and genetic diseases, and presence of key regulatory agencies across Asia-Pacific regions and their efforts to promote quality control systems in molecular diagnosis.

Substantial R&D Investment in China and Japan Drives the Asia-Pacific Market Growth

In 2018, China and Japan collectively accounted for about two-thirds of the Asia-Pacific molecular diagnostic market, and the growth is primarily attributed to substantial R&D investments by companies and the increased adoption of innovative molecular diagnosis techniques. Australia and India are foreseen to emerge as lucrative marketplaces on account of the growing awareness pertaining to the chronic diseases and increasing disposable income of these economies.

Competitive Landscape

The global molecular quality control market is moderately competitive and consists of several major players. Some of the market players are engaged in expanding their market position by adopting various strategies such as acquisitions and mergers, collaborations, and partnerships. In contrast, some are involved in launching new products to maintain their market share. In April 2019, Bruker Corporation, an American manufacturer of molecular research products, expanded its portfolio for infectious disease quality 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.

In February 2018, Qnostics, a U.K.-based molecular quality control company, entered into a partnership with Randox research institute to use for research and distribute Qnostics’ molecular quality control of products, which has strengthened the Qnostics’ market penetration.

In November 2017, Bio-Rad laboratories launched Amplichek STI, a Multi-analyte Quality Control for use with nucleic acid assays detecting common pathogens causing sexually transmitted infections (STI).

Some of the dominating market players are Bio-Rad Laboratories Inc., Maine Molecular Quality Control Inc., Microbiologics Inc., Thermo Fisher Scientific, ZeptoMetrix Corporation, SeraCare Life Sciences Inc., Abbott Laboratories, Roche Diagnostics, Quidel Corporation, and Qnostics Ltd.

Molecular Quality Control Market Segmentation

By Product

  • Independent Controls
  • Instrument-specific Controls
    • PCR
    • DNA Sequencing & NGS
    • Other Technologies 

By Analyte Type

  • Single-Analyte Controls
  • Multi-Analyte Controls

By Application

  • Infectious Diseases
  • Oncology
  • Genetic Testing
  • Others

By End-User

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

Market Overview

Molecular quality control focuses on testing and reporting of irregularities in molecular diagnostic products, which influences the decision on whether to approve the product for laboratory use. From the last few years, the adoption of molecular diagnostics quality control testing procedures has been on the rise, especially for tests used in the diagnosis of infectious diseases. This can be attributed to the availability of quality control materials, rising clearance from regulatory agencies, published quality control protocols, and possible quantitative estimation with a limited number of analytes. Moreover, specialty quality controls are available for some of the multiplex tests, such as the cystic fibrosis test.

The global Molecular Quality Control market is expected to grow from the U.S.D 136 million in 2019 to the U.S.D 256 million by 2029, at a CAGR of 10.5% during the forecast period 2020-2029.

Molecular-Quality-Control-Market

Market Drivers

Third-Part Agencies Facilitating Independent Assessment to Drive the Market Growth 

The existence of third-party agencies for an independent assessment of the molecular diagnostic devices and laboratory services is expected to raise the current quality standards along with the adoption rate of molecular quality control, which is anticipated to drive the molecular quality control market demand. Third-party quality control service provider, such as Bio-Rad and Randox, entered into a collaboration with hospitals and various molecular diagnostic laboratories for providing resources required for QC services. The American Clinical Laboratory Association (ACLA) reported that more than 7.5 billion molecular diagnostic laboratory tests are performed in the U.S. every year, whereas 80% of clinical decisions are taken based on these laboratory testing.

The Increasing Number of Accredited Clinical Laboratories

Clinical laboratories have proved to be one of the most fundamental units in the healthcare sector’s current value chain. Clinical laboratory tests have not only helped in the identification of disease but also to further monitor the potency of treatment. Clinical laboratories across the world are, nowadays, seeking to become accredited nationally and internationally, primarily to assure more reliable and better laboratory services. Molecular diagnostic laboratories perform more complex tests and are subject to a higher level of regulatory oversight and must adhere to stringent regulatory requirements. Enactment of the Clinical Laboratory Improvement Amendments (CLIA) was the most significant factor overhauling the general regulatory structure of the laboratory industry in the United States. This has led to an increasing number of accredited clinical laboratories that perform molecular diagnostics testing, boosting the demand for molecular quality control systems.

Segment Overview

Cost-Effective and Easy-Detection Feature of Single-Analyte Quality Controls

Single-analyte quality controls have been used extensively in the market, owing to its cost advantage feature and easier detection of molecular changes in specific cell types. For instance, the introduction of a single-cell analysis tool, Rhapsody single-cell analysis system by Becton Dickinson, has enabled the assessment of a significant number of genes across ten thousands of single cells in parallel.

Qualitative and Quantitative Detection Ability of Multi-Analyte Quality Controls 

The multi-analyte quality controls segment is expected to grow at a fast pace due to the cost-effectiveness and time-saving feature for molecular quality control procedures. The multi-analyte testing platform also allows simultaneous quantitative or qualitative detection of a wide range of analytes from a single patient sample. It can screen biological samples expeditiously, accurately, and in an easy-to-use fashion. Randox Laboratories has developed a Biochip array technology (BAT) multi-analyte control system in 2018 and invested around the U.S.D 200 million on research and development of BAT. It comprised of an instrument platform and assay cartridges designed to detect a broad range of pathogens and molecular material in the sample. 

The Clinical Laboratory Segment to Hold the Largest Share Among Other End-Users 

By the end-user, the clinical laboratory segment holds the largest market share on account of the high requirement of molecular quality control, rising adoption of QC techniques, growing incidences of regulatory actions, and increasing expenditure on molecular diagnosis. Centers for Medicare & Medicaid Services have introduced Clinical Laboratory Improvement Amendments (CLIA), which has played a key role in bolstering the adoption rate of Molecular Quality Control procedures in clinical laboratories.

Intensive Research Activities Across Pertaining to Molecular Quality Control

The academic and research Institutes segment holds a significant market share, owing to large scale research activities underway across academic and research institutes. For instance, in 2018, Thermo Fisher Scientific partnered with Sichuan University in China to establish training centers for standardized pathology quality control, standardized pathological diagnosticians, and advanced laboratories.

Impact of COVID-19

The increasing volume of testing for COVID-19 is expected to spur the molecular quality control demand, especially if clinical testing goes beyond symptomatic patients. As the disease continues for a longer duration, the U.S. FDA has made molecular diagnostic tests available under an emergency use authorization (EUA), owing to accuracy and faster development time of molecular testing than serological tests. Roche and Thermo Fisher Scientific are among the molecular diagnostic vendors that have received EUAs for testing COVID-19 as these players have their quality control systems available.

Regional Overview

Geographically, the Molecular Quality Control market is segmented by North America, Europe, Asia-Pacific, South America, and the Middle East and Africa.

Molecular-Quality-Control-Market-Growth

The U.S and Canada’s Robust Health Infrastructure

North America leads the Molecular Quality Control market due to the well-established healthcare infrastructure both in the U.S and Canada, easy accessibility to technologically advanced diagnostic products, and the presence of a slew of leading molecular quality control products manufacturers. The high adoption rate of advanced technology, the burgeoning diagnostic centers, and accredited clinical laboratories are factors that are expected to fuel the regional market growth.

Alarming Rate of HIV Patients in the U.S.

In North America, the United States holds the largest market share due to increased patient pool suffering from cancer, genetic disorders, and infectious diseases. As per the 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. Besides, close to 38,000 new HIV infections occur in the United States each year, resulting in a rapid spread of various infectious diseases.

A Slew of Key Market Players Across the U.S.

The strong presence of key market players in the U.S. such as SeraCare Life Sciences Inc. (the U.S.), ZeptoMetrix Corporation (the U.S.), Bio-Rad Laboratories Inc. (the U.S.), Microbiologics Inc. (the U.S.), and Thermo Fisher Scientific (the U.S.), Maine Molecular Quality Control Inc. (the U.S.), Abbott Laboratories (the U.S.), Roche Diagnostics (Switzerland), Quidel Corporation (the U.S.) is expected to drive the market growth.

Asia-Pacific’s Awareness Regarding Early and Precise Diagnosis of Diseases

Asia-Pacific is expected to emerge as the fastest-growing region in terms of market share for the global Molecular Quality Control market. The growth can be attributed to the high demand for the accurate and high-quality diagnostics tests, rise in awareness for early and precise diagnosis of various diseases such as diabetes, cancer, and genetic diseases, and presence of key regulatory agencies across Asia-Pacific regions and their efforts to promote quality control systems in molecular diagnosis.

Substantial R&D Investment in China and Japan Drives the Asia-Pacific Market Growth

In 2018, China and Japan collectively accounted for about two-thirds of the Asia-Pacific molecular diagnostic market, and the growth is primarily attributed to substantial R&D investments by companies and the increased adoption of innovative molecular diagnosis techniques. Australia and India are foreseen to emerge as lucrative marketplaces on account of the growing awareness pertaining to the chronic diseases and increasing disposable income of these economies.

Competitive Landscape

The global molecular quality control market is moderately competitive and consists of several major players. Some of the market players are engaged in expanding their market position by adopting various strategies such as acquisitions and mergers, collaborations, and partnerships. In contrast, some are involved in launching new products to maintain their market share. In April 2019, Bruker Corporation, an American manufacturer of molecular research products, expanded its portfolio for infectious disease quality 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.

In February 2018, Qnostics, a U.K.-based molecular quality control company, entered into a partnership with Randox research institute to use for research and distribute Qnostics’ molecular quality control of products, which has strengthened the Qnostics’ market penetration.

In November 2017, Bio-Rad laboratories launched Amplichek STI, a Multi-analyte Quality Control for use with nucleic acid assays detecting common pathogens causing sexually transmitted infections (STI).

Some of the dominating market players are Bio-Rad Laboratories Inc., Maine Molecular Quality Control Inc., Microbiologics Inc., Thermo Fisher Scientific, ZeptoMetrix Corporation, SeraCare Life Sciences Inc., Abbott Laboratories, Roche Diagnostics, Quidel Corporation, and Qnostics Ltd.

Molecular Quality Control Market Segmentation

By Product

  • Independent Controls
  • Instrument-specific Controls
    • PCR
    • DNA Sequencing & NGS
    • Other Technologies 

By Analyte Type

  • Single-Analyte Controls
  • Multi-Analyte Controls

By Application

  • Infectious Diseases
  • Oncology
  • Genetic Testing
  • Others

By End-User

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