Molecular Quality Controls Market Size to Hit USD 472.64 Bn by 2030

According to Nova one advisor, the global Molecular Quality Controls market was valued at USD 184.62 million in 2021 and it is expected to hit around USD 472.64 million by 2030 with a CAGR of 12.4% during the forecast period 2022 to 2030.

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The growth of this market is primarily driven by factors such as the rising adoption of third-party quality controls, increasing number of accredited clinical laboratories, the rising demand for external quality assessment support, increasing government funding to support genomics projects, increasing demand for personalized medicines and declining costs of sequencing procedures and increasing prevalence of infectious diseases, cancer & genetic diseases.

COVID-19 Impact on the Molecular Quality Control Market

COVID-19 is an infectious disease caused by the most recently discovered novel coronavirus. Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 moved from a regional crisis to a global pandemic in just a few weeks. The World Health Organization (WHO) declared COVID-19 as a pandemic on March 11, 2020.

The COVID-19 pandemic negatively affected the sales of companies. Lockdowns resulting from the COVID-19 pandemic caused people to delay undergoing health check-ups, affecting the number of tests being performed and sales of reagents. However, a resurgence in testing numbers is seen as countries gradually ease restrictions on movement. With the COVID-19 pandemic, responding to infectious disease has become a pressing medical issue worldwide. In addition to developing vaccines and therapeutic drugs, there is a growing need for developing more precise and simple testing technologies and the expansion of testing structures. COVID-19 has also impacted the regulatory environment and practices, as governments and healthcare providers face unprecedented challenges. Regulatory authorities utilized methods to speed the approval of diagnostic products. Companies have also taken strategic developments to introduce COVID-19 rapid tests, sustain their revenues, and nullify the impact of COVID-19 on their operational capabilities.

Report Scope of the Molecular Quality Controls Market

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Molecular Quality Control Market Dynamics

Drivers: Increasing number of accredited clinical laboratories

Globally, the number of laboratory tests being conducted has increased owing to the rising burden of various diseases worldwide. To meet this demand, the number of laboratories in public as well as the private sector is increasing. In most countries, it is mandatory for clinical laboratories to secure accreditation from regulatory bodies such as the International Organization for Standardization (ISO) 15189:2012 and other similar standards to perform diagnostic tests. During the accreditation process, the respective authorities evaluate the quality system and competence of a laboratory based on specific standards.

In 2020, the number of total laboratory entities registered for CLIA accreditation increased to 286,396 as compared to 259,967 in 2017. Also, in 2018, 15,353 laboratories received CLIA accreditation by several accreditation organizations (Source: CLIA UPDATE – January 2020).

Restraints: Additional costs involved in quality control 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.

Opportunities: Rising demand for multi-analyte control

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 down costs. In addition, these controls save the time involved in separate QC procedures for each individual analyte.

Several companies have also expanded their portfolio by adding new tests. For instance, in February 2020, Bio-Rad Laboratories (US) launched EDX RP Positive Run Control, the first multi-analyte control to target 22 analytes in a single vial, which can save laboratories time and space on their instruments. Also, in April 2020, Thermo Fisher Scientific (US) launched AcroMetrix Coronavirus 2019 (COVID-19) RNA Control to monitor and validate COVID-19 molecular diagnostic tests. The growing availability of such molecular quality controls for infectious diseases diagnostics and other applications is expected to support market growth in the coming years.

Challenges: Changing regulatory framework

Regulatory and legal requirements applied to IVD (including molecular diagnostics) in the US and European countries are becoming more stringent. In the US, IVD products are defined under 21 CFR 809 and regulated under guidelines like medical devices. The FDA released new FDA guidance documents. Under US federal regulations, device manufacturers must submit a 510 (k) application for any further modifications to a device. New applications may require software updates or new software installation in an existing device or any other changes made to these devices.

There are an estimated 1,00,000 laboratories in India, and because of low entry barriers, there is less reliance on molecular products quality with no quality assurance requirements mandate for molecular diagnostic testing procedures. Similarly, in Turkey, there is no accreditation system relevant to clinical laboratories, while in Argentina, laboratory accreditation is a voluntary process. However, laboratories are not opting for such accreditations as this may increase investment (to meet the required standards of accreditation).

Independent controls accounted for the largest share of the molecular quality controls market in 2020

Based on product, the molecular quality control market is segmented into Independent Controls and Instrument Specific Controls. The Independent control segment accounted for the largest share of the molecular quality control market in 2020. The increasing number of accredited laboratories and mandates for the use of quality controls from regulatory bodies to ensure the accuracy of diagnostic test results are driving the growth of the molecular quality control products market.

Single-analyte controls to account for the largest share of the market during the forecast period

Based on analyte type, the molecular quality controls market is segmented into single-analyte controls and multi-analyte controls. Single-analyte controls dominated the molecular quality controls market in 2020 due to the significant use of singleplex assays in hospitals and the advantages associated with the use of single-analyte controls, such as simple analysis & interpretation and low risk of cross-reactivity.

Infectious Disease Diagnostic to account for the largest share of the market during the forecast period

Based on application, the molecular quality controls market is segmented into infectious disease diagnostics, oncology testing, genetic testing, and other applications. The infectious disease diagnostics segment accounted for the largest share of the molecular quality controls market in 2020. The large share of this segment is attributed to the development of advanced assays for infectious diseases, a significant increase in the prevalence of infectious diseases, and the rising awareness about the effective use of molecular diagnostic technologies to control the occurrence and spread of infectious diseases.

Diagnostic Laboratories to account for the largest share of the market during the forecast period

The key end users of molecular quality controls studied in this report include diagnostic laboratories, hospitals, IVD Manufacturers and CROs Academic & Research Institutes, and other end users. The Diagnostic Laboratories segment accounted for the largest share of the molecular quality control market in 2020, increasing number of accredited diagnostic laboratories to provide growth opportunities in the coming years.

The APAC molecular quality controls market is projected to grow at the highest rate during the forecast period.

The molecular quality controls market is segmented into five major regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2020, North America was the largest regional market for molecular quality controls due to the developed healthcare system in the US and Canada, the presence of many leading molecular quality control product manufacturers in the region, and the easy accessibility to technologically advanced products in the region. However, the market in the Asia Pacific is estimated to grow at the highest CAGR during the forecast period. The presence of emerging economies such as China and India and the significant demand for high-quality and accurate diagnostic tests from the large patient population in this region are the major factors supporting the growth of the Asia Pacific molecular quality controls market.

Some of the prominent players in the Molecular Quality Controls Market include: F. Hoffmann-La Roche Ltd. (Switzerland), Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific, Inc. (US), Randox Laboratories Ltd. (UK), LGC Limited (UK), Abbott Laboratories (US), Fortress Diagnostics (UK), SERO AS (Norway), Anchor Molecular (US), Ortho-Clinical Diagnostics, Inc. (US), Quidel Corporation (US), Sun Diagnostics, LLC (US), Seegene Inc. (South Korea), ZeptoMetrix, LLC (US), Qnostics (UK), Bio-Techne Corporation (US), Microbiologics, Inc. (US), Microbix Biosystems Inc. (Canada), SpeeDx Pty. Ltd. (Australia), Maine Molecular Quality Controls, Inc. (US), and Grifols, S.A. (Spain).

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Molecular Quality Controls market

By product

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

By Analyte type

• Single-analyte Controls
• Multi-analyte Controls

By Application

• Infectious Diseases Diagnostics
• Oncology Testing
• Genetic Testing
• Other Applications

By End User

• Diagnostic Laboratories
• Hospitals
• IVD Manufacturers & CROs
• Academic and Research Institutes
• Other End Users

Key Benefits For Stakeholders

• This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the global Molecular Quality Controls industry analysis from 2022 to 2030 to identify the prevailing Molecular Quality Controls industry opportunity.
• The market research is offered along with information related to key drivers, restraints, and opportunities.
• Porter’s five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
• In-depth analysis of the global Molecular Quality Controls industry segmentation assists to determine the prevailing market opportunities.
• Major countries in each region are mapped according to their revenue contribution to the global market.
• Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
• The report includes the analysis of the regional as well as global Molecular Quality Controls industry trends, key players, market segments, application areas, and market growth strategies.

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