Molecular Quality Controls Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The market is segmented by Product (Independent Controls and Instrument-Specific Controls), Application, End-user and Geography

Molecular Quality Controls Market Size

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Molecular Quality Controls Market Size
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Study Period 2019 - 2029
Base Year For Estimation 2023
Forecast Data Period 2024 - 2029
CAGR > 10.50 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Molecular Quality Controls Market Major Player

*Disclaimer: Major Players sorted in no particular order


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Molecular Quality Controls Market Analysis

The molecular quality controls market studied was anticipated to grow with a CAGR of nearly 10.5% 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, 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) report published 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

Molecular Quality Controls Market Trends

This section covers the major market trends shaping the Molecular Quality Controls Market according to our research experts:

Independent Controls are Expected to Hold the Largest Market Share in the Molecular Quality Controls Market

Independent controls are anticipated to hold the largest market share in the molecular quality controls market due to their highly precise, unbiased, and independent assessment of a testing system or method performance test results in a short time with the highest sensitivity rate as they are manufactured independently of the instrument, reagents, and calibrators. Furthermore, a steep rise in the adoption of these products among the third-party independent quality controls owing to their benefits such as a wide range of applications along with reduced operational costs is also expected to drive the use of independent controls fueling the market.

Based on the application, the oncology segment accounts for the highest market revenue due to the rising global prevalence of cancer, increasing research on cancer biomarkers, advanced diagnosis infrastructure and growing focus on personalized medicine. On the other hand, genetic testing is expected to witness the highest CAGR during the forecast period due to the rise in their application in the treatment and genetic diagnosis of various genetically inherited diseases and the determination of bloodlines driving the segment which is likely to propel the global market in the forecast period.

Molecular Quality Controls Market Share

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

North America is expected to dominate the overall molecular quality control 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

Molecular Quality Controls Market Growth

Molecular Quality Controls Industry Overview

The molecular quality control 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 are 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.

Molecular Quality Controls Market Leaders

  1. Bio-Rad Laboratories Inc

  2. bioMerieux Inc

  3. F. Hoffmann-La Roche AG

  4. SeraCare Life Sciences Inc

  5. ZeptoMetrix Corporation

*Disclaimer: Major Players sorted in no particular order

Bio-Rad Laboratories Inc, bioMerieux Inc, F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc, ZeptoMetrix Corporation
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Molecular Quality Controls Market Report - Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increased Demand for Advanced Diagnostics for Sensitve Reports and Accurate Diagnosis

      2. 4.2.2 Rise Global Incidence of Infectious Diseases, Cancers and Genetic Disorders

      3. 4.2.3 Rise in the Volume of Accredited Clinical Laboratories and Adoption of Third-Party Quality Controls

    3. 4.3 Market Restraints

      1. 4.3.1 Complex Regulatory Framework by Authorities Delaying Approvals

      2. 4.3.2 Unfavorable Reimbursement Poilicies for Molecular Tests

      3. 4.3.3 Additional Costs Involved in Quality Control testing Resulting in Budget Constraints for Healthcare Providers

      4. 4.3.4 Lack of Stringent Regulations for Clinical Laboratory Accreditation in Several Emerging Economies

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 By Product Type

      1. 5.1.1 Independent Control

      2. 5.1.2 Instrument Specific-Control

    2. 5.2 By Application

      1. 5.2.1 Oncology

      2. 5.2.2 Genetic Testing

      3. 5.2.3 Infectious Diseases

      4. 5.2.4 Others

    3. 5.3 By End-users

      1. 5.3.1 Hospitals

      2. 5.3.2 Clinical Laboratories

      3. 5.3.3 IVD Manufacturers & CROs

      4. 5.3.4 Others

    4. 5.4 Geography

      1. 5.4.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.4.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.4.4 Middle-East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle-East and Africa

      5. 5.4.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories

      2. 6.1.2 Bio-Rad Laboratories Inc

      3. 6.1.3 F. Hoffmann-La Roche AG

      4. 6.1.4 Microbiologics Inc

      5. 6.1.5 Thermo Fisher Scientific

      6. 6.1.6 SeraCare Life Sciences Inc

      7. 6.1.7 ZeptoMetrix Corporation

      8. 6.1.8 Quidel Corporation

      9. 6.1.9 Qnostics Ltd

      10. 6.1.10 bioMerieux Inc

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments
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Molecular Quality Controls Industry Segmentation

Molecular quality controls are used to evaluate the performance of molecular tests such as in vitro nucleic acid testing procedures for viral load assays, pathogen detection, leukocyte reduced apheresis platelet (LRAP) units, healthcare-associated infections (HAIs) like pneumonia, urinary tract infections and more. These products majorly focus on the detection of defects, quality control, and validation panels to support in the implementation and monitoring assay-kit lot performance for clinical and research laboratories, blood diagnostic centers, and IVD manufacturers.

By Product Type
Independent Control
Instrument Specific-Control
By Application
Genetic Testing
Infectious Diseases
By End-users
Clinical Laboratories
IVD Manufacturers & CROs
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle-East and Africa
South Africa
Rest of Middle-East and Africa
South America
Rest of South America
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Molecular Quality Controls Market Research FAQs

The Molecular Quality Controls Market is projected to register a CAGR of greater than 10.5% during the forecast period (2024-2029)

Bio-Rad Laboratories Inc, bioMerieux Inc, F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc and ZeptoMetrix Corporation are the major companies operating in the Molecular Quality Controls Market.

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Molecular Quality Controls Market.

The report covers the Molecular Quality Controls Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Molecular Quality Controls Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Molecular Quality Controls Industry Report

Statistics for the 2024 Molecular Quality Controls market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Molecular Quality Controls analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Molecular Quality Controls Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)