$4550
The molecular quality controls market is expected to reach US$ 372.64 million in 2028 from US$ 184.62 million in 2021; it is estimated to grow at a CAGR of 10.6% during 2021–2028.
Molecular quality controls help to monitor the performance of testing procedures. These tests are helpful to achieve critical and accurate diagnostic information. These controls are used to determine transmissible and genetic diseases too. Moreover, the molecular quality controls also help to monitor the performance of nucleic acid testing protocols for healthcare associated infections, viral load assays and sexually transmitted infections. The growth of the molecular quality controls market is attributed to the factors such as growing funds for genomics, declining cost of sequencing procedures, and increasing prevalence of genetic diseases fuel the growth of the market. However, the dearth of skilled professionals hinders the market growth.
Lucrative Regions for Molecular Quality Controls Market
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Market Insights
Increasing Prevalence of Genetic Diseases
Molecular quality controls are used to detect genetic diseases as these aid in the interpretation of results. Downs Syndrome is a genetic disorder that causes due to abnormal cell division, which results in an extra full or partial copy of chromosome 21. As per the US Centers for Disease Control and Prevention (CDC), every year, around 6,000 newborns in the US suffer from the Down syndrome. As a result, prenatal testing for Down syndrome is increasing in the country.
Most of the inherited cases of breast cancer are associated with mutations in two genes: BRCA1 (BReast CAncer gene one) and BRCA2 (BReast CAncer gene two). As per the American Cancer Society, around 5% to 10% of breast cancer cases are hereditary, as a result of mutated genes passed from parent to children. Growing awareness of breast cancer increases the adoption of genetic testing for hereditary breast cancer.
Further, as per CDC, sickle cell disease (SCD) is a common genetic blood disorder in the US that affects ~70,000 to 100,000 Americans. Further, as per the WHO, 5% of the world population is the carrier of the genes for hemoglobin disorders, such as sickle-cell disease and thalassemia. Thus, the increasing prevalence of such genetic diseases propels the demand for molecular quality controls.
Product -Based Insights
Based on product, the molecular quality controls market is segmented into independent controls and instrument specific controls. The independent controls segment held a larger share of the market in 2020, whereas the same is anticipated to register the highest CAGR in the market during the forecast period.
Molecular Quality Controls Market, by Product– 2020 and 2028
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Analyte Type -Based Insights
Based on analyte type, the molecular quality controls market is segmented into single analyte controls and multi-analyte controls. The single analyte controls segment held a larger share of the market in 2021, whereas the multi-analyte control segment is estimated to register the highest CAGR in the market during the forecast period.
Application-based Insights
Based on application, the molecular quality control market is segmented into infectious diseases, oncology, genetic testing, and other applications. The infectious diseases segment held the largest share of the market in 2021, whereas the oncology segment is anticipated to register the highest CAGR in the market during the forecast period.
Distribution Channel-based Insights
Based on end user, the molecular quality control market is segmented into clinical laboratories, hospitals, IVD manufacturers & contract research organizations, academic & research institutes, and other end users. The Clinical Laboratories segment held the largest share of the market in 2021 and is estimated to register the highest CAGR of in the market during the forecast period.
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Molecular Quality Controls Market: Strategic Insights
Market Size Value in US$ 184.62 Million in 2021 Market Size Value by US$ 372.64 Million by 2028 Growth rate CAGR of 10.6% from 2021-2028 Forecast Period 2021-2028 Base Year 2021
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We can optimize and tailor the analysis and scope which is unmet through our standard offerings. This flexibility will help you gain the exact information needed for your business planning and decision making.
Molecular Quality Controls Market: Strategic Insights

Market Size Value in | US$ 184.62 Million in 2021 |
Market Size Value by | US$ 372.64 Million by 2028 |
Growth rate | CAGR of 10.6% from 2021-2028 |
Forecast Period | 2021-2028 |
Base Year | 2021 |

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Product launches and approvals are the commonly adopted strategies by companies to expand their global footprints and product portfolios. Moreover, the molecular quality controls market players focus on the collaboration strategy to enlarge their clientele, which, in turn, permits them to maintain their brand name globally.
Molecular Quality Controls Market – by Product
- Independent Controls
- Instrument Specific Controls
Molecular Quality Controls Market – by Analyte Type
- Single Analyte Controls
- Multi Analyte Controls
Molecular Quality Controls Market – by Application
- Infectious Diseases
- Oncology
- Genetic Testing
- Other Applications
Molecular Quality Controls Market – by End User
- Clinical Laboratories
- Hospitals
- IVD Manufacturers & Contract Research Organizations
- Academic & Research Institutes
- Other End Users
Molecular Quality Controls Market – by Geography
- North America
- US
- Canada
- Mexico
- Europe
- France
- Germany
- Italy
- UK
- Spain
- Rest of Europe
- Asia Pacific (APAC)
- China
- India
- South Korea
- Japan
- Australia
- Rest of Asia Pacific
- Middle East and Africa (MEA)
- South Africa
- Saudi Arabia
- UAE
- Rest of Middle East and Africa
- South and Central America (SCAM)
- Brazil
- Argentina
- Rest of South and Central America
Company Profiles
- THERMO FISHER SCIENTIFIC, INC.
- BIO-RAD LABORATORIES, INC.
- F. HOFFMANN LA-ROCHE LTD.
- Abbott
- Quidel Corporation
- Qnostics
- Maine Molecular Controls, Inc.
- Zeptometrix Corporation
- Microbiologics
- Seracare Life Sciences

Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Product , Analyte Type , Application , and End User and Geography

Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
Molecular quality controls help to monitor the performance of testing procedures. These tests are helpful to achieve critical and accurate diagnostic information. These controls are used to determine transmissible and genetic diseases too. Moreover, the molecular quality controls also help to monitor the performance of nucleic acid testing protocols for healthcare associated infections, viral load assays and sexually transmitted infections.
The global molecular quality controls market growth is mainly attributed to factors such growing funds for genomics, declining cost of sequencing procedures, and increasing prevalence of genetic diseases fuel the growth of the market. Moreover, rising adoption of molecular diagnostics is likely to create growth opportunities for the market
The molecular quality controls market majorly consists of the players such as Thermo Fisher Scientific Inc, Bio-Rad Laboratories Inc, F. Hoffmann La-Roche Ltd, Abbott, Quidel Corporation, Qnostics, Maine Molecular Controls, Inc., Zeptometrix Corporation, Microbiologics, and Seracare Life Sciences among others.
The List of Companies - Molecular Quality Controls Market
- TOHERMO FISHER SCIENTIFIC, INC.
- BI-RAD LABORATORIES, INC.
- F. HOFFMANN LA-ROCHE LTD.
- Abbott
- Quidel Corporation
- Qnostics
- Maine Molecular Controls, Inc.
- Zeptometrix Corporation
- Microbiologics
- Seracare Life Sciences
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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