The global molecular quality controls market size was valued at USD 186.7 million in 2023, driven by the increasing incidence of HIV and cancer across the globe. The market size is anticipated to grow at a CAGR of 6.8% during the forecast period of 2024-2032 to achieve a value of USD 337.1 million by 2032.
Molecular quality controls are standardized materials or substances used in molecular diagnostic testing to assess the accuracy, precision, and reliability of the testing process. These controls mimic patient samples and contain known quantities of specific nucleic acids, proteins, or other molecular targets of interest. By including molecular quality controls in the testing process, clinical laboratories can monitor the performance of their molecular assays and ensure that the results are accurate and consistent.
The market for molecular quality controls is driven by advancements in molecular diagnostic technologies, coupled with the continuous evolution of RT PCR (Reverse Transcription Polymerase Chain Reaction) and NGS (Next-Generation Sequencing) technologies. These technologies are becoming increasingly sophisticated and efficient, enabling more accurate and comprehensive molecular diagnostics. The emergence of ultrafast PCR technology, utilizing photothermal nanomaterials, represents a groundbreaking trend in the field. This technology has the potential to revolutionize molecular testing by significantly shortening test times, offering results in a fraction of the time compared to conventional PCR testing. Such innovations are enhancing the speed and efficiency of molecular diagnostics, a crucial trend in the healthcare industry.
The molecular quality controls market growth is also aided by the rising mergers and investments, along with the rising investment from the government on the development of healthcare sector. Furthermore, the collaborative efforts between pharmaceutical companies like Vertex and CRISPR Therapeutics in developing CRISPR-based therapies for conditions like sickle cell disease are opening new frontiers in molecular medicine. If approved, these therapies would mark a historic milestone as the first CRISPR-based treatments for human use. This signifies the growing potential of CRISPR technology to advance human health, making it a prominent trend to watch.
Market Breakup by Product Type
Market Breakup by Analyte Type
Market Breakup by Applications
Market Breakup by End User
Market Breakup by Region
The market for molecular quality controls is driven by the rising prevalence of infectious diseases, which has prompted the need for accurate and reliable molecular diagnostic tests. This increasing demand for diagnostics is fuelling the adoption of molecular quality controls as they play a vital role in ensuring the accuracy and precision of these tests. Rapid advancement in molecular diagnostic technologies is another significant driver which is anticipated to drive the molecular quality controls market demand. As diagnostic methods become more sophisticated and sensitive, the need for equally advanced quality control solutions becomes paramount. Molecular quality controls help diagnostic laboratories validate their tests and maintain high standards of accuracy. The growing emphasis on quality assurance in diagnostic laboratories is promoting the uptake of molecular quality controls. Ensuring the reliability of test results is crucial for patient care, and these controls provide an essential tool for achieving this goal.
Moreover, the widespread adoption of internet-based technologies has facilitated the distribution and management of molecular quality controls, making them more accessible and efficient for laboratories worldwide. The growing adoption of third-party quality controls offer laboratories independent and unbiased assessments of their testing processes.
Furthermore, increasing government funding for genomic projects is driving research and development efforts in the field of molecular diagnostics. This funding helps in the advancement of technology and encourages the development of high-quality molecular quality controls to support these initiatives.
The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Product Type||
|Breakup by Analyte Type||
|Breakup by Applications||
|Breakup by End User||
|Breakup by Region||
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Molecular Quality Controls Market Overview
3.1 Global Molecular Quality Controls Market Historical Value (2017-2023)
3.2 Global Molecular Quality Controls Market Forecast Value (2024-2032)
4 Global Molecular Quality Controls Market Landscape
4.1 Global Molecular Quality Controls Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Molecular Quality Controls Product Landscape
4.2.1 Analysis by Type
4.2.2 Analysis by Technology
4.2.3 Analysis by Application
5 Global Molecular Quality Controls Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Molecular Quality Controls Market Segmentation
6.1 Global Molecular Quality Controls Market by Product Type
6.1.1 Market Overview
6.1.2 DNA- Based Quality Controls
6.1.3 RNA-Based Quality Control
6.1.4 Protein-Based Quality Controls
6.1.5 Nucleic Acid and Protein Mixtures
6.2 Global Molecular Quality Controls Market by Analyte Type
6.2.1 Market Overview
6.2.2 Single Analyte Control
6.2.3 Multi Analyte Control
6.3 Global Molecular Quality Controls Market by Applications
6.3.1 Market Overview
6.3.2 Infectious Diseases
6.3.4 Genetic Testing
6.3.5 Other Applications
6.4 Global Molecular Quality Controls Market by End User
6.4.1 Market Overview
6.4.2 Clinical Laboratories
6.4.4 IVD Manufacturers
6.4.5 Contract Research Organizations
6.4.6 Academic and Research Institutes
6.5 Global Molecular Quality Controls Market by Region
6.5.1 Market Overview
6.5.2 North America
6.5.4 Asia Pacific
6.5.5 Latin America
6.5.6 Middle East and Africa
7 North America Molecular Quality Controls Market
7.1 Market Share by Country
7.2 United States of America
8 Europe Molecular Quality Controls Market
8.1 Market Share by Country
8.2 United Kingdom
9 Asia Pacific Molecular Quality Controls Market
9.1 Market Share by Country
10 Latin America Molecular Quality Controls Market
10.1 Market Share by Country
11 Middle East and Africa Molecular Quality Controls Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.5 South Africa
12 Patent Analysis
12.1 Analysis by Type of Patent
12.2 Analysis by Publication year
12.3 Analysis by Issuing Authority
12.4 Analysis by Patent Age
12.5 Analysis by CPC Analysis
12.6 Analysis by Patent Valuation
12.7 Analysis by Key Players
13 Grants Analysis
13.1 Analysis by year
13.2 Analysis by Amount Awarded
13.3 Analysis by Issuing Authority
13.4 Analysis by Grant Application
13.5 Analysis by Funding Institute
13.6 Analysis by NIH Departments
13.7 Analysis by Recipient Organization
14 Funding Analysis
14.1 Analysis by Funding Instances
14.2 Analysis by Type of Funding
14.3 Analysis by Funding Amount
14.4 Analysis by Leading Players
14.5 Analysis by Leading Investors
14.6 Analysis by Geography
15 Partnership and Collaborations Analysis
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 INDIA CDSCO
16.1.4 JAPAN PMDA
17 Supplier Landscape
17.1 Bio-Rad Laboratories, Inc.
17.1.1 Financial Analysis
17.1.2 Product Portfolio
17.1.3 Demographic Reach and Achievements
17.1.4 Mergers and Acquisition
17.2 Thermo Fisher Scientific, Inc.
17.2.1 Financial Analysis
17.2.2 Product Portfolio
17.2.3 Demographic Reach and Achievements
17.2.4 Mergers and Acquisition
17.3 Roche Diagnostics
17.3.1 Financial Analysis
17.3.2 Product Portfolio
17.3.3 Demographic Reach and Achievements
17.3.4 Mergers and Acquisition
17.4 SeraCare Life Sciences, Inc.
17.4.1 Financial Analysis
17.4.2 Product Portfolio
17.4.3 Demographic Reach and Achievements
17.4.4 Mergers and Acquisition
17.5 QIAGEN N.V.
17.5.1 Financial Analysis
17.5.2 Product Portfolio
17.5.3 Demographic Reach and Achievements
17.5.4 Mergers and Acquisition
17.6 Abbott Laboratories
17.6.1 Financial Analysis
17.6.2 Product Portfolio
17.6.3 Demographic Reach and Achievements
17.6.4 Mergers and Acquisition
17.7 LGC Limited
17.7.1 Financial Analysis
17.7.2 Product Portfolio
17.7.3 Demographic Reach and Achievements
17.7.4 Mergers and Acquisition
17.8 ZeptoMetrix Corporation
17.8.1 Financial Analysis
17.8.2 Product Portfolio
17.8.3 Demographic Reach and Achievements
17.8.4 Mergers and Acquisition
17.9 Microbiologics, Inc.
17.9.1 Financial Analysis
17.9.2 Product Portfolio
17.9.3 Demographic Reach and Achievements
17.9.4 Mergers and Acquisition
17.10 Maine Molecular Quality Controls, Inc.
17.10.1 Financial Analysis
17.10.2 Product Portfolio
17.10.3 Demographic Reach and Achievements
17.10.4 Mergers and Acquisition
17.11 Seracare Life Sciences, Inc.
17.11.1 Financial Analysis
17.11.2 Product Portfolio
17.11.3 Demographic Reach and Achievements
17.11.4 Mergers and Acquisition
17.12 Technopath Clinical Diagnostics
17.12.1 Financial Analysis
17.12.2 Product Portfolio
17.12.3 Demographic Reach and Achievements
17.12.4 Mergers and Acquisition
17.13 Randox Laboratories Ltd.
17.13.1 Financial Analysis
17.13.2 Product Portfolio
17.13.3 Demographic Reach and Achievements
17.13.4 Mergers and Acquisition
17.14 Helena Laboratories
17.14.1 Financial Analysis
17.14.2 Product Portfolio
17.14.3 Demographic Reach and Achievements
17.14.4 Mergers and Acquisition
17.15 Streck, Inc.
17.15.1 Financial Analysis
17.15.2 Product Portfolio
17.15.3 Demographic Reach and Achievements
17.15.4 Mergers and Acquisition
18 Global Molecular Quality Controls Market - Distribution Model (Additional Insight)
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
*Additional insights provided are customisable as per client requirements.
The market attained a value of about USD 186.7 million in 2023, driven by the rapid technological advancements.
The market is anticipated to grow at a CAGR of 6.8% during the forecast period of 2024-2032 and is likely to reach a market value of USD 337.1 million by 2032.
The growing healthcare sector and the continuous advancement in molecular diagnostic technologies is a major factor driving the market growth.
The major regions of the market include North America, Europe, Asia Pacific, Latin America, Middle East and Africa. North America is currently leading the global market.
Various products in the market include DNA-based quality controls, RNA-based quality control, protein-based quality controls, and nucleic acid and protein mixtures, among others.
There are single-analyte control and multi-analyte control in the market.
They find wide applications in infectious diseases, oncology, and genetic testing, among other applications.
End users in the market are clinical laboratories, hospitals, IVD manufacturers, contract research organizations, and academic or research institutes, among others.
Key players involved in the market are Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Inc., Roche Diagnostics, SeraCare Life Sciences, Inc., QIAGEN N.V., Abbott Laboratories, LGC Limited, ZeptoMetrix Corporation, Microbiologics, Inc., Maine Molecular Quality Controls, Inc., Seracare Life Sciences, Inc., Technopath Clinical Diagnostics, Randox Laboratories Ltd., Streck, Inc., and Helena Laboratories.
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