Molecular Quality Controls Market by Product (Independent, Instrument Specific (DNA Sequencing)), Analyte Type (Single Analyte, Multianalyte), Application (Infectious Diseases), End User (IVD Manufacturers, Research Institute) - Global Forecast to 2024
[125 Pages Report] The market for molecular quality controls is expected to grow from USD 132 million in 2018 to USD 237 million by 2024, at a CAGR of 10.2% during the forecast period. The growth of this market is primarily driven by factors such as the growing adoption of third-party quality controls, increasing number of accredited clinical laboratories, and the rising demand for external quality assessment support.
By analyte type, the multi-analyte controls segment is expected to grow at a higher rate in the molecular controls market during the forecast period.
On the basis of analyte type, the molecular controls market is segmented into single-analyte controls and multi-analyte controls. The multi-analyte controls segment is projected to grow at a higher CAGR during the forecast period. Growth in this market can be attributed to factors such as the increasing preference for multi-analyte controls for clinical as well as research applications due to the advantages associated with its use, such as cost-effectiveness, time savings, and the availability of a wide range of formats that enhance flexibility for users.
By application, the oncology segment is expected to grow at the highest CAGR in the molecular controls market.
Based on application, the molecular quality controls industry is divided into four major segments—infectious diseases, oncology, genetic tests, and other applications. The research oncology segment is projected to grow at the highest rate in the market, by application. Factors such as technological advancements, the rising prevalence of cancer, increasing research on cancer biomarkers, and growing focus on personalized medicine are contributing to the growth of this market segment.
North America accounted for the largest share of the molecular controls market in 2018
In 2018, North America accounted for the largest share of this market, followed by Europe. The large share of this regional segment is mainly due to the developed healthcare system in the US and Canada, the presence of a large number of leading molecular quality control product manufacturers, and easy accessibility to technologically advanced products in North America.
Key Market Players
Major molecular quality controls vendors include SeraCare Life Sciences Inc. (US), ZeptoMetrix Corporation (US), Bio-Rad Laboratories Inc. (US), Microbiologics Inc. (US), and Thermo Fisher Scientific (US), Maine Molecular Quality Controls Inc. (US), Abbott Laboratories (US), Roche Diagnostics (Switzerland), Quidel Corporation (US), and Qnostics Ltd. (UK).
Seracare is one of the major players operating in the market. The company has a wide range of product offerings. To maintain its market position, the company mainly focuses on organic and inorganic growth strategies such as product launches, agreements, partnerships, collaborations, and acquisitions. For instance, in the past three years, the company launched 19 molecular quality control materials such as Seraseq NTRK FFPE RNA reference material, Seraseq ctDNA Complete, and Seraseq ctDNA Panels. Similarly, SeraCare collaborated with the United Kingdom National External Quality Assessment Service (UK NEQAS) to provide Non-Invasive Prenatal Testing (NIPT) reference materials for global NIPT external quality assessment (EQA) schemes in 2016. These strategies have enabled the company to expand its quality control and reference material offerings in the market.
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Report Metric |
Details |
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Market size available for years |
2016–2024 |
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Base year considered |
2017 |
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Forecast period |
2018–2024 |
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Forecast units |
Values (USD Million) |
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Segments covered |
Product, Analyte Type, Application, End User, and Region |
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Geographies covered |
North America, Europe, APAC, and RoW |
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Companies covered |
SeraCare Life Sciences Inc. (US), ZeptoMetrix Corporation (US), Bio-Rad Laboratories Inc. (US), Microbiologics Inc. (US), and Thermo Fisher Scientific (US).10 major players covered, in total |
By Product, the molecular quality controls market is segmented as follows:
- Independent Controls
- Instrument-specific Controls, By Technology
- PCR
- DNA Sequencing & NGS
- Other Technologies
By Analyte Type, the molecular quality controls market is segmented as follows:
- Single-analyte Controls
- Multi-analyte Controls
By Application, the molecular quality controls market is segmented as follows:
- Infectious Diseases
- Oncology
- Genetic Testing
- Other Applications
By End Users, the molecular quality controls market is segmented as follows:
- Clinical Laboratories
- Hospitals
- IVD Manufacturers & CROs
- Academic and Research Institutes
- Other End Users
By Region, the molecular quality controls market is segmented as follows:
- North America
- US
- Canada
- Europe
- Asia Pacific
- RoW
Recent Developments:
- In 2018, Seracare partnered with AccuRef Diagnostics, a division of Applied StemCell, Inc (US), to market and sell Accuref’s broad portfolio of CRISPR-engineered cell line reference materials.
- In 2018, Thermo Fisher Scientific partnered with West China Hospital of Sichuan University (China) to establish training centers for standardized pathology quality control, standardized pathologic diagnosticians, and advanced laboratories.
- In 2017, Bio-Rad launched Amplichek STI—a Multi-analyte Quality Control
- In 2018, Microbiologics launched 8 quality control products such as, Human Papillomavirus (HPV) Control Panel, Vaginal Control Panel, Vaginal Verification Panel, Blood Culture (BCID) Control Panel, Enteric Viral Control Panel and others.
Key questions addressed by the report:
- Who are the major market players in the molecular quality controls market?
- What are the regional growth trends and the largest revenue-generating regions for molecular quality controls market?
- What are the major drivers and challenges in the molecular quality controls market?
- What are the major product segments in the molecular quality controls market?
- What are the major application segments in the molecular quality controls market?
- What are the major analyte type segments in the molecular quality controls market?
- What are the major end users for molecular quality controls?
To speak to our analyst for a discussion on the above findings, click Speak to Analyst
Table of Contents
1 Introduction (Page No. - 14)
1.1 Objectives of the Study
1.2 Market Definition
1.3 Market Scope
1.3.1 Markets Covered
1.3.2 Years Covered for the Study
1.4 Currency
1.5 Limitations
1.6 Stakeholders
2 Research Methodology (Page No. - 17)
2.1 Research Data
2.1.1 Secondary Sources
2.1.1.1 Key Data From Secondary Sources
2.1.2 Primary Sources
2.1.2.1 Key Data From Primary Sources
2.2 Market Size Estimation
2.3 Market Breakdown and Data Triangulation
2.3.1.1 Key Industry Insights
3 Executive Summary (Page No. - 24)
3.1 Introduction
4 Premium Insights (Page No. - 28)
4.1 Molecular Quality Controls: Market Overview
4.2 Molecular Quality Controls Market, By Product
4.3 North America: Molecular Quality Controls Market, By End User (2018)
5 Market Overview (Page No. - 31)
5.1 Introduction
5.1.1 Drivers
5.1.1.1 Increasing Number of Accredited Clinical Laboratories
5.1.1.2 Growing Adoption of Third-Party Quality Controls
5.1.1.3 Rising Demand for External Quality Assessment Support
5.1.2 Restraints
5.1.2.1 Additional Costs Involved in Quality Control and Budget Constraints in Hospitals and Laboratories
5.1.2.2 Unfavorable Reimbursement Scenario for Molecular Tests
5.1.3 Opportunities
5.1.3.1 Rising Demand for Multi-Analyte Controls
5.1.4 Challenges
5.1.4.1 Lack of Mandatory Regulations for Clinical Laboratory Accreditation in Several Emerging Countries
5.1.4.2 Complex Regulatory Frameworks
6 Molecular Quality Controls Market, By Product (Page No. - 36)
6.1 Introduction
6.2 Independent Controls
6.2.1 Wide Range of Applications and Reductions in Operational Costs Have Boosted the Use of Independent Controls
6.3 Instrument-Specific Controls
6.3.1 PCR
6.3.1.1 PCR Controls Dominate the Instrument-Specific Controls Market
6.3.2 Dna Sequencing & NGS
6.3.2.1 Advancements in Sequencing Technologies Form A Positive Growth Factor for This Market
6.3.3 Other Technologies
7 Molecular Quality Controls Market, By Analyte Type (Page No. - 44)
7.1 Introduction
7.2 Single-Analyte Controls
7.2.1 Significant Use of Singleplex Assays in Hospitals—A Key Market Driver
7.3 Multi-Analyte Controls
7.3.1 Increasing Preference for Multi-Analyte Controls to Fuel Market Growth
8 Molecular Quality Controls Market, By Application (Page No. - 49)
8.1 Introduction
8.2 Infectious Diseases
8.2.1 Demand for Infectious Disease Testing Controls has Grown Steadily
8.3 Oncology
8.3.1 Growing Cancer Prevalence and Technological Advancements are Key Growth Drivers in This Segment
8.4 Genetic Testing
8.4.1 Advancements in Genetic Testing Drive the Market
8.5 Other Applications
9 Molecular Quality Controls Market, By End User (Page No. - 56)
9.1 Introduction
9.2 Clinical Laboratories
9.2.1 Increasing Number of Accredited Clinical Laboratories to Provide Growth Opportunities in the Coming Years
9.3 Hospitals
9.3.1 Growing Patient Volume Driving the Adoption of Molecular Quality Controls in Hospital-Based Laboratories
9.4 IVD Manufacturers and Contract Research Organizations
9.4.1 Advancements in Molecular Technologies Driving the Adoption of Molecular Quality Controls Among IVD Manufacturers and Contract Research Organizations
9.5 Academic & Research Institutes
9.5.1 Increasing Demand for Ensuring the Accuracy of Diagnostic Tests to Support the Growth of This End-User Segment
9.6 Other End Users
10 Molecular Quality Controls Market, By Region (Page No. - 64)
10.1 Introduction
10.2 North America
10.2.1 US
10.2.1.1 Increasing Clia Accreditation for Clinical Laboratories Driving the Market for Molecular Quality Controls in the US
10.2.2 Canada
10.2.2.1 Government Investments Supporting the Development of Advanced Diagnostic Procedures for Infectious Diseases and Cancer in Canada
10.3 Europe
10.3.1 Growing Demand for External Quality Control Support From End Users Will Provide Growth Opportunities
10.4 Asia Pacific
10.4.1 Strategic Developments By Leading Players to Drive the Market for Molecular Quality Controls in APAC
10.5 Rest of the World
11 Competitive Landscape (Page No. - 84)
11.1 Market Overview
11.2 Market Ranking Analysis, 2017
11.2.1 Competitive Leadership Mapping
11.2.2 Visionary Leaders
11.2.3 Innovators
11.2.4 Dynamic Differentiators
11.2.5 Emerging Companies
11.3 Competitive Benchmarking
11.3.1 Strength of Product Portfolio (15 Players)
11.3.2 Business Strategy Excellence (15 Players)
12 Company Profiles (Page No. - 89)
(Business Overview, Products Offered, Recent Developments, MnM View)*
12.1 Seracare Life Sciences Inc.
12.2 Thermo Fisher Scientific
12.3 Bio-Rad Laboratories
12.4 Microbiologics Inc.
12.5 Zeptometrix
12.6 Roche Diagnostics
12.7 Abbott Laboratories
12.8 Quidel
12.9 Qnostics
12.10 Maine Molecular Quality Controls Inc.
*Business Overview, Products Offered, Recent Developments, MnM View Might Not Be Captured in Case of Unlisted Companies.
13 Appendix (Page No. - 119)
13.1 Discussion Guide
13.2 Knowledge Store: Marketsandmarkets’ Subscription Portal
13.3 Available Customizations
13.4 Related Reports
13.5 Author Details
List of Tables (69 Tables)
Table 1 Molecular Quality Controls Market, By Product, 2016–2024 (USD Million)
Table 2 Independent Controls Market, By Region, 2016–2024 (USD Million)
Table 3 North America: Independent Controls Market, By Country, 2016–2024 (USD Million)
Table 4 Instrument-Specific Controls Market, By Region, 2016–2024 (USD Million)
Table 5 North America: Instrument-Specific Controls Market, By Country, 2016–2024 (USD Million)
Table 6 Instrument-Specific Controls Market, By Technology, 2016–2024 (USD Million)
Table 7 Instrument-Specific Controls Market for PCR, By Region, 2016–2024 (USD Million)
Table 8 North America: Instrument-Specific Controls Market for PCR, By Country, 2016–2024 (USD Million)
Table 9 Instrument-Specific Controls Market for Dna Sequencing & NGS, By Region, 2016–2024 (USD Million)
Table 10 North America: Instrument-Specific Controls Market for Dna Sequencing & NGS, By Country, 2016–2024 (USD Million)
Table 11 Instrument-Specific Controls Market for Other Technologies, By Region, 2016–2024 (USD Million)
Table 12 North America: Instrument-Specific Controls Market for Other Technologies, By Country, 2016–2024 (USD Million)
Table 13 Molecular Quality Controls Market, By Analyte Type, 2016–2024 (USD Million)
Table 14 Single-Analyte Controls Market, By Region, 2016–2024 (USD Million)
Table 15 North America: Single-Analyte Controls Market, By Country, 2016–2024 (USD Million)
Table 16 Multi-Analyte Controls Market, By Region, 2016–2024 (USD Million)
Table 17 North America: Multi-Analyte Controls Market, By Country, 2016–2024 (USD Million)
Table 18 Molecular Control Market, By Application, 2016–2024 (USD Million)
Table 19 Molecular Control Market for Infectious Diseases, By Region, 2016–2024 (USD Million)
Table 20 North America: Molecular Control Market for Infectious Diseases, By Country, 2016–2024 (USD Million)
Table 21 Molecular Control Market for Oncology, By Region, 2016–2024 (USD Million)
Table 22 North America: Molecular Control Market for Oncology, By Country, 2016–2024 (USD Million)
Table 23 Molecular Control Market for Genetic Testing, By Region, 2016–2024 (USD Million)
Table 24 North America: Molecular Quality Controls Market for Genetic Testing, By Country, 2016–2024 (USD Million)
Table 25 Molecular Control Market for Other Applications, By Region, 2016–2024 (USD Million)
Table 26 North America: Molecular Control Market for Other Applications, By Country, 2016–2024 (USD Million)
Table 27 Molecular Control Market, By End User, 2016–2024 (USD Million)
Table 28 Molecular Control Market for Clinical Laboratories, By Region, 2016–2024 (USD Million)
Table 29 North America: Molecular Control Market for Clinical Laboratories, By Country, 2016–2024 (USD Million)
Table 30 Molecular Control Market for Hospitals, By Region, 2016–2024 (USD Million)
Table 31 North America: Molecular Control Market for Hospitals, By Country, 2016–2024 (USD Million)
Table 32 Market for IVD Manufacturers and Contract Research Organizations, By Region, 2016–2024 (USD Million)
Table 33 North America: Molecular Control Market for IVD Manufacturers and Contract Research Organizations, By Country, 2016–2024 (USD Million)
Table 34 Molecular Control Market for Academic & Research Institutes, By Region, 2016–2024 (USD Million)
Table 35 North America: Molecular Control Market for Academic & Research Institutes, By Country, 2016–2024 (USD Million)
Table 36 Molecular Control Market for Other End Users, By Region, 2016–2024 (USD Million)
Table 37 North America: Molecular Control Market for Other End Users, By Country, 2016–2024 (USD Million)
Table 38 Molecular Control Market, By Region, 2016–2024 (USD Million)
Table 39 North America: Molecular Control Market, By Country, 2016–2024 (USD Million)
Table 40 North America: Molecular Control Market, By Product, 2016–2024 (USD Million)
Table 41 North America: Instrument-Specific Controls Market, By Technology, 2016–2024 (USD Million)
Table 42 North America: Molecular Control Market, By Analyte Type, 2016–2024 (USD Million)
Table 43 North America: Molecular Control Market, By Application, 2016–2024 (USD Million)
Table 44 North America: Molecular Control Market, By End User, 2016–2024 (USD Million)
Table 45 US: Molecular Control Market, By Product, 2016–2024 (USD Million)
Table 46 US: Instrument-Specific Controls Market, By Technology, 2016–2024 (USD Million)
Table 47 US: Molecular Control Market, By Analyte Type, 2016–2024 (USD Million)
Table 48 US: Molecular Control Market, By Application, 2016–2024 (USD Million)
Table 49 US: Molecular Control Market, By End User, 2016–2024 (USD Million)
Table 50 Canada: Molecular Control Market, By Product, 2016–2024 (USD Million)
Table 51 Canada: Instrument-Specific Controls Market, By Technology, 2016–2024 (USD Million)
Table 52 Canada: Molecular Control Market, By Analyte Type, 2016–2024 (USD Million)
Table 53 Canada: Molecular Control Market, By Application, 2016–2024 (USD Million)
Table 54 Canada: Molecular Control Market, By End User, 2016–2024 (USD Million)
Table 55 Europe: Molecular Control Market, By Product, 2016–2024 (USD Million)
Table 56 Europe: Instrument-Specific Controls Market, By Technology, 2016–2024 (USD Million)
Table 57 Europe: Molecular Control Market, By Analyte Type, 2016–2024 (USD Million)
Table 58 Europe: Molecular Control Market, By Application, 2016–2024 (USD Million)
Table 59 Europe: Molecular Control Market, By End User, 2016–2024 (USD Million)
Table 60 Asia Pacific: Market, By Product, 2016–2024 (USD Million)
Table 61 Asia Pacific: Instrument-Specific Controls Market, By Technology, 2016–2024 (USD Million)
Table 62 Asia Pacific: Market, By Analyte Type, 2016–2024 (USD Million)
Table 63 Asia Pacific: Market, By Application, 2016–2024 (USD Million)
Table 64 Asia Pacific: Market, By End User, 2016–2024 (USD Million)
Table 65 RoW: Market, By Product, 2016–2024 (USD Million)
Table 66 RoW: Instrument-Specific Controls Market, By Technology, 2016–2024 (USD Million)
Table 67 RoW: Market, By Analyte Type, 2016–2024 (USD Million)
Table 68 RoW: Market, By Application, 2016–2024 (USD Million)
Table 69 RoW: Market, By End User, 2016–2024 (USD Million)
List of Figures (25 Figures)
Figure 1 Research Design
Figure 2 Primary Sources
Figure 3 Bottom-Up Approach
Figure 4 Top-Down Approach
Figure 5 Data Triangulation Methodology
Figure 6 Market, By Product, 2018 (USD Million)
Figure 7 Market, By Analyte Type, 2018 vs 2024 (USD Million)
Figure 8 Market, By Application, 2018 (USD Million)
Figure 9 Market, By End User, 2018
Figure 10 Geographical Snapshot of the Market
Figure 11 Market to Register A Double-Digit Growth Rate During the Forecast Period
Figure 12 Independent Controls Segment to Register the Highest Growth During the Forecast Period (2018–2024)
Figure 13 Clinical Laboratories Accounted for the Largest Share of the North American Market in 2018
Figure 14 Market: Drivers, Restraints, Opportunities, and Challenges
Figure 15 Number of Laboratories That Received Clia Accreditation, By Accreditation Organization (2018)
Figure 16 Geographic Snapshot: APAC Will Be the Fastest-Growing Regional Segment in the Market During the Forecast Period
Figure 17 North America: Market Snapshot
Figure 18 Asia Pacific: Market Snapshot
Figure 19 Rank of Companies in the Global Market, 2017
Figure 20 Market (Global), Competitive Leadership Mapping, 2017
Figure 21 Thermo Fisher Scientific: Company Snapshot (2017)
Figure 22 Bio-Rad Laboratories: Company Snapshot (2017)
Figure 23 Roche Diagnostics: Company Snapshot (2017)
Figure 24 Abbott Laboratories: Company Snapshot (2017)
Figure 25 Quidel: Company Snapshot (2017)
The study involved four major activities in estimating the current market size for molecular quality controls. Exhaustive research was conducted to collect information on the market as well as its peer and parent markets. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. Thereafter, market breakdown and data triangulation were used to estimate the market size of segments and subsegments.
Secondary Research
In the secondary research process, various sources such as Bloomberg BusinessWeek, Forbes, and D&B were referred to, so as to identify and collect information useful for a technical, market-oriented, and commercial study of the molecular quality controls market. These secondary sources include annual reports, press releases & investor presentations of companies, Clinical and Laboratory Standards Institute (CLSI), Clinical Laboratory Improvement Amendments (CLIA), National Accreditation Board for Testing and Calibration Laboratories (NABL), Association for Molecular Pathology, International Organization for Standardization (ISO), World Health Organization (WHO), Quality Council of India (QCI), and College of American Pathologists (CAP). Secondary research was mainly used to obtain key information about the industry’s supply chain, the total pool of key players, market classification, and segmentation according to industry trends to the bottom-most level and regional markets. It was also used to obtain information about the key developments from a market-oriented perspective.
Primary Research
The molecular quality controls market comprises several stakeholders such as raw material suppliers, manufacturers of molecular quality controls, and regulatory organizations in the supply chain. Various primary sources from both the supply and demand sides of the market were interviewed to obtain qualitative and quantitative information. The primary interviewees from the demand side include key opinion leaders in the IVD manufacturers, research laboratories, and academic institutes. The primary sources from the supply side include key opinion leaders, distributors, and molecular quality controls manufacturers. Various primary sources from both the supply and demand sides of the market were interviewed to obtain qualitative and quantitative information. Given below is the breakdown of primary respondents:
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Market Size Estimation
Both the top-down and bottom-up approaches were used to estimate and validate the total size of the molecular quality controls market. These approaches were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
- Key players were identified through extensive secondary research.
- The molecular quality controls industry’s value chain and market size, in terms of value, was determined through primary and secondary research.
- All percentage shares, splits, and breakdowns were determined using secondary sources and verified through primary sources.
- All possible parameters that affect the market covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to obtain the final quantitative and qualitative data.
Data Triangulation
After arriving at the overall market size—using the market size estimation processes explained above—the market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics of each market segment and subsegment, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides of the molecular quality controls industry.
Report Objectives
- To define, segment, and estimate the global market size for molecular quality controls
- To understand the structure of the molecular quality controls market by identifying its various subsegments
- To provide detailed information about the key factors influencing the growth of the market (drivers, restraints, and opportunities)
- To estimate the size of the market and its submarkets in North America, Europe, Asia Pacific, and the Rest of the World (along with their respective key countries)
- To profile key players and comprehensively analyze their core competencies
- To understand the competitive landscape and identify the major growth strategies adopted by players across key regions
- To analyze the competitive developments such as expansions & investments, product launches, and acquisitions in the market
Available Customizations
With the given market data, MarketsandMarkets offers customizations according to company-specific scientific needs.
The following customization options are available for the report:
Regional Analysis
- Further breakdown of the European molecular quality controls market, by country
- Further breakdown of the Asia Pacific molecular quality controls market, by country
- Further breakdown of the RoW molecular quality controls market, by country
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Growth opportunities and latent adjacency in Molecular Quality Controls Market
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