Molecular Quality Controls Market Overview and Forecast by 2031
The molecular quality controls market size is projected to reach US$ 0.52 billion by 2031 from US$ 0.22 billion in 2023. The market is expected to register a CAGR of 12.8% during 2023–2031. Burgeoning demand for personalized medicines will likely remain a key trend in the market.
Molecular Quality Controls Market Analysis
Factors such as growing funds for genomics and increasing prevalence of genetic diseases fuel the growth of the market. Furthermore, a rise in focus on molecular diagnostics is emerging as a key opportunity for the molecular quality control market players.
Molecular Quality Controls Market Overview
Genome sequencing was restricted to the research facilities a few years back. However, it has now become one of the standard techniques in clinical practices. As per the study ‘Integrating Genomics into Healthcare’, over the next few years, the healthcare sector is expected to generate genomic data of over 60 million patients. The growing implementation of genomic sequencing in healthcare systems is supported by substantial government investments, totaling over US$ 4 billion in at least 14 countries. The UK announced the world’s largest genome project as a part of a 200 million public-private collaboration between charitable organizations and pharmaceutical companies.
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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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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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Molecular Quality Controls Market Drivers and Opportunities
Increasing Prevalence of Genetic Diseases
Since molecular quality controls facilitate result interpretation, they are employed in the detection of genetic disorders. An additional whole or partial copy of chromosome 21 is the resultant aberrant cell division that produces the genetic disease known as Downs syndrome. According to the US Centers for Disease Control and Prevention (CDC), around 6,000 babies in the US are born with Down syndrome each year. Prenatal testing for Down syndrome is rising nationwide as a result.
Two genes, BRCA1 (breast cancer gene one) and BRCA2 (breast cancer gene two), are mutated in the majority of hereditary instances of breast cancer. According to the American Cancer Society, faulty genes that are passed on from parents to their offspring account for 5% to 10% of occurrences of breast cancer that are hereditary. Genetic testing for hereditary breast cancer is becoming more popular as breast cancer awareness grows.
Rise in Adoption of Molecular Diagnostics
Molecular diagnostics methodologies are used to detect disturbances between specific sequences in DNA or RNA. The irregularities such as single nucleotide polymorphism (SNP), deletions, rearrangements, and insertions lead to various diseases—such as infectious diseases, cancer, viral diseases, and sexually transmitted diseases (STDs).
As per the Flu Facts and Statistics report, during 2017-2018, there were around 31.4 million outpatient visits due to flu. It also mentioned that 5-20% of the US population gets flu every year. Furthermore, according to the National Cancer Institute, in 2020, around 1,806,590 new cases of cancer will be diagnosed in the US, with an estimated death count of 606,520. The number of people who have cancer is expected to rise to 19 million by 2024. Such high prevalence of infectious diseases and increasing incidence of cancer lead to high traction toward molecular diagnostics, as it is capable of diagnosing diseases with high specificity, further paving the way for treating patients with precision medicine.
Molecular Quality Controls Market Report Segmentation Analysis
Key segments that contributed to the derivation of the molecular quality controls market analysis are product, application, and end user.
- Based on product, the molecular quality controls market is segmented into independent controls and instrument specific controls); analyte type (single analyte controls and multi analyte controls). The independent controls segment held a most significant market share in 2023.
- Based on application, the molecular quality controls market is segmented by infectious diseases, oncology, genetic testing, other applications. The infectious diseases segment held a largest market share in 2023.
- Based on end users, the molecular quality controls market is segmented by clinical laboratories, hospitals, ivd manufacturers & contract research organizations, academic & research institutes, other end users. The clinical laboratories segment held a largest market share in 2023.
Molecular Quality Controls Market Share Analysis by Geography
The geographic scope of the molecular quality controls market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South & Central America.
In North America, the U.S. is the most significant molecular quality control market. The increasing investments and rising funds dedicated to manufacturing companies as well as academic and research institutes for the development of cancer medicines, the growing geriatric population, infectious disease, and other therapeutics are some of the major driving factors.
Diagnostics based on NGS are generally expected to guide care selection in the future to improve patient outcomes. According to the National Cancer Institute, in the United States, an estimated 1,806,590 new cases of cancer will be diagnosed in 2020, with 606,520 people dying from the disease. Similarly, according to The Leukemia & Lymphoma Society (LLS), an estimated 178,520 people in the United States were diagnosed with leukemia, lymphoma, or myeloma in 2020. As a result, the factors mentioned above would boost market growth in the forecasted timeframes.
Molecular Quality Controls Market Report Scope
Molecular Quality Controls Market News and Recent Developments
The Molecular Quality Controls Market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the molecular quality controls market are listed below:
- Abbott and Personalis, Inc. have entered into a collaborative agreement to develop and distribute liquid biopsy controls intended for use in next-generation sequencing (NGS) research. The objective of this collaboration is to enhance the precision and dependability of liquid biopsy procedures for the detection and tracking of cancer. (Source: Abbott, Company Website, May 2024)
- New QuantiTect viral load controls for cytomegalovirus, hepatitis B virus (HBV), and SARS-CoV-2 are now available, according to Qiagen. These controls address the rising requirement for accurate viral infection monitoring in clinical settings. (Source: Qiagen, Company Website, January 2024)
Molecular Quality Controls Market Report Coverage and Deliverables
The “Molecular Quality Controls Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:
- Molecular quality controls marketsize and forecast at global, regional, and country levels for all the key market segments covered under the scope
- Molecular quality controls markettrends as well as market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST/Porter’s Five Forces and SWOT analysis
- Molecular quality controls marketanalysis covering key market trends, global and regional framework, major players, regulations, and recent market developments.
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the molecular quality controls market
- Detailed company profiles
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
North America dominated the molecular quality controls market in 2023
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.
The burgeoning demand for personalized Medicine will likely remain a key trend in the market.
THERMO FISHER SCIENTIFIC, INC., Qnostics, BIO-RAD LABORATORIES, INC., F. HOFFMANN LA-ROCHE LTD., Abbott, Quidel Corporation, Maine Molecular Controls, Inc., Zeptometrix Corporation, Microbiologics, and Seracare Life Sciences.
The market is expected to register a CAGR of 12.8% during 2023–2031.
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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