Global Molecular Quality Controls Market Size study & Forecast, by Product (Independent Control, Instrument Specific Control ), Application, Analyte Type, End User and Regional Forecasts 2022-2032

Description

The Global Molecular Quality Controls Market, valued at approximately USD 2.27 billion in 2024, is poised to expand at a CAGR of 6.60% during the forecast period 2025-2035. Molecular quality controls play a pivotal role in ensuring the reliability, precision, and standardization of molecular diagnostic tests. They act as critical benchmarks for laboratories to verify instrument performance, reagent integrity, and procedural accuracy-elements that are vital in clinical decision-making. This market's growth is being underpinned by the increasing demand for accurate infectious disease diagnostics, the rise in molecular testing volumes, and the ongoing shift towards personalized medicine. Heightened awareness regarding early and precise disease detection has accelerated the adoption of these controls, with healthcare systems prioritizing diagnostic accuracy to improve patient outcomes.

The escalating global burden of infectious diseases, coupled with the rapid pace of technological innovations in PCR and DNA sequencing platforms, has intensified the need for robust molecular quality control solutions. Advances in automation, multiplex assay capabilities, and integrated diagnostic workflows have not only increased testing throughput but also amplified the necessity for rigorous quality assurance. The market is also benefiting from the expansion of molecular diagnostics into decentralized testing environments, such as point-of-care and near-patient settings, where maintaining accuracy is paramount. However, the high cost of advanced quality control products and limited accessibility in emerging economies could temper growth to some extent, particularly in resource-constrained healthcare systems.

Geographically, North America currently commands the largest share of the market, buoyed by a well-established diagnostic infrastructure, stringent regulatory requirements, and the presence of leading molecular diagnostic companies. The U.S., in particular, has seen significant investment in advanced infectious disease testing capabilities, driving sustained demand for quality control materials. Europe follows closely, propelled by supportive healthcare policies, rising adoption of precision medicine, and heightened laboratory accreditation standards. Meanwhile, the Asia Pacific region is forecasted to witness the fastest growth, fueled by expanding healthcare infrastructure, rising investments in molecular diagnostic labs in countries such as China and India, and increasing awareness of early disease detection. Latin America and the Middle East & Africa are also showing promising potential, backed by improvements in public health systems and gradual modernization of laboratory facilities.

Major market players included in this report are:

Thermo Fisher Scientific Inc.
Bio-Rad Laboratories, Inc.
LGC Limited
ZeptoMetrix Corporation
Abbott Laboratories
SeraCare Life Sciences Inc.
Randox Laboratories Ltd.
Roche Diagnostics
Siemens Healthineers AG
QuidelOrtho Corporation
Qnostics Ltd.
Microbiologics, Inc.
Genomic Health, Inc.
Grifols S.A.
Precision Biomonitoring Inc.

Global Molecular Quality Controls Market Report Scope:

Historical Data - 2023, 2024
Base Year for Estimation - 2024
Forecast period - 2025-2035
Report Coverage - Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
Regional Scope - North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Customization Scope - Free report customization (equivalent up to 8 analysts' working hours) with purchase. Addition or alteration to country, regional & segment scope*

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within the countries involved in the study. The report also provides detailed information about crucial aspects, such as driving factors and challenges, which will define the future growth of the market. Additionally, it incorporates potential opportunities in micro-markets for stakeholders to invest, along with a detailed analysis of the competitive landscape and product offerings of key players. The detailed segments and sub-segments of the market are explained below:

By Product:

Independent Control
Instrument Specific Control (PCR, DNA Sequencing)

By Application:

Infectious Disease Diagnostics

By Analyte Type:

[Multiple analyte categories as per industry classification]

By End User:

Hospitals
Diagnostic Lab

By Region:

North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
Rest of Europe (ROE)
Asia Pacific
China
India
Japan
Australia
South Korea
Rest of Asia Pacific (RoAPAC)
Latin America
Brazil
Mexico
Middle East & Africa
UAE
Saudi Arabia
South Africa
Rest of Middle East & Africa

Key Takeaways:

Market Estimates & Forecast for 10 years from 2025 to 2035.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with Country level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approach.
Analysis of competitive structure of the market.
Demand side and supply side analysis of the market.

Chapter 1. Global Molecular Quality Controls Market Report Scope & Methodology

1.1. Research Objective
1.2. Research Methodology
- 1.2.1. Forecast Model
- 1.2.2. Desk Research
- 1.2.3. Top Down and Bottom-Up Approach
1.3. Research Attributes
1.4. Scope of the Study
- 1.4.1. Market Definition
- 1.4.2. Market Segmentation
1.5. Research Assumption
- 1.5.1. Inclusion & Exclusion
- 1.5.2. Limitations
- 1.5.3. Years Considered for the Study

Chapter 2. Executive Summary

2.1. CEO/CXO Standpoint
2.2. Strategic Insights
2.3. ESG Analysis
2.4. Key Findings

Chapter 3. Global Molecular Quality Controls Market Forces Analysis

3.1. Market Forces Shaping The Global Molecular Quality Controls Market (2024-2035)
3.2. Drivers
- 3.2.1. Rising adoption of molecular diagnostics and increasing infectious disease testing volumes.
- 3.2.2. Technological advancements in PCR, NGS and sequencing platforms driving demand for instrument-specific controls.
3.3. Restraints
- 3.3.1. High cost of advanced quality control materials and instrumentation limiting uptake in resource-constrained settings.
- 3.3.2. Regulatory, standardization and reimbursement complexities impacting market penetration.
3.4. Opportunities
- 3.4.1. Expansion of point-of-care and decentralized molecular testing creating new QC product demand.
- 3.4.2. Integration with automation, AI-driven analytics and multiplex controls enabling product innovation and service models.

Chapter 4. Global Molecular Quality Controls Industry Analysis

4.1. Porter's 5 Forces Model
- 4.1.1. Bargaining Power of Buyer
- 4.1.2. Bargaining Power of Supplier
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
4.2. Porter's 5 Force Forecast Model (2024-2035)
4.3. PESTEL Analysis
- 4.3.1. Political
- 4.3.2. Economical
- 4.3.3. Social
- 4.3.4. Technological
- 4.3.5. Environmental
- 4.3.6. Legal
4.4. Top Investment Opportunities
4.5. Top Winning Strategies (2025)
4.6. Market Share Analysis (2024-2025)
4.7. Global Pricing Analysis And Trends 2025
4.8. Analyst Recommendation & Conclusion

Chapter 5. Global Molecular Quality Controls Market Size & Forecasts by Product 2025-2035

5.1. Market Overview
5.2. Global Molecular Quality Controls Market Performance - Potential Analysis (2025)
5.3. Independent Control
- 5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.3.2. Market size analysis, by region, 2025-2035
5.4. Instrument Specific Control (PCR, DNA Sequencing)
- 5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.4.2. Market size analysis, by region, 2025-2035

Chapter 6. Global Molecular Quality Controls Market Size & Forecasts by Application 2025-2035

6.1. Market Overview
6.2. Global Molecular Quality Controls Market Performance - Potential Analysis (2025)
6.3. Infectious Disease Diagnostics
- 6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.3.2. Market size analysis, by region, 2025-2035
6.4. Other Molecular Diagnostic Applications (Research/Translational)
- 6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.4.2. Market size analysis, by region, 2025-2035

Chapter 7. Global Molecular Quality Controls Market Size & Forecasts by Region 2025-2035

7.1. Molecular Quality Controls Market, Regional Market Snapshot
7.2. Top Leading & Emerging Countries
7.3. North America Molecular Quality Controls Market
- 7.3.1. U.S. Molecular Quality Controls Market
  - 7.3.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.3.1.2. Application breakdown size & forecasts, 2025-2035
- 7.3.2. Canada Molecular Quality Controls Market
  - 7.3.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.3.2.2. Application breakdown size & forecasts, 2025-2035
7.4. Europe Molecular Quality Controls Market
- 7.4.1. UK Molecular Quality Controls Market
  - 7.4.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.1.2. Application breakdown size & forecasts, 2025-2035
- 7.4.2. Germany Molecular Quality Controls Market
  - 7.4.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.2.2. Application breakdown size & forecasts, 2025-2035
- 7.4.3. France Molecular Quality Controls Market
  - 7.4.3.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.3.2. Application breakdown size & forecasts, 2025-2035
- 7.4.4. Spain Molecular Quality Controls Market
  - 7.4.4.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.4.2. Application breakdown size & forecasts, 2025-2035
- 7.4.5. Italy Molecular Quality Controls Market
  - 7.4.5.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.5.2. Application breakdown size & forecasts, 2025-2035
- 7.4.6. Rest of Europe Molecular Quality Controls Market
  - 7.4.6.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.6.2. Application breakdown size & forecasts, 2025-2035
7.5. Asia Pacific Molecular Quality Controls Market
- 7.5.1. China Molecular Quality Controls Market
  - 7.5.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.1.2. Application breakdown size & forecasts, 2025-2035
- 7.5.2. India Molecular Quality Controls Market
  - 7.5.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.2.2. Application breakdown size & forecasts, 2025-2035
- 7.5.3. Japan Molecular Quality Controls Market
  - 7.5.3.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.3.2. Application breakdown size & forecasts, 2025-2035
- 7.5.4. Australia Molecular Quality Controls Market
  - 7.5.4.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.4.2. Application breakdown size & forecasts, 2025-2035
- 7.5.5. South Korea Molecular Quality Controls Market
  - 7.5.5.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.5.2. Application breakdown size & forecasts, 2025-2035
- 7.5.6. Rest of APAC Molecular Quality Controls Market
  - 7.5.6.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.6.2. Application breakdown size & forecasts, 2025-2035
7.6. Latin America Molecular Quality Controls Market
- 7.6.1. Brazil Molecular Quality Controls Market
  - 7.6.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.6.1.2. Application breakdown size & forecasts, 2025-2035
- 7.6.2. Mexico Molecular Quality Controls Market
  - 7.6.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.6.2.2. Application breakdown size & forecasts, 2025-2035
7.7. Middle East and Africa Molecular Quality Controls Market
- 7.7.1. UAE Molecular Quality Controls Market
  - 7.7.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.7.1.2. Application breakdown size & forecasts, 2025-2035
- 7.7.2. Saudi Arabia (KSA) Molecular Quality Controls Market
  - 7.7.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.7.2.2. Application breakdown size & forecasts, 2025-2035
- 7.7.3. South Africa Molecular Quality Controls Market
  - 7.7.3.1. Product breakdown size & forecasts, 2025-2035
  - 7.7.3.2. Application breakdown size & forecasts, 2025-2035

Chapter 8. Competitive Intelligence

8.1. Top Market Strategies
8.2. Thermo Fisher Scientific Inc.
- 8.2.1. Company Overview
- 8.2.2. Key Executives
- 8.2.3. Company Snapshot
- 8.2.4. Financial Performance (Subject to Data Availability)
- 8.2.5. Product/Services Port
- 8.2.6. Recent Development
- 8.2.7. Market Strategies
- 8.2.8. SWOT Analysis
8.3. Bio-Rad Laboratories, Inc.
8.4. LGC Limited
8.5. ZeptoMetrix Corporation
8.6. Abbott Laboratories
8.7. SeraCare Life Sciences Inc.
8.8. Randox Laboratories Ltd.
8.9. Roche Diagnostics
8.10. Siemens Healthineers AG
8.11. QuidelOrtho Corporation
8.12. Qnostics Ltd.
8.13. Microbiologics, Inc.
8.14. Genomic Health, Inc.
8.15. Grifols S.A.
8.16. Precision Biomonitoring Inc.