Molecular Quality Controls Market Size & Opportunities Analysis - Growth Strategies, Competitiveness, and Forecasts (2025

Description

The global molecular quality controls market is set for steady growth, with a market size of USD 220 million in 2024. The market is projected to reach USD 388 million by 2032, advancing at a compound annual growth rate (CAGR) of 7.5% from 2025 to 2032. This growth is driven by the increasing demand for accurate and reliable diagnostic testing, particularly in molecular diagnostics, which are essential for disease detection and personalized treatment.

As healthcare continues to evolve with advancements in molecular biology and genetic research, the need for effective quality control in molecular testing laboratories is becoming more critical. Molecular quality controls are used to assess the performance of diagnostic tests, ensuring the accuracy and consistency of results. The market is also benefiting from the growing adoption of molecular diagnostic technologies in areas like infectious disease testing, oncology, and genetic testing.

Key Insights

The global molecular quality controls market is expected to grow at a CAGR of 7.5% from 2025 to 2032, reaching a projected value of USD 388 million by 2032, up from USD 220 million in 2024.

The increasing use of molecular diagnostic tests, which are vital for detecting genetic, infectious, and oncological diseases, is driving the demand for molecular quality controls.

As the healthcare industry focuses more on precision medicine, the need for accurate molecular diagnostic testing is growing, pushing for enhanced quality control to ensure reliable results in clinical laboratories.

The adoption of advanced molecular diagnostic techniques, including PCR (polymerase chain reaction), next-generation sequencing (NGS), and CRISPR-based diagnostics, is a significant factor contributing to the rise of the molecular quality controls market.

Molecular quality controls are essential in maintaining laboratory accreditation and ensuring that diagnostic tests consistently meet regulatory and performance standards.

The market is segmented by product type, including external controls, internal controls, and others, with external controls expected to hold the largest market share due to their widespread use in laboratories for ensuring test accuracy.

The growing demand for molecular quality controls is driven by the increasing number of diagnostic tests performed for infectious diseases, cancer, genetic disorders, and other conditions that require precise and reliable results.

The oncology sector, in particular, is expected to drive significant growth in the market as molecular diagnostics become more integrated into cancer detection, prognostication, and treatment decisions.

Regulatory bodies and guidelines from organizations like the FDA (Food and Drug Administration) and ISO (International Organization for Standardization) are encouraging the use of molecular quality controls to maintain high standards in diagnostic testing.

The competitive landscape features both established players in the molecular diagnostics industry and emerging companies offering specialized molecular quality control products. These companies are focusing on developing innovative solutions that enhance accuracy, sensitivity, and cost-effectiveness.

The market also benefits from the increasing number of accredited testing laboratories and the rising trend of point-of-care molecular diagnostic testing, which is contributing to the need for reliable quality control solutions.

Product Code: 12522

Chapter 1. Research Scope

1.1. Research Objectives
1.2. Market Definition
1.3. Analysis Period
1.4. Market Size Breakdown by Segments
- 1.4.1. Market Size Breakdown, by Product Type
- 1.4.2. Market Size Breakdown, by Analyte Type
- 1.4.3. Market Size Breakdown, by Application
- 1.4.4. Market Size Breakdown, by End User
- 1.4.5. Market Size Breakdown, by Region
- 1.4.6. Market Size Breakdown, by Country
1.5. Market Data Reporting Unit
- 1.5.1. Revenue
1.6. Key Stakeholders

Chapter 2. Research Methodology

2.1. Secondary Research
- 2.1.1. Paid
- 2.1.2. Unpaid
- 2.1.3. P&S Intelligence Database
2.2. Primary Research
2.3. Market Size Estimation
2.4. Data Triangulation
2.5. Currency Conversion Rates
2.6. Assumptions for the Study
2.7. Notes and Caveats

Chapter 3. Executive Summary

Chapter 4. Market Indicators

Chapter 5. Industry Outlook

5.1. Industry Background
5.2. Market Dynamics
- 5.2.1. Trends
- 5.2.2. Drivers
- 5.2.3. Restraints/Challenges
- 5.2.4. Emerging Economies and Key Opportunities
- 5.2.5. Impact Analysis of Drivers/Restraints
5.3. Impact of COVID-19
5.4. Sociopolitical Impact
5.5. Porter's Five Forces Analysis
- 5.5.1. Bargaining Power of Buyers
- 5.5.2. Bargaining Power of Suppliers
- 5.5.3. Threat of New Entrants
- 5.5.4. Intensity of Rivalry
- 5.5.5. Threat of Substitutes
5.6. Innovation and Technology Trends
5.7. Supply Chain and Value Chain Insights
5.8. Economic and Regulatory Impact
5.9. Market Entry Strategies

Chapter 6. Competitive Landscape

6.1. List of Market Players and their Offerings
6.2. Market Share of Key Players (2024)
- 6.2.1. Global
- 6.2.2. North America
- 6.2.3. Europe
- 6.2.4. Asia-Pacific
- 6.2.5. Latin America
- 6.2.6. Middle East and Africa
6.3. Competitive Benchmarking of Key Players
6.4. Product Benchmarking of Key Players
6.5. Recent Strategic Developments by Key Players
6.6. Company Leadership Matrix

Chapter 7. Global Market

7.1. Overview
7.2. Market Revenue, by Product Type (2019-2032)
7.3. Market Revenue, by Analyte Type (2019-2032)
7.4. Market Revenue, by Application (2019-2032)
7.5. Market Revenue, by End User (2019-2032)
7.6. Market Revenue, by Region (2019-2032)

Chapter 8. North America Market

8.1. Overview
8.2. Market Revenue, by Product Type (2019-2032)
8.3. Market Revenue, by Analyte Type (2019-2032)
8.4. Market Revenue, by Application (2019-2032)
8.5. Market Revenue, by End User (2019-2032)
8.6. Market Revenue, by Country (2019-2032)

Chapter 9. Europe Market

9.1. Overview
9.2. Market Revenue, by Product Type (2019-2032)
9.3. Market Revenue, by Analyte Type (2019-2032)
9.4. Market Revenue, by Application (2019-2032)
9.5. Market Revenue, by End User (2019-2032)
9.6. Market Revenue, by Country (2019-2032)

Chapter 10. Asia-Pacific Market

10.1. Overview
10.2. Market Revenue, by Product Type (2019-2032)
10.3. Market Revenue, by Analyte Type (2019-2032)
10.4. Market Revenue, by Application (2019-2032)
10.5. Market Revenue, by End User (2019-2032)
10.6. Market Revenue, by Country (2019-2032)

Chapter 11. Latin America Market

11.1. Overview
11.2. Market Revenue, by Product Type (2019-2032)
11.3. Market Revenue, by Analyte Type (2019-2032)
11.4. Market Revenue, by Application (2019-2032)
11.5. Market Revenue, by End User (2019-2032)
11.6. Market Revenue, by Country (2019-2032)

Chapter 12. Middle East and Africa Market

12.1. Overview
12.2. Market Revenue, by Product Type (2019-2032)
12.3. Market Revenue, by Analyte Type (2019-2032)
12.4. Market Revenue, by Application (2019-2032)
12.5. Market Revenue, by End User (2019-2032)
12.6. Market Revenue, by Country (2019-2032)

Chapter 13. U.S. Market

13.1. Overview
13.2. Economic Indicators
13.3. Demographics and Population Insights
13.4. Regional Hotspots
13.5. Growth Drivers
13.6. Challenges and Barriers
13.7. Competitive Strategies
13.8. Emerging Players
13.9. Import/Export Policies
13.10. Compliance Requirements
13.11. Emerging Investment Areas
13.12. Major Ongoing Projects
13.13. Market Size and Forecast
- 13.13.1. Market Revenue, by Product Type (2019-2032)
- 13.13.2. Market Revenue, by Analyte Type (2019-2032)
- 13.13.3. Market Revenue, by Application (2019-2032)
- 13.13.4. Market Revenue, by End User (2019-2032)

Chapter 14. Canada Market

14.1. Overview
14.2. Economic Indicators
14.3. Demographics and Population Insights
14.4. Regional Hotspots
14.5. Growth Drivers
14.6. Challenges and Barriers
14.7. Competitive Strategies
14.8. Emerging Players
14.9. Import/Export Policies
14.10. Compliance Requirements
14.11. Emerging Investment Areas
14.12. Major Ongoing Projects
14.13. Market Size and Forecast
- 14.13.1. Market Revenue, by Product Type (2019-2032)
- 14.13.2. Market Revenue, by Analyte Type (2019-2032)
- 14.13.3. Market Revenue, by Application (2019-2032)
- 14.13.4. Market Revenue, by End User (2019-2032)

Chapter 15. Germany Market

15.1. Overview
15.2. Economic Indicators
15.3. Demographics and Population Insights
15.4. Regional Hotspots
15.5. Growth Drivers
15.6. Challenges and Barriers
15.7. Competitive Strategies
15.8. Emerging Players
15.9. Import/Export Policies
15.10. Compliance Requirements
15.11. Emerging Investment Areas
15.12. Major Ongoing Projects
15.13. Market Size and Forecast
- 15.13.1. Market Revenue, by Product Type (2019-2032)
- 15.13.2. Market Revenue, by Analyte Type (2019-2032)
- 15.13.3. Market Revenue, by Application (2019-2032)
- 15.13.4. Market Revenue, by End User (2019-2032)

Chapter 16. U.K. Market

16.1. Overview
16.2. Economic Indicators
16.3. Demographics and Population Insights
16.4. Regional Hotspots
16.5. Growth Drivers
16.6. Challenges and Barriers
16.7. Competitive Strategies
16.8. Emerging Players
16.9. Import/Export Policies
16.10. Compliance Requirements
16.11. Emerging Investment Areas
16.12. Major Ongoing Projects
16.13. Market Size and Forecast
- 16.13.1. Market Revenue, by Product Type (2019-2032)
- 16.13.2. Market Revenue, by Analyte Type (2019-2032)
- 16.13.3. Market Revenue, by Application (2019-2032)
- 16.13.4. Market Revenue, by End User (2019-2032)

Chapter 17. France Market

17.1. Overview
17.2. Economic Indicators
17.3. Demographics and Population Insights
17.4. Regional Hotspots
17.5. Growth Drivers
17.6. Challenges and Barriers
17.7. Competitive Strategies
17.8. Emerging Players
17.9. Import/Export Policies
17.10. Compliance Requirements
17.11. Emerging Investment Areas
17.12. Major Ongoing Projects
17.13. Market Size and Forecast
- 17.13.1. Market Revenue, by Product Type (2019-2032)
- 17.13.2. Market Revenue, by Analyte Type (2019-2032)
- 17.13.3. Market Revenue, by Application (2019-2032)
- 17.13.4. Market Revenue, by End User (2019-2032)

Chapter 18. Italy Market

18.1. Overview
18.2. Economic Indicators
18.3. Demographics and Population Insights
18.4. Regional Hotspots
18.5. Growth Drivers
18.6. Challenges and Barriers
18.7. Competitive Strategies
18.8. Emerging Players
18.9. Import/Export Policies
18.10. Compliance Requirements
18.11. Emerging Investment Areas
18.12. Major Ongoing Projects
18.13. Market Size and Forecast
- 18.13.1. Market Revenue, by Product Type (2019-2032)
- 18.13.2. Market Revenue, by Analyte Type (2019-2032)
- 18.13.3. Market Revenue, by Application (2019-2032)
- 18.13.4. Market Revenue, by End User (2019-2032)

Chapter 19. Spain Market

19.1. Overview
19.2. Economic Indicators
19.3. Demographics and Population Insights
19.4. Regional Hotspots
19.5. Growth Drivers
19.6. Challenges and Barriers
19.7. Competitive Strategies
19.8. Emerging Players
19.9. Import/Export Policies
19.10. Compliance Requirements
19.11. Emerging Investment Areas
19.12. Major Ongoing Projects
19.13. Market Size and Forecast
- 19.13.1. Market Revenue, by Product Type (2019-2032)
- 19.13.2. Market Revenue, by Analyte Type (2019-2032)
- 19.13.3. Market Revenue, by Application (2019-2032)
- 19.13.4. Market Revenue, by End User (2019-2032)

Chapter 20. Japan Market

20.1. Overview
20.2. Economic Indicators
20.3. Demographics and Population Insights
20.4. Regional Hotspots
20.5. Growth Drivers
20.6. Challenges and Barriers
20.7. Competitive Strategies
20.8. Emerging Players
20.9. Import/Export Policies
20.10. Compliance Requirements
20.11. Emerging Investment Areas
20.12. Major Ongoing Projects
20.13. Market Size and Forecast
- 20.13.1. Market Revenue, by Product Type (2019-2032)
- 20.13.2. Market Revenue, by Analyte Type (2019-2032)
- 20.13.3. Market Revenue, by Application (2019-2032)
- 20.13.4. Market Revenue, by End User (2019-2032)

Chapter 21. China Market

21.1. Overview
21.2. Economic Indicators
21.3. Demographics and Population Insights
21.4. Regional Hotspots
21.5. Growth Drivers
21.6. Challenges and Barriers
21.7. Competitive Strategies
21.8. Emerging Players
21.9. Import/Export Policies
21.10. Compliance Requirements
21.11. Emerging Investment Areas
21.12. Major Ongoing Projects
21.13. Market Size and Forecast
- 21.13.1. Market Revenue, by Product Type (2019-2032)
- 21.13.2. Market Revenue, by Analyte Type (2019-2032)
- 21.13.3. Market Revenue, by Application (2019-2032)
- 21.13.4. Market Revenue, by End User (2019-2032)

Chapter 22. India Market

22.1. Overview
22.2. Economic Indicators
22.3. Demographics and Population Insights
22.4. Regional Hotspots
22.5. Growth Drivers
22.6. Challenges and Barriers
22.7. Competitive Strategies
22.8. Emerging Players
22.9. Import/Export Policies
22.10. Compliance Requirements
22.11. Emerging Investment Areas
22.12. Major Ongoing Projects
22.13. Market Size and Forecast
- 22.13.1. Market Revenue, by Product Type (2019-2032)
- 22.13.2. Market Revenue, by Analyte Type (2019-2032)
- 22.13.3. Market Revenue, by Application (2019-2032)
- 22.13.4. Market Revenue, by End User (2019-2032)

Chapter 23. South Korea Market

23.1. Overview
23.2. Economic Indicators
23.3. Demographics and Population Insights
23.4. Regional Hotspots
23.5. Growth Drivers
23.6. Challenges and Barriers
23.7. Competitive Strategies
23.8. Emerging Players
23.9. Import/Export Policies
23.10. Compliance Requirements
23.11. Emerging Investment Areas
23.12. Major Ongoing Projects
23.13. Market Size and Forecast
- 23.13.1. Market Revenue, by Product Type (2019-2032)
- 23.13.2. Market Revenue, by Analyte Type (2019-2032)
- 23.13.3. Market Revenue, by Application (2019-2032)
- 23.13.4. Market Revenue, by End User (2019-2032)

Chapter 24. Australia Market

24.1. Overview
24.2. Economic Indicators
24.3. Demographics and Population Insights
24.4. Regional Hotspots
24.5. Growth Drivers
24.6. Challenges and Barriers
24.7. Competitive Strategies
24.8. Emerging Players
24.9. Import/Export Policies
24.10. Compliance Requirements
24.11. Emerging Investment Areas
24.12. Major Ongoing Projects
24.13. Market Size and Forecast
- 24.13.1. Market Revenue, by Product Type (2019-2032)
- 24.13.2. Market Revenue, by Analyte Type (2019-2032)
- 24.13.3. Market Revenue, by Application (2019-2032)
- 24.13.4. Market Revenue, by End User (2019-2032)

Chapter 25. Brazil Market

25.1. Overview
25.2. Economic Indicators
25.3. Demographics and Population Insights
25.4. Regional Hotspots
25.5. Growth Drivers
25.6. Challenges and Barriers
25.7. Competitive Strategies
25.8. Emerging Players
25.9. Import/Export Policies
25.10. Compliance Requirements
25.11. Emerging Investment Areas
25.12. Major Ongoing Projects
25.13. Market Size and Forecast
- 25.13.1. Market Revenue, by Product Type (2019-2032)
- 25.13.2. Market Revenue, by Analyte Type (2019-2032)
- 25.13.3. Market Revenue, by Application (2019-2032)
- 25.13.4. Market Revenue, by End User (2019-2032)

Chapter 26. Mexico Market

26.1. Overview
26.2. Economic Indicators
26.3. Demographics and Population Insights
26.4. Regional Hotspots
26.5. Growth Drivers
26.6. Challenges and Barriers
26.7. Competitive Strategies
26.8. Emerging Players
26.9. Import/Export Policies
26.10. Compliance Requirements
26.11. Emerging Investment Areas
26.12. Major Ongoing Projects
26.13. Market Size and Forecast
- 26.13.1. Market Revenue, by Product Type (2019-2032)
- 26.13.2. Market Revenue, by Analyte Type (2019-2032)
- 26.13.3. Market Revenue, by Application (2019-2032)
- 26.13.4. Market Revenue, by End User (2019-2032)

Chapter 27. Saudi Arabia Market

27.1. Overview
27.2. Economic Indicators
27.3. Demographics and Population Insights
27.4. Regional Hotspots
27.5. Growth Drivers
27.6. Challenges and Barriers
27.7. Competitive Strategies
27.8. Emerging Players
27.9. Import/Export Policies
27.10. Compliance Requirements
27.11. Emerging Investment Areas
27.12. Major Ongoing Projects
27.13. Market Size and Forecast
- 27.13.1. Market Revenue, by Product Type (2019-2032)
- 27.13.2. Market Revenue, by Analyte Type (2019-2032)
- 27.13.3. Market Revenue, by Application (2019-2032)
- 27.13.4. Market Revenue, by End User (2019-2032)

Chapter 28. South Africa Market

28.1. Overview
28.2. Economic Indicators
28.3. Demographics and Population Insights
28.4. Regional Hotspots
28.5. Growth Drivers
28.6. Challenges and Barriers
28.7. Competitive Strategies
28.8. Emerging Players
28.9. Import/Export Policies
28.10. Compliance Requirements
28.11. Emerging Investment Areas
28.12. Major Ongoing Projects
28.13. Market Size and Forecast
- 28.13.1. Market Revenue, by Product Type (2019-2032)
- 28.13.2. Market Revenue, by Analyte Type (2019-2032)
- 28.13.3. Market Revenue, by Application (2019-2032)
- 28.13.4. Market Revenue, by End User (2019-2032)

Chapter 29. U.A.E. Market

29.1. Overview
29.2. Economic Indicators
29.3. Demographics and Population Insights
29.4. Regional Hotspots
29.5. Growth Drivers
29.6. Challenges and Barriers
29.7. Competitive Strategies
29.8. Emerging Players
29.9. Import/Export Policies
29.10. Compliance Requirements
29.11. Emerging Investment Areas
29.12. Major Ongoing Projects
29.13. Market Size and Forecast
- 29.13.1. Market Revenue, by Product Type (2019-2032)
- 29.13.2. Market Revenue, by Analyte Type (2019-2032)
- 29.13.3. Market Revenue, by Application (2019-2032)
- 29.13.4. Market Revenue, by End User (2019-2032)

Chapter 30. Company Profiles

Chapter 31. Appendix

31.1. Sources and References
31.2. Related Reports

Molecular Quality Controls Market Size & Opportunities Analysis - Growth Strategies, Competitiveness, and Forecasts (2025 - 2032)