As per the recent market research conducted by FMI, the global molecular quality controls market is expected to be valued at USD 204 million in 2023. The market is expected to advance at 7.2% CAGR during the forecast period. By 2033, the estimation is anticipated to surge past USD 408 million.
Key factors that might propel the market growth are:
Worldwide, there has been an exponential surge in people suffering from various diseases owing to a lot of factors. To meet the burgeoning demand for conducting laboratory tests for these patients, both public and private sector players are investing in molecular quality controls. These players develop processes that fall in line with the standards set by regulatory bodies, like International Organization for Standardization.
New multi-analyte and multi-instrument controls have been developed due to technological improvements. These cutting-edge controls combine many instrument-specific controls into a single control, allowing clinical laboratories to save money. These controls save time by eliminating the need for separate quality control processes for each analyte. Several companies have also added additional tests to their portfolios. For example, Bio-Rad Laboratories (USA) released the EDX RP Positive Run Control in February 2020. It was the first multi-analyte control that could target 22 analytes in a single vial, saving laboratories time and space on their instruments.
AcroMetrix Coronavirus 2019 (COVID-19) RNA Control was also launched by Thermo Fisher Scientific (USA) in April 2020 to monitor and validate COVID-19 molecular diagnostic assays. The increased availability of such molecular quality controls for infectious disease diagnostics and other applications is likely to drive market expansion.
Regulatory and legal requirements applied to including molecular diagnostics in the United States and European countries are becoming more stringent. As a result, new guidance documents are required to introduce any modifications to the device.
New applications may necessitate software upgrades, new software installation in an existing device, or other device modifications. Because of the low entry barriers, there is less dependence on the quality of molecular goods. There are no quality assurance requirements mandated for molecular diagnostic testing processes in India.
Currently, North America is the dominant market in terms of market share. The presence of key players in the region is believed to be one of the key factors for their market growth. The availability of technologically advanced options for molecular quality diagnostics is also driving market growth. However, in terms of growth rate, Asia Pacific is expected to be the leading market. The presence of developing nations that are investing massive amounts to upgrade healthcare infrastructure is expected to surge the market share.
| Attributes | Value |
|---|---|
| Market Value (2022) | USD 520.8 million |
| Market Expected Value (2023) | USD 204 million |
| Market Forecast Value (2033) | USD 408 million |
| Market Expected CAGR (2023 to 2033) | 7.2% |
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The medical field has been evolving consistently. With the inception of new kinds of viruses, the development seems to have taken an incremental speed. Taking the development aspect into consideration, healthcare experts have developed advanced techniques. For example, in January 2023, a group of experts from the University of Cambridge developed a new test for general respiratory viruses which makes use of DNA as a ‘bait’. Owing to this, it is anticipated that the adoption of molecular quality controls technique might reduce. The stats suggest that while the anticipated CAGR for the market is 7.2%, the historical CAGR for the market was 12.1%. Technological advancements and a higher focus on research and development can change the fortunes of the market in the longer run.
Additional costs involved in quality control and budget constraints in hospitals and laboratories obstruct market growth. In a clinical laboratory, establishing a quality control process necessitates significant expenditure. Laboratories must also keep a dedicated staff to oversee the quality control system.
Quality control procedures entail equal expenses regardless of the number of tests completed. As a result, the cost of implementing quality control processes is prohibitively expensive for clinical laboratories doing modest quantities of diagnostic tests. These factors might challenge the adoption of quality control measures.
Principal Consultant
| Regions | North America |
|---|---|
| Countries | United States |
| CAGR (2023 to 2033) | 7% |
| Regions | Europe |
|---|---|
| Countries | United Kingdom |
| CAGR (2023 to 2033) | 6.3% |
| Regions | Asia Pacific |
|---|---|
| Countries | China |
| CAGR (2023 to 2033) | 6.6% |
| Regions | Asia Pacific |
|---|---|
| Countries | Japan |
| CAGR (2023 to 2033) | 5.7% |
| Regions | Asia Pacific |
|---|---|
| Countries | India |
| CAGR (2023 to 2033) | 5% |
The United States has been witnessing several cases of cystic fibrosis. Based on data published in Medlineplus, the disease occurs in 1 in 2,500 to 3,500 white newborns. The country has been going through massive upgradation in the healthcare infrastructure. Thus, there has been an improvement in the molecular quality controls devices too, as technological upgradation would improve the efficiency of molecular control devices.
| Attributes | Details |
|---|---|
| United States Market Expected Size (2033) | USD 144.5 million |
| United States Market Absolute Dollar Growth | USD 70.8 million |
| CAGR % 2017 to 2022 | 11.7% |
The region has been witnessing a surge in cancer cases as well. In 2022, more than 1.9 million cancer cases were reported in the United States. These numbers are expected to surge in the future. The oncologists make use of molecular quality control technique as it assists them in increasing the precision of the treatment.
The geriatric population has been surging exponentially in the United Kingdom. In 2021, nearly 11% of the population was above the age of 65 years. With improvement in the medical infrastructure, the figures might rise. The people of this age group are susceptible to all kinds of diseases. Thus, to maintain the efficacy of the treatment, doctors generally make use of molecular quality controls to identify the best treatment based on the patient's condition.
| Attributes | Details |
|---|---|
| United Kingdom Market Expected Size (2033) | USD 17.2 million |
| United Kingdom Market Absolute Dollar Growth | USD 7.8 million |
| CAGR % 2017 to 2022 | 10.7% |
Children suffering from Down’s Syndrome are quite high in the United Kingdom. As per the Down’s Syndrome Association, around 1 in 1,000 babies born in the country would be suffering from the disease. Doctors generally make use of molecular quality controls to understand the cause and treat the patients.
China has been vulnerable to the COVID-19 pandemic right from the inception of the virus. Each week, at least 12,000 people are losing their lives. This has led to an increase in demand for molecular quality control devices as the clinical laboratories wanted to address the growing demand for testing solutions.
| Attributes | Details |
|---|---|
| China Market Expected Size (2033) | USD 29.3 million |
| China Market Absolute Dollar Growth | USD 13.8 million |
| CAGR % 2017 to 2022 | 11.3% |
People suffering from Lynch syndrome in China are believed to be one of the most severe kinds of diseases as it increases the probability of developing cancer. The doctors employ this infectious disease quality control technique as it allows them to take proactive measures when it comes to offering suitable treatment.
Women suffering from ovarian cancer are expected to propel the growth rate of the molecular quality control market. The numbers had risen from 4,758 in 2012 to more than 9,000 in 2018, as per AstraZeneca. Health experts make use of molecular quality controls to improve the efficacy of the existing procedures of treatment.
| Attributes | Details |
|---|---|
| Japan Market Expected Size (2033) | USD 23.9 million |
| Japan Market Absolute Dollar Growth | USD 10.2 million |
| CAGR % 2017 to 2022 | 10.2% |
Japan is virtually a hotspot for lifestyle diseases. Lack of proper nutrition has taken a toll on the health of many people. Consequently, they are suffering from several infectious diseases. The prevalence of sickle cell disease is also expected to surge the market share of molecular quality controls in the country.
The medical infrastructure has been evolving at a rapid pace in India. Owing to this, hospitals have started outsourcing certain important aspects of the business which they can afford to focus on other activities. A lot of hospitals are entering into a collaboration with third-party vendors for conducting operations based on molecular quality controls.
| Attributes | Details |
|---|---|
| India Market Expected Size (2033) | USD 14.1 million |
| India Market Absolute Dollar Growth | USD 5.4 million |
| CAGR % 2017 to 2022 | 9.2% |
Many children in India suffer from thalassemia. More than 10,000 children are born with this condition in India, and the survival rate is also not very high. These factors have led to the adoption of molecular quality control devices in hospitals.
| Segment | Analyte |
|---|---|
| Attributes | Single-analyte Controls |
| CAGR (2017 to 2022) | 12% |
| CAGR (2023 to 2033) | 7.1% |
| Segment | End User |
|---|---|
| Attributes | Diagnostic Laboratories |
| CAGR (2017 to 2022) | 11.8% |
| CAGR (2023 to 2033) | 6.4% |
Multiple hospitals and healthcare centers have started opting for single-analyte control as it is a more simplified way to assess and interpret better. These have a low risk of cross-reactivity, which makes them an upfront choice. However, with the development of healthcare, it is expected that the adoption of multi-analyte controls would surge in the future. The ability to cover dozens of parameters at a given time is expected to surge the adoption of multi-analyte controls.
Diagnostic laboratories account for the dominant share of the molecular quality control market. The growth can be attributed due to accredited diagnostic labs opening up. These labs provide their diagnostic services using molecular technology. Apart from that, diagnostic laboratories are entering into collaboration with hospitals, as a result of which they are garnering a huge market share. The diagnostics laboratories make use of QC techniques, which increases the reliability offered by them.
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The start-ups operating in the market make use of innovative molecular diagnostics techniques. They are implementing groundbreaking high-throughput single-cell analyses for clinical research, diagnostics, and drug development. The start-ups are also making use of innovative sustainable biomedical research that would aid in the advancement of medicine.
BostonGene: The start-up has been working on providing comprehensive molecular and immune profiling. This would certainly assist the healthcare workers in treatment. The solution provided by the start-up would aid in innovative clinical decision-making, and also promises to provide AI-backed research solutions for precision oncology. In April 2022, BostonGene raised USD 150 million in the Series B round, propelling the company to unicorn status.
The key players operating in the market are introducing an innovative ‘mixed reality experience’ for use, which is specially designed for blood donors. The innovation is done to improve the experience and attract young blood donors to motivate them for donating blood. In January 2023, Abbott and Blood Centers of America launched first of its kind mixed reality experience for use during blood donation.
Key developments in the market:
Dominant players in the market are
| Company | Description |
|---|---|
| LGC | LGC is the leading global science tools company and has been providing mission-critical components and solutions to high-growth areas in the healthcare sector. LGC has been providing tools for genomics, which are typically embedded within the customers’ products. The company has been working for the progression of research and development, optimizing food production, and enhancing the quality of our food. |
| Abbott | Abbott has been creating breakthrough products in diagnostics, medical devices, nutrition, and branded generic pharmaceuticals. The company has been employing more than 113,000 people across the globe and has been working in more than 160 countries. The company has had the reputation of being Fortune’s most admired company for 9 years consecutively. |
| Microbiologics, Inc. | Microbiologics, Inc. is the world’s leading expert in biological products and services. For more than five decades, the company has been partnering with healthcare and life science laboratories across the globe to create and provide biological control materials, assay services, and consulting for microbiology, molecular diagnostics, and virology. As an award-winning company dedicated to improving operations and performance, the company is well-positioned for continuous success. |
Other key players profiled: Thermo Fisher Scientific, Bio-Rad Laboratories, Inc.
The molecular quality controls market is worth USD 204 million in 2023.
The molecular quality controls market size is expected to reach USD 408 million by 2033.
The molecular quality controls market is rising at a 7.2% CAGR through 2033.
China’s molecular quality controls market is set to be worth USD 29.3 million by 2033.
India market growth is estimated to be USD 5.4 million by 2033.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Market Analysis 2017 to 2022 and Forecast, 2023 to 2033 5. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Analyte 5.1. Single-analyte Controls 5.2. Multi-analyte Controls 6. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Product Type 6.1. Independent Controls 6.2. Instrument-specific Controls 7. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Application 7.1. Infectious Diseases Diagnostics 7.2. Oncology Testing and Genetic Testing 8. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By End User 8.1. Diagnostic Laboratories 8.2. Hospitals 8.3. IVD Manufacturer & CROs 8.4. Academic & Research Institutes 9. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Region 9.1. North America 9.2. Latin America 9.3. Europe 9.4. Asia Pacific 9.5. Middle East and Africa 10. North America Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 11. Latin America Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 12. Europe Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 13. Asia Pacific Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 14. Middle East and Africa Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 15. Key Countries Market Analysis 16. Market Structure Analysis 17. Competition Analysis 17.1. Abbott 17.2. LGC Ltd 17.3. Thermo Fisher Scientific 17.4. Bio-Rad Laboratories, Inc. 17.5. Microbiologics, Inc. 17.6. Roche Diagnostics 17.7. Zeptometrix LLC 17.8. Quidel Corporation 17.9. Maine Molecular Quality Controls, Inc. 17.10. Bio-Techne Corporation 18. Assumptions & Acronyms Used 19. Research Methodology
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Molecular Quality Controls Market
