The PCR and Real-time PCR Molecular Diagnostics Market is segmented by application (infectious diseases, oncology, genetic testing), end-user (hospitals, laboratories, research institutes), technology (conventional PCR, qPCR), and region (North America, Europe, Asia-Pacific)- Market Size, Trends, Opportunity, Forecast 2023-2032

PCR and Real-time PCR Molecular Diagnostics Market: Overview and Definition

The global PCR and real-time PCR molecular diagnostics market size was valued at USD 5.1 billion in 2022 and is projected to reach USD 7.2 billion by 2032, exhibiting a CAGR of 4.5% during the forecast period 2023-2032. The real-time polymerase chain reaction is a molecular diagnostic testing technique used for the identification of the genetic sequence of DNA or RNA is present or not in the given sample. This technique is used to amplify or make more replicas of the genetic material through a series of heating and cooling cycles. This is then further identified by the laboratory equipment and if the amplification is shown means the bacteria, virus, or cancer gene was present in the sample then the result is considered as positive, and if not means it is not present which implies a negative result. This method gives a higher degree of accuracy than microscopy. So, due to the accuracy level provided by real-time PCR, the demand is increasing in the market. 

PCR (Polymerase Chain Reaction) and Real-time PCR (qPCR or quantitative PCR) are molecular diagnostic techniques that are widely used in the field of medical research and diagnostics.

PCR is a technique used to amplify a specific DNA sequence, making it possible to detect even a small amount of DNA from a sample. This technology has revolutionized the field of molecular biology, making it possible to study genetic material at a molecular level. Real-time PCR is a variation of PCR that allows for the detection and quantification of amplified DNA in real-time, as it is happening.

The global PCR and real-time PCR molecular diagnostics market has been growing rapidly in recent years, driven by factors such as increasing prevalence of infectious diseases, genetic disorders, and cancer, as well as increasing demand for personalized medicine.

PCR and Real-time PCR Molecular Diagnostics Market: Key Drivers

There are several factors driving the growth of the PCR and real-time PCR molecular diagnostics market.

Increasing Prevalence of Infectious Diseases: The prevalence of infectious diseases such as COVID-19, tuberculosis, and HIV/AIDS is increasing globally, leading to a rise in demand for molecular diagnostic techniques like PCR and real-time PCR. These techniques provide accurate and quick detection of infectious agents, allowing for early diagnosis, treatment, and control of disease outbreaks.

Growing Demand for Personalized Medicine: The use of PCR and real-time PCR in the development of personalized medicine is increasing, as these techniques can identify genetic markers that can guide treatment decisions. Personalized medicine is becoming more popular, as it allows for more targeted and effective treatment of diseases.

Technological Advancements: Advancements in technology have led to the development of more sophisticated and user-friendly PCR and real-time PCR instruments, reagents, and software. These advancements have improved the accuracy, sensitivity, and speed of PCR and real-time PCR, making them more effective for various applications.

Increasing Funding for Research: Governments, private companies, and non-profit organizations are investing more in research and development of new PCR and real-time PCR products and applications. This has led to the development of new technologies, applications, and reagents that are driving the growth of the market.

Growing Demand for DNA Sequencing: The use of PCR and real-time PCR is increasing in DNA sequencing applications, as they provide a quick and accurate method for DNA amplification. This has led to increased demand for PCR and real-time PCR products from research institutions, pharmaceutical and biotech companies, and academic institutions.

The effectiveness of the real-time PCR molecular diagnostic is the driving factor for market growth. The PCR and real-time PCR molecular diagnostics provide a greater accuracy level as compared to the other process. It is very difficult to make decisions when the result is not accurate. It’s the question of the life and death of the patient.  In 2018, globally Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections are one of the leading causes of chronic liver diseases. As per the research, the World Health Organization declared that more than 250 million people are infected with HBV and more than 70 million with HCV. Around 1.34 million people died due to the Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections globally in 2015. These numbers are high as compared to the number of deaths by HIV. Due to such factors, the concern towards the health of the people globally is rising and the focus of the health organizations is towards the accuracy in the treatment of these diseases and making this count lesser. These factors are spurring the PCR and Real-time PCR molecular diagnostics market in the forecast period.

Globally every day around 1 million sexually transmitted infections (STIs) are acquired. Every year it is estimated that 376 million new infections with 1 of 4 STIs are chlamydia (127 million) gonorrhea (87 million), syphilis (6.3 million), and trichomoniasis (156 million) are happening. Additionally, it is estimated that 65 million people have moderate to severe chronic obstructive pulmonary disease (COPD), from which about 3 million die each year, making it the third leading cause of death globally and the numbers are increasing. More than 334 million crowds suffer from asthma, more affected chronic disease in childhood, affecting 14% of children globally. The prevalence of asthma in children is rising. Such figures show that the need for PCR and real-time PCR molecular diagnostics in the market.  The increasing use of such technologies for infectious diseases testing like HCV and HBV, Sexually Transmitted Infections, Hospital Acquired Infection, Respiratory Infections, and Oncology Testing, Genetic Testing and other application is propelling the market growth in the near future.

PCR and Real-time PCR Molecular Diagnostics Market: Challenges

Despite the growth drivers, there are also several challenges that are being faced by the PCR and real-time PCR molecular diagnostics market. These challenges include:

High Cost of Equipment and Reagents: The cost of PCR and real-time PCR equipment, reagents, and consumables is high, which can be a barrier for small laboratories and clinics. This can limit the adoption of these techniques and hinder market growth.

Competition from Alternative Techniques: There are alternative techniques, such as next-generation sequencing (NGS) and digital PCR (dPCR), which can provide similar or better results than PCR and real-time PCR, depending on the application. This can limit the market growth of PCR and real-time PCR.

Technical Challenges: PCR and real-time PCR can be affected by several technical challenges, such as contamination, variability in amplification efficiency, and limitations in sensitivity and specificity. These challenges can affect the accuracy and reliability of the results, which can be a barrier for adoption in certain applications.

Lack of Standardization: There is a lack of standardization in PCR and real-time PCR protocols and techniques, which can lead to variability in results between laboratories and regions. This can limit the reproducibility and comparability of results, and hinder the adoption of these techniques in clinical and regulatory settings.

Regulatory Challenges: PCR and real-time PCR techniques are subject to regulatory requirements, which can be complex and vary by region. Obtaining regulatory approval can be time-consuming and costly, which can limit the adoption of these techniques by smaller companies and organizations.

PCR and Real-time PCR Molecular Diagnostics Market: Segmentation

By Technology

• Traditional PCR
• Real-time PCR
• Digital PCR

By Product

• Instruments
• Reagents
• Consumables

By Application

• Infectious Diseases Testing
  • HCV and HBV
  • Sexually Transmitted Infections
  • Hospital Acquired Infection
  • Respiratory Infections
  • Others
• Oncology Testing
• Genetic Testing
• Others

By End User      

• Hospitals
• Diagnostic Laboratories
• Academic and Research Centres
• Others

By Region         

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

PCR and Real-time PCR Molecular Diagnostics Market: Regional Synopsis

North America is the most prominent region in the PCR and real-time PCR molecular diagnostics market due to the new technological development processes and growing healthcare industry in U.S., Canada, and Mexico.  These factors will create new opportunities for new entrants in the North American market.  Further, the regulation given by FDA will proliferate the market growth in the forecast period.

Asia pacific is having the second-largest share in the PCR and real-time PCR molecular diagnostics market. Some figures show that 97% of the deaths are due to viral hepatitis in the Western Pacific region. Such factors in the other regions will also fuel the product demand in the near future.

PCR and Real-time PCR Molecular Diagnostics Market: Key Players

• BioMerieux SA
• Danaher Corporation
• Bio-Rad Laboratories
• Becton, Dickinson and Company
• QIAGEN N.V
• F-Hoffmann-La Roche Ltd.
• Genomic Health
• GRIFOLS S.A
• Thermo Fisher Scientific Inc.
• Seegene Inc.
• Abbott Laboratories

PCR and Real-time PCR Molecular Diagnostics Market: Recent Developments

The PCR and real-time PCR molecular diagnostics market has seen several recent developments in terms of technological advancements, product launches, and strategic partnerships. Some notable developments include:

Launch of New PCR and Real-time PCR Instruments: Several leading companies in the market, such as Thermo Fisher Scientific, Bio-Rad Laboratories, and Roche, have launched new PCR and real-time PCR instruments with improved features, including higher throughput, faster run times, and improved sensitivity and specificity.

Increasing Focus on Point-of-Care Testing: There has been a growing focus on developing PCR and real-time PCR platforms for point-of-care testing, which can improve the speed and accuracy of diagnosis in remote or resource-limited settings. Several companies, including Cepheid and BioFire Diagnostics, have developed point-of-care PCR platforms for infectious disease testing.

Expansion of Applications: The range of applications for PCR and real-time PCR has expanded in recent years, with increasing use in areas such as gene expression analysis, genetic testing, and liquid biopsy. This has led to the development of new products and applications, and the market is expected to continue to grow in these areas.

Strategic Partnerships: Several companies have formed strategic partnerships to enhance their offerings in the PCR and real-time PCR market. For example, in 2021, Qiagen and Diasorin Molecular formed a strategic partnership to develop and market automated testing solutions for COVID-19 and other infectious diseases.

Adoption of Digital PCR (dPCR): Digital PCR (dPCR) is an emerging technique that is similar to real-time PCR, but with improved sensitivity and precision. There has been growing adoption of dPCR in areas such as liquid biopsy, prenatal testing, and infectious disease diagnosis, and the market is expected to grow rapidly in the coming years.