Real-time PCR Market Size, Share, and Trends 2024 to 2033

Real-time PCR Market Size and Growth

The global real-time PCR market size was USD 6.04 billion in 2023, calculated at USD 6.35 billion in 2024 and is expected to reach around USD 9.92 billion by 2033, expanding at a CAGR of 5.09% from 2024 to 2033. The rise in genetic disorders and rare diseases in human beings has increased the demand for real-time PCR (real-time Polymerase Chain Reaction), which is estimated to drive the growth of the real-time PCR market over the forecast period.

Real-time PCR Market Key Takeaways

• The North America real-time PCR market size reached USD 2.54 billion in 2023 and is expected to attain around USD 4.22 billion by 2033, poised to grow at a CAGR of 5.20% between 2024 and 2033.
• North America dominated the real-time PCR market with the largest revenue share of 42% in 2023.
• Asia Pacific is expected to grow at a significant rate in the market during the forecast period.
• By product, the reagents & consumables segment dominated the market with the largest share in 2023.
• By application, the clinical segment has contributed more than 51% of revenue share in 2023.
• By end user, the hospitals and diagnostic centers segment dominated the market in 2023.

U.S. Real-time PCR Market Size and Growth 2024 to 2033

The U.S. real-time PCR market size was exhibited at USD 1.07 billion in 2023 and is projected to be worth around USD 1.79 billion by 2033, poised to grow at a CAGR of 5.28% from 2024 to 2033.

North America witnessed the highest revenue share in 2023. The increasing launch of real-time polymerase chain reaction kits by the key players operating in the North American market is estimated to fuel the growth of the real-time PCR market in the North American region.

• For instance, in August 2023, Gold Standard Diagnostics, a company that is focused on manufacturing proprietary instruments for clinical diagnostics based in the U.S., revealed the introduction of the DNAllergen real-time PCR kits used for allergen testing with the molecular method.

Moreover, increasing funding activity and initiatives by the government of Canada is expected to drive the growth of the real-time PCR market in the Canadian region.

• For instance, in May 2024, according to the data published by the National Center for Biotechnology Information, non-profit organization of Library of Medicine, a branch of the National Institutes of Health, announced that nearly US$ 574 million funding has been provided to 19 projects at 14 research institutions across Canada by the Canada Biomedical Research Fund (CBRF), non-profit funding organization along with Biosciences Research Infrastructure Fund (BRIF), non-profit research organization of Canada. Since the introduction of Canada's Biomanufacturing and Life Sciences Strategy in 2021, the federal government has committed US$2.2 billion to the development of state-of-the-art biomanufacturing capabilities.

Asia Pacific is estimated to be the fastest-growing during the forecast period, significantly driven by the launch of new products by the key players operating in the real-time PCR market to meet high clinical needs.

• For instance, in March 2023, Xi'an TianLong Science and Technology Co., Ltd, a medical and diagnostic instrument manufacturing company based in China, announced the introduction of the Gentier mini+ Real-time PCR System and the GeneFlex Nucleic Acid Extractor. The Gentier mini+ Real-time PCR System is a small, lightweight, portable device developed for the prevention and detection of infectious diseases, animal diseases, food safety, and clinical scientific research applications. As this is a portable and lightweight device, it is significantly used in small laboratories, on-site testing requirements, or mobile laboratories.

Market Overview

Polymerase chain reaction (PCR) is a temperature-dependent nucleic acid amplification method that is used to enzymatically amplify DNA (Deoxyribonucleic acid) or RNA (Ribonucleic acid) in vitro. Polymerase chain reaction (PCR) products can be accurately detected and quantified with the use of real-time polymerase chain reaction (PCR), which is a valuable tool. Quantitative polymerase chain reaction (qPCR), a molecular biology laboratory technique based on the polymerase chain reaction (PCR), is another name for real-time polymerase chain reaction (PCR). In contrast to the traditional polymerase chain reaction (PCR) approach, which allows analysis only after the process is finished, the phrase "real-time" refers to the ability to track the amplification's progress while it is taking place.

Real-time polymerase chain reaction (PCR) works on the same amplification mechanism as polymerase chain reaction (PCR). Yet, the reaction is observed in "real-time" as opposed to seeing bands on a gel at the conclusion of the reaction. The reaction is added to a real-time polymerase chain reaction (PCR) apparatus, which uses a camera or detector to monitor the reaction as it happens. While there are numerous methods for tracking the development of a PCR reaction, they are always similar in one way. They all relate the production of fluorescence, which can be easily seen with a camera during each polymerase chain reaction (PCR) cycle, to the amplification of DNA (Deoxyribonucleic acid). Therefore, the fluorescence grows together with the amount of gene copies during the reaction, indicating the reaction's progress. The applications of real-time PCR are mutation detection, gene expression analysis, detection and quantification of pathogens, detection of allergens, species identification, detection of genetically modified organisms, determination of parasite fitness, and monitoring of microbial degradation.

Real-time PCR Market Growth Factors

• Expansion of healthcare services can foster the growth of the real-time PCR market in the near future.
• The increasing launch of the new policy by the government to support gene therapy is expected to drive the growth of the market over the forecast period.
• The rising epidemiology of chronic diseases, infectious diseases, and genetic disorders has shown an increase in the demand for real-time PCR systems, which is expected to drive the growth of the market over the forecast period.
• The increasing geriatric population has raised the demand for rapid diagnostic tests, which is estimated to fuel the growth of the real-time PCR market over the forecast period.
• A rise in research and development activities for the discovery of new drugs is expected to foster the growth of the market in the near future.
• Increasing adoption of inorganic growth strategies like mergers for launching new real-time PCR technology is expected to drive the growth of the market during the forecast period.
• Increasing adoption of organic strategies like marketing and market expansion by the key companies is estimated to drive the growth of the real-time PCR market over the forecast period.

Real-time PCR Market Scope

Real-time PCR Market Dynamics

Driver

Increasing launch of the new real-time polymerase chain reaction system

The rise in the launch of the new real-time polymerase chain reaction system by the key market players operating in the market is expected to drive the growth of the real-time PCR market over the forecast period. The real-time polymerase chain reaction data makes it easy to conduct a fully quantitative analysis of gene expression. Therefore, in contrast to standard preparative PCR, Real-time PCR avoids "false negatives" by enabling the success of numerous polymerase chain reactions to be automatically determined after a short number of cycles without requiring individual inspection of each reaction.

• For instance, in November 2023, F. Hoffmann-La Roche Ltd, a multinational holding healthcare company, announced the introduction of the next-generation LightCycler PRO System, which assists in performing advanced molecular diagnostics. In-vitro diagnostics and translational research are becoming closer with this innovative real-time polymerase chain reaction technology, which also sets new standards for performance and usability. The LightCycler PRO System allows labs to easily and legally move from discovery research to patient clinical sample testing since it is labeled and built for both research and in-vitro diagnostic processes.

Restraint

Challenges and limitations associated with the real-time polymerase chain reaction

The limitations and challenges occurring with real-time polymerase chain reactions can restrict the growth of the real-time PCR market. For instance, in May 2023, according to the data published by the National Center for Biotechnology Information, it was estimated that there are various obstacles and restrictions associated with real-time polymerase chain reaction (PCR). The complexity and expense of microfabrication and detection techniques like electrochemical amplicon or fluorophore-assisted detection make point-of-care testing less feasible.

Furthermore, the PCR process's lengthy amplification time and complexity make it ineffective for diagnosing infectious infections that appear suddenly. The use of PCR in medical sciences and research is further hampered by limited access to sufficient instruments and resources, especially in underdeveloped African nations. Furthermore, bacteriological investigations must be incorporated into laboratory control schemes in order to identify species and assess the viability of microorganisms, as PCR may not be sufficient for these tasks alone. The mentioned hurdles and constraints highlight the necessity for progress in real-time polymerase chain reaction technology to overcome them and enhance its efficacy across a range of uses.

Opportunity

Approval by the regulatory authorities

Increasing approval of the newly innovated products by regulatory bodies is expected to create a lucrative opportunity for the growth of the real-time PCR market.

• For instance, in March 2024, Co-Diagnostics, Inc., a molecular diagnostics company, announced that CoSara Diagnostics Pvt Ltd., its joint venture for sales and manufacturing in India, received approval from the Central Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its SARAPLEX Influenza Multiplex polymerase chain reaction Test Kit to clinical laboratories as an in vitro diagnostic ("IVD") for the differentiation and detection of Influenza B and Influenza A. Based on the company's proprietary Co-PrimersTM technology, the CoSara real-time multiplex PCR test is intended to distinguish between H1N1 and H3N2 and to concurrently identify influenza A (H2N1, H1N1, H10N8, H3N2,  H1N2, H5N1, H7N7,  H9N2, H7N9, H5N6, H7N4, H7N2, and H2N2) and influenza B (Yamagata and Victoria strains).

Product Insights

The reagents & consumables segment held the dominating share of the real-time PCR market in 2023 on account of increasing approval of the newly innovated products by the regulatory bodies.

• For instance, in January 2024, QIAGEN, a company that provides sample and assay technologies for applied testing, pharmaceutical research, molecular diagnostics, and academic research, revealed that the U.S. Food and Drug Administration (FDA) approved the NeuMoDx CT/NG Assay 2.0, which can be used for its integrated polymerase chain reaction-based clinical molecular testing systems NeuMoDx 96 and 288 in the U.S. NeuMoDx Molecular Systems' plan to expand its test menu in the U.S. is supported by this FDA clearance. It also expands upon the 16 European Union's (EU)-certified in-vitro diagnostics (CE-IVD) tests that are compatible with these systems; these are among the most comprehensive on the market in nations that recognize CE-IVD markings, and they include assays for viruses linked to respiratory infections, sexual and reproductive health, transplant recipients, and blood-borne infections.

Application Insights

The clinical segment held the largest share of the real-time PCR market in 2023. The increasing launch of the new clinical trial center for drug development and gene therapy development is estimated to drive the growth of the segment over the forecast period.

• For instance, in April 2024, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), an authorized research center based in the U.S., revealed the introduction of a new center for external and internal experts to discuss new methods for designing and conducting clinical drug trials, dubbed the Center for Clinical Trial Innovation (C3TI).

Furthermore, the forensic segment is expected to show the fastest growth over the forecast period. Forensic genetic genealogy has become an invaluable resource for law enforcement investigations due to the proliferation of consumer DNA testing and open genetic databases. The characteristics of inherited genetics are essential to forensic genetic genealogy. The criminal justice community has benefited significantly from the use of DNA analysis done with the real-time polymerase chain reaction technique in forensic laboratories.

Increasing the launch of the reagent kit for DNA analysis by the polymerase chain reaction technique is expected to foster the growth of the segment over the forecast period. For instance, in March 2024, Promega Corporation, a biotechnology company mainly focused on manufacturing enzymes and molecular biology with a portfolio covering the fields of genetic identity, cellular analysis, genomics, protein analysis, and expression, among others, announced the introduction of the new DNA analysis kit with a different color reagent used to carry out polymerase chain reaction in Europe and used widely in the forensic labs.

The Promega Corporation introduced the PowerPlex 18E System, which combines eight-color short tandem repeat (STR) analysis chemistry to extract more useful information from difficult samples. All of the DNA markers that the European Network of Forensic Science Institutes (ENFSI), monopoly organization in the field of forensic science by the European Commission, monopoly organization in the field of forensic science by the European Commission recommends are included in the kit. Promega Corporation manufactured an eight-color chemistry kit for forensic DNA analysis.

End User Insights

The hospitals & diagnostic centers segment held the largest share of the real-time PCR market in 2023. The increasing prevalence of breast cancer due to changing lifestyles is raising the demand for point-of-care tests as well as oncology testing, which is expected to drive the segment growth over the forecast period. For instance, in March 2023, according to the data published by the World Health Organization, it was estimated that 670,000 deaths took place globally in the year 2022 due to breast cancer. Hence, the increasing prevalence of chronic diseases like breast cancer is raising the demand for oncology testing with real-time polymerase chain reaction techniques at hospitals & diagnostic centers.

Recent Developments

• On June 2024, at the 77th World Health Assembly in Geneva, an event to determine the policies of the Organization, review the healthcare development as well as supervise financial policies, the Truenat platform, a rapid molecular test for the diagnosis of pulmonary, extrapulmonary, and rifampicin-resistant tuberculosis, was praised for its role in fighting tuberculosis and as a potential part of global healthcare solutions. The Truenat platform test is a real-time quantitative micro-PCR system and was developed in India.
• In March 2023, The Technology Development Board (TDB-DST), a statutory body under the Department of Science & Technology, Government of India, signed the agreement with M/s Huwel Lifesciences Private Limited, a diagnostic instrument and medical device company based in India, for ‘Validation and Commercialization of Rapid Real-time PCR reagents for storage and transport at room temperature.’ The Technology Development Board (TDB-DST) of India approved funding of US$ 17,95,284 out of the total project cost of US$ 47,87,376.
• In January 2024, Seegene Inc., a healthcare company that provides PCR solutions, collaborated with Microsoft, an information technology corporation, to develop SG OneSystem in the U.K.The SG OneSystem assists in the development of the diagnostic reagent by using artificial intelligence and digital solutions that combine biotechnology (BT).
  
  

Real-time PCR Market Companies

• Abbott
• Agilent Technologies, Inc.
• bioMérieux
• Bio-Rad Laboratories Inc.
• Eppendorf SE
• GE Healthcare
• F. Hoffmann-La Roche Ltd.
• Fluidigm Corporation
• Thermo Fisher Scientific, Inc.
• TOYOBO Inc.
• Vela Diagnostics
• Takara Bio Inc.
• Lumex Instruments
• Primedesign Ltd.
• QIAGEN
• PerkinElmer Inc.
• Siemens
• Merck KGaA

Segment Covered in the Report

By Product

• Instruments
• Reagents & Consumables
• Software & Services

By Application

• Clinical
  • Pathogen Testing
  • Oncology Testing
  • Blood Screening
  • Liquid Biopsy
  • dPCR-based Non-Invasive Prenatal Testing (NIPT)
  • Others
• Research
  • Stem Cell Research
  • DNA Cloning & Sequencing
  • Recombinant DNA Technology
  • Rare Mutation Detection
  • Gene Expression
  • Single Cell Analysis
  • Microbiome Analysis
  • Copy Number Variation Analysis
  • Library Quantification (NGS)
  • Characterization of Low-fold Changes in mRNA and miRNA expression
  • Species Identification
  • GMO Detection
• Forensic

By End User

• Hospitals & Diagnostic Centers
• Pharmaceutical & Biotechnology Companies
• Research Laboratories & Academic Institutes
• Clinical Research Organization
• Forensic Laboratories

By Geography

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