|
Forecast
Period
|
2026-2030
|
|
Market
Size (2024)
|
USD
13.12 Billion
|
|
Market
Size (2030)
|
USD
20.14 Billion
|
|
CAGR
(2025-2030)
|
7.36%
|
|
Fastest
Growing Segment
|
Reagents
|
|
Largest
Market
|
North
America
|
Market Overview
Global Biological PCR Technology Market was valued
at USD 13.12 Billion in 2024 and is expected to reach USD 20.14 Billion by 2030
with a CAGR of 7.36% during the forecast period. The global biological PCR
technology market is driven by the increasing demand for precise and rapid
diagnostics, particularly in infectious diseases, cancer, and genetic
disorders. PCR’s ability to detect minute amounts of DNA and RNA with high
sensitivity makes it invaluable in clinical and research applications. The rise
in global infectious diseases, such as COVID-19, and the need for pandemic
preparedness have significantly boosted PCR testing adoption. Advancements in
PCR technologies, including real-time and digital PCR, have expanded its
applications in personalized medicine, oncology, and genetic testing. Growing
awareness of early disease detection and the rise of genetic research continue
to support the demand for PCR-based solutions, further fuelling market growth.
Key Market Drivers
Increasing Demand for Accurate and Rapid
Diagnostics
The global biological PCR technology market is experiencing significant growth
due to the increasing demand for accurate and rapid diagnostics in both
clinical and research settings. PCR technology has revolutionized diagnostics
by offering high sensitivity and specificity in detecting pathogens, genetic
mutations, and various disease biomarkers. Traditional diagnostic techniques,
like culture-based methods or serological tests, often lack the speed and
precision required for timely medical intervention. In March 2023, Jiangsu Bioperfectus
Technologies Co., Ltd. introduced two new PCR products: the Mycoplasma Hominis
Real-Time PCR Kit and the Treponema Pallidum Real-Time PCR Kit. When paired
with our extraction solution, these kits offer a comprehensive Total PCR
Solution for the early detection of sexually transmitted diseases that impact a
large number of individuals.
PCR’s ability to detect low levels of DNA or RNA in
a sample means that it can provide results quickly, allowing healthcare
providers to diagnose infectious diseases, such as COVID-19, HIV, and
tuberculosis, more accurately and efficiently. With the increasing complexity
of disease management, especially in oncology and genetic disorders, PCR-based
diagnostics are gaining significant traction. The technology also provides
faster results than conventional testing methods, which is critical for
decision-making in situations where time-sensitive interventions can
significantly improve patient outcomes. This demand for quick, accurate testing
in clinical settings is driving the adoption of PCR technology in hospitals,
diagnostic laboratories, research institutions, and point-of-care settings. As
healthcare systems across the globe focus more on early detection and effective
management of diseases, the use of PCR technology continues to rise, fueling
the market’s expansion.
Advancements in PCR Technology
Technological advancements in PCR technology have been crucial in accelerating
the growth of the biological PCR technology market. Initially, conventional PCR
methods were used for amplifying DNA samples for basic research and
diagnostics. However, with the advancement of real-time PCR (RT-PCR), digital
PCR, and multiplex PCR, the scope and precision of PCR testing have expanded
significantly. Real-time PCR, for example, allows the continuous monitoring of
the amplification process, enabling quantitative measurement of target DNA or
RNA. In November 2022, Bio-Rad Laboratories, Inc., a global leader
in life science research and clinical diagnostic products, and NuProbe USA, a
company specializing in genomics and molecular diagnostics, today announced a
licensing and product development agreement. As part of the agreement, NuProbe
USA will exclusively license its allele enrichment technologies to Bio-Rad for
the development of multiplexed digital PCR assays. This technology will enhance
Bio-Rad's oncology product offerings, enabling highly sensitive and multiplexed
mutation detection to support translational research, therapy selection, and
disease monitoring.
This is particularly useful in research and
diagnostics, where accurate viral load measurements are necessary for
monitoring infections like HIV, hepatitis, and SARS-CoV-2. Digital PCR, on the
other hand, offers unparalleled sensitivity and precision, detecting rare
mutations and low-abundance genetic material, which is essential for early
detection of diseases such as cancer. Multiplex PCR allows simultaneous
amplification and detection of multiple genetic targets in a single test,
improving diagnostic efficiency and reducing test turnaround times. These
innovations have enabled PCR to become indispensable in areas like oncology,
personalized medicine, and genetic testing. As the technology continues to
evolve, the introduction of automated and more cost-effective PCR systems
further enhances market accessibility, driving wider adoption across various
healthcare sectors. The growing focus on miniaturization has led to the
development of portable PCR systems, making it possible for diagnostic testing
to be conducted in remote or resource-limited settings, further expanding PCR
technology’s reach.
Rising Prevalence of Infectious Diseases
The increasing global prevalence of infectious diseases is one of the key
factors driving the growth of the biological PCR technology market. Infectious
diseases, particularly viral infections, represent a major public health threat
worldwide. The rapid spread of pathogens and emerging new diseases require
diagnostic systems capable of identifying infections quickly and accurately.
PCR technology’s high sensitivity allows for the detection of even trace
amounts of genetic material, enabling early diagnosis and timely intervention.
For instance, during the COVID-19 pandemic, PCR-based molecular tests became
the cornerstone of global diagnostic efforts, enabling healthcare professionals
to identify infected individuals quickly and accurately, helping curb the
spread of the virus. Beyond COVID-19, PCR technology plays a vital role in the
detection of various other infectious diseases such as HIV, hepatitis,
influenza, and tuberculosis. As the global population continues to face
emerging infectious diseases, coupled with the growing threat of antimicrobial
resistance, the need for accurate and reliable diagnostics becomes increasingly
critical. PCR-based testing allows for rapid identification of pathogens,
allowing for quicker clinical decision-making and more effective patient
management. The rising incidence of infectious diseases, combined with the
growing awareness of the need for early and precise diagnostics, continues to
drive the adoption of PCR technology in both developed and developing
healthcare settings.
Growing Demand for Personalized Medicine
Personalized medicine is increasingly recognized as a promising approach to
treating patients based on their individual genetic makeup. This shift towards
more tailored treatment regimens has significantly boosted the adoption of
biological PCR technology. PCR plays an integral role in identifying genetic
mutations, which can guide the selection of therapies that are most likely to
be effective for an individual. In oncology, for example, PCR is used to detect
specific genetic mutations in tumor cells, which can help identify patients who
are most likely to benefit from targeted therapies or immunotherapies.
Personalized medicine also requires regular monitoring of biomarkers to
evaluate treatment efficacy, and PCR is crucial for these assessments due to its
ability to detect even low quantities of genetic material. Genetic testing is
becoming increasingly important not only in cancer treatment but also in
managing chronic conditions such as cardiovascular diseases, diabetes, and
neurological disorders. The demand for personalized medicine continues to rise,
driven by the growing availability of genomic data and the increasing emphasis
on precision healthcare. As more patients and healthcare providers recognize
the benefits of personalized treatment plans, PCR technology becomes
indispensable in identifying the right therapeutic interventions, further
fueling the growth of the market.
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Key Market Challenges
High Cost of PCR Equipment and Consumables
One of the significant challenges facing the global biological PCR technology
market is the high cost of PCR equipment and consumables. The advanced PCR
systems, including real-time PCR, digital PCR, and multiplex PCR, are often
expensive to purchase and maintain, making them financially challenging for
small and medium-sized healthcare facilities, laboratories, and research
institutions. In addition to the initial high capital investment, the cost of
reagents, consumables, and maintenance is substantial, which can increase the
overall cost of testing. As a result, many resource-limited settings,
particularly in low-income countries, may face barriers to adopting PCR
technology. This financial burden may limit the widespread adoption of PCR,
particularly in regions where cost-efficiency is a priority. The continuous
need to replenish reagents, replace components, and maintain the system can
create ongoing financial constraints. This challenge necessitates the
development of more affordable PCR systems and reagents to improve
accessibility and drive broader market growth.
Complexity of PCR Procedures and Need for Skilled
Personnel
PCR testing, while highly effective, can be a technically complex procedure
that requires skilled personnel to operate. The preparation of samples, setting
up the PCR system, performing the amplification process, and interpreting the
results require a high level of expertise. This challenge is particularly
evident in developing countries or rural areas where there may be a shortage of
trained healthcare professionals or laboratory technicians. Inadequate training
can lead to inaccurate results, which may undermine the reliability of
PCR-based testing. Due to the complexity of PCR systems, it may take time for
healthcare professionals to become proficient in their use. As the demand for
PCR technology increases, especially in resource-limited settings, there is a
pressing need for standardized training programs and certifications to ensure
consistent and accurate results across the board. Addressing this challenge
would require investments in workforce training, automation, and user-friendly
PCR systems to simplify testing procedures and reduce reliance on skilled
labor.
Limitations in Detection Sensitivity and
Specificity
Although PCR technology is known for its high sensitivity and specificity,
there are certain limitations regarding its ability to accurately detect rare
genetic mutations, mutations in heterogeneous samples, or subtle variations in
pathogen strains. For instance, PCR may sometimes generate false-negative
results if the target DNA or RNA concentration is below the detection threshold
or if there are issues with sample quality. Some complex genetic disorders may
be challenging to detect using traditional PCR methods, leading to the need for
more advanced techniques such as next-generation sequencing (NGS). PCR-based
systems may also struggle to differentiate between very similar pathogen
strains, which could lead to misidentification. As the demand for PCR testing
expands, especially in critical areas such as personalized medicine and
infectious disease detection, improving the sensitivity and specificity of PCR
technology becomes a key challenge. Ongoing research and development are
essential to overcome these limitations and enhance the precision and accuracy
of PCR tests.
Key Market Trends
Expanding Applications in
Research and Clinical Trials
PCR technology has become an indispensable tool in research and clinical
trials, driving its widespread adoption across various scientific disciplines.
In molecular biology, PCR is used to amplify specific DNA sequences for genetic
analysis, which is essential for studies related to gene expression, genetic
mutations, and disease pathogenesis. The versatility of PCR makes it applicable
in a wide range of research fields, including microbiology, genomics, and
epidemiology. In April 2023, Promega Corporation announced the awarding of USD
15,000 grants to researchers utilizing real-time quantitative PCR (qPCR). In
addition, Promega will provide these researchers with VIP technical support and
personalized training.
PCR is crucial in clinical trials, where it is used
to monitor disease progression, assess the efficacy of new treatments, and
identify potential biomarkers for disease. Pharmaceutical companies and
biotechnology firms rely heavily on PCR technology to ensure that their drug
candidates are effective and safe for patients. PCR’s ability to provide rapid,
high-throughput genetic analysis also accelerates the pace of research and
clinical trials, which is vital in the fast-moving healthcare sector. As the
demand for faster and more efficient drug development increases, the reliance
on PCR technology in research and clinical trials will continue to grow,
further expanding its market.
Technological Integration
with Digital Health and Point-of-Care Testing
The integration of PCR technology with digital health solutions and
point-of-care (POC) testing is a key driver of the biological PCR technology
market. The rise of digital health technologies, including telemedicine,
electronic health records (EHRs), and mobile health applications, has
transformed the way healthcare is delivered. PCR technology, when integrated
with these digital tools, enables healthcare providers to access real-time
diagnostic results, improve clinical decision-making, and provide better
patient care. In March 2023, the U.S.
Department of Health and Human Services announced that the U.S. Food and Drug
Administration (FDA) had granted clearance for Simplexa COVID-19 and Flu A/B
Direct. This real-time RT-PCR system is a molecular diagnostic test designed
for the direct amplification and detection of SARS-CoV-2 (COVID-19 virus),
influenza A, and influenza B RNA from nasopharyngeal swab specimens without the
need for nucleic acid extraction.
Point-of-care PCR systems, which can deliver
results outside traditional laboratory settings, have become increasingly
important, particularly in emergency situations or remote areas. These systems
enable clinicians to obtain rapid diagnostic results without waiting for
results from central laboratories, leading to faster treatment decisions. As
the healthcare industry shifts toward more patient-centric care, point-of-care
PCR testing is becoming more widely adopted in settings such as urgent care
centers, physician offices, and home healthcare services. The ability to
perform PCR tests at the point of care, combined with the advantages of digital
health integration, is driving further adoption of PCR technology.
Segmental Insights
Product Type Insights
Based on the Product Type, reagents
have a more dominant role due to their central importance in PCR testing
procedures. Reagents, which include enzymes, primers, buffers, and nucleotides,
are the core elements required for amplifying DNA or RNA in PCR reactions.
Their quality and consistency directly influence the accuracy, sensitivity, and
reliability of PCR results, making them a crucial factor in the performance of
PCR systems.
The market for reagents has grown considerably over
the years as PCR technology has become a standard method for diagnostic
testing, genetic research, and clinical applications. Reagents are needed in
almost every PCR reaction, whether it’s for real-time PCR, digital PCR, or
multiplex PCR, further solidifying their role in the PCR workflow. With the
increasing demand for personalized medicine, cancer research, and genetic
testing, the need for high-quality and highly specific PCR reagents has surged.
PCR testing involves the precise amplification of target DNA or RNA, and any
issues with reagent quality can lead to false positives, false negatives, or
suboptimal results, which is why the market continues to prioritize
high-quality reagents for various applications. Reagents are more frequently
consumed than consumables in the PCR process. PCR tests often require multiple
reagent sets depending on the number of samples and tests being conducted,
leading to frequent purchases and replenishment. The need for reagents is thus
driven by factors such as the volume of testing in clinical laboratories,
diagnostic centers, and research facilities, as well as advancements in PCR
technology that require more specialized or customized reagents. The growing
use of PCR in various fields like oncology, infectious disease diagnostics, and
genetic analysis further elevates the demand for specialized reagents tailored
to specific tests and research needs.
End Use Insights
Based on the end use
segment, molecular testing laboratories are currently dominating,
largely due to their specialized focus on molecular diagnostics and the
increasing demand for genetic and infectious disease testing. These
laboratories play a central role in implementing PCR technology, as molecular
testing relies heavily on the precise amplification and detection of DNA or RNA
to identify genetic markers, pathogens, mutations, and other molecular markers.
The need for such highly accurate diagnostic methods has spurred the growth of
molecular testing laboratories, which are at the forefront of this market.
Molecular testing laboratories are increasingly
sought after due to the rise in demand for genetic testing, cancer diagnostics,
infectious disease detection, and personalized medicine. As PCR technology is
the gold standard for detecting specific genetic sequences and pathogens, these
laboratories are essential for conducting tests like real-time PCR, digital
PCR, and multiplex PCR. Molecular testing is critical in identifying rare
genetic mutations and variations, assessing viral loads in diseases such as HIV
and hepatitis, and determining the presence of bacterial or viral pathogens
like tuberculosis, influenza, and COVID-19. The integration of PCR technology
allows these laboratories to provide highly accurate and reliable results,
which are crucial for disease diagnosis, prognosis, and treatment planning.
The demand for molecular testing has surged in
recent years, primarily driven by the increased awareness of genetic disorders,
the growing prevalence of infectious diseases, and the expanding need for
personalized medicine. PCR-based molecular testing is widely used in clinical
diagnostics for conditions like cancer, genetic disorders, and infections,
providing valuable information for early diagnosis, monitoring, and treatment.
With the rise of personalized medicine, which tailors treatments based on a patient's
genetic profile, molecular testing has become an indispensable part of patient
care. For example, PCR is frequently used in oncology to identify genetic
mutations in tumor cells, which can inform decisions regarding targeted
therapies or immunotherapies. As molecular testing becomes more integrated into
routine medical practice, the demand for PCR technology continues to grow.
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Regional Insights
North America was dominating the global Biological PCR Technology Market.
This dominance is primarily driven by the high level of technological
advancements, strong healthcare infrastructure, substantial investments in
research and development, and an increasing demand for molecular diagnostics in
the region. North America, particularly the United States, is home to some of
the largest and most influential pharmaceutical and biotechnology companies,
academic research institutions, and clinical laboratories. The U.S. has been at
the forefront of adopting PCR technology for a wide range of applications, from
disease diagnostics to genetic research, further solidifying its leadership in
the global market.
One of the key factors contributing to North
America's dominance in the PCR technology market is the region's advanced
healthcare system. The healthcare infrastructure in North America is highly
developed, with a robust network of hospitals, diagnostic centers, and
molecular testing laboratories equipped with state-of-the-art PCR systems. PCR
technology is widely used in hospitals and diagnostic centers for the detection
of infectious diseases such as COVID-19, HIV, and tuberculosis, as well as
genetic testing for cancer, genetic disorders, and personalized medicine. The
region's healthcare providers rely heavily on PCR-based diagnostics due to
their high accuracy, sensitivity, and ability to detect a wide range of genetic
conditions and pathogens. The need for reliable and rapid diagnostic tests has
further increased the adoption of PCR technology in North America.
Recent Developments
- In November 2023, F.
Hoffman-La Roche Ltd introduced the LightCycler PRO System, a next-generation
qPCR system designed to improve the efficiency of molecular diagnostics and
meet clinical needs.
- In September 2024, Takara
Bio USA, Inc., a wholly owned subsidiary of Takara Bio Inc., today announced
the launch of the SmartChip ND Real-Time PCR System, an automated,
high-throughput qPCR solution for infectious disease research, available for
research use only (RUO). Takara Bio USA is now accepting orders for the
SmartChip ND Real-Time PCR System. Designed
to meet the needs of laboratories for flexibility, scalability, efficiency, and
cost-effectiveness, the SmartChip ND system offers customizable assay formats
that allow users to adjust panel compositions at various stages of the
development process. The system can perform up to 5,184 reactions per chip,
accommodating 768 samples or up to 384 targets per sample in a single run. With
automated dispensing, cycling, and analysis, the system achieves a rapid
three-hour turnaround from sample to data, requiring less than 30 minutes of
direct hands-on time. Nanoliter-scale reactions minimize variability by
eliminating the need for preamplification and reduce costs by decreasing
reagent volumes.
- In April 2024, Bio-Rad
Laboratories, Inc. (NYSE: BIO and BIOb), a global leader in life science
research and clinical diagnostic products, today unveiled its first
ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation
Detection Kit. This new assay expands Bio-Rad's Droplet Digital PCR (ddPCR™)
portfolio for the oncology market, providing highly sensitive, multiplexed
mutation detection to support translational research, therapy selection, and
disease monitoring.
- In January 2025, QIAGEN
announced a major enhancement to its QIAcuity Digital PCR (dPCR) system,
boosting its ability to simultaneously analyze more than twice the number of
targets from a single biological sample. This new capability addresses the
assay design limitations of current quantitative multiplex PCR methods, making
the QIAcuity digital PCR system well-suited for applications such as
translational research, microbiome analysis, pathogen detection, and the
development of cell and gene therapies.
Key Market Players
- Thermo Fisher Scientific Inc.
- Agilent Technologies, Inc.
- Bio-Rad Laboratories Inc.
- QIAGEN GmbH
- Takara Bio Inc.
- Merck KGaA
- Bioneer Corporation
- Illumina, Inc.
- Promega Corporation
- Eppendorf SE
|
By Product Type
|
By End Use
|
By Region
|
|
|
- Diagnostic
Laboratories
- Molecular
Testing Laboratories
|
- North
America
- Europe
- Asia Pacific
- South
America
- Middle East
& Africa
|
Report Scope:
In this report, the Global Biological PCR
Technology Market has been segmented into the following categories, in addition
to the industry trends which have also been detailed below:
- Biological PCR Technology Market, By Product Type:
o Reagents
o Consumables
- Biological PCR Technology Market, By End Use:
o Diagnostic Laboratories
o Molecular Testing
Laboratories
- Biological PCR Technology Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia-Pacific
§ China
§ India
§ Japan
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Biological
PCR Technology Market.
Available Customizations:
Global Biological PCR Technology market report
with the given market data, TechSci Research offers customizations according to
a company's specific needs. The following customization options are available
for the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
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