|
Forecast Period
|
2024-2028
|
|
Market Size (2022)
|
USD 4.33 Billion
|
|
CAGR (2023-2028)
|
4.56%
|
|
Fastest Growing Segment
|
Clinical Diagnostics
|
|
Largest Market
|
North America
|
Market Overview
Global Real Time PCR
Market has valued at USD 4.33 Billion in 2022 and is anticipated to project impressive
growth in the forecast period with a CAGR of 4.56% through 2028. Real-time
polymerase chain reactions (PCR) are molecular biology laboratory techniques
that build upon the principles of PCR. In the fields of clinical and veterinary
diagnostics, as well as food safety, real-time PCR has gained significant
recognition as a well-established technology for detecting, quantifying, and
identifying various microbial agents. While the PCR principle may seem
straightforward, it is crucial for creators and users of this technology to be
aware of specific concerns associated with quantitative PCR (qPCR).
These concerns include the
accurate use of terminology and definitions, a comprehensive understanding of
the PCR principle, challenges related to data interpretation and presentation,
as well as limitations of qPCR in different microbial diagnostic applications.
Parameters that are vital for describing qPCR performance also need to be taken
into consideration. Furthermore, in real-time PCR, there are two commonly used
techniques for detecting PCR products. The first technique involves
non-specific fluorescent dyes that intercalate with any double-stranded DNA.
The second technique utilizes sequence-specific DNA probes, which are
oligonucleotides labeled with fluorescent reporters. These probes enable
detection only after hybridization with the complementary sequence. By
addressing these intricate details, researchers and practitioners can ensure
the accurate and effective use of real-time PCR in their respective fields,
contributing to advancements in molecular diagnostics and microbial analysis.
Key Market Drivers
Rising
Incidences of Different Diseases and Genetic Disorders
A study conducted by the
Journal of the Royal Society Interface reveals a significant rise in disease
levels since 1980. It indicates that nearly 30% of diseases are responsible for
a staggering 80% of outbreaks, highlighting the urgent need for effective
disease prevention and management strategies. Furthermore, genetic disorders
have become increasingly prevalent in recent times, posing a major challenge to
global healthcare systems.
According to the World
Health Organization (WHO), genetic disorders now account for over 28% of
hospital admissions and are a leading cause of childhood mortality,
contributing to almost 50% of childhood deaths. These statistics underscore the
critical importance of prenatal diagnosis and carrier testing for genetic
disorders. In this context, quantitative polymerase chain reaction (qPCR) have
emerged as the preferred techniques for accurate and reliable genetic testing.
qPCR has long played a pivotal role in diagnosing diseases by investigating
bacteria and viruses, while dPCR, although still an emerging technology, has
demonstrated its ability to enhance the detection of extremely precise gene
mutations.
The advancements in
real-time PCR technologies have propelled the market forward, opening up new
possibilities for improved disease diagnosis, genetic screening, and
personalized medicine. As researchers continue to uncover the complexities of
the human genome, the demand for innovative PCR solutions is expected to grow,
leading to further advancements in the field. Overall, the findings of the
study emphasize the pressing need for continued research, innovation, and
collaboration in the realm of disease prevention and genetic testing. By
staying at the forefront of scientific developments, we can strive to mitigate
the impact of diseases and genetic disorders, ultimately improving global
health outcomes.
Increasing
Application in Clinical Diagnostics
The increasing application
of real-time polymerase chain reaction (PCR) in clinical diagnostics is
expected to significantly boost the demand for this powerful molecular biology
technique. Real-time PCR, also known as quantitative PCR (qPCR), allows for the
accurate and rapid detection and quantification of DNA and RNA sequences.
Real-time PCR is widely employed for the diagnosis of infectious diseases,
genetic disorders, and various types of cancers. Its high sensitivity and
specificity make it an indispensable tool for detecting pathogens, genetic
mutations, and oncogenes in clinical samples. As the need for accurate and
timely disease diagnosis continues to grow, so does the demand for real-time
PCR. Real-time PCR is instrumental in monitoring the effectiveness of treatment
regimens, such as antiviral therapies or cancer treatments. Clinicians can
track viral load reductions, measure residual disease levels, and assess
treatment responses in real-time, leading to better-informed clinical
decisions.
The increasing application
of real-time PCR in clinical diagnostics reflects its versatility and precision
in disease detection, monitoring, and personalized medicine. As healthcare
systems continue to prioritize accurate and efficient diagnostic tools, the
demand for real-time PCR is expected to rise, with the technology playing a
pivotal role in improving patient care and outcomes.
Rising
Demand for Personalized and Precision Medicines
The rising demand for
personalized and precision medicines is poised to significantly increase the
demand for real-time polymerase chain reaction (PCR) technology. Real-time PCR,
also known as quantitative PCR (qPCR), is a vital tool in tailoring treatments
to individual patients and ensuring the efficacy of personalized medicine
approaches. Personalized medicine relies on the characterization of an
individual's genetic profile to select the most appropriate treatment.
Real-time PCR is instrumental in genetic profiling by accurately quantifying
specific DNA or RNA sequences associated with disease susceptibility, drug
responses, or treatment monitoring. Real-time PCR is essential for diagnosing
and monitoring infectious diseases, including viral load quantification and the
detection of drug-resistant strains. Tailoring antiviral treatments and
antibiotics based on individual patient responses is a hallmark of personalized
medicine in infectious disease management.
The rising demand for
personalized and precision medicines is intrinsically linked to the increasing
use of real-time PCR technology. Its ability to provide accurate, rapid, and
quantitative genetic information makes real-time PCR an indispensable tool for
tailoring treatments to individual patients and optimizing therapeutic outcomes
in the era of personalized medicine.
Technological
Advancements and Applications in Drug Development
Technological advancements
and applications in drug development are expected to drive a substantial
increase in the demand for real-time polymerase chain reaction (PCR)
technology. Real-time PCR, also known as quantitative PCR (qPCR), plays a
pivotal role in various aspects of drug development, offering precise and
efficient molecular analysis. Real-time PCR is used to validate potential drug
targets by quantifying the expression levels of specific genes or proteins in
disease pathways. This information helps researchers identify and prioritize
promising targets for drug development, increasing the efficiency of
early-stage research.
Identifying biomarkers
associated with drug responses, toxicity, or disease progression is crucial in
drug development. Real-time PCR enables the sensitive and accurate measurement
of biomarker expression, aiding in the selection and validation of relevant
biomarkers for clinical trials. Real-time PCR is used for high-throughput
screening of potential drug compounds to identify lead candidates. It can also
be employed for drug profiling, evaluating how drugs impact specific cellular
processes or gene expression patterns, streamlining the drug development
pipeline.
Real-time PCR helps
evaluate the potential safety concerns associated with drug candidates. It can
detect off-target effects, assess the impact on normal cellular functions, and
identify potential adverse events, ensuring safer and more effective drug development.
Technological advancements and applications in drug development are enhancing
the role of real-time PCR as a fundamental tool for molecular analysis. Its
precision, speed, and versatility are essential in accelerating drug discovery,
optimizing drug development processes, and enabling personalized medicine
approaches, all of which contribute to the increasing demand for this
technology in the pharmaceutical industry.
Download Free Sample Report
Key Market
Challenges
High
Cost of Instruments
The equipment and tools
required for conducting PCR tests, particularly qPCR equipment, are often on
the higher end in terms of cost. According to multiple sources, the price range
for dPCR or qPCR machinery can vary from $15,000 to well over $100,000,
depending on the specific model and features. This significant investment is
not limited to the initial purchase alone. There are also ongoing expenses to
consider, such as the annual operational costs of cyclers and the cost of
universal probe mastermixes.
These hidden costs can
accumulate over time and pose challenges to market growth, especially in both
developing and developed economies. The considerable financial implications
associated with acquiring and maintaining the equipment may deter potential users
or limit accessibility, hindering the expansion of PCR testing in various
settings.
Moreover, the costs
associated with PCR testing go beyond the equipment itself. Additional expenses
can arise from sample preparation, consumables, reagents, and the need for
skilled personnel to operate and maintain the equipment. All of these factors contribute
to the overall cost and complexity of implementing PCR testing in different
healthcare settings. As the demand for PCR testing continues to rise, efforts
to address these challenges are crucial. Finding ways to reduce costs, increase
affordability, and streamline the process can help make PCR testing more
accessible and widespread, ultimately benefiting healthcare systems,
researchers, and patients alike.
Emergence
of Alternative Technologies
The emergence of
alternative technologies is expected to exert downward pressure on the demand
for real-time polymerase chain reaction (PCR) technology in specific
applications. While real-time PCR remains a powerful and widely used molecular
biology tool, several alternative methods and technologies have gained
prominence in recent years, offering unique advantages and cost-effectiveness
in certain contexts. NGS technologies
have advanced rapidly and can now provide quantitative information on gene
expression, genetic variations, and pathogen detection. In some cases, NGS can
replace real-time PCR for gene expression profiling and mutation analysis,
reducing the need for separate quantitative PCR assays. The CRISPR-Cas
technology has been adapted for diagnostic purposes, enabling highly specific
and sensitive nucleic acid detection. CRISPR-based assays offer an alternative
to real-time PCR for target amplification and detection.
While these alternative
technologies are making strides in specific niches, it's important to note that
real-time PCR still offers advantages in terms of versatility, quantification,
and assay design flexibility. The choice of technology often depends on the
specific research or diagnostic needs, and real-time PCR is likely to remain a
crucial tool in many molecular biology and diagnostic laboratories despite the
emergence of alternatives.
Key Market Trends
Integration
with Automation and Robotics
The integration of
real-time polymerase chain reaction (PCR) with automation and robotic systems
holds significant promise in increasing efficiency and reducing user-dependent
variability across various fields, particularly in clinical diagnostics, high-throughput
screening, and large-scale research projects. Automated real-time PCR systems
are designed to execute tasks with a high degree of precision and consistency.
Robots can accurately dispense reagents, mix samples, and perform thermal
cycling, minimizing human errors and ensuring reproducibility of results. This
is especially crucial in clinical diagnostics, where accuracy is paramount.
Automated systems can
handle a large number of samples simultaneously, significantly increasing
throughput. This is particularly valuable in high-throughput screening
applications, where hundreds or thousands of samples need to be processed
quickly, such as in drug discovery, genomics, or epidemiology studies. Automated
systems often incorporate sample tracking and data management software,
ensuring full traceability of samples throughout the PCR process. This feature
enhances data integrity, minimizes the risk of sample mix-up, and simplifies
record-keeping, which is vital in clinical diagnostics and regulatory
compliance.
Digital
PCR Integration
Integration of digital PCR
capabilities into real-time PCR platforms will provide researchers and
clinicians with more precise absolute quantification of nucleic acids,
enhancing its utility in applications requiring high sensitivity and accuracy. Digital PCR enables the partitioning of a
sample into thousands or millions of individual reactions, each containing a
single target molecule or none at all. By counting the number of positive
partitions, researchers can determine the absolute quantity of the target
nucleic acid with exceptional precision. This reduces variability and improves
the reliability of quantification, especially for low-abundance targets.
The integration of digital
PCR capabilities into real-time PCR platforms represents a significant
advancement that empowers researchers and clinicians with a powerful tool for
absolute quantification of nucleic acids. This technology enhances sensitivity and
accuracy, making it well-suited for applications demanding precise measurements
and reliable results, ultimately advancing scientific research and clinical
diagnostics.
Segmental Insights
Product Insights
The consumables and reagents segment dominated the
revenue share in 2022, primarily due to the increased demand for early disease
detection. Numerous reputable companies manufacturing PCR consumables and
reagents have also contributed to this. Moreover, the extensive utilization of
consumables and reagents and the expanding demand in healthcare, research, and
other fields further bolster the segment's significant market share.
Additionally, the segment is projected to maintain its leading position throughout
the forecast period.
Furthermore, the escalating prevalence of chronic
conditions and the growing adoption of PCR technology have heightened the
demand for consumables and reagents. Moreover, the pharmaceutical and
healthcare industries' increasing acceptance of technological advancements and
intensified research and development activities will create substantial
opportunities in this market throughout the projected period.
Application Insights
The clinical segment accounted for the largest revenue
share in 2022 due to several factors. These include the growing prevalence of
diseases like cancer, infectious diseases, and diabetes, as well as the high
precision of testing methods. Additionally, the commercialization of reagents
for diagnostics, efficient disease diagnosis, monitoring, and treatment, and
the added benefits in disease detection contribute to this. For example, in
April 2019, Thermo Fisher Scientific Inc. introduced the QuantStudio 6 & 7
Pro RT-PCR Systems, which incorporate features like facial identification,
voice assistant, and RF identification. Similarly, in April 2023, Thermo Fisher
Scientific launched 37 CE-IVD-marked real-time PCR assay kits for different
infectious diseases for its QuantStudio Dx series of instruments. Compared to
existing PCR technologies, it offers highly automated workflows with
significantly faster time-to-result, increased multiplexing, and greater
throughput flexibility.
On the other hand, the forensic segment is expected to
exhibit the fastest growth rate during the forecast period. The segment's
growth is driven by the increasing utilization of novel techniques in forensic
applications such as DNA typing, genetic fingerprinting, and DNA testing.
Furthermore, advancements in existing technologies for preparing the library
for forensic DNA typing from challenging samples contribute to the growth of
this segment.
Download Free Sample Report
Regional Insights
North America accounted
for the largest market share in 2022 and is projected to experience impressive
growth during the forecast period. The United States plays a key role in
driving the North America market, investing billions of dollars annually in
medicines, new technologies, healthcare professionals, and facilities to
enhance healthcare. In 2020, the increased rate of investment in medical and
health R&D contributed to the overall growth rate of health spending in the
U.S.
In 2018, North America led
the regional segment due to the introduction of new systems and test kits by
PCR manufacturers. Thermo Fisher Scientific Inc., for instance, launched VetMAX
MastiType in September 2018, a qPCR-based test package designed to rapidly
detect mastitis pathogens in milk stocks. Furthermore, the strong presence of
leading PCR producers and the growing demand for rapid diagnostic testing in
this region will drive regional growth in the forecast period.
During the forecast
period, Asia Pacific is expected to witness the highest CAGR. The region's
patient pool is projected to expand due to the high prevalence of chronic and
infectious diseases and increasing patient awareness of early diagnosis,
thereby driving the market growth of PCR products.
Recent Developments
- November 2022: Cepheid introduced the Xpert Xpress
MVP, a multiplexed PCR test that detects DNA from organisms associated with
three distinct conditions: bacterial vaginosis (BV), vulvovaginal candidiasis,
and trichomoniasis, from a single sample. This advancement aids in achieving
more accurate diagnoses and antibiotic treatment regimens.
- November 2022: PCR Biosystems unveiled a new range of
qPCR reagent mixes: Clara Probe Mix, Clara Probe 1-Step Mix, and Clara HRM Mix.
- In October 2021, Bio-Rad Laboratories, Inc. announced
the introduction of the CFX Opus 96 Dx System and CFX Opus 384 Dx System. These
state-of-the-art instruments offer real-time PCR detection for in-vitro
diagnostics testing.
- In September 2021, Thermo Fisher Scientific launched
the QuantStudio Absolute Q Digital PCR System, delivering accurate results
within 90 minutes.
Key Market Players
- Thermo Fisher Scientific,
Inc.
- Bio-Rad Laboratories, Inc.
- F. Hoffman-La Roche Ltd.
- Abbott Laboratories Inc.
- Agilent Technologies, Inc.
- Becton Dickinson and
Company
- Enzo Life Sciences, Inc.
- Promega Corporation
- Biomérieux S.A.
- Cole-Parmer Instrument
Company Llc
|
By
Product
|
By
Application
|
By
End User
|
By
Region
|
- Reagents
& Consumables
- Instruments
- Software
& Services
|
- Clinical
Diagnostics
- Research
- Forensic
|
- Hospitals
and Diagnostic Centers
- Pharmaceutical
- CROs
and Biotechnology Companies
- Research
Laboratories and Academic Institutes
- Forensic
Laboratories
|
- North
America
- Europe
- Asia
Pacific
- South
America
- Middle
East & Africa
|
Report
Scope:
In this report, the Global
Real Time PCR Market has been segmented into the following categories, in
addition to the industry trends which have also been detailed below:
- Real Time PCR Market, By Product:
o
Reagents &
Consumables
o
Instruments
o
Software &
Services
- Real Time PCR Market, By Application:
o
Clinical Diagnostics
o
Research
o
Forensic
- Real Time PCR Market, By End User:
o
Hospitals and
Diagnostic Centres
o
Pharmaceutical
o
CROs and
Biotechnology Companies
o
Research Laboratories
and Academic Institutes
o
Forensic Laboratories
- Real Time PCR 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
§ Kuwait
§ Turkey
§ Egypt
Competitive
Landscape
Company
Profiles: Detailed analysis of the major companies present in
the Global Real Time PCR Market.
Available
Customizations:
Global Real Time PCR market
report with the given market data, Tech Sci 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).
Global Real Time PCR Market is an upcoming report to
be released soon. If you wish an early delivery of this report or want to
confirm the date of release, please contact us at [email protected]