|
Forecast Period
|
2024-2028
|
|
Market Size (2022)
|
USD 8.01 billion
|
|
CAGR (2023-2028)
|
6.03%
|
|
Fastest Growing Segment
|
Clinical
|
|
Largest Market
|
North America
|
Market Overview
Global Real-time PCR, Digital PCR
& End-point PCR Market has valued at USD 8.01 billion in 2022 with a CAGR of 6.03%. The PCR (Polymerase Chain Reaction) market is
characterized by three distinct techniques. Real-time PCR, Digital PCR, and
Endpoint PCR. Real-time PCR, valued at approximately USD 4 billion, is the
dominant segment, owing to its versatility in quantitatively measuring DNA
amplification in real-time. It is extensively used in clinical diagnostics,
gene expression analysis, and pathogen detection, with prominent players like
Thermo Fisher Scientific and Bio-Rad Laboratories leading the market. Digital
PCR, though smaller in size at around USD 450 million, is experiencing rapid
growth due to its precision in nucleic acid quantification and applications in
rare mutation detection. Endpoint PCR, a mature technology with a stable market
size, remains essential for various molecular biology applications, including
genotyping, DNA sequencing, and infectious disease diagnostics. All three
techniques continue to evolve with technological advancements and increasing
demand in healthcare and life sciences, catering to specific research and
diagnostic needs.
Key Market Drivers
Rising Incidence Of Chronic
Diseases, Infectious Diseases, And Genetic Disorders
The escalating incidence of
chronic diseases, infectious diseases, and genetic disorders is significantly
propelling the Real-time PCR, Digital PCR, and Endpoint PCR market. The global
burden of chronic illnesses such as cancer, cardiovascular diseases, and
diabetes is on the rise. These diseases necessitate early detection and precise
monitoring. Real-time PCR, with its real-time quantitative capabilities, allows
for the timely identification of genetic markers associated with these
conditions. Digital PCR, known for its unparalleled precision, aids in
detecting rare mutations, facilitating early intervention and personalized
treatment strategies. The emergence of infectious diseases, including recent
pandemics, emphasizes the need for accurate diagnostics. Real-time PCR has been
instrumental in detecting viral, bacterial, and fungal pathogens. Its speed and
sensitivity support swift identification and containment of infectious agents.
Meanwhile, Digital PCR offers enhanced sensitivity for monitoring viral load,
critical for managing infectious diseases.
Genetic disorders demand a
thorough understanding of an individual's genetic profile. Real-time and
Digital PCR are pivotal in genetic testing, enabling the detection of genetic
mutations linked to inherited disorders. This assists in early diagnosis, tailored
treatment, and genetic counseling. Therefore, the surge in these diseases
necessitates advanced diagnostic tools. Real-time PCR, Digital PCR, and
Endpoint PCR, with their precision and sensitivity, are indispensable in
addressing these healthcare challenges, leading to earlier detection, more
targeted treatments, and improved patient outcomes.
Increasing Demand For Rapid Diagnostic Tests
And Growing Adoption Of Qpcr & Dpcr
The Real-time PCR, Digital PCR,
and Endpoint PCR market are witnessing a significant surge in demand due to two
key factors: the increasing need for rapid diagnostic tests and the growing
adoption of qPCR (quantitative PCR) and dPCR (digital PCR) technologies. The
demand for quick and accurate diagnostic tests is escalating, driven by the
need for timely disease detection and monitoring, particularly in the context
of infectious diseases. Real-time PCR, with its ability to deliver rapid and
precise results, has become a cornerstone in diagnostics. It enables healthcare
professionals to swiftly identify pathogens, making it invaluable in situations
like the COVID-19 pandemic.
Quantitative PCR (qPCR) and
digital PCR (dPCR) have gained traction in both research and clinical settings
due to their unmatched precision and sensitivity. Researchers are increasingly
relying on these techniques to quantify nucleic acids accurately. In
diagnostics, dPCR, with its absolute quantification capabilities, is proving to
be a game-changer, especially in monitoring viral loads in infectious
diseases.The convergence of the need for rapid diagnostics and the adoption of
qPCR and dPCR technologies has fueled the growth of the Real-time PCR, Digital
PCR, and Endpoint PCR market. These techniques are not only meeting the demand
for rapid and accurate testing but are also enabling earlier disease detection,
tailored treatments, and improved patient outcomes. As healthcare continues to
evolve, these PCR technologies are poised to play pivotal roles in shaping the
future of diagnostics and research.
implementation of MIQE
(Minimum Information for Publication of Quantitative Real-Time PCR Experiments)
The implementation of MIQE
(Minimum Information for Publication of Quantitative Real-Time PCR Experiments)
guidelines is exerting a significant influence on the Real-time PCR, Digital
PCR, and Endpoint PCR market. These guidelines provide a standardized framework
for conducting and reporting quantitative PCR experiments, promoting data
accuracy, reproducibility, and reliability. Here's how MIQE is driving the PCR
market: MIQE-compliant studies adhere to stringent experimental design and
reporting standards, ensuring the accuracy and integrity of PCR-generated data.
Researchers and clinicians increasingly prioritize high-quality data in their
work, spurring the demand for advanced PCR technologies. MIQE adherence
enhances the credibility of PCR-based research, facilitating greater trust in
the scientific community. This leads to more collaborative studies and
accelerates the pace of scientific discovery, driving the adoption of Real-time
PCR, Digital PCR, and Endpoint PCR technologies. In clinical diagnostics, MIQE
compliance is critical to guarantee the precision of patient test results.
Regulatory bodies and healthcare institutions are increasingly requiring MIQE
adherence for PCR-based diagnostic assays, propelling the use of PCR
instruments and reagents. The strict standards set by MIQE guidelines
necessitate high-quality PCR instruments, reagents, and software. This drives
investments in cutting-edge PCR technology, expanding the market for these PCR
solutions.
Therefore implementation of MIQE
guidelines has become a catalyst for the PCR market's growth. Researchers,
clinicians, and regulatory bodies increasingly recognize the significance of
MIQE compliance, promoting the adoption of Real-time PCR, Digital PCR, and Endpoint
PCR technologies across a wide range of scientific and clinical applications.
Technological advancements in
PCR (Polymerase Chain Reaction)
Technological advancements in PCR
(Polymerase Chain Reaction) are propelling the Real-time PCR, Digital PCR, and
Endpoint PCR market into a new era of precision, efficiency, and versatility.
These advancements are driving the adoption of PCR techniques across various
industries and applications. Continuous research and development efforts have
led to PCR systems with greater sensitivity and precision. Real-time PCR and
Digital PCR, in particular, can now detect and quantify nucleic acids with
unprecedented accuracy, revolutionizing genomics research, clinical
diagnostics, and personalized medicine. PCR techniques have evolved to enable
multiplexing, allowing the simultaneous analysis of multiple genetic targets in
a single reaction. This not only saves time but also conserves resources.
High-throughput PCR systems have emerged, meeting the demand for rapid and
large-scale testing, especially in clinical diagnostics and drug discovery.
PCR instruments are increasingly
being integrated with automation systems, streamlining laboratory workflows and
minimizing human error. This is vital in clinical settings where reliability
and speed are paramount. Miniaturization and portability have resulted in
point-of-care PCR devices that can be deployed in remote or resource-limited
areas. These compact systems are expanding the use of PCR in infectious disease
diagnosis and monitoring. PCR has become an integral component of NGS
workflows, facilitating target amplification before sequencing. This
integration has accelerated advancements in genomics and molecular biology
research. Therefore, technological breakthroughs are reshaping the PCR
landscape, fueling the adoption of Real-time PCR, Digital PCR, and Endpoint PCR
across diverse sectors. These innovations are broadening the scope of PCR
applications, making it an indispensable tool in modern science, medicine, and
diagnostics.
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Key Market Challenges
High Device Costs Associated
With Real Time Pcr
The high device costs associated
with Real-time PCR have become a significant challenge for the Real-time PCR,
Digital PCR, and Endpoint PCR market. While these technologies offer
unparalleled precision and sensitivity, their initial investment and ongoing
operational expenses can be substantial, creating several hurdles: The
considerable upfront cost of purchasing Real-time PCR, Digital PCR, or Endpoint
PCR instruments can deter smaller research laboratories, clinics, and
resource-constrained regions from adopting these technologies. This limits
their access to advanced molecular diagnostic capabilities. Beyond the initial
purchase, PCR instruments require regular maintenance and the use of
specialized consumables, such as reagents and disposables. These ongoing
expenses can strain budgets, particularly in healthcare settings with tight
financial constraints. Proper utilization of PCR systems demands trained
personnel with expertise in molecular biology techniques. Investing in staff
training adds to the overall cost of implementing and maintaining PCR
technologies.
The cost per test with PCR-based
assays can be higher compared to some other diagnostic methods. This can be a
concern for healthcare providers and patients, potentially limiting the
widespread adoption of these techniques. The high cost of PCR instruments has
led to a competitive market, with manufacturers striving to offer
cost-effective solutions. While this benefits consumers, it can pose a
challenge for manufacturers in terms of maintaining profitability. Therefore,
while Real-time PCR, Digital PCR, and Endpoint PCR offer exceptional diagnostic
capabilities, their high device costs present a significant challenge. To
overcome this obstacle and promote broader adoption, the industry must continue
to explore cost-effective innovations, streamline operational expenses, and
facilitate accessibility to these advanced molecular diagnostic technologies
across diverse healthcare and research settings.
Stringent Regulatory Policies
Stringent regulatory policies
present a considerable challenge for the Real-time PCR, Digital PCR, and
Endpoint PCR market. While regulations are essential for ensuring the safety
and reliability of diagnostic devices, they often pose several hurdles to the
industry's growth and innovation. One of the primary challenges lies in the
lengthy and resource-intensive process of obtaining regulatory approvals.
Companies must navigate complex and time-consuming procedures, such as FDA
clearance in the United States or CE marking in Europe. These approval delays
can significantly impede the introduction of new PCR technologies to the
market. Compliance costs are another major concern. Meeting stringent
regulatory requirements demands substantial investments in testing,
documentation, and quality control measures. These expenses can increase the
overall cost of PCR technologies, potentially making them less accessible to
healthcare providers and patients. The stringent regulatory landscape can also
deter smaller, innovative companies from entering the market. Compliance with
complex regulations may require significant financial and human resources,
limiting the development of novel PCR technologies.
Moreover, different regions often
have their own regulatory frameworks, resulting in variations and
inconsistencies. Adhering to various sets of rules can be burdensome for
manufacturers aiming to market their products globally. Therefore, while
regulatory policies are crucial for ensuring patient safety and product
quality, they create significant challenges for the Real-time PCR, Digital PCR,
and Endpoint PCR market. Balancing stringent regulations with innovation and
market access is essential to drive the industry forward and provide healthcare
providers and patients with advanced diagnostic tools.
Key Market Trends
Genomics research
Genomics research is playing a
pivotal role in driving the growth of the Real-time PCR, Digital PCR, and
Endpoint PCR market. This field of study, focused on understanding the complete
set of an organism's genes (its genome), relies heavily on Polymerase Chain
Reaction (PCR) technologies for a multitude of applications.
One of the primary drivers is the
need for DNA amplification and sequencing, which are fundamental processes in
genomics research. PCR techniques enable researchers to selectively amplify
specific DNA regions, facilitating the analysis of genetic variations,
mutations, and gene expression patterns. Moreover, the emergence of
next-generation sequencing (NGS) has further accentuated the importance of PCR.
NGS relies on PCR for target amplification before sequencing, making PCR a
critical component in the genomics workflow. This synergy between PCR and NGS
has propelled genomics research into new dimensions, enabling researchers to
explore complex biological questions and uncover genomic insights.
Additionally, genomics research
has far-reaching implications in fields such as personalized medicine,
agriculture, and evolutionary biology. The demand for accurate,
high-throughput, and cost-effective PCR technologies has surged as genomics
research expands its horizons. Therefore, genomics research's insatiable
appetite for DNA analysis and sequencing has fueled the demand for Real-time
PCR, Digital PCR, and Endpoint PCR technologies. These PCR techniques are
indispensable tools in the genomics researcher's toolkit, contributing
significantly to our understanding of genetics and driving innovations in
science, medicine, and beyond.
Point-of-care testing (POCT)
Point-of-care testing (POCT) has
emerged as a prominent trend in the Real-time PCR, Digital PCR, and Endpoint
PCR market, transforming the landscape of diagnostic and healthcare practices.
This shift is driven by several key factors. The need for rapid and on-the-spot
diagnostics has never been more critical, particularly in scenarios like
infectious disease outbreaks, where quick and accurate results can be a matter
of life and death. PCR technologies, including Real-time PCR and Digital PCR,
have evolved to meet this demand. Portable and compact PCR devices are now
available, allowing healthcare professionals to perform molecular diagnostics
at the patient's bedside or in remote locations. Secondly, the COVID-19
pandemic highlighted the significance of POCT using PCR techniques. Real-time
PCR, in particular, played a central role in mass testing efforts, emphasizing
the technology's adaptability for rapid and widespread diagnostics. Furthermore,
the decentralization of testing facilities is a growing trend in healthcare.
POCT reduces the need for sending samples to centralized laboratories, saving
time and resources. This decentralization also promotes early diagnosis and
treatment, improving patient outcomes. In addition, as PCR devices become more
user-friendly and require less technical expertise, their adoption in POCT
settings becomes more feasible for healthcare providers beyond traditional
laboratories. Overall, the trend towards point-of-care testing using PCR
technologies is driven by the demand for quick, accurate, and accessible
diagnostics. As these technologies continue to evolve, they are expected to
play an increasingly significant role in healthcare, offering timely insights
and improving patient care.
Segmental Insights
Product Insights
The consumables and reagents
segment emerged as the dominant revenue contributor, accounting for a
substantial share of over 56.51% in 2022 within the Real-time PCR, Digital PCR,
and Endpoint PCR market. This dominance can be attributed to several key
factors that have shaped its growth trajectory. The outbreak of the COVID-19
pandemic created an unprecedented demand for diagnostic testing, where PCR
technologies played a pivotal role. Consumables and reagents are fundamental
components of PCR assays, and the surge in testing requirements significantly
boosted their consumption. The need for early and accurate disease detection
during the pandemic further fueled demand. Secondly, the multitude of companies
engaged in the manufacturing of digital PCR consumables and reagents
contributed to the segment's prominence. Competition in this sector led to
product innovation and a wider range of offerings, catering to diverse research
and diagnostic needs.
Moreover, the extensive use of
consumables and reagents across various domains, including healthcare,
research, and other scientific applications, has sustained the segment's large
market share. These consumables are integral to routine laboratory practices,
ensuring the continuity of research and diagnostics. Furthermore, the rising
prevalence of chronic diseases has led to increased utilization of PCR
technologies, consequently bolstering the demand for consumables and reagents.
Additionally, the pharmaceutical and healthcare sectors' growing acceptance of
technological advancements and increased research and development activities
are set to create significant growth opportunities for this segment in the
foreseeable future. In conclusion, the consumables and reagents segment's
dominance in the Real-time PCR, Digital PCR, and Endpoint PCR market is the
result of a confluence of factors, including the COVID-19 pandemic, competitive
manufacturing landscape, widespread application, and the ever-expanding realm
of research and healthcare. This dominance is poised to persist as the market
continues to evolve.
Technology Insights
The quantitative PCR segment
established its dominance in the market, capturing a substantial revenue share
of over 88.63% in 2022. Several driving forces have propelled this segment to
the forefront, shaping its remarkable growth trajectory. Firstly, the rapid
pace of technological advancements has been a catalyst for the quantitative PCR
segment's ascent. These advancements have led to the development of more
sophisticated and user-friendly PCR systems, catering to the evolving needs of
researchers and diagnosticians. Secondly, there is a growing demand for
automated PCR systems and point-of-care diagnostics. The convenience and
efficiency offered by automated systems have garnered significant interest,
further propelling the quantitative PCR segment's growth. Additionally, the
segment has experienced an exponential surge in demand due to the global
response to the COVID-19 pandemic. The introduction of real-time PCR-based
products for COVID-19 screening and diagnosis has played a pivotal role in this
growth. For example, Huwel Lifesciences unveiled a portable RT-PCR machine in
February 2023 designed to test various virus types, enhancing accessibility to
testing.
Furthermore, distribution
agreements, such as the one announced by Bruker Corporation in March 2020 for
the distribution of genesig real-time PCR coronavirus assay, have facilitated
the widespread adoption of quantitative PCR technologies. These agreements have
expanded the availability of critical diagnostic tools in regions including the
U.S., the U.K., Spain, France, and Germany. In conclusion, the quantitative PCR
segment's ascendancy in the market can be attributed to a confluence of
factors, including technological innovations, increased demand for automation
and point-of-care diagnostics, and the pivotal role it has played in COVID-19
testing. This segment is poised to maintain its strong growth trajectory in the
foreseeable future.
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Regional Insights
In 2022, North America took the
lead on the global market stage, capturing a significant revenue share of over
36.10%. This strong position is expected to persist throughout the forecast
period, and several key factors are responsible for this continued dominance. One
of the primary drivers is the presence of favorable regulations and
government-led initiatives aimed at advancing healthcare infrastructure. North
America has actively promoted the development of healthcare technologies,
including PCR diagnostics, through supportive regulatory frameworks.
Additionally, the region grapples with a high prevalence of diseases,
necessitating reliable and efficient diagnostic solutions.
Moreover, North America boasts a
robust presence of leading PCR technology manufacturers, further cementing its
status as a hub for innovation and production in this sector. This homegrown
expertise ensures that the region can meet the escalating demand for rapid and
precise diagnostic tests. Shifting the focus to Asia Pacific, this region
emerges as the most promising and lucrative market. China and Japan stand out
for their notable advancements in integrating PCR technology into various
applications. Furthermore, emerging economies like India and Australia are
actively developing their healthcare, research, and clinical frameworks,
contributing to the region's growth potential.
Overall, North America's
dominance is attributed to regulatory support, government initiatives, and
disease prevalence, while the Asia Pacific region shines with technological
integration and expanding healthcare and research sectors. These factors
position both regions for substantial growth in the PCR market in the
foreseeable future.
Recent Developments
- In July 2023, QIAGEN launched CGT
Viral Vector Lysis kit for the biopharma industry, expanding its range of
digital PCR kits and services. This is aimed at facilitating the development of
cell and gene therapies in the biopharma sector.
- In October 2022, Standard
BioTools (formerly known as Standard BioTools) launched the X9 Real-time PCR
System, a productive and high-capacity genomics platform. With more than 9,000
unique nanoliter-volume reactions in a single run, X9 offers high data output,
ensuring efficient, thorough sample profiling with little operator involvement.
- In September 2021, Thermo Fisher
Scientific launched the Applied Biosystems QuantStudio Absolute Q digital PCR
system, thus expanding its genetic analysis capabilities. It is the first fully
integrated digital PCR (dPCR) system that is designed to provide consistent and
highly accurate results within 90 minutes.
- In June 2021, Bio-Rad introduced
its PREvalence ddPCR SARS-CoV-2 wastewater quantification kit for testing
COVID-19 wastewater at a competitive price.
Key Market Players
- Abbott
Laboratories Inc
- Bio-Rad
Laboratories Inc.
- Thermo
Fisher Scientific, Inc.
- BIOMÉRIEUX
SA
- Fluidigm
Corporation
- F.
Hoffmann-La Roche Ltd
- GE
Healthcare
- Agilent
Technologies, Inc.
- Qiagen
NV
- Microsynth
Ag
|
By
Technology
|
By
Product
|
By
Application
|
By
Region
|
- Quantitative
- Digital
- Endpoint
|
- Consumables & Reagents Instruments
- Software & Services
|
|
- North
America
- Europe
- Asia
Pacific
- South
America
- Middle
East & Africa
|
Report Scope:
In this report, the Global Real-time
PCR, Digital PCR & End-point PCR Market has been segmented into the
following categories, in addition to the industry trends which have also been
detailed below:
- Real-time
PCR, Digital PCR & End-point PCR Market, By Technology:
o Quantitative
o Digital
o Endpoint
- Real-time
PCR, Digital PCR & End-point PCR Market, By Product:
o Consumables
& Reagents
o Instruments
o Software
& Services
- Real-time
PCR, Digital PCR & End-point PCR Market, By Application:
o
Clinical
o
Research
- Real-time
PCR, Digital PCR & End-point 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, Digital
PCR & End-point PCR Market.
Available Customizations:
Global Real-time PCR, Digital PCR
& End-point 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, Digital
PCR & End-point 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]