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Digital PCR Market

Increased Demand for Newly Developed Diagnostic Procedures will drive the Global Digital PCR Market over the Forecast Duration (2023-2033)

Digital PCR Market Segmented By Instruments, Consumables, Services Product Clinical Diagnostics, Basic Research, Applied Research, Forensic Testing

Digital PCR Market Outlook (2023-2033)

Worldwide revenue from the Digital PCR Market stands at US$ 154.3 Mn in 2022, with the global market estimated to expand at a CAGR of 9.2% to reach US$ 403.8 Mn by the end of 2033.

Attributes Key Insights

Digital PCR Market Size (2022)

US$ 154.3 Mn

Projected Market Value (2033)

US$ 403.8 Mn

Global Market Growth Rate (2023-2033)

9.2% CAGR

Market Share of Top 5 Countries

54.3%

As assessed by Persistence Market Research, Instrument contributed the largest share of 70.6% among the products in 2022. The global digital PCR market holds 1.8% of the global PCR market value of US$ 8.5 Bn in 2022.

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Sales Analysis of Digital PCR Market from 2012 to 2022 Vs Market Outlook for 2023 to 2033

The global market for digital PCR recorded a historic CAGR of 7.5% in the last 10 years from 2012 to 2022.

Sykes et al. first proposed the idea of digital PCR (dPCR) in 1992, and Kalinina et al. later developed it into a nanoscale array format in 1997. There has been constant innovations taking place within this arena since then.

A new quantitative PCR technique known as digital PCR, or dPCR, allows for the ultrasensitive and repeatable detection as well as quantification of nucleic acids. A revolution in molecular biology and biotechnology has been brought about by the development of the Polymerase Chain Reaction (PCR), which will boost the d-PCR market during the forecast period as compared to 2012-2022.

The PCR based market has seen an enormous shift in market demand for PCR consumables and reagents due to significant growth in R&D. Especially, during pandemic, companies were involved largely in developing vaccines for treatment against the novel coronavirus disease.

  • In 2020, The Droplet d-PCR SARS-CoV-2 Test Kit was given emergency use authorization by the FDA to Bio-Rad.
  • In 2020, Danaher Corporation received the US FDA Emergency Use Authorization (EUA) for the Xpert Xpress SARS-CoV-2 test.
  • Thermo Fisher created a number of PCR kits and tests for diagnostic and research uses to fight the COVID-19 outbreak. The business developed AcroMetrix Coronavirus 2019 (COVID-19) RNA Control in 2020 after receiving the US FDA's emergency use authorization (EUA) for the SARS-CoV-2 multiplex real-time PCR test.
  • In 2020, The CE Mark has given bioMérieux S.A. permission to conduct SARS-CoV-2 R-GENE testing using saliva samples. Additionally, the business was granted permission for using the BioFire COVID-19 test in an emergency.

Digital PCR also known as dPCR, is a newer PCR technology that has been utilised in molecular genetic analysis to find cancer, mutational analysis, evaluation, and quantitative gene expression study of allelic imbalance. There is an urgent need for the adoption of cutting-edge diagnostic tools and therapies to help with the reduction of disease burden due to the rising incidence of infectious diseases and cancer around the world as well as the rise of rare cancer incidences.

  • On October 14, 2022, QX600™ Droplet Digital™ PCR System which enables Superior six-colour multiplexing enables the QX200TM Droplet Digital PCR System to be used with assays that clearly distinguish between different targets. Researchers that need to quantify many targets with excellent accuracy, reproducibility, and sensitivity can use the QX600 System.
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How are Digital PCR Manufacturers Growing?

“Increased Demand for Newly Developed Diagnostic Procedures”

Robotics integration in qPCR technology allows for the handling and processing of high-throughput samples, even with the detection of extremely small amounts of samples onto the solid substrate platform of nylon membrane or glass slides. These developments will probably lead to an increase in demand for chip-based automated digital PCR in the near future.

Digital PCR (dPCR) use is expanding as a result of causes such as increased demand for newly developed diagnostic procedures, increased public health awareness, growing demand for early diagnosis of viral, infectious, and genetic disorders, and expansion of health care infrastructure globally, etc. As a result, it is projected that the d-PCR market would grow and have a wide range of applications throughout the projection period. The global d-PCR market is expected to expand at a much higher CAGR in the coming years.

Stilla Technologies' 6-Color Digital PCR Access Program was introduced in July 2021. Stilla Technologies is a developer of next-generation digital PCR technologies for molecular diagnostics and life science research. The COVID-19 & infectious disease research, cell and gene treatments, environmental testing, and cancer and liquid biopsy studies can all benefit from the excellent multiplexing and sensitivity of this six-colour digital PCR system. The introduction of such Digital PCR products is anticipated to open up fruitful market expansion potential.

“Advancements for Improvement of Market for Digital PCR”

Due to the utilisation of their novel applications in laboratories, it is anticipated that the global digital polymerase chain reaction market would experience a significant amount of opportunistic emphasis. In the continents of Asia and Africa, the use of digital PCR in veterinary and medical microbiology is a key market driver. Due to its higher efficacy and simplicity of use, clinical diagnostic applications of digital PCR are only anticipated to present an adaptive approach during the course of the forecast period, spurring market expansion.

In addition to identifying new animal species, plants, and diseases, portable digital PCR is also used to identify new plant species. Therefore, a sizable pool of consumers is anticipated to be drawn to the plethora of applications of digital PCR in domains such as healthcare, food, environment, animal health, conservation, and forensics, aside from the detection of diseases.

Additionally, automated sophisticated digital PCR machines have made it possible for researchers to accurately and cheaply process genetic samples. The key draw of automation technology that saves time and lowers foreign contamination is reduced manual labour and user engagement during the programme execution of high-throughput samples.

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How is Market Progress Being Affected to Some Extent?

“Real-Time PCR is Still in Demand

Although the molecular biology sector benefits from the applications of digital PCRs, the high cost of high-tech digital PCR instruments acts as a deterrent when compared to the cost of RT-PCR. As a result of RT PCR's lower cost, real-time PCR is still in demand in applications like genotyping and gene expression studies even if digital PCR is expanding significantly.

The reduced demand for digital PCR is also attributed to growing competition in Next Generation Sequencing (NGS), which is useful for sequencing whole genomes, whole exomes, transcriptomes, and specific gene areas. The market for digital polymerase chain reactions may experience restrained growth as a result of growing demand for targeted next-generation sequencing compared to PCR, which is more cost-effective.

NGS is plagued by its limited sensitivity and high cost, despite its capacity to detect hundreds of mutations in a run. Although digital PCR is known for its great sensitivity, its price is still higher than that of conventional quantitative PCR.

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Country-wise Insights

Why is the U.S. Digital PCR Market Booming?

“Presence of major pharmaceutical and biotechnology companies”

The U.S. accounted for a 23.9% share of the global market in 2022, and a similar trend is expected over the forecast period.

The region holds a dominant share of the North American dPCR market because of the high prevalence of genetic and chronic diseases, coupled with the rising elderly population, the expanding use of d-PCR techniques in academic and research settings, the significant public-private funding of genome analysis, and the dominance of major pharmaceutical and biotechnology companies in the US.

Furthermore, in the US, a well-established market for these technologies, life science researchers frequently use genome analysis techniques in clinical applications (such as pathogen detection, disease diagnosis, and DNA identification) and research applications (such as genomics and molecular research).

Key players have been developing new techniques that can give results in minimal time with high accuracy.

  • In 2020, U.S. FDA authorized emergency use of ALINITY m SARS-CoV-2 ASSAY under EUA guidelines to Abbott

Why is China Emerging as a Prominent Market for Digital PCR Market Suppliers?

“High requirement of digital PCR”

China held the market share of nearly 5.7% in the global d-PCR market in 2022, and over the projection period, this share is expected to grow. As the COVID-19 pandemic spread, demand for PCR tests increased in the China market.

The use of digital PCR technology in the nation's R&D further assesses the development of the digital PCR sector in China. The National Health Commission of the People's Republic of China used digital PCR and analysed its advantages for infection screening in order to test for COVID-19 with high efficiency and sensitive diagnostic evaluation.

Why is Germany Considered a Lucrative Market for Digital PCR in Europe?

“Digital PCR business is boosted by the increase in R&D activities”

Germany holds a commanding 24.1% share of the European d-PCR market.

One of the key nations in pharmaceutical research and development is Germany. By integrating technologies that involve genetic analysis, pioneering approaches like targeted therapy and personalised precision medicine are being developed.

Germany provides significant institutional financing for research and development, which has improved the calibre of research across Europe. The region has seen a rise in the use of molecular diagnostics as a result of the prevalence of diseases, and the application of microarray, PCR, and other genomic and proteomic.

The development of the digital PCR business is boosted by the increase in R&D activities for PCR technology enhancement and in company collaboration agreements. The development of this market is, however, constrained by the high cost of digital PCR instruments and problems with reimbursement for such devices. Collaboration between some of the leading players helps to boost this market for example,

  • In January 2022, a well-known manufacturer of diagnostic tools, Qiagen collaborated with Atila Biosystems and Actome GmbH. to offer non-invasive prenatal testing (NIPT) options for QIAGEN's digital PCR and licence & agreement for joint marketing.

Category-wise Insights

Which Digital PCR Product is Mainly Driving Market Growth?

“Use and the user-friendly aspect of digital PCR instruments”

By product, the instruments project leads the segment by holding nearly over 70% of the global market share and by the conclusion of the forecast period, growth is anticipated to be profitable at a CAGR of 9.2%. This expansion is related to the simplicity and user-friendliness of digital PCR tools.

PCR systems being at a higher cost compared to consumables and services together with its growing demand for various researches applications and  subsequent installations across various healthcare facilities have led this segment to dominate the global market.

Why market share for Research Institutes is Highest among End Users?

Compared to pharmaceutical companies, forensic labs, and agriculture companies, research institutes dominate with 70.0% of end users globally in 2022.

The increasing demand for developing novel products/drugs/devices for the treatment of various diseases, and understanding of risk factors associated, have led many regions to take up initiatives in boosting the research and development sectors. The PCR based systems and techniques hold the highest demand for the same due to wide applicability in research activities, together making research institutes the highly sought after segment within the end user category.

Which Application of Digital PCR Is Considered to Be Widely Popular?

Basic research held the largest share among applications with nearly 33.9% revenue share in 2022. Digital PCR has made progress in the field of parasitic infection diagnostics. This relates to the goal of lowering the global disease burden.

Utilising d-PCR systems for basic research is boosting the global market as it has the ability to give results in minimum time with high accuracy leading to higher productivity. Key players are investing in the R&D sector to develop new techniques to get results more accurately.

COVID-19 impact on Driving Digital PCR Market Growth?

“Positive Impact on Market for Digital PCR”

The COVID-19 pandemic's effects were assessed in various facets of the healthcare sector. Diagnostics was the sector with the most influence. The COVID-19 pandemic had a positive effect on the development of RT-PCR and digital PCR, both of which were used in diagnostics and drug discovery. The creation of novel droplet digital PCR kits for the detection of COVID-19 had been the primary focus of the sector's major players. To control the COVID-19 pandemic's severity, a number of regulatory agencies started the clearance process for such testing.

Since digital PCR tests are utilised to diagnose COVID-19 infection, the COVID-19 epidemic had a positive effect on the growth of the d-PCR market. The market is expanded because of COVID-19 infections.

For instance, a report from the World Health Organization (WHO) stated that as of 19 December 2021, there have been reported over 273 million illnesses and over 5.3 million deaths worldwide. Additionally, the market grew as there were more facilities specifically designed for COVID-19 diagnostics.

  • In January 2021, an announcement was made by QIAGEN, to broaden its offering of COVID-19 testing options, the company has included the "Qiacity" d-PCR platform for wastewater and mutation testing.

Competitive Landscape

The strategy of expansion, new product launches, and approvals by key manufacturers is strengthening their market presence. Many companies have an established presence in clinical diagnostics, such as Bio-Rad Laboratories.

For instance,

  • Bio-Rad Laboratories, Inc. received approval from US FDA in 2019 for, its QXDX AutoDG digital PCR System and the QXDX BCR-ABL %IS Kit.
  • To provide a cartridge-based method for Sanger sequencing and fragment analysis, Thermo Fisher Scientific unveiled the new capillary electrophoresis (CE) system in May 2017.
  • In order to provide NGS library prep assays that enable the CFTR gene to be used for research with the Juno System, Fluidigm Corporation and Baylor Genetics agreed into a licencing agreement in August 2017.

Digital PCR Market Report Scope

Attribute Details

Forecast Period

2023-2033

Historical Data Available for

2012-2022

Market Analysis

USD Million for Value

Key Countries Covered

  • U.S.
  • Canada
  • Brazil
  • Argentina
  • Mexico
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Russia
  • BENELUX
  • India
  • Thailand
  • Malaysia
  • Indonesia
  • China
  • Japan
  • South Korea
  • Australia
  • New Zealand
  • Turkey
  • GCC Countries
  • South Africa

Key Market Segments Covered

  • Product
  • End User
  • Application
  • Region

Key Companies Profiled

  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific Inc.
  • Fluidigm Corp.
  • Formulatrix, Inc.
  • JN Medsys.
  • STILLA TECHNOLOGIES
  • Avance Bioscience
  • Fluidgm corporation,
  • jn medsys
  • Merck KGAA
  • Precigenome LLC
  • QIAGEN N.V
  • Sysmex corporation

Report Coverage

  • Market Forecast
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives

Customization & Pricing

Available upon Request

Key Segments of the Digital PCR Industry

By Product:

  • Instrument
  • Consumables
  • Services

By End User:

  • Pharmaceutical Companies
  • Research Institutes
  • Forensic Labs
  • Agriculture Companies

By Application:

  • Clinical Diagnostics
  • Basic Research
  • Applied Research
  • Forensic Testing

By Region:

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East & Africa

- Companies Covered in This Report -

  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific Inc.
  • Fluidigm Corp.
  • Formulatrix, Inc.
  • JN Medsys.
  • STILLA TECHNOLOGIES
  • Avance Bioscience
  • Fluidgm corporation,
  • jn medsys
  • Merck KGAA
  • Precigenome LLC
  • QIAGEN N.V
  • Sysmex corporation.

- Frequently Asked Questions -

The global market for digital PCR is valued at around US$ 154.3 Mn in 2022.

Sales of the d-PCR market are set to exhibit a growth rate of 9.2% and reach US$ 403.8 Mn by 2033.

Demand for the d-PCR market increased at 7.5% CAGR from 2012 to 2022.

The U.S., Canada, Japan, Germany, and China accounted for the most demand for the d-PCR market and held a cumulative market share of 54.3% in 2022.

The U.S. accounted for a 23.9% share of the global market in 2022.

Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., and Fluidigm Corp., are the top three manufacturers of the d-PCR market.

China held a share of 5.7% in the global market in 2022.

Germany holds a commanding 24.1% share of the European d-PCR market.

The market share of India was 4.2% in the global market for digital PCR in 2022.

European market is expected to grow at a CAGR of 8.9% during the forecast period.

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