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Digital PCR Market Size, Share & COVID-19 Impact Analysis, By Type (Droplet Digital PCR, Chip-based Digital PCR, and Others), By Product (Instruments and Reagents & Consumables), By Indication (Infectious Diseases, Oncology, Genetic Disorders, and Others), By End-user (Hospital & Clinics, Pharmaceutical & Biotechnology Industries, Diagnostic Centers, and Academic & Research Organizations), and Regional Forecast, 2022-2029

Region : Global | Format: PDF | Report ID: FBI102014

 

KEY MARKET INSIGHTS

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The global digital PCR market size was valued at USD 428.7 million in 2021. The market is projected to grow from USD 413.0 million in 2022 to USD 1,847.0 million by 2029, exhibiting a CAGR of 23.9% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with digital PCR experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market exhibited a higher growth of 38.6% in 2020 as compared to 2019.


A digital polymerase chain reaction (dPCR) is a biotechnological advancement of conventional polymerase chain reaction. It is a high-throughput absolute quantitative method that provides a sensitive and reproducible way of measuring the amount of DNA or RNA in a sample.


The rise in prevalence of infectious diseases, cancer, and genetic disorders, the introduction of products, increasing acquisitions, and the growing adoption of digital devices by laboratories are some of the key factors expected to drive the market growth during the forecast period. Moreover, rising technological advancements in digital devices are projected to contribute to the market growth during the forecast period.


COVID-19 IMPACT


COVID-19 Pandemic Propelled the Market Growth due to Increase in SARS CoV-2 Testing


The impact of COVID-19 resulted in considerably high growth of the market in 2020. This is attributed to the vast spread of the virus, thereby increasing the demand for effective diagnostics to control its spread. The global digital PCR market witnessed a humongous growth rate of 38.6% in 2020 as compared to 18.1% in 2019.


The reallocation of healthcare resources for COVID-19 treatment increased the number of people going for the COVID-19 diagnosis and increased the adoption of the device in diagnostic centers and research institutes, thereby fueling the demand for the devices. Furthermore, the positive impact was due to the strong increase in COVID-19 testing in high-burden countries across the world. Additionally, during the initial days of the pandemic, the resources were devoted to fighting the coronavirus pandemic due to the strong infectious nature of the disease. The market players witnessed growth in revenue generated during 2020.


For instance, Bio-Rad Laboratories, Inc., a key player in the market, registered a revenue of USD 2,545.6 million in 2020, an increase of 10.1% as compared to 2019. The growth is attributed to the increased adoption of devices in diagnostics centers for the diagnosis of COVID-19.


LATEST TRENDS


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Shift of Healthcare Providers from Droplet to Chip-based Technology to Boost Market


The shift from droplet to chip-based technology for the diagnosis of various diseases has been pivotal in the advancement of the devices. In commercially available droplet dPCR, the droplets have to be transferred manually, leading to underestimation of the targets. Moreover, ddPCR kits also pose a risk of cross-contamination during the transfer of the sample. On the other hand, in a chip-based digital polymerase chain reaction, droplets always run in channels, reducing the risk of cross-contamination.


This innovation is expected to increase its adoption for the diagnosis of various diseases in the near future. Moreover, the increasing incidence of infectious diseases and the growing prevalence of cancer are expected to shift healthcare providers to chip-based devices. This is further projected to propel the digital PCR market growth during the forecast period.


DRIVING FACTORS


Technological Advancements in dPCR to Enhance Market Growth


Digital polymerase chain reaction is the refinement of conventional polymerase chain reaction that can be used to quantify and clonally amplify nucleic acids directly. Increasing research and development activities and growing demand for innovative devices have led to the introduction of various PCR technologies offering great benefits. The introduction of innovative devices, such as droplet, chip-based, beam, and crystal devices, by key market players is anticipated to drive market growth.



  • For instance, in November 2019, Bio-Rad Laboratories, Inc. announced the launch of the QX ONE device, which provides an absolute measurement of target DNA molecules with more accuracy, precision, and sensitivity.


Such technological advancements are expected to fuel the market during the forecast timeframe, 2022-2029.


Several Benefits of dPCR Over Real-time Polymerase Chain Reaction to Boost Market Globally


Digital polymerase chain reaction helps to deliver a complete measure of target nucleic acid molecules than the relative measure achieved from real-time devices. This absolute DNA quantification allows for reproducibility, sensitivity, and precision, further enabling researchers to quantify smaller differences and precisely measure minor variants.


Additionally, despite the wide application of real-time devices chain reaction, it is not a preferred technique for detecting various parasitic infectious diseases such as malaria and COVID-19 due to multiple types of genomes present in the virus and extremely low template concentration available in the sample. Digital droplet devices overcome those issues and deliver accurate results with better comparability of results from different groups.



  • For instance, in March 2022, according to an article by Clinical Microbiology Review for the detection and diagnosis of SARS-CoV-2, digital polymerase chain reaction has been extensively used over real-time polymerase chain reaction due to various benefits associated with it.


Such various advantages associated with these digital devices over real-time devices are expected to contribute to the market growth during the forecast period.


RESTRAINING FACTORS


High Cost of Systems and Availability of Alternatives such as NGS May Limit Market Growth


Despite various advantageous applications of digital devices, a few limitations are associated with its use, which can hamper its adoption in the market.


Certain limitations, such as higher cost of these digital devices as compared to other options, may limit its adoption. This factor gives rise to multiple alternative options in the market. For instance, counting PCR is an alternative to digital polymerase chain reaction for absolute quantification. It quantifies viral load, copy number variation, and gene expressions. Such an alternative is expected to limit the growth of these digital devices in the market.



  • For instance, in April 2018, according to the NCBI article, digital polymerase chain reaction has some fundamental limitations, such as high cost and high sensitivity, to inhibitors which increase the adoption of an alternative option of nucleic acid amplification technology.


Additionally, trained personnel can only handle these digital droplet devices to perform and quantify the results. Many equipment and reagents are not easily available for microfluidic technologies, limiting their adoption in many underdeveloped countries that are more vulnerable to viral infections.


Such limitations associated with the use of these digital devices coupled with the presence of other effective alternatives can restrain the overall market growth in the coming years.


SEGMENTATION


By Type Analysis


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Droplet Digital PCR Segment to Hold a Major Share due to Increasing Product Launches for Infectious Disease Diagnosis


In 2021, the droplet digital PCR segment held the highest market share. It is anticipated to expand at a substantial CAGR during the forecast period, 2022-2029. The growth is attributed to the increasing emphasis of market players on the development and commercialization of dPCR for infectious disease diagnostics. Furthermore, the increasing prevalence of infectious diseases and the advantages of these devices over other PCR in the diagnosis of diseases are expected to boost the segmental growth during the forecast period.



  • For instance, in 2020, as per an article by Frontiers, microdroplet digital polymerase chain reaction (mdPCR) assays displayed 100% specificity and sensitivity for simultaneous detection of mutation and duplication of the samples.


The chip-based digital PCR segment is projected to expand at a moderate CAGR during the forecast timeframe. The segmental growth is attributed to the sensitivity of chip-based digital PCR in detecting strain’s specificity with less variability compared to the current standard of plate count enumeration and quantitative polymerase chain reaction (qPCR).


By Product Analysis


Instruments to Hold a Major Share due to Increasing Applications of Digital Devices


Based on product, the market is segmented into instruments and reagents & consumables.


The instruments segment accounted for the largest market share in 2021 and is expected to expand at a substantial CAGR during the forecast period. The largest share of the segment is attributed to the increasing initiatives of the market players for the launch of new products and rising applications of this device in the market.


The reagents & consumables segment is projected to expand at the highest CAGR during the forecast timeframe. The growth of the segment is due to increasing commercialization of these digital device kits for diagnosis purposes. Furthermore, due to the COVID-19 pandemic, governments provided emergency use authorization to certain digital kits for the diagnosis of COVID-19, which is anticipated to further boost the market growth in the long run.


By Indication Analysis


Clinically Proven Effectiveness of Digital Devices in Infectious Disease Diagnosis to Strengthen the Segmental Growth


Based on indication, the market is segmented into infectious diseases, oncology, genetic disorders, and others.


The genetic disorders segment dominated the market in 2021 and is expected to expand at a moderate CAGR during the forecast timeframe, 2022-2029. The growth of the segment is attributed to the increasing adoption of these devices to identify gene alterations due to its high sensitivity and specificity in detection.


The oncology segment is projected to expand at a substantial CAGR during the forecast timeframe. The growth of the segment is attributed to the increasing prevalence of cancer diseases and the growing adoption of these digital devices over other devices in cancer research.


The infectious diseases segment is anticipated to expand at the highest CAGR during the forecast period. The clinically proven potential advantages of these droplet digital devices in the diagnosis of infectious diseases, including viral, bacterial, and parasitic infections are expected to boost the adoption of these devices, thereby propelling segmental growth. 


By End-user Analysis


Academic & Research Organizations to Continue Dominance due to Higher Product Adoption in Research Activities


Based on end-user, the market is segmented into hospitals & clinics, pharmaceutical & biotechnology industries, diagnostic centers, and academic & research organizations.


The academic & research organizations segment held the largest market share and is expected to expand at a moderate CAGR during the forecast period. The segment's growth is attributed to the increasing use of these devices in research studies in various fields, including oncology, genetic diseases, and others.


The diagnostics centers segment is projected to expand at the highest CAGR during the forecast timeframe. The segment's growth is attributable to the increasing prevalence of infectious diseases and the rising use of these digital devices for the diagnosis of various types of these diseases. Furthermore, with the outbreak of COVID-19, many market players increased their focus on developing and commercializing COVID-19 diagnostics kits.



  • In March 2020, Bio-Rad Laboratories, Inc. and Biodesix, Inc., a diagnostics company in lung disease, announced their partnership to bring the COVID-19 droplet digital polymerase chain reaction test to the FDA for an Emergency Use Authorization (EUA) approval to support the escalating need for testing in the U.S. Such partnerships for new product approvals related to COVID-19 contributed to the segmental growth in 2020.


REGIONAL INSIGHTS


North America Digital PCR Market Size, 2021 (USD million)

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The North America market was valued at USD 189.9 million in 2021 and is projected to expand at a substantial CAGR during the forecast period. The growth is due to the highly alert and economically stable population. Moreover, the increasing adoption of technologically advanced and high-cost diagnostics in the region is also expected to propel the regional market growth during the forecast period.


Europe is anticipated to expand at a moderate CAGR during the forecast timeframe. The growth is attributable to strong infectious diagnostics volume in key European countries and the rising expenditure on research & development in Europe.


The market in Asia Pacific is expected to grow at the highest CAGR during the forecast period. The market growth across the region is attributed to the improvement in healthcare infrastructure in Asian countries, the high burden of chronic and infectious diseases in the region, and increasing consciousness of individuals in terms of better treatment outcomes.



  • For instance, according to the data provided by the National AIDS Control Organization in April 2022, in response to an RTI query, over 17 lakh people contracted HIV in India in the last 10 years. Such increasing prevalence of infectious diseases has been increasing the demand for effective diagnosis in the region, thereby spurring the market growth in Asia Pacific.


The market in Latin America and the Middle East & Africa is expected to expand at a significant CAGR during the forecast period. The growth is attributable to the growing number of clinical studies to evaluate the efficacy of these devices and the increasing commercialization of such products in the region. Furthermore, increasing efforts to enhance the healthcare infrastructure of these countries are expected to further support market growth across the region.


KEY INDUSTRY PLAYERS


Diverse Portfolio of Leading Players and Strong Focus on Partnerships and Acquisitions to Strengthen their Market Position


The market is consolidated due to large market shares accounted for by key companies operating in the market.


The key companies operating in the market are Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., and Qiagen. In 2021, these three companies together accounted for a major share of the market.


Bio-Rad Laboratories, Inc. dominated the market with the highest digital PCR market share. The company’s market dominance is due to its strong product portfolio offering a wide array of instruments and consumables. Moreover, the company’s strong market share is due to the acquisitions of other digital devices manufacturers in the historical years.


Other prominent players in the global market include Sysmex Corporation, JN Medsys, and Standard BioTools Inc. (Fluidigm Corporation). These companies are focusing on strategic initiatives to gain more market shares during the forecast period.


LIST OF KEY COMPANIES PROFILED:



KEY INDUSTRY DEVELOPMENTS:



  • In April 2022, Stilla and Promega Corporation announced their co-marketing agreement that combined sample preparation with the latest Maxwell systems and digital polymerase chain reaction on the six-color Naica system. This collaboration strengthened both companies’ product portfolio.

  • In March 2022, Stilla announced its partnership with 12 distributors across the EMEA region. With this partnership, the company expanded its presence in the EMEA region.

  • In September 2021, Thermo Fisher Scientific Inc. announced the launch of Applied Biosystems QuantStudio Absolute Q a digital system.

  • In June 2020, Stilla announced the launch of the world’s first six-color digital polymerase chain reaction instrument.

  • In May 2020, Stilla announced the availability of its digital polymerase chain reaction solution, the Naica system. The product can reliably detect the SARS-CoV-2 virus and measure its viral load in all research centers and hospitals involved in the fight against COVID-19.


REPORT COVERAGE


An Infographic Representation of Digital PCR Market

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The research report provides a detailed competitive landscape and market dynamics. It focuses on key aspects such as the prevalence of chronic disease, regulatory scenarios by key countries/regions, and an overview of microfluidic consumables in the market. Furthermore, the report provides information on key industry developments, pricing analysis of consumables by key companies, and detailed product mapping of consumables supplied by key companies. In addition, the report includes insights related to technological advancements in the devices and the impact of COVID-19 on the market.


Report Scope & Segmentation


















































  ATTRIBUTE



 DETAILS



Study Period



2018-2029



Base Year



2021



Estimated Year



2022



Forecast Period



2022-2029



Historical Period



2018-2020



Unit



Value (USD Million)



Segmentation



By Type



  • Droplet Digital PCR

  • Chip-based Digital PCR

  • Others



By Product



  • Instruments

  • Reagents & Consumables



By Indication



  • Infectious Diseases

  • Oncology

  • Genetic Disorders

  • Others



By End-user



  • Hospitals & Clinics

  • Pharmaceutical & Biotechnology Industries

  • Diagnostic Centers

  • Academic & Research Organizations



By Geography



  • North America (U.S. and Canada)

  • Europe (Germany, France, U.K., Italy, Spain, Scandinavia, and Rest of Europe)

  • Asia Pacific (China, Japan, India, Australia, Southeast Asia, and Rest of APAC)

  • Latin America (Mexico, Brazil, and Rest of LATAM)

  • Middle East & Africa (GCC, South Africa, and Rest of MEA)



Frequently Asked Questions

Fortune Business Insights says that the global market stood at USD 428.7 million in 2021 and is projected to reach USD 1,847.0 million by the end of 2029.

The market is expected to expand at a CAGR of 23.9% during the forecast timeframe (2022-2029).

The droplet digital polymerase chain reaction segment is the leading segment in the market by type.

The growing adoption of digital systems over other conventional techniques and the rising incidence of chronic and infectious diseases are some of the factors driving the market.

Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., and Qiagen are the top players in the market.

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