| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 9.26 Billion |
| Market Size (2030) | USD 12.06 Billion |
| CAGR (2025 - 2030) | 5.43 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
PCR Molecular Diagnostics Market Analysis
The Global PCR Molecular Diagnostics Market size is estimated at USD 9.26 billion in 2025, and is expected to reach USD 12.06 billion by 2030, at a CAGR of 5.43% during the forecast period (2025-2030).
The PCR (Polymerase Chain Reaction) molecular diagnostics market has undergone a significant transformation. This evolution has been propelled by technological advancements, a surge in disease prevalence, and an urgent demand for swift diagnostic solutions. The pivotal role of PCR testing in global healthcare systems was underscored during the COVID-19 pandemic, which hastened its adoption. With an emphasis on high-complexity tests and cutting-edge technologies, the market is set for sustained growth, highlighting the crucial role of timely and precise diagnostics in the fight against infectious diseases and cancer.
The landscape of PCR molecular diagnostics is rapidly changing, underscored by key product launches and strategic partnerships that bolster testing capabilities. For instance, MolBio Diagnostics from India, in May 2024, showcased its Truelab Real-Time quantitative micro PCR system. Their hepatitis C PCR tests are in the pipeline for WHO prequalification, emphasizing a commitment to public health and hepatitis screening. Additionally, with an eye on preventive diagnostics, the company is amplifying its focus on cervical cancer screening via HPV tests.
Moreover, in April 2024, Speed Pty Ltd. from Australia unveiled a groundbreaking qPCR test. This test can identify 14 respiratory viruses in one go, is compatible with almost all commercial PCR platforms, and promises quicker results at a competitive price, addressing a pressing need in respiratory virus diagnostics.
Furthermore, the infusion of novel technologies into PCR testing has markedly boosted diagnostic precision and efficiency. For instance, in April 2023, a noteworthy collaboration emerged between ALPCO-GeneProof and Thermo Fisher. They joined forces to promote the TaqPath Menu | GeneProof PCR kits. This alliance integrates ALPCO-GeneProof's molecular diagnostics with Thermo Fisher's extensive supply chain, enabling the seamless integration of 37 CE-IVD molecular diagnostic assays across diverse qPCR instruments.
Rising cancer rates and the prevalence of infectious diseases are key catalysts propelling the growth of the PCR molecular diagnostics market. The World Health Organization underscored this alarming trend in Asia, reporting approximately 9.84 million new cancer cases in 2022. Projections indicate a dramatic rise to 16.2 million cases by 2045, marking a significant 64.5% increase. This escalation not only jeopardizes patient health but also amplifies the need for reliable diagnostic tools crucial for early detection and timely treatment.
With rapid technological strides and a burgeoning demand for effective diagnostics, the PCR molecular diagnostics market is on a pronounced upswing. As the incidence of cancer and infectious diseases escalates, the market's growth potential becomes even more pronounced. However, amidst this optimistic landscape, challenges loom large for the PCR molecular diagnostics market, notably in the form of regulatory obstacles and fierce market competition.
PCR Molecular Diagnostics Market Trends
The Infectious Testing Segment is Expected to Grow Over the Forecast Period
Technological innovations, the rise of multiplex testing, and a heightened emphasis on managing infectious diseases are driving significant growth in the PCR molecular diagnostics market. As new pathogens emerge and healthcare systems evolve, the demand for rapid and accurate diagnostic tools intensifies, signaling a robust expansion in the infectious testing segment.
Recent advancements in PCR technology have enhanced the capabilities of infectious testing. For instance, in India, the ErbaMDx MonkeyPox RT-PCR Kit was launched in August 2024, which signifies a leap in localized testing capabilities. Crafted by the Andhra Pradesh MedTech Zone in collaboration with Transasia Diagnostics, this kit boasts validation from the Indian Council for Medical Research (ICMR) and emergency approval from the Central Drugs Standard Control Organisation (CDSCO). This launch underscores India's commitment to enhancing its capabilities in infectious disease diagnostics and reflects a broader movement towards localizing healthcare solutions for quicker and more efficient responses.
Similarly, in April 2024, Japan witnessed the launch of the QIAstat-D syndromic testing system. This cutting-edge system can identify more than 20 pathogens from a single patient sample, including SARS-CoV-2, facilitating rapid and precise diagnoses of respiratory infections. Equipped with features like cycle threshold (Ct) values and amplification curves, the QIAstat-Dx represents a notable leap in diagnostic accuracy, enhancing clinical decision-making.
The market is also seeing strategic alliances to boost production and distribution. In February 2023, Thermo Fisher Scientific reported that it secured licensing rights for its Applied Biosystems TaqPath PCR kits in India. These kits target a spectrum of infectious diseases, including multi-drug-resistant tuberculosis (MDR-TB), hepatitis B and C, and HIV. By collaborating with Mylab Discovery Solutions, Thermo Fisher is strategically positioned to cater to the surging demand for diagnostics in one of the world's largest healthcare markets. This partnership not only facilitates local manufacturing but also aligns with the Indian government's push for self-reliance in medical technologies.
With technological strides, innovative testing methods, and escalating global health concerns, the infectious testing segment in the PCR molecular diagnostics market is on the brink of significant growth. As healthcare systems increasingly emphasize swift and accurate diagnostics, stakeholders in this domain stand poised to harness the surging demand, ultimately fostering improved health outcomes on a global scale.
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North America Leads the Market During the Forecast Period.
Driven by technological innovations, regulatory advancements, and an intensified focus on healthcare outcomes, the North American PCR molecular diagnostics market is poised for substantial growth. With the region emphasizing swift and precise diagnostics in clinical environments, the landscape is witnessing new product launches and strategic collaborations, particularly bolstering testing capabilities in oncology and infectious diseases.
Technological advancements are propelling the growth of the North American PCR market. For example, in October 2024, Qiagen launched its QIAcuityx Digital PCR System, specifically designed for clinical oncology testing. This introduction not only expands Qiagen's digital PCR offerings but also marks a significant entry into North America's clinical testing market. The system's enhanced sensitivity in quantifying nucleic acids is crucial for oncology, enabling early mutation detection and tailored treatment strategies.
Regulatory approvals play a crucial role in bolstering the PCR diagnostics segment. In January 2024, the U.S. FDA granted clearance to Qiagen's NeuMoDx CT/NG Assay 2.0. This addition to the test menu for the NeuMoDx 96 and 288 integrated PCR systems highlights the increasing demand for thorough sexually transmitted infection diagnostics within the United States healthcare system.
Additionally, Roche's cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test secured Emergency Use Authorization (EUA) from the FDA in June 2024. This automated multiplex RT-PCR assay, yielding results in a swift 20 minutes, is versatile for various healthcare environments. Roche’s breakthrough, enabling rapid diagnosis of multiple pathogens from a single sample, marks a significant leap in respiratory disease diagnostics such as influenza A/B amidst ongoing public health concerns.
With technological strides, regulatory backing, and strategic partnerships, the North American PCR molecular diagnostics market is on an upward trajectory. As healthcare entities increasingly value swift and accurate testing, the market's expansive growth potential stands evident, offering stakeholders a pivotal role in enhancing regional health outcomes.
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PCR Molecular Diagnostics Industry Overview
The PCR molecular diagnostics market is moderately competitive with several players across the globe. In terms of market share, few of the major players currently dominate the market. With the rising patient awareness levels and high prevalence of infectious and cancer diseases, many regional players are expected to grow their presence in the market. Some of the major players in the market are Abbott, Bio-Rad Laboratories, Inc., Qiagen N.V., Takara Bio, Inc., and Thermo Fisher Scientific, Inc., among others.
PCR Molecular Diagnostics Market Leaders
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Abbott
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Bio-Rad Laboratories, Inc
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Qiagen N.V.
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Takara Bio, Inc
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Thermo Fisher Scientific, Inc.
- *Disclaimer: Major Players sorted in no particular order
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PCR Molecular Diagnostics Market News
- September 2024: Roche Diagnostics has launched its inaugural test, leveraging its cutting-edge high-throughput technology. This advancement enables users of Roche's Cobas analyzers to concurrently test for 12 respiratory viruses using a single patient sample. The targeted viruses encompass influenza A and B, RSV, and COVID-19. The test employs a multiplex polymerase chain reaction (PCR) methodology; it is enhanced with color, temperature, and data processing techniques, facilitating the detection of up to 15 pathogens in one PCR test.
- February 2024: Bruker has entered into a Share Purchase Agreement to acquire ELITechGroup, a pioneer in molecular diagnostics. Both companies provide a diverse range of esoteric and mainstream PCR diagnostic assays. These assays cater to various needs, including transplant-related infections, sexually transmitted diseases, respiratory issues, gastrointestinal concerns, blood-borne pathogens, and infections acquired in hospitals.
PCR Molecular Diagnostics Industry Segmentation
As per the scope, PCR, or polymerase chain reaction, is a molecular technique used to amplify DNA sequences. This process employs short DNA sequences known as primers to target specific parts of the genome. The method consists of three key steps: denaturation, annealing, and extension. By adjusting the temperature during these steps, the DNA replication enzyme can effectively copy the desired DNA sequence, resulting in billions of copies within just a few hours.
The PCR Molecular Diagnostics Market is segmented by product type, application, end users, and geography. By product type, the market is segmented by instruments, reagents, consumables, and software. By application, the market is segmented by infectious disease testing, oncology testing, and other applications. Other applications include neurological disease and cardiovascular disease. By end users, the market is segmented by hospitals, diagnostics laboratories, and others. The other end users include clinics and ambulatory centers. By geography, the market is segmented by North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. Additionally, the report provides estimated market sizes and trends for 17 countries across these major regions, presenting values in USD for each segment.
| By Product | Instrument | Standard PCR Systems | |
| Digital PCR Systems | |||
| Real-time PCR Systems | |||
| Reagents and Consumables | |||
| Software | |||
| By Application | Infectious Disease Testing | ||
| Oncology Testing | |||
| Other Applications | |||
| By End User | Hospitals | ||
| Diagnostic Laboratories | |||
| Others | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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PCR Molecular Diagnostics Market Research FAQs
How big is the Global PCR Molecular Diagnostics Market?
The Global PCR Molecular Diagnostics Market size is expected to reach USD 9.26 billion in 2025 and grow at a CAGR of 5.43% to reach USD 12.06 billion by 2030.
What is the current Global PCR Molecular Diagnostics Market size?
In 2025, the Global PCR Molecular Diagnostics Market size is expected to reach USD 9.26 billion.
Who are the key players in Global PCR Molecular Diagnostics Market?
Abbott, Bio-Rad Laboratories, Inc, Qiagen N.V., Takara Bio, Inc and Thermo Fisher Scientific, Inc. are the major companies operating in the Global PCR Molecular Diagnostics Market.
Which is the fastest growing region in Global PCR Molecular Diagnostics Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Global PCR Molecular Diagnostics Market?
In 2025, the North America accounts for the largest market share in Global PCR Molecular Diagnostics Market.
What years does this Global PCR Molecular Diagnostics Market cover, and what was the market size in 2024?
In 2024, the Global PCR Molecular Diagnostics Market size was estimated at USD 8.76 billion. The report covers the Global PCR Molecular Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global PCR Molecular Diagnostics Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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PCR Molecular Diagnostics Industry Report
Statistics for the 2025 Global PCR Molecular Diagnostics market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Global PCR Molecular Diagnostics analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
