CRISPR-Based Diagnostics Market Trends
Global CRISPR-based diagnostics market size was valued at USD 3.08 billion in 2024 and anticipated to grow at a CAGR of 16.57% during the forecast period from 2025 to 2030. The rising global infectious disease burden is one of the primary factors driving the CRISPR-based diagnostics market growth. Tuberculosis (TB) has been the second most infectious disease globally, with 10.8 million cases diagnosed in 2023, according to the World Health Organization's 2024 Report. The highest rates of incidence were seen in African countries, and the lowest were seen in Europe and the Americas. The vast number of disease cases has generated an urgent need for rapid and accurate diagnostics.
CRISPR technologies, which are famous for their accurate identification of certain genetic sequences, provide higher accuracy, reducing false positives and negatives. Their capability to identify diseases at lightning speed and with reliability makes them invaluable tools in the surveillance and control of diseases. With infectious diseases still impacting millions of people worldwide, the demand for new diagnostics such as CRISPR is likely to increase substantially over the forecast period, guaranteeing timely treatment and improved healthcare results.
The increasing prevalence of genetic diseases all over the world is also propelling the demand for sophisticated diagnostic tools like CRISPR-based tests. As per the International Agency for Research on Cancer's estimates in April 2024, new cancer incidence is anticipated to rise significantly, from 21.3 million in 2025 to 35.3 million in 2050. Additionally, studies by the Lancet Regional Health in August 2024 reported unforeseen high prevalence levels of cystic fibrosis in non-European populations, particularly from the Indian subcontinent. Other genetic disorders such as arthritis, heart disease, and diabetes are also on the rise. CRISPR-based diagnostic tests provide unprecedented accuracy in the early identification of genetic mutations, enabling immediate treatment and management of disease. As the world healthcare community increasingly prioritizes prevention and early detection protocols, growing incidences of genetic disease will increasingly propel strong demand for innovative CRISPR-based diagnostic solutions.
Sustained advancements in CRISPR technology are revolutionizing the diagnostic landscape through enhanced test speed, precision, and affordability. In August 2023, CrisprBits, a biotech start-up dedicated to CRISPR gene-editing technology applications, partnered with Molbio Diagnostics to incorporate CRISPR into Point-of-Care (POC) testing platforms. CrisprBits created the PathCrisp platform, which provides rapid, accurate, and cost-effective POC testing for numerous diseases, while Molbio utilized its manufacturing and distribution networks. Such technological improvements are boosting the allure of CRISPR diagnostics among healthcare practitioners across the globe. With the ability to run quick and extremely precise tests with no requirement for sophisticated lab facilities, CRISPR diagnostics are a very attractive option for both developed and developing nations. With continued technology improvement, CRISPR-based tests will further be accessible, further propelling their use in general healthcare services as well as increasing overall market growth over the forecast period.
The broad application of CRISPR-based diagnostics is fueling the need for highly specialized enzymes to enable gene editing and molecular testing. CRISPR-Cas systems such as Cas9, Cas12, and Cas13 play a crucial role in providing diagnostic accuracy and efficiency. In a January 2024 research published in Nucleic Acids Research, the extensive application of Class 2 CRISPR-associated enzymes in clinical, research, and agricultural fields was highlighted. These enzymes allow for the specific targeting and alteration of genetic material, which is necessary for accurate diagnostic results. With the expansion of CRISPR applications from research to clinical diagnostics, the demand for customized, high-performance enzymes will increase. Advances that promote enzyme stability, specificity, and activity will further expand the performance of CRISPR diagnostics. As a result, enzyme production will be an integral part of amplifying the use of CRISPR diagnostics in different types of healthcare setups worldwide.
Public-private partnerships involving biotechnology companies, research facilities, and medical care institutions are driving innovation towards CRISPR-based diagnostics. For instance, in April 2024, Regeneron Pharmaceuticals invested USD 100 million in Mammoth Biosciences to utilize their small Cas enzymes for in vivo gene-editing treatments in more than one type of tissue. These collaborations speed up the creation of new CRISPR tools by integrating technical know-how, capital, and manufacturing capacity. These strategic collaborations not only improve enzyme and diagnostic tool development but also broaden the applications of CRISPR technologies into new therapeutic and diagnostic fields. Through interdisciplinary research and commercialization, these collaborations are likely to drive market growth substantially. With an expanding pipeline of collaborative projects, the CRISPR-based diagnostics market is poised for explosive growth in the next few years.
The expanding use of CRISPR diagnostics in different industries, such as genetic testing, infectious disease treatment, and personalized medicine, is creating new market opportunities. Investments in developing CRISPR's applications-from quick pathogen detection to cancer biomarker identification-are driving its uptake in clinical environments. The synergy between government drives towards genetic screening, growing interest in personalized medicine, and technological innovation in diagnostic enzyme research is setting the stage for market expansion. In addition to this, the ease of portability and accessibility of CRISPR-based testing makes them especially positioned to be used in low- and middle-income nations, where access to central laboratories is limited. While CRISPR diagnostics increasingly demonstrate their versatility and durability, their adoption into standard healthcare services is set to rise significantly in the coming years, leading to lucrative market growth over the forecast period.
Report Coverage & Deliverables
- Competitive benchmarking
- Historical data & forecasts
- Company revenue shares
- Regional opportunities
- Latest trends & dynamics
Market Concentration & Characteristics
CRISPR is always advancing from Cas9 to Cas12, Cas13, and new variants, supporting multiplex, one-pot, thermostable assays, enhanced sensitivity and specificity, coupling with isothermal amplification, paper-based lateral flow, miniaturization, AI-based analysis, lab-on-chip, and digital CRISPR. These advancements extend diagnostic limits, minimizing time to result, streamlining workflows, and growing diagnostic targets. Quick prototyping through synthetic biology speeds up iteration, supporting next-gen platforms that integrate effortlessly with broader healthcare access worldwide.
Strategic mergers and acquisitions are defining the CRISPR diagnostics market. Top biotech companies and diagnostic players are buying start-ups with proprietary CRISPR platforms or enzyme technologies to enhance their pipelines. Recent transactions involve pharma players investing in Cas enzyme manufacturers and point-of-care platform developers. This consolidation drives commercialization and takes advantage of manufacturing capabilities. Increased M&A activity reflects strong investor confidence and will continue as companies look to gain market share.
Regulatory platforms are vital for CRISPR diagnostics uptake and market expansion. Organizations like the FDA, EMA, and China's NMPA are developing gene-editing diagnostics guidelines, finding balance between innovation and safety. Paths of innovation-based pathways and standardized performance standards for CRISPR assays have come into existence, although demanding validation requirements and ethics oversight can be time-consuming in approvals. Uniform global regulations with established performance parameters will be pivotal to make processes more efficient, enabling greater clinical adoption and commercial scale-up.
Companies are quickly broadening CRISPR diagnostic products beyond single-target assays to multiplex panels, at-home tests, and bundled services. New products utilize Cas12 and Cas13 enzymes to analyze multiple pathogens or genetic markers simultaneously in a single assay run. Companies are also bundling CRISPR reagents with sample prep and software to offer end-to-end solutions. This diversification addresses varied customer needs-from hospital labs to community clinics-with improved market penetration across healthcare venues globally.
Established North American and European markets offer robust R&D and regulatory infrastructure. Asia Pacific, Latin America, Middle East and African emerging markets are gaining momentum from local partnerships, government programs, and rising healthcare expenditures driving adoption. Manufacturing localizations and custom distribution networks support affordability and availability. Joint ventures and licensing partnerships allow CRISPR firms to access varied patient populations globally.
Product Insights
In 2024, reagents and kits dominated the market with a 61.73% due to the extensive adoption of CRISPR-based detection systems in research as well as clinical environments. Rising global demand for point-of-care diagnosis, especially for infectious as well as genetic illnesses, has escalated the demand for ready-to-use diagnostic reagents and kits and quality reagents. These kits make difficult CRISPR workflows more convenient, opening up these tools to non-expert users and expanding their use across laboratories, pharmaceutical firms, and hospitals. In addition, further developments in CRISPR enzymes and detection chemistry are driving continuous advances in the performance of these products, increasing adoption levels. With governments and health institutions calling for more rapid disease diagnosis, the kits and reagents segment will see its robust growth continue as a reflection of its pivotal position in CRISPR diagnostic
The software and libraries segment will grow at a CAGR of 17.11% during the forecast period as genetic data analysis becomes more complex and voluminous. With improving CRISPR technologies, there is an increasing demand for powerful bioinformatics tools for the interpretation of diagnostic outputs. Bioinformatics tools help in designing guide RNAs, sequencing data analysis, and target specificity verification, which supports the precision and speed of CRISPR-based tests. Additionally, libraries-containing pre-tested sets of guide RNAs and targets-are paramount to high-throughput screening and multiplexed diagnostics, particularly in infectious disease and oncology use cases. The incorporation of artificial intelligence and machine learning in CRISPR diagnostic platforms is also driving this segment ahead by allowing predictive analytics and real-time interpretation of data. Even though this segment has a smaller market share at the moment compared to reagents and kits, its strategic relevance is increasing, especially in research and pharma environments where accuracy and scalability are critical.
Technology Insights
The Cas9 segment acquired the leading market share in 2024 based on its early involvement in the establishment of CRISPR technologies. Being the first and best-researched CRISPR-associated protein, Cas9 has played a central role in making DNA targeting and cleavage accurate, hence the go-to instrument for genetic diagnosis. The market backed by its proven performance to identify genetic mutations and infectious disease pathogens with high specificity. Although newer enzymes like Cas12 and Cas13 are gaining popularity for their collateral cleavage and RNA-targeting benefits, Cas9 is still the workhorse for most diagnostic pipelines, especially in laboratory-based assays. Its versatility across multiple detection platforms and infrastructure already in place helps ensure continued adoption. Additionally, continued research to enhance Cas9 variants-like high-fidelity or improved-specificity versions-is likely to broaden its use case. In total, the Cas9 segment is increasing steadily, albeit at a slower rate than that of emerging enzymes.
The Cas12 segment is expected to grow at high growth during the forecast period, owing to its distinct biochemical characteristics. In contrast to Cas9, Cas12 has collateral cleavage activity, which allows it to indiscriminately cleave single-stranded DNA upon activation by a target sequence. This property has been leveraged in ultra-sensitive diagnostic platforms, including SHERLOCK and DETECTR, which can identify pathogens like SARS-CoV-2, HPV, and other infectious pathogens with high sensitivity and speed. The need for point-of-care diagnostics and rapid, low-cost testing platforms has driven Cas12 uptake, especially in low-resource and decentralized environments. Its ability to multiplex also allows detection of several targets within a single test-a plus for both field and clinical uses. As CRISPR testing moves from research settings to everyday applications, Cas12's efficiency and versatility maintain considerable commercial and academic interest, making it the prime force for future market growth.
Application Insights
The infectious disease testing was the market leader with a share of 52.89% in 2024, given the critical need worldwide for quick, precise, and scalable testing approaches. CRISPR-based technologies, especially those that utilize Cas12 and Cas13, allow for the highly sensitive detection of viral and bacterial pathogens by locating nucleic acid sequences with precision. The ability was especially precious during the COVID-19 pandemic, with CRISPR-based testing providing quicker turnaround times and point-of-care delivery compared to standard PCR techniques.
At the same time, cancer diagnostics will be the most rapidly growing area during the forecast period. CRISPR technology allows for the detection of individual genetic mutations and biomarkers of different cancers with unparalleled accuracy in diagnosis and patient stratification. For example, CRISPR-Cas systems can identify low-abundance cancer-linked DNA or RNA in blood, urine, or tissue samples, making them ideal for non-invasive liquid biopsy applications. As the incidence of cancer increases worldwide, there is greater need for diagnostics that can detect malignancies early and track response to treatment. CRISPR-based technologies are being incorporated into next-generation diagnostic platforms that deliver fast, real-time results with high sensitivity and specificity. Additionally, advances in guide RNA libraries and CRISPR screening methodologies are speeding up the identification of new cancer biomarkers. Though still on-rising in terms of infectious disease diagnostics, the cancer segment enjoys good growth potential up to 2030 thanks to investment in research and clinic innovation.
End-use Insights
Laboratories are anticipated to hold the largest market share of 44.05% in 2024 and is anticipated to be the fastest-growing segment of the forecast period. The increased incidence of infectious diseases like HIV, hepatitis, tuberculosis, and respiratory infections, which need to be diagnosed correctly and in time. These labs are equipped with good infrastructure and professionals, which allow them to deal with high test volumes effectively. Additionally, the increasing move towards personalized medicine has greatly fueled the demand for molecular diagnostic services. Molecular diagnostics aid in identifying particular genetic markers and pathogens, thereby enabling tailored treatment regimens that are more effective while reducing side effects.
The clinics and hospitals segment is witnessing consistent growth in the market for CRISPR-based diagnostics as healthcare professionals increasingly embrace sophisticated molecular testing for quicker and more precise identification of diseases. CRISPR-based diagnostic products have the advantage of quick turnaround times, high specificity, and potential point-of-care application-making them especially useful in clinical environments. The products are being applied to identify infectious diseases, genetic disorders, and, increasingly, mutations related to cancer directly from hospital labs.
Regional Insights
North America's CRISPR diagnostics market is expected to grow vigorously, supported by a high prevalence of chronic and infectious diseases, increasing emphasis on personalized medicine, high R&D investments, and point-of-care testing advancements. For instance, an October 2024 study by Pathogens states that Mexico alone in 2022 registered 117,412 cases of hepatitis B and 678,258 cases of hepatitis C-two conditions for which CRISPR diagnostics can provide fast, extremely specific pathogen identification. In addition to screening, CRISPR's ability to precisely edit genes also promises to lead to the creation of targeted treatments, providing new ways to both diagnose and treat disease. Forward-thinking collaborations among academia, biotech entrepreneurs, and healthcare professionals are also rapidly advancing the development of CRISPR-based diagnostic products in the region. In October 2024, ERS Genomics Limited provided Université de Montréal with a non-exclusive license to its CRISPR/Cas9 patent portfolio, allowing UdeM to establish two cutting-edge CRISPR/Cas9 screening platforms in its Institute for Research in Immunology and Cancer. Such collaborations not only democratize access to frontier IP but also encourage the development of next-generation diagnostic assays, cementing North America's leadership in the international CRISPR-based diagnostics market.
U.S. CRISPR-based Diagnostics Market Trends
The U.S. CRISPR-based diagnostics market is expanding with great speed, driven by favorable regulation and landmark approvals. Unambiguous FDA guidance streamlined product pathways-most significantly the April 2023 emergency use authorization of the Sherlock™ CRISPR SARS-CoV-2 kit, the first-ever green light for a CRISPR-based infectious disease assay by the agency. This lead not only legitimizes CRISPR's diagnostic use but also speeds the development of user-friendly, point-of-care platforms. By saving time to result and making usability easier for clinicians and patients alike, regulatory and technological advancements are propelling strong market adoption throughout the U.S.
Europe CRISPR-based Diagnostics Market Trends
Europe CRISPR-based diagnostics market is experiencing steady growth, fueled by strong EU funding initiatives (Horizon Europe), translational research networks, and strong regulatory leadership from the European Medicines Agency. Increased healthcare expenditure on precision medicine, combined with rising incidence of genetic and infectious diseases, fuels demand for fast, precise assays. Breakthroughs from top biotech clusters in Germany, France, and Switzerland, combined with scalable manufacturing capacity, further fuel adoption in clinical laboratories and point-of-care settings.
The UK CRISPR diagnostics market is growing fast, fueled by robust federal funding (BMBF), top-notch research institutions (Max Planck, Fraunhofer), and top pharma players. High healthcare spending and early adoption of precision-medicine programs provide fertile ground for rapid assay adoption. German laboratories are leading the development of multiplexed Cas12- and Cas13-based platforms for oncology and pathogen detection. Strategic collaborations between SMEs and large OEMs are enabling scalable manufacturing, with German innovations reaching domestic and export markets quickly.
The German CRISPR-diagnostics market is growing strongly due to robust federal funding (BMBF), top-level research organizations (Max Planck, Fraunhofer), and top-tier pharma companies. High healthcare spending and early adoption of precision-medicine programs provide fertile ground for swift assay adoption. German laboratories are leading the development of multiplexed Cas12- and Cas13-based platforms for cancer and pathogen detection. Strategic alliances among SMEs and major OEMs are enabling scalable production, whereby German innovations find their way into domestic and foreign markets in quick time.
Asia Pacific CRISPR-based Diagnostics Market Trends
Asia Pacific is also being recognized as a high-growth market for CRISPR diagnostics, supported by increasing healthcare infrastructure in India, Southeast Asia, and Australia. Governments are also investing significantly in biotech parks and approval fast-track initiatives, while huge infectious-disease prevalence-from TB to viral epidemics-results in immediate need for low-cost and rapid tests. Local manufacturing collaborations and telemedicine incorporation are also increasing test availability in rural markets. Growing disposable incomes and digital health programs also drive further market growth.
The China CRISPR-based diagnostics market is set for rapid growth, supported by national plans such as "Made in China 2025" and large R&D funding from the Ministry of Science and Technology. NMPA regulatory reforms are simplifying approval processes for in-vitro diagnostics. Cas-based POC devices for large-scale infectious disease and cancer biomarker screening are being developed by domestic biotech champions. Integration with AI and cloud-based data analytics speeds up test interpretation, enabling widespread clinical adoption.
The Japanese CRISPR diagnostics market is about to grow dramatically. Japan aging population and huge focus on preventive care are accelerating CRISPR diagnostics growth. AMED supports academic-industry partnerships on precision oncology panels and rare-disease screening with funding programs. The PMDA's transparent directives on gene-editing assays ensure accelerated product approval. Japanese firms are launching smaller, easy-to-use devices designed for hospital and home use. Integration with Japan's national health insurance system promotes clinician and patient adoption for quick, precise results.
Latin America CRISPR-based Diagnostics Market Trends
Latin America CRISPR-based diagnostics market is growing, fueled by government efforts to upgrade public health laboratories and increasing incidence of infectious diseases like Zika, dengue, and HIV. Collaborations between international biotech companies and regional distributors are reducing costs and facilitating regional production. Accelerated approvals by national regulatory bodies (ANVISA, COFEPRIS) are enhancing market access. Increasing awareness of genetic testing for cancers and inherited diseases further drives demand for sophisticated CRISPR-based assays in Brazil, Mexico, and Argentina.
Middle East & Africa CRISPR-based Diagnostics Market Trends
Middle East and Africa's CRISPR-based diagnostics market is witnessing early but rapidly growing growth because of rising healthcare investment by governments and private organizations. Projects like the UAE Genomics and Precision Medicine plan and South Africa's National Health Insurance schemes prioritize contemporary molecular diagnostics. Projects with foreign biotech companies introduce POC CRISPR platforms to clinics within metropolitan and remote areas. High disease burden, paired with enhanced regulatory systems, is fueling adoption of faster and more precise CRISPR-based tests.
Key CRISPR-based Diagnostics Company Insights
The worldwide market for CRISPR-based diagnostics is competitive, dominated by players such as Thermo Fisher Scientific Inc.; Integrated DNA Technologies, Inc.; Molbio Diagnostics; Horizon Discovery; Synthego Corporation; investing in new product development, research & development (R&D), and strategic mergers and acquisitions to establish their market position and emphasizing speed, accuracy, specialty, and precision in products. For example, In February 2024, CrisprBits Private Limited launched OmiCrisp, a CRISPR-based assay that quickly detects SARS-CoV-2 and separates Omicron lineage variants from other variants of concern. Molecular Solutions Care Health LLP currently uses this weekly test to monitor the Omicron-derived JN.1 variant in wastewater samples taken from 14 different areas in Bengaluru, India.
Key CRISPR-based Diagnostics Companies
The following are the leading companies in the CRISPR-based diagnostics market. These companies collectively hold the largest market share and dictate industry trends.
- Thermo Fisher Scientific Inc.
- Integrated DNA Technologies, Inc.
- Molbio Diagnostics
- Horizon Discovery
- Synthego Corporation
- Mammoth Biosciences
- Sherlock Biosciences
- Caribou Biosciences
- CrisprBits
- ToolGen Inc.
Recent Developments
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In January 2025, CrisprBits opened its Research and Innovation Centre for CRISPR-based gene editing and diagnostics in Bengaluru, India. The centre is well-furnished with state-of-the-art laboratory infrastructure, including areas designated for lyophilization (a method to stabilize reagents at room temperature) and facilities for cell and tissue culture, bacterial culture, molecular biology studies, and cleanroom operations.
Jumpcode Genomics, a genome technology company focused on advancing research in human biology, and Takara Bio USA, Inc., a subsidiary of Takara Bio Inc., resolved their patent lawsuit and entered into an agreement in June 2024. Through the agreement, they plan to join forces in order to merge their intellectual property to allow for the targeted elimination of undesired transcripts, e.g., ribosomal RNAs, from NGS libraries using CRISPR-based technology.
In March 2024, Scope Biosciences, a Dutch biotech firm, raised USD 2.68 million via the EIC Transition program, highlighting its pioneering molecular diagnostics innovation. The funding, derived from a successful two-year partnership with Wageningen University under the ERC-Proof of Concept scheme, will boost the advancement of the scopeDx platform, which aims to accelerate point-of-care diagnosis through high-accuracy reporting in on-site settings.
CRISPR-based Diagnostics Market Report Scope
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Report Attribute |
Details |
|
Market size value in 2025 |
USD 3.51 billion |
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Revenue forecast in 2030 |
USD 7.55 billion |
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Growth rate |
CAGR of 16.57% from 2025 to 2030 |
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Base year for estimation |
2024 |
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Historical data |
2018 - 2023 |
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Forecast period |
2025 - 2030 |
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Quantitative units |
Revenue in USD million/billion, and CAGR from 2025 to 2030 |
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Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
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Segments covered |
Product, technology, application, end-use, region |
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Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
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Country scope |
U.S.; Canada; Mexico; UK; Germany; France; Italy; Spain; Denmark; Sweden Norway; China; Japan; India; Australia; South Korea; Thailand; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
|
Key companies profiled |
Thermo Fisher Scientific Inc.; Integrated DNA Technologies, Inc.; Molbio Diagnostics; Horizon Discovery; Synthego Corporation; Mammoth Biosciences; Sherlock Biosciences; Caribou Biosciences; CrisprBits; ToolGen Inc. |
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Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
|
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
Global CRISPR-Based Diagnostics Market Report Segmentation
Product Outlook (Revenue, USD Million, 2018 - 2030)
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Enzymes
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Kits and Reagents
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Software and Libraries
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Technology Outlook (Revenue, USD Million, 2018 - 2030)
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Cas9
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Cas12
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Others
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Application Outlook (Revenue, USD Million, 2018 - 2030)
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Infectious Disease Diagnostics
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Genetic Disorder Diagnostics
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Cancer Diagnostics
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Others
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End-use Outlook (Revenue, USD Million, 2018 - 2030)
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Hospitals and Clinics Diagnostic
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Laboratories
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Pharmaceutical and Biotechnology Companies
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Others
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Regional Outlook (Revenue, USD Million, 2018 - 2030)
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North America
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U.S.
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Canada
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Mexico
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Europe
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UK
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Germany
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France
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Italy
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Spain
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Denmark
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Sweden
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Norway
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Asia Pacific
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China
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Japan
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India
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Australia
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South Korea
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Thailand
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Latin America
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Brazil
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Argentina
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Middle East and Africa (MEA)
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South Africa
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Saudi Arabia
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UAE
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Kuwait
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