Molecular Diagnostics Market Size & Growth Report to 2030

The global molecular diagnostics market size was valued at over USD 15 billion in 2023 and expected to grow at a significant CAGR of around 7% during the forecast period from 2024 to 2030. The market has seen significant growth due to the increasing demand for accurate and early disease detection, particularly in oncology, infectious diseases, and genetic testing. Technologies like Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), and Isothermal Nucleic Acid Amplification Technology (INAAT) are revolutionizing diagnostics by offering high precision and faster results. The market is also expanding due to the rise of personalized medicine, which tailors treatments based on individual genetic profiles, as well as increasing healthcare investments globally. With the ongoing advancement of diagnostic tools and the growing emphasis on preventive healthcare, molecular diagnostics is becoming essential for detecting and managing chronic diseases, infectious conditions, and genetic disorders.

The market is also benefiting from the rise in global healthcare awareness and improving healthcare infrastructure in emerging economies, especially in the Asia-Pacific region. North America continues to dominate the market, driven by its well-established healthcare system, advanced research capabilities, and high adoption rates of molecular diagnostic technologies. Additionally, the global shift towards home-based and point-of-care testing is fueling growth, enabling quicker results and increasing patient convenience. With an expected CAGR of around 7% from 2024 to 2030, the molecular diagnostics market is poised for continued expansion, supporting advancements in clinical testing and fostering the development of novel diagnostic solutions.

Market Snapshot:

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Market Drivers:

The growth of the global molecular diagnostics market is primarily driven by advancements in diagnostic technologies, enabling more precise, faster, and cost-effective tests. Technologies such as Next-Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR) have revolutionized disease detection, allowing for earlier and more accurate diagnoses, particularly in cancer, genetic disorders, and infectious diseases. The ongoing development of point-of-care (POC) testing devices is another critical driver, making molecular diagnostics more accessible in non-hospital settings. For example, PCR testing became a key tool for detecting infections like COVID-19, showcasing the growing role of molecular diagnostics in public health management and the overall market expansion.

Another major factor driving the market is the increasing demand for early disease detection and prevention. Early detection of diseases such as cancer, through molecular diagnostics, allows for more effective treatments and better patient outcomes. For instance, the American Cancer Society reports that around 2 million new cancer cases are expected in the United States in 2024, further emphasizing the need for advanced diagnostic technologies that can detect cancer at an early, treatable stage. This trend, combined with the global shift towards preventive healthcare and the expanding reach of molecular diagnostic technologies, is contributing significantly to the market’s growth trajectory.

Market Trends:

Point-of-Care (POC) Testing Growth: One of the most significant trends in the molecular diagnostics market is the growing demand for point-of-care (POC) testing. This trend is being driven by the increasing need for faster, more convenient diagnostic tools that can provide real-time results at or near the patient’s location, eliminating the need for extensive laboratory infrastructure. POC devices are especially valuable in settings like rural and remote areas, where access to centralized healthcare facilities may be limited. The development of portable molecular diagnostic tools, such as rapid PCR-based and NGS-based devices, enables clinicians to quickly diagnose diseases like infections or genetic disorders, reducing delays in treatment. During the COVID-19 pandemic, for example, rapid PCR tests played a crucial role in providing timely results and controlling the spread of the virus. The growing use of POC testing is expected to continue, as it improves patient outcomes by allowing for immediate diagnosis and intervention.

Integration of Artificial Intelligence (AI) and Machine Learning (ML): Another critical trend in the molecular diagnostics market is the integration of Artificial Intelligence (AI) and Machine Learning (ML) technologies. These technologies are being increasingly incorporated into molecular diagnostic systems to improve the precision and efficiency of data analysis. AI and ML algorithms can process large volumes of complex genomic and diagnostic data far more quickly and accurately than human analysts. For instance, AI is used to interpret genomic sequences, identify biomarkers for diseases, and predict the likelihood of a patient developing a condition based on genetic factors. By automating these processes, AI can help eliminate human errors, reduce diagnostic time, and improve the overall accuracy of results. This shift is particularly impactful in oncology, where the detection of genetic mutations through molecular diagnostics is crucial for personalized treatment. The use of AI and ML is expected to enhance diagnostic decision-making and streamline workflows, making molecular diagnostics even more valuable in clinical settings.

Personalized Medicine and Genomics: The trend toward personalized medicine is another key driver of growth in the molecular diagnostics market. Personalized medicine involves tailoring healthcare treatments based on an individual’s genetic makeup, which helps to ensure that patients receive the most effective therapies for their specific condition. Molecular diagnostics, particularly Next-Generation Sequencing (NGS), plays a pivotal role in this trend by enabling the identification of genetic mutations and variations that may influence disease progression or drug response. For example, NGS technologies are used to detect cancer-related mutations, allowing clinicians to select targeted therapies that are more likely to succeed. The increasing use of molecular diagnostics for genetic testing is expanding the scope of personalized medicine, particularly in oncology, where genetic profiling can guide treatment decisions. The growing interest in genomics, combined with the need for more precise treatments, is driving demand for advanced diagnostic tools that can provide actionable insights into a patient’s genetic profile.

Increased Adoption in Infectious Disease Diagnostics: The demand for molecular diagnostics has surged, particularly in the field of infectious disease diagnostics. Molecular diagnostics offer significant advantages over traditional diagnostic methods, such as greater sensitivity and specificity, which are essential for detecting pathogens accurately and in a timely manner. This is particularly important in the context of infectious diseases like HIV, Tuberculosis, COVID-19, and hepatitis, where early detection and treatment are critical to improving patient outcomes. For instance, during the COVID-19 pandemic, molecular diagnostics, such as PCR tests, became the gold standard for detecting the virus due to their high accuracy. Molecular diagnostic techniques can detect low viral loads early in infection, even before symptoms appear, which helps in preventing the spread of infectious diseases. The increasing prevalence of infectious diseases globally, combined with the rise of antibiotic resistance, is driving the adoption of molecular diagnostics in clinical laboratories, public health systems, and hospitals.

Regulatory Advancements and Approvals: Regulatory bodies such as the FDA (U.S. Food and Drug Administration) and the European Medicines Agency (EMA) are playing a critical role in the advancement of molecular diagnostics. Regulatory approvals and certifications of new diagnostic platforms are essential for expanding the market and ensuring the reliability and safety of diagnostic tests. Over the past few years, regulatory agencies have expedited the approval processes for molecular diagnostic devices, especially in response to global health crises such as the COVID-19 pandemic. For example, the FDA granted emergency use authorizations (EUAs) for several PCR-based tests, which allowed manufacturers to quickly bring critical diagnostic tools to market. These regulatory advancements are helping to increase the availability of innovative molecular diagnostic solutions, while also ensuring they meet safety and performance standards. As regulatory frameworks continue to evolve, more molecular diagnostic products are likely to be approved, opening up new market opportunities for both established and emerging players in the healthcare sector.

Market Opportunities:

The global molecular diagnostics market presents several key opportunities, particularly with the growing demand for early disease detection and personalized medicine. Early detection of diseases like cancer, genetic disorders, and infectious diseases can significantly improve patient outcomes by allowing for prompt intervention and treatment. The rise in genetic testing, fueled by advancements in Next-Generation Sequencing (NGS), presents a major opportunity for molecular diagnostics, especially in oncology and rare genetic conditions. According to the World Health Organization (WHO), cancer is the second leading cause of death globally, with an estimated 10 million deaths in 2020. This underscores the need for more advanced diagnostic technologies that can detect cancer at an early, treatable stage, making molecular diagnostics a critical tool in cancer management and offering substantial market potential.

Additionally, the growing emphasis on point-of-care (POC) testing and home-based diagnostics opens up new avenues for molecular diagnostics. The COVID-19 pandemic accelerated the adoption of remote diagnostics and home testing, highlighting the need for rapid, user-friendly molecular diagnostic devices. With healthcare systems worldwide shifting towards more accessible and decentralized care models, the demand for portable molecular diagnostic tools is increasing. Companies developing easy-to-use PCR or NGS devices for home testing are tapping into a lucrative market, as patients seek quicker, more convenient ways to monitor their health.

Market Restraints:

Despite its significant growth, the global molecular diagnostics market faces several restraining factors that could limit its expansion. One of the primary challenges is the high cost of molecular diagnostic tests, which can make them inaccessible, especially in low- and middle-income regions. The advanced technologies, such as Next-Generation Sequencing (NGS) and PCR-based tests, require specialized equipment, reagents, and trained personnel, all of which contribute to the overall expense. Additionally, the complexity of these diagnostic tests can lead to longer turnaround times and technical errors, which may reduce their adoption in clinical settings. Furthermore, regulatory hurdles and the lengthy approval processes for new diagnostic tests can slow market growth, particularly in regions with stringent regulatory requirements.

Market Insights:

The global molecular diagnostics market is bifurcated into product, technology, test location, application, and geography. On the basis of product, the reagents dominated the market in 2023 and expected to hold tee largest revenue share of around 2/3 market share by 2030. Reagents are essential to the molecular diagnostic process as they are used in the amplification, detection, and analysis of genetic material. This segment has experienced significant growth due to the increasing demand for highly accurate diagnostic tests across various applications, including infectious diseases, oncology, and genetic disorders. Reagents like primers, probes, buffers, and enzymes are fundamental to tests such as Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS). The increasing adoption of PCR and NGS technologies, driven by their accuracy and ability to detect a wide range of conditions, has propelled the growth of the reagents market.

The dominance of the reagents segment is further supported by the rise in personalized medicine and genomics, which require specialized reagents for tailored diagnostics. Personalized treatments based on genetic information demand highly specific reagents designed for precise diagnostic testing. Moreover, the surge in the prevalence of infectious diseases, such as COVID-19, has increased the global demand for diagnostic tests, thereby boosting the reagents market. For example, the COVID-19 pandemic led to a sharp increase in the need for PCR reagents, which were essential for widespread testing. This trend has significantly contributed to the market growth of reagents and is expected to continue as the demand for molecular diagnostic tools grows across various healthcare sectors.

Market Trends for Reagents Sub-category:

• Customization of Reagents for Personalized Medicine: One of the major trends in the reagents segment is the customization of reagents for personalized medicine. As the demand for tailored treatments based on individual genetic profiles rises, reagents are becoming more specialized. Companies are developing reagents that are highly specific to the patient’s genetic makeup, enabling more precise and targeted diagnostic testing. This trend is particularly strong in oncology, where detecting genetic mutations or alterations can guide treatment choices. The growing focus on personalized therapies is driving the need for reagents tailored to specific conditions, creating new market opportunities for manufacturers.
• Advancements in Multiplexed Diagnostics: Another key trend in the reagents market is the advancement of multiplexed diagnostics, where multiple pathogens or biomarkers can be tested simultaneously. This is particularly useful in detecting co-infections or identifying multiple genetic mutations in a single test. Multiplex assays require reagents that can detect multiple targets at once without cross-reactivity, and as the complexity of molecular diagnostics increases, so does the demand for high-quality, precise reagents. These innovations are expanding the scope of molecular diagnostics across various applications, including infectious disease testing, genetic screening, and cancer diagnostics.

Market Opportunities for Reagents Sub-category:

• Increasing Demand for Infectious Disease Testing: The rising global burden of infectious diseases is driving the demand for molecular diagnostic tests, particularly in the case of HIV, tuberculosis, hepatitis, and other infectious pathogens. As molecular diagnostic tests like PCR gain widespread adoption, the reagents needed for these tests are in high demand. The ongoing global health threats, combined with the need for rapid, accurate diagnostic tests, present significant growth opportunities for reagent manufacturers. This growing need for infectious disease testing, along with the push for better disease surveillance, ensures continued demand for high-quality reagents in the market.
• Expanding Applications in Genetic Testing and Cancer Diagnostics: The growing focus on genetic testing for various conditions such as cancer, rare genetic disorders, and prenatal testing offers substantial opportunities for the reagents segment. Reagents are crucial in processes like Next-Generation Sequencing (NGS) and genetic screening, where they enable the detection of genetic mutations that influence disease development or response to treatment. The increasing prevalence of cancer globally, coupled with the growing emphasis on early detection, creates a strong market opportunity for reagents that support liquid biopsy and genetic profiling. The expansion of these diagnostic techniques into clinical practice ensures continued demand for specialized reagents, creating new revenue streams for manufacturers.

The molecular diagnostics market research report presents the analysis of each segment from 2020 to 2030 considering 2023 as the base year for the research. The compounded annual growth rate (CAGR) for each respective segment is calculated for the forecast period from 2024 to 2030.

Historical & Forecast Period

• 2020-22 – Historical Year
• 2023 – Base Year
• 2024-2030 – Forecast Period

Market Segmentation:

By Product:

• Instruments
• Reagents
• Others

By Test Location:

• Point of Care
• Self-Test or OTC
• Central Laboratories

By Technology:

• In Situ Hybridization
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Chips and Microarrays
• Mass Spectrometry
• Others

By Application:

• Infectious Diseases
• Oncology
• Pharmacogenomics
• Neurological Disease
• Cardiovascular Disease
• Microbiology
• Others

By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Regional Analysis:

Geographically, the North American dominated the global molecular diagnostics market in the benchmark year with the largest revenue share of over 1/3 of the global market in 2023, largely due to the increasing prevalence of diseases such as cancer and genetic disorders. The region’s strong healthcare infrastructure, advanced diagnostic technologies, and growing demand for personalized medicine have all contributed to its market leadership. For instance, the U.S. has seen a significant rise in the use of molecular diagnostics in oncology, particularly in the detection and monitoring of lung cancer. According to the American Cancer Society, lung cancer is the second most common cancer in both men and women in the U.S., with an estimated 234,580 new cases in 2024. The increasing need for early diagnosis and precision treatment options for such diseases has significantly boosted the demand for molecular diagnostic tests, reinforcing North America’s dominance in the market.

In addition to oncology, North America’s market growth is driven by advancements in technologies such as Next-Generation Sequencing (NGS) and polymerase chain reaction (PCR), which are vital for detecting a range of genetic mutations and infectious diseases. The U.S. also leads in the adoption of point-of-care (POC) testing, which facilitates faster and more accurate disease detection. As genetic and infectious diseases continue to rise, the North American molecular diagnostics market is poised for sustained growth, driven by the need for better diagnostic solutions and the continuous innovation in testing technologies. This makes the region the largest and most influential market for molecular diagnostics globally.

Competitive Landscape:

Some of the prominent market players operating in the global molecular diagnostics market are Abbott Laboratories, Agilent Technologies, Inc., Becton Dickinson, BGI Genomics, and bio Merieux SA. Companies are exploring markets by expansion, new investment, the introduction of new services, and collaboration as their preferred strategies. Players are exploring new geography through expansion and acquisition to gain a competitive advantage through joint synergy.

Recent Developments:

• In May 2024, DiaSorin secured FDA 510(k) clearance for its NxTag Respiratory Pathogen Panel, a molecular multiplex test capable of detecting over 20 pathogens linked to respiratory infections.
• In May 2024, Geneoscopy received USFDA approval for ColoSense, a non-invasive, multi-target stool RNA test utilizing RNA biomarkers for precise colorectal cancer screening.
• In November 2023, Roche introduced the LightCycler PRO System, an advanced quantitative PCR platform designed for personalized healthcare and highly accurate diagnostics.

Key Companies:

• Abbott Laboratories
• Agilent Technologies, Inc.
• Becton Dickinson
• BGI Genomics
• bio Merieux SA
• Bio-Rad Laboratories, Inc.
• Danaher
• Grifols, S.A.
• Hologic Inc. (Gen Probe)
• Illumina, Inc.
• Roche Diagnostics

Key Questions Answered by Molecular Diagnostics Market Report

• Global molecular diagnostics market forecasts from 2024-2030
• Regional market forecasts from 2024-2030 covering Asia-Pacific, North America, Europe, Middle East & Africa, and Latin America
• Country-level forecasts from 2024-2030 covering 15 major countries from the regions as mentioned above
• Molecular diagnostics submarket forecasts from 2024-2030 covering the market by product, test location, technology, application, and geography
• Various industry models such as SWOT analysis, Value Chain Analysis about the market
• Analysis of the key factors driving and restraining the growth of the global, regional, and country-level molecular diagnostics markets from 2024-2030
• Competitive Landscape and market positioning of top 10 players operating in the market