Molecular Diagnostics Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Products and Services (Reagents and Kits, Instruments, Services & Software), By Technology (Polymerase Chain Reaction (PCR), Sequencing, In-situ hybridization, Chips and microarrays, Mass spectrometry, Others), By Application (Infectious disease, Oncology testing, Genetic testing, Blood screening, Others), By End User (Hospitals, Academic & Reference Laboratories, Others), By Region, & Competition, 2020-2030F

Market Overview

The Molecular Diagnostics market was valued at USD 17.65 Billion in 2024 and is expected to reach USD 26.70 Billion by 2030 with a CAGR of 7.10%. Molecular diagnostics, as a term, encompasses techniques utilized for the analysis of biological markers implicated in a broad spectrum of human diseases. These diagnostic tests hold pivotal significance within a well-established healthcare system. By providing crucial information, molecular diagnostics aid healthcare providers and patients in making informed medical decisions, resulting in successful outcomes. Moreover, the quantitative measurements offered by molecular diagnostics facilitate comprehensive care management and effective control of various health conditions.

In the clinical setting, molecular diagnostics tools have proven to be beneficial by enabling rapid and sensitive detection methods, thereby facilitating monitoring of a wide array of infectious diseases, including cancers and other chronic illnesses. Genetic testing, microbiology, STDs, oncology, blood screening, virology, tissue typing, and prenatal diagnostics are among the medical conditions successfully detected through the extensive application of molecular diagnostics. Laboratory-based molecular diagnostics serve as indispensable tools for disease identification in humans, employing the analysis of DNA, RNA, or proteins. Reagents and kits specifically designed for molecular diagnostics vary depending on the intended application, with probes targeting specific viral, bacterial, and parasitic sequences. The increasing utilization of biomarker-specific testing kits is poised to drive the growth of the Molecular Diagnostics Market, as these tests prove invaluable prior to the initiation of any therapy or treatment.

 Key Market Drivers

Boosting Prevalence of Chronic Ailments

Due to the rapid mechanization of various industries, the concept of manual work has gradually diminished from people's daily lives. As a result, sedentary lifestyles and poor dietary habits have become prevalent, leading to an alarming increase in needle-stick diseases like cancer. According to estimates by the World Health Organization (WHO), cancer was responsible for approximately 10 million deaths globally in 2021, accounting for nearly one in every six fatalities. This positions cancer as one of the most significant causes of mortality worldwide, underscoring its critical impact on global public health. Of these cases.

Furthermore, the rise in infectious diseases and other communicable ailments has contributed to the growing demand for molecular diagnostics. Conditions such as kidney disease, respiratory infections, and chronic obstructive pulmonary disease have become all too common. According to the National Kidney Foundation, approximately 37 million adults in the United States were living with chronic kidney disease (CKD) as of late 2020. This figure highlights CKD as a major public health concern, reflecting its widespread prevalence and growing burden on the U.S. healthcare system. The prevalence of chronic kidney disease (CKD) is expected to rise to epidemic levels, driven largely by the rapid aging of the global population. CKD represents a critical global health challenge, with its increasing incidence posing significant concerns particularly for low- and middle-income countries where healthcare resources are often limited.

The implications of these health challenges are far-reaching, affecting individuals, families, and communities worldwide. It is crucial for medical professionals, researchers, and policymakers to focus on preventive measures, early detection, and effective treatment strategies to mitigate the impact of these diseases and improve overall public health.

Modernizing Healthcare Infrastructure

In the wake of the overwhelming burden that the ongoing pandemic has placed on the healthcare sector, governments worldwide have recognized the urgent need to expand their healthcare spending. The United States leads global healthcare spending, with annual expenditures exceeding USD4 trillion and projected to reach USD6.2 trillion by 2028. This upward trajectory suggests that healthcare will continue to consume a growing share of the nation’s GDP, potentially accounting for 20% by 2031, underscoring the escalating financial burden on the U.S. economy.

Meanwhile, China has also witnessed a significant increase in healthcare expenditure. In 2020, the government allocated an additional USD1.44 billion (CNY 9.95 billion) to strengthen public health services and support COVID-19 prevention and control efforts. According to the National Health Commission, these funds were primarily directed toward curbing the spread of virus-induced pneumonia and enhancing the country’s epidemic response capabilities.

As the demand for robust healthcare systems continues to rise, countries like India are also amplifying their efforts to enhance their existing healthcare infrastructure. These initiatives aim to ensure that the population has access to quality healthcare services, especially during times of crisis. The global healthcare landscape is witnessing a transformative shift, as governments worldwide recognize the importance of investing in healthcare to protect and improve the well-being of their citizens.

Large Outbreaks of Bacterial and Viral Epidemics

The rising prevalence of numerous bacterial or viral epidemics, such as the recent outbreaks of influenza and COVID-19, has heightened the global demand for point-of-care diagnostics. In response to these challenges, there have been significant advancements in pharmacogenomics, leading to the development and launch of novel molecular diagnostic products. These advancements are expected to drive the expansion of the global molecular diagnostic market throughout the forecast period.

In a groundbreaking development on March 15, 2023, a team of researchers successfully created a quick and effective point-of-care molecular diagnostic tool. This innovative tool specifically identifies a subset of individuals who are highly likely to benefit from hypnotherapy interventions for pain treatment. The researchers also made a remarkable discovery during their study, published in The Journal of Molecular Diagnostics, indicating that a subpopulation of highly hypnotizable people may be more prone to experiencing intense postoperative pain.

To further enhance their research, the scientists designed an SNP genotyping assay utilizing a massive magneto-resistive (GMR) biosensor array. This cutting-edge technology allows for the identification of the most optimal combination of COMT SNPs in patient DNA samples. The GMR biosensor arrays can be easily and conveniently installed in point-of-care settings, utilizing either saliva or blood samples. Not only are these biosensor arrays highly dependable and sensitive, but they are also cost-effective, making them an ideal solution for widespread implementation. With the continuous advancements in molecular diagnostics and the integration of point-of-care technologies, the healthcare industry is poised to revolutionize the diagnosis and treatment of various diseases, improving patient outcomes and overall healthcare efficiency.

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Key Market Challenges

High Cost of Molecular Diagnostics

Although immensely useful, molecular diagnostics do have some restrictions and drawbacks. One of the main limitations is the higher cost compared to more established conventional methods. The expenses involved in molecular diagnostics include not only the cost of equipment and supplies but also the need for highly specialized personnel and maintenance. These factors can make it financially prohibitive for some labs, especially those with limited resources.  However, it is important to note that as molecular techniques become more widespread and adopted by a larger number of labs, the costs are expected to decrease. This is due to economies of scale and advancements in technology that can lead to more affordable equipment and reagents. As a result, labs that currently find the cost of molecular diagnostics prohibitive may choose to outsource their molecular specimens to external reference labs.

Despite these challenges, the field of molecular diagnostics continues to show great potential and has already made significant contributions to healthcare. It is anticipated that as the costs decrease and the technology becomes more accessible, the market for molecular diagnostics will expand further, benefiting patients and healthcare providers alike.

High Initial Installation Costs

The cost of setting up a facility with state-of-the-art technologies like FISH (Fluorescence In Situ Hybridization), NGS (Next-Generation Sequencing), and others is indeed on the higher side. Millions of dollars are required to invest in procuring the necessary machinery, building the facility, and hiring professionals with an adequate amount of knowledge and expertise in these advanced techniques. The implementation of such cutting-edge technologies demands meticulous planning and meticulous execution to ensure accurate and reliable results.

Additionally, the cost of the treatment itself can be quite high, especially for individuals in low-income countries, which can pose a significant challenge to the overall growth of the market. It highlights the need for affordable options and innovative solutions to bridge the gap and make these advanced diagnostic and treatment methods accessible to a wider population. For instance, the expenses associated with acquiring sophisticated instruments can be substantial. A triple quadrupole mass spectrometer, known for its exceptional sensitivity and precise quantification capabilities, can cost around $350,000, depending on the specific features it offers. Similarly, a high-resolution time-of-flight instrument, renowned for its accurate mass measurement and comprehensive analysis, can range from $350,000 to $400,000. And an Orbitrap extended-mass-range model, with its superior resolution and mass accuracy, can have a price tag ranging from $400,000 to $800,000. These hefty costs further underline the significant capital requirements involved in establishing and operating state-of-the-art facilities.

Considering the financial challenges and the increasing demand for advanced diagnostics and treatments, it becomes crucial for stakeholders to explore sustainable approaches that balance cost-effectiveness, accessibility, and quality. This can involve collaborations, strategic partnerships, and innovative financing models that ensure the benefits of these cutting-edge technologies reach a larger population, regardless of their economic background.

Key Market Trends

Increasing Demand for Point-of-Care Diagnostics

The increasing demand for point-of-care (POC) diagnostics has significantly driven the demand for molecular diagnostics, reshaping the landscape of medical testing and healthcare delivery. Several key factors contribute to this growing trend. POC diagnostics offer the advantage of delivering rapid and accurate test results at or near the patient's location, often within minutes. This immediacy is critical in emergency situations, for monitoring chronic diseases, or when making time-sensitive treatment decisions. Molecular diagnostics, with its precision and sensitivity, plays a pivotal role in POC testing by enabling the detection of specific genetic material or biomarkers associated with various diseases, including infectious diseases, cancer, and genetic disorders.

Additionally, as healthcare systems strive to improve patient outcomes while reducing costs, the shift towards decentralized testing at the POC has gained momentum. Molecular diagnostics offers the capability to identify diseases at earlier stages, aiding in personalized treatment plans and ultimately reducing the burden of advanced disease cases and hospitalizations. The evolving landscape of telemedicine and remote healthcare delivery also plays a role in driving the demand for molecular diagnostics at the point of care. Patients in remote or underserved areas can benefit from POC molecular tests that provide timely insights into their health conditions, enabling healthcare providers to make informed decisions and recommendations from afar.

Recent Advancements in Pharmacogenomics

Recent advancements in pharmacogenomics, the study of how an individual's genetic makeup influences their response to medications, have significantly increased the demand for molecular diagnostics. This emerging field of medicine is revolutionizing healthcare in several keyways. Pharmacogenomics allows for highly personalized medicine. By analyzing an individual's genetic profile, healthcare providers can gain insights into how a patient is likely to respond to a particular medication. This information can help tailor treatment plans, ensuring that patients receive the most effective drugs at the right dosages while minimizing the risk of adverse reactions or inefficacy. Molecular diagnostics, such as genetic testing and next-generation sequencing, are essential tools in uncovering these genetic variations that influence drug metabolism and efficacy.

Pharmacogenomics has the potential to enhance patient safety. By identifying genetic variants that may cause severe adverse reactions to certain medications, healthcare providers can proactively avoid prescribing those drugs to patients at risk. This proactive approach reduces the likelihood of harmful side effects and improves patient outcomes.

Segmental Insights

Products and Services Insights

Based on the category of products and services, instruments segment is emerging as the fastest-growing category in the Global molecular diagnostics market. The shift toward decentralized testing models is fueling the demand for portable and easy-to-operate molecular diagnostic instruments. Healthcare systems worldwide are adopting point-of-care molecular platforms for rapid diagnosis of infectious diseases such as COVID-19, influenza, HIV, and tuberculosis especially in remote or resource-limited settings. Instruments such as Cepheid’s GeneXpert, Abbott’s ID NOW, and Roche’s cobas Liat have become critical tools in expanding molecular diagnostic access beyond traditional laboratories.

Hospitals and reference laboratories are making substantial investments in instrument-based diagnostic infrastructure to enhance testing capacity, reduce human dependency, and improve operational efficiency. This is especially relevant in the context of: Rising test volumes driven by chronic and infectious disease burdens, The need for multi-target assays and syndromic testing panels, Workforce shortages in clinical labs. Automated platforms that combine sample-to-answer capability, multiplexing, and AI-enabled data analytics are gaining traction as they streamline workflows and deliver high diagnostic accuracy at scale.

Application Insights

Based on the application segment, The infectious diseases segment dominate the Global Molecular Diagnostics Market during the forecast period. Infectious diseases continue to pose a significant global health threat, particularly in developing and densely populated countries. Conditions such as HIV, tuberculosis (TB), hepatitis B and C, respiratory infections (including COVID-19 and influenza), and sexually transmitted infections (STIs) remain among the leading causes of morbidity and mortality worldwide. Molecular diagnostics enables early and precise detection of these pathogens, even in asymptomatic patients or low viral load scenarios, allowing for faster clinical decisions and improved patient outcomes. The role of molecular testing was especially critical during the COVID-19 pandemic, where RT-PCR emerged as the frontline diagnostic tool, scaling testing efforts globally.

Traditional microbiological methods such as culture and serology often require extended turnaround times and may lack accuracy in detecting fast-evolving or low-abundance pathogens. Molecular diagnostics, in contrast, delivers highly sensitive and specific results within hours, which is crucial in controlling disease transmission, especially in acute infections and hospital-acquired infections (HAIs). The market has witnessed an uptick in point-of-care molecular diagnostic platforms that enable quick decision-making in emergency rooms, outpatient clinics, and even at-home settings further reinforcing the dominance of infectious disease applications.

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Regional Insights

Based on region, North America region emerges as the largest market in the Global Molecular Diagnostics Market. The United States and Canada boast well-established healthcare systems that prioritize early disease detection, personalized medicine, and advanced laboratory testing. Molecular diagnostics particularly PCR, NGS, and point-of-care tests are widely integrated across hospitals, diagnostic labs, and outpatient settings. High penetration of advanced testing solutions is supported by: Readily available reimbursement frameworks (e.g., Medicare and private insurers), A dense network of clinical laboratories and reference labs, Skilled healthcare professionals trained in genomics and molecular biology.

North America faces a high prevalence of chronic diseases such as cancer, cardiovascular disorders, and autoimmune conditions. In parallel, there is growing attention toward infectious disease outbreaks, antimicrobial resistance, and emerging pathogens. These dynamics create sustained demand for high-accuracy, rapid diagnostics to guide treatment decisions. The region was at the forefront of molecular testing during the COVID-19 pandemic, rapidly scaling up RT-PCR testing and surveillance systems. Rising cancer incidence is accelerating adoption of companion diagnostics and liquid biopsy solutions, particularly in oncology care.

Recent Developments

• In June 2025, QuidelOrtho (QDEL) has announced a strategic realignment of its molecular diagnostics portfolio, including the planned acquisition of LEX Diagnostics for approximately USD100 million, contingent on FDA clearance. As part of this shift, the company will discontinue development of its Savanna platform. LEX Diagnostics brings a next-generation molecular testing solution capable of delivering positive results for Flu A, Flu B, and COVID-19 in approximately 6 minutes, and negative results within 10 minutes. FDA 510(k) clearance is anticipated by late 2025 or early 2026.
• In January 2025, Applied BioCode, a leading provider of molecular diagnostics panel testing, has announced a major enhancement to its BioCode® Gastrointestinal Pathogen Panel (GPP) with the inclusion of a nucleic acid extraction claim for the widely used ThermoFisher Scientific KingFisher™ Flex platform. This integration offers clinical laboratories increased workflow flexibility and improved sample processing efficiency when utilizing the BioCode® GPP.
• In December 2024, U.S.-based Co-Diagnostics, Inc., a molecular diagnostics company leveraging a proprietary platform for the development of advanced diagnostic tests, has announced the inauguration of CoSara Diagnostics’ oligonucleotide synthesis facility in Ranoli, Gujarat.
• In October 2024, Researchers at Dana-Farber Cancer Institute have developed a CRISPR-based rapid molecular diagnostic designed to detect gene fusion-driven mutations in two forms of leukemia. The technology enables precise identification of fusion genes associated with acute promyelocytic leukemia (APL) and chronic myeloid leukemia (CML) in patient samples, offering a promising tool for timely and accurate diagnosis.

Key Market Players

• F Hoffmann-la Roche Ltd
• Illumina Ltd
• Hologic Corporation
• Agilent Technologies Inc.
• Qiagen NV
• Grifols S.A.
• Becton, Dickinson and Company
• Abbott Laboratories, Inc.
• Biomerieux SA
• Bio-Rad Laboratories Inc.
• Sysmex Corporation

Report Scope:

In this report, the Global Molecular Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Molecular Diagnostics Market, By Products and Services:

o   Reagents and Kits

o   Instruments

o   Services & Software

• Molecular Diagnostics Market, By Technology:

o   Polymerase Chain Reaction (PCR)

o   Sequencing

o   In-situ hybridization

o   Chips and microarrays

o   Mass spectrometry

o   Others

• Molecular Diagnostics Market, By Application:

o   Infectious disease

o   Oncology testing

o   Genetic testing

o   Blood screening

o   Others

• Molecular Diagnostics Market, By End User:

o   Hospitals

o   Academic & Reference Laboratories

o   Others

• Molecular Diagnostics Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Molecular Diagnostics Market.

Available Customizations:

Global Molecular Diagnostics market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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