Market Overview
Global Molecular Diagnostics Market: Global Size, Trends, Competitive, and Historical & Forecast Analysis, 2025-2034: Advanced disease detection needs and pandemic preparedness drive molecular diagnostics growth, while high costs and infrastructure gaps present hurdles. Technological innovation, decentralized testing, and multi-disease platforms unlock new opportunities in this rapidly transforming healthcare segment.
Report Description
The global molecular diagnostics market is poised for steady expansion, projected to grow from USD 19.3 billion in 2025 to approximately USD 35.2 billion by 2034, reflecting a consistent CAGR of 6.9% over the forecast period.
Decoding the Market Landscape
Molecular diagnostics emerged in the late-20th century alongside foundational breakthroughs such as the Human Genome Project and the invention of PCR, which enabled sensitive detection of genetic mutations and pathogens and marked the transition from laboratory research to clinical diagnostics. In 1985 Kary Mullis published PCR, and by the early 1990s molecular testing for infectious diseases and inherited disorders became routine in hospitals and public health settings. The Association for Molecular Pathology was founded in 1995 to standardize emerging clinical practices. Through the 2000s, technologies such as DNA microarrays, next-generation sequencing (NGS), and digital PCR (including BEAMing) advanced diagnostics in oncology, prenatal testing, and precision medicine transforming the field toward high-throughput automated platforms. The urgency imposed by the COVID-19 pandemic in 2020 catalyzed rapid deployment of RT-PCR and isothermal amplification methods (e.g. LAMP), driving mass testing and accelerating the adoption of portable point-of-care tools in clinical and community settings.
Today, molecular diagnostics plays a central role in public health and personalized care, featuring automated platforms, microfluidic lab-on-a-chip devices, AI-assisted interpretation, and liquid biopsy assays for cancer monitoring. Its importance stems from its ability to detect specific molecular biomarkers with high accuracy and speed, enabling early disease detection, guiding targeted therapies, and supporting outbreak control—functions that traditional diagnostics simply cannot match.
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Market Drivers
Increasing Burden of Infectious Diseases in Low and Middle Income Countries Accelerates the Market Growth
One of the most significant drivers of the molecular diagnostics market is the rising burden of infectious diseases, particularly in low- and middle-income countries. According to the FIND 2023 report, respiratory tract infections, tuberculosis (TB), HIV, and viral hepatitis continue to affect millions of people across LMICs, yet diagnostic gaps remain alarmingly high. For instance, over 40% of TB cases go undiagnosed each year, and many are only identified after significant disease progression or transmission. Molecular diagnostics, especially nucleic acid amplification tests (NAATs), offer the sensitivity required to detect early-stage infections. The GeneXpert system, which delivers results for TB and rifampicin resistance in under two hours, has been scaled up in many countries under the WHO-endorsed diagnostics programs.
Moreover, the Treatment Action Group highlights the increasing push for multi-disease testing platforms that use a single instrument to diagnose multiple infections, improving efficiency and cost-effectiveness in decentralized settings. These platforms are crucial in areas where co-infections (e.g., TB-HIV) are prevalent. As governments and health agencies move toward universal health coverage (UHC), the integration of molecular diagnostics at the primary care level is not only becoming feasible but essential. This shift is expected to continue fueling market expansion in the next decade, as countries strengthen their disease surveillance and outbreak response infrastructure.
Growing Demand for Personalized and Precision Medicine Fuel the Demand of Molecular Diagnostics
Another major force propelling the molecular diagnostics market is the rapid growth of personalized and precision medicine, especially in oncology and genetic diseases. As highlighted in a 2022 report from ASCO Global Oncology, the shift from a one-size-fits-all approach to targeted therapy has created strong demand for biomarker-based diagnostics that guide treatment decisions. For example, the identification of mutations in genes such as EGFR, ALK, and KRAS in non-small cell lung cancer enables oncologists to select therapies tailored to the individual’s genetic profile. This not only improves treatment outcomes but also reduces unnecessary side effects and costs.
According to the NIH’s National Center for Biotechnology Information (NCBI), molecular diagnostic technologies like digital PCR and next-generation sequencing (NGS) are increasingly used to detect minimal residual disease (MRD) and monitor disease progression in real time. The liquid biopsy market, which uses blood-based tests to detect tumor DNA, exemplifies this trend and is becoming more accessible in clinical settings.
The push toward precision medicine is further supported by global policy movements. As the Aspire Circle health diagnostics report notes, diagnostics are essential for ensuring that precision therapies reach the right populations, particularly in regions with rising cancer incidence. Together, clinical need, technology advancement, and policy alignment are making molecular diagnostics a central pillar of the precision medicine ecosystem.
Market Restraints
High Cost and Limited Accessibility in Resource-Limited Settings Restricts Market Expansion
Despite the diagnostic power of molecular technologies, their high cost remains a critical barrier to widespread adoption especially in resource-constrained settings. According to the research, one of the most significant challenges in low and middle income countries is the affordability of molecular diagnostics at the point of care. Many NAAT platforms require expensive instrumentation, maintenance, and trained personnel, making them less feasible in primary healthcare centers. For example, while platforms like GeneXpert have been game-changing for TB diagnosis, the cartridge-based testing model incurs high per-test costs, often exceeding the budgets of public health programs.
Moreover, Treatment Action Group emphasizes that the procurement of diagnostics is fragmented, and donor dependence creates sustainability concerns in many countries. Without consistent funding, maintenance, and supply chains, even installed machines are left idle due to lack of consumables or service contracts. The lack of robust local manufacturing in many low and middle income countries further drives up import costs and limits affordability. Although efforts are underway to introduce open-access platforms and pooled procurement models, the pricing structure of molecular diagnostics remains a major restraint hindering equitable access and slowing down broader implementation, especially in rural or underserved regions where diagnostic access is most urgently needed.
Infrastructure and Skilled Workforce Gaps Slow Down Market Growth
Another pressing limitation in the growth of molecular diagnostics is the infrastructure and human resource gap, particularly in low- and middle-income countries and decentralized health systems. According to the NCBI report on global diagnostics, advanced molecular platforms often require a consistent electricity supply, air conditioning, trained technicians, and biosafety protocols all of which are not guaranteed in many peripheral or rural laboratories. These challenges make it difficult to implement or scale molecular diagnostics outside tertiary care centers or national reference labs.
Furthermore, Aspire Circle’s diagnostic access report highlights that many countries still lack adequate training programs and workforce development policies to build local expertise in molecular testing and interpretation. In practice, this means delays in diagnosis, errors in test handling, and underutilization of high-cost equipment. Even automated point-of-care systems still require personnel who understand sample collection, quality control, and device maintenance. In addition, the complexity of interpreting molecular test results especially for multiplex and next-generation sequencing platforms requires specialized knowledge, which is not widely available across low and middle income countries.
These limitations slow down adoption and limit the scalability of molecular diagnostics, especially in programs aimed at universal health coverage. Without parallel investment in laboratory infrastructure and capacity building, even the most advanced diagnostic tools will remain underutilized in settings where they are needed the most.
Recent Developments/ Press Releases
December 2024: bioMérieux Strengthens Molecular Diagnostics Portfolio by FDA Clearance & New Syndromic Panels
In December 2024, bioMérieux gained FDA clearance for its BIOFIRE® FILMARRAY® Tropical Fever Panel, enabling rapid detection of multiple tropical fever pathogens including dengue, malaria, and chikungunya—a critical tool as these infections spread globally. In February 2025, the company also received FDA 510(k) clearance for its updated Gastrointestinal (GI) Panel Mid, which identifies 11 common bacteria, viruses, and parasites from a single sample in under one hour.
May 2025: bioMérieux Acquisitions Boost Sequencing & Near‑Patient Capabilities
In mid-2025, bioMérieux agreed to acquire Day Zero Diagnostics, a U.S.–based genomics firm that uses machine learning and genome sequencing to address antimicrobial resistance. This acquisition aims to enhance the company's infectious disease surveillance and advanced molecular analytics capabilities.
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Regional Analysis
North America- Leading Market with Advanced Infrastructure
North America remains the dominant region in the global molecular diagnostics market, with the United States at the forefront. The region benefits from a highly developed healthcare system, rapid technological adoption, and substantial R&D investment. According to the research, over 70% of U.S. labs now utilize molecular diagnostics for infectious disease testing. Furthermore, the NIH's All of Us program and other genomic initiatives have integrated molecular assays into broader population health strategies. The FDA’s well-established regulatory framework facilitates quicker approvals of molecular tests, particularly for cancer, genetic disorders, and infectious diseases.
Companies like Thermo Fisher Scientific, Cepheid, and Abbott are actively launching new products, further boosting the region’s innovation cycle. The COVID-19 pandemic also accelerated the deployment of molecular testing platforms, creating long-term infrastructure for broader applications. As a result, North America continues to hold the largest market share globally, setting trends for other regions.
Asia-Pacific– High-Growth Region Driven by Diagnostic Expansion
The Asia-Pacific region is emerging as the fastest-growing molecular diagnostics market, driven by rising healthcare awareness, expanding infrastructure, and a significant burden of infectious diseases. Countries like India, China, and Indonesia are adopting point-of-care molecular diagnostics, particularly for tuberculosis, HPV, and COVID-19. According to the FIND 2023 Market Insights report, India has scaled molecular diagnostics through national programs such as the NTEP for TB and cervical cancer screening initiatives. Meanwhile, China is investing in next-generation sequencing and precision medicine as part of its healthcare modernization goals.
The region also benefits from a growing local manufacturing ecosystem and government incentives for diagnostic startups. However, challenges remain in affordability, lab access, and trained personnel issues being addressed via public–private partnerships and mobile diagnostic units. With improving access and increasing disease surveillance efforts, Asia-Pacific is poised to become a key growth engine in the global molecular diagnostics landscape.
Country-wise Analysis
United States – Powerhouse of Molecular Diagnostics
The United States leads the global molecular diagnostics market, holding approximately 39% of the market share in 2024. This dominance is fueled by a well-established healthcare system, significant investment in research and development, and a robust regulatory environment. Major laboratory networks such as Labcorp and Quest Diagnostics conduct hundreds of millions of tests annually and play a pivotal role in advancing molecular technologies like PCR and sequencing across various fields, including infectious diseases, oncology, and genomics. Government initiatives like the NIH’s All of Us program, along with increased public and private funding in genetic and infectious disease research, are further accelerating innovation.
Additionally, the country’s healthcare ecosystem is well-equipped to support over-the-counter and point-of-care PCR testing, as evidenced by FDA-approved tools such as the Lucira COVID-19 and flu test kit. Together, these factors establish the U.S. as a major force in shaping the growth and modernization of the molecular diagnostics industry.
India – High-Growth Frontier for Molecular Diagnostics
The country carries the world’s highest TB burden, with less than 25% of TB notifications tested using molecular methods; the government is transitioning from smear microscopy to WHO-endorsed technologies like TrueNAT and Xpert MTB/RIF, with nearly 5,000 systems deployed nationally. Further, FIND India (in partnership with public systems) has strengthened over 900 labs, reaching nearly 6.6 million people via capacity-building and multi-disease testing initiatives. Dual testing programs such as integrating COVID‑19 and TB diagnostics using Truenat machines in Mumbai are improving diagnostic workflows and case detection in urban settings. As domestic molecular platforms advance and private sector integration grows, India is rapidly maturing from capacity building to scale-up in both public health and clinical diagnostics.
Market Segmentation
By Product & Service Type:
· Reagents & Kits
· Instruments & Analyzers
· Software & Services
By Technology:
· Polymerase Chain Reaction (PCR)
· Isothermal Nucleic Acid Amplification
· Next-Generation Sequencing (NGS)
· In Situ Hybridization (ISH)
· Others
By Application:
· Infectious Diseases
· Oncology
· Genetic & Genomic Testing
· Blood Screening
· Microbiological Testing
· Others
By End-user:
· Hospitals & Academic Laboratories
· Diagnostic Laboratories
· Research Institutes
· Home Care / Point-of-Care Settings
· Government Health Programs
By Region and Country:
· North America
o U.S.
o Canada
· Latin America
o Brazil
o Mexico
o Rest of Latin America
· Europe
o UK
o France
o Germany
o Italy
o Rest of Europe
· Asia Pacific
o China
o Japan
o South Korea
o India
o Rest of APAC
· Middle East and Africa
o GCC
o South Africa
o Rest of MEA
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Key Market Players
· Roche Diagnostics
· Abbott Molecular
· Thermo Fisher Scientific
· BioMérieux
· QIAGEN
· Cepheid
· Hologic
· Illumina
· Seegene Inc.
· Co-Diagnostics Inc.
· Others
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