Molecular Diagnostics In Pharmacogenomics Market Summary
The global molecular diagnostics in pharmacogenomics market size was estimated at USD 699.7 million in 2024 and is projected to reach USD 1, 256.38 million in 2033, growing at a CAGR of 6.84% from 2025 to 2033. This market focuses on rapid and precise genetic testing that enables tailored drug therapy, improving clinical outcomes and reducing adverse drug reactions.
Key Market Trends & Insights
- North America dominated the market with the largest revenue share of 38.72% in 2024.
- The molecular diagnostics in pharmacogenomics market in the U.S. accounted for the largest market revenue share in North America in 2024.
- Based on product, the kits and assays segment led the market with the largest revenue share of 48.05% in 2024.
- Based on therapeutic area, the oncology segment led the market with the largest revenue share of 33.44% in 2024.
- Based on technology, the PCR-based segment led the market with the largest revenue share of 38.09% in 2024.
Market Size & Forecast
- 2024 Market Size: USD 699.7 Million
- 2033 Projected Market Size: USD 1,256.38 Million
- CAGR (2025-2033): 6.84%
- North America: Largest market in 2024
- Asia Pacific: Fastest growing market
Molecular diagnostics play a central role in identifying patient-specific genetic variations and are widely adopted in areas such as oncology, cardiovascular conditions, infectious diseases, and neurological disorders. Product offerings within the market span across kits, reagents, and specialized testing services, each addressing different stages of pharmacogenomic workflows. Kits and reagents are widely used in clinical laboratories and research institutions for routine and specialized assays. Services are expanding in relevance due to the need for comprehensive interpretation, bioinformatics support, and regulatory-compliant testing. The oncology segment dominates the therapeutic landscape, with lung, breast, and colorectal cancers accounting for significant test volumes, while emerging interest is observed in neurological and immunological disorders.
In terms of technology, polymerase chain reaction (PCR) remains the most widely used method due to its cost-effectiveness and speed. Sequencing technologies, particularly next-generation sequencing (NGS), are gaining ground for their ability to analyze multiple genes simultaneously. Microarrays and other methods like electrophoresis and nucleic acid amplification techniques also contribute to the testing ecosystem. Continuous innovation, along with rising awareness of gene-drug interactions and expanding access to genomic services globally, is expected to reinforce the growth of this market over the forecast period.
Moreover, at AAN’s Annual Meeting in April 2025, leading neurologists underscored the emergent role of pharmacogenomics in neurology. By focusing on genetic drivers across diseases like Alzheimer’s, Parkinson’s, stroke, migraine, and multiple sclerosis, experts envisioned a paradigm shift toward genetically guided treatment selection, with the potential to enhance efficacy and reduce adverse events. These insights point to a growing clinical demand for PGx-enabled molecular diagnostics in neurological care a development reflecting the broader trend of sequencing-based precision diagnostics being adopted beyond traditional therapeutic boundaries.
Overall, the innovation landscape in the molecular diagnostics in pharmacogenomics industry reflects a shift toward faster, more accessible, and clinically actionable testing solutions. The integration of advanced technologies such as AI, point-of-care systems, and multi-omics platforms is expanding the utility of PGx diagnostics beyond traditional hospital settings, supporting broader adoption across diverse therapeutic areas.
Market Concentration & Characteristics
Innovation is high in the molecular diagnostics in pharmacogenomics industry, driven by the demand for rapid, accurate, and gene-targeted testing solutions. Advancements in sequencing technologies, microfluidics, and digital platforms have enhanced multiplex testing and integration with clinical workflows. The market is also witnessing increased interest in portable and decentralized diagnostics that support real-time decision-making and patient-specific treatment selection.
Mergers and acquisitions are moderately active, with larger companies acquiring smaller firms to strengthen their capabilities in pharmacogenomic testing. These activities often focus on accessing proprietary gene panels, expanding bioinformatics resources, or entering new therapeutic areas. Collaborations with pharmaceutical and digital health companies are also rising, aiming to accelerate product development and improve clinical utility.
Regulatory frameworks play a key role in shaping the adoption of pharmacogenomic diagnostics. Agencies such as the U.S. FDA and EMA require stringent validation and clinical evidence for test approval. Global regulatory trends are moving toward structured guidelines for pharmacogenomic reporting and clinical application. Compliance with region-specific standards remains critical for commercialization and reimbursement.
Companies are expanding their molecular diagnostic portfolios to include broader gene panels across multiple therapeutic domains. Test platforms now emphasize modularity, multiplex capability, and ease of use to support diverse clinical environments. Integration with decision-support software and cloud-based analytics is becoming more common, aligning with the shift toward personalized and precision medicine.
While North America and Europe are mature markets with established infrastructure and clinical integration, growth opportunities are expanding across Asia-Pacific, Latin America, and the Middle East. Factors such as improved healthcare access, rising awareness of pharmacogenomics, and supportive government initiatives are contributing to regional market development. Companies are increasingly forming local partnerships to improve affordability and distribution.
Key Molecular Diagnostics In Pharmacogenomics Company Insights
Key participants in the molecular diagnostics in pharmacogenomics industry are prioritizing new product development and obtaining regulatory approvals to diversify their portfolios. In addition, companies are engaging in partnerships, collaborations, mergers, and acquisitions to reinforce their position within the market. These strategies are directed toward expanding technological capabilities, extending geographic access, and improving the availability of pharmacogenomic diagnostic tools across varied care environments.
Key Molecular Diagnostics In Pharmacogenomics Companies:
The following are the leading companies in the molecular diagnostics in pharmacogenomics market. These companies collectively hold the largest market share and dictate industry trends.
- Roche Diagnostics
- QIAGEN
- Thermo Fisher Scientific
- Illumina, Inc.
- Agilent Technologies
- Abbott Molecular
- Genomind
- OneOme
- Myriad Genetics
- Invitae (formerly YouScript)
Recent Developments
- In April 2025, Illumina and Tempus AI announced a strategic partnership aimed at advancing precision medicine through AI-driven genomic innovation. This collaboration focuses on expanding the clinical utility of molecular diagnostics in pharmacogenomics by integrating Illumina’s AI-enabled sequencing platforms with Tempus’s real-world multimodal data. The initiative supports broader adoption of PGx diagnostics across therapeutic areas such as oncology, cardiology, and neurology by generating robust clinical evidence, streamlining regulatory pathways, and enhancing data-informed drug selection strategies.
- In February 2025, Global Precision Diagnosticssigned a Memorandum of Understanding with Sunway Multicare Pharmacy and ReGen Rehab Hospital to deliver clinical pharmacogenomic services in Malaysia. The partnership focuses on expanding access to PGx testing through the PRECISE Pharmacogenomics platform, supporting safer and more personalized treatment by integrating molecular diagnostics into both pharmacy and rehabilitation care settings.
- In October 2024, QIAGENDigital Insights introduced a pharmacogenomics knowledge base named Pharmacogenomic Insights (PGXI). Designed for scientific and medical researchers, PGXI enables interpretation of gene–drug interactions by integrating expert-curated data from sources such as CPIC, FDA, and PharmVar. The tool supports pharmacogenomic diagnostics by streamlining annotation workflows and aiding in the analysis of results from sequencing and array platforms, contributing to the expansion of molecular diagnostics in pharmacogenomics.
About Grand View Research
Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.
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