US personalized medicine market Size, Share, Growth Drivers, Trends, Opportunities & Forecast 2025–2030

US Personalized Medicine Market Overview

• The US Personalized Medicine Market is valued at USD 65 billion, based on a five-year historical analysis. This growth is primarily driven by advancements in genomics, increased adoption of targeted therapies, and a growing emphasis on individualized patient care. The integration of technology in healthcare, such as artificial intelligence and big data analytics, has further propelled the market, enabling more precise diagnostics and treatment options. Additional growth drivers include the rising incidence of chronic diseases such as cancer, cardiovascular disorders, and diabetes, as well as increased healthcare spending and supportive government initiatives that foster innovation in personalized healthcare solutions .
• Key players in this market include major cities like San Francisco, Boston, and New York, which dominate due to their robust healthcare infrastructure, presence of leading biotech firms, and strong research institutions. These regions foster innovation and collaboration, attracting investments and talent, which are crucial for the development of personalized medicine solutions .
• The 21st Century Cures Act, issued by the US Congress in 2016, remains a cornerstone regulation for the sector. This Act aims to accelerate medical product development and bring new innovations to patients faster. It emphasizes the importance of personalized medicine by promoting the use of real-world evidence and streamlining the approval process for personalized therapies and diagnostics, thereby enhancing patient access to tailored treatments. The Act mandates the Food and Drug Administration (FDA) to incorporate patient perspectives and data-driven evidence into regulatory decision-making, directly impacting the development and approval of personalized medicine products .

US Personalized Medicine Market Segmentation

By Product Type:The product type segmentation includes various subsegments such as Personalized Medicine Diagnostics, Personalized Medicine Therapeutics, Personalized Nutrition and Wellness, Personalized Medical Care, Companion Diagnostics, Genomic Sequencing, and Others. Among these, Personalized Medicine Therapeutics is currently the leading subsegment, driven by the increasing demand for targeted therapies that cater to individual patient profiles. The rise in chronic diseases and the need for effective treatment options have further fueled the growth of this segment. Personalized Nutrition and Wellness is also expanding rapidly, reflecting consumer demand for individualized health and lifestyle solutions .

By Technology:The technology segmentation encompasses Big Data Analytics, Artificial Intelligence, Bioinformatics, Gene Sequencing, Drug Discovery Platforms, Liquid Biopsy, Predictive Modeling & Imaging, and Others. Big Data Analytics is the dominant technology in this market, as it enables healthcare providers to analyze vast amounts of patient data to derive insights that lead to personalized treatment plans. The increasing reliance on data-driven decision-making in healthcare is propelling the growth of this segment. Artificial Intelligence is also rapidly gaining adoption, supporting clinical decision-making and accelerating drug discovery processes .

US Personalized Medicine Market Competitive Landscape

The US Personalized Medicine Market is characterized by a dynamic mix of regional and international players. Leading participants such as Illumina, Inc., Thermo Fisher Scientific Inc., Danaher Corporation (Cepheid Inc.), Foundation Medicine, Inc., Myriad Genetics, Inc., Exact Sciences Corporation, Guardant Health, Inc., Genentech, Inc., Pfizer Inc., Roche Holding AG, Novartis AG, GSK plc, AstraZeneca PLC, Merck & Co., Inc., Regeneron Pharmaceuticals, Inc. contribute to innovation, geographic expansion, and service delivery in this space.

US Personalized Medicine Market Industry Analysis

Growth Drivers

• Increasing Prevalence of Chronic Diseases:The US is witnessing a significant rise in chronic diseases, with approximately 60% of adults living with at least one chronic condition as of the future. This translates to around 150 million individuals, creating a substantial demand for personalized medicine solutions. The Centers for Disease Control and Prevention (CDC) reports that chronic diseases account for 7 out of 10 deaths annually, emphasizing the urgent need for tailored treatment options that can effectively address these health challenges.
• Advancements in Genomic Technologies:The US personalized medicine market is being propelled by rapid advancements in genomic technologies, with the cost of whole-genome sequencing dropping to approximately $1,000 in the future. This accessibility allows for broader implementation of genomic testing in clinical settings, enabling healthcare providers to offer more precise and individualized treatment plans. The National Human Genome Research Institute indicates that these technological improvements are crucial for enhancing patient outcomes and driving the adoption of personalized therapies.
• Rising Demand for Targeted Therapies:The market for targeted therapies is expanding, with an estimated 30% of new cancer drugs approved in the future being classified as targeted therapies. This shift is driven by the increasing recognition of the effectiveness of personalized treatment approaches, which are tailored to the genetic profile of individual patients. The American Society of Clinical Oncology reports that targeted therapies can lead to improved survival rates, further fueling demand for personalized medicine solutions across various therapeutic areas.

Market Challenges

• High Costs of Personalized Treatments:One of the significant challenges facing the US personalized medicine market is the high cost associated with personalized treatments, which can exceed $100,000 annually for certain therapies. This financial burden limits access for many patients, particularly those without adequate insurance coverage. The National Institutes of Health (NIH) highlights that while personalized medicine can improve outcomes, the economic implications pose a barrier to widespread adoption and utilization in clinical practice.
• Regulatory Hurdles and Compliance Issues:The regulatory landscape for personalized medicine is complex, with the FDA overseeing numerous guidelines that can delay the approval of new therapies. In the future, the average time for FDA approval of personalized therapies is approximately 12-18 months, which can hinder innovation and market entry. Additionally, compliance with HIPAA regulations regarding patient data privacy adds another layer of complexity, making it challenging for companies to navigate the regulatory environment effectively.

US Personalized Medicine Market Future Outlook

The future of the US personalized medicine market appears promising, driven by ongoing technological advancements and a growing emphasis on patient-centric care. As healthcare systems increasingly adopt value-based care models, personalized medicine is expected to play a pivotal role in improving patient outcomes and reducing overall healthcare costs. Furthermore, the integration of artificial intelligence in treatment planning and diagnostics is anticipated to enhance the precision and efficiency of personalized therapies, paving the way for innovative solutions in the coming years.

Market Opportunities

• Expansion of Telemedicine Services:The rise of telemedicine presents a significant opportunity for personalized medicine, with an estimated 30 million telehealth visits projected in the future. This growth allows for greater access to personalized consultations and genomic testing, particularly in underserved areas. By leveraging telehealth platforms, healthcare providers can offer tailored treatment plans and follow-up care, enhancing patient engagement and adherence to personalized therapies.
• Development of Companion Diagnostics:The increasing focus on companion diagnostics is creating new opportunities in the personalized medicine market. In the future, the companion diagnostics market is expected to reach $5 billion, driven by the need for tests that identify patients who will benefit from specific therapies. This trend supports the development of targeted treatments and enhances the overall effectiveness of personalized medicine, aligning with the growing demand for precision healthcare solutions.