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U.S. Personalized Medicine Market Report Highlights
- By product, the personalized nutrition & wellness segment recorded a dominant revenue share of 51.57% in 2024.
- By product, the personalized medicine therapeutics products segment is projected to record the fastest CAGR during the forecast period.
- By end-use, the hospital segment led the U.S. personalized medicine market with a dominant revenue share in 2024.
- By end-use, the diagnostic center segment is expected to grow the fastest during the forecast period.
The rising prevalence of chronic diseases in the U.S. drives the growth of the market. Increased cases of cancer, cardiovascular diseases, diabetes, and rare genetic disorders are driving demand for targeted therapies. Personalized medicine helps tailor treatments to individual patients, improving outcomes. Increasing adoption of inorganic growth strategies like collaboration and partnership to develop personalized medicine has been estimated to drive the growth of the U.S. personalized medicine market in the near future.
Growth in precision oncology is estimated to drive the growth of the personalized medicine market. Personalized cancer treatments, including targeted therapies and immunotherapies, are gaining traction. Liquid biopsy and tumor profiling help develop patient-specific cancer treatments. For instance, in October 2024, Ataraxis AI, an Al precision medicine startup, came out of stealth with US$4 million in seed funding sponsored by Obvious Ventures and Giant Ventures. The financing was raised in 2023 and has allowed Ataraxis to create innovative diagnostic tests driven by Al that greatly improve patient outcome prediction and allow for more individualized, precise therapies. The business also debuted Ataraxis Breast, the most sophisticated clinically validated test on the market and the first Al-native prognostic/predictive test for breast cancer in history. Traditionally, the industry standard for individualized treatment selection—especially in oncology—has been molecular diagnostic testing. These tests, however, have several drawbacks, including poor accuracy, lengthy development periods, restricted scope, and reliance on processing physical tissue.
Rising government & regulatory support for developing personalized medicine is estimated to drive the growth of the U.S. personalized medicine market in the near future. Initiatives like the All of Us Research Program by the NIH promote precision medicine research. The FDA’s breakthrough therapy designation speeds up approval for personalized drugs. The U.S. Food and Drug Administration (FDA) have been approving a growing number of personalized treatments, particularly for rare diseases and various cancers. In 2023, the FDA approved 16 new personalized treatments for rare disease patients, up from six in 2022.
Increased consumer awareness & demand and biopharmaceutical investment & collaborations: More patients are opting for direct-to-consumer genetic testing (e.g., 23andMe, AncestryDNA) to understand their health risks. Growing preference for tailored healthcare solutions over traditional one-size-fits-all treatments. Major pharmaceutical companies are investing in personalized drug development. Partnerships between biotech firms, diagnostic companies, and research institutions are driving innovation.
U.S. Personalized Medicine Market Trends
• The rise of digital health & telemedicine is estimated to drive the growth of the U.S. personalized medicine market in the near future. Wearable health devices and remote patient monitoring provide real-time data for personalized treatment plans. Telemedicine enables access to specialized precision medicine consultations.
• Strategic Collaborations: Key industry players are engaging in partnerships to enhance access to personalized medicine. For instance, in January 2024, BIOS Health announced a partnership with the city of Bakersfield in California and Kern Venture Group to establish a precision medicine center, aiming to advance personalized healthcare solutions.
• Rapid Development of Personalized Cancer Therapies: Pharmaceutical companies are striving to reduce the manufacturing turnaround time for personalized CAR-T cancer therapies, which currently range from 14 to 37 days. Efforts to expedite this process are critical, as many patients may become too ill while waiting. Reducing the time can expand eligibility to more patients and provide a competitive edge. Prices for CAR-T treatments range from US$400,000 to nearly UA$600,000, with significant profit margins. Improving automation and regulatory adjustments could further trim manufacturing time. For example, Gilead Sciences is researching methods to cut two production days by using healthier cells, and Novartis aims for turnarounds under 10 days with its T-Charge system. Faster treatments could potentially be offered to more patients earlier in their disease progression.
• Technological Advancements: The integration of artificial intelligence (AI) and machine learning into healthcare is enhancing the efficiency of personalized treatments. These technologies facilitate the rapid analysis of vast genomic datasets, leading to more precise and individualized care plans.
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U.S. Personalized Medicine Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2026 |
USD 374.10 billion |
|
Revenue forecast in 2034 |
USD 705.88 billion |
|
Growth Rate |
CAGR of 8.26% from 2024 to 2034 |
|
Actual years |
2018 - 2024 |
|
Forecast years |
2025 - 2034 |
|
Quantitative units |
Revenue in USD billion and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Product, end-use |
|
Key companies profiled |
GE Healthcare, Illumina, Inc., ASURAGEN, INC., Abbott, Dako A/S, Exact Sciences Corporation, Danaher Corporation (Cepheid, Inc.), Decode Genetics, Inc., QIAGEN, Exagen Inc., Precision Biologics, Celera Diagnostics LLC, Biogen, Genelex, IBM, Genentech, Inc., 23andMe, Inc. |
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Artificial Intelligence impact In U.S. Personalized Medicine Market
The integration of AI into the U.S. personalized medicine market is accelerating drug discovery by assisting researchers in analyzing vast datasets to identify potential drug candidates faster. Predictive modeling helps optimize clinical trial design, reducing time and costs. AI-driven simulations improve understanding of drug interactions for personalized treatments. AI-powered imaging and genomic analysis can detect diseases earlier and more accurately. Machine learning algorithms help identify biomarkers for targeted therapies. AI enhances next-generation sequencing (NGS) for personalized cancer treatments. AI analyzes genetic, lifestyle, and environmental data to tailor treatments to individuals. It helps optimize drug dosages and predict adverse reactions. AI-driven clinical decision support systems assist physicians in making real-time treatment adjustments.
Wearable devices and AI-powered apps track real-time health metrics. AI-driven virtual health assistants provide continuous support and reminders about medication adherence. Predictive analytics help prevent disease progression by identifying at-risk patients. AI optimizes supply chains for personalized medicine products. Automating administrative tasks (e.g., billing patient records) reduces costs. AI streamlines insurance approvals and regulatory compliance for faster market access. AI speeds up regulatory documentation by automating compliance checks. Predictive analytics help identify potential safety concerns before FDA submissions. AI-driven real-world evidence supports faster approval of personalized therapies. AI algorithms process extensive patient data, including genetic information, medical records, and lifestyle factors, to create personalized treatment plans. By analyzing patterns and correlations within this data, AI can identify hidden insights and predict individual treatment responses with unprecedented accuracy. AI-powered imaging and genomic analysis can detect diseases earlier and more accurately. Machine learning algorithms help identify biomarkers for targeted therapies. AI enhances next-generation sequencing (NGS) for personalized cancer treatments.
Tempus company specializes in using AI to analyze clinical and molecular data, providing insights for personalized cancer treatment. DeepMind is known for its AI research that applies machine learning to healthcare, including personalized medicine initiatives. Biofourmis utilizes AI to develop digital therapeutics and personalized care solutions, enhancing patient outcomes.
U.S. Personalized Medicine Market Report Segmentation Insights
Product Insights
By product, the Personalized nutrition & wellness segment registered its dominance over the U.S. personalized medicine market. Consumers are increasingly proactive about preventive healthcare, seeking personalized diets, supplements, and fitness plans to optimize their health and prevent diseases. There is growing interest in functional foods, nutraceuticals, and biohacking. The decreasing cost of genetic testing (e.g., DNA-based nutrition plans) has made personalized diets more accessible. Microbiome research has led to tailored probiotic and prebiotic solutions, influencing gut health and overall well-being. AI-driven diet and wellness apps (e.g., Zoe, InsideTracker) analyze biomarkers and user data for customized nutrition recommendations. Wearable health tech (e.g., continuous glucose monitors, smartwatches) helps track metabolic responses and personalize diet/exercise regimens. Healthcare is shifting from treatment-based to prevention-focused models. Functional medicine emphasizes individualized wellness plans, including nutrition, stress management, and sleep optimization. Increasing FDA & regulatory approvals for personalized nutraceuticals and diagnostic tools.
The personalized medicine therapeutics segment is anticipated to grow with the highest CAGR in the market during the studied years. Next-generation sequencing (NGS) and CRISPR gene-editing have enabled targeted therapies based on individual genetic profiles. Companion diagnostics help match patients with the most effective drugs, reducing trial and error in treatment. Cancer, cardiovascular diseases, autoimmune disorders, and rare genetic conditions benefit the most from precision therapeutics. Oncology leads the market with targeted therapies (e.g., immunotherapies, CAR-T cell therapy, and monoclonal antibodies). mRNA technology, gene therapies, and regenerative medicine are transforming treatment approaches. FDA approvals for CAR-T cell therapies (e.g., Kymriah, Yescarta) have driven massive investment in the sector. AI-driven platforms accelerate drug discovery, biomarker identification, and patient stratification. Personalized therapeutics use AI-powered predictive modeling to improve treatment responses. Companion diagnostics (CDx) enable targeted drug development by linking treatments to specific biomarkers. For instance, include HER2-targeted breast cancer therapies (Herceptin) and EGFR-targeted lung cancer drugs (Tagrisso). Oncology is the largest driver, with a shift from chemotherapy to targeted and immunotherapies. Liquid biopsies & NGS allow real-time monitoring and personalized cancer treatment adjustments.
End-use Insights
By end-use, the Hospital segment registered its dominance over the global U.S. personalized medicine market in 2024. Hospitals' need for individualized medicine is a major market driver that is driving improvements in diagnostic and treatment methods. Hospitals that use genomics support the market's expansion by encouraging innovation, enhancing patient outcomes, and putting themselves at the forefront of revolutionary medical procedures that will ultimately influence customized medicine's direction. Hospitals are increasingly adopting Next-Generation Sequencing (NGS) and liquid biopsy for cancer detection, rare diseases, and pharmacogenomics. Biomarker-driven therapies (e.g., PD-L1 for immunotherapy, BRCA for breast cancer) are becoming standard practice. AI-powered clinical decision support systems help analyze patient genetics and suggest personalized treatment plans. Machine learning models predict disease risks and treatment responses. Hospitals are at the forefront of CAR-T cell therapy for cancer, CRISPR-based gene editing, and stem cell therapies. Academic medical centers and large hospitals are investing in in-house cell therapy manufacturing. Hospitals partner with pharma companies for adaptive clinical trials, where treatments are adjusted based on patient responses. Precision oncology programs are designing patient-specific immunotherapies. Hospitals use real-time patient monitoring (e.g., smartwatches biosensors) to track personalized treatment effectiveness. Remote patient management improves personalized medicine accessibility. Some hospitals are implementing microbiome sequencing to tailor probiotics and dietary interventions for conditions like IBD and metabolic disorders. Hospitals are investing in 3D bioprinting for organ and tissue regeneration. Personalized skin grafts and bone regeneration therapies are emerging in hospital-based research.
The diagnostic centers segment is anticipated to grow with the highest CAGR in the market during the studied years. Diagnostic centers lead in Next-Generation Sequencing (NGS), PCR, microarray, and liquid biopsy for genetic profiling and biomarker detection. They provide high-throughput testing capabilities, making them essential for personalized medicine. Unlike hospitals, diagnostic centers often specialize in genetic and molecular testing, offering more accurate and detailed results. They employ bioinformaticians and genetic counselors to interpret complex genomic data. Diagnostic centers operate at scale, reducing the per-test cost compared to hospital-based labs. They offer faster turnaround times due to streamlined operations and automation. Personalized medicine focuses on early disease detection and risk assessment. Diagnostic centers provide predictive genetic testing for cancer, cardiovascular diseases, and neurodegenerative conditions. Companies like 23andMe and AncestryDNA have popularized consumer-focused genetic testing. Diagnostic centers process these tests, expanding their role beyond traditional clinical settings. AI-driven diagnostics improve accuracy in image analysis, genomic sequencing, and biomarker detection. Big data analytics help identify disease patterns and treatment responses.
U.S. Personalized Medicine Market Top Key Companies:
• GE Healthcare
• Illumina, Inc.
• ASURAGEN, INC.
• Abbott
• Dako A/S
• Exact Sciences Corporation
• Danaher Corporation (Cepheid, Inc.)
• Decode Genetics, Inc.
• QIAGEN
• Exagen Inc.
• Precision Biologics
• Celera Diagnostics LLC.
• Biogen
• Genelex
• International Business Machines Corporation (IBM)
• Genentech, Inc.
• 23andMe, Inc.
Recent Developments
• In December 2024, Eli Lilly and Company revealed plans to expand its manufacturing site in Kenosha County, Wisconsin, which it purchased earlier this year, for an additional $3 billion. The company's global parenteral (injectable) product manufacturing network will be expanded with this investment, assisting in meeting the rising demand for its diabetes, obesity, and upcoming pipeline medications across therapeutic categories. Lilly anticipates adding 750 highly skilled positions to the more than 100 employees who now work here. Next year, the business intends to begin building on the expansion. In order to assist more individuals who rely on Lilly's medications, this is another phase in the company's historic industrial expansion plan.
• In January 2025, Plans for factory expansion projects were recently published by Amgen and Eli Lilly & Company, with significant investments of US$1 and US$3 billion, respectively.1.2. The US$1 billion in Amgen's case will go toward the planning of a second drug substance production plant in Holly Springs, North Carolina. Presently, the most recent development places the company's anticipated total investment in the region at over US$1.5 billion, far exceeding its initial US$550 commitment.
• In April 2023, Om1, a software company, launched a new platform powered by artificial intelligence to offer individualized information on clinical trials, risk, diagnosis, treatment, and use. This platform, called PhenOM, has been calibrated using OMi's longitudinal health history database, which has information from more than 300 million patients. PhenOM uses Al to identify particular digital phenotypes associated with ailments and results and to compare patient records to them in order to highlight options and hazards. Life science research and point-of-care clinical decision-making are only two examples of the customized healthcare inputs it may provide throughout the healthcare ecosystem.
U.S. Personalized Medicine Market Report Segmentation
This report forecasts revenue growth regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the U.S. Personalized Medicine Market
By Product
• Personalized Medicine Diagnostics
o Genetic Testing
o Direct-To-Consumer (DTC) Diagnostics
o Esoteric Lab Services
o Esoteric Lab Tests
• Personalized Medicine Therapeutics
o Pharmaceutical
o Genomic Medicine
o Medical Devices
• Personalized Medical Care
o Telemedicine
o Health Information Technology
• Personalized Nutrition & Wellness
o Retail Nutrition
o Complementary & Alternative Medicine
By End-use
• Hospitals
• Diagnostic Centers
• Research & Academic Institutes
• Others
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