U.S. Precision Medicine Market
Estimated at US$ XX billion in 2023, the precision medicine market in the United States is projected to reach around US$ XX billion by 2033, with a compound annual growth rate (CAGR) of XX% from 2024 to 2033. The U.S. market has grown significantly as a result of advances in precision medicine, which have also produced ground-breaking discoveries and FDA-approved medicines that are customized to a patient's genetic composition or tumor profile.
In cancer care, routine molecular testing gives doctors the ability to choose treatments that maximize patient survival and reduce side effects. On the other hand, the quality of the diagnostic tests used to guide treatment choices determines how effective precision care will be. Tests known as Next Generation Sequencing (NGS) are a significant development in clinical precision medicine applications because they can quickly sequence substantial portions of an individual's genome. With the help of these tests, patients, doctors, and researchers can find genetic variations that are essential for understanding, treating, and diagnosing a variety of human diseases.
As precision medicine continues to evolve, fueled by technologies like NGS, it promises to drive further growth and innovation in the U.S. market, transforming the landscape of healthcare delivery and patient outcomes
 

Market Overview
U.S. precision medicine market is experiencing rapid growth fueled by innovative approaches to disease prevention and treatment, such as personalized medicine. This approach considers individual differences in genes, environments, and lifestyles, with the goal of delivering targeted treatments to patients at the right time. The FDA plays a crucial role in ensuring the accuracy of Next Generation Sequencing (NGS) tests, which generate vast amounts of information posing novel regulatory challenges
To address this, the FDA has collaborated with industry stakeholders, laboratories, academia, and patient/professional societies to develop a flexible regulatory framework. This approach leverages consensus standards and state-of-the-art computing technology to support NGS test development, fostering innovation and accelerating access to reliable genetic tests. The Precision Medicine Initiative, led by the NIH, aims to understand how genetics, environment, and lifestyle impact disease prevention and treatment. Short-term goals focus on expanding precision medicine in cancer research, while long-term objectives aim to integrate precision medicine into all areas of healthcare. The All of Research Program, involving at least 1 million volunteers, underscores the initiative's commitment to large-scale precision medicine implementation nationwide
 

Key Takeaways
•    By technology, the drug discovery segment held the dominating share of the market.
•    By application, the oncology segment dominated the U.S. precision medicine market.
•    By end-use, the pharmaceutical company segment held the largest share of the market.
•    By sequencing technology, the single molecule real-time sequencing segment is expected to dominate the market over the forecast period.
•    By product, the consumables segment held the largest share of the market.
•    By route of administration, the oral segment held the largest share of the market.
•    By drugs, the Mepolizumab segment is observed to witness significant growth during the forecast period.

Report Highlights     
By Technology
Bioinformatics, big data analytics, drug discovery, gene sequencing, companion diagnostics, and other areas comprise the U.S. precision medicine market. In this industry, the drug discovery segment is clearly the leading player. By customizing therapy options to patient subgroups based on molecular profiles, lifestyle, and environmental factors, precision medicine holds great promise for improving the success rates of Phase II and III clinical trials. Precision medicine has quickly expanded since its inception into a wide range of medical and healthcare applications, with oncology leading the way in its application.
This paradigm change, which identifies the targets causing diseases in specific patients and groups clinical trials according to underlying molecular causes, is transforming the process of developing new drugs. Precision medicine is expected to lead innovation and developments in the US healthcare system as it develops, opening the door for more individualized and efficient treatment plans.
By classifying patients according to their genetic and molecular profiles, precision medicine transforms clinical trials and makes more individualized and efficient treatment methods possible. In order to understand the biological causes of diseases and eventually achieve the best possible patient outcomes, this strategy combines clinical and molecular patient data. Clinical trials provide the foundation for objectively assessing the safety and efficacy of investigational drugs, technologies, and biologics in human volunteers. These can range from gene treatments to chemotherapeutic agents. Researchers can improve trial efficacy and hasten the discovery of novel therapeutics catered to the specific needs of each patient by incorporating precision medicine into the design of clinical trials. This will propel breakthroughs in the pharmaceutical and healthcare sectors.
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4280791/
By Application Insights
The CNS, immunology, cancer, respiratory, and other areas make up the U.S. precision medicine market, with oncology emerging as the leading industry. According to the US National Cancer Institute, precision medicine makes use of genetic, protein, and environmental data for illness prevention, diagnosis, and treatment. Targeted medication therapy, precision radiation, and surgery are becoming more common in clinical practice for both solid and hematological cancers, albeit definitions may differ within stakeholders. Modern cancer treatment relies heavily on precision medicine, with thorough genomic profiling of tumors being crucial for locating anomalies or biomarkers that can be targeted.
Precision medicine is particularly important in lung cancer, where most cases are anticipated to be treated based on genomic changes. Precision medicine's potential to transform cancer treatment, enhance patient outcomes, and propel the U.S. precision medicine business is evident in its application in oncology.

By End-Use
Pharmaceutical firms have emerged as the major section in the U.S. precision medicine industry, which is segmented by end-users and includes diagnostic companies, pharmaceutical companies, healthcare IT companies, and others. Precision medicine has the potential to completely transform the pharmaceutical industry, impacting everything from early development to go-to-market plans. Pharmaceutical companies have a five-year window of opportunity to seize this transformative potential, and doing so will require aggressive participation and risk-taking throughout the healthcare ecosystem. Precision medicine has the potential to improve preventative healthcare by using analytics to identify patient hazards before they materialize, in addition to improving illness detection, diagnosis, and treatment.
This proactive approach not only improves patient outcomes but also has the potential to lower costs for healthcare systems, underscoring the imperative for pharmaceutical companies to embrace precision medicine and drive innovation in the U.S. market

By Sequencing Technology
Pyrosequencing, sequencing by synthesis, sequencing by ligation, single-molecule real-time sequencing (SMRT), ion semiconductor sequencing, chain termination sequencing, and nanopore sequencing are among the sequencing technologies used to segment the U.S. precision medicine market. During the forecast period, the SMRT segment is expected to lead.
 Despite being a common diagnostic technique in medicine, short-read massive parallel sequencing has several intrinsic drawbacks, including GC bias and challenges with mapping to repetitive regions and differentiating similar sequences. Long-read capabilities provided by single molecule real-time sequencers help to overcome these obstacles by improving consensus accuracy and the ability to detect epigenetic changes in native DNA. The use of SMRT sequencing technology promises to improve the precision and dependability of genetic studies as precision medicine develops, propelling improvements in personalized healthcare and influencing the direction of genomic medicine in the US market.

By Product
In the U.S. precision medicine market, segmentation into consumables, instruments, and services reveals consumables as the leading segment. Precision medicine strategies revolutionize healthcare by delving deeply into patients' genetic and genomic data, enabling accurate disease prediction and effective prevention, diagnosis, and treatment. This approach empowers physicians to select sensitive drugs, optimal dosages, and timing for medication usage, while minimizing adverse side effects
Consumables are crucial to the implementation of precision medicine because they supply the necessary instruments and materials for genetic testing, sequencing, and analysis. The consumables market is expected to increase significantly as precision medicine gains traction. This will allow healthcare practitioners to treat patients with tailored and targeted therapies, which will ultimately improve patient outcomes and completely transform the healthcare system.

By Route of Administration
Oral medication is the largest category in the U.S. precision medicine market according to segmentation by route of administration. Oral administration is the most used method of administering medications since it is convenient, affordable, and widely accepted by patients. Generally, the pace and degree of absorption across the intestinal epithelium determines the medication's bioavailability, with the small intestine acting as the principal site of absorption.
Patients who can take and tolerate oral medication well are most suited for this mode of administration. Furthermore, some drugs with short half-lives are made in sustained-release or timed-release formulations, which enable progressive absorption over a number of hours. Oral medication is still essential for providing patients with focused therapies as precision medicine develops, spurring development and innovation in the US market.

By Drugs Insights
Mepolizumab section is expected to develop significantly in the U.S. precision medicine market, which is divided into drug categories such as Alectinib, Osimertinib, Mepolizumab, Aripiprazole Lauroxil, and others. Mepolizumab is an example of a clinical development program guided by strong scientific principles. It is an anti-IL-5 monoclonal antibody that was created for the treatment of severe eosinophilic asthma. At first, there was little evidence of a significant effect of mepolizumab on lung function in the overall asthmatic population.
 Subsequent studies, however, showed that it was useful in lowering asthma exacerbations, especially in individuals with severe illness. Progress in comprehending the pathobiology of asthma has further revealed a target population and prognostic indicators for mepolizumab. Mepolizumab's customized approach to treating severe eosinophilic asthma positions it for significant growth as precision medicine continues to advance, providing patients with promising outcomes and spurring innovation in the U.S. market.

Market Dynamics
Driver 
Empowering Healthcare
Personalized care, or precision medicine, allows medical professionals to customize a patient's course of therapy according to their unique biological, protein, and genetic profiles. Precision medicine, in particular, focuses on how changes in genes or proteins in cancer cells affect available therapy options. Precision medicine has several uses outside of cancer. It uses information from lab tests to create customized treatment regimens with detailed recommendations.
This method improves the precision of diagnosis and effectiveness of therapy while also enabling well-informed choices on lifestyle adjustments and cancer risk reduction strategies. Precision medicine's ability to improve patient care is what is driving the U.S. precision medicine market's growth, providing patients with hopeful results and encouraging innovation in healthcare delivery.

Restraints
Cost Challenges

Financial stress of receiving a cancer diagnosis is made worse by the high expenses of precision therapy, which can frequently exceed thousands or tens of thousands of dollars each month. Studies show that a large percentage of patients deplete their resources within two years of being diagnosed.
It is anticipated that the Centers for Medicare and Medicaid Services will lose an additional $2.5 billion in revenue annually as a result of its decision to pay for genetic testing for individuals with advanced cancer. These financial limitations impede the expansion of the precision medicine sector in the United States by making novel patient therapies less accessible and affordable.

Opportunities 
Advancing Precision Medicine 
Rapid advancement of precision medicine technologies offers a strong chance to improve patient outcomes by enhancing focused care. But the health systems are also made more difficult by this transition. These technologies have the potential to completely transform a number of facets of healthcare delivery, such as patient experiences, treatment pathways, and healthcare infrastructure, as they become more widely used in ordinary clinical practice.
Precision medicine adoption is expected to bring equity issues to light, guaranteeing fair access to cutting-edge medicines. Accepting these developments offers a chance to expand the precision medicine sector in the United States, spurring innovation and improving the state of healthcare.
 

Recent Developments

•    In October 2022, GSK announced an expanded collaboration with Tempus in precision medicine to accelerate R&D.
•    In June 2022, GE Healthcare advanced the future of precision medicine in oncology with new technology partners at #ASCO22.
 

Key Players in the U.S. Precision Medicine Market
Biocrates Life Sciences
Quest Diagnostics
NanoString Technologies
Pfizer
AbbVie Inc.
AstraZeneca
Johnson & Johnson Services, Inc
Thermo Fisher Scientific, Inc.
Illumina, Inc.
ARIEL Precision Medicine, Inc.

Market Segmentation
By Technology
Bioinformatics
Big Data Analytics
Drug Discovery
Gene Sequencing
Companion Diagnostics
Others

By Application
CNS
Immunology
Oncology
Respiratory
Others

By End-Use
Diagnostic Companies
Pharmaceutical Companies
Healthcare IT companies
 Others

By Sequencing Technology
Sequencing by Synthesis
on Semiconductor Sequencing
Sequencing by Ligation
Pyrosequencing
Single Molecule Real Time Sequencing
Chain Termination Sequencing
Nanopore Sequencing

By Product
Consumables
Instruments
Services

By Route of Administration
Oral
 Injectable