United States Pharmaceuticals Market Analysis

The United States Pharmaceuticals Market size is expected to reach US$ 1,068.02 billion by 2030, from US$ 599.47 billion in 2023, at a CAGR of 8.6% during the forecast period.

Pharmaceuticals refer to prescription and over-the-counter drugs used for diagnosis, treatment, cure, mitigation, or prevention of diseases in humans or animals. The market is driven by rising prevalence of chronic diseases, new drug launches, and increasing healthcare expenditure.

The United States Pharmaceuticals Market is segmented by product type, therapy area, distribution channel, route of administration, and end-user. By product type, the market is segmented into prescription drugs, generic drugs, OTC drugs, biologics, and biosimilars. The prescription drugs segment accounted for the largest share in 2022 owing to new drug launches and rising incidence of chronic illnesses.

United States Pharmaceuticals Market Drivers:

• Increasing Prevalence of Chronic Diseases: The rising prevalence of chronic diseases such as cancer, cardiovascular diseases, diabetes is a major factor driving growth in the United States pharmaceuticals market. The population afflicted with chronic diseases is growing steadily owing to sedentary lifestyles, unhealthy diets, higher stress levels, and an aging population. Pharmaceutical drugs are required on a continuous basis to manage chronic diseases. New drug development is focused on addressing unmet needs for chronic disease treatment. For instance, according to the National Center for Biotechnology Information the bradycardia incidences were majorly reported during COVID-19 in 2021, when remdesvir was administered in patients suffering from coronavirus.  According to World Heath Federation report, in 2021, 1 billion people across the globe suffered from bradycardia in 2020.
• Favorable Regulatory and Reimbursement Scenario: The regulatory framework provided by the US FDA facilitates accelerated review and approval of novel drugs and therapies for patients. Initiatives such as the fast track, breakthrough therapy, accelerated approval, and priority review designations expedite the development and review of drugs for serious illnesses. Further, the reimbursement policies offer coverage for a majority of prescription drug costs under Medicare Part D plans, Medicaid, and private insurers. This provides accessibility and affordability for pharmaceuticals. According to the U.S. Food and Drug Administration (USFDA), any drug that is safe and effective for direct consumer use based on mentioned label instructions and warnings are considered to be over the counter or nonprescription drugs. There are two regulatory pathways for OTC drugs to get approval from the USFDA, which include OTC New Drug Application (NDA) and OTC Drug Monograph. Standards for safety and efficacy, Good Manufacturing Practices (inspections), and Labeling under 21 CFR 201.66 are required to be done for OTC products.

United States Pharmaceuticals Market Opportunities:

• Growing Adoption of Personalized Medicine: Advances in genomics, biomarkers and companion diagnostics are enabling more targeted therapies catered to patients based on their genetic makeup and molecular profiles. Personalized medicine can help avoid trial-and-error prescription and improve outcomes through optimal treatments tailored to the individual. Precision oncology is at the forefront of this opportunity.
• Rising Demand for Cell and Gene Therapies: Cell and gene therapies offer tremendous potential for curing rare genetic disorders and cancers by modifying the body’s own cells or introducing healthy genes. CAR T-cell therapies for blood cancers have already been approved. Significant investment and R&D is focused on next-generation cell & gene therapies to treat a wide range of diseases. Their transformative potential presents a big opportunity.

United States Pharmaceuticals Market Restraints:

• Probablity of Drug Abuse: U.S. over-the-counter drugs market is expected to be hampered due to the lack of stringent regulations and enforcements by the regulatory authorities. This is expected to restrain the growth of the market over the forecast period. For instance, according to DrugAbuse.gov: 2020, approximately 3.1 million young people aged 12 to 25 have used a nonprescription cough and cold medication to get high. Moreover, in the U.S., in the year 2020, there were around 2.1 million hospital visits related to drug abuse, 27.1% involved the nonmedical use of pharmaceuticals (OTC medications). Furthermore, according to the National Institute on Drug Abuse, in the U.S., around 3.4% high school seniors had been misusing cough medicine in 2018. Thus, the high probability of drug abuse is expected to hamper the growth of the market over the forecast period.