US Healthcare Outlook Report, 2025

DelveInsight's "US Healthcare Outlook Report, 2025" report provides comprehensive insights about healthcare scenario, regulatory policies and reimbursement landscape in US. The report also identifies key trends in the healthcare market and provide insights into the demographic and healthcare infrastructure of the country. Along with this the report also provides a brief look into the trends and segmentation of the pharmaceutical and medical devices market of US.

As per DelveInsight analysis, US is headquarter to various major pharmaceutical and medical device companies of the world. Due to this, US pharmaceutical market is the world's most important national market.

US Healthcare Outlook

Overview:

United States, country in North America, a federal republic of 50 states. Besides the 48 conterminous states that occupy the middle latitudes of the continent, the United States includes the state of Alaska, at the northwestern extreme of North America, and the island state of Hawaii, in the mid-Pacific Ocean. The conterminous states are bounded on the north by Canada, on the east by the Atlantic Ocean, on the south by the Gulf of Mexico and Mexico, and on the west by the Pacific Ocean. The United States is the fourth largest country in the world in area (after Russia, Canada, and China). The national capital is Washington, which is coextensive with the District of Columbia, the federal capital region created in 1790.

The US is covering a vast area of North America, with a population of 334.91 million inhabitants, distributed on a territory of 9.834 million square kilometers. The Gross Domestic Product (GDP) in the United States was worth USD 27720.71 billion in 2023, according to official data from the World Bank. The GDP value of the United States represents 26.29 percent of the world economy. The aging population, rising rate of chronic diseases, and exponential advances in innovative, but costly, digital technologies continue to increase health care demand and expenditures.

States manage and pay for aspects of local coverage and the safety net. Private insurance, the dominant form of coverage, is provided primarily by employers. The uninsured rate, 8.5 percent of the population, is down from 16 percent in 2010, the year that the landmark Affordable Care Act became law. Public and private insurers set their own benefit packages and cost-sharing structures, within federal and state regulations.

The US Food and Drug Administration (FDA) is a Federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices among others.

US Industry Overview Chapter

Major Pharmaceutical Companies in the US Healthcare Market

The US is the worldwide leader in per capita prescription drug spending. Many global pharmaceutical companies also have a presence in the US Further, US is hub for various ongoing clinical trials. In the US, the majority of the pharmaceutical wholesaler business is concentrated in a few companies that hold the majority of the market share. There is also a large market in the US for over-the-counter (OTC) medicines. Drugs for conditions like allergies and heartburn that required prescriptions in the past are now available for OTC sale. Use of generic drugs has also increased in recent years.

US government's plan to implement of cost control policies along with tightening of rules by government like delay in approval of complex generics and price erosion in US generics pharmaceuticals market are expected to impact the growth prospect of the US pharmaceuticals industry. Pharmaceuticals companies are forced to reduce their research and development (R&D) spending due to slowdown of growth in last few years which is also expected to hamper growth of the US pharma market as new drugs revenue form large part of pharma firm's revenue due to exclusivity of the drug.

Major Medical Device Companies in the US Healthcare Market

The US medical device industry is one of the largest in the world, with billions of dollars in annual revenue. It contributes significantly to the US economy and provides employment to a substantial workforce, including engineers, scientists, regulatory experts, and manufacturing professionals.

Medical devices in the US are subject to rigorous regulation by the US Food and Drug Administration (FDA). The FDA classifies devices into different categories (Class I, II, and III) based on their risk profile. The level of regulatory scrutiny increases with the device's risk level, with Class III devices requiring the highest level of oversight.

Medical device manufacturers must obtain FDA clearance or approval before marketing their products in the US The approval process involves demonstrating safety and effectiveness through clinical trials for certain devices, while others can enter the market through the 510(k) clearance pathway if they are substantially equivalent to a legally marketed device.

US Healthcare Assessment Chapter

This chapter contains the statistical information containing, number of hospitals, number of beds, number of pharmacies, life expectancy of male and female, Immunization coverage for Hepatitis B and Measles, environmental health (PM 2.5 and CO2 Emissions), number of physicians, nurses, dentists and pharmacists, healthcare expenditure, healthcare expenditure as share of GDP, out of pocket expenditure, pharmaceutical import and export, Gross Domestic Product, Inflation, Unemployment, trade associations and trade fairs in US.

US: Market Access

Market access section of the US Healthcare Outlook report contains information on how to penetrate the pharmaceutical and medical device markets in terms of setting up manufacturing unit, import export licensing, regulations pertaining to patents, trademarks, clinical trials, advertising, pharmacy regulation, labelling and packaging. It also covers detail about healthcare insurance and reimbursement policy.

US Department of Health and Human Services (HHS) is the primary federal agency responsible for overseeing healthcare policy and regulation. It includes several sub-agencies that play significant roles such as Centers for Medicare & Medicaid Services (CMS) which administers the nation's major healthcare programs, including Medicare and Medicaid; Agency for Healthcare Research and Quality (AHRQ) that conducts research to improve the quality and safety of healthcare, amongst others.

US: PESTLE Analysis

The US Healthcare Outlook report covers a thorough analysis of the country through PESTLE analysis tool and give political, economic, social, technological, legal and environmental aspects of healthcare industry.

US Healthcare Outlook Report Highlights

• Overview of the pharmaceutical and medical device markets
• An insightful review of the reimbursement and regulatory landscape, covering the healthcare reimbursement process, regulatory agencies, and the approval processes for new drugs and medical devices
• Detailed analysis of the political and economic environment, including economic indicators, demographics, healthcare infrastructure and healthcare expenditure
• An overview of the opportunities for and challenges to growth in the US healthcare market
• US Report Insights
• US Healthcare Outlook
• US Healthcare Assessment
• US Healthcare Market Access
• US Healthcare Market Perspectives
• US Analyst Views

Key Companies in the US Healthcare Market

• Pfizer
• Johnson & Johnson
• Roche
• AbbVie
• Amgen
• Novartis
• Merck & Co.
• Gilead Sciences
• Sanofi
• Bristol-Myers Squib
• B. Braun

Key Questions:

• What are business strategies and trends shaping and driving the US healthcare market?
• What are reimbursement and regulatory policies, pharmaceutical and medical device market segments and companies likely to impact the US healthcare market in the future?
• How to organize sales and marketing efforts by identifying the market categories and segments that present the best opportunities for consolidation, investment and strategic partnership?
• How to identify, understand and capitalize on the opportunities and challenges in the US healthcare market?