U.S. Generic Drugs Market (By Drug Type: Simple Generics, Super Generics; By Brand: Pure Generic Drugs, Branded Generic Drugs; By Route of Administration: Oral, Injection, Cutaneous, Others; By Distribution Channels; By Therapeutic Application)) - Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2033

The U.S. generic drugs market size was valued at USD 133.59 billion in 2023 and is projected to surpass around USD 188.44 billion by 2033, registering a CAGR of 3.5% over the forecast period of 2024 to 2033. 

U.S. Generic Drugs Market Key Takeaways:

• By type, the pure generic drugs segment accounted for the largest market.
• By route of administration, the oral segment contributed to the biggest market.
• By therapeutic application, the cardiovascular segment captured more market share.
• By Distribution channels, the online pharmacies accounted largest revenue share.

U.S. Generic Drugs Market Overview

Generic drugs are non-patented medications that are bioequivalent to the original drug in terms of dosage, potency, quality, form, efficacy, intended use, side effects, and route of administration. In the United States, there has been a considerable increase in the production of generic drugs, which are less expensive than the original drugs and do not require lengthy research or testing. Furthermore, the introduction of generic drugs has increased patient access while saving taxpayers, employers, and insurers money, so preserving the nation's healthcare system.

Furthermore, the market is now growing rapidly due to the rising prevalence of chronic diseases in the region, including B. Cardiovascular disease, diabetes, Alzheimer's disease, and Parkinson's disease. The FDA Generic Drug Program conducts thorough preapproval evaluations to verify that generic medications fulfill these standards. In addition, the FDA inspects manufacturing facilities to ensure they follow agency requirements on good manufacturing practices.

U.S. Generic Drugs Market Covid 19 Impact:

During Covid 19 pandemic, there is more need of medicines, and generic manufacturers and biosimilar medicines are working day and night to provide needed medicines to Americans. in covid the supply chain is disturb as increasing demand for generic drugs. Because of government restrictions regarding safety and because of boundaries restrictions there is a lack of manufacturing materials and it impacts the manufacturing units and disturbs the supply chain. 

COVID-19 is testing is compulsory in the healthcare system, raising concerns about equity, exploding capacity, social safety nets, and data collection, The pharmaceutical supply chain is disturbed as drug shortages occur mainly in generic drugs. But now, several factors are straining the supply chain, increasing the potential for shortages and risks.

U.S. Generic Drugs Market Report Scope

U.S. Generic Drugs Market Growth

The growth of the U.S. generic drugs market can be attributed to several key factors. Firstly, the increasing demand for affordable healthcare solutions has led consumers and healthcare providers to opt for generic drugs, which are typically more cost-effective than their brand-name counterparts. Secondly, the expiration of patents on many branded drugs has opened up opportunities for generic drug manufacturers to enter the market, resulting in increased competition and lower prices. Additionally, government initiatives aimed at promoting the use of generic drugs, such as the FDA's Generic Drug User Fee Amendments (GDUFA), have streamlined the approval process for generic drugs, facilitating their entry into the market. Furthermore, the aging population and the rising prevalence of chronic diseases have fueled the demand for pharmaceuticals, including generic drugs, driving market growth. Overall, these factors combined create a favorable environment for the expansion of the U.S. generic drugs market.

US Generic Drugs Market Dynamics

Pure generic drugs drive the growth of the market

Generic medicines tend to be less expensive than branded medicines because they do not have to repeat the animal and clinical (human) studies that branded medicines need to demonstrate their safety and efficacy. Additionally, multiple generics are often approved for the same single product. This creates competition in the market and usually drives prices down. Moreover, New-brand medicines are usually protected by patents, which prohibit other companies from selling generic versions of the same medicine. The duration of marketing exclusivity for branded drugs can also affect the timing of generic drug approvals. 

In the United States, generic drug approvals are increasing due to the implementation of the FDA's Drug Competition Action Plan, which aims to remove the barriers faced by generic drug manufacturers. To improve the development and approval process for generic drugs, the U.S. Food and Drug Administration (USFDA) reapproved the Generic License Fee Amendment in 2017, providing the FDA with additional resources for the review of generic drugs.

FDA regulations limit the expansion of the generic drug market

The FDA stringent approval and distribution process restricts the expansion of the generic drug industry, The FDA work on adverse event data, the safety and efficacy of drugs, and ingredients on generic medications If they fail to follow the requirement they are not ready to approve that generic drug and because of this, it hindered the growth 

Prevalence of various life-threatening diseases is providing the future opportunity in to drive the market 

In addition, the market is also catalyzed by an increasingly aging population in the United States. This increases the prevalence of various life-threatening diseases such as cancer, multiple sclerosis, hepatitis, HIV, and autoimmune diseases. For example, the American Cancer Society estimates new cancer cases and deaths in the United States in 2022, with an estimated 1.9 million new cancer cases diagnosed and 609,360 cancer deaths. It will continue to catalyze the generics market in the coming years.

U.S. Generic Drugs Market By Brand Insights

On the basis of brand pure generic drugs are pure generic drugs than branded generic, it required less amount of time in research and development and it required less clinical trials for its approvals as compared to branded generic.

The pure generic drugs segment accounted for more than 52.59% in 2023, it required more money for its research and development process and it required many animal and human trials for its approval, it required more amount of time for its approval from FDA.

U.S. Generic Drugs Market By Route of Administration Insights

For generic medicines and vaccines, according to current estimates, oral formulations make up around 90% of the global market for all pharmaceutical formulations designed for human consumption. Approximately 84 percent of the top-selling medications are drugs taken orally. The World Health Organization estimates that each year there are between 2 and 3 million instances of non-melanoma skin cancer and 132,000 cases of melanoma skin cancer. Due to the fact that topical drug administration is the primary method of therapy for the majority of skin conditions, the market for advanced topical products is projected to grow in the upcoming years.

U.S. Generic Drugs Market By Therapeutic Application Insights

The old age population increases and nowadays diseases impact of all age people because of workload and unhealthy lifestyles.  People are less active physically, so it impacts their physical and mental health hunting many diseases. They are suffering from cardiovascular diseases, Central nervous system (CNS) diseases, Dermatology diseases, and Oncology and Respiratory diseases, According to the American Heart Association Approximately 874,613 cardiac deaths in the United States in 2019. 

In addition to this nearly 15%, of middle-aged and older U.S. adults suffering from lung disorders like chronic obstructive pulmonary disease (COPD) and asthma. Moreover, the Cardiovascular of therapeutic application segment exhibited a major share in 2020, whereas, the oncology segment grow at the fastest rate during the foreseen future.

U.S. Generic Drugs Market By Distribution Channels Insights

Generic drugs are sold in hospitals, pharmacies, and online pharmacies. The retail pharmacy holds a leading position in the distribution channel segment as previously people preferred to buy their medicines from retail shops but nowadays online distribution is more trending as people preferred more online modes of shopping. The online pharmacy will grow fastest in the forecast period.

U.S. Generic Drugs Market Recent Developments

• In March 2021, Teva Pharmaceuticals launched a brinzolamide ophthalmic solution for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma in the United States.
• In May 2022, Pfizer acquired Biohaven Pharmaceuticals, The Biohaven pharmaceuticals is a commercial-stage biopharmaceutical company with best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases.
• In May 2022, Sun pharma industries received approval from the food and drug administration (USFDA) on Mesalamine extended released capsule for treating bowel disease in US market

U.S. Generic Drugs Market Top Key Companies:

• Pfizer Inc
• Teva Pharmaceuticals USA, Inc
• Aurobindo Pharma USA, Inc
• Sun pharma Inc
• Abbott Laboratories Inc
• Lupin Pharmaceuticals, Inc
• Mylan
• Dr. Reddy’s
• Novartis
• Eli Lilly company

U.S. Generic Drugs Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Generic Drugs market.

By Drug Type

• Simple Generics
• Super Generics

By Brand

• Pure Generic Drugs
• Branded Generic Drugs

By Route of Administration

• Oral
• Injection
• Cutaneous
• Others

By Therapeutic Application 

• Central Nervous System (CNS)
• Cardiovascular
• Infectious Diseases
• Musculoskeletal Diseases
• Respiratory
• Oncology
• Others

By Distribution Channels

• Retail Pharmacy
• Hospital Pharmacy
• Online and Others