The U.S. generic drugs market size is calculated at USD 138.82 billion in 2024 and is predicted to reach around USD 197.72 billion by 2034, expanding at a CAGR of 3.6% from 2025 to 2034.
The U.S. generic drugs market refers to the production, distribution, and application of generic drugs, that is, medication created to be the same as an already marketed brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. In the USA, the Food and Drug Administration (FDA) has stated that ‘a generic drug is identical or bioequivalent to a brand name drug in dosage form, strength, safety, quality, route of administration, intended use, and performance characteristics.’ Generic medicines tend to cost less than their brand-name counterparts due to they do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness.
Generic drugs are proven to be safe and effective. They typically cost much less than brand-name drugs. Doctors will generally choose a generic over a brand drug. Also, network pharmacies may replace generic drugs with a brand drug if one is available. Genetic drugs provide significant benefits, including increased accessibility, cost savings, trustworthy quality, and therapeutic equivalence. Genetic drugs are allowed for sale after the patients on the original drugs expire. Due to the active chemical substance being the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs.
The increasing cases of cancer which driving the growth of the U.S. generic drugs market. Cancer treatment can be expensive, specifically with the increasing costs of branded cancer medications. Generic drugs are identical in chemical composition to branded drugs. They cost significantly less due to they do not require research to develop or much testing to determine safety, efficacy, or dosage levels.
Generic drugs offer a more suitable alternative to branded counterparts, enabling patients to access necessary cancer treatments at low costs. Generic drugs in oncology can reduce the cost of care significantly and their multi-source origin may provide a guarantee in supply. The role of generic medicines or drugs in oncology has potential solutions to improve cancer control, including access to vaccines and drugs at affordable prices, awareness-raising campaigns about cancer, research partnerships with developed countries, access to up-to-date medical literature from a range of top peer-reviewed journals, education, and training for new and existing healthcare workers, resources to implement cancer surveillance, detection, prevention, diagnosis, treatment, and palliative care programs, and high investment to support improvements in infrastructure and equipment. Patent expirations create new opportunities for generic manufacturers to enter the market and offer affordable alternatives to branded cancer treatments.
Global market expansion and regulatory support driving the growth of the U.S. generic drugs market. The U.S. is the largest national pharmaceutical market worldwide. In the branded drug market, manufacturers have the power to set prices. By contrast, in the generic market, distributors and other drug purchasers have consolidated into a limited number of purchasing coalitions that have the power to drive down prices. Regulatory support for generic drugs is the action taken by government agencies like the Food and Drug Administration (FDA) in the U.S. to ensure the efficacy, safety, and quality of generic drugs. FDA requires generic drugs to have the same active ingredient, strength, dosage form, and route of administration as the brand name drug. The generic manufacturer must prove that the drug is the same as the brand name.
Published by Kesiya Chacko
