DUBLIN–(BUSINESS WIRE)–The «United States Generic Drugs Market Size and Share Analysis – Growth Trends and Forecast Report 2025-2033» report has been added to ResearchAndMarkets.com’s offering.
United States Generic Drugs Market is expected to reach US$ 131.80 billion by 2033 from US$ 95.87 billion in 2024, with a CAGR of 3.60% from 2025 to 2033.
In terms of dosage, potency, safety, efficacy, mode of administration, and intended purpose, a generic medication is a pharmaceutical product that is bioequivalent to a brand-name medication. It is manufactured and sold following the expiration of the original brand-name drug’s patent protection.
These drugs go through extensive testing by regulatory bodies to guarantee their efficacy, safety, and quality, and they contain the same active components as their name-brand equivalents. A larger population may now afford and receive healthcare due to the many benefits of generic medications, which include reduced costs, improved accessibility, and more affordability. They are essential in boosting competition in the pharmaceutical industry, offering affordable substitutes for name-brand medications, and improving the general effectiveness of American healthcare systems.
The market in the United States is primarily driven by the product’s ease of availability and affordability, which is supported by the growing number of expired patents. In addition, the aging population in the United States necessitates a greater volume of medications, and the expiration of patents for several blockbuster drugs creates growth opportunities for generic manufacturers. Additionally, the market is catalyzed by the rising cost of healthcare, including prescription medications, which forces payers and healthcare providers to encourage the use of generic drugs in order to control costs.
Growth Drivers for the Generic Drugs Market
The region’s growing drug shortage
The region’s drug market is growing stronger as a result of the growing shortage. Brand-name medication shortages can be caused by a number of things, including as problems with manufacturing, difficulties with regulations, interruptions in the supply chain, and rising demand. Generic alternatives may become more popular as a result of these shortages. It may be difficult for pharmacies and healthcare professionals to keep a steady supply of name-brand drugs during a drug shortage. As a result, they turn to generic medications as a substitute to ensure continuity of patient care. Generic medications offer a feasible alternative during these shortages as they are generally widely available, produced by several producers, and competitively priced.
In order to lessen the effect of medication shortages on patient treatment programs, medical professionals may also proactively prescribe generic medications as substitutes. Hospitals and healthcare systems may occasionally put policies in place to encourage the use of generic medications during shortages in order to maximize resource allocation and reduce patient care interruptions. Furthermore, using generic medications during drug shortages helps to solve short-term supply issues and eventually supports the expansion of the generic medicine market. This gives patients, payers, and healthcare professionals a chance to see the benefits and dependability of generic drugs, which could boost use and expand the market for them after the shortage is over.
Increasing need for managing chronic illnesses
The industry is being positively impacted by the rising need for managing chronic diseases. Chronic illnesses that necessitate long-term medication use include diabetes, cardiovascular diseases, and respiratory disorders. Cost-effective medication options are essential as the population ages and the prevalence of chronic diseases rises. Furthermore, generic medications offer a cheap alternative for addressing chronic conditions. They guarantee comparable therapeutic effects at a fraction of the price because they contain the same active ingredients as their name-brand equivalents. This makes them highly attractive to patients, healthcare providers, and payers.
The most common type of heart illness is coronary heart disease, according to a May 2023 report released by the Centers for illness Control and Prevention. Globally, one in twenty persons aged 20 and above, or around 5% of the population, suffers from coronary artery disease (CAD). Approximately 850,000 Americans suffer a heart attack each year, according to the same source. Of these, more than 200,000 people have already experienced a heart attack, and 605,000 have experienced their first. Since the need for affordable medications used during treatment is a major factor in the growth of the generic drugs market, this offers the US generic drug market a sizable market opportunity.
Furthermore, because generic medications have been shown to be safe and effective, medical professionals frequently give them priority when managing chronic illnesses. To increase adherence and cut expenses, they might recommend generic drugs as a first-line therapy choice or urge patients to move from name-brand drugs to their generic counterparts. Furthermore, payers – such as government programs and insurance companies – are aware of the potential cost savings associated with generic medications in the treatment of chronic illnesses. In order to make generic medications more accessible and affordable for patients, they might provide preferential coverage or reduced co-pays. Additionally, formulary management programs may include generics as preferred options, further driving their utilization.
Availability of patent cliffs
The term «patent cliff» describes the situation where patents on popular name-brand medications expire, allowing generic competitors to enter the market. Generic manufacturers are legally permitted to manufacture and market their medicine copies after a patent expires, frequently at much reduced costs. Additionally, patent cliffs are providing generic medicine producers with profitable chances to enter the market and provide less expensive substitutes for name-brand medications. Since there is more competition when patents expire, the market for generic medications is expanding. The cost of drugs is reduced and pricing transparency is encouraged by this greater competition, which benefits both patients and healthcare systems.
Additionally, in order to find ways to cut costs and encourage the use of generics, pharmaceutical corporations and healthcare providers keep a careful eye on patent expirations. To benefit from the cost savings, they might aggressively move patients to generic alternatives. Furthermore, by establishing a competitive environment and stimulating innovation among generic manufacturers, patent cliffs in the pharmaceutical sector increase access to more reasonably priced pharmaceuticals and promote market expansion for generic drugs.
Challenges in the United States Generic Drugs Market
Regulatory hurdles
One major obstacle in the US generic medication business is regulatory barriers. When it comes to sophisticated medications like biologics or biosimilars, the FDA approval procedure for generics can be drawn out. The Abbreviated New Drug Application (ANDA) process is complicated to navigate, involving a lot of paperwork and strict adherence to rules. Furthermore, brand-name companies’ «pay-for-delay» agreements and patent litigation can postpone the entry of generics, decreasing competition and raising consumer costs. These regulatory hurdles often slow down market entry for generics.
Price Volatility
Due to variables like abrupt increases in demand, supply shortages, and market consolidation, price volatility is a significant problem in the generic medication industry in the United States. Generic prices might rise significantly due to unforeseen circumstances like production problems or market monopolies, which puts a burden on patients and healthcare systems. Furthermore, manufacturers’ intense competition causes prices to drop quickly, which affects sustainability and profit margins. The market is unstable because to this volatility, which makes pricing tactics more difficult for insurers and producers alike.
United States Generic Drugs Overview by States
In the United States, the need for generic medications varies by state, with major markets like California, Texas, and New York experiencing more demand because of their larger populations. Due to cost reductions and competition, states with strong healthcare systems and more affordable drug programs – like Florida and Pennsylvania – also have high rates of generic medicine use.
Company Analysis: Overview, Key Persons, Sales Analysis, Recent Developments
- Teva Pharmaceuticals
- Aurobindo Pharma
- Sun Pharmaceuticals
- Abbott Laboratories Inc
- Lupin Pharmaceuticals, Inc
- Viatris
- Sandoz
- Dr. Reddy’s Laboratories
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 200 |
| Forecast Period | 2024 – 2033 |
| Estimated Market Value (USD) in 2024 | $95.87 Billion |
| Forecasted Market Value (USD) by 2033 | $131.8 Billion |
| Compound Annual Growth Rate | 3.6% |
| Regions Covered | United States |
Key Topics Covered:
1. US Generic Drug Market – Introduction
1.1 What are Generic Drugs?
1.2 Unbranded and Branded Generics
1.3 Authorized Generics
1.4 Commoditized and Specialty Generics
2. Why is the US Generic Drug Market So Lucrative
2.1 Patent Expiry of Blockbuster Drugs
2.2 Significant Price Differential between Generics and Innovator Drugs
2.3 Savings for the Government and Third-Party Payers
2.4 Incentives for Dispensing and Prescribing Generic Drugs
2.5 Reimbursement and Lower Co-payments
3. Research & Methodology
4. Executive Summary
5. Market Dynamics
5.1 Growth Drivers
5.2 Challenges
6. United States Generic Drugs Market
7. Market Share Analysis
7.1 By Type
7.2 By Therapeutic Area
7.3 By Drug Delivery
7.4 By Distribution Channel
7.5 By Age Group
7.6 By Payment Type
7.7 By State
8. Type
8.1 Branded Generics
8.2 Unbranded Generics
9. Therapeutic Area
9.1 Heart Disease
9.2 Mental Health
9.3 Diabetes
9.4 Epilepsy
9.5 Cancers
9.6 Allergies & Asthma
9.7 Chronic Obstructive Pulmonary Disease
9.8 Alzheimer’s Disease
9.9 HIV/AIDS
9.10 Crohn’s colitis
10. Drug Delivery
10.1 Oral
10.2 Injectables
10.3 Dermal/Topical
10.4 Inhalers
11. Distribution Channel
11.1 Specialty Pharmacy
11.2 Retail Pharmacy
11.3 Hospital Pharmacy
11.4 Online Pharmacy
12. Age Group
12.1 Children (0-19 years)
12.2 Young Adults (20-39 years)
12.3 Adults (40-64 years)
12.4 Seniors (Above 65 years)
13. Payment Type
13.1 Cash
13.2 Commercial
13.3 Medicaid
13.4 Medicare D
14. State
14.1 California
14.2 Texas
14.3 New York
14.4 Florida
14.5 Pennsylvania
14.6 Ohio
14.7 Illinois
14.8 North Carolina
14.9 Georgia
14.10 Michigan
14.11 Others
15. Porter’s Five Forces Analysis
15.1 Bargaining Power of Buyers
15.2 Bargaining Power of Suppliers
15.3 Degree of Rivalry
15.4 Threat of New Entrants
15.5 Threat of Substitutes
16. SWOT Analysis
16.1 Strengths
16.2 Weaknesses
16.3 Opportunities
16.4 Threats
17. Regulations in the US Generic Drug Industry
17.1 Overview of Pharmaceutical Regulations
17.2 Drug Applications
17.3 Patents and Market Exclusivity
17.4 Regulatory Requirements for Generic Drugs
17.5 The Hatch-Waxman Act
17.6 Certifications
17.7 Other Important Considerations
18. Key Players Analysis
For more information about this report visit https://www.researchandmarkets.com/r/6md1lo
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