North America Generic Drugs Market 2025-2035

North America Generic Drugs Market Size, Share & Trends Analysis Report, By Application (Cancer, CVD, Musculoskeletal Diseases, Infectious Diseases, Neurology, Diabetes, and Others), By Route of Administration (Oral, Topical, Injectable, and Inhaler), Forecast Period (2025-2035)

Industry Overview

North America generic drugs market was valued at $176.6 billion in 2024 and is projected to reach $315.5 billion by 2035, growing at a CAGR of 5.5% during the forecast period (2025-2035). The North American generic drugs market is experiencing significant growth, driven by the rising prevalence of chronic and lifestyle-related diseases. Rising healthcare costs have intensified the demand for affordable medication alternatives, prompting widespread adoption of generics. Companies such as Teva Pharmaceutical Industries Ltd. and Viatris Inc. are actively introducing cost-effective therapies across multiple therapeutic areas. Supportive government policies, including incentives and reimbursement programs for generic drugs, are further enhancing market penetration. Advances in formulation technologies and quality assurance measures are improving drug efficacy and patient compliance.

Market Dynamics

Rising Demand for Chronic Disease Therapies

The North American generic drugs market is witnessing robust growth driven by the increasing prevalence of chronic diseases such as diabetes, cardiovascular disorders, and hypertension. Patients and healthcare providers are seeking cost-effective alternatives to branded medications, which has accelerated generic adoption. Companies like Sun Pharmaceutical Industries Ltd. are expanding their portfolios of generics targeting these conditions, ensuring broad patient access. Government initiatives supporting generic substitution and favorable insurance coverage further enhance market penetration. Improved formulation techniques and bioequivalence studies ensure therapeutic reliability.

Growth of Oral and Patient-Friendly Formulations

Oral medications continue to lead the North American generic drugs market due to their convenience and high patient compliance. Pharmaceutical firms such as Lupin Pharmaceuticals Inc. are actively introducing orally administered generics, including tablets and capsules, across multiple therapeutic areas. The ease of administration, combined with cost-effectiveness, supports their widespread adoption in outpatient care. Regulatory approvals and quality assurance measures strengthen physician and patient confidence in these products. Rising awareness of preventive healthcare further boosts the demand for accessible oral therapies. Together, these dynamics are shaping a favorable environment for market growth.

Market Segmentation

• Based on the route of administration, the market is segmented into oral, topical, injectable, and inhaler.
• Based on the application, the market is segmented into cancer, CVD, musculoskeletal diseases, infectious diseases, neurology, diabetes, and others.

Cardiovascular Disease (CVD) Segment to Lead the Market with the Largest Share

The North American generic drugs market is experiencing steady growth driven by rising demand for cardiovascular disease (CVD) treatments. Increasing prevalence of heart-related conditions has led healthcare providers to prefer cost-effective generic alternatives. For example, Teva Pharmaceutical Industries Ltd. has expanded its portfolio of generic CVD medications to address this demand. Regulatory support for bioequivalent formulations ensures these generics are accessible and reliable. Public awareness initiatives on heart health are also contributing to higher adoption rates. Together, these factors are sustaining momentum in the CVD segment of the market.

Oral : A Key Segment in Market Growth

Oral medications continue to dominate the North American generic drugs market due to convenience, patient compliance, and cost efficiency. Companies such as Viatris Inc. have developed an extensive range of orally administered generics, including tablets and capsules, across multiple therapeutic areas. Ease of administration and wide acceptance in outpatient care further drive demand. Advancements in formulation and quality control improve effectiveness and safety, encouraging physician and patient trust. Health insurance policies favoring generic substitution are also supporting adoption. These combined dynamics reinforce the sustained growth of oral generics in the region.

Regional Outlook

The North America generic drugs market is further divided by countries, including the US and Canada.

Increasing Focus on Cost Containment and Improved Patient Care in the US

The US generic drugs market is expanding steadily, owing to growing demand for affordable treatment solutions across chronic and acute conditions. Mylan Inc. has been instrumental in offering a diverse portfolio of generics that cater to cardiovascular, neurological, and metabolic disorders. Policy measures and insurance coverage that favor generic alternatives are enhancing market access. Technological improvements in drug formulation and production quality ensure safety and efficacy. Increased patient awareness about cost-effective healthcare options further drives adoption. Collectively, these factors are contributing to consistent growth in the U.S. generic drugs sector.

Market Players Outlook

The major companies operating in the North America generic drugs market include Dr. Reddy’s Laboratories Ltd., Sandoz (a Novartis division), Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., Viatris Inc., among others. Market players are leveraging partnerships, collaborations, mergers, and acquisition strategies for business expansion and innovative product development to maintain their market positioning.

Recent Developments

• In August 2025, Teva Pharmaceuticals, Inc., a US affiliate of Teva Pharmaceutical Industries Ltd., announced the FDA approval and US launch of a generic version of Saxenda1 (liraglutide injection). Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market. This approval and launch add to Teva’s continued commitment to its complex generic medicine portfolio as part of its Pivot to Growth Strategy.
• In August 2025, Lupin Ltd. announced the launch of Bosentan Tablets for Oral Suspension, 32 mg, in the US. This follows the approval received by Lupin’s alliance partner, NATCO Pharma Ltd. (NATCO), for its Abbreviated New Drug Application from the US Food and Drug Administration (U.S. FDA). NATCO holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity.
• In January 2024, Amneal Pharmaceuticals, Inc. announced that it had launched 39 new retail and injectable medicines in 2023, as compared to 26 new launches in 2022. In the fourth quarter of 2023, Amneal launched 13 new products, including 5 injectables. New injectable products added include potassium phosphate vials, tranexamic acid, and esmolol intravenous bags. These launches provide a strong foundation for higher injectable revenues going forward.

The Report Covers

• Market value data analysis of 2024 and forecast to 2035.
• Annualized market revenues ($ million) for each market segment.
• Country-wise analysis of major geographical regions.
• Key companies operating in the North America generic drugs market. Based on the availability of data, information related to new products and relevant news is also available in the report.
• Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
• Analysis of market-entry and market expansion strategies.
• Competitive strategies by identifying ‘who-stands-where’ in the market.

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