United States Generic Drugs Market is to reach USD 231.69 billion by 2034 - Driven by Patent Expirations, Rising Chronic Diseases, and Increasing Healthcare Access |DataM Intelligence

Leander, Texas and TOKYO, Japan- The U.S. generic drugs market size was approximately USD 146.04 billion in 2025. It is projected to grow to around USD 231.69 billion by 2034, reflecting a compound annual growth rate (CAGR) of about 5.24% during 2025 to 2034.

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Recent Industry Development in U.S market:

✅ U.S. is one of the largest single-country markets for generic drugs globally.

✅ A USP (U.S. Pharmacopeia) report shows that drug shortages in the U.S. remain high, and they are lasting much longer on average the average shortage now lasts over four years.

✅ The USP's "Medicine Supply Map" and other risk‐monitoring tools are being used to identify weak points in supply chains.

✅ The CREATES Act (in effect since 2020) continues to be relevant: its provisions allow generic manufacturers to sue for access to samples, which helps them bring generics to market.

Recent Industry Development in Japan market:

✅ In Japan itself, generics have historically had lower penetration compared to the U.S.: generics make up 34% by volume in Japan

✅ The Japanese government is strongly promoting generics to control healthcare costs. Various incentives, favorable regulation, and public-awareness campaigns are being used to increase generic adoption

✅ The Social Security Council (Medical Insurance Committee) has set a secondary goal to raise the value share of generics to 65% or more by FY 2029, while also aiming for a volume share of 80% in all prefectures.

✅ from Oct 2024, a "long-listed drug" treatment option was introduced: for some brand-name drugs that have generics, if a patient insists on the branded version, they will have to pay extra co-payment.

Key Investment

- U.S. pharma manufacturing "boon," with US$ 350 B+ being committed to drug manufacturing capacity expansion in the U.S. over coming years.

- Civica Rx is investing US$ 124.5 M to build a sterile injectable manufacturing facility in Petersburg, Virginia.

- In its FY 2024 supplementary budget, the Japanese government allocated 70 billion yen to support generic‐drug industry consolidation effectively co‐funding generics manufacturers to merge or rationalize small, inefficient production lines.

- Alongside the above, ¥65 billion was allocated in the same budget toward supporting domestic production of biosimilars.

Regional insights-

- North America leads with 39.48% market share, driven by the U.S.'s large pharmaceutical infrastructure, high healthcare spending, and favorable regulatory policies supporting generic drug adoption.

- Europe holds 28.58% of the market, with key countries like Germany (15.58%), France (13.58%), and the UK (12.67%) contributing significantly due to strong healthcare systems and generic drug policies.

- Asia-Pacific accounts for 19.12% market share, with China (29.32%), Japan (19.99%), and India (14.30%) as major contributors. This region is the fastest-growing, supported by increasing healthcare access, government support, and rising chronic disease prevalence.

- Latin America holds 7.02% market share, led by Brazil (30.40%) and Argentina (13.87%), driven by expanding healthcare infrastructure and generic drug acceptance.

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Benefits of AI-

1. Accelerated Drug Development
- AI can analyze chemical structures, predict bioequivalence, and simulate formulations faster than traditional R&D.

- Reduces time to bring a generic drug to market, cutting costs and increasing competitiveness.

2. Enhanced Manufacturing Efficiency
- AI-powered process optimization can improve yields, reduce waste, and monitor critical parameters in real-time.

- Predictive maintenance of production equipment lowers downtime and ensures consistent quality.

3. Supply Chain Optimization
- AI algorithms can forecast demand, detect supply chain bottlenecks, and optimize inventory management.

- Helps prevent shortages of high-demand generics and ensures timely delivery.

4. Quality Control & Regulatory Compliance
- Machine learning models can detect deviations in product quality or impurities during manufacturing.

- AI assists with compliance reporting and regulatory submissions, ensuring faster approvals.

5. Cost Reduction
- Automation of formulation, testing, and manufacturing processes reduces labor costs.

- Optimized supply chains and predictive analytics lower operational and inventory costs.

Segmentation Analysis :

By Product:

- Branded Generic Drugs: These are generic drugs sold under a brand name and usually marketed by pharmaceutical companies.

- Pure Generic Drugs: These are non-branded generic drugs, widely accepted for their cost-effectiveness and therapeutic equivalence to branded drugs.
Both product segments show growth, with pure generics being the fastest-growing due to increasing consumer trust and demand for affordable medicine.

By Route of Administration:

- Oral: The most common route, including tablets, capsules, and liquids.

- Topical: Creams, ointments, and gels applied to the skin.

- Parenteral: Injectable drugs used for rapid absorption or targeted delivery.

- Others: Includes inhalable and other specialized delivery methods.
Oral administration dominates due to ease of use and patient compliance.

By Distribution Channel:

- Retail Pharmacies: These remain the largest channel due to widespread accessibility and consumer preference.

- Hospital Pharmacies: Growing steadily, especially due to rising hospital admissions and chronic disease management.

Growth drivers:

Expiring patents on high-revenue branded drugs open significant opportunities for generics, fueling market expansion and competitive pricing.​

Rising prevalence of chronic diseases and aging populations drive sustained demand for cost-effective generic therapies worldwide.​

Government initiatives and regulatory support promoting generic drug adoption through substitution policies and tender systems reduce healthcare costs and accelerate market growth.​

Technological advancements including AI-driven drug formulation, process automation, and complex generics development boost production efficiency, quality, and portfolio diversification

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Key players:

Teva Pharmaceutical Industries Ltd., Sandoz (a Novartis Division), Viatris Inc., Sun Pharmaceutical Industries Ltd, Lupin Limited, Dr. Reddy's Laboratories Ltd, Cipla Ltd, Zydus Lifesciences Ltd, Fresenius Kabi AG, and Amneal Pharmaceuticals Inc.

Key highlights:

- eva Pharmaceutical Industries Ltd.: Largest global generic drug company with around 7% U.S. market share; strong pipeline in complex generics and biosimilars; diversified global presence including Europe and emerging markets.​

- Sandoz (Novartis Division): Focused on biosimilars with double-digit growth in biosimilar sales; achieved $2.48 billion net sales in Q1 2025; strong U.S. launches like Tyruko and Wyost biosimilars; aims for mid-single-digit sales growth.​

- Viatris Inc.: Offers broad portfolio including oral solids, injectables, and topicals; strong North American demand; faced FDA import alert challenges but maintains stable branded business; key generics include Restasis and Symbicort

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This release was published on openPR.