제네릭 의약품 미국 시장 평가 : 용도별, 유형별, 브랜드별, 투여 경로별, 유통 채널별, 지역별, 기회, 예측(2017-2031년)

United States generic drugs market is projected to witness a CAGR of 6.68% during the forecast period 2024-2031, growing from USD 117.32 billion in 2023 to USD 196.79 billion in 2031. The market's growth is boosted by the increasing launch of biosimilars and generics by the market players, the rising prevalence of chronic diseases, and strategic collaborations and partnerships among the key market players. The increasing investments by various companies towards generic drug manufacturing facilities are also supporting the expansion of the United States generic drugs market. In March 2024, Mark Cuban Cost Plus Drug Company, PBC announced that they would start manufacturing generic drugs, beginning with sterile injectables. The company began manufacturing commercial batches of norepinephrine and epinephrine for patients admitted to the intensive care unit (ICU) in March. Cost Plus Drug Company constructed the USD 11 million, 22,000-square-foot fill and finish facility in Dallas to address the drug shortage.

Furthermore, the growing threat of chronic diseases in the country is also augmenting the market's demand, as in most conditions, patients require frequent dosages over a long period of time to manage the condition effectively. This, in turn, is propelling the requirement for generic drugs as they provide effective solutions to patients in a cost-efficient manner.

New Launches by Key Market Players Support Market Expansion

The growing efforts of key market players to bolster the introduction of different generics in the country to combat the growing threat of different diseases and ensure patient accessibility are boosting the United States generic drugs market size. In April 2024, Zydus Group launched Mirabegron with the strength of 25 mg after receiving approval from the United States Food and Drug Administration (USFDA). The generic drug is used for treating overactive bladder. The company is one of the first to launch generic medication and is preparing to launch tablets for the same with 50 mg strength. The rising launch of generics in the United States can also be attributed to the growing number of patent expiration and increasing preference for generics among patients to reduce treatment expenses.

Growing Prevalence of Chronic Diseases Boosts Market Demand

The increasing prevalence of various chronic diseases in the country is providing lucrative growth opportunities to the market. As per the estimates of the National Cancer Institute, in 2024, approximately 611,720 individuals will die from the disease, and 2,001,140 new cancer cases will be diagnosed in the United States. Similarly, the cases of diabetes are also increasing in the country. The American Diabetes Association estimates that over 38 million adults and children in the United States are living with diabetes. The increasing prevalence of such diseases is propelling the United States generic drugs market demand as generic drugs aid patients in effectively managing chronic diseases while ensuring economic efficiency. Generic drugs have the same mechanism of action and contain the same active ingredient as brand-name drugs, thus providing quality treatments to patients.

Retail Pharmacies Account for Significant Market Share

The preference for retail pharmacies in the United States can be attributed to the technology-driven transformation of the segment that is increasing patients' convenience and providing them with personalized solutions to improve the customer experience. As per the 2022 economic report estimates on U.S. pharmacies and pharmacy benefit managers, published in March 2022, approximately 138,000 prescriptions are dispensed annually by retail chains in the United States.

Meanwhile, the online pharmacy segment is expected to grow significantly over the forecast period. This growth can be attributed to the economically efficient and convenient nature of online pharmacies. Patients with chronic diseases and disorders especially prefer these pharmacies as they eliminate the requirement of physically purchasing drugs, reducing the strain on the patients while offering advantages such as one-day delivery and overnight shipping. Additionally, various market players are also focusing on selling their respiratory drugs across online pharmacies. For instance, in September 2023, Lupin Ltd. announced that they would be selling their generic respiratory drugs across the online pharmacy called Cost Plus Drugs.

Biosimilars Hold Major Market Share

The rising approvals by the USFDA for the launch of different biosimilars in the United States support the growth of the segment. In February 2024, the FDA provided approval to Alvotech for AVT02; Simlandi, their adalimumab biosimilar, making it the tenth US approval for the biosimilar referencing Humira (adalimumab) and the first for the company. The medication also received approval as an interchangeable biosimilar. The marketing and commercialization of the drug will be done as part of an exclusive partnership by Teva Pharmaceuticals Industries Ltd., supporting the introduction of additional treatment options for patients and ensuring cost efficiency across the country's healthcare system. Such approvals are expected to bolster the availability of different biosimilars across the country and boost the United States generic drugs market growth. They also mark partnership milestones for Teva, one of the key players in the market, and Alvotech to ensure the uptake and availability of biosimilars across the United States by collaborating on seven biosimilars.

Future Market Scenario (2024-2031F)

As per the United States generic drugs market analysis, the market is estimated to witness significant growth over the forecast period. The rising prevalence of chronic diseases such as diabetes and cancer in the country supports this growth. The market is also expected to witness the introduction of complex biosimilars and generics. A wide range of patents are expiring in the coming years, providing opportunities for the creation of their generics. Meanwhile, the increasing costs of healthcare are bolstering the demand for generics. With increasing the affordability of healthcare being one of the primary focus areas of the government, the market is expected to witness lucrative growth opportunities in the coming years.

Key Players Landscape and Outlook

The rising efforts by key market players in the market to boost the introduction of different generics in the United States are expected to provide lucrative growth opportunities to the market. In August 2024, Glenmark Pharmaceuticals, Inc. introduced a generic eye treatment medication, Olopatadine Hydrochloride Ophthalmic Solution, in the United States. Such introductions showcase the commitment of the key players of the market to provide high-quality solutions to the patients and meet the diverse requirements of the market. Even though the Office of Generic Drugs published 98 drug-specific guidelines last year, the growth potential for generics in the United States is significant, and market penetration can lead to significant profits.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. United States Generic Drugs Market Outlook, 2017-2031F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Application
    • 4.2.1.1. Neurovascular
    • 4.2.1.2. Cardiovascular
    • 4.2.1.3. Dermatology
    • 4.2.1.4. Oncology
    • 4.2.1.5. Diabetology
    • 4.2.1.6. Respiratory
    • 4.2.1.7. Others
  • 4.2.2. By Type
    • 4.2.2.1. Biosimilar Generics
    • 4.2.2.2. Small Molecule Generics
  • 4.2.3. By Brand
    • 4.2.3.1. Branded Generic
    • 4.2.3.2. Pure Generic
  • 4.2.4. By Route of Administration
    • 4.2.4.1. Oral
    • 4.2.4.2. Injectable
    • 4.2.4.3. Topical
    • 4.2.4.4. Others
  • 4.2.5. By Distribution Channel
    • 4.2.5.1. Hospital Pharmacy
    • 4.2.5.2. Retail Pharmacy
    • 4.2.5.3. Online Pharmacy
  • 4.2.6. By Region
    • 4.2.6.1. Northeast
    • 4.2.6.2. Midwest
    • 4.2.6.3. West
    • 4.2.6.4. South
  • 4.2.7. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
• 4.3. Market Map Analysis, 2023
  • 4.3.1. By Application
  • 4.3.2. By Type
  • 4.3.3. By Brand
  • 4.3.4. By Route of Administration
  • 4.3.5. By Distribution Channel
  • 4.3.6. By Region

5. Demand Supply Analysis

6. Import and Export Analysis

7. Value Chain Analysis

8. Porter's Five Forces Analysis

9. PESTLE Analysis

10. Pricing Analysis

11. Market Dynamics

• 11.1. Market Drivers
• 11.2. Market Challenges

12. Market Trends and Developments

13. Regulatory Framework and Innovation

• 13.1. Bioavailability/Bioequivalence Studies
• 13.2. Regulatory Approvals

14. Patent Expiration

15. Case Studies

16. Competitive Landscape

• 16.1. Competition Matrix of Top 5 Market Leaders
• 16.2. SWOT Analysis for Top 5 Players
• 16.3. Key Players Landscape for Top 10 Market Players
  • 16.3.1. Hikma Pharmaceuticals plc
    • 16.3.1.1. Company Details
    • 16.3.1.2. Key Management Personnel
    • 16.3.1.3. Products and Services
    • 16.3.1.4. Financials (As Reported)
    • 16.3.1.5. Key Market Focus and Geographical Presence
    • 16.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 16.3.2. Sandoz Group AG
  • 16.3.3. Viatris Inc.
  • 16.3.4. Aurobindo Pharma US Ltd.
  • 16.3.5. Lupin Ltd.
  • 16.3.6. Sun Pharmaceutical Industries Ltd.
  • 16.3.7. Teva Pharmaceuticals Industries Ltd.
  • 16.3.8. Dr. Reddy's Laboratories
  • 16.3.9. Glenmark Pharmaceuticals Inc.
  • 16.3.10. Zydus Group

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

17. Strategic Recommendations

18. About Us and Disclaimer