学名药的美国市场的评估:各用途，各类型，不同品牌，各给药途径，各流通管道，各地区，机会，预测(2017年～2031年)

美国仿製药市场规模预计将从 2023 年的 1,173.2 亿美元增至 2031 年的 1,967.9 亿美元，预计 2024-2031 年的复合年增长率为 6.68%。市场成长是由市场参与者不断推出生物相似药和仿製药、慢性病患病率上升以及主要市场参与者之间的策略联盟和伙伴关係所推动的。各公司加大对仿製药生产设施的投资也推动了美国仿製药市场的扩张。 2024 年 3 月，马克库班成本加成药品公司 (PBC) 宣布将开始生产仿製药，从无菌注射药物开始。 3 月，该公司开始生产商用批量的去甲肾上腺素和肾上腺素，供重症监护病房 (ICU) 住院患者使用。 Cost Plus Drug Company 耗资 1,100 万美元，在达拉斯建造了一座占地 22,000 平方英尺的填充和加工工厂，以解决药品短缺问题。

此外，该国慢性病威胁的上升也增加了市场需求。这是因为大多数疾病都需要患者长期频繁服药才能有效控制病情。这推动了对仿製药的需求，因为它们以具有成本效益的方式为患者提供有效的解决方案。

主要市场公司推出新市场支持市场扩张

为了应对各种疾病日益严重的威胁并确保患者的便利，各大市场公司都在加强各种仿製药在美国的引进，正在推高市场规模。 2024年4月，Zydus集团获得美国食品药物管理局（USFDA）核准推出米拉博隆25mg。这种仿製药用于治疗膀胱过动症。该公司是最早推出仿製药的公司之一，也准备推出 50 毫克片剂。美国仿製药上市量的增加也可归因于专利到期时间的增加以及患者越来越偏好仿製药以降低治疗成本。

慢性病盛行率上升推动市场需求

该国各种慢性病的盛行率不断上升，为市场创造了利润丰厚的成长机会。美国国家癌症研究所估计，到2024年，美国将有约611,720人死于该疾病，并且将有2,001,140人新诊断出患有癌症。同样，患有糖尿病的人数也在增加。美国糖尿病协会估计，美国有超过 3,800 万名成人和儿童患有糖尿病。此类疾病的日益普及正在推动美国仿製药市场的需求，因为仿製药可以帮助患者有效管理慢性病并确保经济效益。仿製药与原厂药具有相同的作用机制，含有相同的活性成分，能够为患者提供更高品质的治疗。

零售药局占主要市占率

我们将美国零售药局的偏好归因于该细分市场的技术驱动型转型，提供个人化解决方案以提高患者便利性并改善客户体验。根据 2022 年 3 月发布的《2022 年美国药房和药房福利管理者经济报告》估计，美国零售连锁店每年配药约 1??38,000 张处方。

另一方面，线上药局领域预计在预测期内将大幅成长。这种成长可归因于网路药局的经济效益和便利性。患有慢性病和残疾的患者尤其喜欢这些药房，因为它们无需亲自购买药品，减轻了患者的负担，同时提供一日达和隔夜送达等福利。此外，各市场公司也专注于透过网路药局销售呼吸系统药物。例如，2023 年 9 月，Lupin Ltd. 宣布将透过名为 Cost Plus Drugs 的线上药局销售呼吸系统仿製药。

本报告研究和分析了美国仿製药市场，提供市场规模和预测、市场动态以及主要参与者的现状和前景。

目录

第1章 计划的范围和定义

第2章 调查手法

第3章 摘要整理

第4章 美国的学名药市场预测(2017年～2031年)

• 市场规模的分析与预测
  • 金额
  • 数量
• 市场占有率分析与预测
  • 各用途
  • 各类型
  • 不同品牌
  • 各给药途径
  • 各流通管道
  • 各地区
  • 市场占有率分析:各企业(金额)(前五名公司和其他 - 2023年)
• 市场地图分析(2023年)
  • 各用途
  • 各类型
  • 不同品牌
  • 各给药途径
  • 各流通管道
  • 各地区

第5章 供需分析

第6章 进口和出口的分析

第7章 价值链分析

第8章 波特的五力分析

第9章 大环境分析

第10章 价格分析

第11章 市场动态

• 推动市场要素
• 市场课题

第12章 市场趋势与发展

第13章 法规结构和革新

• 生物有效性/生物学的同等性实验
• 法规当局的认证

第14章 专利的有效期限

第15章 案例研究

第16章 竞争情形

• 市场领导者前五名公司的竞争矩阵
• 前五名公司的SWOT分析
• 主要企业前十大企业的形势
  • Hikma Pharmaceuticals plc
  • Sandoz Group AG
  • Viatris Inc.
  • Aurobindo Pharma US Ltd.
  • Lupin Ltd.
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceuticals Industries Ltd.
  • Dr. Reddy's Laboratories
  • Glenmark Pharmaceuticals Inc.
  • Zydus Group

第17章 策略性推荐

第18章 本公司相关资料，免责声明

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

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. United States Generic Drugs Market, By Value, In USD Billion, 2017-2031F
• Figure 2. United States Generic Drugs Market, By Volume, In Number of Prescriptions, 2017-2031F
• Figure 3. United States Generic Drugs Market Share (%), By Application, 2017-2031F
• Figure 4. United States Generic Drugs Market Share (%), By Type, 2017-2031F
• Figure 5. United States Generic Drugs Market Share (%), By Brand, 2017-2031F
• Figure 6. United States Generic Drugs Market Share (%), By Route of Administration, 2017-2031F
• Figure 7. United States Generic Drugs Market Share (%), By Distribution Channel, 2017-2031F
• Figure 8. United States Generic Drugs Market Share (%), By Region, 2017-2031F
• Figure 9. By Application Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 10. By Type Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 11. By Brand Size Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 12. By Route of Administration Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 13. By Distribution Channel Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 14. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2023