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市場調查報告書
商品編碼
1549442

學名藥的美國市場的評估:各用途，各類型，不同品牌，各給藥途徑，各流通管道，各地區，機會，預測(2017年～2031年)

United States Generic Drugs Market Assessment, By Application, By Type, By Brand, By Route of Administration, By Distribution Channel, By Region, Opportunities and Forecast, 2017-2031F
出版日期: | 出版商: Market Xcel - Markets and Data | 英文 128 Pages | 商品交期: 3-5個工作天內

價格

美國仿製藥市場規模預計將從 2023 年的 1,173.2 億美元增至 2031 年的 1,967.9 億美元，預計 2024-2031 年的複合年增長率為 6.68%。市場成長是由市場參與者不斷推出生物相似藥和仿製藥、慢性病患病率上升以及主要市場參與者之間的策略聯盟和夥伴關係所推動的。各公司加大對仿製藥生產設施的投資也推動了美國仿製藥市場的擴張。 2024 年 3 月，馬克庫班成本加成藥品公司 (PBC) 宣布將開始生產仿製藥，從無菌注射藥物開始。 3 月，該公司開始生產商用批量的去甲腎上腺素和腎上腺素，供重症監護病房 (ICU) 住院患者使用。 Cost Plus Drug Company 耗資 1,100 萬美元，在達拉斯建造了一座佔地 22,000 平方英尺的填充和加工工廠，以解決藥品短缺問題。

此外，該國慢性病威脅的上升也增加了市場需求。這是因為大多數疾病都需要患者長期頻繁服藥才能有效控制病情。這推動了對仿製藥的需求，因為它們以具有成本效益的方式為患者提供有效的解決方案。

主要市場公司推出新市場支持市場擴張

為了應對各種疾病日益嚴重的威脅並確保患者的便利，各大市場公司都在加強各種仿製藥在美國的引進，正在推高市場規模。 2024年4月，Zydus集團獲得美國食品藥物管理局（USFDA）核准推出米拉博隆25mg。這種仿製藥用於治療膀胱過動症。該公司是最早推出仿製藥的公司之一，也準備推出 50 毫克片劑。美國仿製藥上市量的增加也可歸因於專利到期時間的增加以及患者越來越偏好仿製藥以降低治療成本。

慢性病盛行率上升推動市場需求

該國各種慢性病的盛行率不斷上升，為市場創造了利潤豐厚的成長機會。美國國家癌症研究所估計，到2024年，美國將有約611,720人死於該疾病，並且將有2,001,140人新診斷出患有癌症。同樣，患有糖尿病的人數也在增加。美國糖尿病協會估計，美國有超過 3,800 萬名成人和兒童患有糖尿病。此類疾病的日益普及正在推動美國仿製藥市場的需求，因為仿製藥可以幫助患者有效管理慢性病並確保經濟效益。仿製藥與原廠藥具有相同的作用機制，含有相同的活性成分，能夠為患者提供更高品質的治療。

零售藥局佔主要市佔率

我們將美國零售藥局的偏好歸因於該細分市場的技術驅動型轉型，提供個人化解決方案以提高患者便利性並改善客戶體驗。根據 2022 年 3 月發布的《2022 年美國藥房和藥房福利管理者經濟報告》估計，美國零售連鎖店每年配藥約 1??38,000 張處方。

另一方面，線上藥局領域預計在預測期內將大幅成長。這種成長可歸因於網路藥局的經濟效益和便利性。患有慢性病和殘疾的患者尤其喜歡這些藥房，因為它們無需親自購買藥品，減輕了患者的負擔，同時提供一日達和隔夜送達等福利。此外，各市場公司也專注於透過網路藥局銷售呼吸系統藥物。例如，2023 年 9 月，Lupin Ltd. 宣布將透過名為 Cost Plus Drugs 的線上藥局銷售呼吸系統仿製藥。

本報告研究和分析了美國仿製藥市場，提供市場規模和預測、市場動態以及主要參與者的現狀和前景。

目錄

第1章 計劃的範圍和定義

第2章 調查手法

第3章 摘要整理

第4章 美國的學名藥市場預測(2017年～2031年)

  • 市場規模的分析與預測
    • 金額
    • 數量
  • 市場佔有率分析與預測
    • 各用途
    • 各類型
    • 不同品牌
    • 各給藥途徑
    • 各流通管道
    • 各地區
    • 市場佔有率分析:各企業(金額)(前五名公司和其他 - 2023年)
  • 市場地圖分析(2023年)
    • 各用途
    • 各類型
    • 不同品牌
    • 各給藥途徑
    • 各流通管道
    • 各地區

第5章 供需分析

第6章 進口和出口的分析

第7章 價值鏈分析

第8章 波特的五力分析

第9章 大環境分析

第10章 價格分析

第11章 市場動態

  • 推動市場要素
  • 市場課題

第12章 市場趨勢與發展

第13章 法規結構和革新

  • 生物有效性/生物學的同等性實驗
  • 法規當局的認證

第14章 專利的有效期限

第15章 案例研究

第16章 競爭情形

  • 市場領導者前五名公司的競爭矩陣
  • 前五名公司的SWOT分析
  • 主要企業前十大企業的形勢
    • 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 策略性推薦

第18章 本公司相關資料，免責聲明

Product Code: MX11873

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