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市場調查報告書

學名藥的美國市場的未來展望 (2018年)

US Generic Drug Market Outlook 2018

出版商 RNCOS E-Services Pvt. Ltd. 商品編碼 324705
出版日期 內容資訊 英文 110 Pages
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學名藥的美國市場的未來展望 (2018年) US Generic Drug Market Outlook 2018
出版日期: 2015年02月01日 內容資訊: 英文 110 Pages
簡介

美國是全球最大的醫藥品市場,不過,其中約45%為學名藥。 由於各式各樣的因素 (有成本效率的醫藥品的需求擴大、醫療費用支出的增加、老年人口的增加、根據暢銷藥物的專利到期、政府的輔助等),近幾年這個比率急速上升。同時,來自藥物價格的上升,及FDA (食品藥物管理局) 的支援不足、產品認證期間長、法律上的矛盾等,今後可能妨礙產業成長。美國的學名藥的市場規模,2013年達到435億美元,再加上推算2013∼2018年約以11%的年複合成長率(CAGR) 擴大。由於今後也在各種領域發展學名藥的適用,一般認為也將保持擴大市場趨勢。

本報告提供美國的學名藥的市場相關分析、市場結構和最新趨勢、主要市場促進與阻礙因素、今後的產品開發的可能性及市場成長的方向性、競爭環境、主要企業簡介等調查。

第1章 分析師的見解

第2章 調查手法

第3章 推動市場要素

  • 醫療費用支出的增加
  • 可支配所得的擴大
  • 老年人口的增加
  • 暢銷藥物的專利到期
  • 企業合併、收購 (M&A)

第4章 市場課題

  • 學名藥的價格急劇上升
  • 產品認證流程長
  • 法律上的矛盾

第5章 非專利部門概要

  • 美國的醫藥品市場
  • 首發醫藥品/學名藥的市場佔有率
  • 學名藥市場

第6章 主要治療領域的學名藥的市場可能性

  • 腫瘤
  • 肥胖、膽固醇
  • 心理健康 (精神病治療藥、抗憂鬱劑)
  • 高血壓 (血管收縮素II受體)
  • 糖尿病
  • 抗潰瘍藥 (質子幫浦阻斷劑)
  • 甲狀腺
  • 呼吸

第7章 市場趨勢與發展

  • 新產品的上市
  • 生技仿製藥 (生技學名藥) 的上市
  • GDUFA (學名藥使用費法案) 相關發展
  • 「Pay-for-delay (給學名藥商延遲上市給付) 」政策重新評估

第8章 法規環境

  • DESI (藥物功效研究實施) 計劃
  • Hatch-Waxman法案
  • 侵犯專利權訴訟
  • Para IV和180天的壟斷的銷售
  • FDA的要求事項
  • GIVE (低價格、高功效的學名藥的措施)
  • 醫療改革法案 (Healthcare Bill,2013年)
  • 「Pay for delay」解決法的禁止
  • 歐巴馬健保案法案 (Patient Protection and Affordable Care Act)

第9章 競爭環境

  • 代表性企業的市場佔有率
  • 代表性學名藥的市場佔有率
  • 簡介
    • Teva Pharmaceuticals USA
    • Actavis Plc
    • Mylan Inc.
    • Pfizer Inc.
    • Sandoz Inc. (Novartis)
    • Endo International Plc.
    • Lupin Limited
    • Dr. Reddy's Laboratories Ltd.
    • Zydus Pharmaceuticals Inc.
    • Amneal Pharmaceuticals

圖表一覽

目錄

The US is the largest pharmaceutical market in the world. Driven by the factors such as large healthcare spending, high per-capita income, and strong research & development investments, the pharmaceutical market in the US has witnessed an upward surge over the past few years. Additionally, the share of Generics has increased steadily in the pharmaceutical market, in terms of both revenue and prescriptions.

The US generic drugs market accounts for a share of around 45% in the global Generics market. This share has been growing at a fast pace on the back of factors, such as demand for cost-effective medications, rising healthcare expenditure, increasing ageing population, patent expiration of blockbuster drugs, and enhanced government support. Besides, factors such as surging drug prices, lack of FDA support, long product approval process, and legal controversies related to drug approvals are holding back growth in the Generics industry.

According to RNCOS "US Generic Drug Market Outlook 2018", the US Generics market, which was US$ 43.5 Billion in 2013, is anticipated to grow at a CAGR of around 11% during 2013-2018. Currently, the market is witnessing significant developments in terms of new product categories that are attracting huge investments from both public and private players. The Generics market in the US will showcase a healthy growth potential in various therapy segments, such as oncology, respiratory, thyroid, ulcers as well as cholesterol disorders in the coming years. Growth in the aforementioned segments will be the result of patent expirations of a number of the major drugs in the next few years. The support from the US government in the form of approvals and incentives, will also act as a catalyst for future growth in the generic domain.

The report covers all the important aspects of the US Generics market and provides an in-depth analysis on the current status of the market, emerging trends, competitive landscape and future outlook, among other pointers. It also provides valuable information to pharmaceutical and generic drug companies and investors looking to enter this market. Facts and figures regarding market size, growth, share, regulatory environment and trends in technology development have been thoroughly analyzed in the report to provide clients a comprehensive overview of the market.

Table of Contents

1. Analyst View

2. Research Methodology

3. Market Drivers

  • 3.1 Inclining Healthcare Expenditure
  • 3.2 Rising Disposable Incomes
  • 3.3 Increasing Ageing Population
  • 3.4 Patent Expiry of Blockbuster Drugs
  • 3.5 Mergers & Acquisitions

4. Market Challenges

  • 4.1 Surging Generic Drug Prices
  • 4.2 Long Product Approval Process
  • 4.3 Legal Controversies

5. Overview of Generics Sector

  • 5.1 US Pharmaceutical Market
  • 5.2 Share of Branded vs. Generics
  • 5.3 Generics Drugs Market

6. Market Potential for Generic Drugs in Key Therapies Segments

  • 6.1 Oncology
  • 6.2 Obesity & Cholesterol
  • 6.3 Mental Health (Antipsychotics & Anti-Depressants)
  • 6.4 Hypertension (Angiotensin II Receptor)
  • 6.5 Diabetes
  • 6.6 Anti-Ulcerants (Proton Pump Inhibitors)
  • 6.7 Thyroid
  • 6.8 Respiratory

7. Market Trends & Developments

  • 7.1 New Product Launch
  • 7.2 Launch of Biosimilars (BioGenerics)
  • 7.3 Progress in User Fees for Generic Manufacturers (GDUFA)
  • 7.4 Revision of Pay-for-delay Agreement Policies

8. Regulatory Environment

  • 8.1 Drug Efficacy Study Implementation (DESI) Program
  • 8.2 Hatch-Waxman Act
  • 8.3 Patent Infringement Litigations
  • 8.4 Para IV & the 180-day Marketing Exclusivity
  • 8.5 FDA Requirements
  • 8.6 Generic Initiative for Value & Efficiency (GIVE)
  • 8.7 Healthcare Bill 2013
  • 8.8 Ban on "Pay for delay" Settlements
  • 8.9 Patient Protection and Affordable Care Act

9. Competitive Landscape

  • 9.1 Market Share of Leading Players
  • 9.2 Market Share of Leading Generic Drugs
  • 9.3 Profiles
    • 9.3.1 Teva Pharmaceuticals USA
    • 9.3.2 Actavis Plc
    • 9.3.3 Mylan Inc.
    • 9.3.4 Pfizer Inc.
    • 9.3.5 Sandoz Inc. (Novartis)
    • 9.3.6 Endo International Plc.
    • 9.3.7 Lupin Limited
    • 9.3.8 Dr. Reddy's Laboratories Ltd.
    • 9.3.9 Zydus Pharmaceuticals Inc.
    • 9.3.10 Amneal Pharmaceuticals

List of Figures:

  • Figure 3-1: Personal Disposable Income (Billion US$), 2008-2013
  • Figure 3-2: Total Health Expenditure (Billion US$), 2008-2013
  • Figure 3-3: Share of Public & Private Health Expenditure (2008-2013)
  • Figure 3-4: Population above 65 Years (Million), 2008-2013
  • Figure 5-1: US Pharmaceutical Market (Billion US$), 2013-2018
  • Figure 5-2: US Pharmaceutical Supply Chain
  • Figure 5-3: Share of Branded and Generics Drugs by Revenue (2013)
  • Figure 5-4: Market Share by Total Prescriptions (2011-2013)
  • Figure 5-5: Generic Drugs Market (Billion US$), 2013-2018
  • Figure 6-1: Estimated Cancer Deaths (2012 & 2013)
  • Figure 6-2: Adult Obesity Rate (%), 2013 & 2030
  • Figure 6-3: Diabetic Patients in Age Group 20-79 Years ('000), 2013 & 2030
  • Figure 8-1: Generic Drugs Approval Process
  • Figure 9-1: Share of Key Players in Generics Market (2013)
  • Figure 9-2: Teva Pharmaceuticals - Generics Revenue Share by Geographic Regions (2014)
  • Figure 9-3: Actavis Plc - Revenue Share by Geographic Regions (2013)
  • Figure 9-4: Mylan Inc - Revenue Share by Geographic Regions (2013)
  • Figure 9-5: Mylan Inc - Generics Revenue Share by Geographic Region (2014)
  • Figure 9-6: Pfizer - Revenue Share by Business Segments (2013)
  • Figure 9-7: Pfizer - Revenue Share by Geographical Regions (2013)
  • Figure 9-8: Sandoz - Revenue Share by Business Segments (2014)
  • Figure 9-9: Novartis - Revenue Share by Geographic Regions (2014)
  • Figure 9-10: Endo International Plc - Revenue Share by Business Segments (2013)
  • Figure 9-11: Lupin Ltd - Revenue Share by Business Segments (2013)
  • Figure 9-12: Lupin Ltd - Generics Share in the US by Value (2012 & 2013)
  • Figure 9-13: Lupin Ltd - Revenue Share by Geographic Regions (2013)
  • Figure 9-14: Dr. Reddy's Laboratory - Revenue Share by Business Segments (2013)
  • Figure 9-15: Dr. Reddy's Laboratory - Revenue Share by Geographical Regions (2013)
  • Figure 9-16: Amneal Pharmaceuticals - Revenue (Million US$), 2007 & 2014

List of Tables:

  • Table 3-1: Total Health Expenditure (% of GDP), 2008-2013
  • Table 3-2: Blockbuster Drugs Going Off Patent (2014-2016)
  • Table 3-3: Premium Deals in the US Generics Industry (2013- 2015)
  • Table 6-1: Patent Expiration of Key Oncology Drugs
  • Table 6-2: Patent Expiration of Key Antipsychotic Drugs
  • Table 6-3: Patent Expiration of Key Antidepressant Drugs
  • Table 6-4: Prevalence of High Blood Pressure by Age & Gender (2013)
  • Table 6-5: Patent Expiration of Key Human Insulin Drugs
  • Table 6-6: Top 10 Proton Pump Inhibitors by Sales (Million US$), 2013
  • Table 6-7: Patent Expiration of Key Proton Pump Inhibitors
  • Table 6-8: Patent Expiry of Key Thyroid Drugs
  • Table 6-9: Patent Expiry of Key Respiratory Drugs
  • Table 7-1: Generic Drugs Launched in the US Market (2013 & 2014)
  • Table 7-2: List of Biosimilars under Development in the US
  • Table 9-1: Top Generic Drugs by Sales (Million US$), 2013
  • Table 9-2: Top Generic Drugs by Prescription (2013)
  • Table 9-3: Teva Pharmaceuticals - Revenue by Business Segments (Million US$), 2013 & 2014
  • Table 9-4: Teva Pharmaceuticals - Generics Revenue by Geographic Regions (Million US$), 2013 & 2014
  • Table 9-5: Actavis Plc - Revenue by Business Segments (Million US$), 2012 & 2013
  • Table 9-6: Mylan Inc - Revenue by Business Segments (Million US$), 2013 & 2014
  • Table 9-7: Pfizer - Revenue by Business Segments (Million US$), 2011-2013
  • Table 9-8: Endo International Inc - Revenue by Companies (Million US$), 2011-2013
  • Table 9-9: Lupin Ltd - Revenue by Business Segments (Million US$), 2011-2013
  • Table 9-10: Dr. Reddy's Laboratory - Revenue by Business Segments (Million US$), 2011-2013
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