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美國的學名藥市場機會的展望 2020年

US Generic Drug Market Opportunity Outlook 2020

出版商 KuicK Research 商品編碼 353062
出版日期 內容資訊 英文 100 Pages
商品交期: 最快1-2個工作天內
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美國的學名藥市場機會的展望 2020年 US Generic Drug Market Opportunity Outlook 2020
出版日期: 2016年02月25日 內容資訊: 英文 100 Pages

本報告提供美國的學名藥市場相關調查分析,提供您市場概要,Hatch-Waxman 法案與其影響,FDA的學名藥相關評估,美國學名藥法的支援功能,學名藥的進口對美國經濟的影響,美國的學名藥市場未來展望,及主要企業簡介等系統性資訊。

第1章 美國的學名藥市場:簡介

第2章 Hatch-Waxman 法案 (Hatch-Waxman Act) 與其影響

  • Hatch-Waxman 法案的前提
  • Hatch-Waxman 法案的優點
  • Hatch-Waxman 法案的差異檢測

第3章 FDA的學名藥相關評估

第4章 美國的學名藥市場概要

第5章 美國的學名藥法支援功能

  • 學名藥開發者所檢討的功能
  • 引導學名藥投入市場的要素

第6章 與患者保護法並列之醫療費負擔合理化法 (PPACA)

  • PPACA的目的
  • PPACA及學名藥的節約
  • 藥物供給管理 (PBM)
  • 對醫療保險領取者的影響

第7章 美國的學名藥市場上進步

  • 改善處理能力的電子申請
  • GDUFA法
  • Fair Access for Safe and Timely (FAST) Generics Act

第8章 美國的首發醫藥品·學名藥 製造商商務策略

  • 研究開發的外包
  • 首發醫藥品企業的M&A
  • 學名藥市場上首發醫藥品的行銷
  • 學名藥製造的壟斷
  • 新興各國的製造外包

第9章 藉由學名藥,達成更高成本裁定的方法

  • 健康保險計劃
  • 自動學名藥替代調劑
  • 透過零售連鎖的降低成本計劃
  • 節約學名藥處方費的創新手段

第10章 美國的首發醫藥品·學名藥的市場情況

第11章 學名藥的進口對美國經濟的影響

  • 為何美國需要學名藥的進口?
  • 便於新興各國學名藥製造擴大的要素
  • 學名藥的最大出口國──美國
  • 美國的學名藥進口的潛在威脅

第12章 線上藥局在美國學名藥市場擴大上所扮演的角色

第13章 美國的學名藥市場動態

  • 醫療費的增加
  • 疾病發病率的增加
  • 美國的人口高齡化
  • Hatch-Waxman 法案的實施
  • 暢銷醫藥品的專利到期
  • 學名藥的易於製造
  • 學名藥的外包
  • 容易受到法規的影響
  • PPACA的實施

第14章 美國的學名藥市場上商業化的課題

  • 專利侵害審判
  • 新學名藥的不足
  • 學名藥價格的上升
  • 法規對學名藥的難點

第15章 美國的疾病分析

  • 癌症發病率的增加
  • 心血管疾病
  • 中樞神經系統 (CNS) 疾病

第16章 美國的學名藥市場未來展望

第17章 競爭情形

  • Accord Healthcare
  • Alvogen Inc.
  • Amneal Pharmaceuticals
  • ANI Pharmaceuticals Inc.
  • Apotex Inc. (Apotex Corporation)
  • Aurobindo India (Aurobindo Pharma USA Inc.)
  • Baxter Healthcare Corporation
  • Dr. Reddy's Laboratories
  • Fresenius Kabi (Fresenius Kabi USA LLC)
  • G & W Laboratories
  • Glenmark Generics
  • lmpax Laboratories
  • Lupin Pharmaceuticals
  • Mallinckrodt Pharmaceuticals
  • Momenta Pharmaceuticals
  • Mylan
  • Par Pharmaceutical
  • Perrigo Company
  • Sagent Pharmaceuticals
  • Sandoz
  • Sun Pharmaceutical Industries
  • Teva Pharmaceuticals
  • Therapeutic Proteins International
  • West- Ward Pharmaceuticals
  • Wockhardt
  • Zydus Pharmaceuticals



Advent of generic medicine in US market is few decades old and its roots could be traced back to the Drug Price Competition and Patent Term Restoration Act of 1984. It is also known as Hatch-Waxman Act which paved the path for generic drugs in US. No proper guidelines were available in US before introduction of this law. Generic drug makers have to go through ordeal before this law was applied. Its implications are wide and numerous that has helped in shaping present US generics drug market. It has helped in both government's spending on healthcare system and relieving burden on patient's financial expenditure. It has also helped in development of global generic pharmaceuticals industry. Several developing nations have been able to take part of these regulations in past years due to which US generic drugs market has increased several folds.

US regulators are continuously improving the existing infrastructure for approval of generic drugs. Development of regulations is quite important for achieving higher cost savings without compromising with patients' health. Orange book has been made which consists of list of RLD and generic drugs. Physicians can use it as reference to prescribe less costly alternative containing same API. Role of health insurance companies is also being investigated in prescription of generic drugs because they will go for cheaper alternative with same pharmacological efficacy. Orange book is expected to help in this scenario by being used as a comparator. Generic drug developers are expected to take advantage of this scenario by promoting their products as patient friendly solutions. FDA is continuously involved in the updating of orange book so that physicians may recommend newly available generic drugs to the patients.

Generic drugs are being actively accepted by various stake holders of US pharmaceutical industry due to higher cost arbitrage without compromising in quality. They do not have to go through legal issues due to which number of generic firms is increasing. Manufacturing process is already standardized due to which lesser input in terms of technological development is required. Physicians also have familiarity with these drugs making them easy to try generic versions of branded drugs. It helps both patients and government in long-term to achieve higher cost arbitrage. Several regulations have been made in past years which makes it easy for generic firms to enter in competition. With time, improvement has been made in existing infrastructure making it possible to achieve higher growth in US market.

Generic drugs have emerged as an important part of US pharmaceutical industry due to which it has become imperative to develop this industry. However, some critics have raised concerns over increasing commercialization of generic medicines. Developers of new drugs are investing a lot in research and development segment and presence of generic will compete with their product in same category leading to loss of market shares. This scenario will lead to aversion among pharmaceutical developers leading to lesser innovation and introduction of costly drugs. Balance between rights of developers and profits has to achieve by regulators in coming years. FDA is patient centric organization and it would not expose patients to undue risk for cost saving purposes. Their regulations have been changed with time in order to make them more amenable for both patients and drug developers.

"US Generic Drug Market Opportunity Outlook 2020" Report Highlight:

  • Introduction to US Generic Drugs Market
  • Hatch-Waxman Act & Its Implication
  • FDA Review on Generic Drugs
  • Supportive Features of US Generic Drug Laws
  • Effect of Generic Drug Import on US Economy
  • Methods to Achieve Higher Cost Arbitrage by Generic Drugs
  • Role of Online Pharmacies in Expansion of US Generic Drugs Market
  • US Generic Drugs Market Future Prospects

Table of Contents

1. Introduction to US Generic Drugs Market

2. Hatch-Waxman Act & Its Implication

  • 2.1 Premises of Hatch-Waxman Act
  • 2.2 Benefits of Hatch-Waxman Act
  • 2.3 Differential Measures in Hatch-Waxman Act

3. FDA Review on Generic Drugs

4. US Generic Drugs Market Overview

5. Supportive Features of US Generic Drug Laws

  • 5.1 Features Considered by Generic Drug Developers
  • 5.2 Factors Leading to Market Introduction of Generic Drugs

6. Patient Protection & Affordable Care Act (PPACA)

  • 6.1 Objectives of Patient Protection & Affordable Care Act (PPACA)
  • 6.2 Affordable Care Act & Savings on Generic Drug
  • 6.3 Pharmacy Benefit Manager (PBM)
    • 6.3.1 Pharmacy Networks
    • 6.3.2 Mail Service Pharmacies
    • 6.3.3 Health Information Technology (HIT)
  • 6.4 Impact on Medicare Beneficiaries

7. Advancements in US Generic Drugs Market

  • 7.1 Electronic Submission for Improved Processivity
  • 7.2 Generic Drug User Fee Amendments (GDUFA) Fees
  • 7.3 Fair Access for Safe & Timely Generics Act

8. Business Strategies of Branded & Generic Drug Manufacturers in US

  • 8.1 Outsourcing of Research & Development
  • 8.2 Merger & Acquisition by Branded Drug Companies
  • 8.3 Marketing of Branded Drug in Generic Market
  • 8.4 Monopoly in Generic Drug Manufacturing
  • 8.5 Outsourcing Manufacturing to Emerging Countries

9. Methods to Achieve Higher Cost Arbitrage by Generic Drugs

  • 9.1 Health Insurance Plans
  • 9.2 Automatic Generic Substitution
    • 9.2.1 Measures Taken for Generic Substitution
    • 9.2.2 Counter Arguments against Generic Substitution
  • 9.3 Cost Saving Plans by Retail Chains
  • 9.4 Innovative Methods to Save Money on Generic Drug Prescription

10. Market Scenario of Branded & Generic Drugs in US

11. Effect of Generic Drug Import on US Economy

  • 11.1 Why US Needs Generic Drug Import?
  • 11.2 Factors Favoring Increase of Generic Drug Manufacturers in Emerging Countries
    • 11.2.1 Regulatory Framework
    • 11.2.2 Patent Loss
    • 11.2.3 Increasing Number of Generic Drug Manufacturers
    • 11.2.4 Implementation of International Standards
    • 11.2.5 Lower Production Costs
  • 11.3 US as Largest Importer of Generic Drugs
  • 11.4 Potential Threat to US Generic Imports

12. Role of Online Pharmacies in Expansion of US Generic Drugs Market

13. US Generic Drugs Market Dynamics

  • 13.1 Increasing Health Expenditure
  • 13.2 Increasing Disease Incidences
  • 13.3 Ageing US Population
  • 13.4 Implementation of Hatch-Waxman Act
  • 13.5 Patent Expiry of Blockbuster Drugs
  • 13.6 Easy Manufacturing of Generic Drugs
  • 13.7 Outsourcing Generic Drugs
  • 13.8 Amenable Regulations
  • 13.9 Implementation of Affordable Care Act

14. US Generic Drugs Market Commercialization Challenges

  • 14.1 Patent Infringement Lawsuits
  • 14.2 Lack of New Generic Drugs
  • 14.3 Increasing Prices of Generic Drugs
  • 14.4 Difficult Regulation of Generic Drugs

15. US Disease Profiling

  • 15.1 Increasing Cancer Incidences
  • 15.2 Cardiovascular Ailments
  • 15.3 Central Nervous System (CNS) Diseases
    • 15.3.1 Epilepsy
    • 15.3.2 Alzheimer's Disease
    • 15.3.3 Parkinson's Disease

16. US Generic Drugs Market Future Prospects

17. Competitive Landscape

  • 17.1 Accord Healthcare
  • 17.2 Alvogen Inc.
  • 17.3 Amneal Pharmaceuticals
  • 17.4 ANI Pharmaceuticals Inc.
  • 17.5 Apotex Inc. (Apotex Corporation)
  • 17.6 Aurobindo India (Aurobindo Pharma USA Inc.)
  • 17.7 Baxter Healthcare Corporation
  • 17.8 Dr. Reddy's Laboratories
  • 17.9 Fresenius Kabi (Fresenius Kabi USA LLC)
  • 17.10 G & W Laboratories
  • 17.11 Glenmark Generics
  • 17.12 lmpax Laboratories
  • 17.13 Lupin Pharmaceuticals
  • 17.14 Mallinckrodt Pharmaceuticals
  • 17.15 Momenta Pharmaceuticals
  • 17.16 Mylan
  • 17.17 Par Pharmaceutical
  • 17.18 Perrigo Company
  • 17.19 Sagent Pharmaceuticals
  • 17.20 Sandoz
  • 17.21 Sun Pharmaceutical Industries
  • 17.22 Teva Pharmaceuticals
  • 17.23 Therapeutic Proteins International
  • 17.24 West- Ward Pharmaceuticals
  • 17.25 Wockhardt
  • 17.26 Zydus Pharmaceuticals

List of Figures

  • Figure 1-1: Difference between Generic & Branded Drugs
  • Figure 1-2: Similarities between Generic vs. Branded Drugs
  • Figure 1-3: Factors Responsible for Lesser Prices of Generic Drugs
  • Figure 1-4: Misconceptions Related to Generic Drugs
  • Figure 2-1: Main Premises of Hatch-Waxman Act
  • Figure 2-2: Implications of Hatch-Waxman Act
  • Figure 3-1: Application Required for Different Drugs
  • Figure 3-2: Benefits of New Chemical Entity
  • Figure 3-3: Increasing Generic Trade in US
  • Figure 3-4: Issues with Labelling of Generic Drugs
  • Figure 3-5: Patent Evergreening to Prevent Generic Drugs
  • Figure 4-1: Market Shares Occupied by Generic Drugs in US
  • Figure 4-2: Generic Drug Savings in US (Billion US$), 2005-2014
  • Figure 4-3: Generic Drug Saving in US by Therapy (Billion US$)
  • Figure 4-4: Generic Drugs Saving by Payer (%)
  • Figure 5-1: Features Considered by Generic Drug Developers
  • Figure 5-2: Factors Leading to Market Introduction of Generic Drugs
  • Figure 5-3: Approval Process of Generic Drugs
  • Figure 5-4: New Drug Application (NDA) for Branded Drugs
  • Figure 6-1: Objectives of Affordable Care Act
  • Figure 6-2: Offering Made by Affordable Care Act
  • Figure 6-3Objectives of Pharmacy Benefit Manager (PBM)
  • Figure 6-4: Different Roles Played by Pharmacy Benefit Manager (PBM)
  • Figure 7-1: Improvements in US Generic Market
  • Figure 8-1: Various Strategies Employed by Branded & Generic Drug Manufacturers
  • Figure 9-1: Few Methods to Achieve Higher Cost Arbitrage
  • Figure 9-2: Types of Managed Care Plan
  • Figure 9-3: Walmart's Generic Drug Business Model
  • Figure 9-4: Benefits of Pill Splitting
  • Figure 10-1: Types of Drugs Available in US Pharmaceuticals Market
  • Figure 11-1: Favorable factors for Generic Drug Manufacturing in Emerging Countries
  • Figure 12-1: Mode of Operation of Online Pharmacies
  • Figure 12-2: Benefits of Online Pharmacy
  • Figure 13-1: Favorable Market Factors
  • Figure 13-2: Estimated Number of Older People (65 years of more) in US, 2020, 2040 & 2060
  • Figure 14-1: Commercialization Challenges

List of Tables

  • Table 2-1: Benefits of Hatch-Waxman Act
  • Table 4-1: Generics Drug Saving by State (US$)
  • Table 7-1: Generic Drug User Fee Amendments (GDUFA) Fees, Financial Year 2016
  • Table 9-1: Different Co-Pays According to Health Insurance Plan
  • Table 9-2: Few Important Drug Substitution Laws in US
  • Table 10-1: Prospective of US Patients on Generics & Branded Drugs
  • Table 10-2: Few Most Prescribed Branded Drugs in US, 2015
  • Table 10-3: Few Important Generic Drugs in US
  • Table 15-1: Few Generic & Branded Drugs for Cardiovascular Ailments
  • Table 15-2: Few Generic & Branded Drugs for Epilepsy available in US
  • Table 15-3: Few Alzheimer's Disease Generic & Branded Drugs available in US
  • Table 15-4: Few Generic & Branded Drugs for Parkinson's available in US
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