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米国の医薬品産業におけるジェネリック医薬品部門の分析

Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry 2017

発行 Aruvian Research 商品コード 482463
出版日 ページ情報 英文 195 Pages
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米国の医薬品産業におけるジェネリック医薬品部門の分析 Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry 2017
出版日: 2017年03月01日 ページ情報: 英文 195 Pages
概要

当レポートでは、米国の医薬品産業におけるジェネリック医薬品部門について調査分析し、与える影響、研究開発戦略、訴訟、コスト分析など、体系的な情報を提供しています。

A. エグゼクティブサマリー

B. ジェネリック医薬品とは

  • ジェネリック医薬品の紹介
  • ジェネリックの経済学
  • 米国のジェネリック医薬品の承認プロセス
  • ジェネリック vs. ブランド医薬品
  • 主要製薬会社に対するジェネリック部門の影響
  • ジェネリック部門に対する上位製薬会社の戦略
  • 研究開発戦略
  • コスト抑制とジェネリックの役割
  • ジェネリックの影響
  • ブランド製品の保護方法

C. 世界のジェネリック部門の概要

  • 部門の定義
  • 産業の概要
  • 産業の金額・数量分析
  • 産業区分:地域別
  • 特許期間の満了
  • 特許期間の満了:治療分野別
  • 世界のジェネリック産業の構造
  • 市場参入
  • 産業の研究開発

D. 米国のジェネリック産業

  • 産業のプロファイル
  • 産業の金額・数量
  • 産業区分:地域別
  • 小企業が恩恵を受ける
  • 米国のジェネリック競合の影響
  • 産業の予測

E. 米国のジェネリック産業:ファイブフォース分析

  • イントロダクション
  • バイヤーの交渉力
  • サプライヤーの交渉力
  • 同業者間の競争
  • 新規参入の脅威
  • 代替品の脅威

F. ジェネリックの価格と償還

  • 概要
  • 規制
  • 健康保険
  • ジェネリックの価格
  • 償還シナリオ
  • 動向とケーススタディ
  • 課題

G. 米国の医薬品産業における公認ジェネリック (AG) の参入

  • イントロダクション
  • ハッチ・ワックスマン法の枠組み
  • AGの参入
  • AGに影響を与える規制決定
  • 最近の規制措置
  • AGと訴訟
  • DEFRAの制定
  • 結論

H. 米国市場におけるジェネリック医薬品競争の促進

  • イントロダクション
  • FDA承認プロセスの問題
  • ハッチ・ワックスマン法の役割
  • オレンジブックの役割
  • ジェネリック医薬品出願者によるインセンティブ
  • ハッチ・ワックスマン法の成果
  • 大手製薬会社の視点
  • ジェネリック医薬品の可用性
  • FDA承認における対立を取り除く

I. ブランドメーカーの戦略

  • イントロダクション
  • 特許訴訟への新しいアプローチ
  • 製品ライン拡大

J. ジェネリック医薬品の役割

K. ケーススタディ:ジェネリック抗鬱剤

L. ケーススタディ:Blue Cross

M. 主要な参入企業

N. 付録

O. 用語集

目次

A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

Generic drugs are less expensive because generic manufacturers don't have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment - including research, development, marketing, and promotion - by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don't have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.

Generic manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. In most countries, generic manufacturers must only prove that their preparation is bioequivalent to the existing drug in order to gain regulatory approval. It has been estimated that the average cost to brand-name drug companies of discovering and testing a new innovative drug (with a new chemical entity) may be as much as $800 million.

The United States is the biggest generic drugs market in the world. In fact, nearly 80% of the prescriptions written in the US are for generic drugs.

Aruvian Research presents Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry 2017 - a comprehensive coverage of the generic drugs market in the United States. Beginning with a sectional description on generic drugs, the report covers topics such as the impact of the generics sector on major pharma companies, R&D strategies being implemented by major pharma companies in the generics sector, the long debate over generic drugs versus branded drugs, and much more - a cost analysis of branded drugs versus generic drugs being a highlight.

An overview of the global generics sector builds up the scene for the analysis of the US generics industry. The all-important Hatch-Waxman Framework, the DEFRA Regulation, and other recent regulatory measures are included in this analysis from Aruvian's, along with the emerging issue of promoting generic drug competition in the US Market.

Being a major section of the report, Promoting Generic Drug Competition in the US Market covers topics such as issues with the FDA Approval Process, the role of the Orange Book, the positive and negative outcomes of the Hatch Waxman Act, the manipulation of this act, promoting methods for generic drug availability, amongst other points of discussion.

Strategies for survival employed by branded manufacturers, the role of generic drugs in lowering US drug re-importation, a case study on generic antidepressants, the approval of the generic version of GSK's drug Coreg, the introduction of Bill S.438, and the substantial move by Blue Cross in major changes to its drug plans, are discussed and analyzed in this report.

We also include a Porter's Five Forces analysis of the US Generic Drugs Industry.

Analysis of major industry players such as Teva Pharmaceutical Industry, Mylan N.V., Sandoz, Sanofi SA and others concludes this comprehensive research report from Aruvian Research.

Table of Contents

A. Executive Summary

B. What are Generic Drugs?

  • B.1 Introduction to Generic Drugs
  • B.2 Economics of Generics
  • B.3 Approval Process for US Generic Drug
  • B.4 Generics versus Brand Name Drugs
  • B.5 Impact of the Generics Sector on Major Pharmaceutical Companies: A Graphical Representation
  • B.6 Strategies for Top Pharma Companies Competing against the Generics Sector: A Graphical Representation
  • B.7 Research & Development Strategies Engaged by Majors in the Generics Sector: A Graphical Representation
  • B.8 Cost Containment & Role of Generics
  • B.9 Impact of Generics on Treatment Costs versus Cost Effectiveness
  • B.10 How to Protect the Branded Product?

C. Overview of the Global Generics Sector

  • C.1 Sector Definition
  • C.2 Industry Overview
  • C.3 Industry Value & Volume Analysis
  • C.4 Industry Segmentation by Geography
  • C.5 Patent Expiries
  • C.6 Patent Expiries by Therapeutic Areas
  • C.7 Global Generic Industry Structure
  • C.8 Market Entry
  • C.9 Research & Development in the Industry

D. Generics Industry in the United States

  • D.1 Industry Profile
  • D.2 Industry Value & Volume
  • D.3 Industry Segmentation by Geography
  • D.4 How Small Companies are Benefiting from Big Pharma's Branded Medicines?
  • D.5 Impact of Generic Competition in the US on the Overall Return to Investment
  • D.6 Industry Forecast

E. Generics Industry in the US: Porter's Five Forces Strategy Analysis

  • E.1 Introduction
  • E.2 Bargaining Power of Buyers
  • E.3 Bargaining Power of Suppliers
  • E.4 Competitive Rivalry in the Industry
  • E.5 Threat of New Entrants
  • E.6 Threat of Substitutes

F. Pricing and Reimbursement of Generics in the US

  • F.1 Overview
  • F.2 Regulation
  • F.3 Health Insurance
    • F.3.1 Health Insurance Coverage
    • F.3.2 Health Insurance Providers
  • F.4 Generics Pricing
    • F.4.1 340B Drug Pricing Program
  • F.5 Reimbursement Scenario
    • F.5.1 Health Insurance Companies
    • F.5.2 Pharmacy Benefit Managers
    • F.5.3 Reimbursement Programs in the US
    • F.5.4 Case Studies
    • F.5.5 Discount Programs in Other States
  • F.6 Trends & Case Studies
    • F.6.1 Case Study: Pricing and Reimbursement in Oncology
    • F.6.2 Major Trends
  • F.7 Challenges

G. Entry of Authorized Generics in the US Pharmaceutical Industry

  • G.1 Introduction
  • G.2 Hatch-Waxman Framework
  • G.3 Entry of Authorized Generics
  • G.4 Regulatory Decisions Affecting Authorized Generics
  • G.5 Recent Regulatory Measures
  • G.6 Authorized Generics & Litigations
  • G.7 Enactment of DEFRA
  • G.8 Conclusion

H. Promoting Generic Drug Competition in the US Market

  • H.1 Introduction
  • H.2 Problems with the FDA Approval Process
  • H.3 Role of the Hatch-Waxman Act
  • H.4 Role of the Orange Book
  • H.5 Incentives Provided for the Generic Drug Applicant
  • H.6 Outcome of the Hatch-Waxman Act
    • H.6.1 Positive Consequences
    • H.6.2 Negative Consequences
  • H.7 Point of View of Big Pharma
  • H.8 How to Promote Generic Drug Availability & Solving Overall Industry Crisis
    • H.8.1 Overview
    • H.8.2 Lowering the Cost of Prescription Drugs
    • H.8.3 Introduction of the McCain-Schumer Bill
  • H.9 Removing Conflicts from the FDA Approval Process
    • H.9.1 Overall Process
    • H.9.2 Conclusion

I. Strategies for Branded Manufacturers

  • I.1 Introduction
  • I.2 Developing a New Approach to Patent Litigations
  • I.3 Employing Line Extensions

J. Generic Drugs' Role in US Drug Re-importation

K. Case Study: Generic Antidepressants

L. Case Study: Major Change to Drug Plan by Blue Cross

M. Leading Industry Players

  • M.1 Allergan Plc
    • M.1.1 Corporate Analysis
    • M.1.2 Financial Analysis
    • M.1.3 SWOT Analysis
  • M.2 Mylan N.V.
    • M.2.1 Corporate Analysis
    • M.2.2 Major Products & Services
    • M.2.3 Financial Analysis
    • M.2.4 SWOT Analysis
  • M.3 Par Pharmaceutical Companies, Inc.
    • M.3.1 Corporate Analysis
    • M.3.2 Major Products & Services
    • M.3.3 Therapeutic Snapshot
    • M.3.4 Financial Analysis
    • M.3.5 SWOT Analysis
  • M.4 Sanofi SA
    • M.4.1 Corporate Analysis
    • M.4.2 Major Products & Services
    • M.4.3 Financial Analysis
    • M.4.4 SWOT Analysis
  • M.5 Teva Pharmaceutical Industries
    • M.5.1 Corporate Analysis
    • M.5.2 Major Products & Services
    • M.5.3 Therapeutic Snapshot
    • M.5.4 Financial Analysis
    • M.5.5 SWOT Analysis
  • M.6 Sandoz International GmbH

N. Appendix

  • N.1 Role of the Hatch-Waxman Framework in the U.S. Generic Drug Market
    • N.1.1 Introduction
    • N.1.2 Enactment of the Policy & Motivations
    • N.1.3 Regulation & Generic Drugs
    • N.1.4 Market Entry by Generics before Patent Expiration
    • N.1.5 Issues with Generic Exclusivity
    • N.1.6 Present State of the Generic Exclusivity Law
    • N.1.7 Solution to the Exclusivity Law
    • N.1.8 Conclusion

O. Glossary of Terms

List of Figures

  • Figure 1: Historical Revenues of Leading Generic Companies (in USD Million), 2008-2009
  • Figure 2: Growth of the Global Generics Industry by Value (in USD Billion), 2012-2016
  • Figure 3: Generics Percentage of Total Pharmaceutical Volume & Market Volume of Global Generics Industry (%), 2012-2016
  • Figure 4: Global Generics Market Segmentation by Geography (%), 2016
  • Figure 5: Revenues of Top 10 Drugs that went off Patent between 2010-2014 (in USD Million)
  • Figure 6: Value of Drugs to Lose Patent Protection during 2010-2014 by Therapeutic Area (%)
  • Figure 7: Market Share of Leading Generic Companies Worldwide (%), 2016
  • Figure 8: Comparison of Revenues of Leading Generic Companies (in USD Million), 2013-2014
  • Figure 9: Value of the Generics Market in the US (in USD Billion), 2012-2016
  • Figure 10: Volume Growth of the Generics Market in the US (%), 2012-2016
  • Figure 11: Share of the US in the Global Generics Industry (%), 2016
  • Figure 12: Costs and Revenues Associated with Bringing a Product to Market
  • Figure 13: Forecast of the Generics Market in the US (in USD Billion), 2016-2021
  • Figure 14: Volume Forecast of the Generics Market in the US (%), 2016-2021
  • Figure 15: Porter's Five Forces Analysis of the US Generics Industry
  • Figure 16: Bargaining Power of Buyers in the US Generics Industry
  • Figure 17: Bargaining Power of Suppliers in the US Generics Industry
  • Figure 18: Competitive Rivalry in the US Generics Industry
  • Figure 19: Threat of New Entrants to the US Generics Industry
  • Figure 20: Threat of Substitutes to the US Generics Industry
  • Figure 21: Private and Government Health Insurance in the US
  • Figure 22: Distribution Channel and Logistics of Generics in the US
  • Figure 23: Fee for Service, Preferred Provider Organization & Health Maintenance Organization in the US
  • Figure 24: Yearly Price Index Change of Prescription Drugs in the US (%), 2010-2012
  • Figure 25: Yearly Retail Price Index of Generic Drugs in the US (%), 2010-2012
  • Figure 26: Standard Medicare Part D Benefit Comparison of 2011 & 2020 in the US
  • Figure 27: Cost Sharing of Generic Drugs in the US (%), 2011-2020
  • Figure 28: Revenues & Profitability of Allergan Plc (in USD Million), 2011-2015
  • Figure 29: Revenues & Profitability of Sanofi SA (in USD Million), 2011-2015
  • Figure 30: Revenues & Profitability of Teva Pharmaceutical (in USD Million), 2011-2015

List of Tables

  • Table 1: Growth of the Global Generics Industry by Value (in USD Billion), 2012-2016
  • Table 2: Generics Percentage of Total Pharmaceutical Volume & Market Volume of Global Generics Industry (%), 2012-2016
  • Table 3: Global Generics Industry, Segmentation by Geography (in USD Billion), 2016
  • Table 4: Major Patent Expiries
  • Table 5: Patent Expiries for Leading Biologic Drugs, 2010-2016
  • Table 6: Value of the Generics Market in the US (in USD Billion), 2012-2016
  • Table 7: Volume Growth of the Generics Market in the US (%), 2012-2016
  • Table 8: Share of the US in the Global Generics Industry (% & USD Billion), 2016
  • Table 9: Forecast of the Generics Market in the US (in USD Billion), 2016-2021
  • Table 10: Volume Forecast of the Generics Market in the US (%), 2016-2021
  • Table 11: Average Retail Coinsurance Rates by Tier, (%)
  • Table 12: Reimbursement Programs in the US
  • Table 13: State Discount Programs in the US
  • Table 14: Yearly Price Index Change of Prescription Drugs in the US (%), 2010-2012
  • Table 15: Yearly Retail Price Index of Generic Drugs in the US (%), 2010-2012
  • Table 16: Changes in Standard Benefit Parameters of Medicare Part D in the US (in USD), 2008-2012
  • Table 17: Cost Sharing of Generic Drugs in the US (%), 2011-2020
  • Table 18: Key Financials of Allergan Plc (in USD Million), 2011-2015
  • Table 19: Key Financials of Sanofi SA (in USD Million), 2011-2015
  • Table 20: Key Financials of Teva Pharmaceutical (in USD Million), 2011-2015