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米国のジェネリック抗癌剤市場の見通し

US Cancer Generics Market Outlook 2022

発行 KuicK Research 商品コード 448762
出版日 ページ情報 英文 100 Pages
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米国のジェネリック抗癌剤市場の見通し US Cancer Generics Market Outlook 2022
出版日: 2017年02月24日 ページ情報: 英文 100 Pages
概要

当レポートでは、米国のジェネリック抗癌剤市場について調査分析し、米国のジェネリック医薬品の薬事法、健康保険シナリオ、ブランド/非ブランドのジェネリック医薬品、市場の概要、将来見通しなど、体系的な情報を提供しています。

第1章 ジェネリック抗癌剤:控えめなレジメン

  • イントロダクション
  • ジェネリック製剤が必要な理由
  • ジェネリック抗癌剤の優位性

第2章 米国のジェネリック医薬品の法規

  • ハッチ・ワックスマン法 (1984年)
  • ジェネリック医薬品の経緯

第3章 ジェネリック抗癌剤の特許への道

  • 米国のジェネリック医薬品の薬事関係法規
  • 米国のジェネリック抗癌剤の特許戦争

第4章 米国の処方薬の経済的負担

  • 抗癌剤の高コスト
  • ジェネリック医薬品による医療費の節約

第5章 ジェネリック抗癌剤:米国市場では依然として高値

  • 誰も買えなければ、技術革新も無意味
  • 米国がジェネリック医薬品と争う理由

第6章 米国の健康保険シナリオと癌

  • 抗癌剤補償の提供
  • 民間健康保険オプション
  • 政府資金による保険

第7章 ブランド/非ブランドのジェネリック医薬品の側面

  • 市場における認可ジェネリック医薬品のデビュー
  • 未認可のジェネリックの規制

第8章 オンコロジー分野のジェネリック医薬品

  • 抗癌標的治療薬
  • モノクローナル抗体におけるジェネリック医薬品の状況
  • 小分子阻害剤のジェネリック医薬品への改革

第9章 米国のFDA承認のジェネリック抗癌剤

  • Taxotere (Docetaxelのジェネリック医薬品)
  • Imatinib (Glivecのジェネリック医薬品)
  • Sorafinib (Nexavarのジェネリック医薬品)

第10章 米国のジェネリック抗癌剤市場の概要

  • 米国のジェネリック抗癌剤市場の紹介
  • 欧州のジェネリック医薬品市場
  • アジアのジェネリック医薬品市場

第11章 米国のジェネリック抗癌剤市場力学

  • 市場促進要因
  • 障壁

第12章 米国のジェネリック抗癌剤市場の将来見通し

目次

"US Cancer Generics Market Outlook 2022" report gives comprehensive insight on the various indicators and trend analysis related to the emergence and integration of cancer generics drugs in mainstream pharmaceutical market in US. The report analyzes various clinical and non-clinical parameters responsible for the growth on cancer generics drugs in recent years. The introduction of generics has resulted in saving of billions of dollars for various stake holders involved US cancer drug market. It is expected that total savings from generics in cancer therapy (in treatment & post treatment) will surpass US$ 30 Billion by 2022 and will further give the required thrust to adoption of generics drugs in cancer therapy as compare to prescribed branded drugs.

Even though most of the attention and spending in the oncology segment in the US has been focused on the remarkable scientific inventions of the newer targeted drugs but the overburdening of the economic high cost of cancer drugs has made US to follow up the line of generics. Certainly, after the existence of Hatch-Waxman Act, the entries of generic products were acceptable between the Americans.

The beneficial aspects of generic regimens are already well established, as the delivery of equal therapeutic efficacy in low price is the principal aim of cancer generics. The cost for patented oncological drugs and the generic drugs have wide gap which is getting shorter with the emerging patent cliff for cancer drugs in US and the arrival of the cancer generics era.

Concerning the cost, indeed cancer generics provide an exceptional solution towards high cost, yet the scenario is different for the Americans. However, in US cancer generics cost much higher in contrary to the other nations, reason being is the no negotiation mode of government in the pharmaceutical sector. The prices paid for generics in US are many fold higher than developing countries like India and China.

Certainly, among the developed nations the usage and prescription of generics is quite higher depicting the greater medical needs due to overburden of massive diseases and cancer is one of them. The demand for cancer generics is so high that the trend has created a shortage landscape. It is a part of the problem of the scarcity of generics across all medical specialties, but its oncology is particularly vulnerable. The reason of the shortages is multi-factorial but is largely economic and is due to the lack of incentives to produce generics.

"US Cancer Generics Market Outlook 2022" report highlights:

  • Introduction to Cancer Generics
  • US Generic Drugs Legislature
  • US Health Insurance Scenario & Cancer
  • Aspects of Branded & Non-Branded Generics
  • US Cancer Generics Market Overview

Table of Contents

1. Cancer Generics: A Modest Regimen

  • 1.1 Introduction to Cancer Generics
  • 1.2 Why There Exist is Need for Generic Forms?
  • 1.3 Supremacy of Cancer Generic Drugs
    • 1.3.1 Cost
    • 1.3.2 Quality & Safety
    • 1.3.3 Large Number of Manufacturer
    • 1.3.4 Approved by FDA
    • 1.3.5 Concerns in Cancer Generic Medication

2. US Generic Drugs Legislature

  • 2.1 Hatch-Waxman Act, 1984
  • 2.2 The Generic Drugs Chronological Disgrace

3. Trail towards Patenting of Cancer Generic Drugs

  • 3.1 US Generic Pharmaceutical Regulation
  • 3.2 Patenting Wars of Cancer Generics in US

4. Economic Burden of Prescription Drugs in US

  • 4.1 High Cost of Cancer Drugs
  • 4.2 Healthcare Savings by Virtue of Generics

5. Cancer Generic Drugs: Still Overpriced in US Market

  • 5.1 Innovation is Meaningless if Nobody can Afford It
  • 5.2 Why US Contends More in Generics?

6. US Health Insurance Scenario & Cancer

  • 6.1 Provisions for Cancer Drug Coverage
  • 6.2 Private Health Insurance Options
  • 6.3 Government Funded Insurance

7. Aspects of Branded & Non-Branded Generics

  • 7.1 Debut of Authorized Generics in Market
  • 7.2 Anti-Authorized Generic Legislation

8. Generics in Oncology World

  • 8.1 Anti-Cancer Targeted Therapy Drugs
  • 8.2 Status of Generics in Monoclonal Antibodies
  • 8.3 Crusade of Small Molecule Inhibitor towards Generics

9. FDA Approved Anti-Cancer Generics in US

  • 9.1 Taxotere (Generic Docetaxel)
  • 9.2 Imatinib (Generic Glivec)
  • 9.3 Sorafinib ( Generics Nexavar)

10. US Cancer Generics Market Overview

  • 10.1 US Cancer Generics Market Introduction
  • 10.2 Europe Generics Market Contrary to US
  • 10.3 Asia Generics Market Contrary to US

11. Cancer Generics Drug Market Dynamics

  • 11.1 Accelerative Parameters
    • 11.1.1 Expiration of Patents
    • 11.1.2 Unaffordability of Cancer Drugs
    • 11.1.3 Cost Containment by Government
    • 11.1.4 Generic Drug User Fee Amendments (2012)
    • 11.1.5 High Cancer Risk & Aging Population of US
  • 11.2 Pitfalls Confronted by Generic Industry

12. US Cancer Generics Market Future Prospect

List of Figures

  • Figure 1-1: US - Savings through Generic Drug usage (US$ Billion), 2010-2015
  • Figure 1-2: Zofran- Price of Branded & Generic Pill (US$)
  • Figure 1-3: Illustration of Pros & Cons of Generic Drugs
  • Figure 2-1: Interests of Brand drug & Generic Drug Industry over Hatch-Waxman Act
  • Figure 3-1: Major Exclusivity under the NDA Statutory Requirements
  • Figure 3-2: Demonstration of Bringing Generic Drug into Market
  • Figure 3-3: US - FDA Rules for Generics Production
  • Figure 4-1: Branded V/S Generic Prescription Drug Revenues (2005-2015)
  • Figure 4-2: US - Expected Cost Savings through Generics in Cancer Therapy (US$ Billion), 2016-2022
  • Figure 4-3: US - Potential Cost Saving Across Biologics in
  • Figure 5-1: US - Representation of Generic Cost of Gleevac
  • Figure 6-1: Distribution of Medicare Savings in FY2016 Budget
  • Figure 6-2: Cost Sharing of Generic Drug in Medicare Part D Coverage Gap (%), 2015-2020
  • Figure 6-3: Various Medicare Beneficiaries Provided by US Government
  • Figure 6-4: US - Share of Medicare & Self Payment for Generics Drug (%)
  • Figure 7-1: Illustration of the Profits Earned During the 180-Day Exclusivity
  • Figure 7-2: Strategies for Launching Authorized Generics in Market
  • Figure 8-1: US - Proportion of Branded & Generic Drug Revenues (%), 2010-2015
  • Figure 8-2: FDA Approved Monoclonal Antibodies in Cancer Therapeutics
  • Figure 8-3: Development Cost of Generics v/s Biosimilar
  • Figure 9-1: Cost Comparison of Gleevac in Branded & Generic Versions
  • Figure 9-2: Naxawar Price Difference in Generic & Branded Version
  • Figure 10-1: Global - Top Generics Manufacturers Based on Revenues (US$ Billion), 2015
  • Figure 10-2: US - Generics Drug Market Opportunity (US$ Billion). 2016-2022
  • Figure 10-3: US - Savings through Generic Drug usage in (US$ Billion), 2017-2022
  • Figure 10-4: US - Share of Leading Generic Companies
  • Figure 11-1: Major Accelerative Parameters for the Growth of Generic Market
  • Figure 11-2: Current Challenges Faced by Generic Pharmaceutical
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