表紙
市場調查報告書

醫藥品市場上學名藥的機會前五名 (2019年的關注趨勢):未來展望

Top 5 Generic Opportunities in Pharmaceuticals to Watch in 2019: Perspective for the Future

出版商 BCC Research 商品編碼 920064
出版日期 內容資訊 英文 74 Pages
訂單完成後即時交付
價格
Back to Top
醫藥品市場上學名藥的機會前五名 (2019年的關注趨勢):未來展望 Top 5 Generic Opportunities in Pharmaceuticals to Watch in 2019: Perspective for the Future
出版日期: 2019年12月23日內容資訊: 英文 74 Pages
簡介

本報告提供全球醫藥品市場上學名藥或生物相似藥醫藥品的主要的5個機會的相關調查,學名藥的涵蓋範圍與其特徵相關的討論,學名藥/生物相似藥醫藥品主要課題、機會的考察,產品級、作用機制、適應症和禁忌的說明,詳細的專利分析,及主要企業的簡介等系統性資訊。

第1章 簡介

第2章 學名藥及生物相似藥商務的展望

  • 學名藥及生物相似藥概要
  • 生物相似藥

第3章 專利及專利懸崖

  • 專利及IP

第4章 學名藥及生物相似藥商務的法規

  • 美國
  • EU

第5章 產品簡介分析

  • 概要
  • 簡介分析
  • Xolair
    • 作用機制
    • 適應症、禁忌
    • 用法、容量
    • 銷售業績和成長率
    • 主要活動的時間軸
    • 主要的法規核准
    • 價格及年度的治療成本
    • 偏好學名藥/生物相似藥的開發的要素
    • 生物相似藥臨床開發
    • 商務/開發介入的主要企業的簡介
    • 開發生物相似藥版的企業
  • Revlimid
  • Orencia
  • Pradaxa
  • Fingolimod

第6章 結論

關於BCC Research

目錄
Product Code: PHM223A

Report Highlights:

In the context of the huge impact of generic drug development and its implication in cost savings, an attempt has been made to analyze various pharmaceutical original products which experience patent expiry and likely to go off patents. The report also covers a section illustrating the case for development and opportunities that lie for manufacturers engaged in the generic or biosimilar business for the key drugs.

Report Includes:

  • An overview of top five opportunities for generic or biosimilar drugs in pharmaceuticals market 2019
  • Coverage of generics and discussion on their characteristics
  • Information on Hatchmann-Wax act and its effect on market competitiveness impacting pricing and development of original drugs
  • Insights on the key challenges and opportunities in the development of generics or biosimilar drugs
  • Description of product class, mechanism of action, indications and contraindications,
  • Clinical and generic development of the prominent products
  • Detailed patent analysis i.e. expiry and exclusivity, regulations and policies and patent expiry and market impact
  • Profiles of key competitors engaged in the development of generic and biosimilars

Table of Contents

Chapter 1: Introduction

  • Study Goals and Objectives
  • Scope of Report
  • Information Sources
  • Methodology
  • Analyst's Credentials

Chapter 2: Perspectives of Generics and Biosimilar Business

  • Overview of Generics and Biosimilars
    • Generics
    • Types of Generics
  • Biosimilars
    • Lifecycle of a Biosimilar Drug
    • Development of a Biosimilar
    • Manufacturing of a Biosimilar
    • Preclinical Studies and Validation of a Biosimilar
    • Clinical Trials
    • Generics vs. Biosimilars
    • Market Landscape of Generics and Biosimilars
    • Competitive Landscape of Generics and Biosimilars
    • Trends
    • Structure of the Generics Industry
    • Biosimilars Competitive Landscape
    • Bio-intellectual Companies
    • Opportunistic Companies
    • Emerging Trends in Biosimilar Industry Structure

Chapter 3: Patents & Patent Cliffs

  • Patents and IP
    • Supplementary Protection Certificates
    • Patent Regulations in Favor of Branded Biologics
    • Patent Regulations in Favor of Biosimilars-Emerging Trends

Chapter 4: Regulation of Generics and Biosimilars Business

  • United States
  • European Union
    • EU Marketing Authorization Systems
    • Types of Applications
    • Regulation of Biosimilars
    • EU Provisions
    • Evolving Situation in the U.S.
    • User Fees
    • Defensive Strategies by "Big Pharma"
    • Authorized Generics
    • User Fees
    • Changing Climate for Generics
    • Situation in Europe

Chapter 5: Product Profile Analysis

  • Overview
  • Profile Analysis
    • Xolair
    • Mechanism of Action
    • Indications and Contraindication
    • Dosage and Administration
    • Historical Net Sales and Growth Rates of Xolair for Novartis
    • Timeline of Key Events-Xolair (Omalizumab)
    • Key Regulatory Approvals
    • Pricing and Annual Cost of Xolair Associated with Treatment
    • Factors Favoring Generic/Biosimilar Development of Xolair
    • Biosimilar Clinical Developments
    • Profiles Key Companies engaged in the Business/Development of Xolair and Biosimilar Omalizumab
    • Companies Developing Biosimilar Version of Omalizumab
  • Revlimid
    • Mechanism of Action
    • Indications and Contraindication
    • Dosage and Administration
    • Historical Net Sales and Growth Rates
    • Timeline of Key Events-Revlimide (Lenalilomide)
    • Pricing and Annual Cost of Revlimid Associated with Treatment
    • Factors Influencing Generic Development
    • Business & Legal Challenges
    • FDA's Campaign of "Naming and Shaming of Branded Pharmaceuticals Adopting Anti-Trade Practices"
    • Revlimid Generics Development/Marketed Drugs
    • Company Profiles
    • Generic Manufacturers of Revlimid
  • Orencia
    • Mechanism of Action
    • Indications and Contraindication
    • Dosage and Administration
    • Historical Net Sales and Growth Rates of Orencia for Bristol-Meyers Squibb
    • Timeline of Key Events-Orencia
    • Pricing and Annual Cost of Orencia Associated with Treatment
    • Factors Favoring Generic/Biosimilar Development of Orencia
    • Biosimilar Clinical Developments
    • Profiles Key Companies Engaged in the Business/Development of Xolair and Biosimilar Omalizumab
    • Companies Developing Biosimilar Version of Omalizumab
  • Pradaxa
    • Mechanism of Action
    • Indications
    • Adverse Reaction
    • Dosage and Administration
    • Historical Net Sales and Growth Rates of Pradaxa
    • Clinical Development
    • Timeline of Key Events-Pradaxa (Dabigatran)
    • Pricing and Annual Cost of Pradaxa
    • Factors Favoring Generic Development of Pradaxa
    • Generics Clinical Developments
    • Profiles of the Pradaxa Manufacturer
    • Generic Manufacturer of Pradaxa
  • Gilenya
    • Mechanism of Action
    • Indications
    • Dosage and Administration
    • Historical Net Sales and Growth Rates of Gilenya for Novartis
    • Timeline of Key Events-Gilenya
    • Pricing and Annual Cost of Gilenya Associated with Treatment
    • Factors Favoring Generic/Biosimilar Development of Gilenya
    • Generic Clinical Developments
    • Profiles Key Companies Engaged in the Business/Development of Gilenya
    • Companies Developing Generic Version of Gilenya

Chapter 6: Conclusion

  • Improved Understanding of Pharmaceutical Technologies
  • Access to Pharmaceutical Technologies and Production Methods
  • Shift in the Business Model of Pharmaceutical Industry
    • Challenges
    • Future Perspectives

List of Tables

  • Table 1: List of Biosimilars Produced in E. Coli
  • Table 2: List of Biosimilars Produced in Mammalian Cells
  • Table 3: Number of Approved Biosimilars, by Type
  • Table 4: Generics vs. Biosimilars
  • Table 5: List of Key Products
  • Table 6: Sales of Xolair, Through 2018
  • Table 7: Approved Indications for Use of Revlimid
  • Table 8: Sales of Revlimid, Through 2018
  • Table 9: Dosage Recommendation Per Patient Weight
  • Table 10: Sales of Orencia, Through 2018
  • Table 11: Sales of Pradaxa, Through 2018
  • Table 12: Sales of Gilenya, Through 2018

List of Figures

  • Figure 1: Xolair Key Events, 2003-2018, Post 2020
  • Figure 2: Revlimid Key Events, 2005-2019
  • Figure 3: Orencia Key Events, 2005-2019
  • Figure 4: Pradaxa Key Events, 2008-2017
  • Figure 5: Gilenya Key Events, 2010-2019
Back to Top