의약품 시장에서 제네릭 의약품의 기회 Top 5(2019년 주목 동향) : 향후 전망

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세계 의약품 시장에서 제네릭 의약품 또는 바이오시밀러 의약품의 5가지 주요 기회에 대해 조사했으며, 제네릭 의약품의 범위와 특징에 대한 논의, 제네릭/바이오시밀러 의약품의 주요 과제와 기회, 제품 클래스·작용기전·적응증과 금기 설명, 상세한 특허 분석, 주요 기업 개요 등의 체계적인 정보를 제공합니다.

제1장 서론

제2장 일반 의약품 및 바이오시밀러 사업 전망

• 제네릭 의약품 및 바이오시밀러 개요
• 바이오시밀러

제3장 특허 및 특허 절벽

• 특허 및 IP

제4장 제네릭 의약품 및 바이오시밀러 사업의 규제

• 미국
• EU

제5장 제품 개요 분석

• 개요
• 프로파일 분석
• 졸레어(Xolair)
  • 작용기전
  • 적응증과 금기
  • 용법 및 용량
  • 판매 실적과 성장률
  • 주요 이벤트의 타임라인
  • 주요 규제 승인
  • 가격 및 연간 치료 비용
  • 제네릭/바이오시밀러 개발을 선호하는 요인
  • 바이오시밀러의 임상 개발
  • 비즈니스/개발에 참여하고 있는 주요 기업 개요
  • 바이오시밀러 버전을 개발하고 있는 기업
• Revlimid
• Orencia
• Pradaxa
• Gilenya

제6장 결론

BCC Research에 대해

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

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