Global Markets for Generic Drugs

Table of Contents

Chapter 1 Introduction

Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Intended Audience
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports

Chapter 2 Summary and Highlights

Market Size and Evolution

Chapter 3 Market Overview

Introduction
Recent History of the Generic Drug Industry

• Roche-Bolar
• Generics Lobby
• ICH

Chapter 4 Impact of COVID-19

Overview

• Short-Term Impact on the Pharma Industry
• Long-Term Impact on the Pharma Industry

Impact of COVID-19 on the Market for Generic Drugs

• Impact on the Supply Chain

Chapter 5 The New Generics Era

Overview
The Patent Cliff
Types of Generic Drugs

• Simple Generics
• Super Generics
• Biosimilars

ANDA (Abbreviated New Drug Application) Approvals

Chapter 6 Major Issues Within the Market for Generic Drugs

Regulatory Environment

• U.S.
• European Union
• Japan

Regulation of Biosimilars

• EU Provisions
• Evolving Situation in the U.S.
• User Fees

Defensive Strategies Used by Big Pharma
Authorized Generic Drugs

• User Fees
• Changing Climate for Generics
• Situation in Europe

Patents and IP

• Supplementary Protection Certificates

Chapter 7 Global Market for Generic Drugs

Global Pharmaceutical Market: Brand Name and Generic Drugs
Global Market for Generic Drugs

• Market Opportunities by Product Class
• Market Shares of Pharmaceutical Drugs by Therapeutic Area

Chapter 8 Market Breakdown by Region

Introduction
North America

• U.S.
• Canada

Asia-Pacific

• China
• Japan
• India
• Rest of Asia-Pacific

Europe

• France
• Germany
• Italy
• U.K.
• Spain
• Rest of Europe

Rest of the World

Chapter 9 Industry Trends

Competitive Landscape
Market Trends
Structure of the Generic Drug Industry
Recent Mergers and Acquisitions
Brand Name Company Involvement

Chapter 10 Company Profiles

ASPEN HOLDINGS
CIPLA INC.
FRESENIUS KABI
LUPIN LTD.
MYLAN INC.
PFIZER INC.
SANDOZ INTERNATIONAL GMBH
SANOFI
SUN PHARMACEUTICAL INDUSTRIES LTD.
TEVA PHARMACEUTICAL INDUSTRIES LTD.

Chapter 11 Other International Companies

AUROBINDO PHARMA LTD.
DR. REDDY'S LABORATORIES LTD.
EGIS PHARMACEUTICALS PLC
KRKA
PAR PHARMACEUTICAL INC.
STADA ARZNEIMITTEL
STRIDES SHASUN LTD.
WOCKHARDT LTD.
ZYDUS CADILA

Chapter 12 Appendix: Terminology and Acronyms

List of Tables

Summary Table : Global Market for Generic Drugs, by Region, Through 2025
Table 1 : Global Market for Generic Drugs Compared with the Total Pharmaceutical Market, by Region, Through 2025
Table 2 : Coronavirus Reported Cases and Deaths, by Country, as of March 8, 2021
Table 3 : Major Recent and Upcoming Patent Expiries, 2016-2021
Table 4 : Sales of Brand Name Drugs Before and After Patent Expiry
Table 5 : Biologics with Recent or Upcoming Loss of Patent Protection
Table 6 : Recent Approvals of Biosimilars, 2018-2020
Table 7 : ANDA Approvals of Generic Drugs, by Company, 2019
Table 8 : Requirements for NDA and ANDA Applications
Table 9 : Global Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 10 : Global Market for Generic Drugs, by Top 10 Countries, Through 2025
Table 11 : Top 20 Generic Molecules, 2019
Table 12 : Global Top Selling Pharmaceuticals, 2019
Table 13 : Leading Anti-infective Products Sales, 2018
Table 14 : Leading CNS Products Sales, 2018
Table 15 : Leading Cardiovascular Product Sales, 2019
Table 16 : Leading Anti-arthritis Product Sales, 2018
Table 17 : Leading Respiratory Product Sales, 2018
Table 18 : Leading Anticancer Product Sales, 2018
Table 19 : U.S. Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 20 : Canadian Leading Therapeutic Classes in Retail and Hospital Purchases, 2019
Table 21 : Canadian Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 22 : Chinese Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 23 : Japanese Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 24 : Japanese Pharmaceutical Sales, by Top 25 Japanese Pharma Companies, 2018 and 2019
Table 25 : Indian Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 26 : Leading Generic Drug Companies in India
Table 27 : Rest of Asia-Pacific Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 28 : French Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 29 : German Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 30 : Italian Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 31 : U.K. Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 32 : Leading Pharma Companies in the U.K., by Company, 2018
Table 33 : Spanish Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 34 : Penetration of Generic Drugs in the Pharmaceutical Market in the Rest of Europe, by Country, 2019
Table 35 : Rest of European Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 36 : Rest of World Market for Generic Drugs Compared with the Total Pharmaceutical Market, Through 2025
Table 37 : Leading Generic Drug Companies, by Sales, 2019
Table 38 : Acronyms Used in This Report

List of Figures

Summary Figure : Global Market for Generic Drugs, by Region, 2018-2025
Figure 1 : Impact of COVID-19 on the Pharma Industry
Figure 2 : Trends in Global Prescription Drug Sales, 2015-2019
Figure 3 : Global Market Shares of Pharmaceutical Drugs, by Therapeutic Area, 2019
Figure 4 : Global Market Shares of Asthma Drugs, by Product Category, 2015
Figure 5 : Healthcare Expenditures in Major European Markets and the U.S., 2019

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