Market Report Source

Overview

The number of commercially lucrative drugs coming off patent has
catalyzed the growth of the generics industry, creating significant profit
opportunities for generics manufacturers. However, this market faces a
considerable number of threats, with bulk manufacturers from developing
countries becoming internationally competitive and the aggressive actions
of branded pharmaceutical marketers in protecting their patent and
market position resulting in ramifications for the sector as a whole.

Future Growth Opportunities in Generics provides an in-depth analysis
into the direction of the global generics market, evaluating competitive
dynamics through a detailed review of major consolidation activity in the
sector. Opportunities for future success are also explored, including the
potential offered by biosimilars and the increasing focus by
governments on healthcare cost containment, enabling you to
determine the factors crucial to your success in the global generics
market.

Key findings of the report…
• The global unbranded generics market was valued at $38bn in
2005, up 14.3% on 2004 sales of $33bn. The generics market has
witnessed strong growth over the previous five years and has more than
doubled in size since 2001.
• Although, historically the US market has enjoyed a higher rate of
popularity for new generic entrants, due to increased competition,
companies now tend to look into expanding into markets with
developing growth potential, such as the under-penetrated markets
of the EU and the emerging markets in Asia.
• M&A continues to be a main strategy for growth as generics
companies continue to vie to enhance their portfolio status, undertake
geographic expansion or to gain monopoly in a particular region or
therapeutic area, with price pressures and technology access being the
key pressures driving acquisition activity.
• The generics market appears poised for future growth, with
upcoming expiries of blockbuster products forecast to further fuel
growth particularly in hormonal cancers, hypertension,
dyslipidemia, bacterial infections, viral infections, schizophrenia and
epilepsy indications.

Key questions answered in this report
• What key strategies are generic companies utilizing in order to
increase their market share and ensure healthy profit margins?
• Which country markets will see the highest growth and what are the
most attractive therapy areas for generics companies to target?
• What are the current generic market trends within the major therapy
areas of cardiovascular, cancer, gastrointestinal, anti-infectives and
CNS?
• What is the extent of the threat on branded products from the
growth of the global generics market?
• How do branded pharmaceutical companies defend against the
threat of generics competition?
• Which companies are best positioned to succeed in biosimilars?

Top five reasons to order your copy today
• Identify the therapeutic areas with the most potential for generic
growth and ensure your portfolio is aligned with future market
opportunity.
• Understand how geographic expansion is one of the major reasons
behind recent consolidation in the industry, and evaluate which
national markets are poised for growth over the next 5 years.
• Evaluate how the market shares of the leading generics companies,
such as Novartis, Teva and Mylan will change over the next 5 years,
and assess your competitive position within the market.
• Discover what key strategies generics companies are utilizing in
order to increase market share and achieve a competitive advantage.
• Assess the defensive strategies implemented by branded
pharmaceutical marketers to protect their patents and delay generic
entry, and understand how this affects the generics market place.

Table of Contents

Future Growth Opportunities in Generics

Executive Summary

Generics growth opportunities and branded defense strategies

Generics market analysis by country and region

Generics market analysis by therapeutic area

Leading generics players

Consolidation in the generics industry

Chapter 1 Generics growth opportunities and branded defense strategies

Summary

Introduction

Key generics growth opportunities

Availability of off-patent treatments and paragraph IV challenges

Healthcare cost containment policies

The biogenerics/biosimilars opportunity

Mergers and acquisitions

Defense strategies from branded companies

Rx-to-OTC switching

Defensive pricing

Patent litigation

Reformulation

Authorized generics agreements and settlements

Launching in-house generics

Chapter 2 Generics market analysis by country and region

Summary

Introduction

iv

Regional generics market analysis

North American market

Major markets of Latin America

Major European markets

Major markets of Central and Eastern Europe

Japanese market

Chinese market

Selected markets in the Asia-Pacific region

Chapter 3 Generics market analysis by therapeutic area

Summary

Introduction

Market breakdown by therapeutic area

CNS disorders market analysis

Cardiovascular diseases market analysis

Alimentary tract and metabolism market analysis

Cancer market analysis

Anti-infectives market analysis

Therapy area forecasts

Chapter 4 Leading generics players

Summary

Introduction

Key players in the global generics market

Performance of major generics companies by region

Company portfolio analysis

Novartis

Marketed product portfolio

Forecast sales

Teva

Marketed product portfolio

Forecast sales

Mylan

Marketed product portfolio

Forecast sales

Ratiopharm

Marketed product portfolio

Forecast sales

Watson

Marketed product portfolio

v

Forecast sales

Merck KGaA

Marketed product portfolio

Forecast sales

Ivax

Marketed product portfolio

Forecast sales

Apotex

Marketed product portfolio

Forecast sales

Par

Marketed product portfolio

Forecast sales

Alpharma

Marketed product portfolio

Forecast sales

Chapter 5 Consolidation in the generics

industry

Summary

Introduction

Factors influencing M&A deals across markets

Key deals in emerging markets

Dr. Reddy’s

Betapharm acquisition

Roche’s API facility acquisition

Trigenesis acquisition

Ranbaxy

Mundogen acquisition

Ethimed acquisition

Terapia acquisition

Egis

Serdix acquisition

Zentiva

Sicomed acquisition

Key deals in Western Europe

Sandoz/Novartis

Sabex acquisition

Hexal/Eon acquisition

Stada Arzneimittel

Hemofarm acquisition

Nizpharm acquisition

Other acquisitions

Ratiopharm

Magnafarma BV acquisition

vi

Pulmotec acquisition

Ribosepharm acquisition

Merck KGaA

Prasfarma acquisition

NM Pharma acquisition

Actavis

Alpharma acquisition

Amide acquisition

Sindan acquisition

Keri Pharma acquisition

Key deals in the US

Watson

Amarin acquisition

Sekhsaria acquisition

Andrx acquisition

Barr

Pliva acquisition

Mylan

Matrix Labs acquisition

Perrigo

Agis acquisition

Other key deals

Teva

Ivax acquisition

Conclusions

Chapter 6 Appendix

Glossary

Index

vii

List of Figures

Figure 1.1: Generics company growth strategies

Figure 1.2: Number of ANDA and first-to-file approvals, 2001-2006

Figure 1.3: Average monthly ANDA and first-to-file approvals, 2001-2006

Figure 1.4: Pharmaceutical cost containment policies in developed and developing markets

Figure 2.5: Market dynamics in the global unbranded generics market by country, 2004-05

Figure 3.6: Market breakdown of the major therapy classes in the global unbranded generics

market, 2001 & 2005

Figure 3.7: Market dynamics of the major CNS unbranded generics, 2005

Figure 3.8: Market dynamics of the major cardiovascular unbranded generics, 2005

Figure 3.9: Market dynamics of the major alimentary tract and metabolism generics, 2005

Figure 3.10: Market dynamics of the leading cancer unbranded generics, 2005

Figure 3.11: Market dynamics of the leading anti-infectives unbranded generics, 2005

Figure 4.12: Performance of major players in the global generics market, 2001 & 2005

Figure 5.13: Factors shaping M&A deals across the US, EU and emerging markets

Figure 5.14: Key generics M&A by region, 2004-06

Figure 5.15: Competitive pressures influencing generics M&A strategies, 2005-06

List of Tables

Table 2.1: Sales of unbranded generics by country, 2004-05

Table 2.2: Sales of unbranded generics in North America, 2004-05

Table 2.3: Sales of unbranded generics in Latin America, 2004-05

Table 2.4: Sales of unbranded generics in major Western European markets, 2004-05

Table 2.5: Sales of unbranded generics in major Central and Eastern European markets, 2004-

Table 2.6: Sales of unbranded generics in Japan, 2004-05

Table 2.7: Sales of unbranded generics in China, 2004-05

Table 2.8: Sales of unbranded generics in Asia-Pacific, 2001-05

Table 3.9: Sales by major therapeutic area across the global unbranded generics market, 2004–

Table 3.10: Sales of major molecules in the global CNS unbranded generics market, 2004–05

Table 3.11: Sales of major molecules in the global cardiovascular unbranded generics market,

2004–05

Table 3.12: Sales of major molecules in the alimentary tract and metabolic disorders global

unbranded generics market, 2004–05

Table 3.13: Sales of major molecules in the global cancer unbranded generics market, 2004–05

Table 3.14: Sales of major molecules in the global anti-infectives unbranded generics market,

2004–05

Table 3.15: Forecast global unbranded generics sales by therapy area, 2005-11

Table 4.16: Leading ten generics companies by global unbranded generics sales, 2004-05

Table 4.17: Leading generics companies by global generics sales, 2004-05

Table 4.18: Leading products in Novartis’ generics portfolio, 2004-05

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Table 4.19: Forecast sales of Novartis’ current generics portfolio, 2005-2011

Table 4.20: Leading products in Teva’s generics portfolio, 2004-05

Table 4.21: Forecast sales of Teva’s current generics portfolio, 2005-2011

Table 4.22: Leading products in Mylan’s generics portfolio, 2004-05

Table 4.23: Forecast sales of Mylan’s current generics portfolio, 2005-2011

Table 4.24: Leading products in Ratiopharm’s generics portfolio, 2004-05

Table 4.25: Forecast sales of Ratiopharm’s current generics portfolio, 2005-2011

Table 4.26: Leading products in Watson’s generics portfolio, 2004-05

Table 4.27: Forecast sales of Watson’s current generics portfolio, 2005-2011

Table 4.28: Leading products in Merck KGaA’s generics portfolio, 2004-05

Table 4.29: Forecast sales of Merck KGaA’s current generics portfolio, 2005-2011

Table 4.30: Leading products in Ivax’s generics portfolio, 2004-05

Table 4.31: Forecast sales of Ivax’s current generics portfolio, 2005-2011

Table 4.32: Leading products in Apotex’s generics portfolio, 2004-05

Table 4.33: Forecast sales of Apotex’s current generics portfolio, 2005-2011

Table 4.34: Leading products in Par’s generics portfolio, 2004-05

Table 4.35: Forecast sales of Par’s current generics portfolio, 2005-2011

Table 4.36: Leading products in Alpharma’s generics portfolio, 2004-05

Table 4.37: Forecast sales of Alpharma’s current generics portfolio, 2005-2011 103