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Impact of Generics on the Antidepressant Market

Decision Resources, Inc, December 2005, Pages: 13

The depression therapy market is one of the largest in the world. Several antidepressants have achieved blockbuster status. Although the market for antidepressants continues to grow, the rate of growth has slowed, in part because of generics competition. By 2010, the market-leading antidepressants will all face generics competition, at least in the United States. In this report, we examine the current antidepressant market and discuss the effect that increasing generics competition will have.

Business Implications
- Depression is a major health problem. The World Health Organization (WHO) predicts that by 2020 depression will be the second- largest cause of the global health burden. The disease is the central nervous system (CNS) disorder with the highest prevalence— about 40 million diagnosed cases in the United States, France, Germany, Italy, Spain, United Kingdom, and Japan. In the United States, there are 15 million cases of depression. The diagnosis rate for depression should continue to rise as public awareness of the disease increases.
- Antidepressant sales constitute the largest segment of the CNS market, approximately 24%. In 2004, global sales of antidepressant agents exceeded $15 billion. Japan is currently a relatively unimportant market for antidepressants, constituting about 5% of the global market; Europe (19%) and especially the United States (71%) account for most of the global sales of antidepressants.
- Global sales of branded antidepressants exceeded $14 billion in 2004; U.S. sales totaled $9.9 billion. Venlafaxine (Wyeth's Effexor) and sertraline (Pfizer's Zoloft) led the global market, each generating sales of $3.3 billion. Nevertheless, as a result of the expiration
of patents covering some of the leading antidepressant drugs, the market share of generic antidepressants increased from 20% in 2000 to 42% (by volume) in 2004, a trend we expect to continue.
- Over the next five years, generic forms of nearly all the leading branded antidepressants will emerge. Sertraline's patent, for
example, expires in 2005-2006 in key major markets, and challenges to patents covering venlafaxine and escitalopram (Forest/Lundbeck's Lexapro) will likely lead to the availability of generic forms of these products in the United States by 2009 and 2010, respectively.
- As a result of patient expiries, we expect the value of the U.S. antidepressant market to decline by 2.1% per year between 2004 and 2009 and the market share of generics to increase about 75% by volume. (This decline may be lessened if Wyeth succeeds in upholding its key patents on venlafaxine.) The impact on the global market will be less pronounced but still significant.

Introduction
Depression: Disease Burden, Characteristics, and Prevalence
Current Antidepressant Market
Impact of Generics on Branded Drugs: Case Studies
Key Impending Patent Expiries
Antidepressants in Development
Market Outlook

List of Tables and Figures

Table 1. Global Sales of Leading Antidepressant Brands, 2003-2004
Table 2. U.S. Sales of Leading Antidepressant Drugs, 2003-2004
Table 3. Forecasted 2009 U.S. and Global Sales of Antidepressants
Figure 1. The Impact of Generic Fluoxetine on U.S. Sales of Prozac, 2000-2004
Figure 2. The Impact of Generic Paroxetinhe on U.S. Sales of Paxil IR and Paxil CR, 2002-2005
Figure 3. Time Line of key Introductions of new Antidepressants in the U.S., 2000-2010

Companies mentioned in this report include:
- Forest Laboratorie
- Eli Lilly
- Wyeth
- Pfizer
- Lundbeck
- GlaxoSmithKline
- Organon
- Generics
- SmithKline Beecham
- Sanofi-Aventis
- Corcept
- Servier

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