全球非專利藥品指南：第 2 部 - 各國市場的參考範例與策略課題

Abstract

Overview

Introduction

The generics market is undergoing significant change, with intense merger and acquisition activity, a raft of upcoming patent expiries and new legislation being enacted to promote generic prescription in the major markets. In addition, key issues, such as authorized generics, the first biosimilars approvals and increasing competition within the market are also affecting growth dynamics

Scope

• Overview of the size of the generics market in the US, Japan, France, Germany, Italy, Spain and the UK
• Assessment of the various policies being implemented to promote generic prescribing and drug use
• Analysis of key strategic issues including M&A, authorized generics and patent challenges
• Examination of the future areas for generic growth, including an update of the biosimilars situation

Highlights

There is still room for growth in the more mature generics markets, with governments examining methods of increasing generic usage even further. However, pricing pressures may result in this growth not being translated into positive returns for the generics industry.

Competition in the generics market is becoming increasingly intense, with low cost producers expanding globally and branded Pharma becoming involved through subsidiaries or via authorized generic agreements. The wave of consolidation that swept through the generics market has been spurred on by this competition and is unlikely to end any time soon.

The biosimilars market has moved on in 2006, with two products (Sandoz's Omnitrope and Biopartners' Valtropin) being approved in the EU. Omnitrope was finally approved in the US, after a lengthy delay, but the FDA has stated that this does not set a precedent for future approvals of other biosimilars.

Reasons to Purchase

• Identify the key factors and issues that will either promote or prevent generic growth in each of the seven major markets
• Understand the changing competitive dynamics within the generics industry and plan your own strategies accordingly
• Assess the strategic issues that are affecting the generics industry and how the key players are addressing them

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the report
  • Key findings
• CHAPTER 2 GENERICS MARKET DYNAMICS
  • Key findings:
  • The global generics market is worth an estimated $60 billion
    • The seven major markets account for over two thirds of the value of the total generics market
    • Teva and Sandoz dominate the generics market but consolidation and globalization are changing the competitive landscape
  • Increasing healthcare expenditure in each of the seven major markets has led to a variety of measures being implemented to increase generic use
    • The changing healthcare environment in the US will drive future generic use
      • Healthcare expenditure is a concern for many Americans
      • There are a variety of generic substitution policies in place
      • Pharmacists are incentivized to dispense generics
      • Cost savings could be significant if generics were used more widely
      • Healthcare providers are implementing a range of incentives to boost generic use
      • Medicare Part D is expected to lead to greater generic use
      • The growing role of patients in their own healthcare choices will drive generic use
    • Cost-containment measures in Germany have led to a healthy generics market
      • Healthcare services are provided for free in Germany
      • There is a wide range of policies in place to promote generic prescribing
      • The AVWG is expected to drive further generic use
      • Jumbo reference pricing could be a double-edged sword for generics
      • Pricing issues may negatively affect profitability for generics companies
    • The UK is one of the most developed generics markets in Europe
      • The National Health System (NHS) is extremely cost-constrained
      • The UK's pharmaceutical pricing structure lends itself to higher generic penetration
      • There are several drivers and resistors to generic dispensing
    • Generic consumption in France is particularly low
      • Most of the population are covered by National Health Insurance
      • Significant advances have been made in the use of generics in France
      • Measures to increase generic prescribing by physicians have been implemented
      • French prices have been a major deterrent of generic use
      • Changes to reimbursement rules may drive generic growth
      • Pharmacists are being mandated to drive generic dispensing
    • Spanish generic use is among the lowest in the EU
      • Healthcare in Spain is decentralized but provided for free for the population
      • Pharmaceutical prices in Spain are much lower than in other European markets
      • Generic substitution is permitted - to a degree
      • Generic awareness is not especially high among physicians or the public
      • Pharmacists and physicians do not drive generic use
    • The Italian generics market looks unlikely to grow in the short-term
      • The decentralized approach to healthcare provision in Italy means there is a wide variety in policies
      • Pricing policies have been reformed to promote generic use
      • Pharmacists and physicians are not encouraged to prescribe generics
    • The Japanese generics market is currently underdeveloped
      • There has been a lack of incentives for the promotion of generic use
      • Generic substitution has only recently been allowed in Japan
      • Generic drugs are regarded with suspicion by prescribers
  • There are several issues which will affect future growth within the generics market
    • Patent expiries, an aging population and cost constraints should drive generic market growth
      • The wave of patent expiries expected over the next ten years will generate major opportunities for generic companies
      • The aging population will drive future uptake of generic drugs
      • Most countries are becoming increasingly cost-constrained
      • Therapeutic substitution becomes a reality
    • The key growth resister is increasing competition within the market
      • Low-cost manufacturers are creating increased competition
      • Increasing cooperation among generics companies is a double-edged sword
      • Some branded companies have generic subsidiaries
• CHAPTER 3 STRATEGIES FOR SUCCESS: GROWTH THROUGH CO-OPERATION
  • Key findings
  • M&A activity has gained momentum over the last two years
    • There has been increasing consolidation in the generics market
      • 2005 was a major year for M&A activity
      • Two key deals have been announced in 2006
    • M&A multiples depend on the portfolio of the target company
  • Authorized generics are becoming increasingly important
    • There can be several advantages for branded Pharma
      • Authorized generics can be a cost-effective method of settling patent litigation
      • Branded Pharma can gain financially
      • Other advantages include acting as a deterrent against patent challenges and utilization of manufacturing capacity
      • Case study - cooperative authorized generic: Shire settles Adderall XR patent litigation
      • Case study - competitive authorized generic: Sanofi-Aventis's Allegra authorized generic foils Teva and Barr
    • The generics industry is split on the issue of authorized generics
      • Authorized generics can provide a boost for companies with a weaker pipeline
      • The pursuit of authorized generics is a key part of many generics companies' strategy
    • The FTC is investigating the anti-competitiveness of authorized generics
• CHAPTER 4 STRATEGIES FOR SUCCESS: PATENT CHALLENGES
  • Key findings:
  • Patent challenges offer the possibility of significant sales for generics companies
    • Barr obtained 180-days exclusivity after successfully challenging Lilly's Prozac patent
    • Schwarz Pharma's omeprazole generic generated significant sales for the company
    • Teva's strength lies in its patent challenge strategy
  • There have been some important patent challenges taking place in the last two to three years
    • Ranbaxy's Lipitor patent challenge causes concern for Pfizer
      • Key decisions go in Pfizer's favor
      • Ranbaxy has suffered a setback with the loss of the Lipitor challenge
    • Fosamax comes under several patent challenges
      • Merck's outlook takes a turn for the worse
    • Early Toprol generic competition is likely
    • The patent challenge against Plavix is settled but attracts scrutiny
      • BMS/Sanofi-Aventis reach a settlement with Apotex but the move is criticized
• CHAPTER 5 FUTURE OUTLOOK
  • Key findings
  • Several therapy areas are expected to experience their first major patent expiries
    • Although there are generic statins, the US patent expiries of Zocor and Pravachol will significantly change the shape of this market
      • The patent expiry of Zocor is expected to have the greatest impact
      • The impact on Zocor - branded share is expected to be considerably eroded
      • The impact on Lipitor - will its brand loyalty be enough to maintain market share?
      • The impact on the statins market - dynamics will swing in favor of generics
      • Could the statins be a case study for future therapeutic substitution?
    • The patent expiries of Cozaar and Diovan are expected to lead to price reductions throughout the ARB class
      • Could the statins' substitution paradigm established in the US be repeated for the ARBs?
      • Germany readies itself for the first ARB patent expiry
      • The genericization of the ARBs could lead to switching from other classes
    • The patent expiry of Norvasc could lead to new CV combinations
    • The first antiretroviral patent expiries could herald a return to older treatment paradigms
      • Key first-line therapies will be exposed to generic competition
      • The convenience of fixed-dose combinations is not expected to protect them from generic competition
    • Will there be generic asthma combinations?
      • Advair's combination deemed not novel and, therefore, not patent protected
      • Other asthma combinations may be at risk of genericization
    • Biosimilars are now a reality
      • The first biosimilar was approved in Europe in 2006
      • The US has lagged behind Europe in developing a biosimilar regulatory pathway
  • The Japanese market will experience a significant increase in generic usage
    • Considerable savings could be realized through the greater use of generics
    • The next five years will see the Japanese generics market grow
    • The competitive landscape in Japan is expected to change considerably
      • Sawai and Towa are well-positioned to take advantage of the expected increase in generic use
      • Several companies have entered the Japanese generics market
• APPENDIX A: ADDITIONAL INFORMATION
  • Limitations of data
    • Standard units
    • Japanese market data
  • Exhange rates
• APPENDIX B: BIBLIOGRAPHY
  • Journal articles
  • Newspaper articles
  • Company sources
    • Presentations
    • Annual Reports
  • Miscellaneous sources
  • List of Tables
    • Table 1: Five generics companies are among the top 10 in terms of prescriptions filled under Medicare Part D
    • Table 2: The actual generic fill rate varies among the therapeutic classes
    • Table 3: Several branded Pharma companies have generics subsidiaries
    • Table 4: M&A activity was rife in the generics market in 2005
    • Table 5: The sales multiples for generic M&A transactions have varied
    • Table 6: Diovan and Cozaar dominate the ARB class
    • Table 7: There are considerable savings to be realized by using generic drugs
    • Table 8: Significant annual savings can be generated through the use of generics
    • Table 9: Exchange rates*, 2005
  • List of Figures
    • Figure 1: The generic market share as a percentage of total pharmaceutical sales varies across the seven major markets
    • Figure 2: The US dominates the global generics market, generating $24 billion in sales in 2005
    • Figure 3: Generic usage is highest in the US, Germany and the UK
    • Figure 4: Teva and Sandoz were the clear generics market leaders in terms of sales value in 2005
    • Figure 5: More than half of all prescriptions dispensed in the US are generics
    • Figure 6: Generics companies dominate the US pharmaceutical market in numbers of prescriptions
    • Figure 7: Generic use in the US is promoted - a resisted - through a number of channels
    • Figure 8: The generic fill rates in the US for 2003 varied considerably by state
    • Figure 9: The tiered co-payment system will lead to greater use of generics
    • Figure 10: Use of generics is encouraged - and resisted - in Germany through several different mechanisms
    • Figure 11: A fall in reference prices is likely to lead to greater use of generics
    • Figure 12: The UK generics market has experienced strong sales growth since 2001
    • Figure 13: Despite a number of resistors, the generics market in the UK is well-developed
    • Figure 14: The French generics market is much smaller than those in other major European markets
    • Figure 15: Despite measures to promote generic use in France there are several resisters still in place
    • Figure 16: Although generic sales and volume use have increased over the last ten years, the generics market only accounts for a small proportion of the Spanish pharmaceutical market
    • Figure 17: There are few drivers of generic growth in Spain
    • Figure 18: The Italian market has experienced limited growth since 1994
    • Figure 19: Measures to promote generic use in Italy have been implemented
    • Figure 20: The Japanese generic market is underdeveloped because of a number of factors
    • Figure 21: Physicians receive a percentage of the price of a prescribed drug
    • Figure 22: Several key products are expected to lose patent protection in 2006, exposing billions of dollars of brand sales to generic competition
    • Figure 23: 2008 and 2011 are expected to be the next bumper years for generics companies
    • Figure 24: Most big Pharma companies are expected to lose significant sales as patents expire over the next 10 years
    • Figure 25: The age distribution of the world's population is expected to change considerably over the next 50 years
    • Figure 26: As the population ages and birth rates decline, population pyramids for more developed regions are expected to become increasingly top-heavy
    • Figure 27: Pharmaceutical expenditure accounts for, on average, between 12% and 22% of total healthcare spend
    • Figure 28: In Germany, generic statins are significantly cheaper than the branded products
    • Figure 29: Pfizer retained a third of gabapentin volume sales after launching a generic through Greenstone
    • Figure 30: Authorized generics agreements can serve several purposes
    • Figure 31: Branded Pharma can gain from authorized generic agreements
    • Figure 32: Apotex's generic paroxetine sales were considerably reduced by the launch of Par's authorized generic
    • Figure 33: In addition to obtaining a share of generic sales, Sanofi-Aventis also reduced Teva's fexofenadine sales through its authorized generic agreement with Prasco
    • Figure 34: There are positive and negative aspects to authorized generics for companies involved in the generics market
    • Figure 35: The authorized generics settlements made in FY 2005 included both cooperative and competitive agreements
    • Figure 36: Barr's Prozac patent challenge delivered high returns for the company
    • Figure 37: Schwarz Pharma generated significant sales after its exclusivity agreement with Andrx and Genpharm
    • Figure 38: Generics account for a relatively small share of the statins market in the US
    • Figure 39: Pravachol only accounts for 10% of US statin sales value ($m) and 7% of sales volume (SUm)
    • Figure 40: Generic simvastatin sales, assuming a relatively high level of switching from Zocor
    • Figure 41: Generic simvastatin sales, assuming a medium level of switching from Zocor
    • Figure 42: Generic simvastatin sales, assuming a low level of switching from Zocor
    • Figure 43: Depending on the level of switching, Lipitor sales could range between $418m and $3.8 billion in the first six months of generic simvastatin's availablity
    • Figure 44: Generics will account for a growing percentage of statins sales volume after 2006
    • Figure 45: Generic zidovudine has made an inroad into the branded products sales despite being available since September 2005
    • Figure 46: Japanese generic sales are expected to reach Ұ500 billion by 2008