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1、H E A L T H C A R E The Future of The Generics Industry Opportunities, threats and key trends by Tim Wesley ii Tim Wesley Tim Wesley is a freelance writer with more than 20 years of experience covering the global healthcare sector. He has researched and written a broad range of business intelligence
2、 reports. He also produces CEO speeches, corporate reports, in-depth features and news articles for a range of clients that includes multinational healthcare companies, industry associations and national newspapers. Copyright 2010 Business Insights Ltd This Management Report is published by Business
3、 Insights Ltd. All rights reserved. Reproduction or redistribution of this Management Report in any form for any purpose is expressly prohibited without the prior consent of Business Insights Ltd. The views expressed in this Management Report are those of the publisher, not of Business Insights. Bus
4、iness Insights Ltd accepts no liability for the accuracy or completeness of the information, advice or comment contained in this Management Report nor for any actions taken in reliance thereon. While information, advice or comment is believed to be correct at the time of publication, no responsibili
5、ty can be accepted by Business Insights Ltd for its completeness or accuracy. iii Table of Contents The Future of the Generics Industry: Opportunities, threats and key trends Executive Summary 8 The generics industry 8 Generic industry opportunities 9 Generic industry challenges 10 The future of the
6、 generics industry 11 Chapter 1 The generics industry 14 Summary 14 Introduction 15 The global market for generics 15 The generics industry 16 Emergence of the generic giants 18 The impact of acquisitions on Tevas recent expansion 20 Growth of regional and national players 22 Case study: Stadas gene
7、ric growth engine grinds to a halt 24 Multinationals join the generic fray 27 Big pharma generic deals 28 Biosimilars new players for a new market 33 Early biosimilar acquisitions and alliances 34 New players 35 Chapter 2 Generic industry opportunities 38 Summary 38 Introduction 39 Patent expiries 3
8、9 Impact of patent expiries 40 Recent generic targets 41 Amlodipine 41 Simvastatin 43 Future generic targets 44 iv Generic activity in 2010 45 Atorvastatin 47 Emerging generic markets 48 Developed markets 49 Case study: The Japanese generics market 50 Developing markets 55 Case study: the Brazilian
9、generics market 57 Pro-generic healthcare policies 61 Pricing and reimbursement policies 63 Generic price caps 63 Reference pricing 65 Price approvals and reimbursement listings 68 Prescribing policy 68 Dispensing policy 71 Drug purchasing 72 Regulatory policies 73 Financial assistance for generic m
10、anufacturers 74 Biosimilars 75 Early development of the biosimilars market 76 Regulatory pathways 76 Early headway made by biosimilars 79 Biosimilar pricing and reimbursement issues 81 Biosimilar market prospects 82 Biosimilar targets 83 Biosimilar players 85 Chapter 3 Generic industry challenges 88
11、 Summary 88 Introduction 89 Regulatory barriers 89 Patent exclusivity 90 Patent-term extensions 92 Challenging patents 93 Non-patent exclusivity 95 Orphan drug and pediatric exclusivity 96 Quality standards 97 Bioequivalence 98 Good Manufacturing Practice 99 Regulatory pathways 100 Issues surroundin
12、g generic approval and market entry 101 Regulatory pathways for biosimilars 104 Cost-containment policies 105 Public sector procurement 105 Tendering procedures 105 Sole supplier and preferred provider agreements 106 v Pricing and reimbursement policy 111 Discount-based price cuts 112 Lower generic
13、price ceilings and post-patent price cuts 113 More aggressive approaches to reference pricing 116 Originator strategies 118 Strategic use of intellectual property and regulatory frameworks 120 Pay for delay agreements 120 Citizen petitions 122 Patent layering or evergreening 124 Development of origi
14、nal brands or franchises 126 Product hopping 126 Authorized generics 128 Pricing and promotional strategies 129 Pricing tactics 130 Promotional tactics 131 Negative promotional activity 132 Physician, pharmacist and patient attitudes 133 Physicians 134 Shaping physician behavior 135 Pharmacists 136
15、Shaping pharmacist behavior 138 Patients 139 Shaping patient behavior 140 Chapter 4 The future of the generics industry 144 Summary 144 Introduction 145 Generic market prospects 146 The core generics market 146 Emerging markets for branded copies 147 The biosimilars market 148 Generic industry prosp
16、ects 149 Leading players 149 Teva 149 Sandoz 151 Other leading players 152 National players 155 New market entrants 157 The generics industry in 2015 159 vi Appendix 160 Primary research methodology 160 List of Figures Figure 1.1: Top-ranked pharma and generic company sales, 2001 and 2009 17 Figure
17、1.2: Impact of acquisitions on Tevas global generic revenues 22 Figure 1.3: Development of Stadas German generic sales, 2002-2009 25 Figure 2.4: Impact of US patent expiry on Norvascs revenues, 2006-2009 42 Figure 3.5: Impact of extended exclusivity on Lipitors US revenues 119 List of Tables Table 1
18、.1: Top 6 players in the core generics market, 2009 19 Table 1.2: Tevas major generic acquisitions, 2000-2010 21 Table 1.3: Stadas performance in key markets, 2009 26 Table 1.4: Sanofi-Aventis deals targeting the generics sector 31 Table 2.5: Post-patent decline in US sales of Zocor 44 Table 2.6: Ma
19、jor brands facing US patent expiry, 2010-2014 45 Table 2.7: Generic shares of major developed markets, 2009 50 Table 2.8: Leading Japanese generic company financials, 2009 53 Table 2.9: Generic shares of the Brazilian market, 2004-2009 59 Table 2.10: Generic price caps in major pharmaceutical market
20、s 64 Table 2.11: Reference pricing in major pharmaceutical markets 67 Table 2.12: EU biosimilar approvals 77 Table 2.13: Revenues and patent expiry dates for leading biotech brands 84 Table 3.14: Patent-term extensions granted to major brands in the US 93 Table 3.15: The US generic approval backlog,
21、 2005-2009 102 Table 3.16: Comparison of prices in New Zealand with three other markets 107 Table 3.17: Impact of preferred supplier policy on Dutch generic prices 109 7 Executive Summary 8 Executive Summary The generics industry ? Driven by rapid growth and significant changes in the geographic and
22、 therapeutic make-up of the sector, the generics industry has undergone a period of major restructuring over the past ten years. ? Merger and acquisition deals have concentrated growing shares of the global generics market in the hands of the sectors leading players. Between them, the worlds five bi
23、ggest generic manufacturers have invested approximately US$50bn into acquisition deals completed since 2001. ? Teva alone has invested US$24bn in acquisitions. Alongside in-house growth, these have seen generic sales posted by the Israeli company rise almost seven-fold in less than ten years. In 200
24、1, Tevas generic sales were equivalent to just 6% of global revenues generated by the worlds biggest pharmaceutical company. By 2009 the figure was 17%, and Teva was ranked among the worlds 15 largest pharmaceutical businesses in its own right. ? National and regional generic specialists have also e
25、xpanded rapidly. Players with limited geographical reach are heavily exposed to changes in individual market environments, however. The performance of some has been affected by regulatory changes and renewed pharmaceutical cost-containment drives launched by governments in key markets. ? Small and m
26、id-sized generic businesses are also prime acquisition targets not only for established generic majors, but also for multinational pharma companies pursuing entries into the generic and branded generic market segments. All of the worlds five biggest pharmaceutical companies have completed acquisitio
27、ns or licensing deals in the generics market within the past three years. 9 ? The emergence of a market for biosimilars has attracted other new players into the sector. Existing leaders in the generics market have been forced to pursue a new round of acquisitions and alliances in order to access the
28、 expertise required to develop and commercialize follow-on biologics. Generic industry opportunities ? A steady stream of patent expiries, the widespread adoption of stronger pro-generic healthcare policies, the emergence of new generic markets and the establishment of a substantial biosimilars sub-
29、sector will all present major opportunities for the generics industry through the next five years and beyond. ? Patents on original brands with aggregate annual sales of approximately US$200bn will expire over the next five years. Among them is the worlds best-selling pharmaceutical brand, Lipitor (
30、atorvastatin), which will be exposed to generic competition in the key US market from November 2011. Revenues generated by original brands can halve within two years of major patent expiries, with generics achieving increasingly rapid penetration of the market for key targets. ? New markets for gene
31、rics have begun to emerge, and will broaden geographical opportunities for international players in the sector. Japan, where the government is targeting a 10% increase in volume shares accounted for by generics, and Brazil, where generic sales are rising at annual rates in excess of 20%, rank among
32、the most promising new targets. ? Pro-generic policies will be embraced more widely in a bid to curb drug spending. Pricing and reimbursement systems, prescribing and dispensing policies, regulatory frameworks and public sector purchasing strategies will all be remodeled in ways designed to maximize
33、 savings from generics. ? The market for biosimilars will begin to gather momentum as patents on monoclonal antibodies reach expiry, and as more coherent regulations governing the approval and use of follow-on biologics are introduced. Barriers to entry in this 10 new, high-risk sub-sector of the ge
34、nerics market are substantial, but the rewards for success promise eventually to be equally significant. Generic industry challenges ? Regulatory barriers, cost-containment policies, originator strategies and attitudes among prescribers, pharmacists and patients are among the main challenges faced b
35、y the generics industry. Efforts will be made to address some of the key barriers to broader generic use, but these factors will continue to act as constraints on the value of the generics market through the next five years and beyond. ? Exclusivity periods available to many original brands have bee
36、n boosted by recent amendments to patent and data exclusivity provisions in major markets. Overloaded or inefficient regulatory pathways will delay further generic entries in some key developed markets, while the imposition of tighter quality standards will pose a major challenge to small generic ma
37、nufacturers in some emerging markets. ? Cost-containment policies will drive further increases in demand for generics, but will impose growing pressure on prices in the sector. Online tenders, sole supplier and preferred provider schemes will drive institutional purchase prices down, while retail ge
38、neric prices will be affected by the imposition of post-patent price cuts, lower generic price ceilings and more aggressive approaches to reference pricing. ? Originators will exploit loopholes in intellectual property and regulatory frameworks to block or delay the arrival of generic competition fo
39、r their brands. They will also make use of authorized generics, and will employ pricing and promotional strategies designed to disrupt the market for early generic entrants. Some defensive strategies will be curtailed as regulators in the US and Europe take a closer interest in the activities of ori
40、ginators. ? Levels of brand affinity that persist among physicians, pharmacists and patients will be difficult to break down, but will be tackled by governments keen to maximize 11 potential savings from broader generic use. Financial incentives will be employed more widely in a bid to shape prescri
41、bing, dispensing and purchasing trends. The future of the generics industry ? The impact of rising demand for medicines, pro-generic healthcare policies and patent expiries will outweigh growing pressure on prices, driving generic sales up at rates in excess of total pharmaceutical market values thr
42、ough the next five years. By 2015 the sector will be worth more than US$250bn. ? While growth will remain strong, pressure on margins and the imposition of tighter regulations in some developing markets will drive further restructuring in the generics market. Many small and mid-sized companies will
43、be squeezed out. Some will be acquired by generic majors pursuing further growth, or by new entrants building positions in the generics sector. ? Teva will consolidate its position at the top of the generic industry rankings, supplementing solid in-house growth with an aggressive acquisitions progra
44、m. Sandoz will focus primarily on smaller, more strategic targets, building positions in differentiated market niches where margins exceed those in the core retail generics segment. ? The fate of most second-tier generic companies is uncertain. They lack the resources to bridge the gap in scale betw
45、een themselves and the two industry leaders. Some also face pressing financial problems, and few are likely to survive in their current form beyond the next five years. A defensive merger between two second-tier players is possible, but most are now regarded as acquisition targets. Potential buyers
46、include multinationals as well as generic majors ? Pfizer is expected to conclude at least one major generic acquisition in the near future, targeting a stronger position in markets outside the US before Lipitor is exposed to generic competition. Sanofi-Aventis will also announce more acquisitions i
47、n the generics market. Most other multinational pharma companies 12 will confine their involvement to the branded generic segments of emerging markets, though some may eventually follow Merck ? Pro-generic policies: which will be adopted increasingly by governments and other payers attempting to bal
48、ance limited pharmaceutical budgets; ? Emerging generic markets: which will present opportunities for the geographic expansion of existing generics businesses; ? Biosimilars: which are set to emerge as a specialist, high-value segment of the generics industry. The sector will certainly not be withou
49、t its challenges (see Chapter 3), but companies able to take full advantage of emerging opportunities in the sector will continue to post solid revenue growth. Those in a position to make the most of new product and market opportunities could also post higher margins in future. Patent expiries By definition, a golden age for pharmaceutical innovation will be followed eventually by a golden age for generics. And that is exactly what generic manufacturers have been enjoying for the best part of a decade now, as patents on blockbusting brands that fuelled a per