CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Key findings 5
CHAPTER 2 PLANNING FRAMEWORKS - STRUCTURING EARLY PRE-LAUNCH STRATEGY 11
Planning your launch campaign 12
Market assessment 13
Developing your target market 16
Evaluating the commercial potential of a market 18
Competitive assessment 18
Improving diagnoses and building patient awareness is key 18
Prioritizing pricing and reimbursement 20
Prioritize P&R in drug development 20
Setting the price for a new drug 22
Determine which country to launch in first 22
Perform brand strengthening throughout the lifecycle to ensure maximum price and high reimbursement 25
Designing the marketing mix 26
Positioning is key 26
Defining the brand essence 32
CHAPTER 3 REGULATORY ISSUES IMPACTING LATE-STAGE PRE-LAUNCH 36
The road to regulatory approval 37
Overview of trends facing launching manufacturers 37
Regulatory definitions 40
FDA definitions 40
EMEA definitions 41
The number of NDAs submitted is growing in the US and EU 42
Rise in approval rates in 2006 44
Rise in submissions and approvals driven by product modifications 45
Mean approval times by the FDA and EMEA are similar 46
Clinical trials are taking longer 47
Pain drugs experience the shortest mean development times 48
Companies and drug approvals 49
Faster approval times has not affected drug safety 49
Balancing faster development with drug safety 50
Putting a price on approval delays 53
NDAs and BLAs are most likely to receive 'priority review' status 55
Fast Track approvals 57
Orphan drugs and niche markets 60
Advantages of launching an orphan drug 62
Delays in product approvals in the US 63
In-licensed drugs in the US experience a higher rate of first-time approvals 65
Drugs that require input from advisory meetings experience lower first-time approval rates in the US 66
Large US companies have higher FDA approval success rates than small non-US firms 67
Product/application deficiencies hamper the approval process 69
Phase IV studies and post-marketing commitments aid faster approval 73
Post-marketing commitments are on the increase 75
The majority of PMCs are unfinished 76
Regulation of PMCs set to improve 77
CHAPTER 4 ANALYZING LAUNCH STRATEGIES POST-APPROVAL 81
Delays to launch following approval 82
Finalizing pricing and reimbursement delays launches in Europe 82
Patent infringement prevents Novartis from an early launch of Exforge 84
Scheduling delays launch of drugs with abuse liability 85
Drugs are traditionally launched in the US first 86
Drugs historically approved in the US market prior to the 5EU 86
The proportion of drugs approved first in the 5EU has remained flat 88
Between 2002 and 2006 more drugs were launched first in the US market 89
The proportion of drugs launched first in the 5EU has remained flat 90
Approval to launch time is fastest in the US, but the 5EU is catching up 91
US overtakes EU in launching NMEs 95
Launch timing and market entry 97
Product launch determines level of long-term success 97
Case studies: brands which have not followed the traditional uptake curve 100
Predicting the long-term success of a drug based upon its launch 104
Drug quality cannot be relied upon alone to drive commercial success 106
Launch order is not a significant determinant of relative commercial success 108
Case studies: launch order is not significant 109
Seasonal factors should be considered at drug launch 115
ADHD drug manufacturers should be aware of the implications of drug holidays when launching a new product 115
Entering the market in time for the annual flu season is vital for manufacturers of influenza vaccines 117
CHAPTER 5 COMMERCIALIZATION AND PROMOTION STRATEGIES 122
Commercialization 123
Co-promotion versus co-marketing 125
Why choose co-promotion? 126
Why choose co-marketing? 127
Manufacturers increasingly employ global brand strategies 127
Different 5EU and US marketers 130
Lilly's use of a CSO to maximize the launch of Cymbalta 132
Co-development and co-marketing enhances Vytorin's launch and uptake 133
Promotion 135
How much should be spent on promotion? 136
How to prepare your market? 138
Drugs with novel mechanisms of action 138
Drugs with similar therapeutic profiles 142
Launching into a developed market by focusing upon niche subsets of the patient population 142
Which promotional methods can be employed? 144
Prioritizing awareness campaigns 144
Development of a patient education website 144
Television disease advertising 145
Patient mailing 145
Promotional spend at launch 145
Direct-to-consumer advertising 148
Changes to DTC advertising in the US 150
Leading new drugs by DTC spend 152
Detailing and sampling 154
eSampling 155
Celebrex's detailing and sampling drives uptake in arthritis market 156
Lunesta's detailing, sampling and DTC promotion drives uptake 158
CHAPTER 6 LAUNCH CASE STUDY ANALYSIS 160
Failure to launch 161
Pfizer's terminated indiplon collaboration leads to decline in CNS franchise revenues, 2005-10 162
Lilly's Arxxant is no longer expected to gain approval 164
Most successful launches during 2002-06 166
Atripla - the future HIV market leader 167
Lexapro - the most successful CNS drug launched during 2002-06 168
Vytorin - the first combination pill for hypercholesterolemia 170
Neulasta - second generation success for Amgen 171
Key companies in the US market 173
Pharmaceutical companies set to launch a greater number of new products in the future 173
Launch portfolios sales forecast to increase 177
Reliance on sales from launch portfolios expected to increase by 2012 179
Case study analysis of key company launch portfolios 181
GSK forecast to have the strongest launch portfolio by 2012 181
Novartis boasts the largest launch portfolio during 2006-12 182
J&J's launch portfolio is dominated by its 2007 launch products 183
AstraZeneca will rely on line extensions instead of its sparse pipeline to grow sales 184
Forest's 2006 sales rely almost entirely on recently launched products 186
Wyeth's reliance on launch portfolio sales is expected to increase from 0% to 25% in 2012 188
Future launch outlook for leading pharmaceutical companies 190
Pharmaceutical companies forecast to launch a greater number of new products in the future 191
Launch portfolios sales forecast to increase, but return set to fall 191
Reliance on sales from launch portfolios forecast to increase by 2012 191
Key therapy areas 2006-12 193
The value of branded products from the top 50 global companies is expected to grow to $430 billion by 2012 193
20% of products launched by 2012 will be for CNS disorders 194
CHAPTER 7 BIBLIOGRAPHY 196
Datamonitor reports 196
Websites 197
Publications and online articles 203
Conference literature 205
Glossary of terms 205
APPENDIX 210
IMS vs. company-reported data reconciliation 210
List of Tables
Table 1: Average daily sales of the top ten highest selling drugs in the US (2006) 53
Table 2: Single- and multi-cycle approval rates by application type (%) (2002-04) 64
Table 3: Barriers and solutions to approval by the FDA 68
Table 4: Factors leading to delays in FDA product approval (2002-04) 70
Table 5: Comparison of Xolair's US sales - IMS Midas Sales data versus Genentech's company reported sales data ($m) 103
Table 6: No significant difference in commercial success between priority and 'standard reviewed' products in the US (2002-06) 107
Table 7: Number of clinical abstracts presented at conferences in year preceding and following US launch 114
Table 8: Number of journal articles published in year preceding and following US launch 115
Table 9: Drivers and resistors of co-promotion 126
Table 10: Drivers and resistors of co-marketing 127
Table 11: Brands that do not follow a global (US+EU) brand strategy, launched between 2002 and 2006 129
Table 12: Leading drugs by DTC spend, launched in the US between 2001 and 2005 152
Table 13: Leading companies by number of new branded (original or licensed) US product launches (Q2 2002-Q4 2006 and 2006-12) 175
Table 14: Reliance of leading pharmaceutical companies on their launch portfolios during 2002-06 and 2006-12 192
Table 15: The CNS market will experience the greatest number of new drug launches, and largest sales by 2012 194
List of Figures
Figure 1: Planning a product launch framework 7
Figure 2: Stakeholder input should be utilized at all stages of drug development and launch 13
Figure 3: Static and dynamic patient flows in the schizophrenia market 14
Figure 4: Rise of the once-daily ADHD drugs to market leading status in the US, 2001-05 15
Figure 5: The launch of Requip for restless legs syndrome rejuvenated the brand's sales, Q1 2004-Q1 2006 19
Figure 6: Pharmacoeconomic tasks to carry out in each drug development phase 21
Figure 7: The optimal launch across Europe takes place over three waves 23
Figure 8: Proportion of drug launch positions for each country (2003-06) 24
Figure 9: Rebif: promotion focusing upon drug efficacy 27
Figure 10: Lexapro's positioning drove it to blockbuster status during its second year on the market, and has maintained Forest's antidepressant franchise revenues, Q1 2001-Q4 2006 28
Figure 11: Fosamax once-weekly's superior profile significantly grew franchise sales (Q1 1999-Q4 2003) 29
Figure 12: Defining the 'brand essence' 32
Figure 13: Despite its second to market position, Levitra's lack of differentiation has hindered uptake 34
Figure 14: The US currently is leading the world in terms of pharmaceutical R&D (1997-2005) 37
Figure 15: US R&D expenditure is on the increase, with biopharmaceutical companies leading the way, 1980-2006 38
Figure 16: With declining return on investment, successful launches have never been more important for pharmaceutical companies, 1990-2004 39
Figure 17: Since 2001, the number of NDAs received by the FDA has increased year-on-year 42
Figure 18: New drug applications received by the EMEA, 2001-06 43
Figure 19: Approvals and positive opinions in both the US and EU rose in 2006 (2001-06) 44
Figure 20: The number of new active substances launched on the world market is declining (2001-05) 45
Figure 21: Similar approval times for products in the US and 5EU (2000-05) 46
Figure 22: The FDA approved more drugs more quickly than did the EMEA between 2000 and 2005 47
Figure 23: The lengthening clinical trials since 1999-01 are offsetting the advantage gained by shorter product approvals in the US (1984-2004) 48
Figure 24: Faster approval rates have not affected drug safety in the US (1980s-2000) 50
Figure 25: Fastest developing pharmaceutical companies have a one-year and $1 billion advantage (2005) 54
Figure 26: CDER: Number of approvals of Priority and Standard NDAs, BLAs, NMEs and New BLAs (2000-06) 55
Figure 27: CDER approval times for Priority and Standard NDAs, BLAs, NMEs and New BLAs (2000-06) 56
Figure 28: Fast Track determination scheme 57
Figure 29: Fast Track approvals by indication (1998-2006) 58
Figure 30: US Fast Track products approved (1998-2006) 59
Figure 31: Fast Track + Accelerated Review designations lead to the shortest drug development time 60
Figure 32: EMEA orphan drug designation procedures, 2004-06 61
Figure 33: Comparison of orphan drug approvals in the US and 5EU (2000-05) (months) 62
Figure 34: In-licensed drugs experience a higher rate of first-time approvals by the FDA (2002-04) 65
Figure 35: Drugs that require input from advisory meetings experience lower first-time approval rates (2002-04) 66
Figure 36: Experienced sponsors gain higher rates of first-time approvals (2002-04) 67
Figure 37: Larger US-based companies have the highest drug approval rates (2002-04) 68
Figure 38: Safety issues account for one-third of all problems experienced during the FDA approval process (2002-04) 69
Figure 39: The EMEA is finalizing ever more procedures in an increasingly shorter time period (2001-06) 72
Figure 40: Average delay between marketing authorization and effective market access from a sample of products launched between June 2000 and June 2004 83
Figure 41: US forecast of Novartis's Exforge, Diovan and Lotrel sales, 2006-11 85
Figure 42: The majority of drugs were approved in the US first between 2002 and 2006 87
Figure 43: The proportion of drugs approved first in the 5EU has remained flat, 2002-06 88
Figure 44: The majority of drugs launch in the US before entry into the 5EU markets (2002-06) 89
Figure 45: More drugs are being launched in the US earlier, 2002-06 90
Figure 46: Time from drug approval to launch across the 5EU between Q4 2001 and Q3 2006 91
Figure 47: Time from drug approval to first 5EU launch between Q4 2001 and Q3 2006 92
Figure 48: Time from drug approval to launch between Q1 2002 and Q4 2005 93
Figure 49: Time from drug approval to first US launch between Q4 2001 and Q3 2006 94
Figure 50: Since 2000, the US has been the world leader in developing novel drug candidates (1986-2005) 95
Figure 51: US leads the world market in terms of sales for newly launched products, 2005 96
Figure 52: Uptake trends of drugs launched in the US and 5EU between 2002 and 2006 98
Figure 53: Mean country drug uptake trends post launch between 2002 and 2006 98
Figure 54: Wholesaler stocking significantly skewed Inspra's initial uptake, 2003-06 101
Figure 55: Avandamet uptake hit by disruption in supply and launch of competitor product, 2002-06 102
Figure 56: Data collection discrepancy skews Xolair uptake curve, 2003-06 103
Figure 57: Success at launch is correlated to mid- to long-term success (2002-06) 104
Figure 58: No significant difference in commercial success between priority and standard reviewed products in the US (2002-06) 106
Figure 59: Comparison of Q3 commercial success of newest and subsequent product launches for a given disease/condition in the US (2002-06) 108
Figure 60: Despite its second to market position, Levitra's lack of differentiation has hindered uptake 110
Figure 61: Truvada exceeds peak sales of Viread + Emtriva after only 1.5 years on the US market (Q2 2003-Q1 2007 111
Figure 62: Sales of protease inhibitors launched between 2002 and 2006 113
Figure 63: Monthly growth and decline of US ADHD drug revenues, 2001-04 116
Figure 64: US revenues of flu vaccines, 2002-06 117
Figure 65: Launch of MedImmune's FluMist and GSK's Fluarix, 2003-06 119
Figure 66: Promotional spend of FluMist and Fluarix at launch, Q1 2004-Q4 2006 121
Figure 67: Stage of licensing for top 50 deals in terms of 2005 revenues 123
Figure 68: The majority of products launched in the US and 5EU between 2001 and 2005 were marketed by a single company 125
Figure 69: The majority of brands launched between 2002 and 2006 use the same brand name in the US and 5EU 128
Figure 70: Number of drugs launched in the US and 5EU by totally different marketers (2001-05) 130
Figure 71: Key risks and benefits of using contract sales forces 132
Figure 72: Co-marketing helps Vytorin to become a global blockbuster after only two years (Q1 2002-Q4 2006) 134
Figure 73: Top 10 US pharmaceutical companies' promotional spending in 2006 136
Figure 74: Companies with higher promotional spend in 2006 experienced a higher annual growth rate for 2005-06 137
Figure 75: Key determinants driving promotional spend 138
Figure 76: Explanation of Raptiva's mechanism 139
Figure 77: Pre-launch marketing had a striking effect on the uptake of psoriasis drugs Q2 2002-Q1 2007) 140
Figure 78: Example of clear explanation of a complex mechanism for novel biologic therapy in autoimmune disease 141
Figure 79: Xolair pre-launch campaign 143
Figure 80: Methods of promoting drugs to patients and physicians in the US 144
Figure 81: Return on promotional spend for drugs launched in the US during 2004 and 2006 (and subsequently launched in the EU) 146
Figure 82: DTC expenditure in the US, 1997-2005 148
Figure 83: Promotional spend for Vytorin, Zocor and Zetia, 2003-05 154
Figure 84: The optimum sampling strategy combines both traditional and eSampling 156
Figure 85: Top 10 most heavily DTC advertised drugs in 2000 157
Figure 86: Pfizer's Celebrex experienced a much greater return on DTC spend than Merck & Co's Vioxx (2000) 158
Figure 87: Sales of leading drugs launched in the US market, Q4 2004-Q4 2005 159
Figure 88: Fewer pipeline drugs are discontinued as development progresses (1994-2005) 161
Figure 89: Discontinuation of the indiplon franchise has resulted in a decline in Pfizer's CNS franchise forecast sales for 2005-10 163
Figure 90: Discontinuation of Arxxant has resulted in a decline in Lilly's diabetes franchise forecast sales for 2005-10 165
Figure 91: Most successful US launches during 2002-06 166
Figure 92: Atripla yielded half of its constituent branded drug sales within three quarters of launch, Q1 2006-Q1 2007 167
Figure 93: Strong launch of Lexapro has protected Forest's antidepressant franchise in the face of generic competition (Q1 2001-Q3 2006) 169
Figure 94: Uptake of the higher priced Neulasta was less well received in the 5EU markets, 2002-06 172
Figure 95: Leading companies by number of new branded (original or licensed) US product launches (Q2 2002-Q4 2006 and 2006-12) 174
Figure 96: In recent years, research and marketing expenditures have increased, while drugs have a shorter time to make a ROI 176
Figure 97: Leading sales from company's launch portfolios (Q2 2002-Q4 2006 and 2006-12) 178
Figure 98: Reliance on launch portfolio for products launched between Q2 2002-Q4 2006 and 2006-12 180
Figure 99: GSK's $10.5 billion in launch portfolio sales fail to off-set 181
Figure 100: Novartis's launch portfolio plays a significant role in growing sales between 2005 and 2012 182
Figure 101: J&J's launch portfolio is key in maintaining company revenues in the face of flat core product sales and declining expiry portfolio sales, 2005-12 184
Figure 102: AstraZeneca's small launch portfolio offering does little to drive sales, with growth derived primarily through line extensions of key core products, 2005-12 185
Figure 103: Despite relying heavily on its 2002-06 launch portfolio, Forest will depend less strongly on its launch portfolio in the future, 2005-12 187
Figure 104: Wyeth's reliance on launch portfolio sales is forecast to increase from 0% to 25% in 2012 189
Figure 105: Summary of the number of launching products, their sales and company reliance in 2012 190
Figure 106: Effect of launched and marketed drugs on driving global therapy area sales to 2012 193
Figure 107: Reliance on new product sales by therapy area in 2012 195