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Recent years have seen changes in the marketplace that have made successful new drug launches difficult to achieve. Many therapy areas are becoming hypercompetitive, with similar treatments jostling for position, and even those products with evidence of superior efficacy or better tolerability still have to overcome reimbursement hurdles.
Recent years have seen changes in the marketplace that have made successful new drug launches difficult to achieve. Many therapy areas are becoming hypercompetitive, with similar treatments jostling for position, and even those products with evidence of superior efficacy or better tolerability still have to overcome reimbursement hurdles. Pricing is now a global political issue, with payers – insurers, managed care organizations, and government agencies – prioritizing cost containment, with added price pressure provided by generics.
Against this background, certain drugs still manage to put in blockbuster sales. Efficacy is often key – an outstanding treatment that is clearly differentiated from the competition can command a premium price – while high tolerability or more convenient dosing may be enough to drive sales in specific patient subgroups. Either way, companies must ensure they perform well-planned clinical trials in order to make the most of their opportunity and to drive sales.
7 EXECUTIVE SUMMARY
7 Key drivers of commercial success
8 Key resistors of commercial success
10 STRATEGIES FOR COMMERCIAL SUCCESS
12 Companies target niche high unmet needs to differentiate drugs
13 Superior efficacy can command higher prices if there is a lack of competition
15 Success in one niche may be used to leverage overall pricing negotiations
15 Lowering the price may boost sales, and does not preclude future price rises in the US at least
16 More convenient dosing drives sales if efficacy is comparable
17 High tolerability encourages adherence, and may be valued above efficacy in certain scenarios
18 Evidence of an impact on hard outcomes can be an important differentiator, provided there
are sufficient data from clinical trials
19 Well-planned, extensive studies give physicians confidence in prescribing
22 First-to-market status may allow a company to steal a march, but is not infallible
23 Experience with similar products gives a company some advantages
25 Bibliography
30 FACTORS IMPACTING SALES
30 Cost containment is prompting payers to restrict reimbursement
34 Some countries are more price conscious than others
36 Adverse events can restrict the number of patients eligible for a drug
38 The hepatitis C market shows that the lifespan of a bestseller may be short
38 Cost concerns mean payers embrace generics where possible
39 Familiarity with established brands may create switching inertia
40 Bibliography
45 IMMUNOLOGY AND INFLAMMATION CASE STUDY ANALYSIS
48 Cosentyx – superior efficacy overcomes established brands
54 Otezla – good safety data and oral dosing drive uptake, despite lack of efficacy advantages
over established biologics
60 Xeljanz – high cost has restricted patient access in the US, while approval is still awaited in
the EU
65 Future launches to watch out for
68 Bibliography
74 COPD CASE STUDY ANALYSIS
74 Ultibro – extensive clinical trials and promising safety and efficacy will drive sales
80 Breo – GlaxoSmithKline’s once-daily successor to Advair aims to stave off generic competition,
but suffers from slow patient switching
86 Further recently launched products to watch out for
89 Bibliography
92 HEPATITIS C CASE STUDY ANALYSIS
92 Harvoni – excellent efficacy, convenient dosing, and strategic discounting stave off rivals
100 Viekira Pak – blockbuster status, but sales dwarfed by rival Harvoni
107 Future launches to watch out for
111 Bibliography
116 MULTIPLE SCLEROSIS CASE STUDY ANALYSIS
118 Tecfidera – efficacy and high tolerability together drive sales
125 Aubagio – high tolerability, but efficacy is ranked behind Gilenya and Tecfidera, which has
held back sales
131 Future launches to watch out for
133 Bibliography
137 ONCOLOGY CASE STUDY ANALYSIS
137 Tasigna – Novartis’s experience with Gleevec and clinical trials planning aid success
142 Iclusig – adverse events restrict its use to later lines of therapy and T315I patients
148 Recent launches to watch out for
151 Bibliography
154 TYPE 2 DIABETES CASE STUDY ANALYSIS
158 Invokana – superior efficacy, associated weight loss, and low risk of causing hypoglycemia
boost sales
165 Farxiga – delayed launch in lucrative US market places drug behind rival Invokana
173 Trulicity – good glycemic control and convenient dosing put drug on track to become leading
GLP-1 agonist
178 Tanzeum – weak efficacy data and little weight reduction benefit restrict adoption
184 Recent launches to watch out for
186 Bibliography
LIST OF FIGURES
49 Figure 1: Cosentyx for psoriasis – SWOT analysis
53 Figure 2: Cosentyx sales for psoriasis across the US, Japan, and five major EU markets, by
country, 2016–25
56 Figure 3: Otezla for psoriasis – SWOT analysis
60 Figure 4: Otezla sales for psoriasis across the US, Japan, and five major EU markets, by
country, 2016–25
62 Figure 5: Xeljanz for rheumatoid arthritis – SWOT analysis
65 Figure 6: Xeljanz sales in rheumatoid arthritis across the US, Japan, and five major EU markets,
by country ($m), 2014–23
76 Figure 7: Ultibro for COPD – SWOT analysis
80 Figure 8: Ultibro sales for COPD across the US, Japan, and five major EU markets, by country,
2015–24
82 Figure 9: Breo for COPD – SWOT analysis
86 Figure 10: Breo sales for COPD across the US, Japan, and five major EU markets, by country,
2015–24
95 Figure 11: Harvoni for hepatitis C – SWOT analysis
99 Figure 12: Harvoni sales for hepatitis C across the US, Japan, and five major EU markets, by
country, 2015–24
103 Figure 13: Viekira Pak for hepatitis C – SWOT analysis
106 Figure 14: Viekira Pak sales for hepatitis C across the US, Japan, and five major EU markets, by
country, 2015–24
120 Figure 15: Tecfidera for multiple sclerosis – SWOT analysis
124 Figure 16: Tecfidera sales for multiple sclerosis across the US, Japan, and five major EU
markets, by country, 2016–25
127 Figure 17: Aubagio for multiple sclerosis – SWOT analysis
131 Figure 18: Aubagio sales for multiple sclerosis across the US and five major EU markets, by
country, 2016–25
139 Figure 19: Tasigna for chronic myeloid leukemia – SWOT analysis
142 Figure 20: Tasigna sales forecast for chronic myeloid leukemia in the US, Japan, and five major
EU markets, by country, 2014–23
144 Figure 21: Iclusig for chronic myeloid leukemia– SWOT analysis
147 Figure 22: Iclusig sales forecast for chronic myeloid leukemia in the US, Japan, and five major
EU markets, by country, 2014–23
159 Figure 23: Invokana for type 2 diabetes – SWOT analysis
165 Figure 24: Invokana sales for type 2 diabetes across the US, Japan, and five major EU markets,
by country, 2015–24
167 Figure 25: Farxiga for type 2 diabetes – SWOT analysis
172 Figure 26: Farxiga sales for type 2 diabetes across the US, Japan, and five major EU markets,
by country, 2015–24
174 Figure 27: Trulicity for type 2 diabetes – SWOT analysis
178 Figure 28: Trulicity sales for type 2 diabetes across the US, Japan, and five major EU markets,
by country, 2015–24
180 Figure 29: Tanzeum for type 2 diabetes – SWOT analysis
183 Figure 30: Tanzeum sales for type 2 diabetes across the US, Japan, and five major EU markets,
by country, 2015–24
LIST OF TABLES
10 Table 1: Strategies for successful drug launch and commercialization
30 Table 2: Factors impacting sales of a new drug
46 Table 3: Drivers and resistors of commercial success for three profiled marketed drugs in
immunology and inflammation
48 Table 4: Cosentyx drug profile
55 Table 5: Otezla drug profile
61 Table 6: Xeljanz drug profile
66 Table 7: Drivers and resistors of commercial success for selected pipeline agents in
immunology and inflammation
74 Table 8: Drivers and resistors of commercial success for two profiled marketed drugs in COPD
75 Table 9: Ultibro drug profile
81 Table 10: Breo drug profile
87 Table 11: Drivers and resistors of commercial success for selected recently launched products
in COPD
92 Table 12: Drivers and resistors of commercial success for two profiled marketed drugs in
hepatitis C
94 Table 13: Harvoni drug profile
101 Table 14: Viekira Pak drug profile
108 Table 15: Drivers and resistors of commercial success for selected future launches in hepatitis
C
116 Table 16: Drivers and resistors of commercial success for two profiled marketed drugs in
multiple sclerosis
119 Table 17: Tecfidera drug profile
126 Table 18: Aubagio drug profile
132 Table 19: Drivers and resistors of commercial success for selected future launches in multiple
sclerosis
137 Table 20: Drivers and resistors of commercial success for two profiled marketed drugs in
oncology
138 Table 21: Tasigna drug profile
143 Table 22: Iclusig drug profile
149 Table 23: Drivers and resistors of commercial success for selected future launches in oncology
155 Table 24: Drivers and resistors of commercial success for four profiled marketed drugs in type
2 diabetes
158 Table 25: Invokana drug profile
166 Table 26: Farxiga drug profile
174 Table 27: Trulicity drug profile
179 Table 28: Tanzeum drug profile
184 Table 29: Drivers and resistors of commercial success for selected recently launched products
Figure: Strategies for successful drug launch and commercialization
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