New Drug Launch Monitor, 2009–2015

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Important new drugs have been launched in recent years, fueling the growth in pharmaceutical sales. The New Drug Launch Monitor (NDLM) is an upcoming PMPRB publication that identifies recent international drug launches, and provides policy makers, the industry and patients with valuable intelligence on their market uptake and pricing, as well as advanced notice on drugs that may soon be coming to Canada.

The first edition of this annual publication identifies all new active substances (NASs) launched between 2009 and 2014 and reports on related sales in the second quarter of 2015 (Q2-2015) in Canada and/or the seven PMPRB comparator countries (PMPRB7: France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States).

Key Findings

1. Approximately 30+ new active substances were launched each year from 2009 to 2014.

Between 2009 and 2014, 209 NASs were launched, with sales mounting to 13% of the pharmaceutical market in Canada and the PMPRB7 by 2014.

Section 1

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Section 1

Figure description

This stacked area graph depicts the cumulative share of total sales for new active substances launched each year from 2009 to 2014.

Cumulative percentage of sales by year
Year of drug launch 2009 2010 2011 2012 2013 2014
2009 0.11% 0.59% 1.44% 2.18% 2.74% 3.13%
2010 0.07% 0.46% 0.92% 1.24% 1.42%
2011 0.50% 1.40% 1.92% 2.31%
2012 0.13% 0.71% 1.48%
2013 0.22% 4.05%

Note: Sales for the NASs launched in a given year are small in the first year due to the time of launch (potentially later in the year) as well as the slow initial market uptake.

In total, 209 new active substances were launched between 2009 and 2014. The table under the graph gives the number of new active substances launched by year: 2009, 38; 2010, 27; 2011, 34; 2012, 32; 2013, 34; 2014, 44.

2. Canada accounts for a sizable share of the international market for new active substances, especially in terms of use.

While Canada accounts for 2.5% of the international sales for NASs in the analyzed countries, it makes up 6.6% of the volume of use, as high US prices crowd out the market share in terms of sales for all countries.

Section 2

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Section 2

Figure description

This illustration depicts two bar graphs. The left-hand bar gives the international market shares for the volume of sales of new active substances in the second quarter of 2015, and the right-hand bar gives the international market shares for the volume of units.

Left-hand bar (sales)

Sweden: 0.7%; Switzerland: 1.0%; Canada: 2.5%; United Kingdom: 2.8%; France: 3.9%; Italy: 4.0%; Germany: 6.4%; United States: 78.8%.

Right-hand bar (quantity)

Sweden: 1.3%; Switzerland: 1.1%; Canada: 6.6%; United Kingdom: 5.7%; France: 10.3%; Italy: 8.4%; Germany: 15.8%; United States: 50.8%.

3. Sales for the new active substances are highly concentrated, with a small number of drugs accounting for a large proportion of new drug sales internationally.

The top 30 NASs (represented by the darkest blue dots and bar) are high-impact drugs with cumulative annual sales accounting for 77% of all NAS sales. Conversely, more than half of NASs are low-impact drugs, with cumulative sales of 2.1% (lightest blue dots and bar).

Section 3

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Section 3

Figure description

This illustration depicts the sales concentration for high, medium, and low-impact new active substances in the second quarter of 2015. The right-hand graph gives the share of sales and the number of substances for each of the three categories, representing a total of 209 new active substances.

High impact: 77% share of sales; 30 new active substances.

Medium impact: 21% share of sales; 69 new active substances.

Low impact: 2.1% share of sales; 110 new active substances.

The left-hand graph plots this information as a cumulative share of sales by individual new active substance.

4. Canada launched most of the top-selling new active substances.

Canada has launched nearly half (95 drugs) of NASs available in Canada and the PMPRB7. These drugs represented 90% of NAS sales in Q2-2015. Canada also used the most NASs relative to its population size, as the foreign-to-Canadian ratio of drug exposure, expressed in units per million people, is one of the highest.

Section 4

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Section 4

Figure description

This illustration consists of a bar graph and a separate table.

One set of bars on the graph depicts the share of total new active substances launched in Canada and the seven PMPRB comparator countries from 2009 to 2014 by country. A second set of bars depicts the respective sales in the second quarter of 2015. The accompanying table gives the number of new active substances launched between 2009 and 2014, and the foreign-to-Canadian units used per million people.

  Share of new active substances launched in 2009 to 2014 Share of sales of new active substances for the second quarter of 2015 Number of new active substances launched Foreign-to-Canadian ratio: units per million people
United States 82% 99% 172 0.9
Germany 59% 90% 123 1.0
United Kingdom 54% 88% 112 0.5
Sweden 53% 85% 110 0.7
Canada 45% 90% 95 1.0
Italy 45% 57% 95 0.7
Switzerland 41% 63% 85 0.8
France 40% 77% 83 0.7

5. New active substances with high sales have shorter launch lag times in Canada.

The US was the first market to launch the majority of NASs (68%), accounting for the overwhelming share of sales (85%) in Q2-2015. Sweden was the second market to launch almost all the remaining NASs. Canada was the first country of launch for only two drugs, one of which is a top-selling product.

While the 10 top-selling NASs, accounting for 50% of all NAS sales in Q2-2015, were launched in Canada within approximately 5 months of the first international launch, the average lag time increased as the drugs’ share of sales diminished.

Section 5

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Section 5

Figure description

This line graph depicts the Canadian lag time to market new active substances by market size for the second quarter of 2015. The market size is determined by ranking drug sales: 10 top-selling drugs; 11 to 30; 31 to 50; 51 to 70; and 70 to 95 lowest selling drugs. One line on the graph gives the share of sales for each group in the second quarter of 2015 and the other gives the lag time. Generally as the share of sales decreases, the lag time increases. Exact values are given in the table below.

  Top 10 selling drugs 11‒30 31‒50 51‒70 71‒95 (lowest selling drugs)
Share of sales† 50% 30% 13% 5% 3%
Canadian lag* (months) 5 12 10 15 23

6. Hepatitis C drugs dominate sales for new active substances.

Two new hepatitis C drugs launched in 2013 (Sovaldi) and 2014 (Harvoni) accounted for 28% of NAS sales and 5% of all drug sales in Canada and the PMPRB7 in Q2-2015. In Canada, these two drugs accounted for 30% of NAS sales and 5% of all drug sales. Canada has the third highest use and sales for these drugs relative to the size of its population, after the United States and Sweden.

The table† lists the 10 top-selling drugs in Canada and the PMPRB7 in Q2-2015. Most were first launched in the US (7), followed by Sweden (2), with one drug launched first in Canada (Stelara).

Rank Drug Share of sales
Q2-2015
Year of first launch Country of first launch Canadian lag
(months)
1 Sofosbuvir, Ledipasvir (Harvoni) 22% 2013 United States 1
2 Sofosbuvir (Sovaldi) 6% 2014 United States 1
3 Liraglutide (Victoza) 3% 2009 Sweden 11
4 Fingolimod (Gilenya) 2% 2010 United States 7
5 Denosumab (Prolia) 2% 2010 Sweden 3
6 Ustekinumab (Stelara) 2% 2009 Canada
7 Cobicistat (Tybost) 2% 2012 United States 3
8 Elvitegravir (Stribild) 2% 2012 United States 3
9 Abiraterone acetate (Zytiga) 2% 2011 United States 3
10 Canagliflozin (Vokanamet) 2% 2013 United States 13

Data Sources: *Health Canada Drug Product Database. † MIDAS™ Database, Retail and Hospital, Manufacturer Ex-factory Sales, IMS AG. All Rights Reserved.

Disclaimer: Although based in part on data provided under license by the IMS AG’s MIDAS™ Database, the statements, findings, conclusions, views and opinions expressed in this report are exclusively those of the PMPRB and are not attributable to IMS AG.

NPDUIS is a research initiative that operates independently of the regulatory activities of the PMPRB.

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