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.

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.

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).

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.

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.

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).

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.