Market for new medicines in Canada has not slowed over last two years, despite focus on COVID-19 treatments
News release
April 28, 2022 — Ottawa, ON — Patented Medicine Prices Review Board
Two new reports released by the Patented Medicine Prices Review Board (PMPRB) detail the current status of the market for new medicines in Canada, finding an uptick in the number of new medicines approved and a brimming drug pipeline.
Forty-seven new medicines were first approved in the US, Europe, and Canada in 2019 and an additional 50 medicines gained approval in 2020. Many of these new approvals were high-cost specialty treatments, and nearly 60% of the 2020 new approvals listed an orphan designation from the FDA and/or the EMA. By the end of 2020, Canada had approved and sold nearly a quarter of the 2019 new approvals, exceeding the median rate for comparator countries.
Canada also ranks competitively in terms of the time-to-market for new medicines approved over the last five years, with results above the median for the 11 countries the PMPRB will compare Canadian prices to when the amended Patented Medicines Regulations come into force in July 2022.
An analysis of the drug pipeline suggests these trends are likely to continue. Nearly 8,500 new medicines were under clinical evaluation globally in 2021, including 663 vaccines and therapies for the prevention and treatment of COVID-19. Over one third of those in late stages of evaluation were indicated to treat rare diseases.
These results are published in two PMPRB reports, both produced through the National Prescription Drug Utilization Information System (NPDUIS) research initiative. The latest editions in the annual Meds Entry Watch and Meds Pipeline Monitor series—now available on the PMPRB website—provide information on new medicines approved and undergoing clinical trials in Canada and internationally.
Quick facts
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Of the new medicines approved internationally between 2015 and 2019, 37% had Canadian sales by the end of 2020. This group of medicines accounted for 85% of all new medicine sales in the OECD in Q4-2020, indicating that the higher-selling medicines continue to be among those approved and sold in Canada.
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Forty-seven new medicines were approved in 2019, with an additional 50 medicines gaining approval in 2020. Nearly 60% of the 2020 new approvals had an orphan designation from the FDA and/or the EMA.
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Over half of the new medicines approved in 2019 were high-cost: 26 medicines, of which 10 were indicated to treat cancer, had treatment costs exceeding $10,000 per year or $5,000 per 28-day cycle. Nearly 75% of the 2020 new medicines with available sales reached the same threshold.
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In 2021, the drug pipeline contained nearly 8,500 new medicines in various stages of evaluation, of which over one third (35%) were indicated for the treatment of cancer. Of those in Phase III and pre-registration, 33% had an orphan designation.
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As of September 2021, 663 vaccines and therapies were undergoing clinical evaluation globally for the prevention and treatment of COVID-19. Health Canada was reviewing the safety and efficacy of 18 new and supplemental drug submissions for the prevention and treatment of COVID-19 as of January 2022.
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Contacts
PMPRB Media Relations
PMPRB.MediaCentre-CentreMedias.CEPMB@pmprb-cepmb.gc.ca
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