Insight into approvals, marketing, and pricing of emerging and innovative medicines 2021-2025

Blake Wladkya

Presented at the CDA Symposium 2026, April 22–24, 2026

Objective

High-cost specialty medicines are increasingly dominating the landscape of new medicines launched in Canada and around the world. A growing share of these medicines (including biologics, orphan drugs, and oncology products) have annual treatment costs in the tens or hundreds of thousands of dollars. This study provides an overview of new medicine approvals, sales, relative pricing, characteristics, and access in Canada and internationally.

Approach and data

This study explores the market entry dynamics of new active substances approved by Health Canada, the US Food and Drug Administration (FDA), or the Europe Medicines Agency (EMA) from 2021 to 2025. A new medicine is selected for analysis if it received its first market authorization from any of these regulatory bodies during the study period. The analysis explores the availability, treatment cost, and sales of these medicines using the most recent available data up to Q4-2025. Primary data were sourced from the IQVIA MIDAS® database, with supplemental data from the Health Canada, FDA, and EMA online drug databases, and from Canada’s Drug Agency (CDA-AMC). 

Results

1. Trends in approvals of new international medicines

• An average of 54 new medicines were approved each year from 2021 to 2025 with the US approving early and often.
• Orphan medicines consistently made up a significant portion of new approvals.
• High-cost and EDRD† medicines account for the majority of new medicine approvals.

2. Trends in sales of new international medicines 2021-2024

• Of the 218 medicines approved from 2021 to 2024, 44 (20%) had sales in Canada by Q4-2024.
• New medicines which have been sold in Canada account for 77% of new medicine sales throughout the OECD. This ranks Canada above the OECD median of 74%, but below 11 OECD countries.

3. Trends in Canadian approvals, and relative pricing 2021-2025

• Health Canada granted initial market authorization to an average of 41 new medicines each year, with an average of 14 (35%) expensive drugs for rare diseases (EDRDs).
• Of 262 new active substances approved internationally between 2019–2023, 188 (72%) had been submitted for Health Canada review by December 2025. Of those, 163 received a Notice of Compliance (NOC), 16 were still under review, and 9 had an unsuccessful review process.
• Foreign to Canadian price ratios for Canadian new medicines show that Canadian prices are typically much lower than the US, though higher on average than the rest of the OECD.

Conclusion

This study highlights the ongoing prevalence of high-cost and rare disease drugs among newly approved medicines. As Canada continues to approve and market the highest-selling new medicines, there is a need for more information on the impact of new approvals on payers and patients. Data relating to the approval, sales, relative prices and other characteristics of each new medicine will be included in the appendix section of Meds Entry Watch, 10th edition.

Limitations

As this presentation focuses on three approval bodies, it is possible that some new medicines included in the analysis may have an earlier approval date in other jurisdictions, and that some medicines with a first international approval between 2021 and 2025 are not included in the analysis.

Disclaimer

Although based in part on data obtained under license from the MIDAS® database proprietary to IQVIA Solutions Canada Inc. and/or its affiliates ("IQVIA"), the statements, findings, conclusions, views, and opinions expressed in this presentation are exclusively those of the PMPRB and are not attributable to IQVIA.