Meds Pipeline Monitor 2019

Meds Pipeline Monitor (MPM) is a horizon scanning report that features a selection of new medicines in the late stages of clinical evaluation that may have a significant impact on future clinical practice and drug spending in Canada.

Medicines in Phase III clinical trials or in pre-registration with the US Food and Drug Administration (FDA) are considered as candidates if they have the potential to address an unmet therapeutic need, offer a novel mechanism or therapeutic benefit over existing therapies, or treat a serious condition. The final selection features medicines that treat a broad range of therapeutic areas. In addition to identifying new medicines for inclusion in the list, this edition monitors the medicines featured in the 2018 Meds Pipeline Monitor to report on changes to their status in the pipeline. A new section focused on Canada highlights potentially significant medicines currently under review by Health Canada.

The report collects data from two main sources: GlobalData’s Healthcare database is used to identify medicines currently undergoing clinical evaluation, while Health Canada’s Drug and Health Product Submissions Under Review list provides information on new medicines under assessment in Canada.

Together with its companion publication Meds Entry Watch, this report series monitors the continuum of new and emerging medicines in Canada and internationally, providing key information to decision makers, researchers, patients, and clinicians, among other stakeholders.

Highlights of the Meds Pipeline 2019

• In 2019, the pipeline contained 5,584 new medicines in various stages of evaluation.
• Oncology dominated the therapeutic mix, with cancer treatments representing over one third (35%) of medicines in all phases of clinical trials. Therapies for central nervous system diseases such as Alzheimer’s disease and depression accounted for 14% of medicines in clinical trials.
• Nervous system treatments represented the greatest share (19%) of medicines in pre-registration with the FDA in 2019, exceeding the 15% share held by oncology.
• Of the 5,584 new medicines in the pipeline, 697 (12%) were in Phase III clinical trials and FDA pre-registration, representing a wide range of therapeutic areas. One third of these late-stage medicines had an early orphan designation approved through the FDA or EMA, which is consistent with the increasing trend in the prevalence of orphan-designated medicines entering the pharmaceutical market.
• Eight late-stage new medicines, including two gene therapies, were selected for addition to the 2019 MPM list based on their potential impact on the Canadian healthcare system. Some of these medicines may offer breakthroughs in treating previously unmet needs or may have the potential to treat large patient populations.
• Of the 30 new medicines featured in the 2018 edition of the MPM, 16 were retained on the list as they continue to satisfy the selection criteria. Five medicines, including the FDA Breakthrough-designated treatment for spinal muscular atrophy Zolgensma, had been granted market authorization by the US FDA, the EMA, and/or Health Canada as of January 2020.
• The report also highlights nine new medicines currently under review by Health Canada. Of these, more than half had forecasted global revenues nearing or exceeding $1 billion by 2025.

Full report