This article appeared in the October 2026 issue of Cleanroom Technology
By Jacob Stephen, Chief Operating Officer
North America remains at the center of the global pharmaceutical market, led by the US and supported by an increasingly important Canadian life science sector. Since the COVID-19 pandemic, Canada has refocused efforts to expand capacity, developing infrastructure for vaccine and advanced therapeutic manufacturing and strengthening domestic supply chains. The opportunity is significant, but the next challenge is clear: Canada needs to convert its strength in research and innovation into commercial-scale manufacturing capacity.
The pandemic exposed three key manufacturing shortcomings: limited production capacity, dependence on global supplies, and inflexibility when demands changed. Production of sterile injectables like vaccines and the navigation of global supply chain interruptions were especially challenging. This led to a public commitment to strengthen vulnerable supply chains and source domestic solutions to material, product, and service shortages to keep critical drugs accessible.
Canada’s response has centered on agile, responsive domestic policies, including $2.5 billion (CAD) in investments across projects supporting vaccines, therapeutics, critical drugs, and biomanufacturing infrastructure. These investments have established a firm foundation, but long-term value will depend on whether these new capabilities can operate reliably at commercial scale. Today, the Canadian life science industry has several advantages, including growing pharmaceutical and biotech sectors, generics and biosimilar manufacturing, academic research, and the highest per-capita concentration of clinical trials among G7 countries. The country’s pharmaceutical market generated $51.25 billion (CAD) in sales in 2025, representing 2.1 percent of total global pharmaceutical sales and making it the 9th largest market globally. This market is meaningful, but Canada’s commercial capacity has yet to fully capitalize on its research and manufacturing potential.
How it fits together: Building North American manufacturing capacity
Domestic trends: Growing investments in US-based drug development and manufacturing
| Company | Commitment (US$bn) | Timeframe |
|---|---|---|
| Pfizer | $70.0 | Not specified |
| GSK | $30.0 | 5 years |
| Eli Lilly | $27.0 | Not specified |
| Johnson & Johnson | $55.0 | 4 years |
| Roche | $50.0 | 5 years |
| AstraZeneca | $50.0 | By 2030 |
| Novartis | $23.0 | 5 years |
| Sanofi | $20.0 | Through 2030 |
| Biogen | $2.0 | Not specified |
| Merck | $70.0 | Not specified |
| Amgen | $3.45 | Not specified |
| AbbVie | $100.0 | 10 years |
| Gilead Sciences | $32.0 | Not specified |
| Bristol Myers Squibb | $40.0 | Not specified |
| CSL | $1.5 | 5 years |
Looking to the future of biomanufacturing in North America, focus is needed on the resilience of regional supply chains that benefit global partnerships. There’s significant opportunity in expanding production of raw materials, APIs, and fill-finish capacity. Initiatives like the FDA’s PreCheck Pilot program aim to accelerate the establishment of new US pharmaceutical manufacturing facilities (as of 2025, only 11 percent of manufacturers producing APIs used in FDA-approved products were based in the US). Canada has funded the Canadian Critical Drug Initiative with similar aims to reduce dependence on foreign API production and expand domestic drug production capacity for essential medicines.
Regulatory alignment will also be important. Key initiatives like the International Council for Harmonisation promote common technical expectations across major markets, while the revised EU GMP Annex 1 has raised global standards for sterile manufacturing and contamination control. Greater alignment can reduce uncertainty, but it does not eliminate the need for disciplined implementation. Fully realized commercial manufacturing capacity requires standardized platforms, experienced partners, regulatory alignment, and sustained focus on execution.
If Canada and the United States build those capabilities together, North America will be better positioned to deliver critical medicines reliably, both during the next disruption and in the normal course of serving patients. For many life science providers, this means moving beyond a traditional vendor role into a more collaborative, partnership-based framework. Contract manufacturing operations, for example, are increasingly focused on supporting clients through the developmental stages of a drug product to better understand and streamline delivery to patients. And in the area of pharmaceutical manufacturing technology, careful planning for supply, installation, compliance, and operational ramp-up is critical as manufacturers seek efficient pathways to cGMP production.
Our team at AST frames this as being a full-service partner. In practice, this means providing both standardized GMP technologies and resources across the full scope of the drug product lifecycle for supply, service, and validation. Operationally, this approach addresses quality and the logistics of testing, installation, and CQV activities with real, measurable implications for delivering critical medicines. Against the backdrop of the industry’s current focus on supply and capacity, these types of comprehensive models give manufacturers a clearer path to dependable commercial production.
