5 Trends Impacting CMOs In 2025

As 2025 approaches, CMOs and their partners must navigate several key industry shifts, including Annex 1 compliance, the BioSecure Act, AI-driven drug discovery, supply chain disruptions due to tariffs, and pandemic preparedness strategies.

Annex 1, the EU’s updated regulation on sterile manufacturing, will continue shaping industry practices. Companies must ensure best practices in aseptic processing and invest in RABS and isolator technology for compliance. Partnering with CMOs experienced in Annex 1 standards will be crucial for medical products sold in EU markets.

The BioSecure Act, which was removed from the 2025 US defense bill, remains uncertain. If revived, it could restrict partnerships with Chinese life science companies, potentially increasing costs and delaying trials. Pharmaceutical companies are proactively identifying alternative suppliers to minimize disruption.

AI in drug development is rapidly advancing, improving small molecule and biologic discovery. CMOs with expertise in formulation development and clinical trial production will be well-positioned to translate AI-driven discoveries into real-world treatments.

Supply chain stability faces challenges from proposed tariffs—a 25% tariff on Canadian and Mexican goods and 10% on Chinese imports could impact raw material and API costs. CMOs are responding by onshoring and diversifying suppliers.

Finally, pandemic preparedness remains a priority. CMOs are focusing on risk assessments, predictive analytics, and stockpiling critical materials to maintain a resilient supply chain for future health crises. Strategic CMO partnerships will be essential in navigating these industry changes.