Outpacing Change
Building a competitive advantage in unprecedented times.
Geopolitical volatility/tariffs
Trade tensions are greatly impacting existing supply networks for API procurement and making assurance of supply at a commercially viable price a significant challenge.
Technical capabilities
- Biopharmaceutical Analysis
- Strategic API Supplier Management
- Supply Chain Risk Assessment
Enhance Resilience
Faster Recovery
Significantly reduce supply chain disruption impact and restoration time through improved biopharmaceutical understanding.
Competitive Advantage
Market Share Protection
Maintain market position during disruptions while competitors face prolonged supply chain challenges.
Biopharmaceutics understanding is critical. Here's why
- Poorly soluble compounds often require complex formulation and manufacturing processes to ensure reproducible bioavailability.
- Heightened sensitivity to manufacturing variability leads to increased regulatory scrutiny.
- Complex bioequivalence requirements create significant barriers to rapid supplier changes.
When API supply chains are disrupted, BCS Class II drugs face the longest time-to-restoration due to complex bioequivalence requirements. This creates disproportionate impact on healthcare systems and economic value.
The definitive data on which this classification is based is often not available, resulting in incorrect assumptions.
High permeability
High permeability
Low permeability
Low permeability
Significant Impact
The impact of poor biopharmaceutical understanding
Higher Losses
BCS Class II disruptions cause 2–3× greater revenue loss due to complex reformulation and extended timelines.
Supplier Diversification Challenges
Many suppliers require revalidation (12–24 months) when changes are needed, delaying supply restoration.
Regulatory Requirements
Markets have divergent bioequivalence requirements, creating costly redundancies and delays therefore impacting market share.
Key Implications
Patient impact
Essential medicines stockouts directly impact patient care and health outcomes.
Market impact
Competitors gain permanent market share during extended outages, creating long-term business consequences.
Strategic opportunity
Proactive biopharmaceutical understanding creates competitive advantage and resilience against disruptions.
How We Can Add Value
Biopharmaceutical analysis and how it ties in to your supply chain decision making.
Enhanced Resilience
Significantly reduce supply chain disruption impact and restoration time through improved biopharmaceutical understanding.
Regulatory Predictability
Navigate the complex regulatory landscape with confidence through our expertise in divergent bioequivalence requirements.
Competitive Advantage
Maintain market share during disruptions while competitors face prolonged supply chain challenges.
Is Your Current Portfolio at Risk?
Identify vulnerabilities and explore how Greengates Bio can help you build resilience.
- Comprehensive BCS Class II vulnerability analysis
- API supplier diversification strategy
Talk to Our Experts
We’re here to help you reduce risk and grow value. Send us a message and we’ll get back to you soon.