Regulatory Delay Opportunity Cost
Definition
Delays from poor tracking extend pre-market phase ~1 year, preventing sales while competitors enter via faster pathways like Priority Review (150 days).
Key Findings
- Financial Impact: ~1 year market entry delay; AUD 1M+ monthly lost revenue for high-value therapeutics
- Frequency: Per drug approval cycle
- Root Cause: Bottlenecks in manual document review and milestone tracking against TGA phases
Why This Matters
The Pitch: Pharma companies in Australia 🇦🇺 lose AUD 1-5M per drug in forgone sales from 1-year submission delays. Automation accelerates preparation to priority pathway speeds.
Affected Stakeholders
R&D Director, Market Access Lead, Production Manager
Deep Analysis (Premium)
Financial Impact
Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.
Current Workarounds
Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.
Get Solutions for This Problem
Full report with actionable solutions
- Solutions for this specific pain
- Solutions for all 15 industry pains
- Where to find first clients
- Pricing & launch costs
Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Evidence Sources:
- https://www.parexel.com/application/files/resources/assets/Australia%20Regulatory%20Market%20Access%20Article_Third%20in%20a%20three-part%20series%20(1).pdf
- https://springbiosolution.com/blogs/drug-development-and-approval-process-in-australia/
- https://www.adjutor.com.au/how-to-register-a-medicine-in-australia
Related Business Risks
TGA Submission Non-Compliance Fines
TGA Evaluation Fee Overpayments
TGA Non-Compliance Fines
Cost of Poor Quality from Trending Failures
Idle Capacity from Review Delays
Kosten durch TGA-GMP-Abweichungen bei Änderungsdokumentation
Request Deep Analysis
🇦🇺 Be first to access this market's intelligence