🇦🇺Australia

Commercialisation Decision Failures

1 verified sources

Definition

Inadequate skills and funding cause failures in moving from research to market, with no attractive long-term investor returns.

Key Findings

  • Financial Impact: Quantified: Negative returns for all public drug development biotech firms; no big success stories deterring future funding
  • Frequency: Historical sector pattern
  • Root Cause: Weak commercialization ecosystem, domestic funding limits, absence of multinational partners

Why This Matters

The Pitch: Biotechnology companies in Australia 🇦🇺 suffer negative returns from flawed commercialization decisions. Data-driven automation provides visibility to avoid these errors.

Affected Stakeholders

Board Directors, Investors

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Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

Commercialisation Capacity Loss

Quantified: Negative investor returns across public drug development biotech firms; up to US$2.6B total investment risk per drug with single-digit success rates

Regulatory Approval Delays

Quantified: AUD 100,000+ per project in capital carrying costs (logic: 6-12 months delay at 10% cost of capital on AUD 1M+ projects)

TGA CTN/CTA Notification Costs

30-60 hours per trial (at AUD 250/hr specialist rate = AUD 7,500 - 15,000)

Biosafety Non-Compliance Fines

AUD 10,000 - 500,000 per breach (typical civil penalty range for regulatory contraventions)

HREC and SSA Approval Delays

20-40 hours per trial site (at AUD 200/hr = AUD 4,000 - 8,000 opportunity cost)

Embryo Research Licensing Overhead

15-30 hours per licence application (AUD 3,000 - 6,000 at AUD 200/hr)

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