Navigating European Pharma Market Access: Delays, Disparities, and Strategic Investment Opportunities

The European pharmaceutical market is at a crossroads. While the EU's Health Technology Assessment (HTA) reforms aim to streamline market access for innovative therapies, disparities in reimbursement timelines and policy execution across member states are creating both risks and opportunities. For investors, this landscape demands a nuanced approach to capitalize on inefficiencies and emerging markets. Here's how to position portfolios for growth in 2025 and beyond.

The Diverging Landscape of Market Access

The EU's HTA Regulation, now fully implemented, has introduced joint clinical assessments (JCAs) for oncology drugs and advanced therapies. Yet, reimbursement delays persist, with stark regional differences:

• High-Growth Markets (Improving Timelines):
  Norway and Romania have slashed delays by 21% and 9%, respectively, since 2020, thanks to HTA harmonization and policy reforms. Norway's integration of JCAs into its “New Methods” framework has accelerated approvals, while Romania's HTA process now takes ~100 days (down from 208 in 2020).

• Laggards (Persistent Delays):
  Smaller EU states like Cyprus (7% reimbursement rate), Croatia (27%), and Lithuania (19%) remain mired in bureaucratic inefficiencies. Even in Nordic countries, delays for oncology drugs average 881 days—a 2.3% increase since 2023—due to fragmented HTA processes and budget constraints.

Opportunity #1: Acquire Assets in Lagging Markets

Smaller EU markets with delayed access present acquisition opportunities for pharmaceutical firms. Companies can:
1. Target undervalued assets in countries like Cyprus or Croatia, where delayed approvals have suppressed pricing power.
2. Leverage HTA reforms to fast-track approvals for drugs already proven in faster markets (e.g., Norway or Germany).
3. Partner with local distributors to navigate bureaucratic hurdles.

Investment Play: Look for mid-cap European pharma companies with pipelines in oncology or rare diseases but underexposed to lagging markets. Acquiring smaller players in these regions could unlock stranded value as HTA harmonization progresses.

Opportunity #2: Bet on HTA Reform Winners

Firms with strong HTA strategies and pipelines targeting backlogged indications (e.g., oncology, rare diseases) are poised for growth.

• Oncotherapy Leaders: Companies like AstraZeneca (AZN) or Roche (ROCHE), with robust oncology portfolios, benefit from JCAs accelerating access to previously delayed markets.
• Rare Disease Specialists: Biomarin (BMRN) or UniQure (QURE), focused on orphan drugs, stand to gain as HTA reforms expand to rare therapies by 2028.

Risk: 2025 Budget Pressures Will Intensify Reimbursement Hurdles

Despite reforms, budget constraints are worsening. By 2026, Romania's HTA reimbursement backlog could hit 247 cases, while countries like Sweden and Denmark face structural delays due to reliance on alternative treatments. Investors must favor firms with:
- Cost-efficient manufacturing to offset price negotiations.
- Managed-entry agreements (MEAs) to secure reimbursements in fiscally conservative markets.

Investment Strategy: Target Norway, Romania, and HTA-Savvy Pipelines

1. Geographic Focus:
2. Norway and Romania: Invest in companies expanding operations here (e.g., Takeda (TAK) or Novo Nordisk (NVO)), which benefit from streamlined HTA processes.

3. Avoid Lagging Markets: Until reforms mature, prioritize assets in countries with <15% reimbursement rates only if acquired at deep discounts.

4. Pipeline Prioritization:

5. Back oncology/rare disease firms with early-stage RWE data, as HTA reforms increasingly demand real-world evidence.

6. Avoid companies reliant on markets with >500 days to reimbursement (e.g., Switzerland, Greece).

7. Policy Tracking:
   Monitor the HTACG's PICO parameter decisions—disparities here could create arbitrage opportunities (e.g., drugs approved in Norway but delayed in Germany).

Conclusion: Act Now Before 2025 Delays Become Structural

The EU's HTA reforms are a double-edged sword: they'll reduce delays in some markets but amplify disparities in others. Investors who act swiftly to acquire undervalued assets in laggards and back HTA-savvy firms will profit as the market consolidates. Those ignoring budget pressures and bureaucratic inertia, however, risk stranded investments in a sector where access timelines are the new currency.

Final Call: Position portfolios in Norway/Romania plays and HTA-ready pipelines. The window to exploit these disparities is narrowing—act before 2025's budget crunch reshapes the landscape permanently.