In pharma, the calendar matters

Year-end is rarely quiet. It’s when inspection outcomes are reviewed, development data is locked, capacity decisions are revisited, and strategic partnerships are reassessed. For advanced therapies in particular, 2025 has been a year that tested assumptions across labs, manufacturing floors, and leadership teams.

Rather than rushing ahead, this is a natural moment to pause and ask: what did this year actually teach us? And just as importantly—what is it quietly signalling about what comes next?

Below are 10 lessons that stood out in 2025, followed by 5 expectations shaping how advanced therapy organizations are preparing for 2026.

10 things 2025 reinforced for pharma

1. Process understanding beat process speed

In 2025, programs that prioritised deep process understanding over aggressive timelines were consistently more resilient, especially under regulatory scrutiny.

2. Labs are no longer “support functions”

The lab emerged as a strategic asset. Analytical maturity, method robustness, and scientific rationale increasingly defined manufacturing credibility.

3. Inspection readiness Is a daily practice

Teams that treated inspection readiness as continuous—not seasonal—experienced fewer disruptions and more confident regulatory interactions.

4. Development decisions echoed louder in GMP

Choices made early in development had direct consequences at scale, particularly for cell and gene therapies with narrow operating windows.

5. Data integrity became a leadership topic

Data was no longer just a QA concern. Leadership teams became more directly engaged in how data was generated, interpreted, and defended.

6. Purpose-built facilities proved their value

Facilities designed specifically for advanced therapies demonstrated clearer workflows, stronger environmental control, and smoother scale transitions.

7. Communication gaps were costly

Misalignment between development, manufacturing, and partners often surfaced late—sometimes too late to correct without delay.

8. Transparency strengthened partnerships

The most effective collaborations were those where challenges were surfaced early and addressed jointly, not managed behind closed doors.

9. Regulatory conversations became more scientific

Regulators increasingly focused on scientific rationale and control strategies, not just documentation completeness.

10. Long-term thinking outperformed short-term fixes

Programs anchored to long-term manufacturing strategies navigated 2025 with greater confidence than those relying on tactical workarounds.

5 things we expect to shape 2026

1. Earlier manufacturing involvement in development

Manufacturing expertise will be brought into development discussions sooner to reduce downstream translation risk.

2. Increased scrutiny on analytical strategies

Analytical capability will become a clearer differentiator between manufacturing partners—not just capacity or speed.

3. Stronger demand for inspection-ready by design

Organisations will seek environments and partners that are inspection-ready by default, not by exception.

4. More open, science-led partner dialogue

Expect greater emphasis on ongoing scientific communication, shared risk assessment, and joint decision-making.

5. A shift toward fewer, deeper partnerships

Rather than broad supplier networks, many companies will favor fewer partners with deeper technical and operational alignment.

What this means for the sector moving forward

Taken together, the lessons of 2025 and the signals for 2026 point in a clear direction: advanced therapies are maturing, and so are expectations.

Success will increasingly depend on:

• Laboratories that can defend their science

• Manufacturing environments built for long-term therapy lifecycles

• Partners who communicate openly and think beyond the next milestone

The organisations that thrive will be those that treat reflection as a strategic tool, not a retrospective exercise.

An invitation to continue the conversation

Year-end insights are most valuable when shared

As we move into 2026, open dialogue across development teams, manufacturing partners, and scientific leaders will be essential. The challenges ahead are complex—but they’re also solvable when approached collaboratively.

We see this moment not as a conclusion to 2025, but as a starting point for better conversations in the year ahead.

Frequently asked questions (FAQs)

Why is year-end reflection important for advanced therapy programs?

It helps teams identify systemic strengths and weaknesses before entering the next development phase.

What changed most in 2025 for pharma manufacturing?

Greater emphasis on process understanding, data integrity, and scientific justification.

How are CDMO expectations evolving?

Sponsors increasingly expect deeper technical engagement and long-term alignment.

Why is lab maturity becoming more critical?

Because analytical strategies directly influence regulatory confidence and scalability.

What will define strong partnerships in 2026?

Transparency, shared accountability, and consistent scientific communication.

How can teams prepare now for 2026?

By aligning development, lab operations, and manufacturing strategy early and openly.

Looking ahead with clarity

2025 reinforced a simple truth: advanced therapies reward preparation, discipline, and dialogue.

As the sector enters 2026, the opportunity lies not just in new technologies—but in how thoughtfully we design labs, communicate science, and build partnerships that endure.