Biotech at a crossroads: A realistic look back at 2025 and what comes next

Ellie Gadd
12 minutes ago
5 min read

A look back at the realities of 2025 and the lessons shaping biotech’s path into 2026

As 2025 draws to a close, biotech finds itself in a complex but defining phase. The pace of scientific innovation is accelerating, especially in discovery and design, but success increasingly hinges on execution, CMC readiness and the ability to move into the clinic efficiently.

This contrast between scientific momentum and operational challenge has shaped much of the year. Funding remains available, but it is harder to secure, slower to convert, and awarded more selectively than at any time since 2020. Strong science alone is no longer enough. Progress now depends on clarity of development strategy, cost-aware execution, and evidence that programmes can advance toward patients.

Rather than seeing this as a setback, it may be better understood as a recalibration; a shift from growth-by-ambition to growth-by-proof.

The companies advancing today are those progressing with discipline, not just vision.

Europe and France: progress under pressure

Across Europe, investment appetite has stabilised but not softened. Competition for capital is more intense, decision cycles are longer, and investors are prioritising milestones over narratives.

In France, the effect is sharper still. Shorter runways, slower financing cycles and a rising number of insolvency risks mean many early-stage biotechs are making hard choices around prioritisation and pacing. And yet, innovation is still happening, but only when it is paired with thoughtful, confident execution.

Breakthroughs are not stopping, but they are emerging where strategy, discipline and speed align.

Global context is shifting: China is now a viable CMC strategy, not a fallback option

At the same time, a major global shift is underway and it demands attention.

China, once viewed mainly as a low-cost manufacturing base, has rapidly evolved into a full-stack biotech ecosystem capable of delivering credible innovation, development and production.

Some signals are hard to ignore:

In the first half of 2025, ~32% of global out-licensing deal value involved China-originated assets — up from ~21% in 2023–24 and low single-digits less than a decade ago.
Regulatory and infrastructure reform has accelerated development timelines and improved compatibility with international standards.
Chinese biotechs are no longer limited to generics — pipelines now span oncology, metabolic disease, RNA, biologics and next-generation cell technologies.

And critically for Europe and France, China is becoming a practical CMC pathway, not as a compromise, but as a strategic enabler.

European developers are increasingly using China for targeted CMC stages such as:

cell line development
upstream/downstream process optimisation
analytical & characterisation activities
DS/DP manufacture for clinical supply

This isn’t about moving development away from Europe; it is about expanding optionality. When capital is tight, burn matters, and timelines define value, China offers high-quality, cost-efficient momentum without sacrificing standards.

French and European science remains world-class. China expands the routes through which it can reach patients.

Where success is happening: speed, integration and CMC intelligence

Across the sector, one signal was consistent throughout 2025: time to clinic has become a competitive asset.

Reaching first-in-human with quality, safety and manufacturability in place, and doing so swiftly, is increasingly what separates programmes that advance from those that stall. In a capital-selective and globally competitive market, clinical-ready progress is not just desirable; it is decisive.

Case spotlight: DT-7012 — demonstration through delivery

DT-7012, a novel Treg-depleting anti-CCR8 monoclonal antibody, reached first-in-human in just 15 months, from DNA sequence to Drug Product release.

3Biotech supported Domain Therapeutics with an integrated CMC strategy designed for pace, quality and risk control. This included:

Rapid GMP Readiness: Critical manufacturing processes and quality systems were established early, ensuring the programme was GMP-ready well ahead of first-in-human manufacturing. By front-loading these activities, the team minimised later delays and met regulatory standards without compromising speed.
Targeted CDMO Selection: A CDMO partner was carefully chosen based on DT-7012’s specific technical needs and aggressive timeline. This selection – ultimately a partnership with an internationally recognised manufacturer – ensured that stable cell line development and scale-up could proceed on a fast track without sacrificing quality
Seamless Process Development to Fill-Finish: Process development began at the earliest stage and continued through to fill-finish, meaning that drug substance production and final drug product preparation were closely coordinated. This end-to-end approach avoided hand-off gaps, so when the drug substance was ready, fill-finish was primed to deliver the clinical vials immediately.
Risk-Conscious, Milestone-Aligned Planning: The project followed a development plan aligned with key clinical inflection points. Instead of over-investing in activities far ahead of need, the team focused on what was required to reach Phase I efficiently. Risks were actively managed by timing each CMC step with upcoming decisions – for example, deferring extensive process optimisation until initial human data justified it. This way, time and resources were directed where they added the most value, and potential pitfalls were anticipated with contingency measures.

In a year when many programmes slowed, this one accelerated, not through urgency alone, but through deliberate design. It demonstrates what is still possible when strong science meets structured execution.

Looking to 2026: strategy will matter more than scale

With the financing landscape unlikely to loosen quickly and global competition increasing, the coming year will reward those who convert novelty into evidence. Innovation remains abundant. Capital has not disappeared. But value must now be earned, not assumed.

Success in 2026 is likely to reflect three themes:

CMC integrated early, not late Manufacturability, supply chain and regulatory alignment will increasingly determine pace, cost and clinical readiness.
Global collaboration and smart outsourcing
Cost-efficient development routes — including China for selected CMC activities — will act as strategic multipliers, not shortcuts.
First-in-human remains the clearest value gate
Clinical validation continues to be the milestone investors trust most. Programmes that reach it efficiently will continue to unlock capital and collaboration even in a selective market.

Together, these themes point to a simple truth: in 2026, the winners will excel not only in science but in execution.

3Biotech in 2025: progress earned, not assumed

Despite macroeconomic pressures and an increasingly competitive biotech landscape, 3Biotech’s 2025 achievements reflect disciplined, high-value execution rooted in advanced CMC expertise.

First-in-human delivery achieved on multiple programmes, including antibody-drug conjugates (ADC) and bispecific antibodies—each with tailored CMC acceleration frameworks.
A full DNA-to-DP (Drug Product) delivery for a T-cell engager completed in just 15 months, including the design and qualification of novel dual-expression cell lines.
Execution of an mRNA-LNP platform readiness project for a global partner, including lipid component selection, analytical method development, and regulatory filing support.
Strategic manufacturing network established for a cell therapy client, with integrated CDMO oversight across viral vector and autologous product supply chain.
Expansion of cross-border CMC programmes across EU and North America, including complex comparability assessments and regulatory bridging strategies.
CMC recognised by partners not merely as a support function, but as a strategic enabler for competitive advantage and product differentiation.

These milestones validate not only 3Biotech’s executional strength but also its ability to operate at the frontier of biologics innovation, ensuring quality, speed, and technical clarity in the most demanding therapeutic areas.

2026: A year for intelligent acceleration in a global biotech landscape

The coming year will not reward velocity alone, but well-designed velocity, supported by thoughtful planning, global execution pathways and clinical-facing strategy.

Biotech does not lack ideas.

- It needs pathways.

- It needs efficiency.

- It needs delivery.

That is where 3Biotech will continue to operate: turning promising science into clinical progress, faster and more cost-effectively.

We step into 2026 not with unfounded optimism, but with evidence, momentum and purpose ready to deliver in a world where innovation is global, competition is expanding, and execution is everything.