The biotech landscape is shifting. After a few years of cautious funding, more venture capital, regulatory alignment, and emerging therapeutic modalities are driving certain biotechs into “scale-up” mode. 

Below I take a look at key players, trends, and what this means for talent needs in clinical development and medical affairs.

What’s Fueling Scale-Up in Biotech

R&D Funding Rebound & Productivity Gains

According to IQVIA’s Global Trends in R&D 2025, R&D funding has increased for the second consecutive year. Clinical trial starts have mostly returned to pre-pandemic norms, and “clinical program productivity” (i.e. success rates, especially in Phase III) has improved.

Novel Modalities & Rare Disease Focus

Cell and gene therapies, biologics beyond small molecules, and rare disease programs are increasingly prominent. These assets require specialist clinical, regulatory, manufacturing, and medical affairs capabilities - often teams that are harder to assemble. 

Emerging Biopharma Players Taking More Stage

Emerging biopharma companies (pre-commercial or early commercial) are doing more of the heavy lifting - origination, late‐stage development, and sometimes commercialization, rather than simply being acquired or licensing out early. 

Strategic Therapeutic Areas Driving Momentum

Oncology remains a focus, but obesity / metabolic disease, immunology, and novel therapeutic areas (neurology / rare neurology) are seeing increased trial starts and investment. 

Biotech Companies to Watch in 2025

Here are some biotechs that appear to be scaling up notably this year (or are well placed to do so), with implications for clinical development and medical affairs leadership:

• Aro Biotherapeutics
• Castle Creek Biosciences
• Neurogene
• Azitra
• EvolveImmune Therapeutics

Challenges to Scaling and What Quality Talent Can Solve

Scaling in biotech is not just about having good science. It often stalls because of operational bottlenecks. 

Some recurring challenges:

• Regulatory & Compliance Complexity in novel modalities (gene therapy, RNA, microbiome).
• Clinical Trial Timelines: patient recruitment / enrollment still a big drag; moving between phases (especially Phase II → III) requires robust trial ops leadership.
• Medical Affairs & Commercial Readiness: as biotechs near commercialization, they often lack internal bench strength in medical affairs - writing publications, preparing for regulatory / HEOR / market access interactions, engaging KOLs.
• Talent Scarcity: people with experience in rare diseases, in advanced modalities (gene, cell, novel biologics), or in cross-border regulatory settings are in limited supply.

What This Means for Life Sciences Companies and Leadership

For senior leaders, the implications are:

• Strategic hiring now is crucial. The best teams are built well before late-stage trials or launch.
• Invest in cross-functional capability: regulatory, safety, quality, trial design, medical affairs. The more novel the therapy, the more integrated these functions must be.
• Consider external partnerships early (CROs, consultancies) to bridge gaps during scaling.
• Monitor trailblazers such as the companies above. Their hiring / activity patterns offer useful leading indicators - for example, where they are hiring medical affairs directors, expanding clinical ops teams, or moving into new modalities.

Looking Ahead

Scaling biotechs are going to be drivers of innovation, but also significant competitors for talent and investment. As more biotech firms move from science to clinical and / or commercial execution, the demand for experienced leaders in clinical development and medical affairs will rise sharply.

If your organization is considering how to stay ahead, whether as employer, partner, or investor, now is a good time to map out what “scale-up readiness” looks like: talent, infrastructure, operations, and regulatory.

If you’d like to talk through what these trends mean for your hiring roadmap, particularly in clinical development or medical affairs, please feel free to reach out. 

I’m happy to share how we’ve helped teams match with high-impact candidates during this scaling phase.

📧 riya.sharma@seclifesciences.com