Why Scalable Teams Matter in Cell & Gene Therapy’s Next Chapter

Cell and gene therapy (CGT) has come a long way over the past decade, and 2025 is shaping up to be a major turning point. With more than 20 FDA-approved therapies on the market and hundreds in the pipeline, CGT is no longer just a promise—it’s becoming a real, commercial force. But turning groundbreaking science into scalable treatments isn’t easy. It takes smart strategy, strong partnerships, and innovation across every part of the process.

A Fast-Growing Market with Big Potential

The global CGT market is expected to hit over $25 billion this year, with steady double-digit growth. The U.S. is leading the way in approvals and development, but Europe and Asia are making big strides too. We’re also seeing some CGT products move toward “blockbuster” status, like Carvykti and Breyanzi, which shows these therapies are not only working, but gaining serious traction.

New Approvals and Pipeline Highlights

So far in 2025, a few standout therapies have gotten the green light:

• Encelto, a cell-based treatment for macular telangiectasia
• Qfitlia, an siRNA therapy for hemophilia A and B

These approvals reflect how regulators and payers are becoming more comfortable with CGTs, and they’re helping move these innovations into real-world care.

The Commercialization Hurdle

Science is progressing quickly, but commercializing CGTs still comes with a lot of challenges. Manufacturing is complex, logistics can be a nightmare, and each patient often requires a tailored approach. Add in steep price tags and a tricky reimbursement landscape, and it’s clear why scaling is such a big challenge.

We’re starting to see more creative payment models, like value-based and outcome-tied reimbursement, but these are still gaining traction.

Manufacturing: The Next Big Push

Manufacturing is where a lot of companies are now focusing. We’re seeing more investment in automation, modular systems, and new production platforms that aim to cut costs and speed things up. Companies like Cellares and Resilience are leading the way here, helping therapies get from lab to market more efficiently.

Why Partnerships Matter

More biotech teams are partnering with CDMOs and tech-focused companies to help fill gaps in their operations. This has fueled a wave of partnerships and M&A deals focused on commercial readiness. It’s all about being able to scale when the time comes.

Tackling Access and Affordability

We’re also seeing new strategies to make these therapies more accessible. Some companies and payers are exploring models like Medicaid pooling or annuity-based payments to help balance cost and access—especially for rare disease therapies where the need is urgent.

Looking Ahead

The rest of 2025 is set to bring more approvals and smarter commercialization strategies. Expect to see more standardization in how CGTs are delivered, more payer education, and a greater push toward global markets.

Success in this space will come down to more than great science. It’ll require the ability to scale smartly, build strong teams, and deliver real value to patients, providers, and payers alike.

Need help building your CGT team?
The Remedy Group partners with biotech and pharma companies advancing cell and gene therapy. From Market Access to Trade Strategy, we help you find the right people to grow with confidence.