From Europe’s Evidence Framework to the U.S. Commercial Opportunity in CGT
Last week in our Lonrú Lens we explored how Europe is redefining post-approval evidence and market access for cell and gene therapies through our interactive continent-wide tool. That article guides enabling-technology providers through the complex national HTA, registry and long-term follow-up requirements across the UK, Germany, France and Italy.
This week, we turn our attention to the United States. While Europe emphasises harmonisation and alignment, the U.S. remains the global bellwether for where commercial and technical demands land first. With almost two-dozen CGT approvals under the belt, the VantagePoint™ Cell & Gene Therapy Evidence & Access Navigator now maps how each U.S. therapy brings a tail of obligations - obligations that translate directly into opportunities for enabling-technology providers.
Introducing the U.S. View: The Evidence & Access Navigator for Cell & Gene Therapy
Our U.S. edition of the Navigator captures every U.S. approval from the first CAR-T therapy in 2017 through the latest 2025 entry. Each record links modality, indication, manufacturing constraints and post-market commitments to a set of “vendor signals” - concrete indicators of where analytics, manufacturing, logistics, diagnostics and patient-support vendors will be needed. By doing so, enabling-technology companies can anticipate what will be built next and plan with purpose.
Why This Matters for Enabling-Technology Providers
Every approval isn’t just a win for a therapeutic sponsor - it’s a signal for the ecosystem. Future-proof tools don’t just respond to science; they align with the administrative, regulatory and delivery burdens that follow.
If your company provides QC or analytics platforms, the key question isn’t “What therapy got approved?” but “What is the comparability or potency-data demand that results from this approval?” If you specialise in RWE or registry services, you’ll want to know which products carry 15-year safety or durability commitments. If you build logistics or cryostorage systems, you’ll ask “Which approvals require autologous chain management or temperature-sensitive vector delivery?”
The Navigator makes those questions answerable. Instead of chasing vague trends, you can shape your product roadmap around real obligations - giving you line of sight into where sponsors will spend next, and where your enabling technology fits.
What the Data Shows
The U.S. dataset illustrates that the enabling-technology market is entering a phase of sustained demand, not just one-off launches. Across the 19 therapies captured:
Manufacturing complexity appears in every one of them—confirming that robust process, vector/cell supply, and comparability infrastructure remain foundational.
RWE and long-term follow-up commitments appear in fourteen therapies, signalling that real-world platforms and outcomes tracking are now table stakes.
Analytics obligations similarly stretch across fourteen therapies—highlighting that data-interpretation and assay-readout engines remain a key service layer.
Supply-chain/logistics burdens surface in twelve therapies—particularly for high-dose AAV, autologous harvest, or cold-chain sensitive administration.
Patient-support and diagnostics are less frequent, but highly strategic, especially for new modalities such as gene editing, ocular delivery, or topical therapy.
These patterns tell a clear story: the market is shifting from therapy-by-therapy “first-in” launches toward infrastructure-enabled scale. The tools that deliver continuity, data clarity and execution speed will define the next era of CGT.
How to Use the Navigator
The Navigator is built with enabling-technology providers in mind. You’ll begin by filtering by Modality, Year, or Vendor-Signal to zoom into your space of interest - whether that’s AAV manufacturing, RWE platforms or next-gen diagnostics. Then, by expanding a therapy row, you’ll see its commitments and vendor-signal cue-words - giving you clarity on who needs what next.
Users can export the data and embed or annotate it in your internal strategy processes without worrying about shifting inputs. If you’d like a focused slice, or expand to include VantagePoint™ - say, all 2024 AAV approvals with supply-chain complexity - we can tailor that for you.
Explore the Data
VantagePoint™ Cell & Gene Therapy Evidence & Access Navigator
A VantagePoint™ INSIGHTS Product
The VantagePoint™ Cell & Gene Therapy Evidence & Access Navigator sits firmly within Lonrú’s Insights suite - where we convert regulatory and market intelligence into actionable commercial foresight. For enabling-technology companies, it offers a vantage point into where capability gaps turn into growth opportunities.
