By the PharmaTradz BD Team. Published November 2026.
Cell and gene therapies have changed what is possible for some blood cancers and rare genetic diseases. Yet for most patients outside the United States and Western Europe they remain out of reach. Commercial CAR-T products in the US were listed at roughly 460,000 to 600,000 US dollars in 2025, and even in Europe only about two in ten eligible lymphoma patients receive CAR-T.
This guide is for hospitals, health ministries, distributors and pharmaceutical companies in other regions that want to make these therapies available. It sets out the practical routes, what each needs, and where partnerships fit. For the wider debate on cost, see our article Cell and gene therapy costs millions: can ordinary patients ever benefit?
Why these therapies are hard to supply
A CAR-T therapy is made from the patient's own cells. Cells are collected at the hospital by apheresis, shipped frozen to a manufacturing site, modified and expanded, tested, and shipped back for infusion. Commercial vein-to-vein times have a median of about four to seven weeks, and longer waits are linked to worse survival. Gene therapies are usually single doses that are less sensitive to time, but they still require specialised handling, ultra-cold storage and strict chain-of-custody controls.
So access depends as much on the hospital as on the product. A treating centre needs trained staff, apheresis and cryopreservation capacity, an intensive care unit able to manage cytokine release syndrome and neurotoxicity, and qualification by the therapy's manufacturer.
Route 1: Commercial products through named-patient or managed access
Where a therapy is not registered locally, hospitals can often import it for a specific patient under a named-patient or special access scheme, or through a manufacturer's managed access programme. Our global guide to named patient import programs explains how these work country by country.
- Works best for: one-time gene therapies and occasional CAR-T cases at well-equipped centres.
- Requirements: centre qualification by the manufacturer, import permits for the product and often for the patient's cells, cryogenic shipping, and funding approved before the cells are collected.
- Limits: price, and the time needed to qualify a new centre.
Route 2: Treating patients abroad
Some health systems and insurers send patients to qualified centres in another country. It avoids building local capacity but involves travel for the patient and family, long stays for follow-up and the full commercial price. It is often a stopgap while local capacity is built.
Route 3: Local or point-of-care manufacturing
A growing number of hospitals and academic groups make CAR-T cells close to the patient. Spain's public health system reimburses an academic CAR-T at about one-third of commercial pricing. Hospital programmes in Israel, Germany and Canada report production times of around 10 to 15 days, and India approved its first domestically developed CAR-T in 2023, with point-of-care production costs reported at about 35,000 US dollars per product before the cost of the viral vector.
- Works best for: countries and hospital groups with steady patient numbers and a commitment to build skills.
- Requirements: a cleanroom or closed automated manufacturing system, a reliable supply of viral vector, a quality control laboratory, and a regulatory pathway for hospital-made or locally made advanced therapies.
- Partnership model: technology transfer from an academic or commercial developer, with training, vector supply and quality system support.
Route 4: Regional licensing and manufacturing partnerships
Pharmaceutical companies in emerging markets can license approved or late-stage cell and gene therapies for their region, or partner with a developer to manufacture locally. These deals usually combine a licence, a technology transfer plan, vector and reagent supply, and a commitment to qualify treatment centres.
What a hospital or health system should prepare
- Accreditation. Many manufacturers require international cellular therapy accreditation for collection and processing, or a site audit of their own.
- Clinical team. Haematology, intensive care, neurology and pharmacy staff trained in managing therapy-specific toxicities, with the necessary supportive medicines in stock.
- Logistics. Validated cryogenic shipping, liquid nitrogen storage and chain-of-identity systems.
- Funding. Agreement on payment before cells are collected, including outcome-based or instalment models where the manufacturer offers them.
- Follow-up. Long-term follow-up and registry reporting, for up to 15 years for some gene therapies.
How PharmaTradz helps
We work with hospitals, distributors and pharmaceutical companies on access to advanced therapies: sourcing approved products for named-patient use, and connecting partners for licensing, technology transfer and supply of vectors and reagents.
- Browse cell and gene therapies.
- Need an approved therapy not available in your country? See innovator drug sourcing.
- Offering a therapy, technology or manufacturing capacity? Partner with us.
- Have a specific requirement? Send your RFQ.
The bottom line
Access to cell and gene therapies outside the richest markets will not come from one route alone. Named-patient imports serve individual patients today, treatment abroad fills gaps, and local manufacturing and regional partnerships are the only way to reach patients at scale. The hospitals and companies that prepare now, with qualified centres, logistics and partners in place, will be ready as prices fall and more therapies are approved.
This article is general business information, not medical, legal or regulatory advice. Requirements differ by country; check the current position with the relevant authority or a qualified adviser.
Frequently Asked Questions(FAQs)
Can CAR-T therapy be imported for a single patient?
Often yes, through a named-patient or special access scheme, provided the treating hospital is qualified by the manufacturer and the import permits and funding are in place before cells are collected.
What is point-of-care CAR-T manufacturing?
Production of CAR-T cells at or near the treating hospital, often using closed automated systems. It shortens the time from cell collection to infusion and can lower costs significantly.
What does a hospital need to give cell therapies?
Apheresis and cryopreservation capacity, a trained haematology and intensive care team, cryogenic logistics, chain-of-identity systems and, in most cases, accreditation or audit by the manufacturer.
Why are gene therapies so expensive?
They are complex to make, are produced in small batches, need long-term follow-up and are often given once for a rare disease, so development costs are recovered over few patients.
Can companies in emerging markets license cell and gene therapies?
Yes. Regional licensing and technology transfer deals are increasingly common, usually combining a licence with vector supply, training and treatment-centre qualification.
