IVA ATMP report: what Sweden must fix to stay competitive

IVA wants Sweden to concentrate its ATMP resources into three named super-ecosystems, to give clinicians paid time inside research and innovation rather than treating healthcare as the recipient of finished products, and to simplify regulation and strengthen incentives in Sweden and the EU. The IVA ATMP report, published in June, sets out these three recommendations, but the substance sits in the six proposals and the action points beneath them.

The sharpest of those action points is a transferable fast-track voucher. A company whose ATMP is approved by the EMA would receive priority review for another drug in its pipeline, and would be free to sell that voucher on. IVA argues the proceeds could offset a meaningful share of the original development cost.

The report is specific about who Sweden is competing against and how. The United States leads on approvals and hosts most first launches, supported by FDA fast-track programmes for regenerative medicine. China has built a dual-track trial system, aligned its frameworks with international standards and invested in domestic production. Germany runs a national gene and cell therapy strategy with pricing tied to demonstrated clinical benefit, while the United Kingdom operates the MHRA Innovative Licensing and Access Pathway alongside an Advanced Therapy Treatment Centre Network. France, Spain, Japan and South Korea are each credited with national strategies or dedicated legislation of their own.

Sweden is described as well integrated into international collaboration but losing investment and clinical trials to larger markets. On capital, the report cites an estimate that seed and early-stage funding available in Europe runs 80 percent below the United States.

The market itself is harsher than the enthusiasm around the field suggests. Ten years after the first approval, 19 ATMPs hold authorisation for the EU market, and close to a third of those approved in the EU were subsequently withdrawn, which the report attributes mainly to commercial non-viability rather than clinical failure. In 2025 the FDA approved two cell therapies, three gene therapies and one tissue-engineered product, against 31 small-molecule drugs and 12 biologics.

Manufacturing economics explain much of the attrition. Building capacity to treat between 5,000 and 15,000 patients a year with autologous cell therapy is put at USD 4 to 6 billion, equivalent to SEK 40 to 65 billion.

Much of what holds Sweden back is internal. The report describes a life science sector of many small and often underfunded companies that struggle to push projects past early development, the gap it calls the valley of death.

Reimbursement is misaligned with where value lands. Costs are carried by the regions, while savings accrue elsewhere, to health insurance, to municipal care, and to the state through tax revenue when patients return to work sooner. Clinical research competes for capacity against waiting lists and routine care. Data volumes are large but often unusable in practice, with quality registries still carrying incomplete entries because much of the input remains manual.

Two regulatory ambiguities are singled out for national guidance:

• How the hospital exemption should be interpreted, and who carries responsibility under it.
• How GDPR applies to secondary use of health data, where diverging interpretations between regions and providers slow implementation.

On technology the focus is narrow by design: diagnostics, cell technology and industry-agnostic production systems that can be reused across therapies and disease areas. On money the proposals are institutional rather than aspirational. Outcome-based reimbursement would be developed through TLV and the regions. Credit guarantees through the Swedish National Debt Office would reduce the risk of building GMP production capacity, with EIB loans covering smaller players, tied to the EIB and Commission initiative under TechEU to mobilise around EUR 10 billion for European biotech across 2026 and 2027. Public-private co-investment would use a first-loss structure, with public capital absorbing initial risk while private investors supply most of the capital and take most of the return. On state aid, the report argues the rules shape how measures are designed rather than prevent them, pointing to Belgium and the Netherlands routing public investment through research infrastructure and open platforms.

ATMP Sweden is named in the report as one of two national interest groups in the field, alongside Cell and Gene Therapy Sweden. The three proposed super-ecosystems map onto Stockholm-Uppsala, Västra Götaland-Oslo and Skåne-Öresund, organised on a hub-and-spoke model where central hubs carry manufacturing, quality control and traceability while connected nodes handle recruitment, treatment and follow-up.

Two Swedish examples carry weight. GeneNova, a gene therapy consortium of academic and industry partners, is credited with cutting production costs to roughly one seventieth of traditional processes and bringing three products to market. Sweden also screens all newborns for 26 treatable rare diseases, with one more expected to be added in 2026 as a new gene therapy becomes available.

The IVA report was written by a working group active from February to May 2026 and chaired by Maria Anvret, with participants from Karolinska Institutet, KTH, Lund University, Karolinska ATMP Center, AstraZeneca, HealthCap, Flerie, Lif, Region Stockholm and Region Skåne. Participants contributed in a personal capacity rather than as representatives of their organisations.