Oncology Pipeline Monitor 2026. Pilot Approach of Using IHSI Data to Inform Hospital Decision-Makers in Austria on Emerging Medicinal Products. Summary Report

Background/Objectives: The development and availability of new medicinal products are progressing rapidly, particularly in oncology, substantially affecting clinical practice and pharmaceutical expenditure in the Austrian inpatient sector. By raising awareness of medicinal products that may come to market in the next few years, horizon scanning enables decision-makers to assess potential opportunities and challenges and to prepare the healthcare system accordingly. The present report uses data from the IHSI Database to provide a snapshot of the regulatory oncology pipeline. It also highlights a selection of medicinal products prioritised by the Austrian stakeholders as expected to have a substantial impact on future clinical practice and pharmaceutical expenditure in the Austrian hospital setting.

Methods: The methodology combined systematic identification of the pre-regulatory oncology pipeline using the IHSI Database with an aggregate assessment of the emerging pipeline and an exploratory selection of medicinal products with potentially high clinical, organisational, and economic impact. The approach comprised three steps: (1) initial screening and application of predefined selection criteria to derive oncology pipeline, (2) development of a snapshot of the oncology pipeline by its systematic analysis across relevant characteristics, and (3) selection and profiling of medicinal products deemed potentially highly impactful for the Austrian inpatient sector. The oncology pipeline was restricted to originator oncology medicinal products with the expected opinion of the EMA Committee for Medicinal Products between July 2026 to December 2028.

Results: The pipeline consisted of 236 compounds that in aggregate accounted for 377 records in the IHSI Database. In terms of indications covered, medicinal products were developed across 70 cancer types, with 73.7% targeting solid tumours and non-small cell lung cancer being the most represented condition. The majority of pipeline medicinal products were intended for the adult population only (345; 91.5%) and targeted advanced or metastatic disease. From the European regulatory perspective, most submissions would represent new medicine applications (58.1%) supported by Phase 3 data (63.4%). 112 records (29.7%) carried at least one confirmed EMA regulatory designation (ATMP, Orphan, PRIME). Small-molecule targeted therapies represented the largest drug class (43.2%), followed by cell & gene therapies (11.0%), and immune checkpoint inhibitors (7.6%). Experts selected 20 medicinal products across 25 indications, predominantly novel biologics for rare cancers.

Conclusion: The analysis revealed that the oncology pipeline is shaped by two concurrent dynamics: the expansion of established therapies into new indications and the emergence of novel modalities for areas of high unmet need. Increasingly biomarker-driven indications pose challenges for diagnostic infrastructure. With over 90% of cost-estimated products exceeding € 25,000 per patient per year, health systems face growing budgetary pressure. Regular pipeline updates are essential for reliable horizon scanning. A weighted scoring system for systematic identification of high-impact medicinal products is planned for future editions to improve transparency and reproducibility of the selection process.