Last year, there were signs that the tide was starting to turn for the approval of innovative Alzheimer’s disease (AD) drugs, when the United States Food and Drug Administration (FDA) approved Aduhelm (adacanumab) from Biogen. Despite the first-to-market advantage, the months of controversy following Aduhelm’s approval marked a major setback, as did the rejection by the European Medicines Agency (EMA) at the end of the year. last. Despite all its controversies, the launch of Aduhelm in the United States has prompted policy makers and health technology assessment (HTA) organizations to focus on what lies ahead for the AD market over the next few years. . European horizon scanning initiatives have been at the forefront of these efforts to predict which drugs have the best chance of regulatory success and which present the greatest potential cost challenges.
Last month, the transnational alliance BeneluxA attracted attention by publishing forecasts responding to European regulatory and reimbursement systems. The focus is on potential new AD pharmaceutical products that could potentially enter the market over a five-year period from the end of this year until 2027. Clinical trial statuses, including their use of biomarkers, are summarized, as are possible challenges, both at HTA level and in terms of expected burden on healthcare finances.
The BeneluxA Foresight Analysis Instrument is intended to provide a complete picture of potential new product launches and to create a repository of non-confidential information regarding future cost estimates to enable budget preparation. What is relatively unique about BeneluxA is that it uses a sliding scale to signify the chances of EU marketing authorization from ‘unlikely’ to ‘uncertain’. The analysis provides a forecast of the estimated commercial launch date based on a typical average time of 13 months required for EMA assessment, Committee for Medicinal Products for Human Use (CHMP) opinion and l marketing authorization from the European Commission (EC). The market authorization estimate is also based on filing after the earliest end date of the Phase III trial.
It is worth contextualizing BeneluxA’s findings with GlobalData’s forecasts of market entry of new AD drugs and market size in the four largest EU markets, namely France, Germany , Italy and Spain.
GlobalData recently updated its projections for the size of the AD market internationally. By early 2028, the global market is expected to reach $11.9 billion per year, compared to a previous market forecast of $12.9 billion. The rationale for this downward adjustment relates to lower expected uptake of Aduhelm, coupled with a 50% reduction in annual US treatment costs for Aduhelm this year. Despite this, for the four largest EU markets, GlobalData still expects rapid growth over the forecast period. This will be driven by the planned market entry of the upcoming investigational candidates Aduhelm, Roche’s gantenerumab and Eisai/Biogen’s lecanemab, for which BeneluxA estimates market authorization dates in the future. EU this year and next year respectively. Contrary to BeNeLuxA’s somewhat optimistic launch outlook, GlobalData predicts that sales of gantenerumab and lecanemab will not be generated in the largest EU markets until 2025 or 2026.
GlobalData AD Market Forecast predicts that pharmaceutical spending in the four largest EU markets will grow from $268.7 million this year to a market size of $717.5 million by 2027. Generally speaking, the model’s average annual growth rate of 26.5% in the four largest EU markets from now to 2027 can be extrapolated to the situation in the smaller BeneluxA countries. Additionally, based on GlobalData’s assessment of the four largest EU markets, 2025 is shaping up to be the most pivotal year in terms of drug launches and sales growth. This would also be the case in the BeneluxA sphere, where a potential annual increase of 105% in the value of the AD market could be deduced from the model.
More speculatively, market impacting events contained in the BeneluxA Foresight Analysis Report could become a catalyst for the alliance to play a future role in voluntary joint HTA assessments and pricing negotiations for certain AD therapies between the Austria, Belgium, Ireland, Luxembourg and the Netherlands. Although not all Member States may opt for this approach, at least some participating HTA agencies may prefer to leverage BeneluxA as a joint assessment and negotiation vehicle. Despite this, BeneluxA’s joint procurement model would still mean that pricing and reimbursement decisions would remain at the sole discretion of national authorities in its member countries. A good indication that other sub-regional alliances of European countries, such as FINOSE or Valletta, might consider triggering their own joint HTA assessments of AD drugs would be the preparation of parallel horizon scanning reports.
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