Emerging product-process archetypes in oncology: informing the sustainable provision of next-generation medicines

Abstract

The emergence of more targeted molecular therapies has contributed to accelerated growth within the oncology market. Projected to become the leading therapeutic area by 2017, forecast spends are expected to be in the range of $74-84 billion. Coupled with its many specificities around pricing, insurance implications, and ethics, we argue that the oncology segment may best inform future pharmaceutical value network design characteristics-in supporting the sustainable manufacture and supply of next-generation medicines. Through exploration of future state scenarios and opportunities areas, driven by the adoption of emerging process and digital technologies, a base framework is extended to enable a systematic assessment of a series of candidates representative of the wider oncology market. These include niche, low volume drugs on-patent with high QALYs (quality-adjusted life years), through to higher volume generics with a history of supply shortages. A series of emerging product-process 'archetypes' in oncology are proposed-classified as 'New Niche', 'Old Niche' and 'Established Generics'-with associated models for reconfiguration, based on the clustering of potential supply benefits. A key application of this systems approach is the potential of informing economies of drug 'repurposing', through its extension from commercial to drug discovery, development and clinical trial contexts, and in matching emerging process capabilities to future adaptive supply requirements-for the sustainable provision of next-generation medicines.

2D and 3D inkjet printing of biopharmaceuticals – A review of trends and future perspectives in research and manufacturing

“…There is an increasing need for new biologic-related rare disease treatments and the threat of COVID-19 type pandemics will likely spur the development of biologic vaccines [22]. With its many specificities, (niche and personalised, low volume -high variety, targeting for sub-populations) it is argued that the oncology segment may best exhibit the characteristics of next-generation therapeutics [23]. The segment is also representative of growing complexity -with more than 300,000 new cancers (excluding skin cancers) diagnosed annually in the UK, across over 200 different cancer types [24].…”

“…This is also reflected in the oncology segment fast becoming one of the major therapeutic areas in the sector, capturing 31% of all R&D effort [25], and experiencing the fastest growth compared to other therapy areas [26]. The emergence of more targeted molecular therapies has contributed to accelerated growth within the oncology market, with forecast spends expected to be circa $74-84 billion by 2018 [23].…”

“…When analysing the potential impact of printing on this sector, these will have different considerations. Production processes involving injectables currently involves a series of technological and process challenges (e.g., freezing and sublimation steps), that may lead to opportunities for radical disruptions involving printing technologies within the process [23]. Oral dose forms, on the other hand will benefit greatly from a technology disruption both in continuous (primary) manufacturing and the manufacturing of pharmaceutics.…”