Category Intelligence on Clinical Trial Supply (CTS) covers the following
The global clinical trial supplies market is expected to grow at a CAGR of 7.2 percent during 2015-2022. This will be driven by the growth in biologics pipeline, growth of clinical trial footprint in the emerging markets (Brazil, China, India, Russia, South Korea) and increase in adoption of comparator studies
Continuous change in regulations and regional governing bodies will affect the importing of clinical trial supplies. Utilizing an import broker to overcome regional difficulties like compliance with import/export regulations for shipments of clinical trial supplies will benefit pharma in smooth running of clinical trials
Lack of regulatory clarity between UK and rest of EU countries, it is inevitable for pharma to plan and execute long term clinical strategies till EMA re-establishes its base.
Post BREXIT, non-EU countries cannot import the clinical trial supplies into UK to distribute throughout EU and it will be critical to work with EU based QP with UK based QP for smooth running of trials
EU one health action plan against AMR
EMA has developed A European One Health Action Plan against AMR which contains initiatives like:
Regulation 536/2014 (CTR)
Clinical Trial Regulation (Regulation 536/2014, CTR), which can provide a centralized database and entry point to for information related to EU clinical trial data submissions will not be available before 2019 due to delay in establishing the IT infrastructure because of the no clarity in EMA shift from UK
Clinical trial authorization for investigator initiated studies
Additional Clinical Trial Authorization (CTA) should be submitted for Investigator Initiated Clinical Studies (IIS) - Investigational Medicinal Product Dossier (IMPD) information, Summary of Product Characteristics (SPC) for marketed drugs and if non-authorized products are used, Cross-reference-letter by the manufacturer referencing to an existing IMPD available from the Health Authorities should be submitted
Strategic partnership with features like price benchmarking, spend consolidation and demand forecasting will bring the buyer and supplier in the clinical trial services industry to equilibrium in the next 2-3 years.
The core providers of clinical trial services provide the most comprehensive range of services dedicated for pharmaceutical industry. E.g., Fisher, Marken, Parexel, Catalent etc.
The information on clinical trial sourcing shows that majority of clinical trial supply services are outsourced. Secondary packaging, shipping and distribution accounts to the larger portion of the outsourced services.
The comparator sourcing for clinical trials has market share as follows: Myoderm + Clinigen + Fisher Clinical - 35% and Others - 65%.
Most suppliers of comparator trial drugs are relatively small and tend to be nationally focused or part of larger organizations (usually wholesalers). The margin charged by the suppliers can vary based on the complexity of the supply chain. Supply market consolidation can increase the market share of top suppliers.