Global Clinical Trial Supply Market Outlook
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
- The global clinical trial supply and logistics market is expected to grow at a CAGR of 7.1 percent, and the market is estimated at $14.84 billion in 2016 and $21.5 billion in 2021
- The global clinical trial supply market is expected to grow at a CAGR of 7.2 percent and estimated to reach $1.2 billion by 2020 from $904.3 million in 2015.
Drivers and Constraints
- Stringent Regulatory Environment : FDA and other regulatory authorities have increased stringency of quality, storage, packaging and labeling, distribution, and recall of ancillary products. Companies now source ancillary products at different levels, like central sourcing and regional sourcing.
- Globalization of Clinical Trials: Due to globalization of clinical trials, pharma companies are conducting clinical trials, especially phase III clinical trials in distinct geographies, including the fast-growing Eastern Europe, China, Korea, and Taiwan. This has led to increase in planning and sourcing ancillary materials
- R&D Investments: Increase in R&D investments and government support increased the scope to conduct more research
- High Waste and Overage : Clinical trials are experiencing a very high level, approximately 150–200 percent of clinical supply waste leads to unwanted cost escalation and high inventory. This impacts the use of internal resources within pharma and biotech companies
- Interactive Response Technology: Regulatory environment in many countries is very dynamic for some time and change comes very fast. This, along with a high initial cost for installing IRT, proves to be an obstacle in the path of integrating Clinical Ancillaries with Interactive Response Technology (IRT) and most of the work is done on manual basis using excel sheets
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:
- Making EU the best practice region in terms of fighting Antimicrobial Resistance (AMR) growth
- Boosting research, development and innovation
- Shaping the global agenda by making EU more influential on AMR internationally
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