Clinical Trial Supply (CTS) Market Intelligence

Clinical Trial Supply (CTS) Market Description

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. This growth is mainly driven due to the increase in biologics pipeline, a rise in adoption of comparator studies, and the maturity of the clinical trial footprint in emerging markets such as Brazil, China, India, Russia, and South Korea. The use of technology in clinical trial supplies has further changed the dynamics of logistics services. This was achieved by decreasing the wastage of supplies and increasing the patient-centric approach of clinical trials.

The report discusses the various technological trends in the clinical trial supplies industries. The globalization of clinical trials has led pharma companies to conduct clinical trials, especially phase III clinical trials in different geographies such as Eastern Europe, China, Korea, and Taiwan, which are fast-growing economies. The report further includes Porter’s Five Forces analysis which states that the strategic partnership with aspects such as price benchmarking, spend consolidation, and demand forecasting will bridge the gap between the buyers and the suppliers. Strategic model and Fee-For-Service are the most prevalent engagement and pricing models opted by the clinical trial supplies industry as the workload is different across the supply chain.

Beroe gathers intelligence through primary sources that include industry experts, researchers, and consultants, as well as current suppliers, producers and distributors. Secondary sources can include business journals, newsletters, magazines, market research data, company sources, and industry associations. Following data collation, analysis, and strategic review, the Final Research Report is published on Beroe LiVE.

Report Coverage

Technological Trends
Supplier Analysis
Supplier Profiling
Best Practices

Clinical Trial Supply (CTS) Market Trend, Analysis & Forecast

Category Intelligence on Clinical Trial Supply (CTS) covers the following

Information relating to market, supply, cost, and pricing analysis
Hard to find data on cost and TCO models, supplier details, and performance benchmarks
Macroeconomic and regional trends impacting cost, supply, and other market dynamics
Category-specific negotiation and sourcing advice

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Executive Summary

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Market Analysis

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Supply Analysis

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Cost & Pricing Analysis

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Best Practices

1. Clinical Trial Supply Executive Summary

1.1 Executive Summary
1.2 BREXIT Impact

2. Clinical Trial Supply Market Analysis

2.1 CTS Market Overview
2.2 Drivers and Constraints
2.3 Market trends
2.4 Porter’s Five Forces Analysis
2.4 Category Segmentation

3. Clinical Trial Supply Best Practices

3.1 CTS Cost Break up Analysis
3.2 Best Practices
3.3 Comparator Sourcing Market

4. Clinical Trial Supply Supply Market Overview

4.1 Supplier Analysis
4.2 Supplier Analyisis comparator Sourcing
4.3 Supplier Profiling
4.4 Supplier Development

5. Clinical Trial Supply Market Insights

5.1 Digitalization
5.2 Others
5.3 Logistics
5.4 Turnaround Time

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.

clinical-trial-supply-market-size

Drivers and Constraints

Drivers

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

Constrains

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

Regulatory Trends

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

BREXIT

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

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