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The Europe Clinical Trials market report is segmented by Phase (Phase I, II, III and Phase IV), Design, and Geography
The European clinical trials market is expected to register a CAGR of 5.1% over the forecast period. Factors that are responsible for the growth of this market include high R&D spending of the pharmaceutical industry and increasing prevalence of diseases.
Another driving factor is the increasing focus on rare diseases and multiple orphan drugs in the pipeline. As rare diseases have considerably low prevalence rate, as compared to other diseases, drug manufacturers were previously not interested in developing drugs for rare diseases, due to the low earnings in this category. However, the situation has changed currently, as companies are increasingly focusing on cures for rare diseases, specifically in developed countries. In fact, the percentage share of orphan drugs approved by FDA increased from 33% in 2013 to 47% in 2015. Favorable government policies contributed majorly to this drive. The United States was the first to implement such policies, starting with the Orphan Drug Act (ODA) of 1983, encouraging pharmaceutical companies to develop drugs for diseases that had less market demand. Tax credits were offered for R&D costs and tax incentives were offered for clinical trials.
The push from different governments has motivated the small, medium, and large players to enter into orphan drug development. Thus, there are multiple drugs in the pipeline. Additionally, the orphan drug presents an avenue of high profit to the leading pharmaceutical companies working in a low CAGR market. As a result, Novartis, GlaxoSmithKline, and Pfizer (among others) have entered this field. However, factors, such as lower healthcare reimbursement in developing countries, may hinder the market growth.
Clinical trials are the experiments conducted in clinical research, and they follow a regulated protocol. They are performed particularly to obtain data on safety and efficacy of a newly developed drug. Clinical trial data is mandatory for further approval of the drug, for it to enter the market.
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Phase III is one of the most critical phases assessing the effectiveness of the new intervention, as well as its value in clinical practice. Most of Phase III clinical trials can be marketed FDA norms, through approval of a New Drug Application (NDA) containing all manufacturing, pre-clinical, and clinical data. The number of patients is huge and varied between 300-3000, and in several cases much higher. And as per the clinicaltrials.gov, there were around 5800 active studies ongoing in 2018; the United States and some European countries had the most number of clinical trials, followed by China and Canada. The Middle East, Australia, and Japan are the regions with a significant number of clinical trials being conducted.
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The European clinical trials market is competitive and consists of several major players. In terms of market share, few of the major players currently dominate the market. With the rising need for new drugs and treatments, advances in healthcare, and an increasing number of new diseases, it is expected that few smaller players will enter into the market and may a hold substantial share in the near future. Some of the major players of the market are Eli Lilly and Company, Pfizer Inc., Pharmaceutical Product Development LLC, Novo Nordisk, and Sanofi, among others.
1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 High R&D Spending of the Pharmaceutical Industry
4.2.2 Increasing Prevalence of Diseases
4.2.3 Focus on Rare Diseases and Multiple Orphan Drugs in Pipeline
4.3 Market Restraints
4.3.1 Lower Healthcare Reimbursement in Developing Countries
4.3.2 Stringent Regulations for Patient Enrollment
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION
5.1 By Phase
5.1.1 Phase I
5.1.2 Phase II
5.1.3 Phase III
5.1.4 Phase IV
5.2 By Design
5.2.1 Treatment Studies
18.104.22.168 Randomized Control Trial
22.214.171.124 Adaptive Clinical Trial
126.96.36.199 Non-randomized Control Trial
5.2.2 Observational Studies
188.8.131.52 Cohort Study
184.108.40.206 Case Control Study
220.127.116.11 Cross Sectional Study
18.104.22.168 Ecological Study
22.214.171.124 Rest of Europe
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Clinipace Worldwide
6.1.2 Eli Lilly and Company
6.1.3 ICON PLC
6.1.4 Novo Nordisk
6.1.6 Pfizer Inc.
6.1.7 Pharmaceutical Product Development LLC
6.1.9 F. Hoffmann-La Roche AG
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments