1. health and fitness

Clinical Trials Market Growth, Trends, Absolute
Opportunity and Value Chain 2015-2025
November 2016
Report Id : REP-GB-384
Status : Ongoing
Category : Healthcare, Pharmaceuticals & Medical Devices
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Research Methodology (1/2)
Systematic Research Approach
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Market profiling
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Formulating discussion guide
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Developing list of respondents
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In-depth secondary research is used to
ascertain overall market size, top
industry players, top products, industry
associations, etc.
PMR formulates a detailed discussion
guide to conduct expert and industry
interviews
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(manufacturers), distributors, retailers
and industry experts
Data collection
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experts, industry players, distributors
and retailers
Data validation
Data is validated by triangulation
method, wherein secondary, primary
and PMR analysis contribute to the final
data
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Data analysis
Insights
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Data is scrutinized using MS-Excel to
obtain qualitative and quantitative
insights about the industry
PMR delivers industry insights and
information in the required format
(PDF)
Data
Collection
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Research &
Intelligence
Data Filter
& Analysis
Identifying key opinion leaders
Questionnaire design
In-depth interviews
Coverage across value chain
Actionable
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Primary
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SOLUTION
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Market participants
Key strengths
Product portfolio
Mapping as per value chain
Key focus segments
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Linkedin
Zoominfo
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Key industry experts
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Company websites
Company annual
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Paid Publications#
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Factiva
GBI
Genios
Meltwater
# includes sources of databases
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Clinical Trials Market
Clinical Trials Market Growth, Trends, Absolute Opportunity and Value Chain 2015-2025
Clinical trials are research studies performed on humans to gain specific information about biomedical
interventions such as novel vaccines, devices, treatments and drugs and thereby generating safety data.
Clinical trials are regulated by health authorities and ethics committees.
Documents required for performing clinical trials are investigator’s brochure (IB) which include current
and relevant scientific information about the investigational product, United States Food and Drug (FDA)
form 1572, protocol and amendments, inform consent, other written information for participants,
recruitment advertisement, financial disclosure form (FDF), master clinical trial agreement (MCTA),
institutional review board (IRB) approval, medical licensure, training records, laboratory accreditation,
visit monitor reports, miscellaneous document, signature sheet and documentation of investigational
drug destruction. The International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) brings together regulatory authorities of Europe,
the United States, Japan and experts from pharmaceutical industry to frame and regulate the technical
and scientific aspects of pharmaceutical product registration. The Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH) states rules and standard
guidelines for clinical trials. ICH guidelines are followed as law by several countries in the world.
Clinical trials are conducted in four phases namely, Phase I, II, III and IV. Phase I is conducted for safety,
phase II is conducted for efficacy, phase III is conducted for final confirmation of safety and efficacy and
phase IV is conducted for post sales studies. Risk to participants involved in clinical trials decreases from
phase I to phase VI.
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Clinical Trials Market
Number of participants increases from phase I to phase IV resulting in increasing cost of trials. Based on
the phases of clinical trials, global clinical trials market is segmented as follows:
Phase I
Phase II
Phase III
Phase IV
Based on indication, global clinical trials market is classified as follows:
Blood disorders
Ophthalmology
Autoimmune diseases
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Clinical Trials Market
Circulatory diseases
Cancer
Genitourinary diseases
Congenital diseases
Musculoskeletal diseases
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Central nervous system (CNS)
Infections
Dermatology
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Clinical Trials Market
Metabolic disorders
Cardio vascular system (CVS) diseases
Gastrointestinal diseases
Mental disorders
Others
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Being relatively costly process, in order to reduce economic burden on company and shift focus on core
business activities, many companies outsource their clinical trial activities to contract research
organizations (CROs). Contract research organizations provide services such as clinical trial management,
clinical research and preclinical research. Factors such as advancement in technology and increasing
demand of innovative solutions in healthcare industry are driving the market of global clinical trials
towards growth. On the other hand, factors such as high cost and stringent regulations are restraining the
growth of clinical trials market globally. Geographically, the global clinical trials market is segmented into
North America, Europe, Asia-Pacific and Rest of the World.
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Clinical Trials Market
North America is the leading consumer of global clinical trials solutions, followed by Europe. Ample
availability of funds to outsource clinical trials serves as the major growth driver for the North America
clinical trials market. Asia-Pacific demonstrates impressive growth potential for clinical trials market and
is expected to show the highest growth rate as compared to other regions in the world. Countries such as
India are attractive markets due to advantages such as availability of skilled practitioners and availability
government support in terms development of outsourcing hubs thus attracting pharmaceutical and
biotechnology companies to outsource clinical trial activities to CROs in this region. Some of the market
leaders contributing to the global clinical trials market include Eli Lilly and Company, Novo Nordisk A/S,
Ranbaxy Laboratories, Ltd., Sanofi Aventis A.S. and Roche Group.
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