Global Clinical Trials

Market
Share, Global Trends,
Analysis, Research, Report,
Opportunities,
Segmentation and Forecast,
2015

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Report
Description
Report Description
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 investigators 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.
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Report
Description
Report Description
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. 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
Circulatory diseases
Cancer

Genitourinary diseases

Report
Description
Report Description
Congenital diseases
Musculoskeletal diseases
Central nervous system (CNS)
Infections
Dermatology
Metabolic disorders
Cardio vascular system (CVS) diseases
Gastrointestinal diseases
Mental disorders
Others

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.

Report
Description
Report Description
Geographically, the global clinical trials market is segmented into North America, Europe,
Asia-Pacific and Rest of the World.
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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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