Clinical trials are generally conducted to collect data regarding safety and efficacy of new drugs and devices development. There are multiple stages of drug approval in clinical trial process before drug or device can be sold in the market. In general, drugs or devices must undergo several phases of clinical trial that include preclinical, clinical trials to get market approval. Clinical trials are done on human subjects in different phases such as phase 0, phase 1, phase 2, phase 3, and phase 4 or post marketing surveillance to testify the products safety and efficacy. Early phase clinical trials include Phase 0, Phase 1, and Phase 2 stages of clinical trials which are essential to ascertain the safety and efficacy of the drug or devices in target population. Clinical trials outsourcing in pharmaceutical and medical devices industry has been a market trend owing to increased expertise of Clinical Research Organizations (CROs) coupled cost saving strategies adopted the numerous drug development companies in the market.
Early phase clinical trial outsourcing market is driven by increasing cost associated with in house clinical trials along with drug discovery companies’ effort to improve cost efficiency of its operations. Several studies indicate that more than 50% of the early phase clinical trials are outsourced to global and speciality CROs. In addition, increased spending on small molecules research & development, increasing investment in small biopharmaceutical companies, rising product pipelines of large pharmaceutical companies expected to boost the revenue growth of early phase clinical trial outsourcing market over the forecast period. However, increased per-patient cost, difficulties in recruiting/retaining the subjects (patients), and sudden dropout or withdrawal of patient from the clinical trial or study may impact the market revenue growth negatively over the forecast period.
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Early phase clinical trial outsourcing market has been segmented on the basis of trail phase, services, end user and region.
Based on the trial phase, the early phase clinical trial outsourcing market is segmented into the following:
- Phase 0
- Phase 1
- Phase 2
Based on the services, the early phase clinical trial outsourcing market is segmented into the following:
- Regulatory Services
- Clinical Data Management (CDM)
- Medical Writing
- Site Management
- Pharmacovigilance (PV)
- Risk-Based Monitoring
- Bio statistical Services
- Protocol Development
Based on end user, the early phase clinical trial outsourcing market is segmented into the following:
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Drug Discovery Companies
- Medical Devices Companies
Early phase clinical trial outsourcing market is undergoing market changes due to the higher competition among key service providers who are scaling up service offering and global capabilities for gaining market share. Majority pharma companies are continuously outsourcing the clinical trials to broad range of service providers (CROs). Non-traditional service providers will also continue to enter into the market place by means of partnership or acquisition. By trial phase type, sub segment such as phase 2 in the global early phase clinical trial outsourcing market is expected to grow in positive traction owing to comparatively larger patient pool and increased number of drug candidates in the above mentioned phase.
Geographically, early phase clinical trial outsourcing market is segmented into regions viz. North America, Latin America, Europe, Asia Pacific and Japan, Middle East and Africa. North America and Europe region is projected to maintain its lions share over the forecast period. Advanced healthcare infrastructure, availability of diverse patient pool is expected to propel the demand for early phase clinical trial outsourcing market during the forecast period in the above mentioned region. Asia Pacific region is expected to be the moderately growing regional market. Growing healthcare facilities, increased healthcare awareness, and conducive regulatory environment for conducting clinical trials in countries like Australia and China are mainly generating the demand for early phase clinical trials in the region.
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The players in early phase clinical trial outsourcingmarket include PRA Health Sciences,INC Research, ICON plc., QuintilesIMS, PAREXEL International Corporation., Chiltern International Ltd., Sofpromed, Covance Inc., Quanticate to name a few.