Clinical Trials play a key role in identifying and monitoring the efficacy and future commoditization of drugs and vaccines. It comprises four phases: Phase I for safety, Phase II for efficacy, Phase III for final testing of safety and efficacy, and Phase IV for product sales studies. Such trials are sometimes regarded with distrust due to underreporting of various cases. But recent policies by various drug regulatory agencies have led to mandatory reporting of such cases. For instance, Pfizer, one of the major pharmaceutical manufacturers, offers compensatory benefits to participants for participating in trials. Difficulty in recruiting participants has led to the outsourcing of this task to contract research organizations (CROs).
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High Success Rate of Biosimilars
The types of indications that demand the need for clinical trials are oncology, cardiovascular diseases, obesity, diabetes, pain management, autoimmune/inflammation, and central nervous system (CNS) disorders. The oncology segment is set for high growth due to extended healthcare budgets in various countries to prevent the growth of various cancers. Biosimilars are drugs that vary from generics due to their complex chemical structure. Their efficacy in treating cancer has led to growing approval by the U.S. Food and Drug Administration (FDA). An example of this is Amgen and Allergan’s Mvasi, a biosimilar to Roche’s Avastin.
In addition, a clinical trial by Celltrion Healthcare and Pfizer displayed the efficacy of biosimilar Inflectra when switched from Remicade, a biologic drug used for treating Crohn’s disease. Lowered manufacturing cost as well as outsourcing of their production to CROs has culminated in saved expenses for the pharmaceutical sector.
Market Outlook
The global clinical trials market is projected to exceed a market size of USD 65 billion by 2025, according to Grand View Research, Inc. Demand for contract research organizations (CROs), increasing prominence of theranostics, and improvements in technology are factors estimated to drive market growth over the forecast period (2014-2025). Increasing demand for biosimilars and outsourcing of R&D to developing economies is expected to have a major impact on market growth. The contribution of clinical trials toward advanced studies in immune-oncology will be paramount in the forthcoming years. The popularity of smartphones has led to major research organizations using it for digital clinical trials.
Key market players include Quintiles IMS, Charles River Laboratories, Paraxel International Corporation, and SGS SA.
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