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Industry Overview

Dynamics Of Drug Development
Drug development is a complex activity that requires a broad array of medical and laboratory expertise, including toxicology, preclinical evaluation, clinical trial design and implementation. Today's drug development process has evolved through decades of scientific, technological and regulatory changes — all aimed at improving the safety and efficacy of new drugs before they come to market.

As a consequence, it can take up to 12 years or more and over U.S. $800 million to bring a new therapy from discovery to market — a time-consuming, capital- and resource-intensive process. In face of this, many pharmaceutical and biotech companies look to outsourcing some or all of their drug development activities.

Factors Driving Drug Development Outsourcing

  • Pharmaceutical companies need to develop drugs faster to maximize patent protection and secure marketplace advantage.
  • The emergence of biotech companies and the consequent explosion in new compounds in the early drug development pipeline.
  • Sophisticated therapeutic and regulatory expertise is needed to successfully develop a compound.
  • More complex, multinational clinical trials, requiring sophisticated diagnostic and laboratory testing.
  • Opportunities for pharmaceutical companies to reallocate resources and strategic investments to other core competencies, such as manufacturing.
Through strategic alliances with Bionefit, biopharmaceutical companies can access additional therapeutic and regulatory expertise, extensive nonclinical and clinical drug development experience, and state-of-the-art technology — without adding the associated fixed costs to their R&D overhead.
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