White Paper

Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start

Source: Thermo Fisher Scientific
Vials on conveyor belt

The pharmaceutical industry must constantly evolve as companies race to develop the next blockbuster drug. As they face pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process, explains analyst Kate Kuhrt from Clarivate Analytics. Outsourcing eliminates the need to maintain expensive in-house facilities while providing access to a broad range of different technologies and expertise.

A Nice Insight survey published in January 2017 found that the synthesis of a drug’s biologically active component–the active pharmaceutical ingredient, or API–is the most frequently outsourced part of drug manufacturing. A 2016 survey by the same agency found that 56% of pharmaceutical and biotechnology companies outsourced the synthesis of small-molecule APIs at the clinical scale, and about one third of the companies outsourced commercial small-molecule API production. The reverse trend is being reported for biological products, such as vaccines and cellular therapies, Kuhrt says. “In the area of biologics, we’re seeing that outsourcing is decreasing due to the complexity and the promise of developing new intellectual properties.” Nevertheless, a recent Transparency Market Research report predicted that the global API market would expand from $134.7 billion in 2015 to $219.6 billion by 2023.

This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.

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