Tackling The Challenges Of Biologics Development And Manufacturing

It’s no secret that biologics are a growing, promising solution to address unmet medical needs.

• The global biologics market could reach U.S. $479.7 billion by 2024, up from $231.2 billion in 2017 [TMR report]
• Different market studies show compounded annual growth rates for biologics reaching — or even exceeding — 10 percent
• Eight of the 10 best-selling prescription drugs in 2016 were biologics [That’s Nice]
• Half of all new molecular entities approved in 2016 by the U.S. FDA were biologics [That’s Nice]
• IQ4Q estimates that approximately 21% of biopharma R&D spending is on biologics development [IQ4Q]

Biologics offer distinct advantages that small molecule drugs do not, but they are far more complex to develop and manufacture.

“Biologics manufacturing can be much riskier because it requires far more planning, investment and experienced personnel to carry it out,” says Jennifer Cannon, the new Vice President, Commercial Operations Development at AbbVie Contract Manufacturing. “Biologics are temperature and light sensitive, susceptible to shearing and degradation, and not as durable and robust as small molecules.”  It is therefore critical to have the right manufacturing partner to minimize challenges as a therapy moves from discovery to commercialization.