Category | Large Molecule
.Over the past decade, the biologics industry has seen double digit growth and an overall increase of market share. In fact, according to a 2020 market forecast report, the global biologics market is expected to be worth approximately $150 billion by 2026.
While this presents a great opportunity for biologics innovators, it also creates a fiercer market of competing small and emerging biotech companies who are all working their hardest to get that coveted, first-in-market position. Thankfully, regulatory authorities such as the US Food and Drug Administration (FDA) have recognized the uptick in innovative, specialty drugs, and have developed four distinct and successful approaches to making such drugs available as rapidly as possible. These approaches include:
With all being said, biotech innovators cannot rely solely on regulators to quickly get their biologics to market. There is a lot that can be done at the lab level to help accelerate a biologic’s journey from development to commercialization. It cannot be stressed enough—the name of the game in the ever-growing biologics market is speed, and for biologics innovators, speed can make or break your chances of getting to market first.
To help accelerate the development of your biologics, it’s important to have the right, innovative technology in place—particularly in the early phases. In fact, truly innovative technology can help speed up development timelines by six to sometimes eight weeks—if properly utilized. The right technology is out there, and it’s important to evaluate technology on how rapidly it can accelerate development:
For many years, smaller operations have taken a multi-vendor approach when it comes to the development, manufacturing, and commercialization of their biologics. While this may sound good in theory—i.e., if we use individual specialists, we don’t have “all our eggs in one basket”—in practice, it may cause longer timelines, which can lessen your chances of getting a first-to-market position.
In order to be agile and quickly get your biologics to market, reducing the number of links in your chain from development to commercialization is paramount. Simply put, a chain with an increased number of links will increase the risk of delays.
More times than not, multiple vendors don’t have much of an incentive to work beyond what they’ve been contracted to do. Furthermore, many vendors have differing methodologies and definitions which cannot only slow your project down, but cause confusion for the next vendor. When your operation is responsible for handing off parts of your biologic’s journey, mistakes, oversights, and liabilities are bound to happen—which produces lengthy rework, slower timelines, and may increase cost.
To curb these risks, a more holistic, single vendor approach when it comes to outsourcing is becoming the wisest choice. This eliminates your need to coordinate and manage multiple vendors and will ease the overwhelming logistics of biologics development, manufacturing, and commercialization. In doing this, you will have more time and resources to do what your operation does best—discovering the next life-changing biologics innovation.
As the biologics industry continues to pivot and adapt to the changes and challenges due to COVID-19, the savvy CDMO will still find ways to accelerate development. By effectively leveraging technology transfers and streamlining validation pathways, CDMOs can shave months off the development timeline of standard programs:
Lastly, if a CDMO claims they have an end-to-end solution, make sure they can back it up. Many vendors will promote such an offering, but unless they can provide tangible evidence that their internal programs can accelerate development timelines and a proven track record of quickly getting biologics to market, their claims may be more promotional than an actual reality.