As the biopharmaceutical/biosimilar market continues to grow what are some of the broad market drivers that are pushing the market forward?
The number of programs receiving accelerated review are on the rise, helping to get therapies to patients sooner, but developers and manufacturers need to prepare to move quickly through clinical trials. This means that they should evaluate their development plan and look for areas to accelerate their timelines where possible, including by leveraging risk-based and phase-appropriate standards, where applicable. There is also a continual focus on patient experience and the safety of healthcare providers, leading to advancements in delivery technologies and devices. Companies are evaluating whether they can utilize less invasive delivery methods, such as subcutaneous versus intravenous injection. They are also moving toward auto-injectors to aid in patient compliance and syringe accessories, such as safety devices, to protect healthcare providers who may be administering the drug.
Are there any obstacles to the growth of this market segment? Do you foresee any issues regarding such topics as: capacity, regulatory oversight, financial/pricing concerns?
Capacity remains an issue, especially in fast-growing areas of biologics such as gene therapy. Companies can sometimes experience long lead times for their manufacturing batches, which can delay the ability to get biologics into the clinic or out to the market. Regulatory oversight is an area that everyone is waiting to learn more about; how will agencies assess readiness for commercial manufacturing in a segment that is growing much faster than traditional biologics? Manufacturers may only have a handful of batches (and much lower volumes than traditional biologics) completed at time of fi ling. I anticipate an increase in post-approval change controls, which will be further complicated by the individualized nature of some cell and gene therapy products (e.g., one batch per patient). Pricing has already come up in the gene therapy space; as a contract development and manufacturing organization (CDMO) we do not set market pricing, so I am eager to see how this evolves as more treatments become available.
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As more companies begin to develop biopharmaceuticals, what advice would you give them regarding such topics as patient-centricity, drug delivery methods, and international manufacturing?
As companies embark on their development journey, they should think long-term. For example, while they may enter phase 1 faster by starting out in vials, there may be healthcare provider and patient benefits to utilizing different container closures such as pre-filled syringes. It may save time and resources in the long run to start out in syringes rather than switching from vials to syringes later in clinical trials. Additionally, companies may be planning to launch their biologic into one market initially, with other follow on markets planned for a later date. Even though the focus may be on the first market that the company plans to supply, it may make sense to start planning at the outset for each market that the company plans to enter. Depending on regulatory, import/export and other differences in market requirements, it may make sense to utilize manufacturing sites in the markets themselves, which may mean that companies will need to gain regulatory approval to manufacture at those sites. Anticipating and planning for these needs earlier in the development process may have long-term benefits.
How do companies that supply products and services to the biopharmaceutical industry fi t in? Are they full-fledged partners with biopharma companies? How has this relationship evolved over time?
These companies play an important role in biologic development and manufacturing. Ideally, they will have the expertise and proven track record to provide confidence that their products and services are of the highest quality. As the industry has evolved, relationships between biopharma companies and their suppliers have shifted from the purely transactional to be more strategic. This is due to the unique challenges of biologic development and manufacturing that can require customization and greater partnership to generate the best results. Strategic relationships can cover multiple molecules in a company’s pipeline and be mutually beneficial when done well (e.g., prospective and shared risks, simplifying oversight). This can improve development and manufacturing efficiency, which benefits the marketing company, and ultimately delivers products more quickly to patients.
Looking forward do you foresee any additional industry issues or trends that will affect this segment of this industry? Can you elaborate?
An increased focus on personalized medicine and orphan diseases is leading to more approvals of biologics that treat smaller patient population sizes. Additionally, technology improvements such as increased gene expression and continuous processing are decreasing the batch sizes needed to supply the market. Both trends have implications for manufacturing, as the same facilities that are well equipped to manufacture blockbuster biologics may not have the resources needed to efficiently manufacture smaller batch sizes. Finding or equipping facilities with the right resources will be critical to meeting development and commercial supply needs.