Cell and gene therapy pipeline is expected to manufacture thousands of targeted, potentially curative therapies. These therapies have recently made huge advances in providing potent treatments for a variety of conditions, from cancers to rare diseases. Its emergence is providing us the possibility to repair and replace cells and genes not just to control diseases but to cure them. Nevertheless, there are still significant challenges leading before the technologies can become a possible treatment option for most patients. These challenges includes logistics, commercialization and market access that causes derail to the success of a product.
Challenges within the execution of logistics in cell and gene therapy comprises the globalization of clinical trials, accurate temperature control for storage and packaging processes, meeting the regulatory requirements involved in the production, transport and testing of treatments, and the necessity for a secure chain-of-custody and supply chain at the global level where it demands additional focus on each shipment, testing the limits of logistics provider’s capabilities.
Regarding the commercialization, these therapies are probably to encounter commercial headwinds even if it vanquishes market access challenge. The supply chain and manufacturing processes for these therapies are complicated and time-consuming involving samples with restricted period of time to be sent to various processing centers and points-of-care. It requires high-touch sales and marketing efforts. Predictive analytics and the development of biomarkers and related diagnostics were expected and even a required tool in the successful commercialization of these therapies. Concerning the safety and value of these therapies, getting the right decision makers should be required who may need different interdisciplinary go-to-market models and message delivery platforms. Lots of cell and gene therapy will have shorter commercial life cycles since most patients will be seized within the first few years after launch, limiting future sales only to incident patients. The cautiousness of cell and gene therapies will not be enabled for improvements not similar to traditional molecules in mode of administration, delivery or expansions to new indications that could expand a therapy’s lifecycle, and will instead need to depend on the expansion of the platform rather than the drug itself.
Cell and gene therapy have the prospective to distort the healthcare market thus manufacturers should expand their capabilities to accomplish this potential and take on the corresponding development, launch, and continued commercialization challenges. Giving attention to these challenges will give strategic mindsets working within multifaceted partnerships that capitalize on each stakeholder group’s strengths around a patient-centric approach.
The market of cell and gene therapy is supposed to arise to more than $50 billion by 2025. However, in terms of market access, these therapies must be evaluated concerning of value like with other new products which is quantified in different ways by a number of different payers, Health Technology Assessment (HTA) bodies, and independent Health Economics and Outcomes Research (HEOR) agencies. The healing nature and timing mismatch between perceived benefits and cost outlays of cell and gene therapies complicates pricing discussions, especially in light of short-term pressures to manage total healthcare system spending. Payment should be phased over time and make payment mechanisms impact on the commercialization of these therapies. Facilitating access for cell and gene therapies will entail the implementation of new pricing and payment models through public, private, and hybrid partnerships that reassign risk burden and introduce shifting roles for both current and new stakeholders.
Don’t miss out our very first Cell and Gene Therapy Strategy Meeting on 26th September 2018 that will take center stage for one day in Radisson Blu Hotel, Zurich Airport Switzerland to address and find solutions to these challenges featuring our influential speakers organized for senior executives within the life science and healthcare sectors!
By Catherine de Vera
Content Strategist-Europe Projects, Proventa International