January/February 2022 • PharmaTimes Magazine • 22-23
// MARKET ACCESS //
Tailored, multidisciplinary strategies for marketing these advanced treatments must be implemented as early as possible in the development process
By Christian K Schneider
The coronavirus pandemic has not only boosted many pharmaceutical companies’ revenues, it has also bolstered their reputations.
The value of pharma innovation is undoubted, after COVID-19 vaccines were developed at record speed. Pharma manufacturing and supply chains have so far delivered 7.5bn vaccine doses, and also kept supplies of most other medicines on track. And despite outcry from emerging markets over the uneven distribution of vaccines, the patent system seems to have survived intact. The industry is entering 2022 in good shape, less vilified, more central to government policy, and with less budget pressure than in recent years. Even so, there will be challenges ahead.
Market growth will not be one of them. Overall, we expect pharmaceutical sales in the 60 biggest markets worldwide to increase by 4.6% in US-dollar terms to about US$1.5trn. That is about half the growth rate seen in 2021, but still faster than that seen in most of the previous decade. Little wonder that many pharma companies, having upgraded their 2021 earnings forecasts, are issuing bullish (if tentative) forecasts for 2022. COVID will continue to be a major driver for several companies. Pfizer expects earnings from its Comirnaty vaccine to be around U$29bn in 2022, only slightly down from the expected earnings of US$36bn. Add in revenues from its new COVID treatment, and prospects are good. Even AstraZeneca will finally start charging commercial rates for its COVID vaccine in 2022.
Nevertheless, there are challenges as well as opportunities within the sector, particularly when it comes to commercialisation of products. Innovative therapies employ a model that differs considerably from conventional development paradigms – one which requires a more tailored approach. At heart, the ‘traditional’ clinical development paradigm is often not applicable because ATMPs deal with smaller patient populations; they have special requirements for manufacturing, where patients’ lives can depend on the speed in which a therapy can be made available, and they offer pricing models that payers may see as prohibitive.
Companies need to do three things to plan for – and mitigate – the risks along the way:
With advanced therapies, there are many complexities to consider in the commercialisation process. The smaller and more targeted patient populations typical of this sector also have specific logistical requirements. For instance, manufacturing considerations and patients’ lives can depend on the speed at which a product moves from the bedside to the facility and back again, especially if shelf life is short.
Advanced therapies may be potentially transformative, but pricing for them could ultimately put off some payers. Meanwhile, the underlying quality, regulatory and manufacturing guidelines that apply to traditional drug development must still be considered. Companies should therefore:
Rushing from research to development without an integrated product development plan is risky. Organisations must go through the planning process with the understanding that this will just be a starting point and that the plan will adapt as the science evolves. More importantly, through upfront structured planning, the company will avoid road bumps and move faster as it progresses towards commercialisation of the product.
Developers of innovative therapies face challenging and complex considerations. However, with proper strategic planning, organisations can clear the obstacles that lie ahead and move closer to commercialising the novel – even curative – therapies that patients require.
‘Align manufacturing readiness with the regulatory pathway, patient population and planned dosing regimen.’
Christian K Schneider, MD, is head of biopharma excellence and chief medical officer (biopharma) at PharmaLex