Editor’s Note: This article was published in Pharmaceutical Technology Europe’s March 2021 print issue.
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The rapid and efficient delivery of innovative treatments through the COVID-19 pandemic has demonstrated the value of collaborations within the bio/pharma industry.
The global COVID-19 pandemic has caused significant disruptions to industries, economies, and life in general. Within the bio/pharma industry, despite the challenging situation, companies have been working at great speeds to help develop solutions to tackle the virus. Additionally, outsourcing activity has surged within the industry, largely driven by the unprecedented demands for research, development, and manufacturing the pandemic is creating.
“The biggest challenge facing the pharmaceutical and biopharma markets in 2021 will be striving to meet the high demand for COVID-19 treatments and vaccines, while also continuing R&D of new treatments for other conditions that were in the pipeline before the global pandemic,” confirms Tony O’Sullivan, chief commercial officer, ChargePoint Technology. As a result of the search for effective vaccines and treatments for COVID-19 being a priority, the development and manufacture of other treatments have been delayed, he adds.
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s March 2021 print issue.
“To tackle this issue, we will need to see considerable investment in expanded production capacity and greater investment in R&D in 2021,” O’Sullivan says. “With new lines and new manufacturing facilities, the industry will hopefully be able to meet global demand for the newly developed COVID-19 vaccines once they are approved. While the recruitment of more R&D talent will enable them to progress their other innovations to ensure that non-COVID patients are properly served.”
In concurrence, Marcelo Cruz, director business development and marketing, Tjoapack, also specifies COVID-19 as the biggest challenge for the industry in 2021 and emphasizes the importance of not believing the turmoil is over with the approval of several vaccines. “The need to develop vaccines quickly this year forced organizations across the industry to work more closely together than ever before and has highlighted the value of collaboration when it comes to developing and commercializing new products quickly and effectively,” he says. “This cross-industry and cross‑enterprise coordination looks set to become the norm in the near future—businesses will need to take steps now to ensure they can adapt to this changing market landscape.”
For Mark Quick, executive vice‑president–Corporate Development, Recipharm, pharmaceutical companies will be required to maintain their efforts to social distance in workplaces and have only essential team members on-site for the foreseeable future, as it will take a considerable amount of time to complete the required mass vaccination. “At the same time, [pharma companies] will have to find ways to achieve higher levels of productivity with fewer people on site in order to meet anticipated spikes in the demand for manufacturing capacity to deliver the required number of COVID-19 vaccine doses, as well as treatments for those already dealing with coronavirus symptoms,” he adds. “Investment in new production line equipment to increase output and reduce manual processing may be required [this year] to achieve these goals.”
Another key challenge for Cruz is the growth of the pharmaceutical industry in China, which is increasing the competitive landscape. “Approvals of Chinese innovations have grown significantly in recent years, and the country is expanding its research, development, and manufacturing capabilities all the time,” he notes. “More, Chinese and Asian regulatory authorities take a different approach to reviewing and approving treatments compared with those in the United States and Europe. This [approach] means that often Chinese products can reach the market in a much faster timeframe than those developed in the West, where companies have to wait for trial results before seeking approval. It is likely, therefore, that we will see Chinese companies challenge European and North American rivals in established markets more and more, particularly in the arena of cellular and gene therapy, where Western regulators are much more cautious.”
A major disruptive factor for the pharma industry may also be in the form of the rise of the self-medication sector, continues Cruz. As clinical advances are allowing the treatment of more diseases with lower cost, over‑the‑counter medications, the model for the pharma industry of heavy investment into potential blockbuster drugs and recouping monies spent, and gaining a profit, via drug pricing may need to be adapted, he emphasizes. “A solution may be a further increase in partnerships between pharmaceutical companies and contract manufacturers, which can help to keep the costs for development, production, packaging, and logistics under control,” Cruz states.
“The pandemic resulted in a greater enthusiasm among pharmaceutical companies for outsourcing development and manufacturing to contract development and manufacturing organizations (CDMOs), as organizations worked together to develop COVID-19 vaccines and treatments,” Quick says. Through these industry collaborations, many developers have gained benefits, such as reduced time-to-market for new products, he specifies. Therefore, Quick believes that there will be more companies leaning towards outsourced services in the future, for development work and commercialization phases too.
“CDMOs are well placed to support pharma companies in meeting high levels of demand for the production of COVID-19 vaccines and treatments, while also maintaining production of other vital medicines,” Quick adds. “[CDMOs] have the capacity and flexibility to help customers ramp up production and can provide expertise in delivering complex specialist dosage forms, such as inhalation and modified release, to support customers in commercializing new treatments quickly.”
Given the disruption to the global pharmaceutical supply chain that has been experienced during the pandemic, O’Sullivan predicts that there will be opportunities for API suppliers in Europe, and elsewhere, to prosper from increased local demand, so long as the capacity and flexibility to deliver the required quantities are on available. “Therefore, we will see significant investment by European API suppliers in expanded production capacity and capabilities in 2021 in order to attract Europe-based customers on the look-out for new local partners,” he says. “We may also see suppliers from outside Europe seeking to establish new facilities on the continent in order to continue to serve the European pharmaceutical market.”
Careful consideration of the equipment to be used on manufacturing lines must be made by any API supplier seeking to invest in their manufacturing capabilities, stresses O’Sullivan, so that safety, quality, and sterility can be assured when delivering optimum production speeds. “By working with equipment suppliers [early on], API suppliers will be well placed to maximize their return on investment and benefit from the localization trend in 2021,” he adds.
In concurrence, Quick states that given the fact that global governments are questioning the sustainability of the current globalized supply chain it is unsurprising that pharma manufacturers are already taking steps to localize and diversify API partnerships to create more resilient supplies. “In 2021 and beyond, I think we will see more companies rethinking their supply chains and favouring more local or regional partners. It is also likely that ingredient suppliers and other contract organizations will look to expand their local presence in their target markets to cater to customers onshoring their supply chains,” he says. “Whilst the costs of doing this may be a challenge for existing products, it is highly likely that new products will have a more localized supply chain.”
Cruz highlights three areas of opportunity for growth within the pharma industry for 2021 and beyond. The first area Cruz specifies as a growth prospect is cell and gene therapy, which he states have started to “come into their own as a meaningful commercial approach to treat disease.”
“The entry of [cell and gene] therapies on the market highlights the challenges posed by cutting-edge innovation both for the pharmaceutical industry and on contract manufacturers bearing the cost of disruption,” Cruz says. “However, with the right approach to manufacturing and commercialization, these new treatments look set to deliver positive change for patients.”
Secondly, Cruz emphasizes the rise of electronic health and customer records across Europe as an exciting prospect, particularly as it can lead to companies gaining a greater insight into treatments and customer needs. Then, the third area of opportunity for Cruz, is personalized medicines. “This area is set to become a key pharma trend in the near future,” he says. “Eventually, the goal is for drugs to be customized to a patient’s specific needs based on that individual’s examination reports and medical records. We still have a way to go before we reach this point, and it will certainly not happen in 2021. However, what we can expect to see in the [near future] is the greater collection and storage of health data, which will lead to enhanced personalization within health marketing.”
The biggest change that will be witnessed within the pharma industry post-COVID-19 is an increased reliance on contract development, reveals Cruz. “The pandemic really demonstrated the value of collaboration in delivering innovative and effective treatments at speed and at scale,” he says. “More, it strengthened connections and relationships between industry peers, and particularly between professionals working for drug developments and those working for CDMOs, contract packaging organizations, and other contract organizations.”
When considering all the changes that have occurred to industry as a result of the COVID-19 pandemic, Cruz believes that the future will see even more reliance of developers on partners to help with development and commercialization of drug products. “Contract development organizations will need to take steps now to ensure they can deliver the speed, efficiency, flexibility, and global reach needed to attract developers and remain competitive,” he concludes.
Felicity Thomas is the European editor for Pharmaceutical Technology Group.
Pharmaceutical Technology Europe
Vol. 33, No. 3
Pages: 44–45, 48
When referring to this article, please cite it as F. Thomas, “Demonstrating the Value of Collaboration,” Pharmaceutical Technology Europe 33 (3) 2020.