The COVID-19 pandemic has dominated almost every aspect of the pharmaceutical industry over the past few years. This year has brought on challenges, but the industry has also experienced positive changes catalyzed by the various global lockdown measures. One of which, most importantly, was unprecedented collaboration and innovation while the industry has worked relentlessly in the fight against the virus.
Addressing the challenges of the pandemic
Much M&A activity stalled in 2022. However, there are now signs of renewed energy in this area. The focus on vaccines and continued interest in other biologics have driven capacity expansions worldwide and increased lyophilized products. There has also been a big focus on the lack of commercial manufacturing capacity for complex products, and essential medicines, particularly sterile drug products, and investments in the CDMO sector will be essential to meet this demand.
The push for additional capacity in the industry also impacted the workforce. As companies have ramped up manufacturing in anticipation of new biologics and vaccines being approved to treat COVID-19, they have realized that they need the right talent. This has led to companies building diverse and sustainable teams and fueled a talent war that is still ongoing.
This year has seen a delay in M&A and a slowdown in R&D in many areas outside of vaccines, including oncology, although this is picking up again. This has led to a lot of uncertainty, and while the industry will remain focused on tackling the big disease states such as cancer, diabetes, and cardiac issues, there will now be a big focus on immunity.
The pandemic also exposed some of the frailties of existing supply chains. Many countries are reliant on global supply chains for their medicines. When international travel and transport were restricted between some countries, it became apparent that multinational arrangements can be high risk in certain circumstances. Discussions are ongoing regarding whether onshoring API and drug product production is necessary for essential medicines. Still, it will likely be a key discussion point and the foundation of new outsourcing relationships in the coming years.
Pharma by the numbers
Despite the challenges of a global pandemic, the FDA approved several pharmaceutical products and published industry guidance that will lead to new treatment options for patients and advances in health care for the American public. Key statistics from FDA activities include:
- 49+ novel drug approvals (NDAs)
- 8+ biologic license approvals (BLAs)
- 900+ ANDA approvals (tentative and full)
- 250+ Product-Specific Guidances (PSGs), including nearly 100 for complex drug products
And while the media focus has been on vaccine approvals, specialty and orphan drug product growth remained strong, comprising over 50% of new drug approvals in 2020. Altogether, the pharma industry and the FDA made significant progress in 2022. This collaboration will continue into 2023 as the Agency drives innovation in pharma through funded research, workshops, and continued drug/biologic approvals.
This level of collaboration was unprecedented, spanning organizations of every size, type, and capability from large pharma companies to niche contract partners to academic and public health institutions. The industry should be proud of these achievements. The spirit of collaboration adopted during the pandemic must continue as we meet the world’s health and well-being challenges.
Pharma needed to keep operating during the pandemic. Digitization has been an area of focus for the industry for some time but 2022 demonstrated that there is a lot that we can and now should continue to do remotely. One of the main areas of change is how we talk to customers and how sales teams operate – digital communication has grown exponentially and will likely continue.
Parenteral continues to grow
One of the trends that remained strong throughout 2022 is the increasing adoption of parenteral drug delivery. This trend has been driven by the rise in insoluble small molecules and the growth of biologics. Linked to this, we have seen an increased interest in new excipients and techniques, such as spray drying or nanomilling, that increase the bioavailability of drug compounds. The outsourcing sector, has created a greater need for flexibility because we are not dealing with blockbusters anymore. Pharmaceutical companies looking to capitalize on the growing trend of parenteral administration need to be strategic when selecting a partner in this space. Increasingly specialized capabilities and new capacities in these areas are worth exploring.
Author: Nick DiFranco