Introduction
The Covid-19 pandemic took over 6 million lives and over 635 million confirmed cases globally. It was a nightmare for both people and healthcare systems with its rapid spread globally. The biopharmaceutical industry and regulatory agencies reduced the dread with relentless efforts but still continue tackling the aftermaths of the pandemic transitioning to an endemic.
Vaccines were swiftly designed, formulated, and manufactured at massive scales to battle the pandemic within 10 months. Since then, 184 countries administered over 12.7 billion doses but some nations could not afford it. The pandemic has left numerous lessons, challenges, and opportunities for the biopharmaceutical industry.
1. Variable Support
The biopharmaceutical industry develops drugs and vaccines globally. Experts expect more growth as more companies emerge with new technologies. Product approvals, demand for targeted therapies and development of biosimilars continue adding speed to meet demand and supply, but with new challenges.
Stress to the biopharmaceutical industry is driven by the emergence of new variants of viruses. With increased demands for faster approvals of emerging alternate and advanced therapies, vaccines and personalized medicines, the industry faces a perfect storm, needing large-scale investments from both public and private sectors.
It is good having more active investments in healthcare but it also gets more challenging and complex simultaneously. The support and funding needed to innovate new drugs vary globally and costs have increased significantly due to geopolitical situations.
2. Reduced Flexibility
New challenges are inevitable with the emergence of personalized medicines. According to Lynn Allen, Vice President of Business Development at MedPharm, as drug production gets more targeted, it reduces the size of batches and products to be manufactured with varying levels of complexities and requirements. For example, those orphan drugs and drugs for rare diseases target only a specific set of patients. Lynn further explains that the small-sized batch manufacturing requirements lead developers to use SMEs or CDMOs to meet such demands. When the focus gets narrowed down to a very tiny patient population, the rest of the patients and diseases get either left behind or out.
3. Lack of Flexibility in the EU
During the pandemic, the EU could not contribute much to the biopharmaceutical industry. The German SME BioNTech had to partner with Pfizer-USA to develop and market the vaccine on a global scale. The AstraZeneca-Oxford University vaccine partnership was notably significant. But Brexit made it more challenging. For the EU to continue playing a critical part of the industry and its growth post-pandemic, it will need to address central issues around conservatism and regulatory complexities. The challenges from the Ukraine-Russia war are taking heavy tolls on supply and logistics.
4. Adapting to New Technologies
Adopting new technologies such as mRNA vaccines and scaling up for mass production have been significant challenges for CDMOs at short notice. Now, adjusting to and embracing these newer technologies are critical to success. Quoting James Choi, an Executive Vice President and Chief Information & Marketing Officer at Samsung Biologics,
“CDMOs must not only familiarize themselves with this technology quickly but also be fully equipped with the right capacity and capabilities, as demand for manufacturing support for mRNA products is set to increase further.”
5. Reaching a Market with Speed and Quality
Reaching any market in time is always a hurdle during and post-pandemic it has become highly challenging than ever. The latest report of the US FDA states that 34 out of 50 (around 74%) of drugs approved by the FDA used review pathways or expedited approvals for fast delivery. This is not only sustainable but also risky for public health and safety.
Examples of review pathways include Fast Track Designation (36%), Priority Review (68%), Accelerated Approval (28%), and Breakthrough Therapy Designation (28%).
The market demands the drugs to reach the fastest possible, but the supply chain delays increased multifold during the pandemic. Manufacturers need to ensure that these delays are reduced to ensure growth and it is not going to end soon. Now with the zero-covid policy of China, the global supply chains are experiencing numerous delays, increased costs, and humongous efforts.
6. Lack of Talent Supply
Financial Times and Cytiva published the Inaugural Global Biopharma Resilience Index in 2021, where talent supply is highlighted as the weakest link in the biopharmaceutical industry. The survey was based on data from 1165 pharma and biopharma executives and healthcare policymakers from 20 countries. The report shows that the biopharma industry lacks talent supply and a skilled workforce to meet the demands.
The key contributing factors are:
- Advanced manufacturing
- Diversification of biopharmaceuticals
- Increased demands for talents
- Workforce trends (mass resignation)
The pandemic played a significant impact on talent supply but also opened up the surge in demand for the healthcare workforce, globally. India, being the world’s largest medicines manufacturer and supplier to the world, stopped exporting 26 drugs and specific active ingredients during the pandemic. Such restrictive measures are inevitable and temporary but had dire consequences to other parts of the world that depend on such supplies. Investing in developing homegrown talents, automation with new technologies, and digitalisation are time-critical. Digital technologies are evolving faster than before and the biopharmaceutical industry requires speed, unique skills and various digital competencies.
Conclusion
The post-pandemic challenges faced by the biopharmaceutical industry vary from the shortage of skilled workforce, and supply chain disruptions to the timely delivery of life-saving medicines, and much more. The biopharmaceutical industry must strategise, innovate, and partner with other sectors to ensure faster delivery of safe and effective medicines. A shortage of skills may not last long but collaborating with the right partners, investors, manufacturers, and supplier organisations has become more critical than ever before.
References
- WHO Coronavirus (COVID-19) Dashboard | WHO Coronavirus (COVID-19) Dashboard With Vaccination Data
- The Global Biopharma Resilience Index – Financial Times – Cytiva
- https://www.europeanpharmaceuticalreview.com/article/154092/driving-biopharma-innovation-post-covid-19/
- Biopharma reaches for homegrown talent – Financial Times – Cytiva
- From emergency to security: Healthcare collaboration in the post-Covid world – Financial Times – Cytiva
- https://www.fda.gov/media/155227/download
