Innovations in biologics, digital solutions, and the ongoing impact of COVID-19 are having a significant impact on the biopharmaceutical manufacturing industry. Trends that emerged in 2020 and 2021 are likely to develop and become even more important in 2022. That includes the production of biosimilars and the intensification of bioprocesses. At the same time, the industry continues to grapple with COVID 19-related supply chain and labor challenges that have lingered even as the pandemic winds down.
These four trends to watch are likely to guide the further transformation of biopharmaceuticals in 2022. Manufacturers would be wise to employ these strategies to gain ground in the new year.
1. Biosimilars Continue to Gain Ground
The production of biosimilars is on track to bring new products and stakeholders to the biopharma market in 2022. According to the most recent update from the Biosimilars/Biobetters Pipeline Directory, there are nearly 1,100 biosimilars currently in development worldwide. A smaller number of biobetters and follow-on products are also in development. In total, the Pipeline Directory counts 1,666 pipeline products.
A recent report from biosimilars manufacturer Amgen found that biosimilar uptake is accelerating and says first-to-launch biosimilars tend to capture more of the market than later entrants. This possibility for profit and the potential costs of waiting to develop biosimilars may push manufacturers to invest in them sooner rather than later.
In addition to market growth and profit potentials, major FDA approvals of new biosimilars in 2021 may encourage American biopharma manufacturers to invest more in these products next year. This includes the first ophthalmology biosimilar to gain approval in the United States and the acceptance of insulin glargine to treat diabetes.
Changing regulations may also encourage investment in biosimilar development and manufacturing. Only one biosimilar currently approved and on the market in the U.S. has an interchangeable designation. Pharmacists can substitute these for a prescribed reference product. If it becomes easier for biosimilars to gain approval with the interchangeable designation, manufacturers may be more likely to develop these products.
2. Intensified Bioprocesses
Increased competition and demand put additional pressure on biopharmaceutical manufacturers. Intensification of existing manufacturing processes will be essential to navigate current market conditions. Manufacturers will need to take advantage of processing styles that lend themselves to speed, high throughput, and efficient use of facility space.
This pressure is likely encouraging manufacturers to adopt more intense processes. This could explain the growing popularity of continuous flow systems in place of other flow or batch processes—as well as the continuing rise of single-use systems and high-tech expression systems.
At the same time, flexibility will also likely continue to be essential for manufacturers. Facilities increasingly need the ability to manufacture multiple products at the same time, often at different scales, necessitating processes and equipment that enable fast switchovers. At a larger scale, flexibility will also continue to be important to biopharma manufacturing business operations. Strategies that enable the fast construction of new facilities will help them develop flexibility at a business level.
Expanding global manufacturing capacity and streamlining processes will likely help companies increase productivity at the same time. Next year, we may see manufacturers work more often with international partners and seek to regionalize to gain and maintain this business flexibility.
3. Ongoing Supply Chain Changes and Challenges
The impact of COVID-19 has had a major effect on biopharmaceutical supply chains. Like most other industries, these manufacturers continue to struggle with sourcing raw materials and ensuring the timely delivery of finished goods. Supply chain experts believe these challenges aren’t likely to end anytime soon. Ports in America and around the world continue to deal with record levels of congestion, and labor shortages are hampering the ability of logistics companies to move goods—including vaccines and drugs—over land. Manufacturing disruptions caused by outbreaks of COVID-19 in East Asia may also make the procurement of raw materials and essential product components much more difficult than before the pandemic began.
Resilience has become more important than ever for pharma supply chains. In response to these challenges, biopharmaceutical manufacturers are looking for ways to strengthen their supply chains against ongoing volatility and emerging threats, like cyberattacks. In general, biopharma manufacturers are outsourcing and regionalizing more, as well as looking for second sources that can make supply chains more resilient. As a result, companies are coordinating increasingly global and distributed strategies.
In 2022, these new supply chain strategies could become the norm for major manufacturers, especially as businesses continue to struggle with the ongoing impact of COVID-related supply chain challenges.
4. New Digital Initiatives
Investment in Industry 4.0 technology—such as Internet of Things (IoT), artificial intelligence (AI) and machine learning (ML)—and accelerated adoption of digital solutions will help businesses implement automation and adopt machine decision-making.
In big pharma R&D, scientists can use systems like computer-aided biology (CAB) that leverage machine learning to enable the more effective design and modeling of biological systems. At the same time, automation supported by AI, IoT, and robotics can streamline laboratory processes, allowing scientists to more efficiently and accurately run experiments to test hypotheses.
In manufacturing, digital solutions will be most effective in automating work and measuring different aspects of the process. McKinsey researchers estimate that as much as 30% of biopharma’s production workforce, employees like manufacturing technicians and packaging operators, may be displaced by automation by 2030. Repetitive work, like packaging finished products, is typically the easiest to automate with existing technology. Biopharma manufacturers will likely look to mechanize these tasks with AI and other automation tools.
How Biopharma Manufacturing Is Likely to Change in 2022
Next year, experts believe many of the challenges that began in 2020 or 2021 will linger. Ongoing supply chain issues, labor shortages, and increased competition require new practices, manufacturing techniques, and business strategies. As a result, many biopharma manufacturers continue to turn to automation, intensified bioprocesses and digital solutions that will help them manage current and future market conditions. If they do that, 2022 is likely to be a successful year.