The COVID-19 pandemic was a wake-up call for the biopharma industry to rethink how life-saving therapies are designed and delivered. Contract manufacturing quickly became a vital solution that enabled companies to scale volume in some of the shortest times possible. However, that was not the singular change. The pandemic ultimately changed supply chain strategies, changed international collaboration and sped up the use of next-generation technologies. Today, in the biopharma contract manufacturing world, outsourcing manufacturing is only the start; success is largely predicated on innovation, flexibility, and resilience. Many companies are leading the industry forward as it evolves in terms of automation, digitalisation, and advances in adopting and modelling flexible manufacturing. What does this mean for the future of biopharma manufacturing? These are the emerging trends that are defining this.
Forecasts for CDMO and CMO growth:
Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing Organizations (CMOs) have grown significantly in 2024, with an average growth rate of 13.8%. According to BioPlan Associates' annual report, this growth reflects a return to the stable long-term trends seen over the past 20 years.
• Demand Variability for CDMO Services for Large Molecules
Over the last number of years, CDMO services for large molecules have seen significant variability. Much of this variability has reflected changes in demand related to the COVID-19 pandemic. Temporary demand volatility notwithstanding, the longer-term trend in outsourced manufacturing continues to be robustly positive which indicates the sectors ongoing dependence on external manufacturing capacity.
• Historical Market Trends
A more detailed analysis of actual sales growth in bioprocessing sectors from 2007 to 2024 provides historical context and real-time signals for predicting changes in demand in biopharmaceutical manufacturing. The usage of consumables and raw material line markets, such as spent cell culture media and single-use system (SUS) devices, provide sequential indicators of the sector's health.
• Raw Materials and Consumables Recovery from COVID-19
The Raw Materials and Consumables segment was prone to significant volatility during the pandemic. Once suppliers experienced double-digit growth in volume, the double-digit declines followed in the subsequent years. For example, BioPlan research in 2023 reported, on average, an 18% decline in device volume for SUS and other suppliers. Further research in 2024 showed that these suppliers expect an increase of 28% in volume with expected growth by mid-2025. The rebound closely tracks overall growth in the biopharma industry growth, similar to large molecule contract manufacturing growth.
• Resilience and Innovation in Biomanufacturing
The biomanufacturing industry is likely to continue to demonstrate solid stability, despite economic concerns and global supply chain complications over the last two decades. Resiliency is based on a strong pipeline of innovative therapies, increasing use of technological advancements, and rising biosimilars in developing markets, driving demand for more external CMO services.
• Continuously Increasing Efficiency through Technology
Compared to biologics innovators, CMOs have deployed technological advancements at a much faster rate, specifically advancements in advanced manufacturing technologies, such as process intensification. This is primarily because CMOs focus on efficiency and optimize production through next-generation manufacturing strategies. Continuous upgrade and adaptation of cutting-edge technologies keep CMOs at the forefront of biomanufacturing industry advancements and equally important contributions to secure industry growth, long-term.
Increasing Demand for Flexibility through Single-Use Technologies:
The biopharmaceutical sector is currently undergoing a marked transition toward single-use technologies (SUTs) due to a demand for increased flexibility, efficiency, and cost savings. Traditional stainless-steel bioprocessing systems have been effective, but are generally associated with heavy capital commitments, thorough cleaning regimens, and considerable set times. In contrast, single-use technologies provide more efficient operations that adjust to the changing demands of the biopharmaceutical industries.
• Increased Flexibility in Manufacturing
One of the bigger advantages of SUTs, is the flexibility in biomanufacturing that they afford. Single-use products (e.g., bioreactors, filters, tubing, bags) allow manufacturers to change rapidly based on the production demands. This flexibility is very helpful in multi-product facilities, and/or contract development and manufacturing organizations (CDMO’s) that require fast turnaround on products.
Manufacturers can respond rapidly to market demand fluctuations with the ability to easily switch production batches. This flexibility is important in personalized medicine and small-batch biologics production, where production runs vary considerably.
• Reduced Risk of Contamination
SUTs eliminate the repetitive cleaning and sterilizing steps, greatly lowering the risk of contamination. Each batch uses a new component that has been sterilized before use, thereby minimizing the chance of microbial contamination and enhancing product integrity and safety, as well as avoided cleaning verification issues when SUT's reduces downtime.
• Sustainability Issues
In spite of the numerous benefits SUTs provided manufacturers, questions remain about the amount of plastics used and how they impact the environment. Manufacturers are actively developing new recycling options and waste programs. These as well as in-depth analysis of other materials and biodegradable options are being researched to lessen all environmental impacts of SUT.
The Changing Dynamics of Outsourcing through Strategic Alliances and Mergers:
Outsourcing is transforming the way to do business, no longer simply about cost cutting but a strategic initiative to gain access to specialized skills, enhanced technologies and global market access. Organizations increasingly partner with contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) service providers to improve efficiency and scalability.
Organizations focus on strategic outsourcing or partnerships for many significant reasons, including cost savings, decreased fixed investment in infrastructure and operating costs, access to specialized skills that are deeply embedded in companies that have specialized technological capabilities, speed to market, increased production rates and efficiencies with outsourcing networks to utilize, and scalability, organizations use outsourcing to increase the capacity of the organization with low capital investment.
Mergers and acquisitions (M&A) have become an important strategic decision of companies to enhance their organizations’ outsourcing activities. With the acquisition or merger with specialized organizations, companies can improve their competitive position and service capabilities and expand their global market reach. There are numerous key factors driving M&A activity in outsourcing. The first is market expansion, in which firms acquire organizations with an established market presence in emerging markets, allowing the acquirer's firm to obtain a competitive advantage.
Adapting to New Control Measures in the Post-COVID Era:
Historical precedent shows industries have experienced some of the most disruptive events, caused by COVID-19, which has prompted major changes to regulatory landscape as it relates to pharmaceuticals and biotechnology industries. As we transition to a new such-COVID world, organizations will need to quickly adapt to new, changing regulatory requirements intended to foster preparedness, safety, and innovation.COVID-19 had implications for everything we do, including drug development and medicated devices, clinical trials and supply chains, which means businesses will need to be more flexible and compliance oriented, both surely affecting all things organizationally moving forward.
Mechanisms for Engineering a Successful Transition
For an organization to successfully transition into compliance with the regulations, we believe there are a few important mechanisms that can be implemented.
• Invest in Regulatory Intelligence: Consider a traditional regulatory tracking system or perhaps an AI-augmented regulatory tracking system.
• Increase Engagement with Regulators/Stakeholders: No single organization embraces compliance expectations identically; it is always fruitful to have an early-stage dialogue with regulators, to attend compliance-related workshops to be engaged and proactive in compliance-related discussions.
• Set Agile Compliance Policies: Create an agile manual/policy to modify the organization's compliance expectations as changes arise in the future.
• Continuous Learning and Training: Promote continuous learning and training to improve the compliance culture throughout the organization.
Conclusion:
The changes in contract manufacturing in biopharma since COVID-19 has shown the focus the industry is shifting towards agility, innovation, and resilience. The continued emergence of Contract Development and Manufacturing Organizations (CDMOs), and contracted manufacturing organizations (CMOs) as well as single-use technologies, automation, and strategic partnerships improve efficiencies and flexibility in manufacturing.
