The adoption of new technologies and solutions across the drug development and manufacturing landscape has transformed the biopharmaceutical industry in many ways. For example, digitizing operations through automation and robotics is improving efficiency and product quality. At the same time, a departure from antiquated business models is opening up opportunities to address the unmet needs of smaller patient populations. In addition, emerging biotechs now developing more than 90% of next-generation biotherapeutics are diversifying the field of competition1, increasing the set of companies potentially in scope for significant volume requirements. Although these changes are exciting, they also make it difficult for suppliers to plan for the level of demand expected from the industry during this rapid phase of growth.

Adding to this issue is the current strain on supply chains due to the COVID-19 pandemic. These delays in production as well as staff shortages have led to delays in critical raw material and finished goods production. Even with significant effort and resources devoted to projecting and forecasting demand levels across their portfolio, customer base level forecasts of demand before COVID were low. Suppliers base their manufacturing requirements and volumes according to the base level of customer demand, plus a buffer level for contingency, so inaccurate levels of forecasting mean that vulnerabilities can be introduced into the system that are then highlighted in a crisis situation.

TIP: Receiving forecasts as early and as completely as possible is critical to the success of the supply chain continuum. This would not only strengthen the supply chain planning and investment strategies but also improve the ability to provide the biopharma industry with the highest levels of support throughout the life cycle of therapeutic products and get them to market faster.

Anticipating Demand In A Rapidly Growing Industry

The challenge of predicting demand is a widely recognized issue in today’s industry. Decisions about the development of a new product (i.e., raw materials, capacity, etc.) must be made years before anyone knows how successful it will be or what the market will look like once the drug becomes available. “Without accurate information about demand, raw material suppliers may size their businesses incorrectly or place impossible demands either internally on their manufacturing operations or externally with their own supply base,” says David Raw, Supply Risk Management Leader at Cytiva. “Even overestimating demand has negative consequences, potentially leaving suppliers with excess production, costs, and liabilities. Both scenarios can have a major impact on production schedules, delaying products and affecting timelines across supply chains.”

The exceptional and unanticipated demand brought on by the COVID-19 pandemic has only exacerbated this challenge, as ever-increasing volumes of new biologic drugs reach clinical and manufacturing phases. Pre-COVID, the annual production of vaccine doses was about five billion.2 Now, due to COVID, the industry needs to not only maintain the production of five billion standard doses but also produce more than 10 billion new COVID vaccine doses (possibly up to 14 billion).2 In addition to the massive increase in volume requirements, COVID has had indirect impacts on supply and distribution.3 Compounded by a record number of innovative FDA approvals for biologics in 2020 ― the highest in the last 10 years4 ― suppliers are being called upon to provide equipment and consumables at an unprecedented scale and pace.

Even if there was a sufficient volume of total capacity and materials, forecasting remains a recognized barrier in the biomanufacturing process. The International Federation of Pharmaceutical Manufacturers and Associations has identified bioreactor bags, single-use assemblies, and cell culture media, as just some of the products of particular concern to the biopharma industry as a whole.5 For example, an ongoing shortage of single-use supply could have far-reaching consequences to an industry trying to make a paradigm shift toward flexible manufacturing, especially with small-volume manufacturing on the rise. Additionally, a limited supply of recombinant protein and hormone suppliers ― required for cell culture production, which is essential for three out of four technology platforms ― threatens the manufacturing capacity of COVID-19 vaccines.

For suppliers like Cytiva, risk mitigation demand planning is a key component in combatting these challenges, with accurate forecasting from our customers being a critical factor in supporting this effort.

Accurate Demand Planning Requires Early Insight And Collaboration

Forecasts provide valuable insights into how a product is expected to perform over the next three- to five-year period. “This is not a binding commitment but rather an indication about the expected size of the business over that timeframe,” explains Raw. “As a critical supplier, we use this information to aggregate our customer forecasts, which ensures we make the appropriate investments in our manufacturing operations and various aspects of the supply chain. That insight also feeds deeper into the entire supply network, such as to our raw material suppliers that also need to know what to expect moving forward and how to size their businesses and invest for the future.”

TIP: Overall, better forecasting directly benefits biopharma companies by reducing process lead times and enabling on-time, in-full delivery. It also improves security of supply and business continuity management and enhances risk mitigation.

Oftentimes, we see the responsibility of gathering forecasting data within a company is with Sourcing; however, they are not always aware of the company’s total demand. This leads to a lack of visibility into the entire funnel of company operations. As a result, there can be a significant gap between what customers have forecasted and their actual demand, adding to the ongoing challenge of managing an already constrained global supply chain of equipment, consumables, and raw materials. Yet, the best perception of how manufacturing schedules are developing comes from those directly involved with that aspect of the business.

TIP: Appointing a dedicated point of contact for demand planning that can synthesize these needs at a global level and then break that down to a regional level is one of the most valuable tools a company can offer a supplier.

Monthly forecasts that include short-term expectations about demand as well as longer-term planning allows suppliers to provide the highest possible levels of assurance. If an exact forecast is not yet certain, a range indicating minimum and maximum values is helpful when it is provided early (although suppliers understand it is naturally subject to change).

TIP: Proactively put risk mitigation measures in place, to ensure timely and accurate order fulfilment in the short term and strategic risk mitigation in the long term. Even just an indication of the likely trending in the future (i.e., up/down /flat) is better than no forecast at all.

Mapping uncertainty enables teams to plan capacity and safety stock around what is known versus unknown. Raw explains, “This information allows suppliers to deliver the strongest possible signal across their own supply chain and helps secure timely supply of the components and material needed to support their manufacturing lines.” Suppliers can then foresee the possibilities of expected demand and plan the base level of provision. In addition to the base level, suppliers also factor in ancillary needs such as buffer/contingency capacity in case of unforeseen circumstances, giving them the ability to better cope with unexpected surges in product need. This is done by using process knowledge of products and leveraging historical order data to increase forecast accuracy and transparency.

TIP: Best practice is a collaborative approach throughout the course of a project. This includes monthly reviews of this information with our security of supply and demand planning experts, who are available to support our customers.

Cytiva’s goal is to foster relationships with new customers and continue to drive this approach with existing partners. We want to limit the divergence between forecasted and actual demand to ~10%, which requires a collaborative effort that enables deployment of resources and investments in capacity in the most effective and efficient way. This is especially important in a post-COVID environment, where a continued strain on supplies is leaving less room for error in demand forecasting.

Looking Forward

Prior to COVID, investing heavily in capacity in order to stay ahead of the curve was easier (based on market research).6 However, the onset of the pandemic in 2020 and the fallout as a result brought to light a number of existing barriers for production at a sudden and massively increased scale. Adaptive measures currently underway to combat these, based on demand planning, include:

  • business continuity measures, such as maintaining the strategic reserve of resins and dual manufacturing sites for critical materials
  • capacity expansion for key product areas to meet increasing demand
  • outsourcing of certain elements of production, where possible, to provide extra capacity
  • supplier risk evaluation and management for raw materials as well as identifying and qualification of second (and even third) suppliers

In addition, to meet the industry’s fast-growing capacity needs, companies are working on risk mitigation and executing expansion plans that involve several components, such as

- review of warehouses for contingency stock
- strategic reserves for high demand and high impact portfolio items
- investments to increase global production capacity
- focus on securing manufacturing capacity and long-term supply of single-use components
- new facilities for cell and gene therapy customers

The emerging market needs driven by the rapidly growing biopharma pipeline signal a rallying cry from current and future customers that a substantial effort must be made by suppliers to support their path forward. That is why suppliers like Cytiva are taking every possible step to answer the call by making major investments in capacity and supply as well as ensuring a true partnership that promotes open communication and collaboration. We hope this can help us meet the moment by providing demand forecasts that serve as the foundation we need to fulfill our commitments to customers and, most importantly, the patients we all serve.

To learn more about Cytiva’s approach to supply risk management, visit our Security of supply resource page.

References

  1. Van Arnum, Patricia. (January 22, 2020). DCAT Value Chain Insights. Emerging Biopharma Companies: Tracking Their Contribution to Innovation.
  2. Cueni, T. (April 25, 2021). Financial Times. Waiving IP rules will not deliver more Covid vaccines. 
  3. International Federation of Pharmaceutical Manufacturers & Associations. Facts and Figures 2021. 
  4. Global Data. (April 2021). New Drug Approvals and Their Contract Manufacture – 2021 Edition. 2021
  5. International Federation of Pharmaceutical Manufacturers & Associations. (March 2021). Landscape of Current COVID-19 Supply Chain and Manufacturing Capacity, Potential Challenges, Initial Responses, and Possible “Solution Space” ― a Discussion Document.
  6. Online research conducted by Bioinformatics for Cytiva, 2019.