Biopharma customers often have very strict sourcing criteria and are therefore highly cautious consumers. Often, they take their time when making purchasing decisions. They value control and oversight, and seek to minimize or eliminate risk.
Understanding the constraints of the bioprocesses industry is crucial for companies looking to tap into this industry.
Biopharma customers operate within one of the most scrutinized and regulated markets.
Biopharmaceutical companies are subject to a high degree of regulation and control, which makes each choice a painstaking one. Although regulators oversee suppliers and service providers in this industry, biopharma customers typically bear the accountability for contamination issues, disruptions to supply, or any other issues affecting their therapeutics.
Biopharma customers use a rigorous procurement process. They seek to ensure that products meet their needs and manufacturing processes conform to cleanroom specifications. They will vet suppliers to meet long-term needs.
Biopharma customers will invest in long-term partnerships they see as stable.
Due to the extraordinary amount of time and investment required to bring a single molecule across the finish line, biopharma customers are extremely cautious when selecting partners. Biopharma firms seek stability and look for partners they trust will be around for at least the next decade.
Therefore, potential suppliers must instill trust in any new product, technology, service, or company.
Risk mitigation is a critical element of all decision making by biopharma customers.
When selecting suppliers, vendors, and partners, biopharma customers routinely scan the horizon for potential risk exposure. The two biggest risks: Supply chain disruptions and contamination.
Biopharma customers mitigate supply chain disruptions by deploying a dual-sourcing strategy, where multiple vendors fit into their procurement strategy. When a dual-sourcing approach is not feasible, biopharma firms evaluate suppliers based on redundant manufacturing strategies and an ability to ensure dual-sourcing of critical components.
Contamination presents a dangerous risk, given that it can lead to patient infections, stop-productions, facility remediation, and regulatory scrutiny. Suppliers must document their cleanroom environments, testing procedures, and cleaning processes. They should anticipate that any potential partner will ask to see logs.
Biopharma firms are extremely risk-averse.
In a highly regulated industry, where individuals work on one project at a time for decades, the need to control and manage risk is exceptionally high. Biopharma companies use a “build it here” or “do it here” mentality to maintain oversight of all aspects of the project and resolve any challenges in accordance with their quality compliance programs.
This need for control slows down the decision-making process, leading to an average sales cycle of approximately 18 months. This is one reason why more aspects of biopharma production and manufacturing have not been outsourced, because relinquishing control of processes and technology creates risk exposure.
