During the global fight to end the COVID-19 pandemic and with unprecedented marketplace fluctuation, the Pharmaceutical Industry has faced daunting new challenges in delivering life-saving medicines, drugs, biologics, therapies, treatments, and other products to market. These heightened performance demands have stressed the industry’s people, systems, and supply chains and will continue to be a factor for years to come.
Pharma Manufacturing predicts significant opportunities and challenges that will impact the US Pharmaceutical Manufacturing Industry going forward. These new factors include innovations and advancements such as Biogen’s Alzheimer’s treatment, T-Cell banking, sterile injectables, the growth of niche medicines and therapies, increased investment in the treatment of infectious diseases, and the biopharma revolution.
At the provider and consumer levels, the industry has had to accommodate momentous behavioral changes as well. Consumers and healthcare providers delayed medical care, surgeries, and treatments during the lockdown, slowing demand for some medicines and healthcare-related products. Innovations such as the advent of telehealth appointments, general access to care and services altered the patient/provider relationship, perhaps forever, and impacted demand.
Simultaneously, the race for a viable, approved, manufactured, and delivered vaccine for COVID-19 and leaps forward in other innovative therapies and treatments increased demand across some industry areas.
Over the coming years, Pharmaceutical manufacturing will face additional performance stressors such as the growth of small-scale operations, capacity issues, workforce talent acquisition, training, and retention concerns, the integration of new manufacturing equipment and technologies, ultra-low temperature (ULT) infrastructure, and a reinvigorated emphasis on quality practices and workplace culture.
The Pharmaceutical supply chain faces pressure from heightened refrigerated storage requirements and the growth of the high-potency active pharmaceutical ingredient (HPAPI) space. Secondary sourcing and minimizing stockout risk will give rise to new active pharmaceutical ingredient (API) suppliers. The importance of novel raw materials suppliers will continue to increase. Investment in reshoring manufacturing and suppliers will weigh against the concerted push against reshoring by Pharmacy Benefit Management (PBM).
From a regulatory perspective, the Pharmaceutical Industry will fight to keep efficiency gains from policy changes during the pandemic. The advancement of the digital tools used by regulators will increase global visibility into all supply chain corners. And the full impact of the technical and organizational changes coming to EMA (Emergency Medicines Agency) Annex 1 has yet to be felt.
Beyond the mission-critical operations, maintenance, and supply chain challenges, the Pharmaceutical Industry faces significant upheaval and changes in the competitive landscape itself with new energy for mergers and acquisitions (M&A), the growth of revolutionary biologics, niche medicines, and more.
In the face of these highly dynamic and volatile demand fluctuations and disruptive supply chain conditions, how does your Pharmaceutical Manufacturing operation respond and remain flexible to meet what’s ahead?
1. Zero in on the fundamentals of supply chain management
The undergirding principle of best-practice Supply Chain Management (SCM) is that waste reduction and enhanced supply chain performance come only through internal and supplier-side functional integration, information sharing, and cooperation. Investigate your SCM practices. Have you achieved operational, functional, and systemic harmony across all the partners in your organization’s supply chain?
By improving your supply chain partner relationships and practices, supply chain management’s primary goals: waste reduction, time compression, flexible response, and unit cost reduction, will become more achievable. In strengthening your core SCM practices, your organization will also become much more agile in responding to shifting market demand.
2. Reduce the risk that may be inherent in your supply chain.
Risk management is a top priority for most large industrial manufacturing companies. This agenda is even more pressing in the Pharmaceutical Industry, where there may be global health ramifications. Beyond mitigating potential loss, reducing supply chain risk can increase market responsiveness, flexibility, and agility. To minimize risk across your supply chain, you must first identify and map all the resource material inputs for your products and flag any single-source components.
From there, your organization must diversify your suppler partnerships across manufacturing sites and different regions globally. Evaluate any “make versus buy” inputs and determine if bringing any components in-house is viable. Identify your most vital partners and build on those relationships with higher volume or longer-term contracts.
Share real-time information across your supply chain network to create cooperative data, communication, and collaboration. And finally, stress test your supply chain regularly. You will likely uncover areas of vulnerability and can implement corrective measures.
3. Streamline your supply chain.
To respond effectively to volatile shifts in marketplace demand, the primary goal of managing your organization’s supply chain must be agility. Streamlining your supply chain, or implementing a shorter supply chain cycle, can translate directly into increased responsiveness and agility.
This approach doesn’t necessarily mean reducing supplier partnerships or slashing your network to the bone. Instead, a streamlined supply chain seeks to automate and harmonize activities, communication, and collaboration with all partners in your value chain.
This increased integration across your supply chain network helps your organization adapt to changes quickly and efficiently, so you can meet any unexpected demand shifts with a unified supply chain strategy across all partner relationships. Without collaborative processes and transparency between partners, bottlenecks are inevitable, and your responsiveness slows.
Focusing on streamlining processes and cutting out weak or inefficient links can make your supply chain more flexible and resilient.
4. Focus on training your frontline leaders.
Market volatility typically results in an equally volatile labor force. Meeting dynamic demand often introduces new technology and requires bringing on and training new people and retaining valued frontline leaders that form the foundation of employee knowledge continuity.
As a recent PharmaTimes article points out, in the face of virtual marketplace upheaval, training, particularly that of front-line leaders, will significantly impact the industry’s ability to adapt to dynamic market forces.
5. Connect your company culture to operational performance outcomes.
Focusing on internal operational performance challenges, external market dynamics, and shifting demand places tremendous pressure on your entire workforce. As a result, morale and, ultimately, performance can slip, impacting your ability to be responsive and agile in the face of wildly fluctuating marketplace demand.
A fully-trained and committed leadership team and workforce, acting on your organization’s core values every day, is inherently more agile and equipped to deal with rapid marketplace fluctuations.
If increasing your organization’s agility to respond to fluctuating marketplace demand is vital to your organization, we’d like to speak with you. We have significant experience with global leaders in the Pharmaceutical Industry. We can help your firm meet the challenges of the ever-dynamic Pharmaceutical Industry marketplace head-on.
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