The recent Coronavirus outbreak has brought to the fore a systemic opportunity and challenge facing the pharmaceutical supply chain: the major role China has come to play in the industry both from the demand and supply sides. As companies respond to the crisis and attempt to move forward, they will need to take time to reconsider what this fact means for their supply chains and how they can improve their resiliency going forward.
Over the past several years, it has become clear that China is a strategic growth market for pharmaceutical companies. The increase in disposable income and improved access to health care in China presents tremendous opportunity for growth. The rapidly shifting age demographic in China is yet another factor. By 2050, 330 million Chinese will be over age 65. In comparison, the number of Chinese over the age of 65 as of 2019 was about 160 million. As a result, pharmaceutical companies are exporting quite a lot of specialty drugs and medical devices to China. A recent study of large pharma companies' earnings shows that the revenues in China grew by 29% as compared to a growth of 8.2% in the U.S. for a comparable period.
At the same time, China is also a major source of supply in the pharmaceutical supply chain. In recent years, China and India have emerged to be big players in the pharma space, especially in the over-the-counter and generic pharmaceutical segments. According to the U.S. Food and Drug Administration, 31% of all the U.S. registered drug chemical facilities are in India or China. Furthermore, just in the last year, China accounted for 95 percent of U.S. imports of ibuprofen, 91 percent of U.S. imports of hydrocortisone, 70 percent of U.S. imports of acetaminophen, 40 to 45 percent of U.S. imports of penicillin, and 40 percent of U.S. imports of heparin, according to Commerce Department data. In all, 80 percent of the U.S. supply of antibiotics are made in China. Even as India rises as an alternate source to China for generic and over-the-counter medications, facilities in the country still depend heavily on Chinese sources for active pharmaceutical ingredients (APIs) and key starting materials (KSMs). All in all, at this point, China has such a high degree of concentration of pharma sourcing, whether it is finished product, APIs, or KSMs, that the current outbreak puts it in the spotlight.
What's on the horizon
Given the above factors, let us examine the short-term impacts and implications of COVID-19 on the industry.
Drug shortages will not be immediate, but they could be significant. Several leading pharmaceutical companies have put out statements assuring their investors and the general public alike that they are well covered in terms of inventories and alternate sources of supply. However, given the industry's level of dependency on China, one has to be skeptical. The pharma industry as a whole does have a sufficient inventory buffer. In fact, the median inventory is about 180 days for the industry as a whole. However, drug manufacturing has long lead times, meaning the effects of the manufacturing shutdowns in China will take time to cycle through the supply chain. If the supply disruptions of APIs or finished products made in China prolong, the effects will be severe. Missed deliveries could be punitive for pharma companies due to penalties by purchasing entities. Additionally, it will be hard for the industry to respond in an agile manner. It is not easy to switch sources of supply in the pharmaceutical industry given its highly regulated nature and the rigorous compliance requirements set by the regulatory bodies. Furthermore, in comparison to other industries, such as fast-moving consumer goods, the pharma industry has only recently started focusing on supply chain management and is not as well equipped to respond to disruptions in supply.
The industry is continuing to see shortages of essential supplies. Demand for face masks (most of which are, coincidentally, sourced from China) and hand sanitizer has significantly increased during the pandemic, and companies have not been able to keep up. Individuals and governments alike are stocking up on these supplies, causing a significant spike in demand. The industry will also need to keep an eye on the logistics and distribution challenges related to fulfilling these demand spikes as transportation capacity has been taken away due to disruptions at the ports, crew quarantines, and labor shortages due to lockdowns. However, as the economies start to open up and lockdowns end, the situation will probably improve.
Supply chains need to plan now for how to support the launch of a vaccine. A few companies are already vigorously working towards developing a vaccine for COVID-19. However, launching a new product is not trivial. The sense of urgency in combating the virus will open doors for fast tracking regulatory approvals. However, to capitalize on the opportunity, the companies working on the treatment should consider the capacity needs and any tradeoffs they need to make in their overall portfolio offerings, as speed to market is critical for a successful launch.
How to respond
In light of the above, what are some actions that pharma executives should focus on? In the short term, the first step should be to quickly find answers to the following questions:
What part of my supply, and how much of it, is coming from China?
What finished products is this supply going into?
What alternate sources do I have to meet the demand?
Answering the above questions will help executives understand and quantify their company's risk exposure. To ensure continuity of supply, companies need to identify alternate sources and then select which suppliers to work with based on landed cost. They should also be aware, however, that as supplies start going on allocation, being the first mover to lock in on the allocation will significantly reduce risks. As pharmaceutical industry veteran Atul Tandon recommends, companies need to make sure that they are rigorous in ensuring that supplies are released per human health and business priority criteria. In exceptional situations, such as the current crisis, constant monitoring for excess consumption and diversions due to customer hoarding is key so you can take mitigating actions in a timely manner. One action, for example, is to compare current consumption with historical needs. Even after accounting for COVID-19 stockpiling, the consumption patterns from the past can help indicate where there is excess consumption. Diversion can be caused by players buying products to sell in secondary markets. Government crackdowns can help to an extent, and in exceptional situations, public-private enterprise can should collaborate with public entities to ensure better allocation of supply.
For most companies, answering the aforementioned questions is not a trivial matter. Given the complexity in the pharma industry, analytics are essential for organizations to assess risks. However, most companies' technological capabilities are anchored upon enterprise resource planning (ERP) and other planning systems that are simply not equipped to help enable resilient supply chains of the future. In the intermediate to longer term, companies will need to look to advanced algorithms powered by artificial intelligence to help them better design their supply chains in order to build resiliency and monitor for risks.
In addition, as mentioned before, source switching can be expensive in pharma, both in terms of cost and time. Companies should evaluate their supply networks for single points of failure and build redundancies into the system by identifying alternate sources. While building redundancies can come with increased costs, the downside of not having the protection when you need it can be very expensive. Designing resiliency into the supply chain should also incorporate placing inventory at the right nodes of the network. This does not mean increasing a company's working capital. It is about rightsizing the inventory in consideration of risk and resiliency.
The coronavirus impact on the pharma industry as a whole can be significant if the uncertainty persists. This is yet another reminder for the need to factor risk and resiliency into designing the supply networks.
Container imports at U.S. ports are seeing another busy month as retailers and manufacturers hustle to get their orders into the country ahead of a potential labor strike that could stop operations at East Coast and Gulf Coast ports as soon as October 1.
Less than two weeks from now, the existing contract between the International Longshoremen’s Association (ILA) and the United States Maritime Alliance covering East and Gulf Coast ports is set to expire. With negotiations hung up on issues like wages and automation, the ILA has threatened to put its 85,000 members on strike if a new contract is not reached by then, prompting business groups like the National Retail Federation (NRF) to call for both sides to reach an agreement.
But until such an agreement is reached, importers are playing it safe and accelerating their plans. “Import levels are being impacted by concerns about the potential East and Gulf Coast port strike,” Hackett Associates Founder Ben Hackett said in a release. “This has caused some cargo owners to bring forward shipments, bumping up June-through-September imports. In addition, some importers are weighing the decision to bring forward some goods, particularly from China, that could be impacted by rising tariffs following the election.”
The stakes are high, since a potential strike would come at a sensitive time when businesses are already facing other global supply chain disruptions, according to FourKites’ Mike DeAngelis, senior director of international solutions. “We're facing a perfect storm — with the Red Sea disruptions preventing normal access to the Suez Canal and the Panama Canal’s still-reduced capacity, an ILA strike would effectively choke off major arteries of global trade,” DeAngelis said in a statement.
Although West Coast and Canadian ports would see a surge in traffic if the strike occurs, they cannot absorb all the volume from the East and Gulf Coast ports. And the influx of freight there could cause weeks, if not months-long backlogs, even after the strikes end, reshaping shipping patterns well into 2025, DeAngelis said.
With an eye on those consequences, importers are also looking at more creative contingency plans, such as turning to air freight, west coast ports, or intermodal combinations of rail and truck modes, according to less than truckload (LTL) carrier Averitt Express.
“While some importers and exporters have already rerouted shipments to West Coast ports or delayed shipping altogether, there are still significant volumes of cargo en route to the East and Gulf Coast ports that cannot be rerouted. Unfortunately, once cargo is on a vessel, it becomes virtually impossible to change its destination, leaving shippers with limited options for those shipments,” Averitt said in a release.
However, one silver lining for coping with a potential strike is that prevailing global supply chain turbulence has already prompted many U.S. companies to stock up for bad weather, said Christian Roeloffs, co-founder and CEO of Container xChange.
"While the threat of strikes looms large, it’s important to note that U.S. inventories are currently strong due to the pulling forward of orders earlier this year to avoid existing disruptions. This stockpile will act as an essential buffer, mitigating the risk of container rates spiking dramatically due to the strikes,” Roeloffs said.
In addition, forecasts for a fairly modest winter peak shopping season could take the edge off the impact of a strike. “With no significant signs of peak season demand strengthening, these strikes might not have as intense an impact as historically seen. However, the overall impact will largely depend on the duration of the strikes, with prolonged disruptions having the potential to intensify the implications for supply chains, leading to more pronounced bottlenecks and greater challenges in container availability, " he said.
A coalition of freight transport and cargo handling organizations is calling on countries to honor their existing resolutions to report the results of national container inspection programs, and for the International Maritime Organization (IMO) to publish those results.
Those two steps would help improve safety in the carriage of goods by sea, according to the Cargo Integrity Group (CIG), which is a is a partnership of industry associations seeking to raise awareness and greater uptake of the IMO/ILO/UNECE Code of Practice for Packing of Cargo Transport Units (2014) – often referred to as CTU Code.
According to the Cargo Integrity Group, member governments of the IMO adopted resolutions more than 20 years ago agreeing to conduct routine inspections of freight containers and the cargoes packed in them. But less than 5% of 167 national administrations covered by the agreement are regularly submitting the results of their inspections to IMO in publicly available form.
The low numbers of reports means that insufficient data is available for IMO or industry to draw reliable conclusions, fundamentally undermining their efforts to improve the safety and sustainability of shipments by sea, CIG said.
Meanwhile, the dangers posed by poorly packed, mis-handled, or mis-declared containerized shipments has been demonstrated again recently in a series of fires and explosions aboard container ships. Whilst the precise circumstances of those incidents remain under investigation, the Cargo Integrity Group says it is concerned that measures already in place to help identify possible weaknesses are not being fully implemented and that opportunities for improving compliance standards are being missed.
By the numbers, overall retail sales in August were up 0.1% seasonally adjusted month over month and up 2.1% unadjusted year over year. That compared with increases of 1.1% month over month and 2.9% year over year in July.
August’s core retail sales as defined by NRF — based on the Census data but excluding automobile dealers, gasoline stations and restaurants — were up 0.3% seasonally adjusted month over month and up 3.3% unadjusted year over year. Core retail sales were up 3.4% year over year for the first eight months of the year, in line with NRF’s forecast for 2024 retail sales to grow between 2.5% and 3.5% over 2023.
“These numbers show the continued resiliency of the American consumer,” NRF Chief Economist Jack Kleinhenz said in a release. “While sales growth decelerated from last month’s pace, there is little hint of consumer spending unraveling. Households have the underpinnings to spend as recent wage gains have outpaced inflation even though payroll growth saw a slowdown in July and August. Easing inflation is providing added spending capacity to cost-weary shoppers and the interest rate cuts expected to come from the Fed should help create a more positive environment for consumers in the future.”
The U.S., U.K., and Australia will strengthen supply chain resiliency by sharing data and taking joint actions under the terms of a pact signed last week, the three nations said.
The agreement creates a “Supply Chain Resilience Cooperation Group” designed to build resilience in priority supply chains and to enhance the members’ mutual ability to identify and address risks, threats, and disruptions, according to the U.K.’s Department for Business and Trade.
One of the top priorities for the new group is developing an early warning pilot focused on the telecommunications supply chain, which is essential for the three countries’ global, digitized economies, they said. By identifying and monitoring disruption risks to the telecommunications supply chain, this pilot will enhance all three countries’ knowledge of relevant vulnerabilities, criticality, and residual risks. It will also develop procedures for sharing this information and responding cooperatively to disruptions.
According to the U.S. Department of Homeland Security (DHS), the group chose that sector because telecommunications infrastructure is vital to the distribution of public safety information, emergency services, and the day to day lives of many citizens. For example, undersea fiberoptic cables carry over 95% of transoceanic data traffic without which smartphones, financial networks, and communications systems would cease to function reliably.
“The resilience of our critical supply chains is a homeland security and economic security imperative,” Secretary of Homeland Security Alejandro N. Mayorkas said in a release. “Collaboration with international partners allows us to anticipate and mitigate disruptions before they occur. Our new U.S.-U.K.-Australia Supply Chain Resilience Cooperation Group will help ensure that our communities continue to have the essential goods and services they need, when they need them.”
A new survey finds a disconnect in organizations’ approach to maintenance, repair, and operations (MRO), as specialists call for greater focus than executives are providing, according to a report from Verusen, a provider of inventory optimization software.
Nearly three-quarters (71%) of the 250 procurement and operations leaders surveyed think MRO procurement/operations should be treated as a strategic initiative for continuous improvement and a potential innovation source. However, just over half (58%) of respondents note that MRO procurement/operations are treated as strategic organizational initiatives.
That result comes from “Future Strategies for MRO Inventory Optimization,” a survey produced by Atlanta-based Verusen along with WBR Insights and ProcureCon MRO.
Balancing MRO working capital and risk has become increasingly important as large asset-intensive industries such as oil and gas, mining, energy and utilities, resources, and heavy manufacturing seek solutions to optimize their MRO inventories, spend, and risk with deeper intelligence. Roughly half of organizations need to take a risk-based approach, as the survey found that 46% of organizations do not include asset criticality (spare parts deemed the most critical to continuous operations) in their materials planning process.
“Rather than merely seeing the MRO function as a necessary project or cost, businesses now see it as a mission-critical deliverable, and companies are more apt to explore new methods and technologies, including AI, to enhance this capability and drive innovation,” Scott Matthews, CEO of Verusen, said in a release. “This is because improving MRO, while addressing asset criticality, delivers tangible results by removing risk and expense from procurement initiatives.”
Survey respondents expressed specific challenges with product data inconsistencies and inaccuracies from different systems and sources. A lack of standardized data formats and incomplete information hampers efficient inventory management. The problem is further compounded by the complexity of integrating legacy systems with modern data management, leading to fragmented/siloed data. Centralizing inventory management and optimizing procurement without standardized product data is especially challenging.
In fact, only 39% of survey respondents report full data uniformity across all materials, and many respondents do not regularly review asset criticality, which adds to the challenges.