Global Syringe Shortage Jeopardizes Mass Vaccination CampaignsEverstream Team
- Global vaccination campaigns have been stymied by a syringe shortage as disposable syringes, made out of plastics, are being widely used by healthcare workers worldwide to inoculate people. The world needs around 8-10 billion syringes to administer the COVID-19 vaccine doses alone.
- The syringe shortage is likely to persist in the coming months as production of polypropylene (PP), the main raw material used in the making of disposable syringes, was disrupted following the passage of a winter storm in Texas, U.S. in February 2021 that temporarily disrupted the petrochemical sector and exacerbated a supply shortage, resulting in record-high spot prices for certain plastics.
- The shortage has been further exacerbated by export bans. At present, 98 countries have imposed export restrictions on medical equipment and devices, pharmaceutical goods and their active ingredients as well as other essential goods, while Brazil and the U.S. have imposed export bans on syringes to counter the fallout from domestic shortages. It is likely that more countries may join in listing syringes under the export ban of medical devices if the situation deteriorates.
- Syringe manufacturers are facing numerous challenges including the time, manpower, and technology needed to ramp up production capacity quickly. In some cases, specialized equipment may be needed to establish new production lines for low dead space syringe, a special type of syringe needed to extract the excess doses of mRNA vaccines from their vials.
- A global syringe shortage may have mid to long-term implications for countries relying on mass vaccination programs to aid in their economic recovery. Customers sourcing materials and syringes from countries with export bans as well as rising COVID-19 infection cases are advised to stay abreast of current regulations, and assess the impacts on their sub-tier suppliers.
Disrupted Petrochemical Production Causes Shortage in Raw Materials
As many countries focus on carrying out COVID-19 vaccination programs, the demand for syringes have surged at an unprecedented rate in the past few months. Governments have come to realize that not only is it difficult to secure an ample supply of COVID-19 vaccines but syringes are also essential to administer the doses. Thus, the roll-out of the COVID-19 vaccine has put great pressure on manufacturers to ramp up the production of syringes. Amid this pressure and resurgence of COVID-19 cases, there are numerous challenges, from procurement of raw materials to manufacturing of the syringes themselves, that continues to exacerbate its availability.
Disposable syringes, largely made up of plastics, are widely being used by healthcare workers worldwide. One of the supply chain challenges is that polypropylene (PP), the main raw material used in the making of disposable syringes, is currently facing sharp price increase and scarcity due to the ongoing global plastics shortage. Petrochemical plants in Texas, the United States, which hosts the world’s largest petrochemical complex is still reeling from the impacts of the 2020 hurricane season and a series of production halts stemming from COVID-19 restrictions of last year. The situation was aggravated by Winter Storm Uri, which hit the Gulf of Mexico in February 2021, triggering mass blackouts in Texas and halting the production of a third of petrochemical plants in the city. This latest event compounded the challenges faced by petrochemical supply chains, with knock-on effects on various industries that rely on basic chemical building blocks for production activities.
According to reports, 75 percent of polyethylene, 62 percent of polypropylene, and 57 percent of PVC were shut down as around 70 force majeure declarations were issued by petrochemical companies in the U.S. and Mexico in the aftermath of the winter storm. As a result, the price and supply of polypropylene (PP), polyethylene (PE), and other chemical elements have more than doubled since mid-2020, adding an additional challenge to international supply chains amid the ongoing pandemic. The storm’s repercussion had an impact on other chemical elements such as the supply of acetone, which is used as a solvent in pharmaceuticals, medical devices, and cosmetics industries as indicated in an earlier report published by Everstream Analytics. Although gradual resumption at most plants have started, industry reports suggest that the plastic shortage is forecasted to take more than 6 to 12 months to normalize given the current demand spike.
The petrochemical industry is important not only for the life sciences and healthcare sector but also for a vast majority of manufacturing-based industries as it turns oil and gas and other byproducts into plastics, which are used in various industrial applications. This includes packaging for consumer products, plastic parts for the automotive industry, electronic gadgets such as smartphones, and textiles used for personal protective equipment (PPE), and medical applications such as syringes, an area where demands have surged since vaccination campaigns started.
Manufacturing of disposable syringes on a massive scale to meet the global demand will be challenging, especially in the coming months if the global plastics shortage continues. Moreover, the upcoming annual Atlantic hurricane season, which will begin in June and run until November, may put the petrochemical industry around the Gulf of Mexico at further risk while it is still trying to recover. As syringes are a necessary component needed for successful mass inoculation, a few countries have scrambled to ban syringe exports similar to last year when the pandemic broke out in the first quarter of 2020.
Export Controls May Exacerbate Syringe Shortages
The pandemic prompted an unprecedented demand for medical products including personal protective equipment (PPE), pharmaceuticals, and its active pharmaceutical ingredients (APIs). This has led governments to impose export controls limiting the flow of critical pharmaceutical ingredients and associated medical kits and in some cases, led to inequitable delivery and access to COVID-19 treatments.
Export controls have significant implications in pharma supply chains. According to the International Trade Centre’s Market Access Map, 98 countries have imposed export restrictions as of May 31, 2021. This is an increase from last year, where 85 countries imposed export restrictions out of which, 58 percent of the products were medical devices or medicines. A significant number of these export restrictions remain as some member countries have reintroduced certain measures amid the resurgence of COVID-19 cases. For example, the U.S. government announced the use of the Defense Production Act (DPA) to limit the export of raw materials in February in order to speed up its domestic vaccine production and Turkey introduced a temporary export authorization for certain types of PPEs.
Figure 1 depicts countries that are currently exercising some of form of COVID-19 temporary export ban. Affected products include PPE, pharmaceuticals and their active ingredients, and other essential products such as food, iron, and steel.
While syringe is not included in the COVID-19 PPE list, the need to acquire an ample supply of syringes has come under the radar of most nations. Currently, the world needs around 8-10 billion syringes for COVID-19 vaccines alone. Prior to the pandemic, only 5-10 percent of 16 billion syringes produced globally were used for vaccines and immunizations.
The U.S. Federal Emergency Management Agency (FEMA) first published a temporary rule in April 2020 that restricted companies based in the United States from exporting five types of personal protective equipment (PPE), such as surgical gloves, N95 masks, and certain types of respirators, without the explicit approval of FEMA in order to have adequate supply of medical equipment required for domestic COVID-19 cases. In December 2020, FEMA added certain syringes and hypodermic needles to the list of scarce medical supplies, and the restriction is in effect at least until June 30, 2021. The temporary rule relies on the Federal government’s emergency powers from the Defense Production Act (DPA) that was used by former President Trump and the current President Biden’s administrations to tackle the COVID-19 crisis in the U.S. Although the Defense Production Act (DPA) may have been spurred by U.S. authorities’ desire to reduce its dependence on China’s API supply, such legal restrictions on the export of critical supplies may hamper the vaccine rollout all over the world.
Similarly, the Brazilian government issued a decree to restrict the export of needles and syringes as it scrambles to acquire sufficient syringes to vaccinate the local population. Under the regulation, an export of needles, syringes, masks, gloves, and ventilators that are associated with alleviating the COVID-19 pandemic will require special licenses for export. The needles and syringes were added to the banned list in January after the Ministry of Health forecasted that there will be a surge in demand in the vaccination program.
Syringe Makers Face Challenges Amid Unprecedented Demand
Disposable syringe manufacturing is complex as different countries require syringes with different safety features. While the U.S. and the EU require them to be specially designed to prevent needle injuries, a majority of developing countries need auto-disable (AD) syringes to avoid reuse. Moreover, low dead space syringes (LDSS), a special type of syringe that can get extra doses out from mRNA vaccine ampoules, are a niche product and will take time for syringe makers to commit to manufacturing more of. In the global syringe market, the U.S. is the largest syringe supplier by sales followed closely by China and India. The United States currently manufactures around 663 million syringes annually. However, the government estimated that an additional 850 million syringes will be required for vaccine distribution. Key syringe manufacturers in the North America market are Becton Dickinson; Smiths Medical; B. Braun Melsungen AG; Thomas Scientific; McKesson Medical-Surgical Inc.; and Cardinal Health.
Though governments are pressuring local and international syringe makers to ramp up production, challenges remain. These include the procurement of plastics and needles, the financial investment in technology needed to automate the production process, specialized manufacturing equipment needed to produce new types of syringes like the long dead space needles, and labor shortage amid the COVID-19 safety precautions. But most importantly, time is required for syringe makers to ramp up production and work through these challenges.
Because of this, Chinese syringe makers are cautious in taking new orders and warn that they may only be able to fulfill some orders as late as June despite working around the clock, raising prices, and trying to expand production lines. After receiving export contracts two times more than the pre-COVID-19 era, Chinese syringe maker Zhejiang KangKang Medical Devices quadrupled its production capacity for certain types of syringes in May. Despite these efforts, it can only partly fulfill large orders. Another syringe maker, Shandong Qiaosen, a supplier to the U.S.-based Becton Dickinson, has taken similar cautious steps when accepting orders, especially with foreign orders increasing. According to the company, the orders received in February can only be fulfilled in May or June indicating some production delay.
Similar production delays can be expected in the U.S. as the government had contracted Becton Dickinson, the world’s largest syringe maker, to provide 286 million syringes, including around 40 million low dead space syringes, after it imposed the Defense Protection Act to increase low dead space syringe production. The company announced that it will spend USD 1.2 billion (EUR 9.8 billion) over the next four years to expand its production capacity to deal with the crisis. While there has not been any information on sourcing difficulties by Becton Dickson amid the global plastics and labor shortages, the company’s decision to expand capacity highlights the high costs and longer-term planning needed to source raw materials that are currently tight in supply, procure equipment, and invest in specialized technology.
India’s top medical instrument manufacturer, Hindustan Syringes & Medical Devices Ltd (HMD), has recently recruited 500 people to scale up the production of AD syringes to 1 billion by June 2021 and to 1.2 billion by September 2021 to support the vaccination drive against COVID-19. It plans to export to Nepal, Sri Lanka, and Brazil, as it reportedly ordered 79 million standard disposable syringes to counter the shortages. However, HMD has cited concern around the time needed and the availability of machines required to fulfill large productions. Although pharma factories can continue to operate amid curfews and lockdowns, the labor ratio is slightly lower than normal. For manufacturers that rely heavily on labor availability, the risk of workers contracting the virus is a concern. In the event that the crisis worsens, the government can limit the number of workers at a facility at any time, thus delaying productions schedules. Moreover, the annual cyclone season with peak periods in May and June may further compound supply and delivery challenges.
In the case of South Korea, Poonglim Pharmatech, one of several suppliers of low dead space syringes have scaled up their production capacity to 10 million syringes per month by partnering with Samsung Electronics under the government’s scheme to improve production and efficiency to double capacity. Samsung Electronics assisted Poonglim in technology and financial aid as specialists were sent to assist in the automation process through innovative molding technology to expand Poonglim’s production lines within a month. Without the tech giant’s support, production would take at least a year. The company is planning to export more than 260 million syringes to 20 countries, including 180 million to the United States and 75 million to Japan.
Countries Facing Syringe Shortages
Although Brazil also produces syringes and needles, the local price for plastic syringes has increased significantly since 2020 due to tight supply in the local resin markets. Nevertheless, local syringe producers have committed to delivering 30 million units by mid-2021. Brazil’s reliance on sourcing from India is fragile as manufacturing capacity is dependent on the COVID-19 situation in India. At present, the COVID-19 situation is fluid and the dire conditions have caused Indian states to impose lockdowns, which are being monitored and extended on a weekly basis.
In the United States, the number of syringes available to facilitate mass vaccination programs remains unclear though it is sourcing from offshore suppliers while engaging with domestic syringe makers. In Europe, ten member states — Belgium, Croatia, Hungary, Latvia, Liechtenstein, Luxembourg, Malta, the Netherlands, and Portugal — have also reported challenges in their vaccination program due to a lack of low dead space syringes and needles to extract more doses from vaccine vials.
Despite being one of the first developed nations to receive the vaccine, Japan is lagging behind in its vaccine campaign due to lack of syringes and healthcare workers, though it is planning to vaccinate senior citizens by the end of July. In the event that the summer Tokyo Olympics were to proceed as scheduled and the country continues to delay the vaccination process amid the typhoon season, COVID-19 infection cases will continue to rise affecting Japan’s key manufacturing industries such as automotive, electronic equipment, machine, and chemicals. Japan is already facing slow industrial growth in May due to the emergency curbs to stem a rise in infections, which is hampering its economic recovery.
Monitor COVID-19 restrictions: Customers are advised to monitor Everstream Analytics’ COVID-19 Intelligence Center, where weekly updates of national or statewide regulations that may potentially disrupt the movement of goods or the production of vaccines and syringes are published. As the healthcare sector is regarded as an essential sector in most countries, a complete production halt is highly unlikely compared to other industries. Governments may limit staff capacity at manufacturing sites to curb human transmission in case infection rates continue to rise.
Keep abreast of export controls related to COVID-19: Due to recurring waves of COVID-19 infections, countries have been imposing export controls on pharmaceuticals, APIs, and medical kits as well as other types of raw materials that are essential to industries such as glass, chemicals, and plastics manufacturing to stockpile supplies for domestic needs. However as the international healthcare supply chain is closely interlinked, it is crucial for customers to monitor the ever-changing export controls that may have an impact on sub-tier suppliers. Everstream Analytics provides near-real-time alerts on such measures which can be viewed and analyzed in the context of one’s own supply chain data.
Map critical suppliers: Customers should have an up-to-date database of all critical suppliers, their products’ Bill of Materials, and key contacts at supplier locations. By having visibility into one’s supplier network, organizations can take swift actions in locating sites affected by restriction measures and minimize response times to avoid production delays.
Identify alternative suppliers: Customers are advised to identify alternative sources should their supplies become limited or even halted. If inventory stock is close to the critical level in the short-term, securing alternative sources will save valuable time and effort and shorten ad-hoc response times.
Assess countries affected by the syringe shortage: Customers are advised to closely assess the syringe shortages in the affected countries, as this may impact mass vaccination programs, as well as a given country’s path to economic recovery in the mid to long-term. This may be critical for countries where organizations may have a strong supplier footprint or where critical raw materials are sourced from.
According to industry reports, the forecasted growth of the global syringe market size is anticipated to reach USD 32.39 billion (EUR 26.55 billion) by 2027 with disposable syringes experiencing the fastest growth over this period. Nevertheless, simultaneous supplies of COVID-19 vaccines and syringes are required to complete mass inoculation programs.
Syringe manufacturers will need to keep abreast of vaccine production as different vaccines may require different types of syringes. India’s HMD had to re-work production lines to meet last-minute requirements for 0.3 ml syringes to support the supply of Pfizer’s vaccines while its 0.5 ml syringes are pre-qualified by the World Health Organization.
Unlike some COVID-19 vaccines that need temperature-sensitive storage and transport arrangements, there are no logistics challenges for syringe delivery. However, the immediate concern for manufacturers continues to be sourcing and production. Global shortages are emerging due to various factors ranging from reduced production capacities stemming from COVID-19 measures and external factors such as natural disasters affecting sub-tier suppliers. The situation is likely to be exacerbated with the tropical cyclone season for the Atlantic, Indian, and the Pacific oceans commencing, when more disruptions to the supply chain are likely.
Lastly, new COVID-19 variants emerging from various countries have created panic among governments with on-and-off border closures and export bans. This is likely to remain in the coming months as more countries partake in “vaccine nationalism” as well as stockpiling products amid the uncertain period. India’s Serum Institute of India, the world’s largest COVID-19 vaccine producer has recently announced that it will delay the export of vaccines to COVAX and other countries at least until October to reserve for domestic use. A global coordination effort will be needed to ensure supplies and address bottlenecks.