Can in vitro diagnostics (IVD) supply keep up with demand? Lessons learned from the COVID-19 pandemic

A 20-fold rise in the demand for molecular tests was seen in Europe and the United States between March 2020 and October 2020.¹

While COVID-19 has united the industry around a common goal, it has also shone a light on the challenges the industry faces in developing and commercialising diagnostic tests in unprecedented circumstances. It is important that we learn from these so that our industry is better prepared to face any future threats to the supply chain.² 

The COVID-19 pandemic has emerged as one of the most significant threats we have faced in recent history and rapid, reliable testing is critical to containing the virus and mitigating its impact.¹

Molecular assays, regarded as the gold standard for identifying active infections, and immunoassays are the two main diagnostic technologies widely used as part of the COVID-19 testing strategy.¹ As the COVID-19 pandemic progressed, the global capacity for molecular tests increased. The current global capacity for analysing laboratory-based molecular tests is around 14–16 million tests per week, but due to a shortage of tests the number actually being carried out each week is less than 10 million.¹ Demand is expected to continue growing while the virus remains uncontained;³ therefore, increasing the supply of diagnostic tests, and ensuring that those who need tests have timely access to them, remains crucial to containing the virus.

Figure 1.

Molecular assays performed per week in Europe and the United States,⁴ millions

Calculated from data available as of Nov 5, 2020

Vulnerability of the IVD supply chain

Performing a lab-based molecular-assay typically requires around 20 different reagents, raw materials, consumables and other pieces of equipment.¹

Despite the importance of COVID-19 diagnostic assays, major shortages have been reported in RNA-extraction kits and reagents including enzymes and primers,⁵ which in this instance has led to RNA-extraction kits being the bottleneck to higher diagnostic capacity.²  One explanation for this is that a significant quantity of the reagents being manufactured are those that run on open, less-integrated systems that can perform a wider range of testing methods. These reagents are not compatible with the high-throughput, closed-system machines typically used in developed countries that require cartridges loaded with proprietary reagents manufactured by the original equipment manufacturer (OEM). Furthermore, most of the available manufacturing capacity is based in China, potentially making access to it more difficult, given validation and export considerations.²

COVID-19 has exacerbated any pre-pandemic issues in relation to breaks in the supply chain. The grounding of flights and global travel restrictions has resulted in supplies not arriving, unanticipated delays of raw materials to manufacturing sites, and made estimated-time-of-arrival (ETA) calculations for raw materials and goods unreliable. Without accurate ETAs, manufacturers and distributors of diagnostics cannot reliably guarantee deliveries to customers, resulting in a bottleneck of materials and goods. Additionally, the cost of finished diagnostics has increased four- to five-fold in many instances, which further exacerbates vulnerabilities in the supply chain.⁶

^{COVID-19 vaccine development has placed immense pressure on the diagnostics supply chain}

Manufacturing plant personnel describe challenges in obtaining reagents and certain chemicals, as well as glass vials, syringes and other hardware.⁷

Over the last 18 months, pharmaceutical companies have scrambled to develop and distribute vaccines for COVID-19 with the first two vaccines to be granted emergency approval in the United States both taking the novel approach of using mRNA.⁷ Raw materials are an essential requirement at each step of the mRNA vaccine manufacturing process. For instance, oily lipid nanoparticles are used to protect mRNA and are required to package the vaccines, as well as promoting uptake by human cells. Prior to the COVID-19 pandemic, these raw materials were only produced in the amounts needed for clinical research, which is nowhere near sufficient to sustain the production of billions of doses of vaccines.⁷

In November 2020, mRNA vaccine production was halved from 100 million to 50 million doses due to shortages of crucial raw materials demonstrating the devastating impact of raw material shortages.⁷

We understand the demands of IVD companies because we’ve been supporting their needs for decades.

We understand the demands of IVD companies because we’ve been supporting their needs for decades.

We have been supporting major players in the global IVD industry for decades. We bring our experience of the IVD industry into a focused portfolio of enzymes and ancillary materials specifically targeted for IVD applications. Supported by manufacturing expertise and fully integrated research and development, quality and engineering, and a long-established supply chain, the SEKISUI Advantage provides customers access to the raw materials needed for their IVDs and immunodiagnostics, supplied directly from a diagnostic company. 

With our expertise in microbial fermentation and protein purification, we deliver enzymes and specialty biochemicals needed for polymerase chain reaction (PCR) testing, immunoassay production and the formulation of clinical chemistry reagents or use in biosensor applications.

The SEKISUI Advantage

Learn how our range of DNA Polymerases and Smartbond Streptavidin can support your molecular and immuno-assay diagnostics 

Find out how SEKISUI Diagnostics can support your diagnostic needs

Why should IVD manufacturers invest in appropriate business continuity measures?

During times of economic disruption, it’s important for industries to engage in business continuity planning to provide the resources and frameworks needed to mitigate the negative impact of disruptions while continuing to fulfill key objectives. 

 Our global capabilities allow us to continue to meet the specific needs of our wide range of customers. 

SEKISUI Diagnostics are suppliers of high-quality materials for a variety of diagnostic applications. As leaders in the manufacture of high-quality enzymes and specialty biochemicals for the global diagnostics industry, we are committed to assuring a sustainable supply chain and business continuity for our customers. 

SEKISUI Diagnostics is a reliable partner for all things IVD

During periods of uncertainty, such as the current global pandemic, SEKISUI Diagnostics continues to embrace change and challenge new frontiers in order to create unique, high-quality products and services that will leave our customers truly satisfied. 

Learn more about our extensive enzyme range suitable for laboratory and point-of-care testing.

References: 

1. McKinsey & Company. Pharmaceutical & Medical Products Practice. COVID-19: Overcoming supply shortages for diagnostic testing. Available at: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/covid-19-overcoming-supply-shortages-for-diagnostic-testing (accessed August 2021). 
2. Technology Networks Diagnostics. Vital Lessons for the Diagnostics Industry From COVID-19. Available at: https://www.technologynetworks.com/diagnostics/articles/vital-lessons-for-the-diagnostics-industry-from-covid-19-338075 (accessed August 2021).
3. McKinsey & Company. Pharmaceuticals & Medical Products Practice. 
4. Covid-19 and in vitro diagnostics: New market forces at play. Available at https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/covid-19-and-in-vitro-diagnostics-new-market-forces-at-play (accessed August 2020).
5. Biopharm International. Increases in Manufacturing Capacity Target Vial and Syringe Shortages. Available at https://www.biopharminternational.com/view/increases-in-manufacturing-capacity-target-vial-and-syringe-shortages (accessed August 2020).
6. Abbot B. Wall Street Journal. Shortage of test components forces labs to beg, borrow and improvise. Wall Street Journal, April 5, 2020, wsj.com. Available at https://www.wsj.com/articles/shortage-of-test-components-forces-labs-to-beg-borrow-and-improvise-11586102401 (accessed August 2021).
7. Barry-Jester A, Bluth R, and Hart A. California’s coronavirus testing still a frustrating patchwork of haves and have-nots. Available at https://www.npr.org/sections/health-shots/2020/05/03/849243723/californias-coronavirus-testing-still-a-frustrating-patchwork-of-haves-and-have (accessed August 2021).