Meridian Growing Demand for Sustainability in IVD industry …

Meridian is a primary manufacturer of specialized high-quality molecular reagents and offers solutions to a wide range of industries to diagnose and treat diseases, discover new therapeutics or develop tests for environmental, food and cosmetic safety.

Driving Sustainability in the IVD Industry: Key Market Trends and Strategic Approaches

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In recent years, the healthcare industry has made significant strides in adopting sustainable practices, and diagnostic testing is no exception. The imperative to reduce the industry’s ecological impact arises from the convergence of several factors: rapid industrialization, healthcare expansion, technological advances, growing environmental awareness, regulatory pressures, economical and ethical concerns and the rise of greener technologies. As global awareness of environmental issues grows, industries across the board are re-evaluating their operations to minimize their ecological footprint. These efforts not only align with ethical goals but also corporate goals by enhancing efficiency and reducing costs, leading to long-term financial benefits. Remarkably, healthcare systems in industrialized nations contribute nearly 10% of greenhouse gas emissions—more than the aviation or shipping industries 1 . If the global healthcare sector were a country, it would rank as the fifth-largest emitter of greenhouse gases, generating two gigatons of CO 2 annually 2 . The COVID pandemic amplified this further as the increase in diagnostic testing produced a significant amount of waste from single-use tests and personal protective equipment, and 25,000 metric tons of it have ended up in the ocean. 3 As concern around minimizing waste grows in the life science industry, more companies are adopting sustainable practices. McKinsey research shows a rise in companies committed to “Science Based Target” initiatives, from only 7 in 2019 to 104 in 2022. To meet new sustainability initiatives, life science companies must implement the principles of Reduce, Reuse, and Recycle. However, this can be challenging in clinical testing when most of the waste produced is infectious or hazardous. The main opportunities for reducing waste and CO2 emissions involve utilizing sustainable materials, optimizing processes, reducing reagent volumes, and employing multiplex testing to reduce resource consumption.

For most industrialized nations, Healthcare systems account for nearly 10% of national greenhouse gas (GHG) emissions .

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Key Drivers of Sustainability in Life Sciences

Regulatory Pressure Government regulations on sustainability are tightening globally, putting pressure on life sciences companies to adopt more sustainable practices. A 2023 Deloitte survey found 74% of companies in their study cited regulatory compliance as a key driver for sustainability initiatives. The toughest regulation so far is the EU’s Green Deal, aiming for climate neutrality by 2050, which mandates a 55% reduction in net greenhouse gas emissions by 2030. Life sciences firms must develop roadmaps and set KPIs to meet these targets. For the diagnostics industry, this means adapting supply chains, improving energy efficiency, and adopting greener technologies—transforming challenges into opportunities for long-term sustainability and cost efficiency. 4 Need for Supply Chain Sustainability The pandemic exposed supply chain vulnerabilities, leading to record freight rates and disruptions. As a result, industries are rethinking supply chain management to ensure future resilience 5 . A 2023 survey of supply chain executives across various sectors found that only 46% had the visibility and resilience needed to handle disruptions 6 . For life science organizations, the challenge is greater, with 70% of emissions tied to supply chains outside their direct control 7 . Enhancing supply chain sustainability requires a holistic approach across every stage of development & manufacturing and includes sourcing eco-friendly materials and partnering with like-minded suppliers committed to sustainability metrics. Such collaborations also lead to sharing of best practices, optimizing resource use, and enhancing a collective influence on sustainability. Creating a sustainable and resilient supply chain requires organizations to rethink logistics, find resource-efficient material sources, and adopt technologies that foster sustainability while withstanding disruptions.

https://www.weforum.org/agenda/2022/06/why-sustainability-is-crucial- for-corporate-strategy/

Other key aspects include:

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Ensuring that raw materials and components are sourced responsibly, with considerations for environmental impact, human rights, and fair labor practices. Practicing ethical sourcing:

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Building effective risk management frameworks:

Identifying and mitigating risks related to environmental and social factors in the supply chain, including those arising from natural disasters or ethical issues. Optimizing transportation and logistics to reduce carbon footprints, such as using energy-efficient shipping methods and consolidating shipments. Utilizing green logistics:

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Embracing innovation and collaboration:

Investing in and adopting new technologies and practices that enhance sustainability and working with industry partners to advance shared sustainability goals.

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Increase Revenue Growth & Business Efficiency With the recent surge in inflation, businesses face greater pressure to cut costs wherever possible. Traditionally, there has been a belief that implementing sustainable practices leads to higher expenses. A study by the Economic Intelligence Unit found that perceived increased costs are a major barrier to adopting supply chain sustainability strategies (38%) 8 . Additional findings in 4C’s Transformative Procurement 2023 Report, 9 found that over three-quarters (76.8%) of procurement organizations have limited approach, to sustainability, primarily citing potential costs increases as a barrier. While the need for cost reduction may seem to conflict with sustainability goals, many initiatives aim to improve efficiency and reduce resource consumption, ultimately leading to significant cost savings. Strategies such as optimizing packaging, sourcing sustainable materials, and streamlining production enhance resource management and boost cost efficiency through lean principles. Prioritizing sustainability also offers a competitive edge, helping companies stand out in the market, and cultivate strong customer loyalty. When cost reduction and sustainability are approached holistically—sometimes requiring a shift from traditional perspectives—it can result in both financial success and enhanced environmental responsibility for a company. Sustainability initiatives often lead to innovation and product differentiation, enabling organizations to tap into new markets and meet evolving consumer expectations .

Product Lifecycle Sustainable Practices Evaluate the Environmental Impact at Each Phase

https://www.scilife.io/global-quality-outlook-2024/sustainability

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Strategies for Adopting Sustainability in Life Sciences

A well-defined sustainability strategy aligns business objectives with environmental and social considerations, providing a roadmap to achieve sustainability goals.

Implementing sustainability goes beyond compliance; it’s an opportunity to optimize processes and gain a competitive edge. Sustainable businesses are more resilient and better equipped to adapt to disruptions, positioning them for long-term success. Sustainability initiatives foster innovation and product differentiation, allowing organizations to access new markets and meet changing consumer demands. By adopting approaches that enhance environmental responsibility and operational efficiency, companies can align with evolving regulations and consumer expectations.

Making diagnostic assays more sustainable by design involves integrating eco-friendly principles into their development and production. This approach aims to reduce resource consumption, minimize waste, and use sustainable materials while maintaining performance and accuracy. Incorporating sustainability throughout the product life cycle fosters “built-in” eco-friendly practices in both product and process. 10 1. Consider alternative sample types & patient self-collection D iagnostic blood samples collected by phlebotomy are the most common biological specimens sent to laboratories. According to a study published in 2020 examining the carbon footprint of pathology testing for five common hospital pathology tests, most carbon dioxide equivalent (CO2e) emissions are associated with sample collection 5 . Replacing venous blood collected by a phlebotomist for patient self-collection of capillary blood using a fingerprick could quickly reduce carbon emissions by eliminating PPE and patient travel to collection sites. Additionally, using alternative sample types such as saliva and urine, which remain stable and are not sensitive to environmental factors, can further decrease carbon emissions. These samples are easily mailed, do not require refrigeration, and generally use simpler collection devices, resulting in less hazardous waste. Make tests more sustainable by design

Making Tests More Sustainable by Design

2. Reduce the steps and materials used in an assay workflow Plastics and single-use items contribute significantly to an assay’s environmental footprint. Most molecular qPCR tests currently require RNA or DNA extraction, which is expensive, time-consuming, and requires expertise. Eliminating this step for direct detection can streamline workflows, reduce complexity, speed up processing, and lower reagent usage. G enerally, improving an assay’s efficiency can reduce its carbon footprint through strategies like removing steps, minimizing reagent volumes, and employing multiplex testing, all of which decrease hazardous waste. However, to implement these strategies, the reagents used must meet certain criteria. High-concentration reagents are required to reduce assay volume, inhibitor-tolerant master mixes must be formulated to achieve a high sensitivity without nucleotide extraction and uniform multiplexing requires a mix to perform uniformly, with unbiased amplification of different targets. AVOID – Simplest to Implement Reduce waste: high-concentration enzymes SHIFT – Rethink Design Efficiency Remove cold-chain logistics with lyophilization Skip the extraction step with direct qPCR detection INNOVATE – Adopt Green Tech Sustainable raw materials such as animal-free blockers, nonbacterial enzymes

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The total cost benefit of lyophilization can be between 8–43% 10 , depending on the shipping requirements such as coolers, icepacks, boxes, and dry ice. The further the distance to travel, the more significant the savings.

Implement Green Logistics 1. Reduce shipping and packing costs with lyophilization

3. Use animal-free reagents whenever possible In recent years, there has been a growing push for animal-free reagents, led by the European Medicines Agency (EMA) and the 3Rs principles (Replace, Reduce, Refine) to minimize animal use in diagnostics. U sing animal-free reagents can enhance assay performance and reproducibility, lower costs, and promote sustainability. These alternatives reduce land use, water consumption, and greenhouse gas emissions by eliminating animal farming and minimizing chemicals used in processing of animal-derived reagents. Antibodies, antigens, and enzymes from animal-free sources are increasingly available, whether as recombinant proteins/ enzymes or derivatives from plants or bacteria. Animal-free reagents generally exhibit minimal variability, and a lower risk of contamination compared to animal-origin counterparts. Their adoption represents a pivotal step towards ethical and sustainable practices in diagnostic manufacturing.

D iagnostic manufacturers often produce reagents centrally and distribute them globally, resulting in significant CO 2 emissions. Many products require cold-chain shipping and storage to maintain integrity, contributing to greenhouse gas emissions and incurring hidden costs and supply chain risks, with dry ice transport being particularly expensive. As the industry, especially point-of-care testing, seeks greener solutions, alternatives to cold-chain logistics are essential for growth. Lyophilization technology offers a green alternative by stabilizing reagents at room temperature through moisture removal, thus preventing degradation. Lyophilized diagnostic assays have extended shelf lives, reducing waste, and are lighter and more compact, making shipping easier. While there is an upfront cost for lyophilization, the benefits include significant freight savings and reduced environmental impact, with cost reductions ranging from 8% to 43% 11 depending on shipping requirements. O ther technologies, such as air drying, provide a cost-effective and less energy-intensive alternative to lyophilization, though they require careful optimization to ensure the enzymes are tolerant to heat. As innovation advances in the air-drying sector, companies are creating ready-to-use formulations for molecular diagnostic assays, streamlining. 2. Source materials locally Sourcing materials locally offers a valuable opportunity to cut transportation emissions and bolster local economies. It also enhances supply chain resilience by minimizing reliance on global networks, mitigating transportation disruption risks, and creating jobs within the local community.

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Conclusion

As the industry continues to evolve, sustainability will undoubtedly remain at the forefront, driving a greener, more eco-friendly future for life sciences.

The growing demand for sustainability in life sciences reflects a broader societal shift towards environmental responsibility. By adopting sustainable manufacturing practices, effective waste management, sustainable sourcing, and leveraging innovation, the life sciences sector can substantially reduce its environmental impact. While challenges exist, the benefits of embracing sustainability—ranging from regulatory compliance and cost savings to enhanced reputation and market competitiveness—make it an attractive strategic priority. As the industry continues to evolve, sustainability will undoubtedly remain at the forefront, driving a greener, more sustainable future for life sciences. At Meridian, we believe sustainability starts with us. Across our entire operation, we strive to integrate the principles of sustainability and ethical practices into our business to deliver innovative, eco-conscious products to our customers and help empower them to achieve their sustainability goals. Some of our leading innovative and environmentally conscious products include: Specimen-specific mixes formulated for sensitive detection from alternative sample types such as saliva, urine and stool Lyo-Ready and Air-dryable ™ master mixes as well as glycerol-free enzymes designed for creating ambient-temperature stable assays High-concentration enzymes suited to assay miniaturization Inhibitor-tolerant master mixes developed for direct amplification from crude lysates Optimized and ready-to use qPCR/RT-qPCR master mixes and LAMP master mixes to simply assay development Animal-free HAMA, HA and Rf immunoassay blockers For more information about Meridian’s sustainability solutions, please visit:

www.meridianbioscience.com/sustainable-innovation

References: 1. Lenzen, M. et al. (2020). The environmental footprint of health care: a global assessment. The Lancet Planetary Health . 4(7). e271-e279. https://doi.org/10.1016/S2542-5196(20)30121-2. 2. Fernandez, M. and Pérez, L.(2023). Accelerating the transition to net zero in life sciences. McKinsey & Company . https://www.mckinsey.com/industries/life-sciences/our-insights/ accelerating-the-transition-to-net-zero-in-life-sciences 3. Lanese, N. (2021). 28,000 tons of COVID-19 waste now swirling around in our oceans. LiveScience . https://www.livescience.com/plastic-pandemic-waste-clogs-oceans 4. KPMG. (2022) Life Science Perspectives on ESG. https://assets.kpmg.com/content/dam/kpmg/ uk/pdf/2022/11/life-science-perspectives-on-esg-v1-web.pdf 5. Sultan, T. (2022). 5 ways the COVID-19 pandemic has changed the supply chain. World Economic Forum . https://www.weforum.org/agenda/2022/01/5-ways-the-covid-19- pandemic-has-changed-the-supply-chain/ 6. C apgemini (2024). Resilient and sustainable supply chains for life sciences. https://www.capgemini.com/au-en/insights/research-library/resilient-and-sustainable-supply- chains-for-life-sciences/ 7. H eim, M. Entrup, M., Miranda, W. (2023) Making biopharma’s supply chains more environmentally sustainable. Deloitte Center for Health Solutions . https://www2.deloitte.com/us/en/insights/industry/health-care/scaling-pharmaceutical- supply-chain-sustainability-efforts.html 8. 4C Transformative Solutions Sustainable Impact. (2023) Sustainability and Cost Reduction: Are They Mutually Exclusive? https://www.4cassociates.com/sustainability-and-cost-reduction-are- they-mutually-exclusive/ 9. 4C Transformative Solutions Sustainable Impact. (2023) The Case for Change: Procurement Annual Report 2023. https://www.4cassociates.com/the-case-for-change-procurement-annual- report-2023/ 10. Scilife. (2024). A long term view of sustainability in the life sciences. https://www.scilife.io/global-quality-outlook-2024/sustainability 11. W oodard, W. How to Eliminate Hidden Cold Chain Costs- Lyophilizing Diagnostic Assays: The True Costs of Cold Chain Logistics Are Not What You Think. Argonaut Manufacturing Servcies. https://www.argonautms.com/wp-content/uploads/2023/04/Lyophilizing-Diagnostic-Assays- TLCold-Chain-Apr-2023.pdf

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About Meridian

Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products and critical raw materials. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that redefine the possibilities of life from discovery to diagnosis. As the Life Science division of Meridian, our focus is on supporting immunological and molecular test manufacturers with original raw materials for human, animal, plant, and environmental applications. The large portfolio of antigens, antibodies, blockers, molecular enzymes, nucleotides, and optimized mixes for qPCR and isothermal amplification applications are designed to simplify assay design and enable accurate test results. We strive to provide our customers with solutions they need when they need them – from novel antigens and antibodies to major disease outbreaks such as Zika and SARS-CoV-2 to pioneering the market with our innovative air-dried qPCR/RT-qPCR mixes. We take pride in providing our customers with unparalleled support, customer service, and quality.

Authors

Valerie Midgley, Ph.D. Senior Manager, Commercial Marketing LIFE SCIENCE

Dale Clash Strategic Marketing Manager LIFE SCIENCE

Alpha Chen Product Specialist LIFE SCIENCE

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