Merck & Co, Inc

Performance in the 2026 Benchmark

Weak performance. MSD shows room for improvement in R&D and Appropriate Access & Stewardship. Clear evidence to ensure access to any of the products assessed is lacking, and its approach towards stewardship remains largely unclear. It has the smallest pipeline of all large research-based companies, focused on vaccines, with no projects targeting ‘critical’ or ‘high’ priority pathogens. Its performance in Responsible Manufacturing can also be strengthened. It reports an environmental risk management strategy, but details on quantification methods and compliance are limited, and transparency could be improved. 

*For the 2026 AMR Benchmark, MSD declined to submit data meaning its evaluation is solely based on publicly available information.

Opportunities for MSD

Expand breadth of R&D pipeline projects and depth of access and stewardship plans. MSD’s pipeline size has declined by 85% compared to the previous Benchmark, which now has just two vaccine projects in clinical development. It can reinforce its commitment to AMR by diversifying its pipeline and focusing on vaccine development for resistant pathogens with high burdens in LMICs. In addition, it can expand the depth and breadth of access planning for its late-stage R&D projects, which is currently limited to registration in countries where clinical trials are conducted. These plans can be strengthened by incorporating equitable pricing, supply strategies and extending the scope to additional LMICs. 

Expand appropriate access to its innovative medicines and vaccines. MSD has enabled generic supply for its Reserve antibiotic, tedizolid (Sivextro®), through a voluntary licensing agreement in India. However, it did not disclose appropriate access strategies for any of its other on-patent medicines or vaccines assessed. The company can expand access to its innovative products in LMICs through increased registrations, voluntary licensing, and/or appropriate access strategies, prioritising countries with the greatest unmet need.  

Improve access to and transparency around its surveillance data. MSD already regularly shares aggregated data from its ‘Study for Monitoring Antimicrobial Resistance’ (SMART) surveillance programme publicly via its interactive data dashboard. While it also shared raw data from SMART with the AMR Register in the past, it has an opportunity to regularly update its dataset to enable access to up-to-date surveillance data. In addition, MSD can report more information on the methods used to collect and analyse its surveillance data and disclose this information publicly.   

Ensure compliance with discharge limits directly in wastewater and improve transparency on antibacterial waste management practices. MSD publicly reports setting discharge limits in the receiving environment at its own and suppliers’ sites. To further safeguard AMR risk from antibacterial manufacturing, it can publicly report compliance with discharge limits directly in wastewater for all its own and suppliers’ sites – a step beyond its current practice of setting discharge limits in receiving waters – in line with the ‘stringent’ WHO guidance. It can also publicly report the quantification methods used. 

Changes since November 2023 Update Report on Previous Benchmark Opportunities

• In June 2024, MSD’s newest pneumococcal conjugate vaccine, CAPVAXIVE™ (21-valent), received approval. The vaccine is indicated for adults and expands protection against additional Streptococcus. pneumoniae serotypes, which can cause pneumococcal pneumonia and invasive infections, such as pneumococcal sepsis and pneumococcal meningitis. 

• Therapeutic areas: Cardiovascular, infectious diseases, metabolic diseases, neuroscience, oncology, vaccines

• Product categories: Animal health, innovative medicines, vaccines

• Investments in AMR: In 2020, MSD was a founding partner and invested USD 100mn over 10 years in the AMR Action Fund, with the goal of bringing 2 to 4 new antibiotics to patients by the end of 2030.

• M&A news: None identified in the antibacterial and/or antifungal sectors.

Sample of Pipeline and Portfolio Assessed by the Benchmark

Performance by Research Area

Research & Development

Weak performance. MSD has the smallest pipeline of all the large research-based pharmaceutical companies. It has no projects that address ‘critical’ or ‘high’ priority pathogens, nor does it have innovative antimicrobial medicines in clinical development. Its pipeline is focused on vaccine development. Although it has access plans in place for its late-stage candidates, they are limited to registration plans in countries where it conducts clinical research.

Small pipeline focused on sole pneumococcal vaccine. MSD’s small pipeline includes 2 projects targeting a pathogen in scope. Both relate to CAPVAXIVE™ (V116), an antibacterial vaccine indicated for invasive pneumococcal disease and pneumonia, which received market approval for adults in 2024 (within the period of analysis). The second project, a Phase III trial of V116 in at-risk children aged 2-17 years, was recently completed. Neither project addresses ‘high’ or ‘critical’ priority pathogens as defined by WHO, nor does MSD have any innovative medicine in its pipeline; its only clinical projects are vaccines, which fall outside the scope of WHO’s innovation assessment of medicines. MSD publicly reports in-house antibiotic discovery activities targeting pathogen(s) in scope, including research on darobactin and a narrow-spectrum Gram-negative asset.

Lagging performance with limited access planning. MSD has access plans for both its late-stage projects. Within its access plans, the company commits to securing registration in countries where it conducts clinical trials: South Africa, Colombia and Thailand. Beyond registration commitments, no additional plans for access were identified.   

Responsible Manufacturing

 Low-performing. Reports an environmental risk management strategy aimed at mitigating AMR at both its own and suppliers’ sites. It does not report the number of products manufactured at its own or supplier sites that meet discharge limits, or whether it incorporates AMR provisions into supplier contracts. MSD publicly discloses limited details of its AMR mitigation strategy. 

Basic environmental risk management to mitigate AMR at both its own sites and suppliers’; tracks compliance of antibacterials with discharge limits. MSD’s environmental risk-management strategy is based on the AMR Industry Alliance Antibiotic Manufacturing Standard (Industry Standard). It quantifies antibacterial discharge levels at its own sites. However, the underlying quantification details are not disclosed, nor is the number of its antibacterial products that comply with PNECs. The company requires its antibacterial suppliers to follow the Industry Standard, as well, but it is unclear whether related contractual provisions have been implemented. It reviews supplier discharge levels through audits; however, it does not specify the quantification methods used, nor whether CAPAs are implemented if PNECs are exceeded. Additionally, MSD does not disclose how many antibacterial products meet discharge limits at its supplier sites. No information could be identified on whether MSD engages with external waste treatment plants to minimise AMR risk from manufacturing.

Publicly discloses limited details of its AMR mitigation strategy and is not transparent about compliance with discharge limits. MSD publicly reports implementing discharge limits across its supply chain, as outlined in the Industry Standard. However, for both its own sites and its suppliers’ sites, it does not publicly disclose the quantification methods implemented, audit results, the number of products complying with PNECs or the names and locations of manufacturing sites for each of its antibacterial products. 

Appropriate Access & Stewardship

Weak performance. Takes some steps to ensure continuous supply through monthly demand planning, data sharing, and maintaining buffer stocks of 1-3 months’ finished products. MSD also shows efforts in surveillance, running the multinational AMR surveillance programme ‘Study for Monitoring Antimicrobial Resistance Trends’ (SMART), and sharing aggregated data online. However, MSD did not report details on product registrations or access and stewardship strategies for any assessed products, leaving its efforts to expand access unclear. To what extent MSD addresses appropriate use across its business practices also remains unclear. 

MSD’s performance on product registrations is inconclusive. MSD does not disclose any registration data to the Benchmark. Based on public information, it is unclear if MSD engages in any mechanism to facilitate registrations for the products selected for analysis.   

Below-average performance, with limited evidence of access and stewardship strategies for 5 on-patent products assessed. MSD has entered a licensing agreement with Sun Pharma to develop, manufacture and commercialise its Reserve antibiotic, tedizolid (SIVEXTRO®), in India. The second Reserve antibiotic assessed, ceftolozane/tazobactam (Zerbaxa®), is included in the ‘Study for Monitoring Antimicrobial Resistance Trends (SMART)’ surveillance programme, active in countries in scope; however, no evidence of access strategies has been found. MSD has not disclosed, either publicly or to the Benchmark, any specific access and stewardship strategies for the other 3 products assessed. However, the company reports a general approach for pricing and stewardship for its antibacterial and antifungal medicines in its 2024 Global AMR Action Plan. Only the total global number of patients reached across MSD’s portfolio has been disclosed publicly. 

Below-average performance, with no evidence of access and stewardship strategies for any of the 2 off-patent/generic products assessed. MSD has not disclosed, either publicly or to the Benchmark, any specific access and stewardship strategies for its antifungal, caspofungin, and its antibiotic, imipenem/cilastatin sodium. Nevertheless, the company’s general approach for pricing and stewardship for its antibacterial and antifungal medicines, set out in its 2024 Global AMR Action Plan, includes a commitment to provide these products at their lowest price in lower-income countries. Only the total global number of patients reached across MSD’s portfolio has been disclosed publicly.   

Below-average performance, with no evidence of access strategies for any of its 3 on-patent vaccines assessed. MSD has not disclosed, either publicly or to the Benchmark, any access strategies for the 3 products assessed: the pneumococcal 15-valent conjugate vaccine Vaxneuvance®, hexavalent combination vaccine (DTaP-IPV-Hib-HepB) Vaxelis® and haemophilus b conjugate vaccine Liquid PedvaxHIB®. Nevertheless, MSD publicly reports high-level commitments and policies to ensure access and affordability of its vaccines, including in LMICs. Only the total global number of patients reached across MSD’s portfolio has been disclosed publicly.   

Some efforts to mitigate stockouts/shortages. Limited reported evidence of systems to ensure product quality. MSD implements demand planning and data sharing through a monthly internal Integrated Business Planning process to review and communicate supply chain issues. It maintains direct communication with distributors and, in Brazil and China, also engages hospitals to monitor stock levels and projections. It communicates with customers about current or upcoming shortages, including their causes and expected duration, but does not specify a forecasting timeframe.  

MSD maintains the safety stock of 1-3 months’ supply of finished goods at all its distribution centres to buffer against underestimated demand or supply delays. It also implements supplier diversification strategies through its global business development strategy, often involving sourcing from multiple global upstream suppliers, though local sourcing is not specified. It is also unclear whether MSD implements an automated inventory management system. It mitigates substandard and falsified products through its global product integrity strategy on tackling counterfeit products. However, MSD does not report verifying its suppliers’ credentials, the number of sites that are GMP compliant or any additional quality measures implemented in countries with developing regulatory systems.

Does not address appropriate use across its business practices. It is unclear whether MSD at least partly decouples incentives for its sales agents from sales volume targets or whether incentives are also linked to other qualitative measures. However, targets are set at the individual level. MSD does not report whether it also applies its sales incentive plan to third parties working on its behalf.  MSD's global public policy on business ethics does not explicitly specify measures to ensure ethical interactions with HCPs. MSD voluntarily discloses information on transfers of value publicly in New Zealand.

MSD is active in 1 multinational AMR surveillance programme. MSD runs the multinational 'Study for Monitoring Antimicrobial Resistance Trends’ (SMART) programme, covering 44 genera of bacteria, 17 antibacterial medicines and 63 countries. Raw data from SMART has been shared with the AMR Register in the past and is still available upon request. No new raw data was shared during the period of analysis. However, updated aggregated data is available via the SMART website. The methods MSD uses to collect surveillance data for SMART are partially clear, including where the analysis is conducted and how deduplication is considered.