Case Study
Exploratory Research – Alternative/Rapid Microbiological Methods for Biopharmaceutical Manufacturers
Objective of the Study
The penetration of ARMM in the pharmaceutical industry remains quite low compared to other industries (such as industrial food microbiology).
oMany rapid technologies are available from many suppliers, but there doesn’t seem to be an industry leader or standard at the moment.
oRecent advances in rapid technologies have encouraged the pharmaceutical and biopharmaceutical industries to validate and implement ARMMs in place of their traditional microbiology methods within QC/QA labs and on the manufacturing floor.
oOur client wanted to investigate and uncover insights to help them with their strategy of becoming the sole leader for ARMM routine implementation.
Methodology
GEOGRAPHICAL SCOPE:
Across 3 regions: Americas, EMEA and Asia-Pacific
METHODOLOGY:
Desk research
IDIs
Strategic workshop with client and FMR teams to work on subsequent post-research steps
TARGET DETAILS:
QC Microbiology Managers
Corporate ARMM Experts
Production / Plant Managers
Other key stakeholders (influencers)
MAIN RESULTS
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Limited Penetration of ARMM:
- ARMM adoption in the pharmaceutical sector is notably lower compared to other industries, like the food sector.
- While multiple rapid technologies are available, no industry leader or gold standard has been established yet.
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Advancements and Encouragement for ARMM:
- Recent technological advancements are encouraging the pharmaceutical industry to shift from traditional methods to ARMM for QC/QA labs and manufacturing processes.
- However, ARMM validation and implementation are still in their early stages, requiring more industry-wide engagement.
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Client’s Strategic Interests:
- The client is interested in becoming the leader for routine ARMM implementation, aiming to fill the gap in the biopharmaceutical market.
KEY TAKE-AWAY
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Market Opportunity for ARMM:
- There is a growing market opportunity for ARMM technologies, especially for unmet needs in QC labs.
- Future business development will focus on addressing barriers and highlighting drivers for ARMM adoption.
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Differentiated Needs:
- Market demands and ARMM requirements vary across regions (Americas, EMEA, and Asia-Pacific) and targeted stakeholder segments (e.g., QC Managers, ARMM Experts, Plant Managers).
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Strategic Recommendations:
- Prioritize marketing efforts by region and stakeholder groups based on identified needs.
- Focus on clear communication of ARMM benefits to encourage wider adoption and address any barriers to implementation.
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Collaboration for Future Steps:
- Post-research, a strategic workshop with the client and internal FMR teams will focus on outlining next steps and refining the marketing and business strategy for ARMM solutions.
