Company: RPID
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001380106-25-000058
Chunk: 20

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 20
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 the growing demand for innovative therapies such as biologics and cell and gene therapies. Biologics and cell and gene therapies require complex multi-step manufacturing processes which demand rapid, efficient automated MQC processes. 

•Greater efficiency and focus on six sigma lean manufacturing principles — The pharmaceutical industry is under significant pressure to commercialize products faster in order to maximize their patent life. There is continued focus on concepts such as lean manufacturing and six sigma to drive efficiencies in the manufacturing process and a greater emphasis on automating MQC testing to reduce errors and decrease manufacturing lead times and inventory requirements in supply chains. 

•Rebuilding of domestic growth supply chain / increasing scrutiny of outsourced materials with focus on reshoring drug development process — We believe the reshoring of manufacturing operations will further necessitate the need for efficient automated MQC testing.

•Labor shortages — With labor shortages facing many companies in the global pharmaceutical industry, we believe that automated MQC processes can not only make their manufacturing processes more efficient and cost-effective but also help mitigate worker scarcity.

Market opportunity

Our core market of MQC testing encompasses a ubiquitous and high-volume testing process deployed across all pharmaceutical manufacturing operations. 

We believe the total addressable market for MQC testing is large and growing. Based on a total global sales opportunity of an estimated 10,000 Growth Direct systems and our current pricing for our products, we estimate the market for system sales to be approximately $5.0 billion. In addition, based on an estimate of approximately 350 million tests conducted annually that could be addressed by our MQC testing solutions, we estimate the market for annual recurring sales of our consumables and services to be approximately $5.0 billion.

We are especially focused on serving the high-growth biologics and cell and gene therapy markets, which have the highest MQC testing intensity per batch of manufactured product, and are expected to grow at a faster rate than the broader market. We seek to drive substantial growth by establishing Growth Direct as the standard for MQC automation in advanced bioprocessing for biologics, cell, and gene therapies. 

The Growth Direct platform

Our proprietary Growth Direct platform fully automates and digitizes the trusted growth-based method of MQC and enables customers to perform this critical testing process more efficiently, accurately, and securely. Our platform comprises the Growth Direct system, proprietary consumables, LIMS connection and other software, and comprehensive customer support and validation services. The platform’s suite of products reflects our expertise at innovating and integrating across multiple technology disciplines, including systems design,