Traditional approaches to GMP facility design often tend to focus on the physical attributes or the process scales as a function of single-product throughput. This approach neglects the foundation of flexibility, especially in the process of balancing the quality of product and manufacturing costs. Hence, the design and implementation of flexible production processes is being established globally to meet the industry’s emerging economic and production capacity requirements. The flexible biomanufacturing platform is characterized by operational and functional integration in the biomanufacturing process to adapt quickly to changing markets and production capacity demands for the improvement in quality, cost, complexity, and scale. Various flexible models have been proposed for biomanufacturing plants, which can be customized according to the program needs. Flexible biomanufacturing platform incorporates various tools in the process, such as manufacturing of multiple products with fast changeover, easy adoption of the manufacturing process, accommodation of both large and small volume production requirements, and easy conversion from clinical manufacturing to commercial production. Flexibility can be achieved in the equipment, process, or manufacturing facility.
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Globalization of the biopharmaceutical industry, patent expirations of blockbuster biopharmaceutical products, increasing pressure to reduce manufacturing costs, and shift in new product development toward more personalized products are expected to drive the flexible biomanufacturing platform market during the forecast period. However, regulatory requirements, selection of host manufacturers, high initial set-up cost, requirement of substantial pre-planning, concerns regarding product safety, efficacy, and quality, and capital investment and total product costs or profitability can hamper the growth of the flexible biomanufacturing platform market.
The global flexible biomanufacturing platform market has been segmented based on technology and modality. In terms of technology, the market has been segmented into four types: single-use technology, modular environment, advanced process automation, and standardization. Single-use technology is the most preferred mode in flexible biomanufacturing process, accounting for the largest share of the flexible biomanufacturing platform market in terms of revenue in 2015. Dominance of the segment is attributed to its cost effectiveness, productivity, and efficiency. The technology reduces cross-contamination and allows multi-product bioprocessing of molecules. The single-use technology segment is projected to witness fastest growth as it lowers cost of equipment and saves labor time and cost. Modular environment is the second most popular segment of the flexible biomanufacturing platform market, wherein the controlled environmental modules (CEMs) handle and regulate each unit of operation. Based on modality, the flexible biomanufacturing platform market has been segmented into machine flexibility, material handling flexibility, and operational flexibility. Machine flexibility is the most commonly utilized technique and the segment captured the largest market share in 2015. Quick relocation of capacity, fast adaptability to capacity turnovers, and reduced time and labor costs are the major drivers of the machine flexibility segment.
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Geographically, the global flexible biomanufacturing platform market has been divided into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted for the largest market share in terms of revenue in 2015. This is attributed to the rising number of complex molecules in the biologic pipeline, advancements in bioprocesses and capabilities, and rapid increase in product approvals in the pharmaceutical sector. Increasing demand for access to affordable biologic products in the developing economies such as Russia and Brazil, a desire for local production, and rising focus on personalized medicine for niche markets are the major factors anticipated to boost the flexible biomanufacturing platform market in North America and Europe in the next few years.
Key players in the global flexible biomanufacturing platform market are GE Healthcare Life Sciences, Patheon, Inc., JHL Biotech, Xcellerex, Inc., McKinsey & Company, Nelson Biomedical, Setpoint Systems, Inc., R-Pharm, and Blue Ocean Biomanufacturing, among others. Management of disposable elements and increasing interaction with suppliers are the major strategies followed by key players to sustain in the flexible biomanufacturing platform market.
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