Rising Adoption of Continuous Manufacturing in Biopharmaceuticals to Propel Market Growth

Continuous Bioprocessing Market is projected to reach $1.32 billion by 2031 at a CAGR of 19.6% from 2024 to 2031.

Continuous bioprocessing, already well-established in various industries, is gaining significant momentum in the biopharmaceutical sector due to its compelling benefits, including improved product quality, increased efficiency, and scalability. This method is poised to become the future of biomanufacturing, as it supports both clinical and commercial production at similar scales using flexible facilities that can quickly respond to changing market conditions. The shift from batch to continuous manufacturing is being driven by the growing demand for innovative and complex therapies, along with heightened competition among biopharmaceutical manufacturers. 

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While batch processing remains the most common approach, continuous manufacturing is rapidly gaining traction due to its commercial advantages. Some key benefits include: 

• Reduced operational, environmental, and running costs: Continuous bioprocessing facilities are roughly 70% smaller than batch production sites, significantly lowering operational expenses. 

• Simplified scale-up processes: In continuous bioprocessing, the same equipment used during process development can be scaled up for full production, minimizing validation challenges and reducing costs. 

• Increased profitability: Continuous processing allows for more efficient facility design, reduces the cost of goods by lowering media and energy usage, and enhances automation, thereby reducing the need for manual intervention and lowering service costs. 

• Advancements in personalized medicine: Single-use technologies are increasingly being employed in continuous bioprocessing to manufacture personalized medicines, speeding up supply chains, improving productivity, and reducing contamination risks. 

• Real-time monitoring and process control: By integrating sensors and measuring equipment with continuous manufacturing systems, manufacturers can achieve real-time feedback control, improving both process efficiency and product quality. This approach aligns with the FDA’s quality-by-design (QbD) philosophy, allowing continuous process optimization. 

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These advantages have prompted substantial investments in continuous bioprocessing. For example: 

• In December 2018, WuXi Biologics invested USD 357 million to build a new biologic manufacturing facility in Ireland, featuring single-use bioreactors compatible with continuous processing. 

• In November 2018, Innovate UK awarded USD 1.85 million to a collaboration involving Cell and Gene Therapy Catapult, Cobra Biologics, and Pall Corporation to explore continuous bioprocessing of adeno-associated virus for gene therapy. 

The U.S. FDA has been actively encouraging the adoption of continuous manufacturing within the pharmaceutical industry. In February 2019, the FDA issued draft guidance outlining quality considerations for continuous manufacturing of small molecule and solid oral drug products. Leading companies like GlaxoSmithKline, Johnson & Johnson, and Vertex Pharmaceuticals have partnered with the FDA to create an environment that fosters broader adoption of continuous manufacturing. 

Studies suggest that continuous manufacturing offers significant cost-saving potential. Capital expenditures for continuous manufacturing facilities could be reduced by 20% to 76%, while overall costs could decrease by 9% to 40%. 

Additionally, public-private partnerships and supportive government initiatives are fueling further innovations in biopharma manufacturing. For example, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has announced various projects and funding aimed at advancing biopharmaceutical manufacturing. In 2020 alone, NIIMBL provided USD 10 million for biomanufacturing innovations. 

In summary, the growing shift towards continuous manufacturing, coupled with major investments and its many advantages, is propelling the growth of the global continuous bioprocessing market. According to Meticulous Research®, the market is projected to grow at a CAGR of 23.0%, reaching USD 348.9 million by 2027. 

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