Rising Adoption of Continuous Bioprocessing in Biopharmaceuticals Fuels Market Growth

According to the latest report by Meticulous Research®, the continuous bioprocessing market is expected to grow at a CAGR of 19.6%, reaching a projected value of $1.32 billion by 2031

Continuous bioprocessing, already well-established in various manufacturing sectors, is gaining significant traction in biopharma, where its numerous advantages are becoming increasingly apparent. These advantages include enhanced product quality, improved efficiency, and rapid scalability. As the demand for innovative and complex therapies continues to rise and competition intensifies among biopharmaceutical manufacturers, there has been a notable shift from traditional batch manufacturing to continuous bioprocessing. While batch manufacturing remains prevalent, the commercial benefits of continuous manufacturing are driving its growing adoption in the pharmaceutical industry.

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Key Advantages of Continuous Bioprocessing:

1. Reduction in Operational and Environmental Costs: Continuous bioprocessing facilities are up to 70% smaller than batch production facilities. This size reduction results in significant savings in both operational and running costs, along with lower environmental impact.
2. Ease of Scaling: Continuous bioprocessing uses identical equipment during process development and production scaling. This eliminates validation issues and saves costs by simplifying the scaling process.
3. Increased Profitability: Continuous processing boosts profitability in two primary ways: it allows for more efficient facility designs and reduces the cost of goods due to smaller facility footprints, lower media and energy consumption, and increased automation, which in turn reduces service and labor requirements.
4. Support for Personalized Medicine: Continuous processes, combined with single-use technologies, facilitate the production of personalized medicines. These methods enhance productivity, shorten the supply chain, and minimize contamination risks, making personalized medicine production more efficient.
5. Real-Time Monitoring and Process Control: The integration of real-time sensors and measurement equipment into continuous manufacturing systems allows for continuous monitoring and feedback control. This enables process improvements through data analysis and supports the FDA’s Quality by Design (QbD) approach, ensuring better product quality and enhanced productivity.

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Investments and Industry Initiatives:

The advantages of continuous bioprocessing have led to substantial investments in the field, with industry players and governments pushing for wider adoption.

• WuXi Biologics (China) invested USD 357 million in December 2018 to establish a biologic manufacturing facility in Ireland, featuring single-use bioreactors compatible with continuous bioprocessing.
• In November 2018, Innovate UK granted USD 1.85 million to a collaboration between Cell and Gene Therapy Catapult, Cobra Biologics, and Pall Corporation to explore continuous bioprocessing for gene therapy applications.
• U.S. FDA Support: In February 2019, the U.S. FDA released draft regulatory guidance to encourage the adoption of continuous manufacturing for small molecule and solid oral drug products. Major pharmaceutical companies like GlaxoSmithKline, Johnson & Johnson, and Vertex Pharmaceuticals are working closely with the FDA to foster a favorable regulatory environment for continuous manufacturing.

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Cost-Reducing Potential:

Research indicates that continuous bioprocessing holds immense potential for reducing costs. Capital expenditures for continuous manufacturing facilities could be 20% to 76% lower compared to batch facilities, while overall costs are projected to be 9% to 40% lower.

Public-Private Partnerships Driving Innovation:

Public-private partnerships and supportive initiatives are accelerating advancements in biopharmaceutical manufacturing. In January 2019, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced 22 new projects worth approximately USD 13 million to advance biopharma manufacturing. Additionally, NIIMBL has consistently invested in new technologies and talent development to push the boundaries of bioprocessing innovations. In May 2020, it allocated USD 10 million in funding to further support these efforts.

Market Outlook:

With such strong momentum, the global continuous bioprocessing market is on a steep growth trajectory. According to Meticulous Research®, the market is expected to grow at a compound annual growth rate (CAGR) of 23.0%, reaching USD 348.9 million by 2027.

In summary, the combination of supportive regulatory initiatives, substantial investments, and the clear advantages of continuous bioprocessing over traditional methods is driving the rapid growth of this market.

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Continuous manufacturing is positioned to play a pivotal role in shaping the future of biopharmaceutical production.

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