Continuous Bioprocessing Market to Reach USD 764.3 Mn by 2032

The continuous bioprocessing market, projected to reach a valuation of USD 429.0 million in 2025, is set for steady expansion. It is expected to grow significantly to USD 764.3 million by 2032, registering a strong CAGR of 8.6% over the forecast period. The rising demand for efficient and cost-effective biopharmaceutical manufacturing processes primarily drives this growth. Continuous bioprocessing offers several advantages over traditional batch processing, including enhanced productivity, reduced production times, and improved scalability. The increasing adoption of biologics, particularly monoclonal antibodies and cell therapies, is further fueling demand for advanced processing technologies. Moreover, ongoing advancements in process analytical technologies (PAT), automation, and control systems are supporting the market growth, while the growing acceptance of continuous manufacturing by regulatory bodies is encouraging wider industry adoption.

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The continuous bioprocessing market is experiencing sustained growth as biopharmaceutical manufacturers increasingly seek efficient, flexible, and scalable production solutions. A primary driver of this trend is the rising demand for biologics—including monoclonal antibodies, vaccines, and cell and gene therapies—which require high-throughput, cost-effective manufacturing systems. Continuous bioprocessing offers several advantages over traditional batch methods, including reduced production time, lower capital and operational costs, and improved product consistency and quality.

For instance, in August 2023, life sciences company Sartorius and Repligen Corporation launched an integrated bioreactor system that incorporates Repligen’s XCell ATF upstream intensification technology into Sartorius’ Biostat STR bioreactor. This innovation simplifies the implementation of intensified seed trains and N-perfusion processes for biopharmaceutical manufacturers.

Advancements in single-use technologies, PAT, and automation are further enhancing the feasibility and scalability of continuous operations. These innovations support real-time monitoring and adaptive manufacturing, enabling faster product release and improved quality assurance.

However, challenges persist, including high upfront investment costs, integration complexity, and a shortage of skilled personnel capable of managing advanced systems. Small and mid-sized companies, in particular, may struggle with limited infrastructure and technical expertise when transitioning from batch to continuous formats.

Despite these hurdles, the market is poised for steady expansion, driven by the demand for agile manufacturing, smaller facility footprints, and the continued growth of biologics pipelines. Strategic collaborations among technology providers, contract manufacturing organizations (CMOs), and drug developers are also fostering innovation and accelerating adoption across the industry.

The integration of real-time monitoring and control systems through advanced PAT and automation tools is emerging as a key trend in continuous bioprocessing. These technologies enhance process control, enable adaptive manufacturing, and support faster product release, aligning closely with the industry's shift toward Quality by Design (QbD) principles.

In September 2022, Merck and Agilent Technologies announced a collaboration to develop PAT tools aimed at improving downstream bioprocess monitoring and control. This partnership focuses on integrating online High-Performance Liquid Chromatography (HPLC) systems into bioprocessing workflows, enabling real-time analysis and facilitating automated process control.

Regulatory bodies like the FDA and EMA are increasingly supporting the shift toward continuous manufacturing by providing clearer guidance and pilot programs. These regulatory efforts are encouraging more companies to invest in and adopt continuous bioprocessing technologies.

In July 2023, the EMA adopted the International Council for Harmonisation (ICH) Q13 guideline, providing a comprehensive framework for the development, implementation, and lifecycle management of continuous manufacturing processes for drug substances and products. This guideline offers regulatory clarity and supports the global harmonization of standards.

The increasing development and commercialization of biologics such as monoclonal antibodies, vaccines, and advanced cell and gene therapies are driving the demand for more efficient, scalable, and cost-effective manufacturing solutions. Continuous bioprocessing enables faster production cycles, improved product quality, and reduced operational costs, making it highly attractive for biopharma manufacturers.

In September 2024, the FDA published a draft strategy to accelerate the adoption of innovative manufacturing approaches, including continuous bioprocessing. This regulatory encouragement is expected to facilitate faster product development and cost-effective production of biologics and advanced therapies.

The growing pipeline of personalized therapies such as CAR-T cells and gene therapies is creating demand for flexible, small-scale, yet scalable manufacturing systems. Continuous bioprocessing allows for controlled and reproducible production in closed systems—ideal for sensitive biologics.

In October 2023, Lonza announced new investments in continuous manufacturing platforms to support the production of autologous and allogeneic cell therapies, citing faster turnaround times and improved scalability.

In November 2023, WuXi Biologics successfully implemented a fully integrated continuous bioprocessing platform, WuXiUP, achieving a productivity of approximately 6 g/L/day at pilot scale. This end-to-end continuous manufacturing process, encompassing perfused cell culture to final ultrafiltration/diafiltration (UF/DF) pool, demonstrated significant improvements in efficiency and scalability for monoclonal antibody (mAb) production. The platform also utilized custom-fit Process Analytical Technology (PAT) for real-time monitoring, facilitating process control and product release. This advancement underscores the potential of continuous bioprocessing in meeting the growing demand for biologics, including gene and cell therapies.