Next Generation Biomanufacturing Market Size, Share, Growth, Trends, and Global Industry Analysis: By Workflow Type (Upstream, Single-use, Downstream), By Application (Monoclonal Antibodies, Vaccines, Recombinant Protein, Hormones), By End-User (Biopharmaceutical Companies, Research Institutions, Contract Research Organizations), and Region Forecast 2020-2031

Next Generation Biomanufacturing Market size was valued at US$ 18,947.3 million in 2024 and is expected to reach US$ 33,109.0 million by 2031, growing at a significant CAGR of 8.3% from 2025-2031. The market refers to the advanced and innovative processes used to produce biological products, including vaccines, therapeutics, enzymes, and other biologics, using cutting-edge technologies. This market focuses on integrating automation, synthetic biology, continuous manufacturing, and data analytics to improve efficiency, scalability, and product quality in bioproduction. It encompasses diverse techniques such as cell culture, fermentation, and gene editing, aimed at overcoming limitations of traditional manufacturing methods by reducing production time, costs, and resource consumption while ensuring regulatory compliance.

The market overview highlights the rapid growth driven by increasing demand for biologics in healthcare, rising investments in biopharmaceutical R&D, and the urgency for faster responses to global health crises such as pandemics. Advances in single-use technologies and modular manufacturing facilities contribute to flexible and cost-effective production. Additionally, collaborations between biotech firms, contract manufacturing organizations, and technology providers accelerate innovation. The increasing adoption of Industry 4.0 principles, including AI and IoT integration, further enhances process monitoring and control, positioning next-generation biomanufacturing as a transformative force in the life sciences industry.

Facts & Figures

• The U.S. Food and Drug Administration (FDA) has approved over 60% of new biologic therapies in the past five years, reflecting the growing prominence of biologics in healthcare and the need for advanced manufacturing techniques.
• According to the World Health Organization (WHO), global biopharmaceutical production capacity has expanded by over 30% since 2020, driven by investments in flexible and modular manufacturing technologies.
• The U.S. National Institutes of Health (NIH) reports that continuous bioprocessing can reduce production cycle times by up to 50%, enhancing efficiency and enabling faster drug availability.
• Data from the European Medicines Agency (EMA) indicates that the adoption of single-use bioreactors has increased significantly, with over 40% of new biomanufacturing facilities incorporating disposable technologies to minimize contamination risk and lower costs.

Recent Developments:

• In April 2025, Eli Lilly & Co. announced plans to invest $5.9 billion in a new biomanufacturing facility in northeast Houston. This project is expected to create over 2,000 construction jobs and 600 permanent positions. The proposed 236-acre site in Generation Park aims to produce active pharmaceutical ingredients, marking Lilly's first significant manufacturing presence in the Houston area.
• In March 2025, Merck introduced the first single-use reactor developed exclusively for producing antibody drug conjugates (ADCs).

Next Generation Biomanufacturing Market Segmentation:

Based on the workflow type:

• Upstream
• Single-use
• Downstream

The single-use workflow segment is anticipated to be the leading driver in the next-generation biomanufacturing market due to its flexibility, cost-efficiency, and ability to accelerate production timelines. Single-use technologies replace traditional stainless-steel equipment with disposable bioreactors, tubing, and filtration systems, significantly reducing cleaning, sterilization, and cross-contamination risks. This advantage is critical for biologics and personalized therapies, which often require smaller batch sizes and faster changeovers. The reduced upfront capital investment and faster facility turnaround enable manufacturers to respond swiftly to changing market demands and regulatory requirements.

Additionally, single-use systems facilitate modular and decentralized manufacturing models, allowing for scalable, geographically distributed production. Their growing adoption is supported by advancements in materials science and regulatory acceptance, especially for complex biologics and gene therapies. As manufacturers seek to enhance efficiency while maintaining product quality, single-use workflows stand out as a transformative force shaping the future of biomanufacturing.

Based on the application:

• Monoclonal Antibodies
• Vaccines
• Recombinant Protein
• Hormones

The monoclonal antibodies (mAbs) segment is anticipated to be the leading driver in the next-generation biomanufacturing market, propelled by their increasing therapeutic applications across oncology, autoimmune diseases, and infectious diseases. Monoclonal antibodies represent one of the fastest-growing classes of biologics due to their high specificity, efficacy, and versatility in targeting complex disease mechanisms. Advances in biomanufacturing technologies such as continuous processing, single-use systems, and automation are enabling scalable and cost-effective production of mAbs, meeting rising global demand.

Furthermore, regulatory bodies worldwide have streamlined approval pathways for mAbs, fostering rapid clinical adoption. The expanding pipeline of biosimilars and next-generation antibody formats, including bispecific and antibody-drug conjugates, is also accelerating growth. As personalized medicine gains momentum, the ability to manufacture highly specific mAbs efficiently is critical. Therefore, the monoclonal antibodies application remains a cornerstone driving innovation and investment in next-generation biomanufacturing.

Based on the end-user:

• Biopharmaceutical Companies
• Research Institutions
• Contract Research Organizations

The biopharmaceutical companies segment is anticipated to be the leading driver in the next-generation biomanufacturing market, fueled by the growing demand for innovative biologic therapies and the need for efficient, scalable manufacturing solutions. These companies are at the forefront of developing cutting-edge biologics, including monoclonal antibodies, gene therapies, and vaccines, which require advanced production technologies to meet stringent quality and regulatory standards. With increasing competition and pressure to reduce time-to-market, biopharmaceutical firms are investing heavily in automation, continuous processing, and single-use systems to enhance productivity and flexibility.

Moreover, strategic partnerships and collaborations with technology providers enable them to adopt next-generation manufacturing platforms rapidly. The rising prevalence of chronic diseases and personalized medicine further amplifies the need for adaptable manufacturing capabilities that biopharmaceutical companies seek to address. Consequently, this segment is a critical force driving innovation, technology adoption, and market expansion in next-generation biomanufacturing