Next Generation Biomanufacturing Market Size, Share, Growth, Trends, and Global Industry Analysis: By Workflow and Product type (Continuous Upstream Biomanufacturing, Single use upstream Biomanufacturing, down streaming Biomanufacturing), Application (Vaccines, Hormones, Monoclonal Antibody, Recombinant Protein, Others), End Uses (Commercial Stage, Preclinical Stage, Development Stage), and Region Forecast 2020-2031

Next Generation Biomanufacturing Market size was valued at US$ 5.67 billion in 2024 and is expected to reach US$ 11.3 billion by 2031, growing at a significant CAGR of 15% from 2025-2031. The market is projected to reach around US$?11.3?billion by 2031 at a CAGR of 9.85?%. Moreover, the U.S. market is projected to grow significantly, reaching an estimated value of US$?3.14?billion by 2031. The worldwide next-generation biomanufacturing industry is an advanced and innovative bioprocessing industry that maximizes the use of leading-edge innovation like continuous manufacturing, single-use technologies, synthetic biology, and artificial intelligence to become more efficient, flexible, and scalable in biologic production. The industry breaks the bottle neck of conventional batch operation by offering less turnaround time, lower operation cost, and consistency of product. BioPharma businesses are resorting more to modulated and automated technologies to address the rising market demand for sophisticated biologics, such as monoclonal antibodies, cell and gene therapies, and vaccines. The technologies enable flexible manufacturing and quick reactions to developing therapeutic demand and international health crises.

The industry is experiencing triggered development driven by rising R&D spending, rising demand for personalized medicine, and supportive regulatory environments that fuel innovation in manufacturing. Governments and global health agencies are enabling the implementation of cutting-edge bioprocessing solutions to ensure better healthcare preparedness and resilience for future pandemics. Above this, success in AI-assisted predictive modelling, real-time monitoring, and digital twin technologies is also transforming process optimisation and quality control in biomanufacturing. Strategic collaboration among such biopharma players, CDMOs, and technology partners is also driving acceleration. As next-generation platforms reach maturity, they will shape the future of bioproduction as more sustainable and faster.

Facts & Figures:

• The Personalized Medicine Coalition currently lists 132 biomarker-driven personalized medicines on the market, underscoring the shift toward patient-specific treatments. This growth fuels demand for flexible bioprocessing solutions such as single-use bioprocess bags, that enable rapid, scalable manufacturing of complex therapies like CAR-T and gene therapies, positioning them as critical enablers in next-generation biomanufacturing.
• Monoclonal antibodies dominate the market due to their complex structure and therapeutic use in cancer and autoimmune diseases. Advanced manufacturing technologies and growing biosimilar approvals are boosting production and investment in this segment.

Key Developments:

• In March 2024, Phenomenex Inc. introduced Biozen dSEC-7, a state-of-the-art SEC solution for accurate aggregate analysis of adeno-associated viral vectors (AAVs). This new addition to Biozen's product portfolio strengthens its family of advanced analytical workloads in gene therapy, monoclonal antibodies, biosimilars, and other high-complexity biologics.
• In Nov 2023, Molecular Devices introduced the ValitaTiter IgG titer assay in North America and Europe, providing fast 10-minute results that are natively compatible with its SpectraMax microplate readers. Constructed to outperform conventional approaches such as HPLC and ELISA, ValitaTiter saves time, expense, and complexity of workflow by making wash-free direct analysis possible in cell culture, with greater efficiency in high-throughput cell line and process development.
• In June 2023, Beckman Coulter Life Sciences has introduced a Light Array Module (LAM) for its BioLector XT microbioreactor for photosynthetic organism growth through programmable illumination across the complete range of 400–700 nm. Sixteen addressable LEDs provide a maximum of 3,500 µmol m?² s?¹ photon flux with user-programmable day-night cycling and allow precise optimization of light-dependent bioprocesses.

Next Generation Biomanufacturing Market Segmentation:

Based on the Workflow and product type:

• Continuous Upstream Biomanufacturing
• Single Use Upstream Biomanufacturing
• Downstream Biomanufacturing

For the segments that have been recognized, Single-Use Upstream Biomanufacturing is at the forefront of next-generation biomanufacturing with its operational flexibility, reduced risk of contamination, and scalability across various production scales. Single-use technologies versus stainless-steel systems cut cleaning validation time by greatly enhancing it and capital costs on infrastructure, enabling rapid turnaround between batches. Efficiency is of utmost importance to CDMOs and biotech start-ups with the need for rapid biologics development. Moreover, surging demand for targeted/personalized medicine and small-scale batches of biologics has heightened the popularity of single-use and modular technology, solidifying the success of single-use upstream platforms in modern biomanufacturing processes.

Based on the application:

• Vaccines
• Monoclonal Antibody
• Hormones
• Recombinant Proteins
• Others

Monoclonal Antibodies drive the application sector of the next-generation biomanufacturing market through their rising therapy uses in cancer, autoimmune, and infectious diseases. Their complex molecular structure and high clinical efficacy require advanced, precision-driven biomanufacturing systems, making them ideal candidates for continuous and single-use facilities. Robust pipeline construction, approvals, and the rising biosimilars market have also driven large-scale and small-batch manufacturing demand. While big pharma is concentrating on targeted biologics, investment in process optimization against antibodies is on the rise. Such strategic overlap of therapeutic demand and technological promise has solidified monoclonal antibodies as drivers of next-generation biomanufacturing adoption.

Based on the end user:

• Commercial Stage
• Preclinical Stage
• Development Stage

Commercial-stage users are at the forefront of the next-generation biomanufacturing sector, leveraging fully approved products to enhance production capacity, improve cost efficiency, and address increasing market demand. With biologics that generate revenue requiring consistent, large-scale production, these companies prioritize advanced methods such as continuous-flow manufacturing to boost both yield and quality. Their mature supply chains and adherence to stringent regulatory standards accelerate the adoption of cutting-edge technologies, leading to reduced batch variability and faster time-to-market. Investment activity is heavily focused on this stage, as the shift from developmental to commercial-scale operations delivers strong returns and reinforces long-term competitiveness. As a result, the commercial stage stands as the largest end-user segment, driving innovation in biomanufacturing technologies and shaping global industry trends.