Next-gen Biomanufacturing Market

The global Next-gen Biomanufacturing Market is valued at USD 23.42 Billion in 2024 and is projected to reach a value of USD 63.44 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 9.50% between 2025 and 2035.

Key Highlights of Next-gen Biomanufacturing Market

• The North American region led the Next-gen Biomanufacturing market in 2024, with 36.5% of the total market share,
• The Asia Pacific region is projected to remain the fastest-growing region throughout the forecast period,
• In 2024, the Monoclonal Antibodies segment dominated the market, with a market share of around 48.2%,
• Based on End-user, the Biopharmaceutical Companies segment significantly contributed to the market’s expansion, constituting over 45.1% of the overall revenue share in 2024.

Next-gen Biomanufacturing Market: Regional Overview

In 2024, North America Next-gen Biomanufacturing market held a significant dominance with 36.5% of the total revenue. With many of the worlds leading biopharmaceutical companies based in North America, the region holds a dominant position in driving the adoption of Next-gen Biomanufacturing technologies. Supported by robust R&D infrastructure and collaboration between universities, research centers, and government organizations, North America is at the forefront of developing innovative biomanufacturing techniques. These advancements are poised to boost productivity and revolutionize production processes, driving revenue expansion in the Next-gen Biomanufacturing market.

Meissner Corporation, a key player in the bioprocessing sector, is set to significantly expand its manufacturing footprint with a new facility in AthensClarke County, USA. The companys investment underscores the growing demand for advanced products and systems in the pharmaceutical & biopharmaceutical industries. The new campus, featuring state-of-the-art cleanroom facilities, laboratories, and research & development spaces, will more than double Meissners manufacturing capacity in the U.S. Operations at the new site are expected to commence in early 2026, further contributing to the growth of the North America Next-gen Biomanufacturing Market.

Next-gen Biomanufacturing Market: Application Overview

• The Monoclonal Antibodies segment dominated the Global Next-gen Biomanufacturing market in 2024, with 48.2% of revenue share.
• Monoclonal antibodies play an important role in the treatment of a broad range of diseases, which has resulted in their dominant position within the biopharma sector. The production of monoclonal antibodies with next generation Biotechnological techniques provides advantages over traditional manufacturing methods, and also strengthens their position on the market. Companies are increasingly exploring the development of monoclonal antibodies across various disease areas, highlighting their versatility & therapeutic potential.
• Acumen Pharmaceuticals' ACU193, the first clinical-stage monoclonal antibody targeting toxic soluble amyloid beta oligomers (AβOs) for early Alzheimers disease treatment, exemplifies groundbreaking advancements in the monoclonal antibody segment. Awarded the prestigious "Monoclonal Antibody Solution of the Year" by the BioTech Breakthrough Awards program, ACU193 underscores the significance of targeted therapies in addressing complex neurological conditions.

Key Trends

1. The shift towards single-use bioprocessing systems continues to grow, driven by benefits such as reduced risk of contamination, faster changeovers, and lower capital costs.
2. In order to improve the efficiency, consistency and quality control of bioprocessing processes, automation and digitization technologies are increasingly incorporated including robotics, artificial intelligence, or machine learning MLML.
3. Significant investments in the infrastructure for cell and gene therapy manufacture, as well as development of novel bioprocessing technologies that are adapted to these therapies, have been made due to an increasing demand for personalized medicine.
4. Potential benefits of continuous bioprocessing, such as increased productivity, a smaller footprint and improved process control, are also available in comparison to conventional batch processing. It is expected that, in particular for the production of monoclonal antibodies, the adoption of continuous manufacturing approaches will increase.
5. To gain access to specialized expertise, capacity flexibility and cost savings, pharmaceutical companies are outsourcing their production activities to Contract Development and Manufacturing Organizations.
6. To enable proactive decision making, optimize process parameters and ensure product quality consistency and consistency, real time monitoring, data analytics and predictive modeling have been integrated into bioprocessing processes.
7. Research & development efforts are focused on improving expression systems for recombinant protein production, including novel cell lines, vectors, and engineered microorganisms, to enhance yield, product quality, and scalability.

Next-gen Biomanufacturing Market – Government Initiatives

• National Biotechnology and Biomanufacturing Initiative Launch: The United States government announces significant investments and resources to advance President Biden’s initiative. A Summit on Biotechnology & Biomanufacturing, led by key officials, highlights steps to lower prices, create jobs, strengthen supply chains, improve health outcomes, and reduce carbon emissions, with over $2 billion in funding.
• Strengthened Supply Chains Leveraging Biotechnology: Initiatives include investing $40 million in biomanufacturing for essential medications and pandemic response, launching a program with over $270 million investment over five years to enhance defense supply chains, and utilizing sustainable biomass for domestic fuel, chemicals, and materials production, thereby stabilizing prices amidst global supply chain disruptions.
• Expansion of Domestic Biomanufacturing Infrastructure: Investments of $1.2 billion over five years aim to catalyze the establishment of accessible domestic bioindustrial manufacturing bases. Additionally, a $500 million grant program will support innovative American fertilizer production, utilizing advancements in biotechnology.
• Commercialization of Bio-Products: Funding for biomass conversion R&D with up to $100 million, scale-up activities with an additional $60 million, and industry partnerships through Manufacturing USA institutes aim to bring biobased fuels, chemicals, and plastics to market.
• Next-Generation Biotechnologist Training: Expansion of entrepreneurship programs, immersive experiences for underrepresented students, and funding with $68 million for research and education initiatives aim to train a skilled workforce for the biotechnology industry.
• Advancement of Measurements and Standards: Increased investment of $14 million in biotechnology research programs will develop measurement technologies, standards and data crucial for engineering biology, biomanufacturing processes, and utilizing artificial intelligence for biological data analysis.
• Biosecurity Innovation Investments: A new bioassurance program with $20 million will enhance U.S. capabilities in anticipating, assessing, detecting, and mitigating biotechnology and biomanufacturing risks, integrating biosecurity into development processes to reduce risks effectively.

Premium Insights

The burgeoning expansion of biologics & biosimilars in recent years has underscored the critical role of biomanufacturing technologies in todays pharmaceutical landscape. The sector has become a cornerstone of healthcare development, offering cutting edge treatments and cures in the face of biologics developments that account for around 40% of research & development expenditure. Biomanufacturing is a catalyst for research progress, prosperity and job creation in addition to its key role in health care. Moreover, biotechnological production has a far greater impact on the development of green technologies and industrial waste reduction as opposed to conventional manufacturing paradigms. It constitutes a cornerstone of Modern Industry Practices due to its inherent advantages, such as affordability, scalability & growth potential. Strategic partnerships with industry leaders like Danaher Corporations Life Sciences Division are being forged by new businesses that embrace the next generation of biomanufacturing. From R&D to cGMP production, these flexible partnerships provide novel processes that range from each stage of manufacture.

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Market Dynamics

• Collaboration between Waters Corporation and Sartorius expands to deliver comprehensive bioanalytics for downstream biomanufacturing. Integrating Waters' PATROL™ UPLC™ Process Analysis System with Sartorius' Resolute® BioSMB™ platform empowers bioprocess engineers with enhanced analytical capabilities, optimizing yields, reducing waste, and driving down manufacturing costs.
• With the rapid evolution of genomic technologies such as mRNA and cell & gene therapies, the biomanufacturing landscape faces a crucial period of adaptation. The expected 33% growth rate in cell & gene therapies by 2026 underscores the urgency for innovation. Flexible manufacturing systems are emerging as a solution, capable of accommodating diverse therapeutic modalities and scaling production dynamically.
• Phenomenex introduces Biozen dSEC-7, a cutting-edge Size Exclusion Chromatography (SEC) product designed for the analysis of adeno-associated viral vectors (AAVs) in gene therapy. Overcoming size and sample constraints, Biozen dSEC-7 offers unprecedented speed and efficiency in aggregate analysis, contributing to advancements in gene therapy research & development.
• Meissner Corporations investment in a new manufacturing facility in Athens, Georgia, underscores the growing demand for advanced microfiltration & therapeutic manufacturing systems. With a focus on pharmaceutical drugs, biologics, and cell and gene therapies, the project is set to create over 1,700 new jobs, reinforcing Meissners position as a leader in the bioprocessing sector.

Competitive Landscape

• Biopharmaceutical firms are poised to seize a substantial market share in Next-gen Biomanufacturing. Advanced biomanufacturing strategies are needed to address their focus on protein production & personalized medicine. Key companies are projected to shift their manufacturing processes toward customized Biologics for individual patients, in view of the growing demand for personalized medicines.
• Danaher Corporations launch of the Beacon Initiative marks a strategic move towards fostering innovation in gene therapy. Partnering with Duke University, the initiative aims to leverage breakthrough science in genomic medicines, precision diagnostics, and Next-gen Biomanufacturing. By investing in product innovation, Danaher seeks to advance human health outcomes.

Recent Market Developments

• In March 2024, Sartorius and LFB BIOMANUFACTURING entered a collaboration to enhance cell line development and manufacturing capabilities. Sartorius, a prominent life science group, and LFB BIOMANUFACTURING, an established Contract Development and Manufacturing Organization (CDMO) specializing in recombinant proteins, have announced a partnership agreement. Under this agreement, LFB BIOMANUFACTURING will delegate cell line development services to Sartorius, leveraging the respective expertise of both entities to deliver increased value to customers.
• In March 2024, Esco Lifesciences Group and its affiliate, Esco Aster, signed a Memorandum of Understanding (MoU) with the Medical and Pharmaceutical Industry Technology Development Center (PITDC) Taiwan. This strategic alliance between Esco Aster and PITDC Taiwan aims to elevate manufacturing standards and bolster Taiwans position in the rapidly expanding cell therapy sector.
• In February 2024, GEA announced an EUR 18 million investment in a technology center for alternative proteins in Wisconsin, USA. GEAs cutting-edge technologies and a team of biotechnology experts will facilitate the scaling of novel food production for industrial purposes, meeting the growing demand for alternative proteins in the USA. The groundbreaking ceremony for the new GEA campus is scheduled for spring 2024, with the opening expected one year later.

The global Next-gen Biomanufacturing market can be categorized as Workflow Type, Application, End-user, and Region.