Global Next-Generation Biomanufacturing Market Size (2024 – 2030)

The global market for next-generation biomanufacturing reached a valuation of USD 22.51 billion and is anticipated to attain a market size of USD 43.31 billion by the culmination of 2030. Across the projection period spanning from 2024 to 2030, the market is forecasted to exhibit a Compound Annual Growth Rate (CAGR) of 9.8%. Significant growth drivers of the next-generation biomanufacturing market include the escalating approvals of biologics and biosimilars, heightened adoption of automation technologies among biomanufacturing providers, increased development and commercialization of digital bioreactors, augmented investment in Research and Development (R&D), and an array of benefits such as enhanced bioproduction workflows resulting in reduced costs, time, and labor.

Next-Generation Biomanufacturing Market

Industry Overview:

Biomanufacturing, entailing the production of commercially significant biomolecules through biological systems, finds applications in medicine, industry, and food and beverage processing. Biological systems such as blood, animal cells, plant cells, and microbial cultures are commonly employed in biomanufacturing processes. Additionally, cells utilized in production can be obtained through genetic engineering techniques. The advent of next-generation biomanufacturing facilities has notably bolstered the supply of biologic medicines, driven by increasing awareness among the populace. Market growth is further fueled by the expanding commercialization and pipeline development of therapeutic products due to the rising incidence of conditions like cancer, diabetes, and liver and kidney diseases worldwide. Automation technologies have gained prominence in the biomanufacturing sector, offering streamlined control, heightened speed, accuracy, and productivity. The proliferation of biopharmaceutical firms globally is poised to propel the next-generation biomanufacturing market in the forthcoming years, with many companies innovating to penetrate this evolving market landscape.

Impact of the COVID-19 Pandemic on the Next-Generation Biomanufacturing Market

The COVID-19 crisis accelerated vaccine development within the biomanufacturing sector. This advancement in vaccine technology is anticipated to positively impact the growth trajectory of the biopharmaceutical industry post-pandemic. Certain bioprocessing entities, such as GE Healthcare, experienced significant disruptions due to supply-demand imbalances resulting from the pandemic. Conversely, key market players like Danaher Corporation witnessed substantial revenue growth attributed to heightened demand for bioprocess solutions. The outbreak prompted biomanufacturing firms in the United States to prioritize vaccine development, which is poised to stimulate market growth in the forecast period.

Market Drivers:

Rising approvals of biologics and biosimilars are propelling the next-generation biomanufacturing market forward.

The number of programs enrolled in the FDA’s Biosimilar Biological Product Development Program is on the rise, with 100 biosimilar development initiatives registered as of Q4 of Fiscal Year 2021. The surge in biosimilar development and approvals over the past couple of years has resulted in a total of 33 approvals across 13 molecules to date. This uptick in biosimilar availability and utilization is expected to yield significant cost savings in drug expenditure, with projections estimating savings of USD 100 billion over the next five years. Legislative measures enabling FDA approval of biosimilars in the U.S. have paved the way for biological products exhibiting comparability to reference products in terms of purity, potency, and safety, thereby bolstering the next-generation biomanufacturing market.

Increased adoption of automation technologies among biomanufacturing providers is driving market growth.

Automation technologies are witnessing escalating adoption within the biomanufacturing domain owing to their capacity to enhance speed, precision, and productivity. The automation systems market is experiencing rapid expansion, with numerous companies investing in and introducing novel automation solutions to market, aimed at delivering more centralized and streamlined control. Biopharmaceuticals constitute a vital segment of pharmaceutical companies' drug portfolios, necessitating investments in automation and digitalization of biopharmaceutical Research and Development (R&D) endeavors to efficiently discover new biopharmaceuticals and develop subsequent manufacturing processes.

Augmentation of the market is further facilitated by the increasing development and commercialization of digital bioreactors and heightened investments in R&D.

The global next-generation biomanufacturing market is witnessing rapid expansion fueled by substantial investments from both public and private sectors towards developing facilities equipped with advanced biomanufacturing instrumentation. Heightened funding from private investors and governmental bodies towards the establishment of next-generation biomanufacturing facilities is fostering rapid technological advancements in biomanufacturing products. Biopharmaceutical companies are adopting innovative biomanufacturing strategies with a heightened focus on achieving a balance between innovation in process design, efficiency, performance, speed, and cost. The burgeoning commercialization, expanding biopharmaceutical sector, and widespread adoption of advanced technology and innovation globally are poised to accelerate the growth trajectory of the next-generation biomanufacturing market.

Benefits such as streamlined bioproduction workflows resulting in reduced costs, time, and labor are contributing to market growth.

Enhanced upstream and downstream processes, alongside Single-Use Systems (SUS) technologies, offer a plethora of facility options necessitating fewer resources and facilitating management within smaller, cost-effective facilities. Single-use products confer various advantages, including cost savings, heightened flexibility in multi-product facilities, and diminished risks of product contamination.

Market Restraints:

The scarcity of skilled professionals in the next-generation biomanufacturing market poses a potential restraint.

Biopharmaceuticals present technological and operational challenges, necessitating manufacturing capabilities of unprecedented proficiency to reliably produce complex molecules at an industrial scale. The dearth of a skilled talent pool in biologics constitutes a primary impediment to market expansion. Additionally, prolonged process durations, expensive raw materials, low yields, and the requisite for highly skilled experts to operate production facilities present significant challenges.

Complex production steps and operational intricacies can impede the growth of the Next-Generation Biomanufacturing Market.

Downstream processing encompasses a series of unit operations involving diverse filtration and chromatography steps. Numerous factors, including limited capacity associated with these multiple steps, pose challenges to product quality and productivity in downstream processing. Chromatography columns utilizing resin often exhibit slow mass transfer rates and are oversized to accommodate higher flow rates, thereby enhancing productivity. However, such oversizing strategies can be costly and inflexible. To enhance productivity, flexibility, and cost-effectiveness, a shift towards continuous processing is underway, albeit presenting its own set of downstream processing challenges. While various technologies are addressing these challenges, their application in biopharmaceutical production remains primarily confined to large-scale operations.

Next-Generation Biomanufacturing Market – By Workflow Type

• Single-Use Upstream Biomanufaturing Workflow
• Upstream Biomanufacturing Workflow
• Downstream Biomanufaturing Workflow

The categorization of the Next-Generation Biomanufacturing Market based on Workflow Type includes Single-Use Upstream Biomanufacturing Workflow, Upstream Biomanufacturing Workflow, and Downstream Biomanufacturing Workflow. The Upstream Biomanufacturing Workflow segment secured the primary position within the global next-generation biomanufacturing market. Compared to downstream biomanufacturing, upstream biomanufacturing involves a substantial number of high-cost equipment. Anticipated to experience significant growth during the forecast period, the Downstream Biomanufacturing Workflow segment is driven by continuous product innovations observed in chromatography product lines and filtration systems utilized in downstream processing.

Next-Generation Biomanufacturing Market – By Application

• Monoclonal Antibodies
• Recombinant protein
• Vaccines
• Hormones
• Others

The segmentation based on Application comprises Monoclonal Antibodies, Recombinant proteins, Vaccines, Hormones, and Others. Expected to lead the next-generation biomanufacturing market, the Monoclonal Antibodies segment owes its dominance to a high rate of product approval. Following closely, the vaccines segment accounted for the second-largest share in the market, primarily due to the substantial development of vaccines spurred by the recent coronavirus outbreak.

Next-Generation Biomanufacturing Market – By End User

• Biopharmaceutical Companies
• Research Institutions
• CMOs/CDMOs

The segmentation based on End User encompasses Biopharmaceutical Companies, Research Institutions, and CMOs/CDMOs. Foreseen to capture the largest revenue share, the Biopharmaceutical Companies segment is driven by rapid digitalization and the adoption of advanced technologies like artificial intelligence, digital twins, and augmented reality. These advancements are pivotal in resolving challenges in producing and supplying biologic medicines. Moreover, the adoption of novel biomanufacturing strategies aimed at enhancing efficiency, productivity, and reducing operating costs further fuels market growth. Increased investor and government funding also contribute to expanding the next-generation biomanufacturing market.

Next-Generation Biomanufacturing Market - By Region

• North America
• Europe
• Asia-Pacific
• Rest of the World

Geographically, the North American Next-Generation Biomanufacturing Market dominated the global market in 2021 in terms of revenue share. This can be attributed to well-equipped biomanufacturing facilities, robust investments in the sector, and the presence of key industry players. The expanding biopharmaceuticals and biologics industry in North America presents significant growth opportunities for the market, attracting investor interest. Following North America, Europe is expected to hold the second-largest share during the forecast period.

The Asia Pacific Next-Generation Biomanufacturing Market is poised to witness the fastest CAGR, fueled by the increasing population in countries such as China and India. Moreover, the adoption of technologically advanced biomanufacturing equipment in emerging nations like Japan, South Korea, India, Australia, and Singapore further drives market growth. Investments in new capacity installations to meet rising product demand in Asia-Pacific are anticipated to boost market growth.

In contrast, the Next-Generation Biomanufacturing Market in Latin America, the Middle East, and Africa is expected to have the smallest share during the forecast period due to lower adoption of advanced technology.

Major Key Players in the Market

1. Applikon Biotechnology BV
2. Thermo Fisher Scientific Inc.
3. bbi-biotech GmbH
4. Danaher Corporation
5. Eppendorf AG
6. Esco Group of Companies
7. Meissner Filtration Products, Inc.
8. Merck KGaA, PBS Biotech, Inc.
9. Pierre Guerin
10. Sartorius AG
11. Shanghai Bailun Biotechnology Co. Ltd
12. Solaris Biotechnology Srl
13. GEA Group Aktiengesellschaft
14. ZETA GmbH

Over the past five years, the market has witnessed 115 key developments in biomanufacturing and automation by these companies, ranging from acquisitions to partnerships and collaborations.

Notable Developments in the Global Next-Generation Biomanufacturing Market:

• In August 2021, Sartorius Stedim Biotech partnered with McMaster University to enhance manufacturing processes for antibody and virus-based treatments.
• In September 2021, Thermo Fisher Scientific's clinical sequencing business collaborated with AstraZeneca to co-develop next-generation sequencing-based companion diagnostics.
• In November 2021, Donaldson Company, Inc. acquired Solaris Biotechnology Srl, a developer and manufacturer of bioprocessing equipment.
• In February 2020, Honeywell International Inc. collaborated with Bigfinite, Inc. to enhance process automation and technology control in medical therapies.
• In April 2020, Akron Biotech announced the acquisition of Cambryn facility in Sarasota, Florida, equipped with state-of-the-art equipment.
• In March 2019, Rockwell Automation and GE Healthcare agreed to combine their automation single-use solution expertise to develop digital bioprocessing operations.