Bio-Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028, Segmented By Workflow (Continuous Upstream Biomanufacturing, Single-Use Upstream Biomanufacturing, Downstream Biomanufacturing), By Application (Monoclonal Antibodies, Hormones, Vaccines, Recombinant Proteins, Others), By End User (Biopharmaceutical Companies, Research Institutions, CMOs/CDMOs), By Region and Competition

Market Overview

Global Bio-Manufacturing Market has valued at USD 19.08 Billion in 2022 and is anticipated to project robust growth in the forecast period with a CAGR of 7.72% through 2028. The biomanufacturing market refers to the sector of the biotechnology and pharmaceutical industry that involves the production of biological products, including biopharmaceuticals, cell therapies, gene therapies, vaccines, and other biologically derived products. Biomanufacturing encompasses the processes of designing, developing, scaling up, and producing these products on a large scale to meet the needs of patients, healthcare systems, and research efforts. The biomanufacturing market is a critical component of the biotechnology and pharmaceutical industry, contributing to the production of lifesaving and life-enhancing products. As technology and scientific understanding continue to advance, the biomanufacturing field is likely to evolve, bringing about new therapies, improved production processes, and enhanced capabilities to meet the growing demands of healthcare and patient needs.

Key Market Drivers

Adoption of Advanced Technology and New Innovation

The rise in the geriatric population and the prevalence of chronic respiratory disorders are anticipated to drive the demand for ventilators. Increasing awareness of lung cancer symptoms and a growing number of patients in medical facilities contribute to the significant market growth of ventilators. However, it should be noted that the use of mechanical ventilation may pose certain risks, such as increased infection risk and potential damage to the lungs. These considerations should be taken into account when assessing the market growth potential of Bio-Manufacturing. Advanced technologies such as automation, robotics, and process control systems can streamline biomanufacturing processes, reduce human error, and enhance overall production efficiency. This can lead to quicker turnaround times and increased production capacity, meeting the growing demand for biologics. Innovative bioreactor designs, single-use technologies, and flexible manufacturing platforms allow for easier scalability of production. As demand for bio manufactured products grows, the ability to quickly scale up production will become essential. Continuous manufacturing approaches, as opposed to traditional batch processes, can lead to consistent product quality, reduced wastage, and improved resource utilization. These advantages can boost demand for bio manufactured products.

Rising Environmental Concerns

The global biomanufacturing market is poised for growth, driven by escalating environmental concerns, pollution levels, water scarcity, and seamless manufacturing services for medication. Furthermore, the implementation of next generation biomanufacturing in plants will contribute to increased market demand. Additionally, the adoption of a single-use product strategy will facilitate cost reduction, minimize product contamination, and enhance flexibility, thereby fueling the demand for next-generation biomanufacturing. Heightened environmental awareness and concerns about pollution have prompted industries, including biomanufacturing, to adopt more sustainable and environmentally friendly practices. This includes reducing waste generation, optimizing resource usage, and implementing cleaner manufacturing processes. As biomanufacturing strives to minimize its environmental impact, the demand for eco-friendly biomanufacturing processes and products is likely to increase.

Water scarcity is a critical global issue that impacts various industries, including biomanufacturing. Implementing water-efficient manufacturing processes and recycling technologies can help mitigate water scarcity concerns while maintaining the production of biopharmaceuticals and other biologically derived products.

Increasing Number of Biopharmaceutical Businesses

During the forecast period, the growth of the next generation bio-manufacturing market is anticipated to be fueled by the rising number of biopharmaceutical companies globally. The need for advanced biomanufacturing to meet the demands of patients is expected to drive the progress of the next generation biomanufacturing industry. The global biopharmaceutical industry has been experiencing substantial growth, driven by advancements in medical science, increasing healthcare needs, and the development of novel therapies. As more biopharmaceutical companies emerge and existing companies expand their product pipelines, there is a growing demand for efficient, scalable, and technologically advanced biomanufacturing processes to produce these innovative therapies. Overall, the rising number of biopharmaceutical companies and the need to meet patient demands for cutting-edge therapies are driving the progress and growth of the next generation biomanufacturing industry. As the industry continues to innovate and develop advanced manufacturing solutions, it will play a critical role in shaping the future of healthcare and contributing to improved patient outcomes.

Growing Demand for Biopharmaceuticals

The growing demand for biopharmaceuticals is a significant driver that is increasing the demand for biomanufacturing. Biopharmaceuticals are a class of drugs that are produced using living organisms or biological systems, such as bacteria, yeast, mammalian cells, or plant cells. These drugs include monoclonal antibodies, vaccines, gene therapies, cell therapies, and more. The unique nature of biopharmaceuticals and their increasing prominence in medical treatments have led to a higher demand for specialized biomanufacturing processes. Biopharmaceuticals have revolutionized the treatment landscape for various diseases, offering targeted therapies with high specificity and reduced side effects. As more biopharmaceuticals enter the market and offer innovative treatment options, the demand for their production increases. The development of new and advanced therapies, such as gene therapies and cell therapies, is contributing to the growing demand for biopharmaceutical manufacturing. These therapies require complex manufacturing processes that involve genetic modification and manipulation of cells, highlighting the need for specialized biomanufacturing expertise.

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Key Market Challenges

Huge Capital Expenditure

The biomanufacturing process involves intricate and specialized equipment, facilities, and technologies, which can require significant financial investments. Setting up a biomanufacturing facility or upgrading existing infrastructure requires substantial initial capital investment. This includes the construction or renovation of specialized cleanrooms, purchase of bioreactors, purification equipment, and other sophisticated tools necessary for biopharmaceutical production. The substantial capital required for biomanufacturing can divert resources away from other critical areas such as research and development, marketing, and business expansion. This resource allocation challenge can impact a company's overall growth strategy. The high capital expenditure can result in overestimation or underutilization of manufacturing capacity. If demand for the manufactured product is lower than anticipated, the investment may not yield the expected returns.

Lack of Skilled Professionals

The lack of skilled professionals is a significant challenge that can hamper the growth of the biomanufacturing market. Biomanufacturing is a highly specialized field that requires expertise in various scientific, engineering, and technical disciplines. The shortage of skilled professionals can impact the efficiency, quality, and capacity of biomanufacturing operations.

Biomanufacturing involves complex processes, such as cell culture, fermentation, purification, and quality control. The shortage of skilled professionals can lead to a gap in expertise required for these specialized tasks. Insufficient skilled manpower can result in delays in production timelines, slowing down the availability of biopharmaceuticals and other biologically derived products in the market. Skilled professionals are essential for maintaining rigorous quality control and assurance throughout the manufacturing process. The absence of such professionals can compromise product quality and safety. Skilled professionals play a crucial role in driving innovation and process improvement within biomanufacturing. The lack of innovation can hinder the adoption of advanced technologies and hinder overall market growth. As the demand for biopharmaceuticals increases, companies may struggle to expand their manufacturing capacity due to the lack of skilled personnel required to manage and operate new facilities.

Key Market Trends

Emergence of Continuous Biomanufacturing

The emergence of continuous biomanufacturing has the potential to significantly boost the growth of the biomanufacturing industry in the future. Continuous biomanufacturing represents a departure from traditional batch processes by enabling the seamless, uninterrupted production of biopharmaceuticals and other biologically derived products. This innovative approach offers several benefits that can positively impact efficiency, flexibility, cost-effectiveness, and overall market expansion.  Continuous biomanufacturing allows for continuous monitoring and adjustment of process parameters in real-time. This leads to improved process control, reduced variability, and enhanced product consistency, resulting in higher process efficiency and reduced production times. Continuous biomanufacturing systems are generally more compact and require less physical space than traditional batch systems. This reduction in facility footprint can lead to cost savings and greater flexibility in facility design and location. Continuous biomanufacturing can enable higher production capacities by running processes continuously, thereby increasing output without the need for significant facility expansion. This increased capacity can meet the growing demand for biopharmaceuticals and other biologically derived products.

Development Of a Next-Generation Biomanufacturing Process

The advancement of a next generation biomanufacturing process enables the production of biological medications for critical ailments like liver and kidney disease, cancer, and diabetes. Moreover, the growing adoption of single-use products such as single-use bioreactors and bio containers, along with increased financial support from private investors and governments for the development of next-generation biomanufacturing units, are key drivers of the global next-generation biomanufacturing market. These trends are expected to persist throughout the forecast period.

Segmental Insights

Application Insights

Based on the application, monoclonal antibodies are one of the most commonly produced products using biomanufacturing processes. Monoclonal antibodies (mAbs) are a class of therapeutic proteins that are designed to target specific antigens in the body, such as cancer cells or immune system molecules. They have become a cornerstone of modern medical treatment, and their production often involves biomanufacturing techniques. Monoclonal antibodies are widely used in the treatment of various diseases, including cancer, autoimmune disorders, and infectious diseases. They are produced using biomanufacturing processes that involve culturing mammalian cells to express the specific antibodies. Bioreactors and advanced cell culture techniques are commonly used for mAb production.

However, hormones segment is the fastest growing segment as hormones, such as insulin, growth hormone, and erythropoietin, are also produced using biomanufacturing. These therapeutic proteins are used to treat hormonal deficiencies and other medical conditions. Biomanufacturing involves using recombinant DNA technology to insert the gene for the hormone into host cells (e.g., bacteria or yeast), which then produce the hormone in large quantities. The manufacturing of hormone for rising cases of diabetes and other hormone deficiency related disorders is expected to boost the demand for biomanufacturing of hormones around the globe.

Workflow Insights

Based on the workflow segment, continuous upstream biomanufacturing allows for continuous and steady production of biopharmaceuticals, eliminating the stop-start nature of traditional batch processes. This can lead to improved process efficiency, reduced downtime, and better resource utilization. The consistent environment and controlled conditions of continuous bioreactors can lead to higher cell densities and improved product yields compared to batch processes. Continuous biomanufacturing systems are often more compact than traditional batch systems, which can help in optimizing facility space and reducing operational costs. Continuous processes can result in more consistent and uniform product quality due to reduced variability and more precise process control.

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Regional Insights

North America, is dominating the market as the region has a well-developed and advanced healthcare infrastructure, including research institutions, academic centers, and medical facilities. This infrastructure supports biomanufacturing activities and facilitates collaboration between academia, research organizations, and industry players. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) have established rigorous but well-defined guidelines for the approval and oversight of biopharmaceutical products. This regulatory expertise provides confidence to both investors and consumers in the safety and quality of bio manufactured products. North America has a strong venture capital ecosystem and financial markets that support the funding of biopharmaceutical startups and established companies. This access to capital fuels innovation and research efforts.

The Asia-Pacific region, including China and India, has been experiencing growth in the biomanufacturing sector due to factors like lower manufacturing costs, a large talent pool, and increasing demand for biopharmaceuticals in the region. Some countries have actively focused on developing biomanufacturing clusters and infrastructure to attract investments and boost their biopharmaceutical capabilities.

Recent Developments

• In April 2020, Cambryn Biologics in Sarasota, Florida, was acquired by Akron Biotech. The facility is a state-of-the-art biomanufacturing plant equipped with cutting-edge technology.
• In February 2020, Honeywell International Inc. partnered with Bigfinite, Inc. to contribute to the advancement of process automation and controls technologies. They utilized Bigfinite's AI, data analytics, and machine learning platform to support the pharmaceutical and biotech sectors in accelerating medicinal therapies.
• In December 2022, Merck, a renowned science and technology corporation, acquired Erbi Biosystems, the Massachusetts-based creator of the Breez 2 ml micro-bioreactor platform technology. This acquisition expanded Merck's upstream therapeutic protein offering by providing scalable cell-based perfusion bioreactor processes ranging from 2 ml to 2000 ml, along with rapid lab-scale process development capabilities. Additionally, it opened up possibilities for future advancements in innovative modalities such as cell treatments.

Key Market Players

·         Illumina Inc.

·         Thermo Fischer Scientific Inc.

·         Oxford Nanopore Technologies plc

·         Agilent Technologies, Inc.

·         BGI

·         PerkinElmer Inc.

·         QIAGEN

·         Eurofins Scientific

·         F. Hoffmann-La Roche Ltd

·         Takara Bio Inc.

Report Scope:

In this report, the Global Bio-Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Bio-Manufacturing Market, By Workflow:

o   Continuous Upstream Biomanufacturing

o   Single-Use Upstream Biomanufacturing

o   Downstream Biomanufacturing

• Bio-Manufacturing Market, By Application:

o   Monoclonal Antibodies

o   Hormones

o   Vaccines

o   Recombinant Proteins

o   Others

• Bio-Manufacturing Market, By End User:

o   Biopharmaceutical Companies

o   Research Institutions

o   CMOs/CDMOs

• Bio-Manufacturing Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

§  Kuwait

§  Turkey

§  Egypt

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Bio-Manufacturing Market.

Available Customizations:

Global Bio-Manufacturing market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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