Forecast Period
|
2024-2028
|
Market Size (2022)
|
USD 19.08 Billion
|
CAGR (2023-2028)
|
7.72%
|
Fastest Growing Segment
|
Single-Use Upstream Biomanufacturing
|
Largest Market
|
North America
|
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.
