|
Forecast Period
|
2024-2028
|
|
Market Size (2022)
|
USD 24.82 billion
|
|
CAGR (2023-2028)
|
8.15%
|
|
Fastest Growing Segment
|
Recombinant Proteins
|
|
Largest Market
|
North America
|
Market Overview
Global Biopharmaceutical
Fermentation Market has
valued at USD 24.82 billion in 2022 and is anticipated to project impressive
growth in the forecast period with a CAGR of 8.15% through 2028. COVID-19 has
impacted the growth of the biopharmaceutical fermentation market. The pandemic
resulted in an unprecedented demand for enzymes essential for innovative
point-of-care diagnostic kits and mRNA vaccines. For instance, according to the
report published by Mass Bio, in December 2022, it has been observed that the
COVID-19 epidemic has increased and reinforced the demand for complex
fermentation products in the pharmaceutical and biotechnology industries.
Globally, companies and populations benefited from crucial supplies of enzymes
produced by fermentation. Moreover, the production of new biologic drugs during
the pandemic period for the treatment of COVID-19 infection increased which has
impacted the market growth. For instance, in December 2021, Samsung Biologics
and AstraZeneca expanded a strategic biopharmaceutical production partnership
to include therapies for Covid-19. However, the emergence of a new variety of
viruses accelerates vaccine production which involves the fermentation step.
For instance, in July 2022, CEPI funded USD 30 million to bring a new
nanoparticle vaccine offering protection against a range of coronaviruses to
clinical trials. Thus, with such initiatives, the studied market is expected to
grow and regain its full potential in the coming years.
Factors such as the increasing demand for
biotech-based drugs and rising research and development activities to produce
novel biological drugs are boosting market growth. For instance, according to
the 2021 annual report of AbbVie, Humira is one of the top-selling
biotechnology drugs in the world which accounted for net revenues of USD 20.7
billion and approximately 37% of AbbVie's total net revenues in 2021. Globally,
Humira sales increased by 4% in 2021 compared with the previous year.
Similarly, as per the 2021 annual report of Merck & Co, the sales of
Keytruda, one of the major biotech-based drugs of the company, grew by 20% to
USD 17.2 Billion, compared to USD 14.9 Billion in the year 2020. Thus, the
increasing sales of biotech-based drugs in the market indicates the increasing
demand for these drugs in the market which in turn is anticipated to fuel the
market growth over the forecast period.
Furthermore, the rising company focus on developing
novel biological drugs is also expected to fuel the demand for fermentation
services and products which is anticipated to propel the market growth. For
instance, in November 2022, Eikonoklastes Therapeutics, a preclinical biotech
company, and Forge Biologics, a gene therapy-focused contract development and
manufacturing organization entered a manufacturing partnership that will
advance Eikonoklastes' AAV-based gene therapy, ET-101, into clinical trials for
the treatment of patients with amyotrophic lateral sclerosis (ALS). Also, in
August 2022, Sanofi and Innovent Biologics entered a strategic collaboration to
accelerate the development of two biologic oncology medicines (tusamitamab
ravtansine, SAR444245) and expand their presence in China.
Therefore, owing to the factors, such as the rising
company activities and increasing demand for biotech-based drugs, the studied
market is anticipated to grow over the forecast period. However, the high cost
of biopharmaceutical fermentation and installation is likely to impede the
growth of the biopharmaceutical fermentation market over the forecast period.
Key Market Drivers
Growing pipeline of biopharmaceuticals
The dominant driver for the
Biopharmaceutical Fermentation market is the growing pipeline of
biopharmaceuticals. This trend is driven by several key factors that highlight
its centrality to the market: Biopharmaceuticals offer innovative solutions for
a wide range of diseases, including cancer, autoimmune disorders, and rare
diseases. The expanding therapeutic landscape necessitates the development of
new biopharmaceuticals, fueling the pipeline. Biologics, a subset of
biopharmaceuticals, are gaining prominence due to their specificity and
effectiveness. As research uncovers new targets and mechanisms of action,
biologics with diverse applications are being developed. The emergence of
biosimilars, which are highly similar to approved biopharmaceuticals, but often
more cost-effective, contributes to the growing pipeline. These products aim to
provide affordable alternatives to existing biopharmaceuticals.
Biopharmaceutical companies
are heavily investing in R&D to bring novel therapies to market. This
includes monoclonal antibodies, vaccines, gene therapies, and cell-based
therapies. Emerging markets are increasingly adopting biopharmaceuticals,
creating new opportunities for drug development. This global expansion of the
biopharmaceutical market drives research and innovation. Stringent regulatory
approvals necessitate thorough research and testing, encouraging a continuous
stream of biopharmaceutical candidates in the pipeline. The shift towards
precision medicine, where therapies are tailored to individual patients based
on their genetics and biology, requires a diverse array of biopharmaceuticals
for various genetic profiles. In summary, the growing pipeline of
biopharmaceuticals is dominant in the Biopharmaceutical Fermentation market
because it reflects the industry's dynamism and its commitment to addressing
unmet medical needs. As biopharmaceutical companies seek to develop more
effective and personalized treatments, fermentation processes remain essential
for producing these complex and life-changing therapies.
Expanding biosimilars market
The dominance of the expanding biosimilars market
in the Biopharmaceutical Fermentation market is a testament to its pivotal role
in shaping the biopharmaceutical landscape. Several key factors underline its
dominance: Biosimilars are highly similar versions of approved
biopharmaceuticals. They offer cost-effective alternatives to expensive
reference biologics, increasing patient access to essential therapies. This
economic advantage is driving the demand for biosimilars. Many blockbuster
biopharmaceuticals have reached or are approaching patent expiration, opening
doors for biosimilar manufacturers. As patents expire, biosimilar competition
intensifies, encouraging the development and production of these products. Biosimilars
are instrumental in containing rising healthcare costs. Governments and
healthcare systems globally are incentivized to promote biosimilar adoption to
reduce expenditures on biopharmaceuticals. The biosimilars market is expanding
rapidly, encompassing a diverse range of therapeutic areas, including oncology,
autoimmune diseases, and diabetes. This growth fuels the need for efficient
biopharmaceutical fermentation processes to meet rising demand. Regulatory
agencies worldwide have established clear pathways for biosimilar approval.
This regulatory clarity has boosted confidence in biosimilars and encouraged
investment in their development.
Biosimilars have the potential to provide essential
medicines to a global patient population. This accessibility aspect is crucial
for improving healthcare outcomes and addressing unmet medical needs. Intense
competition in the biosimilars market is driving innovation in
biopharmaceutical fermentation technologies. Manufacturers are continually
optimizing processes to enhance product quality and cost-effectiveness. In
summary, the expanding biosimilars market is dominant in the Biopharmaceutical
Fermentation market because it epitomizes the convergence of economic
viability, regulatory support, and the imperative to provide affordable and
accessible biopharmaceuticals. As biosimilars continue to gain traction and
enter new therapeutic areas, fermentation processes play a central role in
their production, solidifying their significance in the biopharmaceutical
industry.
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Key Market Challenges
Regulatory complexities
Regulatory complexities represent a key challenge
for the Biopharmaceutical Fermentation market due to the intricate and
stringent requirements imposed by regulatory authorities worldwide. Several
factors contribute to these complexities: Biopharmaceutical products must meet
exceptionally high safety and efficacy standards. Regulatory agencies, such as
the U.S. FDA and the European Medicines Agency (EMA), scrutinize every aspect
of the manufacturing process, including fermentation, to ensure patient safety.
Any deviation or inconsistency can lead to regulatory hurdles. Fermentation
processes can exhibit inherent variability, which is a natural challenge when
dealing with living organisms. Controlling and minimizing this variability to
meet regulatory standards can be complex and resource-intensive. Regulatory
authorities demand comprehensive validation of biopharmaceutical manufacturing
processes, including fermentation. This entails extensive documentation, data
collection, and adherence to strict protocols throughout the product's
lifecycle. Regulatory frameworks are not static; they evolve over time. Keeping
up with changing regulations, especially in different regions, poses a
challenge for manufacturers aiming to ensure compliance with the latest
standards.
Different countries have their own regulatory
requirements, adding complexity for companies operating on a global scale.
Harmonizing these requirements while meeting local standards is a formidable
task. Ensuring consistent product quality is paramount. Manufacturers must
implement rigorous quality control measures to comply with regulatory
standards, which often necessitates substantial investments in infrastructure
and technology. The regulatory approval process can be lengthy, leading to
delays in bringing biopharmaceutical products to market. Navigating these
timelines and securing approvals can be financially taxing. In summary,
regulatory complexities in the Biopharmaceutical Fermentation market stem from
the need to maintain the highest safety and efficacy standards while dealing
with the inherent variability of living organisms. These complexities require
significant expertise, resources, and a proactive approach to ensure compliance
with evolving global regulations and to meet the demands of a highly regulated
industry.
Ensuring consistent product quality
Ensuring consistent product quality is a paramount
challenge in the Biopharmaceutical Fermentation market due to the unique
characteristics of biopharmaceuticals and the rigorous demands of the industry.
Several factors contribute to the significance of this challenge: Fermentation
processes for biopharmaceuticals involve living organisms, such as bacteria,
yeast, or mammalian cells, which can exhibit inherent variability. Maintaining
consistent conditions, such as temperature, pH, and nutrient supply, is critical
to ensure reproducibility and product quality. Biopharmaceuticals are large,
complex molecules, often protein-based. Even minor deviations in the
fermentation process can lead to changes in the final product's structure,
functionality, and efficacy. Ensuring consistent quality requires meticulous
control at all stages. Regulatory agencies, such as the FDA and EMA, have
stringent quality requirements for biopharmaceuticals. These standards
necessitate rigorous documentation, validation, and adherence to Good
Manufacturing Practices (GMP) to demonstrate product consistency. Consistency
is directly linked to patient safety. Any variation in product quality could
lead to adverse effects or compromised therapeutic outcomes. As
biopharmaceuticals are often used to treat serious diseases, maintaining
quality is of utmost importance.
Achieving batch-to-batch consistency can be
challenging, as fermentation processes can be sensitive to small changes in
environmental conditions or microbial behavior. Manufacturers must implement
robust control strategies to minimize variability.
Continuous monitoring of fermentation processes and
advanced analytical techniques are essential to detect and address variations
promptly. Investing in state-of-the-art monitoring equipment and analytics is
necessary but resource-intensive. Scaling up fermentation processes from
laboratory to commercial production can introduce new complexities. Ensuring
that product quality remains consistent at larger scales requires careful
planning and process optimization. In summary, ensuring consistent product
quality in the Biopharmaceutical Fermentation market is a multifaceted
challenge that demands meticulous attention to detail, adherence to regulatory
standards, investment in advanced technology, and a deep understanding of the
intricacies of bioprocesses. Overcoming this challenge is critical to providing
safe and effective biopharmaceutical products to patients worldwide.
Key Market Trends
Continuous fermentation
Continuous fermentation has
emerged as a prominent trend in the Biopharmaceutical Fermentation market,
revolutionizing the way biopharmaceuticals are produced. Unlike traditional
batch processing, continuous fermentation involves the uninterrupted and
ongoing production of biopharmaceuticals. This trend is gaining momentum for
several compelling reasons: Continuous fermentation offers higher levels of
efficiency by maximizing equipment utilization and reducing downtime between
batches, resulting in increased productivity. Real-time monitoring and control
in continuous processes enhance product consistency and reduce batch-to-batch
variability, ensuring a high level of product quality. Continuous fermentation
can lead to significant cost savings, including reduced labor and materials
costs, making it an economically attractive option for manufacturers. This
approach is flexible and can be adapted to various scales, from small
laboratory setups to large-scale commercial production, allowing for seamless
scalability. Continuous processes often generate less waste and require smaller
volumes, aligning with sustainability goals and reducing the environmental
footprint of biopharmaceutical production.
Advances in automation,
sensors, and process control technologies have made continuous fermentation
more feasible and accessible to biopharmaceutical manufacturers. With the
increasing demand for biologics in the healthcare sector, continuous
fermentation holds the potential to meet these market needs more efficiently
and effectively. In conclusion, continuous fermentation represents a
transformative trend driven by the pursuit of improved efficiency, product
quality, and cost-effectiveness in biopharmaceutical manufacturing. As
bioprocessing technologies continue to evolve, continuous fermentation is
poised to play a pivotal role in optimizing the production of critical
biopharmaceuticals and meeting the growing global demand for these life-saving
therapies.
Single-use bioreactors
Single-use bioreactors have
emerged as a prominent and transformative trend in the Biopharmaceutical
Fermentation market. These bioreactors replace traditional stainless-steel
systems with disposable, pre-sterilized plastic bags and components for cell cultivation
and bioprocessing. Here's why single-use bioreactors are gaining traction: They
offer greater flexibility in terms of process scalability and adaptability.
Manufacturers can easily switch between different production scales without the
need for extensive cleaning and validation. Single-use systems minimize the
risk of contamination, as they are sterile and disposable, reducing the need
for time-consuming cleaning and sterilization procedures. The elimination of
cleaning, maintenance, and validation procedures results in cost savings. It
also reduces the risk of cross-contamination between batches.
Single-use bioreactors
streamline the production process, accelerating time to market for
biopharmaceutical products. They are considered more environmentally friendly
due to reduced water and energy consumption compared to traditional
bioreactors. Single-use systems offer high-quality and consistent production,
contributing to better product quality and patient safety.
As the demand for biologics
and personalized medicine grows, single-use bioreactors facilitate rapid and
flexible bioprocess development to meet these evolving needs. In conclusion,
single-use bioreactors are a transformative trend driven by their versatility,
cost-efficiency, and suitability for a wide range of biopharmaceutical
applications. They enable manufacturers to respond quickly to market demands
while ensuring product quality and safety, making them a critical component in
the biopharmaceutical industry's future.
Segmental Insights
Product Type Insights
Based on the Product Type, Downstream products play
a dominant role in the Biopharmaceutical Fermentation market due to their
critical importance in the bioprocessing chain. Downstream processing
encompasses purification, separation, and recovery of biopharmaceutical
products after fermentation. Here's why downstream products are of paramount
significance:
Downstream processes are essential for achieving
the required purity and quality of biopharmaceuticals. They remove impurities,
aggregates, and contaminants to ensure the final product meets stringent
regulatory standards. Ensuring the safety of biopharmaceutical products is a
top priority. Downstream processing removes any potential harmful components,
ensuring patient safety. Downstream products and technologies are crucial for
optimizing product yield, reducing product loss, and maximizing the efficiency
of bioproduction.
Regulatory agencies require thorough downstream
processing to demonstrate product safety, efficacy, and consistency, making it
a critical component for market compliance and approvals. Downstream processes
help control product variability, ensuring each batch of biopharmaceuticals is
consistent in terms of efficacy and safety. Downstream products are designed to
be scalable, enabling biopharmaceutical manufacturers to transition from
small-scale laboratory production to large-scale commercial manufacturing seamlessly.
Efficient downstream processing minimizes production costs by optimizing
resource utilization, reducing the need for reprocessing, and enhancing process
efficiency. In summary, downstream products are dominant in the
Biopharmaceutical Fermentation market as they are integral to ensuring the
quality, safety, and market compliance of biopharmaceutical products. They
contribute significantly to the success of bioprocessing, making it possible to
deliver safe and effective therapies to patients worldwide.
End User Insights
Biopharmaceutical industries wield significant
dominance within the Biopharmaceutical Fermentation market. These industries
encompass a wide array of companies engaged in the development and production
of biologically derived therapeutics and vaccines. Their prominence is rooted
in several key factors: Biopharmaceutical industries are hubs of innovation,
continually pioneering new biologic treatments and therapies for various
diseases and medical conditions.
The surging global demand for biopharmaceuticals to
address diverse health challenges propels industry growth, making it a dominant
market force. These industries allocate substantial resources to research and
development, driving advancements in bioprocessing techniques, including
fermentation.
Maintaining diverse portfolios of biologic products
necessitates robust fermentation capabilities to produce a broad range of
biopharmaceuticals. Biopharmaceutical industries operate on a global scale,
ensuring the widespread availability of biologic medications and treatments. Adhering
to stringent regulatory standards, they lead in ensuring product safety,
efficacy, and quality.These industries consistently explore emerging markets,
further cementing their dominance in the global biopharmaceutical fermentation
landscape. In essence, biopharmaceutical industries' dominance is a testament
to their pivotal role in advancing healthcare through cutting-edge
bioprocessing technologies and the production of life-saving
biopharmaceuticals. They drive industry growth, establish standards, and are
instrumental in delivering innovative therapies to patients worldwide.
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Regional Insights
North America is expected to witness significant
growth in the biopharmaceutical market over the forecast period owing to the
factors such as the increasing demand for biotech-based drugs, rising research
and development activities, and growing expenditure for the development and
advancements in biopharmaceutical fermentation. In addition, the rise in the
frequency of chronic diseases rises the consumption of medicines which in turn
helps to grow the biopharmaceutical industry and offers growth opportunities for
the market players by increasing demand for biologics and biotech drugs which
will ultimately propel the utility of biopharmaceutical fermentation.
The rising demand for biopharmaceutical
fermentation in the biopharmaceutical sector to reduce the toxicity of drugs
and bacterial resistance and increase its efficacy attracts various companies
to research and development using biopharmaceutical fermentation. For instance,
in August 2022, the National Institute for Innovation in Manufacturing
Biopharmaceuticals (NIIMBL) of the United States granted funding of USD 15.8
million for 14 new technology and workforce development projects that address
key opportunities for innovation in the biopharmaceutical sector.
Additionally, the growing prevalence of diseases,
such as diabetes, rheumatoid arthritis, and cancer in the region is
contributing to the market's growth owing to the use of biopharmaceutical
fermentation in manufacturing biotech drugs and biological drugs. For instance,
about 32 million and 14 million living in the United States and Mexico were
suffering from diabetes in 2021 and this number is projected to reach 36.2
million and 21.8 million by 2045, respectively. Also, as per the 2022
statistics published by ACS, about 1.9 million people living in America were
diagnosed with cancer in the United States in 2022. Thus, the high burden of
cancer and diabetes among the population raises the demand for effective
biological drugs which in turn is anticipated to fuel the market growth over
the forecast period.
Furthermore, the rising company focuses on adopting
various business strategies such as product launches, approvals, fundraising,
and partnerships to expand their offerings in the biopharmaceutical industry
are expected to drive the growth of this market. For instance, in February
2022, Kerry Group plc acquired Enmex S.A., an enzyme manufacturer based in
Mexico for EUR 62 million. The acquisition accelerates Kerry's innovation
capabilities in enzyme engineering, fermentation, and bioprocess development.
Also, in September 2021, Thermo Fisher Scientific announced its plan to expand
its Nashville, Tenn. site by establishing a dedicated single-use technology
manufacturing facility at the site, doubling capacity. The expansion is likely
to use bioreactors on a large scale for the manufacturing of biological drugs.
Therefore, owing to the factors such as the high
burden of diabetes, and cancer, growing demand for biopharmaceutical
fermentation, and rising company activities, the studied market is anticipated
to grow over the forecast period.
Recent Developments
- In December 2022, MilliporeSigma acquired
Massachusetts-based Erbi Biosystems, a developer of the 2 ml micro-bioreactor
platform technology, known as the Breez. The acquisition assists the company to
strengthen company’s upstream portfolio in therapeutic proteins by enabling
scalable cell-based perfusion bioreactor processes from 2ml to 2000L with rapid
lab-scale process development.
- In October 2022, Froilabo (Japan) introduced a new
line of completely automated lab-scale bioreactors. The bioreactors, which
complement their line of temperature-controlled laboratory equipment, provide a
wide range of application possibilities for academics, research, process
development and optimization, scale-up, and manufacturing.
Key Market Players
- Agilent
Technologies Inc
- Thermo
Fisher Scientific Inc.
- Lonza
Group AG
- Sartorius
Stedim Biotech GmbH
- Eppendorf
Inc
- Danaher
Corporation
- F.
Hoffmann-La Roche Ltd.
- Nova
Biomedical Corporation
- Merck
KGaA
- Becton, Dickinson
and Company
|
By Product
Type
|
By
Application
|
By End User
|
By Region
|
- Upstream
Products
- Downstream
Products
|
- Antibiotics
Recombinant Proteins
- Others
|
- Biopharmaceutical
Industries
- Contract
Research Organization
- Academic
Research Institutes
- Others
|
- North
America
- Europe
- Asia
Pacific
- South
America
- Middle
East & Africa
|
Report Scope:
In this report, the Global Biopharmaceutical
Fermentation Market has been segmented into the following categories, in
addition to the industry trends which have also been detailed below:
- Biopharmaceutical
Fermentation Market, By
Product Type:
o Upstream Products
o Downstream Products
- Biopharmaceutical
Fermentation Market, By
Application:
o Antibiotics
o Recombinant Proteins
o Others
- Biopharmaceutical
Fermentation Market, By
End User:
o Biopharmaceutical
Industries
o Contract Research
Organization
o Academic Research
Institutes
o Others
- Biopharmaceutical
Fermentation 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
Competitive Landscape
Company Profiles: Detailed analysis of the major companies
present in the Biopharmaceutical Fermentation Market.
Available Customizations:
Global Biopharmaceutical Fermentation 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).
Global Biopharmaceutical Fermentation Market is an
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