Bioprocess Validation Market to Grow with a CAGR of 13.71% through 2029
Increasing global
demand for biopharmaceuticals and high demand for outsourcing bioprocess
validation services is expected to drive the Global Bioprocess Validation
Market growth in the forecast period.
According to
TechSci Research report, “Bioprocess Validation Market – Global Industry
Size, Share, Trends, Competition Forecast & Opportunities, 2029”,
the Global Bioprocess Validation Market stood at USD 298.05 million in 2023 and
is anticipated to grow with a CAGR of 13.71% in the forecast period, 2025-2029.
The market is experiencing growth due to the significant demand for bioprocess
validation services. This is driven by stringent safety and quality regulations
governing product certifications and testing, not only within the
biopharmaceutical and pharmaceutical industries, but also by the increasing
demand for outsourcing bioprocess validation. Additionally, the rise in R&D
expenditure contributes to this trend.
Pharmaceuticals and healthcare represent a substantial segment within the public-private sector, with each participant commanding a significant market share. Given the critical nature of these industries, federal government institutions play a crucial role in their regulation, control, and oversight. The potential risks to public health underscore the government's responsibility to guarantee the development, manufacturing, and distribution of top-tier products. A poignant illustration of this imperative is the tragic incident involving children in African nations, who suffered from acute kidney failure due to the consumption of cough syrups produced in India. The absence of bioprocess validation, ensuring consistent viability, feasibility, reliability, and quality of pharmaceutical products, not only impacts consumers, manufacturers, and corporate reputations but also tarnishes the global reputation of the nation. Hence, there's a renewed focus on establishing a robust and all-encompassing regulatory framework to ensure the availability of superior-quality pharmaceuticals. The escalating prevalence of acute and chronic healthcare conditions has fueled advancements in pharmaceuticals and biotechnology, necessitating government oversight to ensure accountability. The government's increased scrutiny of pharmaceuticals, biotechnology, and other bioprocessing applications to deliver high-caliber products will propel market growth.
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"Global Bioprocess Validation Market”
The
bioprocessing sector is currently facing operational and personnel-related
challenges, which are often a result of increased activity. However, all
bioprocessing-related industrial activities are continuing without major
disruptions in terms of operations and output. Many bioprocessing processes are
being utilized for the development of vaccines against coronaviruses. Various companies,
including developers and service suppliers, are intensifying their
pandemic-related research and manufacturing efforts. The use of single-use
bioreactors, disposable components, and process automation is expected to
enhance quality control and validation of bioprocessed vaccines and therapies.
Suppliers are anticipating an upswing in business as companies and governments
rapidly develop and test pandemic-related vaccines. Additionally, service
providers are experiencing a surge in inquiries and orders primarily related to
pandemic vaccines or therapeutics. Many equipment and service suppliers have
already scaled up their activities in response to this increased demand. The
coronavirus pandemic has impacted the global economy through direct effects on
production, disruptions in supply chains and markets, and financial
implications for firms and financial markets.
Moreover, the
production, import, and export of finished goods have been affected due to the
shutdowns in COVID-19-affected countries. Delayed shipments and production
schedules may also pose financial challenges for heavily indebted companies.
The growth of the global bioprocess validation market is driven by stringent
safety and quality regulations, increasing demand for biopharmaceuticals, and
the rising trend of outsourcing bioprocess validation. Furthermore, the market
is propelled by the growing need for specific types of tests in R&D
activities and the increasing reliance on outsourcing laboratory testing
services. Market players are expanding their market share by offering a wide
range of services and solutions to cater to the outsourcing laboratory testing
trend. Major players are also adopting strategies such as mergers,
acquisitions, and other developments to strengthen their position in the
market.
There is an
increasing adoption of single-use technologies (SUTs) in bioprocesses for
various reasons. The primary advantage of SUTs is the ease of implementation
for bioprocess validation, as they eliminate the need for time-consuming and
costly cleaning and sterilization procedures. As a result, SUTs offer
significant advantages to smaller biotech companies that may lack the resources
to invest in extensive cleaning and sterilization equipment. Furthermore, one
of the key features of SUTs is their flexibility in terms of process scale-up
and scale-down, as they can be easily disposed of after use. Therefore, these
benefits and the applications of single-use technologies in bioprocesses are
expected to drive the growth of the bioprocess validation market during the
forecast period.
Global Bioprocess
Validation Market is segmented into testing type, stage, mode, regional
distribution, and company.
Based on its testing
type, the segment of extractables and leachables is experiencing rapid growth,
primarily driven by the presence of current good manufacturing practice
guidelines and US FDA regulations. This has led to an increased demand for certified
quality bioproducts. Biopharmaceutical and biotechnology companies are actively
involved in the production of cGMP-certified bioproducts, thereby bolstering
the market. Furthermore, in the drug discovery process, it is imperative to
identify the hazards posed by leachables originating from closed processing
systems and packaging, as these can negatively impact the integrity of
bioproducts. These dynamic fuels growth in the global industry. The testing of
extractables and leachables plays a crucial role in identifying potentially
harmful chemicals that may be transferred to patients through drugs or
medicines. Although these chemicals are not inherent to the drugs themselves,
they can be introduced from the packaging or storage of these medicines. Through
rigorous laboratory testing, extractables and leachables are identified to
prevent undesirable consequences. This testing process takes into account a
comprehensive validation approach to ensure appropriate materials are used for
drug storage and packaging. It is a highly effective procedure that is vital to
safeguarding the quality of drugs. Any compromise in the drug's quality due to
harmful chemical transfer from its packaging not only poses risks to patient
well-being but also impacts the reputation of the brand associated with the
high-quality drugs. Consequently, market players have made substantial
investments in extractables and leachables testing services.
Based on region,
North America segment is expected to grow during the forecast period. North
America emerged as the market leader, driven by significant outsourcing
services. This has fueled the growth of biologics manufacturing and life
sciences research, thereby bolstering the global market. North America holds a
substantial share in the bioprocess validation market, attributable to the
increasing number of R&D activities, investments, and the growing demand
for biopharmaceuticals and outsourcing bioprocess validation. Moreover, North
America's biopharmaceutical and biotechnology industries have obtained FDA
approval. Additionally, increased government funding for clinical studies and
the bioprocess validation process have contributed to the sector's growth. The
presence of major companies such as Thermo Fisher Scientific, Danaher Corporation,
and Europhins further fortifies the market in North America. Meanwhile, the
Asia Pacific region is projected to exhibit the highest growth rate during the
study period. This can be attributed to advancements, rising healthcare costs,
and government-backed funding for R&D. The region's initiatives to expand
and develop the biopharmaceutical industry are supported by the growing
awareness of the benefits of vaccines and biopharmaceutical medications for
treating chronic diseases. Furthermore, countries like China and India are
evolving into new industrial hubs due to lower manufacturing costs and
increased production output. The rapid industrialization and economic growth in
the Asia-Pacific region are expected to have a significant impact on the global
bioprocess validation market.
Major companies
operating in Global Bioprocess Validation Market are:
- Merck
KGaA
- SGS
S.A.
- Eurofins
Scientific SE
- Sartorius
AG
- Pall
Corporation
- Cobetter
Filtration Equipments Co., Ltd
- Laboratory Corporation of America Holdings
- DOC
S.r.l
- Meissner Corporation
- Thermo
Fisher Scientific, Inc.
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“The growing
demand for outsourcing bioprocess validation services in hospitals and clinics
to maintain compliance with good manufacturing practices (GMP) is a key driver
for market growth. This is further supported by the implementation of stringent
quality and product safety regulations by governments. Additionally, the increasing
prevalence of various chronic diseases and the rising demand for
biopharmaceuticals are contributing to the widespread adoption of bioprocess
validation in the healthcare sector, thus promoting market growth. Moreover,
the extensive use of bioprocess validation by pharmaceutical and CMO companies
to ensure the accuracy, purity, efficiency, and safety of drugs during the
manufacturing of novel vaccines and biosimilars, especially during the COVID-19
pandemic, is another factor fueling growth. In addition, significant
technological advancements in bio-manufacturing infrastructure and the ongoing
bioprocess validation of bioreactors to ensure cost-effective and scalable drug
production are driving market growth. Furthermore, the emerging trend of outsourcing
laboratory testing services, the increasing need for personalized medicines,
and continuous research and development (R&D) activities to ensure optimal
drug quality are creating a favorable outlook for the market.,” said Mr. Karan
Chechi, Research Director with TechSci Research, a research-based management
consulting firm.
“Bioprocess Validation Market Segmented
By Testing Type (Extractables & Leachables Testing, Bioprocess Residuals
Testing, Viral Clearance Testing, Filtration & Fermentation Systems
Testing, Others), By Stage (Process Design, Process Qualification, Continued
Process Verification), By Mode (In house, Outsourced), By Region and
Competition, 2019-2029F”, has evaluated the future growth potential of Global
Bioprocess Validation Market and provides statistics & information on
market size, structure and future market growth. The report intends to provide
cutting-edge market intelligence and help decision makers take sound investment
decisions. Besides, the report also identifies and analyzes the emerging trends
along with essential drivers, challenges, and opportunities in Global Bioprocess
Validation Market.
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