Newark, Feb. 27, 2023 (GLOBE NEWSWIRE) -- The brainy Insights estimates that the USD 350 million in 2022 bioprocess validation market will reach USD 828.57 million by 2032. The recent news events questioning the quality of Indian-manufactured cough syrups, which caused deaths induced by acute kidney failure in children who consumed these products, highlight the need to have robust quality checks and controls in the pharmaceutical sectors. There are other examples of product recalls, as these medicines caused deaths that were not identified during their trials and approval process. Such lax bioprocess validation leads to preventable deaths. It damages the brand's reputation and dwindles its resources. It is also a source of embarrassment for the company and government of its native country. Therefore, there is a renewed push toward having a well-defined, sophisticated, pragmatic, and reliable quality control of drugs, which will drive the global bioprocess market's growth.
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Key Insight of the Bioprocess Validation Market
The North American region is expected to dominate the market during the forecast period.
Some of the most important pharmaceutical and biotechnology companies are in North America. Numerous acute and chronic health issues are becoming more prevalent in the area's large population, creating lucrative market opportunities that pharmaceutical companies can take advantage of by launching new medications. A strong healthcare industry and broad pharmacists retail networks like Walgreens and CVS are also present in the area, which supports the expansion of the local market. The region's market development is aided by the strict regulatory structure, such as the US FDA (Food and Drug Administration), that governs the implementation of quality controls, checks, and approvals.
In 2022, the extractable and leachable segment dominated the market with the largest market share of 37% and market revenue of 129.50 million.
The testing type segment is divided into extractables and leachables testing, integrity testing, bioprocess residuals testing, filtration and fermentation, viral clearance testing, systems testing, compatibility testing, microbiological testing, physiochemical testing, bacterial retention testing, adsorption testing, and others. In 2022, the extractable and leachable segment dominated the market with the largest market share of 37% and market revenue of 129.50 million.
In 2022, the filter elements accounted for the largest share of the market, with 38% and a market revenue of 133 million.
The process component segment is divided into filter elements, freezing and thawing process bags, bioreactors, connectors, samplers, media containers and bags, mixing systems, transfer systems, and others. In 2022, the filter elements accounted for the largest share of the market, with 38% and a market revenue of 133 million.
In 2022, the pharmaceutical companies segment dominated the market with 43% and a revenue of 150.50 million.
The end-user segment is divided into pharmaceutical companies, contract development and manufacturing organizations, biotechnology companies, research laboratories and institutions, and others. In 2022, the pharmaceutical companies segment dominated the market with 43% and a revenue of 150.50 million.
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Advancement in market
September 2022 - At the company's 2022 Investor & Analyst event last year, it was announced that the two bioprocess divisions of Danaher will be combined to form "The Biotechnology Group." After first purchasing and "carving out" the two businesses - Pall in 2015 for USD 13.8 billion and Cytiva for USD 21 billion in 2020 - and then allowing the brands to "stand up and be successful," Danaher CEO Rainer Blair announced the combined company to stakeholders.
Market Dynamics
Driver: The stringent government regulations
Both public and private businesses hold sizable market shares in the pharmaceutical and healthcare industries. However, because of the critical nature of pharmaceuticals and healthcare, federal government organizations must regulate, oversee, and monitor these industries. Since these industries can directly hurt the general populace, the government must ensure the manufacture and distribution of high-quality goods. The customer, producer, company brand, and nation's international standing suffer when bioprocess validation is not used to ensure consistent viability, feasibility, reliability, and quality of pharmaceutical goods. Therefore, there is a renewed focus on building a strong and thorough regulatory framework to guarantee high-quality pharmaceutical products. Given the rise in acute and chronic medical issues, there is a greater need for medications, therapies, and treatments. To assure accountability, the government will regulate research and development in pharmaceuticals and biotechnology. The government's increased monitoring of biotechnology, medicines and other bioprocessing applications will spur the market's expansion.
Restraint: The shortcomings of bioprocess validation in quality controls
There are flaws in both the testing procedures and the stages of the validation processes. The individuals carrying out the validation procedure may be causing some unknown error or inherent faults. False positives or false negatives from the samples may affect the outcomes. These minor mistakes can constrain the market's growth because they occasionally result in large losses for the company.
Opportunities: The rising capital expenditure on novel drug developments
The pandemic's early months led to the alarming deaths of millions, thereby prompting a hastened development of vaccinations and their subsequent emergency authorization. As vaccination rates rose over time, the pandemic's final months saw a decline in fatalities. Covid-19 brought to the forefront the significance of a strong research and development infrastructure for developing diagnostics, vaccines, medications, therapies, and treatments. The improvements made in the pharmaceutical industry due to increased R&D spending, reinvigorated government support, and federal funding are expected to continue growing in the future. Increased regulatory monitoring, internal controls, accountability measures, and quality assurances such as bioprocess validation are also required. Therefore, increased R&D will fuel market expansion and provide industry players with lucrative new business prospects. Collaborations between the public and private sectors are increasing, furthering the market's expansion.
Challenge: Poor implementation of regulatory guidelines
Pharma giants continue to blatantly flout regulatory oversights despite the strict, well-defined guidelines and rules supported by legislative provisions designed to ensure quality checks and controls. One of the biggest challenges in implementing these accountability mechanisms is the absence of political will to enforce these policies. Other significant contributing causes to the failure of these entities are the inadequate money provided to regulatory institutions and understaffed offices. Because of the pervasive corruption in the system, big-budget pharmaceutical companies can circumvent these quality controls and take advantage of regulatory loopholes to save costs. Therefore, the market's potential to flourish will be hampered by regulatory authorities' inability to ensure accountability from market participants.
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Some of the major players operating in the bioprocess validation market are:
• Almac Group
• Cobetter Filtration Equipment Co. Ltd.
• Danaher Corporation
• Eurofins Scientific Inc.
• Merck KGaA
• Pall Corporation
• Sartorius AG
• SGS SA
• Thermo Fisher Scientific
• Toxikon Corporation
Key Segments cover in the Market:
By Testing Type
• Extractables and Leachables Testing
• Integrity Testing
• Bioprocess Residuals Testing
• Filtration and Fermentation
• Viral Clearance Testing
• Systems Testing
• Compatibility Testing
• Microbiological Testing
• Physiochemical Testing
• Bacterial Retention Testing
• Adsorption Testing and Others
By Process Component
• Filter Elements
• Freezing and Thawing Process Bags
• Bioreactors
• Connectors
• Samplers
• Media Containers and Bags
• Mixing Systems
• Transfer Systems
• Others
By End User
• Pharmaceutical Companies
• Contract Development and Manufacturing Organizations
• Biotechnology Companies
• Research Laboratories and Institutions
• Others
By Region
• North America (U.S., Canada, Mexico)
• Europe (Germany, France, the U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America)
• The Middle East and Africa (UAE, South Africa, Rest of MEA)
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About the report:
The market is analyzed based on value (USD Million). All the segments have been analyzed worldwide, regional, and country basis. The study includes the analysis of more than 30 countries for each part. The report analyzes driving factors, opportunities, restraints, and challenges for gaining critical insight into the market. The study includes porter's five forces model, attractiveness analysis, Product analysis, supply, and demand analysis, competitor position grid analysis, distribution, and marketing channels analysis.
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