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The bioprocess validation market size is forecast to increase by USD 364 million, at a CAGR of 12.88% between 2023 and 2028. The growth of the market depends on several factors, including increasing demand for biopharmaceuticals, increasing need for quality control in pharmaceutical and biotechnology industries, and rising demand for personalized medicine. Factors such as high costs associated with bioprocess validation, the need for highly trained personnel for conducting bioprocess validation, and the lack of standardized protocols and guidelines for bioprocess validation will hamper the growth of the market. Nevertheless, the increasing adoption of single-use technologies, the rising number of drug approvals, and increasing investments in biopharmaceutical manufacturing facilities will propel the growth of the market.
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The market is driven by heightened scrutiny on Impurities, particularly in Vaccines and Drug products amidst global health concerns like the SARS-CoV-2 virus. The demand for Precision medicines and Biosimilars propels Leading biopharmaceutical companies towards innovative Bioproduction activities and scaling Bioproduction volumes. However, challenges lie in addressing Chronic diseases and navigating socioeconomic factors affecting access. Trends favor Outsourcing services for efficiency while highlighting critical roles for Integrity Testing Services, Physiochemical Testing Services, and Extractables/Leachables Testing Services in ensuring safety and quality standards. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
One of the key factors driving the market growth is the increasing demand for biopharmaceuticals. There is a growing demand for biopharmaceuticals across the healthcare sector, and therefore bioprocess has become essential. This validation helps ensure that consistent and high-quality products are produced, which ultimately offers efficacy and safety for patients. component during drug development.
For instance, one of the key examples of where bioprocess validation has a significant impact is in the biomanufacturing of monoclonal antibodies. Hence, a well-designed bioprocess validation plan is the most important element to ensure that the final product meets the necessary regulatory standards and specifications. Similarly, bioprocess plays a significant role in the manufacture of biosimilars. Hence such factors are e expected to drive the market during the forecast period.
A key factor shaping the market growth is the increasing adoption of single-use technologies. There is a growing adoption of single-use technologies (SUTs) in bioprocess due to several reasons. The main advantage of SUTs is the ease of implementation for bioprocess validation as the use of SUTs eliminates the need for cleaning and sterilization procedures, which can be time-consuming and costly.
Hence, STUs are very advantageous to smaller biotech companies that may not have the resources to invest in extensive cleaning and sterilization equipment. Additionally, one of the main features of STU is that provides greater flexibility in terms of process scale-up and scale-down, as they can be easily disposed of after use. Hence such benefits and applications of single-use technologies in bioprocess are expected to drive the growth of the market during the forecast period.
High costs associated with bioprocess validation are one of the key challenges hindering market growth. Even though bioprocess validation is a crucial aspect of ensuring the safety and efficacy of biopharmaceutical products, the costs associated with bioprocess validation are high and mainly comprise three main categories: equipment, personnel, and time.
For instance, bioprocess validation needs specialized equipment, such as bioreactors, chromatography systems, and mass spectrometers, among others. These pieces of equipment can be expensive or affordable to acquire, maintain, and calibrate. Hence, the high cost, as well as the initial investment associated with the bioprocess validation equipment, can significantly hinder the growth of the market during the forecast period.
The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Market Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Agilent Technologies Inc: The company offers bioprocess validation services called ClinGuide GMP CRISPR sgRNAs for Human Therapeutics system.
The research report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:
Qualitative and quantitative market research and growth analysis of companies have been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. In market growth analysis, data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market share growth by the pharmaceutical companies segment will be significant during the forecast period. Some of the main classifications of the pharmaceutical companies segment in the market large players and small and medium-sized enterprises (SMEs).
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The pharmaceutical segment was valued at USD 119.40 million in 2018. Some prominent pharmaceutical companies such as Pfizer, Johnson, and Johnson (J and J), and Novartis AG (Novartis) have a significant impact on the global market because of their extensive resources, expertise, and experience in the field. One of the main contributions of large pharmaceutical companies to the market is the development of innovative and complex biologics. These large enterprises have a robust pipeline of biologic products, most of which require advanced and sophisticated processes that require thorough validation to ensure product quality, yield, and consistency. Hence, such factors are expected to drive the growth of this segment which in turn will drive the growth of the market during the forecast period.
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North America is estimated to contribute 40% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period. Some of the key factors that are significantly contributing to the growth of the market in North America are the rising demand for biopharmaceuticals and the increasing focus on ensuring product safety. Several prominent players such as Pfizer Inc (Pfizer), Merck Group (Merck), Biogen Inc (Biogen), and Amgen Inc (Amgen) are developing biopharmaceuticals and investing in bioprocess validation activities to ensure the quality and safety of their products. Also, regulatory bodies such as the FDA in the US, have strict guidelines mandating the validation of bioprocesses to improve the safety of such processes. Hence, such factors are expected to drive the growth of the market in the region during the forecast period.
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD million" for the period 2024 to 2028, as well as historical data from 2018 to 2022 for the following segments.
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The market is a critical component of the Biopharmaceutical manufacturing process, ensuring the safety and efficacy of Vaccines and Drug products. With the emergence of the SARS-CoV-2 virus, there's a heightened emphasis on Impurities management and Drug safety protocols. The market encompasses various segments like Residuals testing, Extractables and leachables, and Continued process verification, each crucial for maintaining Precision medicines standards. Innovations in Analytical testing methods and Continuous process monitoring are driving trends, aiding Bioproduction activities and Bioprocessing facilities. Challenges include managing Extractable testing services and Microbiological testing services efficiently, ensuring the integrity of Bioprocess instruments and Validation protocols, and adopting advanced Automation technologies and Robotics for robust Bioproduction volumes and Life science research advancements.
Moreover, the market is pivotal in ensuring the safety and efficacy of products in the Biotechnology industry, particularly in areas like Biosimilars and Biologics. Key segments such as Residuals testing, Extractables and leachables, and Continued process verification play critical roles in upholding regulatory standards. Physiochemical testing services and Integrity testing services are integral components, ensuring the quality and reliability of Recombinant proteins and therapies for Chronic diseases like Cell therapy and Gene therapy. This necessitates robust Validation procedures and a skilled workforce of Trained professionals adept in utilizing Digital tools for Real-time release testing and employing Advanced analytics and Modelling techniques.
Further, the market is influenced by Biopharmaceutical RD expenditure and the strategies of Leading biopharmaceutical companies in the Biopharmaceutical manufacturing sector, including partnerships with Contract manufacturing organizations (CMOs) for Outsourcing services. The trend towards Single-use systems and In silico modeling is driven by advancements in High-resolution mass spectrometry and addressing challenges like Degradation products and socioeconomic factors. Extractables/Leachables Testing Services, Integrity Testing Services, Physiochemical Testing Services, and Compatibility Testing Services are crucial for ensuring the integrity of Filter elements, Media containers and bags, Freezing and thawing process bags, and Mixing systems in the bioprocess validation landscape.
Market Scope |
|
Report Coverage |
Details |
Page number |
168 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 12.88% |
Market Growth 2024-2028 |
USD 364 million |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
11.55 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 40% |
Key countries |
US, Germany, China, Canada, and Japan |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
Agilent Technologies Inc., Asahi Kasei Corp., Avantor Inc., Bangalore Biotech labs Pvt. Ltd., Charles River Laboratories International Inc., Corning Inc., Danaher Corp., Eurofins Scientific SE, GEA Group AG, Hangzhou Cobetter Filtration Equipment Co. Ltd., Laboratory Corp. of America Holdings, Lonza Group Ltd., Meissner Filtration Products Inc., Merck KGaA, Porvair Plc, ProPharma Group Holdings LLC, Sartorius AG, SGS SA, Thermo Fisher Scientific Inc., and W. L. Gore and Associates Inc. |
Market dynamics |
Parent market analysis, Market forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period. |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
We can help! Our analysts can customize this market research report to meet your requirements.
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by End-user
7 Market Segmentation by Type
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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