Enjoy complimentary customisation on priority with our Enterprise License!
The bioprocess validation market size is estimated to grow at a CAGR of 11.39% between 2022 and 2027. The market size is forecast to increase by USD 280.93 million. 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.
This bioprocess validation market report extensively covers market segmentation by end-user (pharmaceutical companies, contract development and manufacturing organizations, and others), type (in-house and outsourced), and geography (North America, Europe, Asia, and the Rest of the World (ROW)). It also includes an in-depth analysis of drivers, trends, and challenges. Furthermore, the report includes historic market data from 2017 to 2021.
To learn more about this report, Request Free Sample
Our researchers analyzed the data with 2022 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 bioprocess validation 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 bioprocess validation market during the forecast period.
A key factor shaping the bioprocess validation 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 is expected to drive the growth of the bioprocess validation market during the forecast period.
High costs associated with bioprocess validation are one of the key challenges hindering the bioprocess validation 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 bioprocess validation 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.
Global Bioprocess Validation Market Customer Landscape
Vendors 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 vendors, including:
Qualitative and quantitative analysis of vendors has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize vendors as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize vendors 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 bioprocess validation market large players and small and medium-sized enterprises (SMEs).
Get a glance at the market contribution of various segments View the PDF Sample
The pharmaceutical segment was valued at USD 107.57 million in 2017 and continued to grow until 2021. Some prominent pharmaceutical companies such as Pfizer, Johnson, and Johnson (J and J), and Novartis AG (Novartis) have a significant impact on the global bioprocess validation market because of their extensive resources, expertise, and experience in the field. One of the main contributions of large pharmaceutical companies to the bioprocess validation market is the development of innovative and complex biologics. These large enterprises have a robust pipeline of such 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 bioprocess validation market during the forecast period.
For more insights on the market share of various regions Download PDF Sample now!
North America is estimated to contribute 39% 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 which are significantly contributing to the growth of the bioprocess validation 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 bioprocess validation market in the region during the forecast period.
In 2020, during the COVID-19 pandemic, the growth of the global bioprocess validation market witnessed significant growth as big pharma and biotech companies in the region are pursuing vaccine production, which has led to an increase in the demand for bioprocess validations in the region in North America. However, in 2021, the initiation of large-scale vaccination drives?lifted the lockdown and travel restrictions, which led to the restoration of operations in healthcare units, which further increased the demand for bioprocess validation. Such factors are expected to drive the market during the forecast period.
The bioprocess validation market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 to 2027.
Technavio categorizes the global bioprocess validation market as a part of the global biotechnology market within the overall healthcare industry. The parent global biotechnology market covers products and companies engaged in research and development (R&D) or production of all types of biotechnology products, such as biologics, biosimilars, bio-betters, and biotech reagents. Our market research report has extensively covered external factors influencing the parent market growth during the forecast period.
Bioprocess Validation Market Scope |
|
Report Coverage |
Details |
Page number |
157 |
Base year |
2022 |
Historic period |
2017-2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 11.39% |
Market growth 2023-2027 |
USD 280.93 million |
Market structure |
Fragmented |
YoY growth 2022-2023(%) |
11.23 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 39% |
Key countries |
US, Canada, Germany, China, and Japan |
Competitive landscape |
Leading Vendors, Market Positioning of Vendors, 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 growth inducers and obstacles, Fast-growing and slow-growing segment analysis, 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 Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
Get lifetime access to our
Technavio Insights
Cookie Policy
The Site uses cookies to record users' preferences in relation to the functionality of accessibility. We, our Affiliates, and our Vendors may store and access cookies on a device, and process personal data including unique identifiers sent by a device, to personalise content, tailor, and report on advertising and to analyse our traffic. By clicking “I’m fine with this”, you are allowing the use of these cookies. Please refer to the help guide of your browser for further information on cookies, including how to disable them. Review our Privacy & Cookie Notice.