Bioprocess Validation Market Trends – Growth & Forecast 2023-2033

Bioprocess Validation Outlook (2023 to 2033)

As per the current market research conducted by FMI, the global Bioprocess Validation Market is expected to record a CAGR of 9.20% from 2023 to 2033. In 2023, the market size is projected to reach a valuation of USD 449.03 million. By 2033, the valuation is anticipated to reach USD 996.29 million.

The bioprocess validation market is expected to experience significant growth in the coming years, driven by several key factors.

A Few of the Primary Drivers of Market Expansion are Listed Below:

Increasing Demand for Biologics:

The biopharmaceutical industry is growing rapidly, with increasing demand for biological drugs. This has led to a corresponding increase in the demand for bioprocess validation services, as companies seek to ensure the safety and quality of their products.

Stringent Regulatory Requirements:

Regulatory agencies such as the FDA and EMA have established strict guidelines for the manufacture and validation of biological drugs. Compliance with these guidelines is essential for obtaining approval to market biologics. This has led to an increased demand for bioprocess validation development to ensure compliance with these regulations.

Advancements in Technology:

The development of new technologies such as single-use systems and continuous manufacturing has led to new challenges for bioprocess validation. Companies are increasingly seeking validation services that can keep pace with these technological advancements.

Increasing Demand for Biologics:

The biopharmaceutical industry is growing rapidly, with increasing demand for biological drugs. This has led to a corresponding increase in the demand for bioprocess technology, as companies seek to ensure the safety and quality of their products.

Increasing Outsourcing of Biopharmaceutical Manufacturing:

Many bioprocessing in pharma companies is outsourcing their manufacturing to contract manufacturing organizations (CMOs). This has led to an increased demand for bioprocess validation services from CMOs, as they seek to ensure the quality and safety of the products they manufacture.

Growing Focus on Risk Management:

As the biopharmaceutical industry continues to grow, there is a growing focus on risk management. Bioprocess validation plays a critical role in risk management by ensuring that processes are validated and compliant with regulatory requirements.

Attributes	Value
Bioprocess Validation Value (2022)	USD 411.2 million
Bioprocess Validation Market Expected Value (2023)	USD 449.03 million
Bioprocess Validation Market Forecast Value (2033)	USD 996.29 million
Bioprocess Validation Market Expected CAGR (2023 to 2033)	9.20%

Here are Some Growth Trends in this Market

Increasing Adoption of Single-use Technologies: Single-use technologies have gained popularity in the biopharmaceutical industry due to their flexibility, cost-effectiveness, and reduced risk of cross-contamination. This trend has led to an increased demand for bioprocess validation services that can address the unique challenges associated with single-use technologies.

Growing Demand for Biosimilars: Biosimilars are becoming increasingly popular as a cost-effective alternative to biologics. This trend has led to an increased demand for bioprocess validation services to ensure the safety and quality of biosimilars.

Shift Towards Continuous Manufacturing: Continuous manufacturing is gaining popularity in the biopharmaceutical industry due to its potential to increase efficiency, reduce costs, and improve product quality. This trend has led to an increased demand for bioprocess validation services that can address the unique challenges associated with continuous manufacturing.

Increasing Adoption of QbD Principles: Quality by Design (QbD) principles are becoming increasingly popular in the biopharmaceutical industry. QbD involves designing quality into a product from the outset, rather than relying on testing and inspection to ensure quality. This trend has led to an increased demand for bioprocess validation services that can support QbD initiatives.

Growing Importance of Data Integrity: Data integrity has become a critical issue in the biopharmaceutical industry, with regulatory agencies placing increasing emphasis on ensuring the accuracy and completeness of data. This trend has led to an increased demand for bioprocess validation services that can address data integrity issues.

The bioprocess validation market is experiencing several growth trends, driven by a variety of factors. These trends are expected to continue in the coming years, as the biopharmaceutical industry continues to evolve and innovate.

While the Bioprocess Validation Market is Expected to Grow Significantly in the Coming Years, Several Factors May Restraint the Market Development

• One of the primary restraining factors is the high cost of bioprocess validation, which can be a significant barrier to entry for small and medium-sized biotechnology and pharmaceutical companies.
• The lack of skilled personnel in bioprocess validation is also a significant challenge for the industry. The training and development of qualified personnel require significant investment, which can drive up the cost of bioprocess validation.
• One of the most significant restraining factors is the complex and stringent regulatory environment governing bioprocess validation. Compliance with various regulations and guidelines, such as those set forth by the FDA and EMA, can be challenging, time-consuming, and expensive. The implementation of the necessary measures to ensure compliance with these regulations is likely to drive up the cost of bioprocess validation.
• Need for specialized equipment and facilities, such as clean rooms and analytical equipment, can also be a limiting factor for some companies. These facilities and equipment require significant investment, which can drive up the cost of bioprocess validation.

Category-wise Insights

Testing Type Segment Insights

Bioprocess Residuals Testing Segment: In 2023, the bioprocess residuals testing segment is likely to hold a significant market share, accounting for 28.77% of the market. This segment involves testing for impurities such as upstream and downstream contaminants, buffer contents, and anti-foam agents in biologics manufacturing processes.

The demand for high-quality, safe, and impurity-free drugs, vaccines, and therapeutic products has led to significant demand for bioprocess residual testing services from the biotechnology, biopharmaceutical, and pharmaceutical industries.

Extractables & Leachables Testing Segment: The extractable and leachable segment is expected to be rapidly growing in the bioprocess validation market. This is attributed to the presence of current good manufacturing practice guidelines and the United States FDA regulations, which have created a demand for certified high-quality bioproducts.

Biopharmaceutical and biotechnology companies are increasingly producing cGMP-certified bioproducts, which is driving growth in this segment. Besides, in the drug discovery process, it is crucial to identify the hazards posed by leachable that may arise from closed processing systems and packaging, which can potentially damage bioproducts. This has also boosted the demand for extractable and leachable testing services, driving growth in the global industry.

The continued process verification segment is expected to dominate the bioprocess validation market in 2023, accounting for a share of 43.3%. This segment involves the collection, storage, processing, and analysis of data from every batch to ensure consistent product quality.

The adoption of automation in this process has contributed to the growth of this segment. For instance, in May 2021, Aventior implemented the CPV-Auto solution, which digitizes the CPV process and complies with 21 CFR Part 11.

This technology replaces the conventional batch record process and image processing with automated digitization, driving the growth of the segment. This trend is expected to continue, also fueling the growth of the segment during the forecast period.

Stage Segment Insights

Continued Process Verification Segment: During the projected period, the process design segment is expected to dominate the bioprocess validation market. Process design is a critical step in bioprocess validation, as it involves creating stringent protocols and defining the manufacturing pathways necessary for efficient production.

The implementation of strict protocols and well-designed processes is crucial to ensuring the delivery of high-quality products, which is a driving factor in the growth of this segment.

Mode Segment Insights

In-house Segment: In 2023, it is expected that the in-house sector is likely to dominate the market share. This is because several industries and biopharmaceutical companies are involved in the production of raw materials and tools that are necessary for the bioprocess validation process in the manufacturing of products. The segment is positively influenced by the rising levels of funding, as well as mergers and collaborations among market players who are focused on bioprocess development.

Outsourced Segment: The outsourced sector is expected to record a CAGR of 10% over the forecast period. The demand for testing services is particularly high among biopharmaceutical and biotechnology companies involved in the production of bio-products and conducting bioprocess validation. This market growth is driven by the outsourcing of services related to the manufacturing of biopharmaceutical drugs and therapeutics. Also, the increase in healthcare spending and the supply of raw materials required by key market players contribute to the growth of the industry.

Besides, the market is being propelled by a surge in Contract Development and Manufacturing Organizations (CDMOs) that offer drug development and manufacturing services to the pharmaceutical and biopharmaceutical industries. This is expected to result in a significant share and domination of the market by this segment in the upcoming forecast period.

Region-wise Insights

The bioprocess validation market is a rapidly growing industry that involves the validation of biopharmaceutical manufacturing processes. The market is segmented into several regions based on geography, and the demand for bioprocess validation services varies across different regions.

North America: North America is expected to dominate the bioprocess validation market and is expected to continue to do so in the forecast period. It is likely to dominate the regional market with a share of 39.73% in 2032. The presence of significant biopharmaceutical companies, increasing research and development activities, and well-established healthcare infrastructure are the key factors driving the growth of the market in this region. Along with the aforementioned factors, the North American bioprocess validation market is also driven by the presence of key players such as Thermo Fisher Scientific Inc., Danaher Corporation, Eurofins, and others.

These companies contribute significantly to the growth of the market through their extensive Research and development activities and innovative product offerings.

For instance, in June 2022, the Jefferson Institute of Bioprocessing announced the launch of its bio technician training and bioprocess validation program in the United States, at the Budd Bioworks research space in Philadelphia. This development is expected to drive the growth of the bioprocess validation market in North America by providing skilled professionals and training programs for the biopharmaceutical industry

Europe: Europe is likely to be the second-significant market for bioprocess validation, and it is expected to experience significant growth during the forecast period. The region is home to many prominent biopharmaceutical companies and is investing heavily in research and development activities. The presence of strict regulations in the region also contributes to the demand for bioprocess validation services.

Asia Pacific: Asia Pacific is expected to be the rapidly growing market for bioprocess validation in the forecast period. The increasing demand for biopharmaceutical products, growing research and development activities, and the presence of a huge population base are the key factors driving the growth of the market in this region. Also, the lower cost of labor and raw materials in the region makes it an attractive destination for outsourcing bioprocess validation services.

Latin America: Latin America is expected to experience moderate growth during the forecast period. The growing demand for biopharmaceutical products and increasing investment in healthcare infrastructure are the key factors driving the growth of the market in this region.

The Middle East and Africa: Middle East and Africa are expected to experience slow growth during the forecast period. The limited presence of biopharmaceutical companies and inadequate healthcare infrastructure are the key factors restraining the growth of the market in this region.

In conclusion, the bioprocess validation market is expected to experience significant growth in the coming years, with North America and Europe leading the market, followed by Asia Pacific, Latin America, and the Middle East and Africa. The growth of the market is driven by several factors, including the increasing demand for biopharmaceutical products, growing R&D activities, and well-established healthcare infrastructure.

Competitive Background

The demand for bioprocess validation services is consistently rising encouraging several newcomers to venture into the market. Consequently, competition is increasing in the market. Established companies are focusing on strategic collaborations to gain a competitive edge.

Prominent Key Players

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Eurofins Scientific, Inc.
• Merck KGaA
• Lonza
• Danaher Corporation
• SGS S.A.
• Charles River Laboratories
• Toxikon Corporation
• Cobetter Filtration Equipment Co., Ltd.

Scope of Report

Attribute	Details
Market Size Value in 2022	USD 411.2 million
Market Forecast Value in 2033	USD 996.29 million
Global Growth Rate	9.20% CAGR
Forecast Period	2023 to 2033
Historical Data Available for	2018 to 2022
Market Analysis	MT for Volume and USD million for Value
Key Regions Covered	North America; Latin America; Europe; East Asia; South Asia; Oceania; and the Middle East and Africa(MEA)
Key Countries Covered	United States, Canada, Brazil, Mexico, Argentina, Chile, Peru, Germany, France, Italy, Spain, United Kingdom, Netherlands, Belgium, Nordic, Russia, China, Japan, South Korea, India, Thailand, Malaysia, Indonesia, Singapore, Australia, New Zealand, GCC Countries, South Africa, Central Africa, North Africa, and others
Key Market Segments Covered	Testing Type, Mode, Stage, and Region
Key Companies Profiled	Thermo Fisher Scientific Inc.; Sartorius AG; Eurofins Scientific, Inc.; Merck KGaA; Lonza; Danaher Corporation; SGS S.A.; Charles River Laboratories; Toxikon Corporation; Cobetter Filtration Equipment Co., Ltd.
Pricing	Available upon Request

Table of Content

• 1. Executive Summary | Bioprocess Validation Market
• 2. Market Overview
• 3. Market Background
• 4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033
• 5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Testing Type
  • 5.1. Extractable & Leachable Testing
  • 5.2. Bioprocess Residuals Testing
  • 5.3. Viral Clearance Testing
  • 5.4. Filtration & Fermentation Systems Testing
  • 5.5. Others
• 6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Stage
  • 6.1. Process Design
  • 6.2. Process Qualification
  • 6.3. Continued Process Verification
• 7. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Mode
  • 7.1. In House
  • 7.2. Outsourced
• 8. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region
  • 8.1. North America
  • 8.2. Latin America
  • 8.3. Europe
  • 8.4. South Asia
  • 8.5. East Asia
  • 8.6. Oceania
  • 8.7. MEA
• 9. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
• 10. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
• 11. Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
• 12. South Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
• 13. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
• 14. Oceania Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
• 15. MEA Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
• 16. Key Countries Market Analysis
• 17. Market Structure Analysis
• 18. Competition Analysis
  • 18.1. Eurofins Scientific, Inc.
  • 18.2. Sartorius AG
  • 18.3. Merck KGaA
  • 18.4. Thermo Fisher Scientific Inc.
  • 18.5. Lonza
  • 18.6. Danaher Corporation
  • 18.7. Charles River Laboratories
  • 18.8. SGS S.A.
  • 18.9. Toxikon Corporation
  • 18.10. Cobetter Filtration Equipment Co., Ltd.
• 19. Assumptions & Acronyms Used
• 20. Research Methodology