Bioprocess Validation Market to expand at a CAGR of 5.82% by 2030

Introduction

Bioprocess validation comprises several activities that occur throughout the bioproduct manufacturing cycle. An essential component of bioprocess validation is the evaluation of active medicinal components and other possible contaminants. This evaluation is required throughout the development and production of animal medicines and other biological products. For each project phase, precise data are collected, examined, and documented at all desired levels. In this way, bioprocess validation establishes the scientific evidence that a process can produce consistently high-quality products. Regarding operations and output, most bioprocessing-related industrial activities continue primarily unaffected. Numerous bioprocessing processes are employed in the development of coronavirus vaccinations.

The growth of the global bioprocess validation market is driven by stringent safety and quality regulations, a rise in the need for biopharmaceuticals, and an increase in the demand for outsourcing bioprocess validation. In addition, increased R&D expenditures in biosciences are predicted to stimulate market growth. However, issues around extractables are expected to restrict this growth. On the other hand, the expiration of bio-product patents and the penetration of emerging markets are predicted to present several expansion opportunities.

Market Dynamics

Strict Safety & Quality Standards and the Growing Need for Outsourcing Bioprocess Validation to Drive the Global Bioprocess Validation Market

The production techniques for bioproducts are intended to yield products with uniform quality attributes. It is eliminating impurities and contaminants from chromatographic media, including endotoxins, viruses, cell membranes, nucleic acids, proteins, culture medium components, process chemicals, ligands, and product changes, aggregates, and inactive forms. Verifying manufacturing processes should involve the application of a scientifically rigorous and well-documented procedure that demonstrates the effectiveness of each method and piece of equipment used in the process. The Food and Drug Administration (FDA) document Guideline on General Principles of Process Validation defines process validation as the construction of documented evidence that provides a high level of assurance that a particular process will consistently produce a product that meets its predetermined specifications and quality attributes. In addition, the CQAs (critical quality attributes) of a biopharmaceutical product are the physical, chemical, biological, and microbiological testing features and characteristics that must be managed within an acceptable range to ensure the quality of the intended product. Consequently, increasing the demand for bioprocess validation.

Bioprocess validation is an integrated process in the pharmaceutical industry, as FDA and EMA national and international requirements must be met. Validation ensures that all procedures comply with CGMP regulations. Any validation method requires thorough documentation that adheres to standard operating procedures and current operations. Pharmaceutical production is currently outsourced to third-party service providers to boost manufacturing yields. The widespread use of disposable technology in manufacturing medications helps to cut production expenses. Single-use bioreactors have boosted the adaptability of processes and diminished the risk of cross-contamination significantly. This produces trustworthy products and decreases the time needed to bring them to market. In addition, pharmaceutical businesses outsource their research to universities and corporate contract research organizations (CROs) to remain competitive and flexible in a rapidly expanding information, advancing technology, and an unpredictable economy. Consequently, market growth for bioprocess validation.

The Emerging Markets to Create Global Bioprocess Validation Market Opportunities

In developing countries, untapped markets for bioprocess validation services may emerge due to an increase in disposable income and the implementation of new testing services regulations. India and China are becoming new industrial hubs due to their lower manufacturing costs and increased output. Rapid industrialization and economic expansion in Asia are anticipated to substantially impact the global bioprocess validation market and create potential prospects.

Regional Insights

North America will command the market with the largest share while growing at a CAGR of 4.9%. The bioprocess validation market in North America is developing consistently due to increased demand for outsourcing bioprocess validation, growth in life science research related to biologics, and increased investments by pharmaceutical and biotechnology companies. In addition, the North American market for bioprocess validation is well-established, and the U.S. government has expanded financing for validation services in response to increased testing by pharmaceutical and biotechnology companies across the country. The strong presence of prominent businesses in North America, such as Danaher Corporation, Thermo Fisher Scientific, Inc., Toxikon Corporation, Eurofins, Meissner Filtration Products, Inc., and others, boosts the market expansion in this area. Moreover, there seems to be a rise in the presence of essential players in the region, driving the development of the North American bioprocess validation market.

Europe will grow at a CAGR of 5.8% and hold USD 130 million. The Europe market is increasing significantly due to a boost in the number of new testing services, the growth of healthcare infrastructure in nations such as the United Kingdom, France, and Germany, and an increase in bioprocess validation. Increases in regulatory approvals, product launches, and services, together with the availability of government funding in critical areas, are expected to boost the global bioprocess validation market. In 2020, for instance, Almac Group debuted its biologics testing solutions, which offer a comprehensive range of configurable pharmaceutical testing services to support clients' drug development operations in line with FDA, EMA, and PMDA regulations. Consequently, it is projected that introducing new products and services in the bioprocess validation market will contribute to its growth in this area. A strong presence of bioprocess validation companies, such as Almac Group, Sartorius, Porvair Plc, and Merck KGaA, will continue to impact the market expansion of bioprocess validation.

Key Highlights

• The global bioprocess validation market had a revenue share of USD 302 million in 2021, envisioned to reach USD 475 million growing at a CAGR of 5.82% during the forecast period. 
• Based on test type, the extractable testing services division is projected to advance at a CAGR of 4.8% and hold the largest market share.
• Based on the process component, the filter elements division is projected to advance at a CAGR of 6.5% and hold the largest market share.
• Based on end-user, the pharmaceutical & biotechnology companies division is projected to advance at a CAGR of 6% and hold the largest market share.
• Based on regional analysis, North America will command the market with the largest share while growing at a CAGR of 4.9%.

Competitive Players

1. Almac Group
2. Biozeen
3. Cobetter Filtration Equipment Co., Ltd
4. Danaher Corporation (Pall Corporation)
5. Merck KGaA
6. Meissner Filtration Products, Inc
7. Porvair Plc
8. Sartorius
9. Thermo Fisher Scientific, Inc
10. Toxikon Corporation

Recent Developments

• In 2022 Thermo Fisher Scientific, Inc and Moderna, Inc. revealed a 15-year strategic collaboration deal to permit dedicated large-scale manufacturing of Spikevax®, Moderna's COVID-19 vaccine, and additional investigational mRNA therapies in its pipeline in the United States.
• In 2022, Thermo Fisher Scientific acquired PeproTech.

Segmentation

1. By Test Type
   1. Extractables Testing Services
   2. Microbiological Testing Services
   3. Physiochemical Testing Services
   4. Integrity Testing Services
   5. Compatibility Testing Services
   6. Other Testing Services
2. By Process Component
   1. Filter Elements
   2. Bioreactors
   3. Other Process Component
3. By End-User
   1. Pharmaceutical & Biotechnology Companies
   2. Contract Development & Manufacturing Organizations