Bioprocess Validation Market

Market Overview

The global bioprocess validation market size was valued at USD 302 million in 2021, envisioned to reach USD 475 million growing at a CAGR of 5.82% during the forecast period.

Bioprocess validation comprises various actions that occur during the complete production cycle of a bioproduct. Examining active pharmaceutical ingredients and other potential contaminants is essential for bioprocess validation. This evaluation must take place during the process of developing and manufacturing animal pharmaceuticals or other biological products. Precise data are gathered, reviewed, and documented at all desired levels for each project step. In this manner, bioprocess validation establishes scientific proof that a process can consistently produce high-quality products. In operations and production, virtually all bioprocessing-related industrial activities remain unaffected. Numerous bioprocessing techniques are being utilized in the creation of coronavirus vaccines.

The expansion of the worldwide bioprocess validation market is propelled by stringent safety and quality standards, an increase in the need for biopharmaceuticals, and a rise in the demand for outsourcing bioprocess validation. In addition, rising life science R&D expenditures are anticipated to drive market expansion. However, concerns related to extractables are expected to limit this expansion. On the contrary, patent expiration of bio-products and tapping into emerging markets are anticipated to present several expansion chances.

Market Dynamics

Market Driving Factors

Strict Safety & Quality Standards and the Growing Need for Outsourcing Bioprocess Validation

Bioproduct manufacturing procedures are meant to provide products with uniform quality characteristics. They involve eliminating impurities and contaminants from chromatographic media, such as endotoxins, viruses, cell membranes, nucleic acids, proteins, culture media components, process chemicals, ligands, product alterations aggregates, and inactive forms. Manufacturing processes should be verified by applying a scientifically rigorous and well-documented exercise demonstrating that the method and each piece of equipment utilized are effective. The Food and Drug Administration (FDA) document Guideline on General Principles of Process Validation defines process validation as constructing documented evidence to provide a high degree of assurance that a particular process will consistently produce a product meeting its predetermined specifications and quality attributes. Moreover, a biopharmaceutical product's CQAs (critical quality attributes) are the physical, chemical, biological, and microbiological testing features and characteristics that must be managed within an acceptable range to assure the intended product quality. Hence, boosting the market for bioprocess validation. 

In the pharmaceutical sector, bioprocess validation is an integrated process, as compliance with FDA and EMA national and worldwide standards is necessary. Validation verifies that all procedures adhere to the stated CGMP requirements. Any validation method necessitates exhaustive documentation that conforms to standard operating procedures and ongoing activities. Also, pharmaceutical manufacturing is now outsourced to third-party service providers to increase production yields. The widespread use of disposable technologies in medication development helps to reduce production costs. Single-use bioreactors have increased the adaptability of processes and drastically decreased the possibility of cross-contamination. This results in reliable products and reduces the time required to get them to market. In addition, pharmaceutical corporations are outsourcing research efforts to academia and corporate contract research organizations (CROs) to remain competitive and flexible in rapidly expanding information, advancing technology, and an unstable economy. Thus, propelling the bioprocess validation market share. 

Market Restraining Factors

The Problems Associated with Extractables &Leachable 

The pharmaceutical and food sectors are familiar with the difficulties in dealing with the trace quantity of contaminants generated by the extraction or leaching process. Despite the FDA and EMEA's stringent rules, corporations still disregard these issues and risk the lives of patients/consumers. Pharmaceutical manufacturers and regulatory agencies are increasingly concerned with extractable and leachable. Any pharmaceutical packaging and container system, including glass, plastic bottles, foil pouches, packing materials, and labeling ink, has the potential to leach undesirable pollutants into a drug product or food ingredient. In addition, oral and oral drug products and parenteral and ophthalmic products often pose more significant dangers.

Key Market Opportunities

The Emerging Markets to Boost Market Opportunities

With a rise in disposable income and the implementation of new testing services legislation, several undiscovered markets for bioprocess validation services may emerge in developing nations. As a result of their lower manufacturing costs and higher output, countries like India and China are becoming new industrial hubs. Asia's rapid industrialization and economic growth are predicted to significantly impact the worldwide bioprocess validation market and provide growth opportunities.

Segmental Analysis

The global bioprocess validation market is classified based on test type, process component, end-user, and region. 

By Test Type Analysis

Based on test type, the fragments include

• Extractable testing services.
• Microbiological testing services.
• Physiochemical testing services.
• Integrity testing services.
• Compatibility testing services.
• Other testing services.

The extractable testing services division is projected to advance at a CAGR of 4.8% and hold the largest market share. During the drug development process, it is crucial to identify and quantify potentially hazardous leachable for various chemicals that migrate from container closure systems, medical devices, medical device packaging, and process equipment & packaging to contaminate pharmaceutical goods. To detect any dangers of product adulteration, regulatory bodies demand extractable testing. Extractable studies are intended to be optimized and tailored to the pharmaceutical container or closure under investigation, including materials and their compatibility with extraction solvents, type of container, type of contact between the container and the medicinal product, storage conditions, specific administration or reconstitution procedures, medicinal kind of product, route of administration, dosing regimen, and associated threshold requirements.

The integrity testing services division will hold the second-largest share. Sterilization filter integrity testing is a must for essential process filtration applications in the pharmaceutical industry. Following FDA regulations, filters used in the processing of sterile solutions such as large volume parenteral (LVPs) and small volume parenteral (SVPs) must undergo integrity testing (SVPs). In addition, new technologies introduced to the market for bioprocess validation can deliver exact results, including the highest level of data integrity required by regulatory bodies.

By Process Component Analysis

The fragments include filter elements, bioreactors, and other process components based on the process component.

Filter Elements Process Component Segment to Hold Prime Share Due To the High Demand for the Evaluation of Specific Filter Elements

The filter elements division is projected to advance at a CAGR of 6.5% and hold the largest market share. In the bioprocessing industry, filtration is a crucial step for conventional unit operations or other unit operations for the separation, isolation, and purification of biotherapeutics, such as recombinant proteins, vaccines, gene therapy, and cell therapy products. In bioprocessing, filters are utilized not just as downstream unit activities but also to support practically every other step. Due to the safety and efficacy of biopharmaceutical products, stringent regulations and industry standards for biopharmaceutical products, the increasing use of a variety of filters in bioprocessing, and the high demand for the evaluation of specific filter elements and their impact on the final drug product are the major factors driving the market for filter elements in bioprocess validation.

The bioreactors division will hold the second-largest share. The bioreactor is an integral part of the bioprocessing workflow and should be considered a strategic benefit. This fundamental technology must be carefully selected, specified, designed, and supported in the present and the future. When generating biologics, single-use bioreactors can offer fewer capital expenditures, lower operational costs, and a smaller environmental footprint. In addition, it provides the flexibility to make a more significant number of smaller batches in a shorter amount of time than conventional stainless steel.

By End-User Analysis

Based on end-user, the fragments are pharmaceutical & biotechnology companies and contract development & manufacturing organizations. 

The pharmaceutical & biotechnology companies division is projected to advance at a CAGR of 6% and hold the largest market share. Businesses in the pharmaceutical & biotechnology sectors have the problem of increasing their manufacturing capabilities rapidly and cost-effectively while preserving product and patient safety. As FDA and EMA (European Medicines Agency) national and international criteria must be met, bioprocess validation is an integral part of the pharmaceutical and biotechnology sectors (European Medicines Agency). Every phase of the production process in pharmaceutical and biotechnology companies comprises subsequent procedures and adjustments that are rigorously tested to assure the absolute protection of the pharmaceutical products on which people rely daily. Bioprocess validation assists in bridging the gap between ever-evolving quality requirements and dynamic market dynamics.

The contract development & manufacturing organizations division will hold the second-largest share. Contract development and manufacturing organizations or CDMOs offer drug development and manufacturing services to the pharmaceutical and biotechnology industries. From formulation screening & development, analytical development, stability studies, and pre-clinical safety assessment studies to sterile & non-sterile production as well as clinical trial material, including packaging and logistics, a CDMO offers comprehensive solutions to expedite the development and manufacturing of a wide range of product types, delivery systems, and dosage forms.

Regional Analysis

The region-wise segmentation of the global bioprocess validation market includes North America, Europe, Asia-Pacific, and LAMEA.

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 growing continuously due to an increase in demand for outsourcing bioprocess validation, a rise in life science research specific to biologics, and a rise in pharmaceutical and biotechnology company investments. In addition, the North American market for bioprocess validation is well-established and is increasing in testing by pharmaceutical and biotechnology companies across the country. The U.S. government has increased funding for validation services. The strong presence of key companies in North America, including Danaher Corporation, Thermo Fisher Scientific, Inc., Toxikon Corporation, Eurofins, Meissner Filtration Products, Inc., and others, further support the growth of the market in this region. Moreover, there seems to be a rise in the presence of key players in the area, boosting the bioprocess validation market share expansion in North America. 

Europe will grow at a CAGR of 5.8% and hold USD 130 million. The Europe market is expanding rapidly as a result of an increase in the number of new testing services, the development of healthcare infrastructure in countries such as the United Kingdom, France, and Germany, and growth in bioprocess validation. Increases in regulatory approvals, product launches, and services, as well as the availability of government financing in critical areas, are anticipated to propel the worldwide bioprocess validation market forward. In 2020, for instance, Almac Group introduced its biologics testing solutions, which provide a complete variety of customizable pharmaceutical testing services to support clients' drug development programs following industry requirements, such as FDA, EMA, and PMDA under GMP standards. Consequently, it is anticipated that new product launches and services in the bioprocess validation market will help expand the global market in this region. A strong presence of bioprocess validation businesses, such as Almac Group, Sartorius, Porvair Plc, and Merck KGaA, will continue to impact the bioprocess validation market growth.

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.

Bioprocess Validation Market Segmentation

By Test Type

• Extractables Testing Services
• Microbiological Testing Services
• Physiochemical Testing Services
• Integrity Testing Services
• Compatibility Testing Services
• Other Testing Services

By Process Component

• Filter Elements
• Bioreactors
• Other Process Component

By End-User

• Pharmaceutical & Biotechnology Companies
• Contract Development & Manufacturing Organizations

By Region

• North America 
• Europe
• Asia Pacific
• LAMEA