Global Bioprocess Validation Market - 2022-2029

Market Overview

Bioprocess Validation Market size was valued at USD 224,687.30 million in 2021 and is estimated to reach at a compound annual growth rate (CAGR) of 11.20% over the forecast period 2022 to 2029.

Bioprocess Validation is a process that involves collecting documentary evidence to ensure that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. An important part of bioprocess validation requires evaluating active pharmaceutical ingredients (APIs) and possible contaminants, such as mycoplasma, bacteria, endotoxin, and others, during the development and manufacture processes of animal disinfectants or other biological products.

Market Dynamics

Increasing global demand for biopharmaceuticals is expected to boost the demand for the bioprocess validation market

The huge demand for biopharmaceuticals is facilitated by an accelerating focus on research and development-related investments. High demand for outsourcing bioprocess validation services, stringent safety and quality regulations governing product certifications and testing beyond the biopharmaceutical and pharmaceutical industries in the healthcare industry to maintain the agreement with good manufacturing practices are the important factors propelling the growth of the global bioprocess validation industry.

Issues related to extractables and leachables are expected to restrain the global bioprocess validation market

Single-use technology has been adopted widely in bioprocess development and biopharmaceutical manufacturing in recent years. While the benefits of such technologies are well recognized, there are significant concerns regarding extractable and leachable from the components of single-use systems owing to their potential effect on product quality and patient health. A risk assessment is normally required to assess the probability of extractable and leachables migrating into the product stream and their potential risk to the patient. During the forecast period, the issues related to extractables and leachables are expected to restrain the growth of the global market for bioprocess validation.

Expansion into emerging markets is expected to generate new opportunities for the global bioprocess validation market

In the Asian region, China is a high-potential market for bioprocess validation, followed by India. The growth in this market can be attributed to favorable government support, rising private investments, a growing geriatric population, and a rising trend of outsourcing to emerging Asian countries. India, Japan, and Brazil are expected to be the new revenue pockets for market players. Also, the high investment in bio-manufacturing infrastructure is a key factor responsible for the high-growth potential of these markets. The new opportunities offered by the emerging markets are expected to boost the growth of the global market.

Stringent government regulations on bioprocess validation are expected to present challenges for the global market for bioprocess validation

Validation is a regulatory requirement for pharmaceutical and biotechnology companies to confirm that they consistently manufacture safe medicines for the public. Companies must be able to provide proof of validation activities when requested, such as during an audit by regulatory agencies. The complexity of government regulations for bioprocess validation prevents its adoption for a wider range of applications and presents a challenge to the growth of the global bioprocess validation market.

Market Segmentation:

The scope of the report covers segmentation based on test type, process component, end-user and region. The global bioprocess validation market is segmented by test type into extractables/leachables testing services, microbiological testing services, integrity testing services, physiochemical testing services, compatibility testing services and others. The global market is segmented by process component into media containers and bags, freezing and thawing process bags, filter elements, bioreactors and others. The global market is segmented by end-user into pharmaceutical companies, biotechnology companies, contract development and manufacturing organizations and others. The global market is segmented by region into North America, South America, Europe, Asia-Pacific, Middle East and Africa.

Pharmaceutical Companies: Pharmaceutical companies have a large share of the end-user segment, which can majorly be attributed to the increasing production of biopharmaceuticals and the corresponding increase in the number of impurities to be checked for, the stringency of standards and regulations regarding the quality and validity of bioprocesses involved in the production

Biotechnology Companies: The biotechnology sector is experiencing rapid growth due to favorable governmental policies. Government initiatives are oriented towards modernizing the drug regulatory pathway, standardizing clinical studies, improving reimbursement policies, and speeding up the product approval process, thereby offering lucrative growth opportunities to the market.

Contract Development & Manufacturing Organizations: With developments in the pharmaceutical industry, leading contract development and manufacturing organizations (CDMOs) aim to seek and bridge capability gaps. CDMOs offering multiple services increase convenience, save time, and enhance cost efficiency as pharmaceutical companies have to only deal with a single entity. The relationship also creates opportunities for the CDMOs to sell more services to the same customer and lock in products at earlier stages of their life cycles

Others: The segment mainly includes laboratories and research institutes. Process-related cell-derived impurities such as buffer components, antibiotics, surfactants, anti-foaming agents, process enhancing agents, catalysts, or compounds that leach from contact materials can impede research projects. Therefore, process validation studies require a broad set of testing capabilities and expertise.

Regional Classification:

According to the DataM Intelligence market research report, the global bioprocess validation market is divided into;

North America - United States, and Canada

South America - Brazil, Argentina, Peru, Chile, and Rest of the South American countries

Europe - UK, Germany, Italy, France, Spain, Russia, and the rest of the European countries

Asia-Pacific - China, India, Japan, South Korea, Singapore, Australia, Malaysia, and the Rest of the Asia Pacific countries

Middle East and Africa - UAE, KSA, Qatar, South African Countries, and the Rest of the Middle East countries

Competitive Landscape:

The global bioprocess validation market is moderately competitive with several international and regional players. The major players adopt several growth strategies such as licensing activities, collaborations, mergers and acquisitions, government tie-ups, and joint ventures, thereby contributing to the growth of the global bioprocess validation market.

Major Companies:

Some key companies contributing to the growth of the global bioprocess validation market include Cobetter Filtration Equipments Co., Ltd., SGS S.A., DOC S.r.l., Thermo Fisher Scientific, Sartorius Stedim Biotech, Merck KGaA, Meissner Filtration Products, Inc., Eurofins Scientific, Boston Analytical and Danaher Corporation (Pall Corporation), among others.

Recent Developments in the Industry:

In July 2022, Vaccizone, a vaccine manufacturer, announced a partnership with Exothera, a biotechnology research company, to use Exothera's scale-X technology to develop Vaccizone's COVID-19 vaccine with expedited bioprocess validation.

In June 2022, Alder Therapeutics announced a deal to help with the bioprocess validation for NorthX Biologics, a Swedish biotech company. The deal will enable NorthX Biologics to expand into pluripotent stem cell research.

In June 2022, the Jefferson Institute for Bioprocessing (JIB) announced the commencement of its bio technician training and validation program at the Budd Bioworks research space in Philadelphia, U.S.

COVID-19 Impact Analysis

COVID-19 had a significant impact on the market. The pandemic caused significant manufacturing and supply-chain operations disruptions due to various precautionary lockdowns and other governmental restrictions globally. Because validation is required at all stages of drug development to monitor accuracy, efficiency, and safety, demand for bioprocess validation increased during the pandemic. The pandemic has increased the demand for bioprocess validation and is expected to positively impact the bioprocess validation market growth.