Bioprocess Validation Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2024 - 2030)

Bioprocess Validation Market Size

Bioprocess Validation Market Trends & Drivers

Rising Requirement for Outsourcing and Stringent Safety and Quality Standards

Quality needs to be maintained throughout the process of manufacturing bioproducts. In turn, the maintenance of quality standards involves the elimination of contaminants and impurities from chromatographic media, which contains viruses, endotoxins, nucleic acids, cell membranes, proteins, culture media components, ligands, process chemicals, product alterations aggregates, and inactive forms of microbes.

The manufacturing processes are needed to be verified with the use of a scientifically rigorous and well-documented exercise that indicates that the equipment and methods used are effective. The FDA’s General Principles of Process Validation guidelines require the building of documented evidence at all stages of bioprocess validation studies, so as to provide a high degree of assurance that the product created by this process will assure consumers of the intended product quality.

Validation is an integrated process that must follow the FDA and EMA regulations, along with other national and worldwide standards. It is aimed at the verification of all the procedures and ensure they follow all the cGMP requirements. National and international guidelines make exhaustive documentation necessary in order to confirm that the process is conducted according to the standard procedures.

In order to increase production yields, several drug makers are outsourcing to third-party service providers. The production cost can be reduced further with the use of disposable technologies during medication development. The adaptability of processes has increased with the use of single-use bioreactors, which has also significantly decreased the possibility of cross-contamination. This will benefit the market as the process reduces the commercialization duration for the products and ensures they are reliable.

Bioprocess Validation Market Analysis

Extractables/Leachables Testing Dominates Service Segment

Extractables/leachables testing dominates the service segment, this is attributed to the increasing risk of product adulteration and the presence of regulatory guidelines related to testing services. Among the most-prominent guidelines in this regard are those of the FDA and the current good manufacturing practice guidelines.

Individuals are also becoming increasingly concerned for the purity, safety, and quality of pharma products; therefore, they are now adopting only quality-certified bioproducts. The identification of the hazards posed by the leachables contained in packaging and closed processing systems has become essential in the drug discovery procedure, as a significant enough presence of leachables can lead to the premature perishing of bioproducts.

The bioprocess residuals testing category will grow significantly in the coming years. Bioprocess residuals include downstream impurities, cell-culture-derived upstream impurities, buffer content, and anti-foaming agents. The demand for safe, impurity-free, and quality-approved drugs, vaccines, and other therapeutic products manufactured by the biotechnology, biopharmaceutical, and pharmaceutical industries is increasing, thus propelling the category’s advance.

Filter Elements Are Expected To Grow at Highest CAGR

Filter elements are expected to grow at the highest CAGR, majorly owing to the rising usage of a variety of filters in different bioprocessing techniques. They are required to ensure the efficacy and safety of biopharmaceutical products at every step of their production.

The usage of bioreactors for the manufacturing of vaccines, medicines, and other pharmaceutical components is also burgeoning. For instance, monoclonal antibodies for the treatment of rheumatoid arthritis, cancer, and many other diseases are manufactured with the help of bioreactors. In many areas of the healthcare industry, especially research, bioreactors are used for the conversion of in-vitro 2D culture models and suspensions to the 3D form and imitating the natural physiological stateat the site.

They are also utilized to stop natural biochemical processes, by holding organisms. In a batch bioreactor, everything is added simultaneously, and the pressure and temperature are adjusted once in a controlled and sealed environment. Moreover, before opening the other system, biochemical reactions are allowed. After that, the contents can be utilized, extracted, disposed of, or further processed. It produces quality-oriented products because the conditions are accurately maintained and the product is extracted only at the end of the process.

Currently, the usage of these systems is growing for the production of viral vaccines. For instance, in May 2022, Pall Corporation announced the development of a nano bioreactor, which aids in the production of viral vectors for CAR-T therapy.

Pharmaceutical and Biotechnology Companies Are Largest End Users

Pharmaceutical and biotechnology companies are the largest end users, ascribed to the rising requirement for biopharma products. This means that the need to check for impurities will increase, driven by the stringent regulatory standards implemented to ensure the quality and validity of the bioprocesses involved in biopharmaceutical production. The high cost of the materials used by biopharma companies for the development of various products for the treatment of individuals further encourages the development of the category.

Regional Analysis

North America Region Has Largest Market Share

North America has the leading position in the bioprocess validation market, and it will hold the same position till 2030, with a value of USD 334 million. This is attributed to the fast adoption of new and advanced technologies and the growing production of biologics.

In North America, the U.S. holds the leading position, and it will grow with a CAGR of around 10%, attributed to the large number of key players and the rising government funding to make bioprocess validation services available to end users.

Moreover, the presence of a huge number of outsourcing service providers in the region fuels the demand. Further, the region has the existence of a large number of FDA-approved biopharmaceutical and biotechnology companies. Additionally, various novel bioprocess validation programs have been launched in the region to ensure the procedures comply with current good manufacturing practices.

In addition, the Canada and U.S. are spending increasingly on pharma/biopharma research and development. According to government websites, in 2022, the National Institutes of Health invested most of their budget of around USD 45 billion in medical research. This massive investment is forecast to boost the growth of the market in the country, itself driven by the burgeoning requirement for new active pharmaceutical ingredients and drugs.

Market Breakdown

This fully customizable report gives a detailed analysis of the bioprocess validation industry from 2019 to 2030, based on all the relevant segments and geographies.

Based on Offering

• Product Type
  • Filter elements
  • Media containers and bags
  • Freezing and thawing process bags
  • Mixing systems
  • Bioreactors
  • Transfer systems
• Service Type
  • Extractables/ Leachables testing services
  • Bioprocess residuals testing
  • Viral clearance testing
  • Filtration and fermentation systems testing

Based on End User

• Pharmaceutical Companies & Biotech Companies
• Contract Development & Manufacturing Organizations

Geographical Analysis

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
• Asia-Pacific
  • Japan
  • China
  • India
  • South Korea
  • Australia
• Latin America
  • Brazil
  • Mexico
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • U.A.E.

Top Bioprocess Validation Companies