Preparative and Process Chromatography Market: Regulatory Environment and Compliance Challenges

The global market for preparative and process chromatography was valued at $9.5 billion in 2022 and is expected to grow at a rate of 9.08% annually until 2030. This growth is fueled by the increasing demand and approval of monoclonal antibodies in the pharmaceutical and biotechnology industries. Additionally, the expanding biopharmaceutical industry, the need for advanced purification techniques, and the pursuit of more efficient and cost-effective processes are driving the market.

Technological advancements and the development of innovative chromatography products are anticipated to further boost market growth. For example, in October 2021, CEM introduced the Prodigy Preparative HPLC system, which offers enhanced resolution and separation capabilities due to its elevated temperature capability. The COVID-19 pandemic positively impacted the market due to the high demand for COVID-19 vaccines and treatments. The pharmaceutical and biotechnology industries are projected to experience significant growth in the future, driven by the emerging production and demand for preparative and process chromatography. The separation process and preparative chromatography can be utilized in the analysis of materials used in the manufacturing of the coronavirus vaccine.

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Product Segmentation Insights

The chromatography market is divided into two main segments: process/analytical chromatography and preparative chromatography. In 2022, process chromatography accounted for the largest share of the market, at 59.03%. These methods are widely used in industries to purify various biomolecules. They are designed for large-scale biopharmaceutical manufacturing and process scale-up. The pharmaceutical industry's growing use of automated systems is the primary driver of this segment. Preparative chromatography is expected to experience the highest growth rate during the forecast period due to its ability to deliver precise results. Chromatography has become a standard laboratory process in various industries due to continuous advancements in technology and methodology.

Preparative chromatography is the most reliable method for isolating and purifying large quantities of valuable compounds. Implementing single-use technology is considered a cost-effective solution in terms of labor, costs, capital, and materials. Currently, there are several disposable chromatography column systems available that comply with current good manufacturing practices for preparative and process chromatography. Single-use batch chromatography systems, such as single-use/disposable chromatography columns and membrane products, are expected to gain popularity in the bioprocessing industry.

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