Global Single Use Assemblies Market Size and Trends

Global single-use assemblies market is expected to reach US$ 34.73 Bn by 2030, from US$ 11.03 Bn in 2023, exhibiting a CAGR of 17.8% during the forecast period.

Global Single-use Assemblies Market - Restraints

High costs associated with single-use assemblies: High costs associated with single-use assemblies are significantly restraining the growth of the global single-use assemblies market. The production and procurement costs of single-use components and assemblies are considerably higher compared to their reusable counterparts. This is primarily due to the expenses involved in manufacturing single-use products with high-quality materials that can withstand stringent sterilization procedures and avoid contamination during their intended short operational lifecycle. Moreover, the costs associated with validations, cleaning, and waste treatment or disposal of single-use parts add to the overall financial burden on end users.

The high initial investment required for setting up single-use production lines and facilities by biopharmaceutical manufacturers is also slowing the adoption rate. Significant capital is needed for purchasing assemblies, installation of required equipment such as plastic welding machines, assembly robots, and sterile manufacturing suites. Additionally, frequent production line clearances and changeovers further inflate the operational costs. These substantial expenses pose serious budgetary challenges, especially for small and medium-sized biopharmaceutical companies with limited financial resources. As a result, some drug developers prefer conventional stainless-steel based reusable equipment over single-use technologies for large-scale commercial production.

Lack of standardized manufacturing processes: The lack of standardized manufacturing processes is one of the key factors restraining the growth of the global single-use assemblies market. When there are no standardized processes, each manufacturer has to develop their own unique process flows, specifications, and protocols. This leads to inconsistencies in quality, specifications and performance of the single-use products coming from different sources. Establishing standardized manufacturing techniques would help ensure harmonization and quality control across different manufacturers. This becomes especially important since these assemblies are single-use and meant for critical bio manufacturing applications. Any variability or quality issues can directly impact the end products like biologics which are meant for human use.

Having a diverse range of non-standardized manufacturing procedures also increases the compliance burden and operational costs for bio manufacturers. They have to validate and qualify every new vendor and product individually due to differences in manufacturing and quality standards. This leads to longer approval cycles and delays in setting up new production lines or making vendor changes. It also prevents the feasible and timely scale-up of manufacturing during periods of high demand like the ongoing COVID pandemic. With standardized manufacturing under a harmonized framework, the changes and additions of new contract manufacturing partners could be done more efficiently and swiftly to meet any unexpected rise in market requirements.

Figure 2. Global Single-use Assemblies Market Share (%), By Product, 2023