Single-use Bioprocessing Market is expected to grow at a CAGR of 13.2% during the forecasting period (2020-2027).

Published Date: 2021-05-07

health-care

DataM forecast The Global Single-use Bioprocessing Market is anticipated to grow at a CAGR of 13.2% from 2020 to 2027

The single-use bioprocessing market valued USD 3,964.2 million in 2019 and it is expected to grow at a CAGR of XX% during the forecast period to reach USD XX million by 2027.

Single-use bioprocessing systems are the bioprocessing equipment that are used for once and disposed. Single-use bioprocessing systems are made up of the plastic components that can be sterilized and sealed by using the gamma irradiation. Single-use bioprocessing systems are used for mixing, filtration, purification, upstream expression, storage and separation of biopharmaceutical products. The market is dominated by the availability of the several single-use bioprocessing systems such as bioreactors & fermenters, mixers, bags, bioprocess containers, filtration devices, tubing, sampling systems, connectors & clamps, and probes & sensors. The market is driven by the increasing demand for the single-use bioprocessing systems with the growing penetration of the biopharmaceuticals. Single-use bioprocessing systems are widely used for the production of the biopharmaceutical products such as vaccines, monoclonal antibodies (mAbs), personalized medicine, and others. Single-use bioprocessing systems have several advantages such as high energy efficiency, low water usage, less floor space requirement, and very low or no risk of product cross contamination. Single-use bioprocessing systems are faster to implement.

Market Dynamics

Drivers

  • Increasing demand for biopharmaceuticals
  • Technological advancement in single-use bioprocessing systems
  • Advantages of single-use bioprocessing systems over fixed bioprocessing systems

Restraints

  • Environmental concerns with the usage of single-use bioprocessing systems 
  • Extractability and leachability issues regarding disposable components

Advantages of single-use bioprocessing systems over fixed bioprocessing systems

Bioprocessing systems using single-use technologies (SUTs) offer several advantages to users at process stages from buffer and media preparation through filling and shipment, and from laboratory-scale to large-scale production. However, the need for waste disposal at end-of-life has called the environmental sustainability of SUTs into question. Hence, several life cycle assessments (LCAs) have been conducted to investigate and characterize the environmental impact of SUTs over the life cycle from sourcing to end-of-life. The conventional fixed systems have a higher environmental impact, at all process scales examined, than single-use systems.  The single-use technologies (SUTs) provide many economic and other advantages over fixed stainless-steel systems, with companies on average spending about US$1 million/year on disposable equipment. Even comparable overall costs, SUTs offer compelling advantages over stainless steel. Greater flexibility allows companies to buy and assemble systems as needed and store them on site for future use Single-use plastics in bioprocessing provide significant environmental advantages when compared to the stainless steel alternatives. In addition to providing pharmaceutical companies with flexible, scalable solutions, single-use bioprocessing equipment has proven to be a much more environmentally-friendly option than reusable stainless steel bioreactors. This holds true for scales ranging from small pilot facilities to 20,000 L bioreactor skids. Single-use systems use less water and energy, and have a lower overall environmental impact compared to conventional fixed systems. The high environmental impact of fixed systems is driven by water usage and the energy consumption required for cleaning and sterilization processes (process water, steam, and the water for injection still) during the use-phase of the product life cycle. In contrast, single-use systems are sterilized by irradiation, reducing or eliminating the need for large quantities of process water, steam and water for injection, and the energy associated with those processes. For a typical process, single-use systems reduce water consumption by 87%, energy consumption by up to 29%, and CO2 emissions by 25%. This shows the utility savings at the facility compared to conventional systems

Geographical Analysis

The North America Single-use Bioprocessing market is valued at USD 1,189.7 Mn in 2019 and is estimated to grow at a CAGR of YY% over the forecast period to reach a USD YY Mn by 2027.

North America is dominating the global single-use bioprocessing market in 2019 accounting for a share of about 30.01% and estimated to hold significant market size over the forecast period (2020-2027). North America is expected to hold a significant market share in the global single-use bioprocessing market due to high R&D expenditure, the presence of largescale manufacturing units, the growing popularity of disposables, increasing healthcare expenditure, and the presence of well-established healthcare infrastructure. Adoption of disposables has become a trend among the contract manufacturing organizations (CMO), and this region is recognized as a significant market for contract service providers. This factor serves as a catalyst for continued investments by local and global companies, for the implementation of disposables in the contract development and manufacturing organizations and bio manufacturing plants in the region. In 2019, Applikon Biotechnology (Getinge) launched a single-use "AppliFlex ST lab-scale bioreactor" as a significant extension to its range of innovative bioreactor systems. It is a fully customizable and scalable stirred-tank single-use bioreactor that uses 3D printing technology to provide a head plate that is uniquely configured to each individual process, including custom impeller design, and different sample port connections. Furthermore, increasing demand for biopharmaceutical drugs from the geriatric population and patient expiries of biologics are some more factors that are also fueling the growth of the overall regional market to a large extent. A significant share of North America in this market for single-use bioprocessing can be attributed to the presence of large-scale biopharmaceutical manufacturing facilities in U.S. The biopharmaceutical sector is considered as the most R&D intensive in this country. Taking into consideration the growing popularity of disposables, U.S.-based companies continue to launch novel SUS to effectively serve domestic as well as global end-users. Such new product launches in the region are anticipated to boost the revenue share of the market for single-use bioprocessing in North America in the forecast period. The adoption of disposables has become a trend among CMOs, and this region is recognized as a significant market base for contract service providers. This factor serves as a catalyst for continued investments by local and global companies for the implementation of disposables at CDMO’s bio manufacturing plants in the U.S.For instance, in January 2019, Boehringer Ingelheim expanded its commercial biologics manufacturing site in China. The expansion covered incorporation of a bioreactor with all required infrastructure and utility to support the GMP operations of 2x 2.000 L single-use bioreactor manufacturing lines.



 

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