Single-use Bioprocessing Market Size, Market Research and Industry Forecast Report, 2027 (Includes Business Impact of COVID-19)

  • TBI738868
  • November 28, 2020
  • Global
  • 132 pages
  • Lucintel
                                          

Industry Insights, Market Size, CAGR, High-Level Analysis: Single-use Bioprocessing Market

The global single-use bioprocessing market size was valued at USD 12.6 billion in 2019 and is projected to witness a CAGR of 12.8% during the forecast period. Single-use technology (SUT) has become a leading technology in pre-commercial manufacturing, including preclinical and clinical scale. Over the past years, there has been a rapid growth in the adoption of SUT-based process lines, to an extent that SUT has dominated the upstream pre-commercial biopharmaceutical manufacturing. Most of the bioprocessing facilities employ a significant amount of various disposable products, contributing to revenue growth for the market for single-use bioprocessing. One of the key parameters that has resulted in the rapid adoption of SUT-based process lines is flexibility and speed offered by single-use products while keeping total operating expenditure to a minimum. Also, the introduction of automation and intelligent biomanufacturing has boosted the efficiency of SUTs exponentially. With the rising advancements, the penetration of the single-use bioprocessing model is expected to increase substantially. Several end-users have considered Single-use Systems (SUS) as a mainstream approach to achieve maximum productivity and process efficiency. Presence of key OEMs such as GE Healthcare which has been at the forefront of single-use innovation from the introduction of disposable bioreactors and chromatography columns to entire single-use process and biomanufacturing facilities is driving market revenue at a lucrative growth rate. SUTs have been proven to be robust and scalable from lab/scale-up to cGMP production applications. As per the BioPharm International, nearly 85% of pre-commercial biomanufacturing involves the use of single-use bioprocessing equipment. On the contrary, commercial manufacturing is still dominated by stainless steel-based products. However, with the expanding product line of disposable bioreactors with high working volume,it is expected to witness considerable profit at commercial scale in the coming years. The market for single-use bioprocessing is anticipated to incorporate big data-based machine learning in the coming years. This would result in the introduction of analytical models that would enable prediction and improvement in process parameters to boost product yields. The growing interest of investors to fund the incorporation of innovative technologies, such as automation and big data, with SUS is anticipated to drive innovations in the space.

Product Insights of Single-use Bioprocessing Market

The highest penetration of tubing, filters, connectors, and transfer systems in terms of usage and product availability has attributed to the largest revenue share of simple and peripheral elements in 2019. Moreover, the availability of a wide range of bags that are equipped with ports, connectors, and automation are used for multiple applications, such as storage of cell cultures, buffers, sterile media, sera, and reagents. This, in turn, is driving segment revenue in the market for single-use bioprocessing. Furthermore, the demand for disposable probes and sensors continues to grow within the biopharmaceutical industry. The growing interest in disposables probes and sensors is displayed by both in-house manufacturers and CMOs. However, the availability of sensors is limited to a few basic analytes. This, in turn, creates opportunities for the players in the market for single-use bioprocessing, striving to capitalize on the untapped revenue in this segment. However, apparatus and plants are expected to grow at a significant pace owing to the continuous developments in single-use bioreactors in terms of scale, application, and capacity. For instance, in January 2019, Sartorius launched BIOSTAT RM TX single-use bioreactor for closed and automated expansion of various cellular therapies.

Workflow Insights

The single-use bioprocessing market is expected to grow due to the introduction of a wide array of SUS to be used during various phases of biomanufacturing. Single-use bioprocessing products range from bioreactors for the fermentation process to several filtration systems for downstream processing. Implementation of SUS for cell culture, liquid handling, and storage has contributed to the large share of upstream processing. The introduction of SUTs has not made as much of an impact in downstream processing as it has made in upstream processing. In particular, the implementation of SUTs in chromatography purification is an important bottleneck for the expansion of this market for single-use bioprocessing. The primary challenge in shifting chromatography to disposable format is the cost of affinity/Ion Exchange (IEX) resins. The end-users need to amortize for resins through clean-and-reuse programs. These challenges need to be addressed to leverage SUTs in downstream single-use bioprocessing. The growing popularity of SUS has encouraged several suppliers to develop disposable products for downstream processing. For instance, the introduction of single-use centrifuges enables the handling of very high cell densities, thereby benefitting the downstream processing techniques.

End-use Insights

The biopharmaceutical manufacturing industry is expected to significantly benefit from the growing popularity of disposables among CMOs. Contract service providers are engaged in the expansion of single-use capacity by installing new single-use bioprocessing products at their facility, thereby aiding in revenue regeneration. Installation of expensive stainless-steel bioprocessing equipment including bioreactors at large scale for in house biomanufacturing has attributed to the relatively lesser market share for in house bio manufacturers. However, this technology has facilitated smaller firms to have control over biomanufacturing by keeping it in-house. This is anticipated to drive the uptake of disposables within in-house bio manufacturers in the market for single-use bioprocessing. SUS has made a significant impact in clinical research settings. Single-use blood bags, transfer sets, T-flasks, and pipettes have been effectively used for cell therapy-based clinical research. The presence of training institutes like the National Institute for Bioprocessing Research and Training (NIBRT) that offer training and research solutions for the bioprocessing industry covering the various aspects of single-use bioprocessing is expected to have a positive influence on the market.

Regional Insights of Single-use Bioprocessing Market

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 coming years. 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 CDMOs biomanufacturing plants in the region. 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.

Market Share Insights of Single-use Bioprocessing Market

Some key participants in the market for single-use bioprocessing include Meissner Filtration Products, Inc.; Sartorius AG; Eppendorf AG; General Electric Company (GE Healthcare); Corning Incorporated; ThermoFisher Scientific; Rentschler Biopharma SE; Merck KGaA; Pall Corporation; JM BIOCONNECT; Kí¼hner AG; Lonza; Infors AG; Entegris, Inc.; and PBS Biotech, Inc. The key OEMs in the market for single-use bioprocessing are engaged in offering robust products with a competitive advantage over conventional technologies. Process technologies developed by major manufacturers including Mobius series (Merck), ReadyToProcess- or FlexFactory series (GE Healthcare), FlexAct series (Sartorius Stedim Biotech), and Allegro series (Pall Life Sciences) have been proven to be superior to the stainless-steel equipment. With the recent expansions in the market, OEMs are now collaborating with independent suppliers to fill technological gaps. Suppliers like PendoTECH are involved in selling a substantial volume of its sensors and monitors to OEMs for GMP production, pilot and toxicology studies, and clinical batches, resulting in revenue growth.

Segmentations, Sub Segmentations, CAGR, & High-Level Analysis overview of Single-use Bioprocessing Market Research Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2030. For the purpose of this study, this market research report has segmented the global single-use bioprocessing market report on the basis of product, workflow, end use, and region:

Product Outlook (Revenue, USD Million, 2019 - 2030)

  • Apparatus & Plants
  • Bioreactors, By Capacity
  • Up to 1000L
  • Above 1000L to 2000L
  • Above 2000L
  • Filtration system

Mixing, Storage, & Filling Systems

  • Chromatography Systems
  • Others

Simple & Peripheral Elements

  • Bags

Tubing, Filters, Connectors, & Transfer Systems

  • Sampling Systems
  • Probes & Sensors
  • pH Sensor
  • Oxygen Sensors
  • Pressure Sensors
  • Temperature Sensors
  • Conductivity Sensors
  • Flow Sensors
  • Other sensors
  • Others
  • Work Equipment
  • Cell Culture System
  • Syringes
  • Others

Workflow Outlook (Revenue, USD Million, 2019 - 2030)

  • Upstream
  • Fermentation
  • Downstream

End-use Outlook (Revenue, USD Million, 2019 - 2030)

  • Biopharmaceutical Manufacturer
  • CMOs & CROs
  • In-house Manufacturer
  • OEM
  • Academic & Clinical Research Institutes
  • Others

Table of contents
Chapter 1 Executive Summary                  1.1 Market Snapshot                  1.2 Competition Milieu                  1.3 Segment OutlookChapter 2 Research Methodology                  2.1 Information Procurement                  2.2 Information or Data Analysis                  2.3 Market Formulation & ValidationChapter 3 Single-use Bioprocessing Market Variables, Trends & Scope                  3.1 Parent Market Analysis                  3.2 Market Dynamics                      3.2.1 Market driver analysis                          3.2.1.1 Several advantages associated w
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