Single Use Downstream Bioprocessing Market

Single Use Downstream Bioprocessing Market by Type of Product (Single-use Chromatography Systems, Single-use Filtration Systems, Single-use Sampling Systems and Single-use Connectors), Scale of Operation and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035

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Single Use Downstream Bioprocessing Market Overview

The single use downstream bioprocessing market is estimated to be worth $1.14 billion in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 15.0% during the forecast period. The biopharmaceutical industry has witnessed significant growth over the past few years. Till date, more than 620 biologics have already been approved by the USFDA, while 8,000 are under clinical evaluation. The increased number of approvals and ongoing clinical trials demonstrate the growing popularity of novel treatment options for a variety of ailments and diseases. As a result, several stakeholders have opted to modernize their conventional biomanufacturing technologies in order to cope up with the increasing demand for biologics and to reduce the cost and time involved in bioprocessing. One such example is the use of single-use technology for various upstream and downstream processes involved in biologics manufacturing. The use of single-use technologies, such as single-use chromatography systems, in biopharmaceutical manufacturing has been steadily increasing over the years. Specifically, the adoption of single-use technology in downstream bioprocessing has witnessed a remarkable increase in the last few years. Single-use downstream technologies offer various advantages over the traditional stainless-steel technologies, such as reduction in CO2 emissions (by 35%), reduction in project lead time (by 8 months), removal of cleaning and sterilization expenditure throughout the development stage, increased productivity, less labor intensive, and low risk of contamination.

The image provides context of Single-use Downstream Bioprocessing Technology Market. The rising popularity and demand for biologics have prompted the developers and innovators to upgrade the conventional stainless-steel equipment to single-use technology This image provides list of Single-use Downstream Bioprocessing Equipment. Currently, more than 210 single-use equipment are available for downstream processing; these equipment have been developed by over 25 stakeholders and can be used for the manufacturing of different types of biologics The image provides details on the current Single-use Chromatography Systems market landscape. Majority of the single-use chromatography systems can be operated at a pressure of 4 bar; of these, over 65% systems available in the market can be used for commercial scale of operation

Given the various benefits of single-use downstream bioprocessing technology and its increasing adoption, several companies have developed and launched their proprietary single-use products, such as single-use chromatography systems, single-use filtration systems, single-use sampling systems, single-use connectors and single-use centrifugation systems, for the faster production of finished and high-quality biologics intended for the treatment of a wide array of disease indications. In addition, some stakeholders have also taken initiatives to automate their single-use systems, by introducing several key features, such as visual data display, remote accessibility, data processing capability, built-in system control sensors, irradiation (gamma or x-ray), provision for alarms / alerts and input / output compatibility in order to make the equipment more user friendly. Driven by the increasing adoption of single use technology and the ongoing efforts to enhance features and capabilities of various single-use equipment, the opportunity within this market is likely witness a noteworthy market growth during the forecast period.

Key Companies in Single Use Downstream Bioprocessing Market

Examples of key companies engaged in single use downstream bioprocessing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include 3M, Agilitech, CPC (Colder Products Company), Cytiva Lifesciences, Pall Corporation, Pneumatic Scale Angelus and Thermo Fisher Scientific. This market report includes an easily searchable excel database of all the companies providing single use downstream bioprocessing technologies, worldwide.

The image provides details on the current Single-use Filtration Systems market landscape. More than 55% of the equipment use membrane filters for the purification of media; of these, ~40% of the systems can be used for the production of monoclonal antibodies, vaccines and cell and gene therapies The image provides details on the current Single-use Sampling Systems market landscape. Over 75% of the single-use sampling systems are bags; of these, 50% use polyethylene as the construction material for tubing The image provides details on the current Single-use Connectors market landscape. Close to 65% of the single-use connectors are made of polycarbonate; of these, ~40% can be used across more than two application areas

Recent Developments in Single Use Downstream Bioprocessing Market:

Several recent developments have taken place in single use downstream bioprocessing market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In June 2023, Waters expand its collaboration with Sartorius with an aim to deliver comprehensive bioanalytic for downstream biomanufacturing. 
  • In June 2023, Cytiva announced the addition of Culture Bio’s 250 mL bioreactor vessel to its portfolio in order to tackle scaling bottlenecks.

Scope of the Report

The “Single Use Downstream Bioprocessing Market by Type of Product (Single-use Chromatography Systems, Single-use Filtration Systems, Single-use Sampling Systems and Single-use Connectors), Scale of Operation (Preclinical / Clinical and Commercial) and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin-America, Middle East and North Africa and Rest of the World): Industry Trends and Global Forecasts, 2022-2035” market report features an extensive study of the current landscape, market size and the likely future potential of single use downstream  bioprocessing technology and equipment developers, over the forecast period. The market research report also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in single use downstream bioprocessing market.

The image provides details on the current market landscape of Single-use Downstream Bioprocessing Equipment Providers. Majority of single-use downstream bioprocessing equipment providers are based in North America; more than 45% of these developers are well-established companies founded between 1951-2000 This infographic looks at the brand positioning of stakeholders involved in the single-use downstream bioprocessing market. Over time, stakeholders have established strong brand positions; in order to cater to increasing demand for single-use systems, a number of players have stepped up to introduce technologically advanced systems The image looks at the competitive landscape across Single-use Sampling Systems. In pursuit of gaining a competitive edge, single-use downstream bioprocessing equipment developers are presently focusing on the integration of advanced features in their respective products

In addition to other elements, the market research report includes:

  • A detailed assessment of the market landscape of single-use chromatography systems based on a number of relevant parameters, such as product / device dimensions, flow rate, volume range, pressure, weight, mode of operation (batch, fed-batch and continuous), scale of operation (preclinical, clinical and commercial), key features (scalability, visual data display, remote accessibility, data processing capability, built-in system control sensors, I / O compatibility and provision for alarms / alerts)and application area (monoclonal antibody production, vaccine production, cell and gene therapy, therapeutic protein / hormone and others). In addition, it presents details on the companies developing single-use chromatography systems, highlighting their year of establishment, company size, and geographical location.
  • A detailed assessment of the market landscape of single-use filtration systems based on a number of relevant parameters, such as filter pore size, type of membrane construction material, type of connector used, maximum temperature, pressure range, type of filter (membrane, capsule, cartridge and cassette), scale of operation (preclinical, clinical and commercial), key features (sterilizability, irradiation (gamma or x-ray), easy organization and fast aseptic connectors) and application area (monoclonal antibody production, vaccine production, cell and gene therapy, therapeutic protein / hormone and others). In addition, it presents details on the companies developing single-use filtration systems, highlighting their year of establishment, company size, and geographical location.
  • A detailed assessment of the market landscape of single-use sampling systems, based on several relevant parameters, such as type of sampling unit (bag, bottle, tube-transfer and syringe), type of sterilizability (irradiation (gamma or x-ray) and autoclavability), key features (scalability and pre-assembled), volume range and tubing material. The chapter also presents details on the companies involved in the development of single-use sampling systems, based on their year of establishment, company size, and geographical location. In addition, the chapter presents overview of the overall market landscape of single-use centrifugation systems.
  • A detailed assessment of the market landscape of single-use connectors based on number of relevant parameters, such as type of valve / gender (male, female and genderless), pack size, operating temperature, termination size, material of construction and application area (fluid transfer, sampling, process piping). In addition, it presents details on the companies developing single-use connectors, highlighting their year of establishment, company size, and geographical location.
  • A detailed competitiveness analysis of single-use chromatography systems, single-use filtration systems, single-use sampling systems and single-use connectors, taking into consideration several relevant parameters. For single-use chromatography systems, the parameters taken into account include the product strength (key features, mode of operation, scale of operation, elution method compatibility and application area) and supplier strength (company size and years of experience). For single-use filtration systems, the parameters taken into account include the product applicability (connectors used, type of filter, scale of operation, key features and application area) and supplier strength (company size and years of experience). For single-use sampling systems, the parameters taken into account include the product strength (sterilizability and key features) and supplier strength (company size and years of experience). For single-use connectors, the parameters taken into account include the product strength (type of valve / gender, easy to use, application area) and supplier strength (company size and years of experience).
  • Tabulated profiles of the key players providing single-use downstream bioprocessing technologies, which are headquartered in North America, Europe and Asia-Pacific. Each profile includes an overview of the company, information on the financial performance (if available), service portfolio, product portfolio, recent developments, and an informed future outlook.
  • An in-depth analysis of various patents that have been filed / granted for single-use downstream bioprocessing technology, till December 2021, highlighting key trends associated with these patents, across type of patents, publication year, application year, issuing authorities involved, type of organizations, emerging focus area, patent age, CPC symbols, leading patent assignees (in terms of number of patents granted / filed), patent characteristics and geography. It also includes a detailed patent benchmarking and an insightful valuation analysis.
  • A detailed brand positioning analysis of the key industry players (including single-use chromatography system developers, single-use filtration system developers, single-use sampling system developers and single-use connector developers), highlighting the current perceptions regarding their proprietary products by taking into consideration several relevant aspects, such as experience of the manufacturer, number of products offered, product diversity, and number of patents published.
  • An informed estimate on the current and future demand for biologics and demand-supply scenario for biologics manufactured using single-use downstream bioprocessing technologies, for the forecast period 2022-2035.
This image looks at the details of patents related to single-use downstream bioprocessing domain. To protect the intellectual property related to single-use downstream bioprocessing technologies, innovators have filed close to 450 patents across different regions of the globe This image looks at the demand and supply related to single use downstream bioprocessing. Given the growing demand for biologics and existing capacity crunch, biopharmaceutical companies are extensively adopting novel technologies for efficient bioprocessing in shorter time spans This image provides details on Single-use Downstream Bioprocessing Technology market size. The market is projected to grow at a CAGR of over 10%; the forecasted opportunity is likely to be distributed across different scales of operation, types of equipment, and geographical regions

One of the key objectives of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity of single use downstream bioprocessing market. Based on multiple parameters, such as overall downstream bioprocessing equipment market, and share of single-use technology, we have provided an informed estimate of the evolution of the market for the forecast period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of scale of operation (preclinical / clinical and commercial), type of product (single-use chromatography systems, single-use filtration systems, single-use sampling systems and single-use connectors), and key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

Frequently Asked Questions

Question 1: What is single use bioprocessing?

Answer: Single use bioprocessing includes the use of units / vessels which are used only once and then discarded, either in upstream or downstream bioprocesses.

Question 2: How big is the single use downstream bioprocessing market?

Answer: The single use downstream bioprocessing market size is estimated to be worth $1.14 billion in 2022.

Question 3: What is the projected market growth of the single use downstream bioprocessing market?

Answer: The single use downstream bioprocessing market is expected to grow at compounded annual growth rate (CAGR) of 15% during the forecast period 2022 - 2035.

Question 4: Who are the leading companies in the single use downstream bioprocessing market?

Answer: Examples of key companies engaged in single use downstream bioprocessing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include 3M, Agilitech, CPC (Colder Products Company), Cytiva Lifesciences, Pall Corporation, Pneumatic Scale Angelus and Thermo Fisher Scientific.

Question 5: How many patents related to the single use downstream bioprocessing have been filed / granted till date?

Answer: Till date, over 410 patents have been filed / granted related to the single use downstream bioprocessing.

Question 6: Are single use chromatography systems available for commercial scale operations?

Answer: 65% of the identified single use chromatography systems can be used for commercial scale operation.

Question 7: Which region is the hub for companies engaged in the single use downstream bioprocessing market?

Answer: North America emerged as the hub for companies engaged in the single use downstream bioprocessing market, with close to 60% of the companies established in the region.

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