Single-Use Assemblies - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2024 - 2029)
The Single-Use Assemblies Market size is estimated at USD 2.94 billion in 2024, and is expected to reach USD 6.18 billion by 2029, growing at a CAGR of 15.96% during the forecast period (2024-2029).
Key Highlights
The key factors expected to drive the market’s growth are increased demand for low-risk contamination systems, increased R&D investments by biopharmaceutical companies, and a growing biologics market.
The adoption of single-use assemblies in the global biopharmaceutical industry has increased over time due to its advantages, such as the decreased chances of cross-contamination hazards, simplified cleaning procedures, and increased drug development activities. Moreover, the growing adoption of single-use assemblies and systems in biopharmaceutical manufacturing and increasing new product introductions by market players to foster biopharmaceutical operations are expected to accelerate market growth over the study period. For instance, in April 2023, Cytiva launched X-platform bioreactors to streamline single-use upstream bioprocessing operations.
The newly launched product boosted process efficiency and streamlined supply chain operations. This rapid implementation allowed manufacturers to respond swiftly to changing market demands and production schedules, thereby increasing operational efficiency and upsurging the growth of single-use assemblies.
In addition, the growing demand for novel therapeutics and established roles of single-use assemblies in production lines have pushed market players to expand their single-use technology manufacturing capabilities, which in turn is projected to accelerate industry expansion over the study period. For instance, in February 2023, Foxx Life Sciences invested USD 2.5 in India to expand capabilities in pharmaceutical SUT (single-use technology) for new therapeutics manufacturing.
Similarly, in September 2022, Merck KGaA invested EUR 130 million (USD 132 million) in beefing up the ability of its manufacturing arm—MilliporeSigma—to employ single-use assemblies at its facility in Molsheim, France. Thus, such investments and facility expansions undertaken by industry participants are further projected to drive revenue growth for the market.
Moreover, the growing biologics market and increasing demand for monoclonal antibodies, vaccines, and cell therapies have accelerated the demand for single-use assemblies such as filtration systems, transfer systems, valves, bags, and other consumables as these reduce the risk of cross-contamination associated with biologics manufacturing. Thus, the growth in the biologics market has driven the demand for single-use assemblies, which, in turn, is expected to drive market growth during the forecast period.
Furthermore, several strategic initiatives undertaken by industry participants to strengthen their business avenues are further expected to drive market growth. For instance, in April 2023, Merck launched the Ultimus Single-Use Process Container Film. According to the company, the film was designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications. Thus, the introduction of such products is expected to drive the industry's growth forward.
Therefore, the advantages of single-use assemblies over traditional processes and increased biopharmaceutical R&D activities propel market growth. However, issues related to extractables and leachables are expected to hamper the market’s growth.
Single-use Assemblies Market Trends
Biopharmaceutical and Pharmaceutical Companies Segment Accounted For Significant Market Share
Biopharmaceutical companies utilize a single-use system to manufacture the final product by using large-scale single-use assemblies. It allows process components or lines to be disposed of when a project has been completed instead of cleaning and sterilizing stainless steel or glass equipment. Such advantages drive the pharmaceutical and bio-pharmaceutical sectors to adopt single-use assemblies.
In addition, the increased burden of chronic diseases and a higher need for advanced therapeutics prompted pharmaceutical and biopharmaceutical companies to expand their manufacturing capabilities, which, in turn, is projected to foster the demand for single-use assemblies.
For instance, in April 2024, Aptar Pharma announced a capacity expansion plan in North America at its Aptar Congers, New York site. Aptar Pharma is significantly expanding the manufacturing capacity of its proprietary Unidose (UDS) Nasal Spray Systems via the addition of molds and assembly lines in cleanroom manufacturing settings and the installation of an assembly line to expand further the manufacturing of its bag-on-vale (BOV) technology. This expansion is anticipated to drive the application of single-use bottle assemblies, which is, in turn, expected to accelerate segmental market growth during the forecast period.
Similarly, in January 2024, AbbVie Inc. invested USD 223 million to expand Singapore's Tuas Biomedical Park manufacturing facility. The investment is anticipated to add more than 100 jobs and new biologics manufacturing capacity to AbbVie's global network and promote the application of single-use systems and assemblies.
Therefore, factors such as the rising adoption of single-use assemblies in biopharmaceutical companies and rising investments from key market players are expected to drive the growth of the biopharmaceutical and pharmaceutical companies segment during the forecast period.
North America is Expected to Witness Significant Growth Opportunities Over the Study Period
The factors responsible for the significant market in North America include the well-established biopharmaceutical sector, widespread availability of single-use assemblies supplied by regional market leaders, and rising biologics and biosimilar manufacturing.
The increasing investments in biopharmaceutical sectors by pharmaceutical companies and public organizations are expected to foster the demand for single-use assemblies to reduce cross-contamination and promote cost-effective manufacturing. For instance, according to the fact sheet released in September 2022 by the Department of Health and Human Services, the government planned to invest USD 40 million to expand the role of biomanufacturing in active pharmaceutical ingredients (APIs), antibiotics, and the critical starting materials to produce essential medications and respond to pandemics. Thus, such investment activities in the region are likely to accelerate the adoption of single-use assemblies over the study period.
Similarly, in June 2023, the government of Canada invested more than USD 2.1 billion in 36 projects in the biomanufacturing, vaccine, and therapeutics ecosystem across the country. Thus, such investment in biomanufacturing is likely to create a high demand for single-use assemblies in the region, as the single-use technologies can lower turn-around costs by reducing or eliminating the need for expensive stainless-steel equipment and the associated expenses of installation and cleaning, which ultimately expected to fuel the regional market growth over the forecast period.
Moreover, the presence of several key players in the region and strategic initiatives undertaken by them are further projected to accelerate regional market expansion. For instance, in November 2022, Cardinal Health expanded its single-use device reprocessing facility in Riverview, Florida, with a capacity of 100,000 sq. ft. In addition, in August 2022, Thermo Fisher Scientific Inc. opened one of the largest single-use technology manufacturing sites in Greater Nashville. An investment of USD 105 million in the facility adds capacity to enable more life-saving vaccines and therapies. Thus, such initiatives undertaken by market players are projected to foster industry expansion over the study period.
Thus, owing to the above-mentioned factors, such as increasing demand for single-use assemblies, growing investments in the biopharmaceutical sector, and several strategic initiatives undertaken by industry participants, market growth in North America is expected to accelerate during the study period.
Single-Use Assemblies Industry Overview
The single-use assemblies market is semi-consolidated in nature and consists of many significant players. In terms of market share, a few major players dominate the market. Some companies operating in the market are Sartorius AG, Thermo Fisher Scientific Inc., Cytiva (Danaher), Merck KGaA, Avantor Inc., Parker Hannifin Corporation, and Saint-Gobain.
Additional Benefits:
The market estimate (ME) sheet in Excel format
3 months of analyst support
Key Highlights
The key factors expected to drive the market’s growth are increased demand for low-risk contamination systems, increased R&D investments by biopharmaceutical companies, and a growing biologics market.
The adoption of single-use assemblies in the global biopharmaceutical industry has increased over time due to its advantages, such as the decreased chances of cross-contamination hazards, simplified cleaning procedures, and increased drug development activities. Moreover, the growing adoption of single-use assemblies and systems in biopharmaceutical manufacturing and increasing new product introductions by market players to foster biopharmaceutical operations are expected to accelerate market growth over the study period. For instance, in April 2023, Cytiva launched X-platform bioreactors to streamline single-use upstream bioprocessing operations.
The newly launched product boosted process efficiency and streamlined supply chain operations. This rapid implementation allowed manufacturers to respond swiftly to changing market demands and production schedules, thereby increasing operational efficiency and upsurging the growth of single-use assemblies.
In addition, the growing demand for novel therapeutics and established roles of single-use assemblies in production lines have pushed market players to expand their single-use technology manufacturing capabilities, which in turn is projected to accelerate industry expansion over the study period. For instance, in February 2023, Foxx Life Sciences invested USD 2.5 in India to expand capabilities in pharmaceutical SUT (single-use technology) for new therapeutics manufacturing.
Similarly, in September 2022, Merck KGaA invested EUR 130 million (USD 132 million) in beefing up the ability of its manufacturing arm—MilliporeSigma—to employ single-use assemblies at its facility in Molsheim, France. Thus, such investments and facility expansions undertaken by industry participants are further projected to drive revenue growth for the market.
Moreover, the growing biologics market and increasing demand for monoclonal antibodies, vaccines, and cell therapies have accelerated the demand for single-use assemblies such as filtration systems, transfer systems, valves, bags, and other consumables as these reduce the risk of cross-contamination associated with biologics manufacturing. Thus, the growth in the biologics market has driven the demand for single-use assemblies, which, in turn, is expected to drive market growth during the forecast period.
Furthermore, several strategic initiatives undertaken by industry participants to strengthen their business avenues are further expected to drive market growth. For instance, in April 2023, Merck launched the Ultimus Single-Use Process Container Film. According to the company, the film was designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications. Thus, the introduction of such products is expected to drive the industry's growth forward.
Therefore, the advantages of single-use assemblies over traditional processes and increased biopharmaceutical R&D activities propel market growth. However, issues related to extractables and leachables are expected to hamper the market’s growth.
Single-use Assemblies Market Trends
Biopharmaceutical and Pharmaceutical Companies Segment Accounted For Significant Market Share
Biopharmaceutical companies utilize a single-use system to manufacture the final product by using large-scale single-use assemblies. It allows process components or lines to be disposed of when a project has been completed instead of cleaning and sterilizing stainless steel or glass equipment. Such advantages drive the pharmaceutical and bio-pharmaceutical sectors to adopt single-use assemblies.
In addition, the increased burden of chronic diseases and a higher need for advanced therapeutics prompted pharmaceutical and biopharmaceutical companies to expand their manufacturing capabilities, which, in turn, is projected to foster the demand for single-use assemblies.
For instance, in April 2024, Aptar Pharma announced a capacity expansion plan in North America at its Aptar Congers, New York site. Aptar Pharma is significantly expanding the manufacturing capacity of its proprietary Unidose (UDS) Nasal Spray Systems via the addition of molds and assembly lines in cleanroom manufacturing settings and the installation of an assembly line to expand further the manufacturing of its bag-on-vale (BOV) technology. This expansion is anticipated to drive the application of single-use bottle assemblies, which is, in turn, expected to accelerate segmental market growth during the forecast period.
Similarly, in January 2024, AbbVie Inc. invested USD 223 million to expand Singapore's Tuas Biomedical Park manufacturing facility. The investment is anticipated to add more than 100 jobs and new biologics manufacturing capacity to AbbVie's global network and promote the application of single-use systems and assemblies.
Therefore, factors such as the rising adoption of single-use assemblies in biopharmaceutical companies and rising investments from key market players are expected to drive the growth of the biopharmaceutical and pharmaceutical companies segment during the forecast period.
North America is Expected to Witness Significant Growth Opportunities Over the Study Period
The factors responsible for the significant market in North America include the well-established biopharmaceutical sector, widespread availability of single-use assemblies supplied by regional market leaders, and rising biologics and biosimilar manufacturing.
The increasing investments in biopharmaceutical sectors by pharmaceutical companies and public organizations are expected to foster the demand for single-use assemblies to reduce cross-contamination and promote cost-effective manufacturing. For instance, according to the fact sheet released in September 2022 by the Department of Health and Human Services, the government planned to invest USD 40 million to expand the role of biomanufacturing in active pharmaceutical ingredients (APIs), antibiotics, and the critical starting materials to produce essential medications and respond to pandemics. Thus, such investment activities in the region are likely to accelerate the adoption of single-use assemblies over the study period.
Similarly, in June 2023, the government of Canada invested more than USD 2.1 billion in 36 projects in the biomanufacturing, vaccine, and therapeutics ecosystem across the country. Thus, such investment in biomanufacturing is likely to create a high demand for single-use assemblies in the region, as the single-use technologies can lower turn-around costs by reducing or eliminating the need for expensive stainless-steel equipment and the associated expenses of installation and cleaning, which ultimately expected to fuel the regional market growth over the forecast period.
Moreover, the presence of several key players in the region and strategic initiatives undertaken by them are further projected to accelerate regional market expansion. For instance, in November 2022, Cardinal Health expanded its single-use device reprocessing facility in Riverview, Florida, with a capacity of 100,000 sq. ft. In addition, in August 2022, Thermo Fisher Scientific Inc. opened one of the largest single-use technology manufacturing sites in Greater Nashville. An investment of USD 105 million in the facility adds capacity to enable more life-saving vaccines and therapies. Thus, such initiatives undertaken by market players are projected to foster industry expansion over the study period.
Thus, owing to the above-mentioned factors, such as increasing demand for single-use assemblies, growing investments in the biopharmaceutical sector, and several strategic initiatives undertaken by industry participants, market growth in North America is expected to accelerate during the study period.
Single-Use Assemblies Industry Overview
The single-use assemblies market is semi-consolidated in nature and consists of many significant players. In terms of market share, a few major players dominate the market. Some companies operating in the market are Sartorius AG, Thermo Fisher Scientific Inc., Cytiva (Danaher), Merck KGaA, Avantor Inc., Parker Hannifin Corporation, and Saint-Gobain.
Additional Benefits:
The market estimate (ME) sheet in Excel format
3 months of analyst support
1 INTRODUCTION
1.1 Study Assumptions & Market Definition
1.2 Scope Of The Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rapid Implementation and Low Risk of Cross-contamination
4.2.2 Increasing R&D Investment by Biopharmaceutical Companies
4.2.3 Growing Biologics Market
4.3 Market Restraints
4.3.1 Issues Related to Extractables and Leachables
4.4 Industry Attractiveness - Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Product Type
5.1.1 Filtration Assemblies
5.1.2 Bag Assemblies
5.1.3 Bottle Assemblies
5.1.4 Mixing System Assemblies
5.2 By Application
5.2.1 Cell Culture and Mixing
5.2.2 Filtration
5.2.3 Storage
5.2.4 Sampling
5.2.5 Fill-finish Application
5.2.6 Other Applications (Aseptic Transfer and Fluid Management)
5.3 By End User
5.3.1 Biopharmaceutical and Pharmaceutical Companies
5.3.2 Contract Research and Contract Manufacturing Organizations
5.3.3 Academic and Research Institutes
5.4 By Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Thermo Fisher Scientific Inc.
6.1.2 Sartorius AG
6.1.3 Danaher (Pall Corporation)
6.1.4 Merck KGaA
6.1.5 Avantor Inc.
6.1.6 Lonza
6.1.7 PARKER HANNIFIN CORP
6.1.8 Saint-Gobain Life Sciences
6.1.9 Repligen Corporation
6.1.10 Corning Incorporated
6.1.11 Entegris
6.1.12 Antylia Scientific (Cole-Parmer)
7 MARKET OPPORTUNITIES AND FUTURE TRENDS
1.1 Study Assumptions & Market Definition
1.2 Scope Of The Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rapid Implementation and Low Risk of Cross-contamination
4.2.2 Increasing R&D Investment by Biopharmaceutical Companies
4.2.3 Growing Biologics Market
4.3 Market Restraints
4.3.1 Issues Related to Extractables and Leachables
4.4 Industry Attractiveness - Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Product Type
5.1.1 Filtration Assemblies
5.1.2 Bag Assemblies
5.1.3 Bottle Assemblies
5.1.4 Mixing System Assemblies
5.2 By Application
5.2.1 Cell Culture and Mixing
5.2.2 Filtration
5.2.3 Storage
5.2.4 Sampling
5.2.5 Fill-finish Application
5.2.6 Other Applications (Aseptic Transfer and Fluid Management)
5.3 By End User
5.3.1 Biopharmaceutical and Pharmaceutical Companies
5.3.2 Contract Research and Contract Manufacturing Organizations
5.3.3 Academic and Research Institutes
5.4 By Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Thermo Fisher Scientific Inc.
6.1.2 Sartorius AG
6.1.3 Danaher (Pall Corporation)
6.1.4 Merck KGaA
6.1.5 Avantor Inc.
6.1.6 Lonza
6.1.7 PARKER HANNIFIN CORP
6.1.8 Saint-Gobain Life Sciences
6.1.9 Repligen Corporation
6.1.10 Corning Incorporated
6.1.11 Entegris
6.1.12 Antylia Scientific (Cole-Parmer)
7 MARKET OPPORTUNITIES AND FUTURE TRENDS
