Single Use Bioprocess System Market

Global Market Study on Single-use Bioprocess Systems: Demand Surging at around 20% CAGR, Mostly from Biopharmaceutical Companies

  • January-2021
  • PMRREP12142
  • 272 Pages
  • Healthcare
  • PPT, PDF, WORD, EXCEL

About the Report

Increasing commercial manufacturing of biopharmaceuticals along with academic biotechnology research & development activities is creating huge opportunities for single-use bioprocess systems. Besides, the advantage of lower cross-contamination chances of using disposable bioprocess products increases the demand for single-use bioprocess systems. Leading biopharma companies are focusing on strengthening their product reach in different countries across the world through various distribution channels. Some companies are focusing to collaborate directly with academic institutions to enhance their industrial research activities in single-use bioprocess system development. On the other hand, few players are focused to modify & to develop a strong product portfolio by launching new innovative products in the global market.

In its new study, the consulting firm Persistence Market Research offers insights about key factors driving demand for single-use bioprocess systems. The report tracks the global sales of single-use bioprocess systems in 20+ high-growth markets, along with analyzing the impact of COVID-19 on the biopharmaceutical industry in general, and single-use bioprocess systems in particular.

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Companies

  • Thermo Fisher Scientific Inc.
  • Sartorius Stedim Biotech
  • Danaher Corporation
  • Merck Millipore
  • Eppendorf AG
  • Celltainer Biotech B.V.
  • Applikon Biotechnology
  • Cellexus Ltd.
  • Parker Hannifin Corp
  • Mettler-Toledo International, Inc.

Historical Trends Positive, But Future Outlook Even Brighter

Drug developers and biopharmaceutical manufacturers are constantly looking forward to the development and production of biosimilars. Increasing government initiatives for continuous biosimilar manufacturing in large amounts to meet growing patient needs has led to a surge in demand for single-use bioprocess systems.

For instance, the U.S Food and Drug Administration’s process analytical technology (PAT) initiative for upstream bioprocessing promotes improved process understanding of process analytical technology toward the production of high-quality mAbs and recombinant proteins.

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According to Persistence Market Research’s analysis, single-use bioprocess system sales have grown at 14% CAGR over the past 5 years.

Rapid process improvement for continuous biologics production over the years and rising demand for disposable bioprocess technologies are key factors responsible for high market growth.

Further, increasing biotechnology research & development activities around the globe are also expected to accelerate demand for single-use bioprocess systems during the forecast period. Leading biopharmaceutical companies are also looking forward to establish their manufacturing plants in emerging countries of the world, such as India and China, where the cost of production is comparatively low, due to which, production capacity can be increased with comparatively lower investments. These developments present a positive growth outlook for the market, which is expected to expand at close to 20% CAGR through 2030.

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Will Increasing Prevalence of Chronic Diseases Influence Demand for Single-use Bioprocess Systems?

Chronic diseases such as cancer, diabetes, stroke, and heart diseases requires biological drugs for their management and treatment. Low-cost manufacturing of biologics using disposable bioprocessing products and increasing chronic disease patient population are factors that drive demand for single-use bioprocess systems. Rise in demand for biologics in large amounts to meet the global need is also accelerating the growth of the single-use bioprocess systems market. Increasing demand for continuous manufacturing of biologics with high speed and low contamination chances are further complementing market expansion.

For instance, according to WHO, globally, the number of deaths from cancer will continue to rise and reach around 13.1 billion by 2030. It also suggests that, global cancer prevalence will increase by around 75% from 2008 to 2030. A rapid growth in incidence of cancer across the globe will lead to increased number of patients who will undergo cancer management and treatment. This, in turn, would increase demand for biologics, thereby driving the expansion of the single-use bioprocess systems market size over the coming years.

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Why are R&D Investments Key to Single-use Bioprocess Systems?

Single-use bioprocess system manufacturers are investing in research & development processes that can create sustainable solutions for life science and biopharmaceutical manufacture and production. Sustainable single-use bioprocess solutions, including bioprocess containers, transfer and storage bags, recyclable plastics, etc., address sustainability concerns by lowering environmental impact and increasing the recycling rate.

Manufacturers are also keen on investing in innovation and products that address key recycling challenges, such as recycling of multi-layer containers and bags that comprise base material plastic and barrier material. Segregation of multi-layer flexible vessel storage solutions is increasingly being observed as a key issue in the sustainable bioprocessing ecosystem. However, growing trend of sustainable single-use bioprocess products is expected to result in market players investing in research & development targeted at sustainable solutions.

What is the Commercial Potential of Disposable Bioprocess Technology?

Use of stainless steel reusable bioreactors in conventional bioprocessing systems has a lot of disadvantages. Introduction of single-use bioprocess systems having advantages of reduced contamination, no cleaning efforts and sterilization need, and potential cost savings as compared with those of traditional stainless steel mixers is a factor expected to drive market growth. Use of disposable products for bioprocessing application enhances upstream and downstream processes with better safety, sterility, and reliability.

As the quality of biopharmaceutical manufacturing continues to improve across the world, it is anticipated that the global single-use bioprocess systems market will benefit from growth in demand for newer and better pharmaceutical manufacturing solutions.

What is the Impact of Expansion of Bioprocess Facilities by Key Manufacturers on the Market?

Majority of companies are expanding their existing services in untapped regions to maintain or gain market share. Substantial investments in the expansion of single-use bioprocess product manufacturing facilities is one of the major trends among key players in the global market. Leading companies are looking forward to holding a strong position in the international market by opening new product distribution facilities.

  • For instance, in September 2020, Thermo Fisher Scientific announced the opening of its new Bioprocessing Collaboration Center (BCC) in St. Louis.
  • In June 2017, Parker Hannifin, created a new parker bioscience filtration division in Birtley, the U.K., and Oxnard, California, the U.S., to deliver international bioprocessing, food and beverage, and healthcare solutions.

How is New Product Development Accelerating Demand for Single-use Bioprocess Systems?

Single-use bioprocess systems have been used increasingly, both, in commercial and clinical biomanufacturing. Major advantages of single-use bioprocess systems include elimination of batch-to-batch cross-contamination, relatively low capital investment, reuse of cleaning validation efforts, shortened product lifecycle, and greater flexibility in the manufacturing process. Consequently, enormous product development activities have been made in single-use bioprocess systems, allowing manufacturers to adopt the technology in critical applications within their commercial-scale facilities. Manufacturers are now focusing on introducing new technological advanced single-use bioprocess systems to enhance the efficacy and reliability of bioprocessing.

  • For instance, in January 2017, Eppendorf AG launched the new advanced BioFlo 120 fermenter/bioreactor instrument, capable of microbial fermentation as well as mammalian cell culture applications for research & development.

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Country-wise Insights

Why is there Huge Opportunity for Single-use Bioprocess Systems in the U.S.?

Persistence Market Research has projected North America to remain as one of the most lucrative markets throughout the forecast period. One of the key factors supporting expansion is the U.S’s high spending in healthcare. As per forecasts by CMS’ Office of the Actuary, overall healthcare spending has increased faster  at around 4.6% in 2019 than the overall economic growth of 4.0% in the United States measured by Gross Domestic Product (GDP) in 2019.

Furthermore, the U.S. remains one of the largest markets biopharmaceuticals in the world, which invariably makes it a lucrative pocket for single-use bioprocess system manufacturers. According to the CRS report, annual cost of some biologic medications in the U.S., such as Vimizim (elosulfase alfa) and Soliris (eculizumab), exceeds US$ 250,000 per patient. Further, in the U.S, spending on biologics was totaled at around US$ 120.1 Bn in 2017, a 12.5% increase over 2016, which is indicative of remarkable scope for the expansion of product portfolios and services for key single-use bioprocess system market players.

High per capita healthcare spending and favourable healthcare policies have created a conducive environment for the adoption of single-use bioprocess systems in the U.S. Also, the presence of leading players such as Thermo Fisher Scientific and Danaher Corporation is supporting growth in the U.S. Key business strategies followed by these companies include product launches and expansion plans, which will continue aiding overall expansion in the U.S.

How is the Presence of Key Market Players Shaping the German Single-use Bioprocess Systems Market?

Rise in biopharmaceutical and biotech companies in large numbers is expected to accelerate single-use bioprocess system sales in Germany. Further, the presence of three big single-use bioprocess systems market players such as Sartorius AG, Merck KGaA, and Eppendorf AG is also supporting market expansion. According to data from Statista, the number of dedicated biotech companies in Germany was 593 in 2015, which increased to 679 in 2018.

Growing life science research & development activities in Germany and the presence of a large number of small and big market players are also creating a lucrative landscape for single-use bioprocess systems. Increasing recognition for disposable bioprocess products and higher manufacturing capacities are some of the factors creating high demand for single-use bioprocess systems

Will China’s High Export Capability Aid its Single-use Bioprocess Systems Market?

China is known for its high export activities of biopharmaceuticals and Active Pharmaceutical Ingredients (APIs) for chemical drugs. Presently, China exports almost five types of biopharmaceutical products such as therapeutic antibodies, bio-chemicals, vaccines, recombinant insulin, and blood products. China is considered as the second-largest market for pharmaceuticals. Manufacturers in the West are moving toward China and looking for large-scale investments to expand their bioprocess business in the country.

  • For instance, Sartorius opened a bioprocessing tech support centre in Zhangjiang, Shanghai China, in July 2019. The company planned to open this tech support centre within six months due to robust growth of its bioprocessing business and gradual commercialization of its biopharma projects in China in a year.

How are Government Initiatives Boosting Single-Use Bioprocess Systems in India?

Increasing government programs to provide affordable and quality healthcare are expected to complement growth of India's biopharma as well as single-use bioprocess systems market. High adoption of generic drugs in India also fuels demand for single-use bioprocess systems. Moreover, India is also considered as one of the top 12 destinations for biotechnology research in the world, increasing the need for single-use bioprocess systems in the region. Increasing patient pool due to rise in population, emergence of new diseases, and lifestyle changes are also boosting demand for biopharmaceuticals, which is expected to provide high opportunity for providers of single-use bioprocess systems.

Category-wise Insights

What’s the Market Share of Bioreactors?

The bioreactor segment will continue accounting for around half of the global share among components through the forecast period. According to Persistence Market Research, the segment is expected to hold around 45% of the market, in terms of component, in the year 2020. Single-use bioreactors offer greater precision and straightforward usage, along with having low cross-contamination chances, which are the leading factors behind the dominance of this segment.

Increasing use of bioreactors in cell culture and fermentation processes to reduce manufacturing time, ensure safety, and make do with low capital investment are major factors behind the high revenue share of the segment.

Why Does GMP and Commercial Production Hold High Share?

Accounting for around 72% of overall market share through the forecast period, GMP and commercial production continues to account for bulk use of single-use bioprocess systems. Growing adoption of single-use bioprocess systems by the pharmaceutical industry for continuous manufacturing is likely offering impressive growth to the market. Single-use bioprocess technology offers several advantages such as elimination of batch-to-batch cross-contamination, relatively low capital investment, reuse cleaning validation efforts, and greater flexibility to the GMP and commercial production of the biologics in large quantities.

The fast-growing market of biopharmaceutical manufacturing is also looking forward to advanced technology to maintain consistency and high volumetric productivity. Single-use bioprocess systems are widely being accepted by several emerging pharma companies due to lower cross-contamination risk, lesser required maintenance, and faster installation advantages.

Competitive Landscape

Companies operating in the single-use bioprocess systems market are aiming at the strategic acquisition of medium and small manufacturers to expand their product manufacturing and address the demand of an expanding patient pool.

  • For instance, in January 2021, Thermo Fisher Scientific completed the acquisition of Halogen, Novasep's viral vector manufacturing business in Belgium.
  • In July 2020 Merck KGaA acquired Raman Technology Sensor to expand its bioprocessing business.

Manufacturers are also focusing on the expansion of their product portfolios by launching new technologically advanced products.

  • For instance, in May 2018, Parker Bioscience Filtration Division launched a new system SciLog SciPure FD System, an automated single-use system for the filtration and dispensing of products into either bottles or bags
  • Meanwhile, in February 2020, Eppendorf launched its SciVario twin bioprocess control system. This twin bioprocess control system supports glass and single-use bioreactors, and can run cell culture as well as microbial applications without any hardware modifications.

Some of the leading companies operating in the market are:

  • Thermo Fisher Scientific Inc.
  • Sartorius Stedim Biotech
  • Danaher Corporation
  • Merck Millipore (Merck Group)
  • Parker Hannifin Corp
  • Mettler-Toledo International, Inc.
  • Eppendorf AG
  • Celltainer Biotech B.V.
  • Applikon Biotechnology
  • Cellexus Ltd.

*The list is not exhaustive, and only for representational purposes. Full competitive intelligence with SWOT analysis available in the report.

Scope of Report

Attribute

Details

Forecast Period

2020-2030

Historical Data Available for

2015-2019

Market Analysis

USD Million for Value and Units for Volume

Key Regions Covered

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania
  • Middle East & Africa

Key Countries Covered

  • US
  • Canada
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Russia
  • China
  • Japan
  • South Korea
  • India
  • Thailand
  • Malaysia
  • Indonesia
  • Australia
  • New Zealand
  • GCC Countries
  • Turkey
  • Northern Africa
  • South Africa

Key Segments Covered

  • Component
  • Application
  • End User
  • Region

Key Companies Profiled

  • Thermo Fisher Scientific Inc.
  • Sartorius Stedim Biotech
  • Danaher Corporation
  • Merck Millipore (Merck Group)
  • Parker Hannifin Corp
  • Mettler-Toledo International, Inc.
  • Eppendorf AG
  • Celltainer Biotech B.V.
  • Applikon Biotechnology
  • Cellexus Ltd.

Report Coverage

  • Market Forecast
  • Company Share Analysis
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives

Customization & Pricing

Available upon Request

Single-Use Bioprocess Systems Market by Category

Component

  • Bioreactors
    • Cell Culture Bioreactors
    • Fermentation Bioreactors
  • Mixers
  • Bioprocess Containers
  • Transfer and Storage Bags
  • Sampling Systems
  • Filtration Systems
  • Chromatography Columns
  • Probes & Sensors
  • Tubing Assemblies
  • Connectors & Clamps
  • Filling Systems

Application

  • Research & Development (R&D)
  • GMP and Commercial Production

End-User

  • Biopharmaceutical Companies
  • Contract Research Organizations
  • Contract Manufacturing Organizations
  • Research Institutes

Region

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania
  • Middle East and Africa (MEA)

Key Questions Answered in Report

Q1. Which is the most lucrative market for single-use bioprocess systems?

The U.S. currently leads the global market for single-use bioprocess systems. Sales in the U.S will be around 29% of total demand over the forecast period.

Q2. Which is the top-selling single-use bioprocess system?

Bioreactors are highly sought-after in every market. Demand for bioreactors is expected to remain high in the near future, especially due to ease of usage and commercial demand for cell culture.

Q3. For which application is single-use bioprocess systems mostly used?

GMP and commercial production continues to remain the leading industry with high adoption and use of single-use bioprocess systems. Increasing burden of chronic and lifestyle diseases is likely to accelerate the adoption of single-use bioprocess systems.

Q4. Which are some of the leading companies offering single-use bioprocess systems?

Some of the leading companies offering single-use bioprocess systems are Thermo Fisher Scientific Inc., Sartorius Stedim Biotech, Danaher Corporation, Merck Millipore (Merck Group), and Parker Hannifin Corp, among others.

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Is this research conducted by Persistence Market Research?

Yes, the research has been conducted by expert analysts of persistence market research through a combination of primary research and secondary research. To know more about how the research was conducted, you can speak to a research analyst.

What research methodology is followed by Persistence Market Research?

Persistence Market Research follows a methodology that encompasses the demand-side assessment of the market and triangulates the same through supply-side analysis. This methodology is based on the use of standard market structure, methods and definitions. Request a detailed methodology.

Who are the respondents for primary research?

Persistence Market Research speaks to stakeholders across the spectrum, including C-level executives, distributors, product manufacturers, industry experts. For a full list of primary respondents, please reach out to us.

What are the sources of secondary research?

Persistence Market Research conducts extensive secondary research through proprietary databases, paid databases, and information available in the public domain. We refer to industry associations, company press releases, annual reports, investor presentations, and research papers. More information about desk research is available upon request. 

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