Global Single-use Bioprocessing Market Growth, Share, Size, Trends and Forecast (2024 - 2030)

The global single-use bioprocessing market has witnessed significant growth over the past decade, driven by several factors including the rising demand for biopharmaceuticals, advancements in technology, and increasing focus on cost-effectiveness and efficiency in bioprocessing operations. Single-use bioprocessing systems offer numerous advantages over traditional stainless steel systems, such as reduced risk of cross-contamination, lower capital investment, and faster setup times. These benefits have led to widespread adoption across various stages of bioproduction, from research and development to commercial manufacturing.

One of the key drivers of market growth is the expanding biopharmaceutical industry, which continues to develop innovative therapeutics such as monoclonal antibodies, vaccines, and cell and gene therapies. Single-use bioprocessing technologies enable biopharmaceutical companies to accelerate their production timelines, respond to changing market demands more effectively, and enhance flexibility in manufacturing operations. Additionally, the scalability of single-use systems allows manufacturers to quickly adapt to fluctuations in production volumes, thereby improving overall efficiency and reducing time-to-market for new drugs.

Sringent regulatory guidelines and quality standards imposed by regulatory authorities such as the FDA and EMA have encouraged the adoption of single-use bioprocessing technologies. These systems offer enhanced control over process parameters, leading to consistent product quality and reduced risk of product contamination. Furthermore, the growing trend towards personalized medicine and the increasing use of biological drugs for the treatment of various diseases are expected to further drive the demand for single-use bioprocessing solutions in the coming years.

Despite the numerous advantages offered by single-use bioprocessing systems, challenges such as concerns regarding extractables and leachables, limited scalability for large-scale manufacturing, and the lack of standardized components remain significant barriers to market growth. However, ongoing research and development efforts aimed at addressing these challenges, coupled with advancements in material science and manufacturing technologies, are expected to drive further innovation and expansion in the global single-use bioprocessing market.

Global Single-use Bioprocessing Segment Analysis

In this report, the Global Single-use Bioprocessing Market has been segmented by Workflow, End Use and Geography.

Global Single-use Bioprocessing Market, Segmentation by Workflow

The Global Single-use Bioprocessing Market has been segmented by Workflow into Upstream, Fermentation and Downstream.

The upstream segment encompasses processes involved in cell culture, including cell expansion, media preparation, and inoculum development. Single-use bioreactors and disposable bags are extensively used in upstream workflows due to their flexibility, scalability, and cost-effectiveness. These technologies enable biomanufacturers to rapidly adapt to changing production needs, reduce the risk of contamination, and lower operational costs associated with cleaning and validation.

In the fermentation stage, single-use bioprocessing technologies play a critical role in microbial fermentation and cell culture processes. Single-use bioreactors, mixing systems, and filtration units are commonly employed to facilitate efficient nutrient delivery, oxygenation, and agitation, thereby optimizing cell growth and product yield. The adoption of single-use fermentation technologies is driven by their ability to streamline operations, minimize cross-contamination risks, and accelerate time-to-market for biopharmaceutical products.

Downstream processing involves the purification and isolation of biopharmaceutical products from the fermentation broth or cell culture supernatant. Single-use chromatography columns, filtration systems, and disposable tubing assemblies are widely utilized in downstream workflows to achieve high product purity and yield while reducing the need for cleaning and validation. These single-use solutions offer greater flexibility, process consistency, and cost-efficiency compared to traditional stainless-steel equipment, making them increasingly preferred by biopharmaceutical manufacturers.

Global Single-use Bioprocessing Market, Segmentation by End Use

The Global Single-use Bioprocessing Market has been segmented by End Use into Biopharmaceutical Manufacturer, Academic & Clinical Research Institutes and Others.

Biopharmaceutical manufacturers represent a major end-use segment within the single-use bioprocessing market. These manufacturers rely on single-use technologies to streamline their production processes, enhance flexibility, and reduce operational costs. The shift towards single-use bioprocessing systems among biopharmaceutical companies is primarily driven by the need for efficient and scalable manufacturing solutions to meet the growing demand for biologics and biosimilars.

Another significant end-use segment is academic and clinical research institutes. These institutions play a crucial role in advancing scientific knowledge and developing new therapies. Single-use bioprocessing technologies offer several advantages to academic and research settings, including simplified workflow, reduced risk of cross-contamination, and lower capital investment compared to traditional stainless-steel systems. As a result, academic and clinical research institutes are increasingly adopting single-use bioprocessing solutions to support their research activities.

The market includes other end-use sectors such as contract manufacturing organizations (CMOs), contract research organizations (CROs), and biotechnology startups. These entities often require flexible and cost-effective manufacturing solutions to support their varied production needs. Single-use bioprocessing technologies provide them with the agility to scale production capacity quickly, accommodate varying batch sizes, and minimize the risk of product cross-contamination.

Global Single-use Bioprocessing Market, Segmentation by Geography

In this report, the Global Single-use Bioprocessing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Single-use Bioprocessing Market Share (%), by Geographical Region, 2023

North America holds a substantial share in the global single-use bioprocessing market, primarily due to the presence of a well-established biopharmaceutical industry and a high level of adoption of advanced bioprocessing technologies. Additionally, favorable regulatory policies and increasing investments in research and development activities further contribute to market growth in this region.

Europe is another prominent market for single-use bioprocessing solutions, driven by a strong biotechnology sector and growing demand for biopharmaceutical products. Countries like Germany, the UK, and France are witnessing significant investments in bioprocessing technologies, leading to the expansion of the market. Moreover, collaborations between academic institutions, research organizations, and industry players are fostering innovation and driving market growth.

The Asia Pacific region is emerging as a lucrative market for single-use bioprocessing, propelled by rapid industrialization, increasing healthcare expenditure, and rising investments in biotechnology and pharmaceutical sectors. Countries such as China, India, and Japan are witnessing a surge in demand for bioprocessing technologies, driven by the growing need for affordable healthcare solutions and the presence of a large patient pool.

The Middle East and Africa, along with Latin America, are also experiencing steady growth in the single-use bioprocessing market. Factors such as government initiatives to promote the biopharmaceutical industry, expanding healthcare infrastructure, and rising investments in research and development activities are contributing to market expansion in these regions.

This report provides an in depth analysis of various factors that impact the dynamics of Global Single-use Bioprocessing Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers

• Biopharmaceutical industry growth
• Cost-effectiveness
• Technological advancements
• Regulatory support

• Increasing demand for vaccines: The global single-use bioprocessing market is experiencing significant growth, primarily driven by the increasing demand for vaccines. With the ongoing COVID-19 pandemic and the need for rapid vaccine development and manufacturing, the biopharmaceutical industry has turned to single-use bioprocessing technologies to streamline production processes. These technologies offer advantages such as reduced risk of cross-contamination, shorter setup times, and increased flexibility, making them ideal for the fast-paced production of vaccines. Additionally, single-use bioprocessing systems help manufacturers scale up production quickly to meet the high demand for vaccines worldwide. As a result, the market for single-use bioprocessing equipment and consumables is expected to continue expanding as biopharmaceutical companies invest in infrastructure to enhance their manufacturing capabilities.

  The increasing prevalence of infectious diseases and the rising awareness of the importance of vaccination programs in preventing their spread are driving the demand for vaccines globally. Governments, healthcare organizations, and pharmaceutical companies are collaborating to develop and distribute vaccines to combat diseases such as influenza, measles, hepatitis, and human papillomavirus (HPV), among others. Single-use bioprocessing technologies play a crucial role in this endeavor by enabling efficient and cost-effective vaccine production. As the global population continues to grow, along with the need for immunization against both existing and emerging infectious diseases, the demand for vaccines is expected to rise further, driving the growth of the single-use bioprocessing market. In essence, the synergy between the demand for vaccines and the adoption of single-use bioprocessing technologies underscores the pivotal role these technologies play in meeting the world's healthcare needs.

Restraints

• Environmental concerns
• Quality concerns
• Lack of standardization
• Material compatibility issues

• Limited scalability: The global single-use bioprocessing market has witnessed significant growth in recent years, driven by its advantages such as reduced contamination risks, lower operational costs, and faster turnaround times. However, one of the key challenges faced by this market is limited scalability. While single-use bioprocessing systems excel in small to medium-scale production, they encounter limitations when it comes to large-scale manufacturing. Scaling up single-use systems to meet the demands of large-scale production often proves to be complex and costly.

  The scalability issue extends beyond the physical infrastructure to include concerns regarding process consistency, reliability, and regulatory compliance. Ensuring consistent product quality and maintaining regulatory compliance become more challenging as the scale increases. As a result, some biopharmaceutical companies may hesitate to fully adopt single-use bioprocessing technologies for large-scale production, opting instead for traditional stainless-steel systems or hybrid approaches that combine single-use and stainless-steel components. Addressing the scalability limitations through technological advancements and regulatory frameworks will be crucial for the continued growth and adoption of single-use bioprocessing in the global biopharmaceutical industry.

Opportunities

• Emerging markets expansion
• Customization options
• Adoption in cell therapy
• Continuous manufacturing adoption

• Contract manufacturing services demand: The global single-use bioprocessing market has witnessed substantial growth in recent years, primarily driven by the increasing adoption of single-use technologies across the biopharmaceutical industry. These technologies offer several advantages, including reduced risk of cross-contamination, lower operational costs, and enhanced flexibility in manufacturing processes. As biopharmaceutical companies strive to expedite production processes while maintaining stringent quality standards, the demand for single-use bioprocessing solutions continues to rise.

  In parallel, there has been a notable surge in demand for contract manufacturing services within the biopharmaceutical sector. Biopharmaceutical companies are increasingly outsourcing manufacturing activities to contract development and manufacturing organizations (CDMOs) to leverage their expertise, infrastructure, and scalability. This trend is fueled by factors such as the complexity of biopharmaceutical manufacturing processes, the need for specialized facilities and equipment, and the desire to focus on core competencies. CDMOs offer a range of services, including process development, manufacturing, and analytical testing, enabling biopharmaceutical companies to accelerate product development timelines and mitigate risks associated with in-house manufacturing. As the biopharmaceutical industry continues to expand and diversify, the demand for contract manufacturing services is expected to remain robust, driving further growth in the global single-use bioprocessing market.

Key players in Global Single-use Bioprocessing Market include:

• General Electric Company (GE healthcare)
• Eppendorf AG
• Corning Incorporated
• Thermo Fisher Scientific, Inc.
• Sartorius AG
• Merck KGaA
• LONZA
• Boehringer Ingelheim GmbH
• Danaher Corporation
• MEISSNER FILTRATION PRODUCTS, INC

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis