Bioprocess Containers Market

Market Overview

The global bioprocess containers market size was valued at USD 2.8 billion in 2022, registering a CAGR of 14.50% during the forecast period (2023-2031). The bioprocess containers market is expected to expand due to lower cross-contamination risk and rising demand for biological products; the shift toward single-use technologies allows shorter production timelines and the increasing privatization of laboratory services.

Bioprocess or single-use or disposable bioprocess containers are specialized containers and bags used in biopharmaceutical manufacturing and bioprocessing applications. These containers are built of biocompatible materials and are used to store, transport, and process biopharmaceutical items such as cell culture media, buffers, vaccines, monoclonal antibodies, and other biologics. Bioprocess containers protect the sterility and integrity of biopharmaceutical materials and processes.

Global market share is expected to rise at 14.50% CAGR due to Lower cross-contamination risk and rising demand for biological products. Biologics and biosimilars will drive the global market throughout the forecast period. The market also expands because the shift toward single-use technologies allows shorter production timelines. The increasing privatization of laboratory services is another key element driving the expansion of the international bioprocess container market.

Market Dynamics

Market Drivers

Rapid Growth in Biopharmaceuticals

The biopharmaceutical industry's rapid expansion is a primary driver of the global bioprocess containers market. Because of their effectiveness in treating numerous diseases and ailments, biopharmaceuticals such as monoclonal antibodies, vaccines, gene therapies, and cell-based therapies have acquired importance in the healthcare business. This surge in demand for bioprocess containers to enable bioprocessing and manufacturing. The COVID-19 pandemic underscored the relevance of biopharmaceuticals, with numerous COVID-19 vaccines and treatments dependent on bioprocessing technologies and bioprocess containers.

Biopharmaceutical businesses are rapidly spending on the research and development of innovative medicines, necessitating bioprocess containers to aid in producing these advanced biologics. As a result, the pandemic has accelerated the Bioprocess containers Market trend. The need for bioprocess containers is predicted to rise in tandem with the growth of the biopharmaceutical business.

Market Restraints

Regulatory Compliance

While strict regulatory regulations are required to protect the safety and quality of biopharmaceutical products, they can also pose obstacles and complications for bioprocess container producers and users. To show the safety and performance of their goods, bioprocess container manufacturers must execute intensive validation methods. This comprises sterilizing process validation, extractable and leachable testing, and compatibility investigations. These procedures can take a long time and require many resources. According to the FDA's "Process Validation: General Principles and Practices" guidance, process validation is vital in ensuring the quality of pharmaceutical products. A set of actions and tests are performed to demonstrate that a manufacturing process consistently generates a product that meets the predetermined standards. Bioprocess container makers must follow such guidelines.

The International Council for Harmonisation (ICH) establishes Good Manufacturing Practice (GMP) guidelines for the pharmaceutical industry. These requirements require strong documentation and record-keeping practices to maintain product quality, safety, and traceability. Regulatory organizations conduct audits and inspections of biopharmaceutical production facilities to guarantee quality and safety standards compliance. Companies that use bioprocess containers should be ready for such audits. Regulatory agencies, such as the FDA in the United States and the European Medicines Agency (EMA) in Europe, audit manufacturing sites regularly to ensure compliance with regulations. Noncompliance may result in regulatory action. The Market growth is projected to be hampered by these issues.

Market Opportunities

Emerging Markets

Emerging areas, particularly in Asia-Pacific, Latin America, and the Middle East, offer tremendous growth potential for the worldwide Industry. These markets are seeing an increase in biopharmaceutical manufacturing and research, and bioprocess container manufacturers can use this to enhance their market position. Biopharmaceutical production in Asia-Pacific countries such as China, India, and South Korea has increased significantly. Factors such as a huge patient population decreased manufacturing costs, and more investments in healthcare infrastructure are driving this expansion. Furthermore, the Middle East is emerging as a manufacturing hub for pharmaceuticals, particularly biopharmaceuticals. Countries such as the UAE are investing in superior healthcare infrastructure and research centers to support biopharmaceutical development. Several emerging markets promote indigenous biopharmaceutical production to lessen reliance on imported drugs. As a result, local manufacturing facilities have been established, and demand for bioprocess containers has surged. 

Bioprocess container manufacturers can capitalize on these opportunities by establishing a strong presence in these regions, providing cost-effective solutions, and collaborating with local stakeholders to meet the growing demand for bioprocess containers while supporting the development of advanced biopharmaceutical products.

Regional Analysis

The global bioprocess containers market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America holds a sizeable global market share and is expected to boost at a CAGR of 14.70% during 2023 to 2031. The North America Bioprocess Containers market is expected to develop significantly during the study period. This is due to the increased demand for biopharmaceuticals in the United States due to an aging population and enhanced healthcare infrastructure. Furthermore, the existence of key companies focusing on research activities, as well as massive investments in healthcare by US-based manufacturers, contribute to the market's impressive global expansion.

The United States is likely to hold a very considerable market share in the market in the North American area because of the large investment in biologics, the country's high number of biologics approvals, and the rising burden of chronic diseases. For example, Catalent announced plans to invest around USD 350 million in its Bloomington, Indiana site to increase biologics therapeutic ingredient and product production capabilities in April 2022. The project will provide new bioreactors, syringe filling lines, and more lyophilization capacity to the industry's robust biologics pipeline across many modalities, supported by quality control laboratories and complicated automated packaging. As a result of the factors above, the North American region will likely hold a large proportion of the bioprocess containers market over the forecast period, with the United States being a key market for bioprocess containers.

Europe Bioprocess Containers Industry share is predicted to rise at a substantial CAGR of 14.40% throughout the forecast period. Europe's market accounts for the second-largest market share; the substantial presence of biotech enterprises fuels the market's expansion. Major European players are focusing more on developing innovative bioprocess containers to improve operational efficiency, which is vital for market growth. Furthermore, rising demand for biological goods and biopharmaceuticals propels the region's bioprocess container market forward.

Furthermore, the UK Bioprocess Europe industry is a vibrant and expanding segment of the biopharmaceutical industry. The benefits of single-use systems, greater biopharmaceutical production, and an emphasis on efficiency and flexibility drive its rise. Companies must negotiate tight regulatory standards while adjusting to changing industry trends in this market.

The Asia-Pacific Bioprocess Containers Market is expected to develop at the quickest CAGR of 15.70% over the projected period, owing to rising R&D activity, improved pharmaceutical infrastructure, and comparatively low labor costs. Merck, for example, built its first collaborative bioprocess scale-up facility with Stelis Biopharma in Bangalore, India, in May 2017, delivering an end-to-end solution for preclinical, clinical, and commercial supplies. Furthermore, the China Bioprocess Containers market held the greatest market share, while the India Bioprocess Containers market was the Asia-Pacific region's fastest expanding market. Rise in key player investment, increase in RandD spending by pharmaceutical corporations, and increasing biopharmaceutical industry provide lucrative bioprocess containers market possibilities in the area.

In addition, based on the market insights, the region's key markets are China and India. Factors such as greater disposable income, healthcare awareness, and government support for biopharmaceutical research propel the Asia-Pacific biopharmaceutical business forward. The number of CROs and CMOs that require single-use bioprocess containers in their manufacturing processes is also rapidly increasing in the region. Because of affordable skilled labor, low production costs, and government incentives to promote international investors in the pharmaceutical sector, China and India provide numerous prospects for outsourcing manufacturing operations. Key market players also concentrate on growing their presence in Asia-Pacific through partnerships, acquisitions, and contract manufacturing agreements with local firms.

The CAGR for the Bioprocess Containers Market in the Middle East and Africa (MEA) is projected as 13.90%, while in the Latin America (LATAM) region, it will be at 13.60%. Latin American countries have regulatory authorities that regulate biopharmaceutical production, such as ANVISA in Brazil and COFEPRIS in Mexico. Compliance with international quality and safety requirements, notably those about single-use bioprocess containers, is critical for market participants operating in the region.

Segmental Analysis

The global market for bioprocess containers is segmented based on type, capacity, application, and end-user.

The type is further segmented into 2D Bioprocess Containers, 3D Bioprocess Containers, and Others.

2D Bioprocess Containers hold the major market share.

2D bioprocess containers are single-layered, flat bags or containers commonly used in biopharmaceutical manufacturing. They are commonly used in storing and transporting liquids or cell cultures. 3D bioprocess containers are multi-layered, three-dimensional containers with more complicated geometries and configurations than 2D containers. They are built to accommodate a variety of procedures and equipment.

By capacity, the market is sub-segmented into Small Volume and large Volume.

Large Volume is a significant contributor to the market

Large-volume bioprocess containers are made to hold large amounts of liquids, cell cultures, or biopharmaceutical products. They are employed for commercial production in large-scale biomanufacturing facilities. Small-volume bioprocess containers are intended for operations that require only a small amount of liquid or culture material. They are commonly utilized in small-scale biopharmaceutical production, R&D, and clinical trials.

The segment can be bifurcated by application into Upstream processes, downstream processes, and process development.

Upstream processes are the most commonly used application in the market

In biopharmaceutical production, upstream processes include cultivating and developing cells or microorganisms to produce the desired biological output. Cell culture, fermentation, and cell multiplication are examples of such activities. Purification and isolation of the biological product from the cell culture or fermentation broth are downstream processes. Filtration, chromatography, and other separation techniques are included.

Based on end-users, the market is fragmented into Pharmaceutical and biotechnology companies, CROs and CMOs, and academic and research institutes.

Pharmaceutical and biotechnology companies are the leading end-users in the market.

Pharmaceutical and biotechnology companies are key actors in the biopharmaceutical industry. They research, develop, and commercialize biological medications and therapies. CROs and CMOs offer specialized services to the pharmaceutical and biotechnology industries. CROs concentrate on research and development, whereas CMOs specialize in contract manufacturing of biopharmaceutical goods.

Recent Developments

• In August 2023, Vscan Air SL, a Wireless Handheld Ultrasound Device for Rapid Assessments of Cardiac and Vascular Patients, was introduced by GE HealthCare.
• In June 2023, Merck invested approximately € 70 million in China to expand reagent manufacturing.
• In August 2023, Thermo Fisher Scientific Introduced the EXENT® Solution with IVDR Certification.