The factor driving the biopharmaceutical tubing market is the increasing pharmaceutical and biopharmaceutical R&D.
Increasing R&D in the pharmaceutical and biopharmaceutical industry is expected to drive market growth in the forecast period
With the rapid growth of single-use systems (SUS) in the biopharmaceutical industry, government and industry groups, have made a massive effort to establish uniform standardization for material integrity and purity for tubing and other components. The common chemical compounds used in pharmaceutical CIP (clean-in-place) and SIP(sterilize-in-place) processes can be transported using silicone tubing and hoses. Special requirements apply to tubing used in pharmaceutical and biotech applications. Among them are the ability to withstand sterilization processes, the delivery of favorable extractable substance test results, and the absence of animal-derived ingredients. These industries also have tubing requirements common to many applications in terms of flexibility, performance, and cost. Many pharmaceutical manufacturers use a peristaltic pump and silicone tubing in their processes. Tubing materials such as TPE’s meet the requirements for a flexible, high purity, peristaltic pump tubing that may be welded and sealed, thereby eliminating multiple materials. Like silicone, certain TPE’s can be molded into connections such as Y’s and T’s, further reducing the need for fittings and the possibility of leaks.
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On October 30, 2018, AdvantaPure launched AdvantaSil Ultra Low-Temperature Silicone Tubing, which can withstand temperatures as low as -112°C. This platinum-cured tubing is intended for single-use, cold temperature applications in biopharmaceutical and pharmaceutical processing, such as bulk drug storage and transport.
The disadvantages or limitations associated with the use of tubing is expected to hamper the global biopharmaceutical tubing market
Most manufacturers of pharmaceuticals and biopharmaceuticals have discovered problems related to animal ingredients and their potential effects on finished products during processing that contain any animal ingredients or animal-derived ingredients. Tubing material can sometimes react with the materials used in the industries. Silicone oils are another potentially hazardous substance. The oils may react with other components, leaving a residue in the finished product. Corrosion/contamination problems in pharma/biotech plants are primarily caused by poor welding and interior tube surfaces. Given that 90 per cent of the contact surface with the product fluid occurs within the tubes and fittings, these components must be manufactured to allow easy and consistent high-quality welding to ensure trouble-free production.
COVID-19 Impact Analysis:
Clinical and regulatory procedures slowed down due to the healthcare system’s shifting priorities, which included reducing the risk of infection to trial patients and delayed inspections of ex-US and ex-EU sites. Commercial launches and supply chain logistics suffered, directly affecting forecast revenues, costs, and margins. Efforts to create a vaccine against the SARS-CoV-2 virus are picking up speed. Traditional vaccines, such as inactivated and attenuated products, are among the candidates. However, the vast majority are more recent DNA, RNA, and protein subunit vaccines. The biotechnology industry has already embraced single-use technologies and is now transitioning to continuous bioprocessing. Hence, the COVID-19 had a mixed impact on the global biopharmaceutical tubing market.
Silicon segment held the largest share in the global biopharmaceutical tubing market
Silicones are one of the most thoroughly tested materials in medical applications. The inherent purity, flexibility, and ease of sterilization of Pt-catalyzed silicone tubing are all advantages. Furthermore, silicone materials are non-toxic and biocompatible, with no negative effects on human health. Resilience, kink resistance, and pressure resistance are also significant advantages of silicone tubing, making it an excellent choice for pharma and biopharma processing. Silicones, classified as thermoset materials, are stable over a wide temperature range, ranging from -80°C to at least 215°C. This silicone class is not sensitizing, pyrogenic, genotoxic, cytotoxic, or hemolytic, and it passes the USP 88 Class VI tests.
For example, On 13 February 2020, Watson-Marlow Fluid Technology Group (WMFTG) launched BioPure silicone transfer tubing, intended to provide a safe, dependable, and cost-effective solution for a variety of bioprocesses fluid transfer applications. The tube provides a wide range of applications, including diagnostics, animal health, and biopharmaceutical R&D. The tubing complies with USP Class VI and contains no animal-derived components. They are manufactured and packed in accordance with EP 3.1.9 in an ISO14644-1 Class 7 cleanroom. The BioPure silicone transfer tubing withstands adverse conditions, it is autoclavable and gamma stable up to 50kGY, making it suitable for even the most demanding bioprocessing applications.
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North America region accounted for the largest market share in the global biopharmaceutical tubing market
The increase in the elderly population in this region is expected to increase geriatric ailments, resulting in a greater demand for diagnostic equipment and drug delivery systems. In the United States, there are more than 46 million older adults aged 65 and older. By 2050, this number is expected to rise to nearly 90 million. As a result, rapid growth in the geriatric population is directly proportional to the rising demand for medical devices that incorporate tubing, drug delivery, dialysis and cardiac bypass, peristaltic pump, and sterile filling and dispensing systems, driving the adoption of biopharmaceutical tubing systems.
The presence of key companies manufacturing biopharmaceuticals in this region is also driving the market growth. For instance, AdvantaPure is NewAge Industries’ high purity products division. It is a U.S based company. Their product AdvantaFlex is a biopharmaceutical grade TPE tubing that is sterile, weldable, and heat sealable. AdvantaFlex is a flexible, translucent, sterilizable, moldable, heat sealable, and weldable biopharmaceutical tubing for fluid processing. Various ISO and USP standards, including Class VI, are met. It meets 18.104.22.168 European Pharmacopoeia standards and is Compliant with REACH, RoHS, and California Proposition 65.
The global biopharmaceutical tubing market is moderately competitive with limited ISO and USP product approvals, company acquisitions and mergers. Some of the major key players in the global biopharmaceutical tubing market are W. L. Gore and Associates, Inc., Freudenberg Group, RAUMEDIC AG, TEKNI-PLEX, NewAge Industries, Inc., Optinova, Zeus Industrial Products, Inc., NORDSON CORPORATION, Watson-Marlow Fluid Technology Group and DuPont de Nemours, Inc.
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