Global Single-use Pumps in the Biopharmaceutical Market Research Report: Forecast (2022-2027)

Market Definition

Pumps are used in the biopharmaceutical industry for the transfer of fluids such as buffer & media through the tubing & deliver them to process equipment. The single-use pump is a disposable pump & a vital component of the single-use technology sector. These single-use pump chambers eliminate traditional cleaning expenses & enable fast changeovers during the production process. Therefore, on account of increasing flexibility & reduction in batch timings, the single-use pumps would experience a flourishing growth in the coming years.

Market Insights

The Global Single-use Pumps in the Biopharmaceutical market is projected to grow at a CAGR of around 6.21% during the forecast period, 2022-2027. The market experienced a flourishing growth during the historical period, owing to increasing biopharma product manufacturing & other advantages associated with the single-use systems, such as flexibility, scalability, etc., in various developed & emerging economies. The majority of biopharmaceutical processes use single-use technologies, including mammalian cell culture, both upstream & downstream.

Moreover, the rising adoption of single-use systems for producing various modalities such as conventional vaccines, monoclonal antibodies, and mRNA-based vaccines in developing nations ultimately drove the demand for single-use pumps across the globe. According to the International AIDS Vaccine Initiative (IAVI), in 2019, there were eight operational monoclonal antibody manufacturing facilities in Argentina, Brazil, China, India, Japan, and Singapore, while five facilities are under construction in these regions.

Further, single-use pumps are expected to have a prominent demand during the forecast period on account of rising acceptance of single-use systems in biopharma facilities & growing biopharma contract development & manufacturing organizations. Furthermore, biopharma companies have shifted their interest toward contract manufacturing & development facilities, which would present a positive growth outlook for single-use systems during 2022-27.

Key Trend in the Market

• Increasing Demand for mRNA-based Vaccines

The demand for the mRNA-based vaccines was boosted during the COVID-19 pandemic, owing to the successful manufacturing of the mRNA-based Moderna & Pfizer BioNTech vaccines, which provide approximately 94% effectiveness to fully vaccinated adults. Further, these vaccines are easier & quicker to produce than traditional vaccines & are manufactured using readily available raw materials. Additionally, the high effectiveness of mRNA-based vaccines against coronavirus has further accelerated researchers' fascination to pursue mRNA platforms for treating infectious diseases.

Moreover, the adoption of single-use pumps would enable mRNA manufacturers to eliminate the risk of contamination & provide several other benefits. Thus, the growing investments & the shift towards mRNA-based vaccines are expected to enhance the demand for single-use pumps during the forecast period.

Impact of Covid-19 on the Global Single-use Pumps in the Biopharmaceutical Market

The outbreak of COVID-19 prompted biopharmaceutical companies to focus on stopping the spread & replication of the virus worldwide. Meanwhile, the biopharmaceutical industry was leading its way in developing & manufacturing vaccines, diagnostics & treatments to combat the widespread of COVID-19. Therefore, rising R&D in the field of therapeutics led to the approval of COVID-19 vaccines manufactured by companies such as Pfizer-BioNTech, Janssen, and Moderna COVID-19 vaccines, as of March 2021. Furthermore, the pandemic resulted in the rapid scaling up of biopharmaceutical production activities, which ultimately led to the increased demand for products such as single-use systems.

Additionally, among all the products required, single-use systems acquired high demand due to benefits associated with them, such as eliminating the risk of cross-contamination, lower manufacturing costs, and increase in production speed & facility. Besides, with the rise in single-use systems, single-use pumps also experienced a substantial increase as it eliminates the cleaning & sterilization cycles in the upstream & downstream processing.

Market Segmentation

Based on Material:

• Polypropylene (PP)
• Polyethylene (PE)

Of them all, the demand for single-use pumps constructed from solid Polypropylene (PP) experienced a notable rise during the historical period, 2017-2021, on account of its wide utilization in the biopharmaceutical industry as it offers high resistance to a broad range of solutions, leachable & can be used even at high temperatures. Moreover, it has a semi-crystalline nature due to which high flexural strength could be achieved in pumps, therefore the researchers preferred polypropylene pumps over the past years.

However, polyethylene (PE) is also expected to witness considerable demand in the forecasted years as it is considered a more cost-effective choice compared to polypropylene materials. Furthermore, these pumps have a greater degree of flexibility & durability than polypropylene pumps, so they are widely used by biopharmaceutical companies. In addition to this, polyethylene provides high compatibility & resistance with strong acids & bases, along with gentle oxidants & reducing agents, these advantages during the production process would further augment the market growth during 2023-2027.

Based on Application:

• Clinical
• Commercial

Among them, Clinical applications of single-use pumps experienced a higher growth during 2017-2021. Biopharma manufacturing, such as drug discovery & development, is rapidly transforming with a major focus on biologics that ultimately led to a rise in FDA approvals of biologic drugs in the market during the historical years. For instance, the US FDA approved SPIKEVAX, an mRNA-based COVID-19 vaccine, as of 31st March 2020. The developed, as well as emerging economies, have made significant contributions to upgrading their clinical segments. According to Clinicaltrials.gov., a developing country such as India has completed 351 clinical studies for cardiovascular disorders & 22 active studies are present in the pipeline.

Furthermore, the enormous hike in biopharma studies, as well as research & development related to life sciences & therapeutics, led to the increase in clinical applications, which eventually fueled the market of single-use technologies & systems, such as pumps, media bags, tube assemblies, etc.

Based on Bioprocessing:

• Upstream
• Downstream

Depending on different bioprocessing processes, upstream processing depicted considerable growth during the historical years, as the implementation of single-use technologies in biopharmaceutical manufacturing & drug development reduces the risk of contamination, scheduling times, and operational efficiencies, therefore eliminating switch overtimes. Moreover, peristaltic pumps & tube assemblies are usually used in upstream bioprocesses & are irradiated with gamma radiation.

Besides, preclinical & clinical sample preparation involves mixing buffer solution, media preparation, and transfer of the products in different media chambers, which are facilitated by the utilization of single-use pumps. However, the biopharmaceutical industry is also making greater use of single-use pumps in the formulation & filling of the final solution prepared, which further projects the growth of downstream processing during the forecast years.

Regional Landscape

Geographically, the Global Single-use Pumps in the Biopharmaceutical Market expand across:

• North America
• South America
• The Middle East & Africa
• Asia-Pacific
• Europe

Of all the regions globally, North America held a considerable market share during the historical period, owing to the growing R&D investments in biopharma product development. The US has contributed significantly to scaling up the R&D related to biologics, drugs, and other therapeutic areas, which has augmented the clinical trials. Hence, the single-use pumps experienced a soaring market demand in the country. In addition to this, the region has received two biological license applications approved by the US FDA in 2017 for the treatment related to retinal dystrophy & Hepatitis B vaccine production. Similarly, in 2018, Vaxelis (vaccine to prevent diphtheria & tetanus) & recombinant Hepatitis B vaccine also got approved by the US FDA.

Besides, the continuous bioprocessing development in the region witnessed an enormous hike due to the outbreak of the COVID-19 pandemic. The research & development to develop the vaccine & drugs generated a tremendous demand for single-use systems such as pumps, bioreactors, containers, etc., to continue the clinical production by eliminating the adulteration risks. The rising chronic ailments, such as cancer, cardiovascular diseases, etc., in the region, have also accelerated drug discovery, therapeutics, and biologics production, which further generated the demand for single-use technologies. For instance

• According to the Globocan Cancer Statistics, in 2020, there were 2,556,862 new cancer cases reported in North America, and there were 9,456,199 prevalent cancer cases from the past five years.

Recent Development by Leading Companies

• In 2021, PSG, an operating company of Dover Corporation, announced the acquisition of Quantex Arc Ltd., which is a provider of single-use pumping technology. This acquisition would help in expanding the product portfolio of single-use systems in different biopharma & industrial markets.
• In 2019, Quattroflow, launched the QF30SU Single-use diaphragm pump for handling a wide variety of pharmaceutical & biotechnology applications that need lower flow rates.

Market Dynamics:

Key Driver: Increasing Demand for Biopharmaceutical Product Manufacturing

Biopharmaceutical product manufacturing is rapidly growing & becoming increasingly competitive. The success of the clinical pipeline has led to an unprecedented number of new biologic launches & an increase in the share of new approvals from the U.S Food and Drug Administration. In addition to this, there has been significant growth in the research & development of orphan drugs as well. According to the European Medicines Agency statistics, 207 initial orphan marketing authorizations have been granted & 126 active initial authorizations of orphan drugs are to be marketed as of 2022. Therefore, the clinical research, as well as commercial manufacturing of orphan & niche drugs, would witness a substantial increase in the coming years.

Further, with the increasing market for a biosimilar, orphan drugs, and other biopharmaceutical products, the demand for single-use systems such as bioreactors, pumps, containers, etc., for clinical as well as commercial purposes would experience a significant uptick in demand during the forecasted years.

Possible Restraint: Limited Number of Gamma Irradiation Facilities

Gamma Irradiation has become the most common irradiation sterilization technology, with approximately 300 irradiation facilities across the globe. The largest application of gamma irradiation is the sterilization of single-use systems & medical devices to ensure a lower risk of infection. Additionally, Cobalt-60 is a radioactive isotope that produces gamma radiation & the amount of Cobalt-60 in an irradiator determines the volume of the product that can be processed. Therefore, the demand for Cobalt-60 continues to grow with the rising adoption of single-use pumps & other technologies.

However, the supply chain of Cobalt-60 is critical in ensuring the global demand for gamma irradiation facilities. Subsequently, the lower production of Cobalt-60 leads to the functioning of a lower number of gamma irradiation facilities, which is considered to restrain the manufacturing of single-use pumps across the globe.

Key Questions Answered in the Market Research Report:

1. What are the overall statistics or estimates (Overview, Size- By Value, Forecast Numbers, Segmentation, Shares) of the Global Single-use Pumps in the Biopharmaceutical Market?
2. What are the region-wise industry size, growth drivers, and challenges?
3. What are the key innovations, opportunities, current & future trends, and regulations in the Global Single-use Pumps in the Biopharmaceutical Market?
4. Who are the key competitors, their key strengths & weaknesses, and how do they perform in the Global Single-use Pumps in the Biopharmaceutical Market based on the competitive benchmarking matrix?
5. What are the key results derived from surveys conducted during the Global Single-use Pumps in the Biopharmaceutical Market study?