Single-use Bioprocessing Market

Market Overview

The global single-use bioprocessing market size was valued at USD 6.64 billion in 2022. It is estimated to reach USD 26.43 billion by 2031, growing at a CAGR of 16.59% during the forecast period (2023–2031).

Single-use systems (SUS) refer to biopharmaceutical manufacturing (bioprocessing) apparatus that is intended to be utilized once (or for a single manufacturing campaign) and then discarded. Single-use bioprocessing technology is intended for the filtration, storage, cell culture, combining, and purification of one-time-use biopharmaceutical products. It is cost-effective, saves time, offers flexibility, and is hassle-free.

Compared to conventional bioprocessing, it increases productivity by eliminating complex stages and reduces the risk of cross-contamination among individuals. It also offers a sustainable production method and lowers energy use, media consumption, and carbon footprint compared to steel. Vaccine production, plant cell cultivation, and the production of monoclonal antibodies all rely on a single-use bioprocessing system.

Market Dynamics

Global Single-use Bioprocessing Market Drivers

Increasing Demand for Flexible Bioprocessing

Flexible manufacturing is significant for biologics and biosimilars because it can shorten development times, reduce the need for shift work, and have a smaller environmental impact. This flexible manufacturing by SUS can be used predominantly by small-scale developers where disposable products can easily perform operations of products. Increased flexibility also ensures lower capital costs by 25-30% and faster setup time by as much as 60%.

Additionally, it enables continuous bioprocessing, resulting in the utilization of efficient facilities with more adaptability. The increased flexibility associated with SUS enables manufacturers to enter new markets and helps in increasing capacity. Single-use manufacturers such as Merck deliver tangential flow filter devices such as Pellicon Capsule with Ultracel membrane allowing flexible biologics manufacturing. Therefore, increased flexibility offered by single-use techniques is boosting its demand in the market.

High Uptake of Biopharmaceuticals and Biosimilars

The global uptake of biopharmaceuticals and biosimilars is expected to increase at a faster rate, influencing bioprocessing developers to manufacture biologics with the use of disposable systems. The biopharmaceuticals market is witnessing a significant rise in revenue, and many new drugs have been approved in the last few years. In 2017, the global biopharmaceutical drugs market was estimated at USD 240 billion and grew at a healthy CAGR of more than 9%. Overall, the percentage share of biopharmaceuticals increased from around 25% in 2016 to around 27% in 2017.

Several regulations related to the manufacturing of biosimilars are being established in developing countries. Countries like Korea, Saudi Arabia, and Turkey have already developed biosimilar guidelines. Recently, India released guidance for biosimilar manufacturing. Biosimilars, which are biological copycat medications, are expected to play a significant role in the growth of the biopharmaceutical market, especially in the Asia-Pacific region. An increase in biosimilar approvals is expected to significantly impact the single-use bioprocessing market's growth.

Global Single-use Bioprocessing Market Restraint

High-Cost of Single-use Bioprocessing

In addition to other considerations related to SUS, such as leachabilities and extractability, the cost is widely recognized as the primary constraint limiting SUS utilization by Contract Manufacturing Organizations (CMOs). A survey of more than 200 respondents investigating the obstruction of disposable techniques by manufacturers and CMOs revealed that CMOs are more likely to reject single-use utilization due to its high cost, i.e., by 26.7%. In contrast, in the case of biotherapeutic manufacturers, it was about 4.8%. Such factors are predicted to restrict market growth.

Global Single-use Bioprocessing Market Opportunities

New Product Launches

Market players in the biopharmaceutical industry focus on introducing innovative products, eventually attracting customers and enhancing their market share. New product launches in the market will offer diversity for consumers in terms of selecting products based on advanced features. It will also assist players in strengthening their product portfolio in the market. Several factors, such as technological change, increasing competition, growth, development, and increasing demand for advanced products, contribute to new product launches.

Most players in the single-use bioprocessing market invest actively in R&D to manufacture innovative products. Companies focus on launching innovative products, particularly to fulfill the single-use requirement among consumers. For instance, Merck launched a new tangential flow filtration capsule called the Pellicon capsule, which can be used for antibody-drug conjugates and monoclonal antibodies. Therefore, continuous innovations in single-use technology will encourage new product launches in the upcoming years, creating opportunities for overall market growth.

Regional Analysis

Based on region, the global single-use bioprocessing market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global single-use bioprocessing market shareholder and is anticipated to exhibit a CAGR of 16.30% during the forecast period. The presence of large-scale manufacturing facilities, increasing expenditure on biopharmaceutical research activities in both the countries mentioned above, and the growing demand for single-use technologies are major factors contributing to the market growth in North America. The rising demand for biopharmaceuticals, mainly due to the increasing incidence of chronic illnesses like diabetes, cancer, autoimmune disorders, and the growing elderly population, also promoted market growth. The rising intake of biologics and biosimilars is also driving market growth in the region.

In addition, the increasing expenditure on R&D of biopharmaceutical products is contributing to the high utilization of single-use solutions. A study conducted on 2nd September 2020 by BDO USA revealed that R&D expenditures in biopharmaceutical industries experienced a huge increase of 22% from 2018 to 2019. New product launches, continuous strategic acquisitions, and collaborations are also accelerating the growth of single-use systems in the region. For instance, the launch of single-use technologies such as the Pellicon capsule, Mobius power mixers, and filters by Merck Millipore observed an increased utilization in the market.

Europe is predicted to exhibit a CAGR of 15.73% over the forecast period. Countries such as Germany, France, Switzerland, the UK, Italy, and Spain are significant revenue contributors in the Europe single-use bioprocessing market. Factors such as the increasing adoption of disposable bioprocessing, increasing manufacturing of biopharmaceuticals, and rising prevalence of chronic diseases are mainly boosting the market growth in the region. According to several studies, it has been estimated that nine out of ten individuals in Europe die from chronic diseases. The increase in the prevalence of these chronic diseases is eventually leading to the development of biologics for better treatment.

Furthermore, it was estimated that between 70 and 80 percent of healthcare expenses go toward treating chronic diseases. In light of the rising use of disposables in cutting-edge disciplines like gene and cell therapy, Europe is seen as the ideal location for single-use manufacturing due to its abundance of domestic facilities. This is boosting the preference of Europe as a single-use production location by many American companies.

In Asia-Pacific, the increasing R&D infrastructure, growing awareness of disposables, patent expiries of blockbuster biologics, government initiatives, and increased demand for biologics are prominent factors contributing to market development. In the Asia-Pacific single-use bioprocessing market, China, Japan, Australia, South Korea, and India are the major revenue contributors. The rising focus on research activities and high R&D expenditure in the region is resulting in increased utilization of single-use technologies to produce biopharmaceuticals. In addition, China, Japan, India, and South Korea are aggressively increasing their investments in R&D activities in the Biotech industry. For instance, China is continuously boosting its R&D expenditure, which increased by 12.5% compared to 2018 (USD 275 billion). In 2019, China invested approximately USD 322 billion in internal R&D activities, and Japan's R&D expenditure was USD 158 billion.

In Latin America, the single-use bioprocessing platform is developing with the increasing number of new product launches, acquisitions, and collaborations. Acquisition of selected assets of Danaher by Sartorius Stedim Biotech increased its single-use chromatographic solutions. In December 2019, Danaher further acquired the Biopharma Business of GE Healthcare for USD 21.4 billion. Danaher completed the acquisition of Pall Corporation in August 2015. Several research activities related to rare diseases and research conducted by academics and institutes are also increasing the utilization of single-use technologies in the region. However, the market growth was limited in Latin America owing to disadvantages associated with SUBs, such as extractable and leachable and increasing cost of disposables.

The Middle East and Africa region is developing at a slower pace than other regions. This is mainly because end-users are still using conventional stainless bioprocessing methods to develop and manufacture biopharmaceuticals and biosimilars. Similarly, bioprocessing research manufacturing activities are relatively low in several countries, with few exceptions. The majority of research and manufacturing facilities of global players are in the Americas, Europe, and Asia-Pacific, with less activity in the Middle East and Africa region.

The lack of awareness about the availability of innovative single-use products and technical difficulties are also anticipated to limit the growth prospects of the single-use bioprocessing market in this region. However, factors contributing to the single-use bioprocessing market growth in the region include a favorable economic landscape, increasing demand for biosimilars, and rising acute and chronic disease burden.

Segmental Analysis

The global single-use bioprocessing market is segmented by product, application, end-user, and method.

Based on product, the global market is bifurcated into single-use bioprocessing equipment and simple and peripheral elements. 

The single-use bioprocessing equipment segment dominates the global market and is expected to exhibit a CAGR of 16.91% over the forecast period. Single-use bioprocessing (SUB) equipment is growing due to advances in SUB equipment, higher scalability, and increased application in the biopharmaceutical industry. Bioreactors and fermenters cover significant shares among SUB. The use of bioreactors and fermenters is growing for the development of biosimilars and biologics. The availability of single-use chromatography systems is considered a solution for single-use downstream bioprocessing.

In downstream processes, end-users are moving toward SUBs because of the utilization of membrane formats, scaling technologies, ion exchange technology, and polymeric column structures. Chromatography systems combined with tangential flow filtrations provide the highest downstream separation and purification productivity. Several innovative products were launched by vendors in the market. For instance, in September 2019, ABEC launched a single-use bioreactor system with a functional volume of 6,000 L to answer scalability needs.

Based on application, the global market is divided into monoclonal antibodies, vaccines, cell therapies, and others. 

The monoclonal antibodies segment is the largest revenue contributor to the market and is expected to exhibit a CAGR of 16.38% over the forecast period. Monoclonal antibodies (mABs) are produced by cloning a specific or unique white blood cell, and it serves as a substitute, which can restore and mimic the immune system cells, including cancer cells. mABs are applicable for diagnosing and treating autoimmune disorders, cancer, and sexually transmitted infections (STIs). They can be used alone or along with other drugs or radioactive substances. The production of mABs via single-use bioreactors also reduces the operating cost and offers more flexibility than traditional stainless-steel equipment.

Additionally, employing SUB in the production of mABs boosts productivity, flexibility, and capacity while lowering costs, investments, footprint, and complexity. SUBs were found to replace the traditional systems for mABs production, including microorganisms, plants, mammalian cells, and mammary glands. The main feature of SUB is that it mimics the stainless-steel equipment in agitation, aeration rate, easy-to-monitor internal conditions, bioreactor geometry, and process.

Based on end-user, the global market is segmented into biopharmaceutical manufacturers, CMOs, and R&D companies and research institutes. 

The biopharmaceutical manufacturers segment owns the highest single-use bioprocessing market share and is estimated to exhibit a CAGR of 16.21% during the forecast period. Due to its extensive adoption in research and commercial manufacturing applications, the biopharmaceutical manufacturers subsegment will likely continue to dominate in the following years. Most biopharmaceutical manufacturers, particularly large and medium-sized businesses, spend over USD 50 million annually on apparatus. Biopharmaceutical manufacturers spend a significant proportion of their capital on single-use bioprocessing, as observed.

In addition, market players actively support biopharmaceutical manufacturers to address unmet needs/challenges by providing end-to-end single-use manufacturing platforms. As a result, the biopharmaceutical industry is becoming increasingly confident in adopting single-use bioprocessing and allowing most end-users to implement such platforms in the most critical applications within the commercial biopharmaceutical manufacturing environment.

Based on the method, the global market is divided into filtration, storage and transport, cell culture, mixing, and purification. 

The filtration segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 13.03% over the forecast period. Single-use depth filters are applied to clarify cell culture streams in the first step of the downstream process. This depth microfiltration is used to remove cells and debris and remove colloidal matter. Tangential flow filtration (TFF) has gained popularity as it has more advantages than depth filtration. A survey conducted on bioprocessing respondents stated that almost 72% of manufacturers prefer single-use TFF systems for ultrafiltration and microfiltration of bioprocessing. In addition, the demand for advanced filtration techniques is growing with increasing challenges in downstream bioprocessing and improvements in biomass concentration during biologics manufacturing. Vendors are also increasing their focus on developing advanced large-scale filtration devices.

Recent Developments

• April 2023- Merck announced the launch of its Ultimus® Single-Use Process Container Film, designed to provide extraordinary durability and leak resistance for single-use assemblies used in bioprocessing liquid applications.
• April 2023- Cytiva, an American company, introduced X-platform bioreactors to facilitate single-use upstream bioprocessing. The X-platform bioreactors, initially available in 50 and 200 L capacities and equipped with the Figurate automation solution software, can increase process efficiency via ergonomic enhancements, increased production capacity, and streamlined supply chain operations.