Bioprocess Technology Market Research Report and Outlook by 2028

The bioprocess technology market is projected to expand from approximately US$ 30,897.49 million in 2022 to around US$ 77,090.05 million by 2028, reflecting a compound annual growth rate (CAGR) of 16.8% during this period.

The primary factors fueling the growth of the global bioprocess technology market include increased investments in research and development aimed at discovering new drug compounds and the rising incidence of chronic diseases. Nevertheless, the market faces challenges due to stringent regulatory frameworks that can impede growth.

Bioprocess technology utilizes microorganisms as biological factories to produce beneficial products for humanity. In this field, microorganisms are cultivated in controlled environments using substrates like sugar and palm oil mill waste. These substrates are converted into commercially valuable biological products, including proteins, platform chemicals, and lipids. Furthermore, effective transfer of bioprocess technology is crucial for ensuring seamless knowledge transfer and maintaining optimal reproducibility of processes.

The Asia Pacific region is experiencing the fastest growth rate in the bioprocess technology market. Within this region, China is expected to hold a significant market share from 2022 to 2028. Additionally, India is anticipated to achieve a remarkable CAGR of 21.3% during the same forecast period. India has established itself as a prominent hub for bioprocess outsourcing, serving as a major supplier of active pharmaceutical ingredients (APIs) and raw materials. The country's bioprocessing capabilities are bolstered by a skilled workforce and cost advantages, creating numerous growth opportunities. Moreover, the production of small molecules is a key strength for pharmaceutical and biotechnology firms in India, with these products being recognized as generics in international markets such as the US and Europe.

Moreover, India is home to numerous early-stage entrepreneurs focused on developing biosimilars in cell and gene therapy. Several leading companies have announced innovative product launches in the country. For instance, in May 2022, Freudenberg Medical introduced a new product called "HeliFlex" in India. This product is a high-purity thermoplastic elastomer (TPE) tubing designed for use in biopharmaceutical fluid transfer applications. The TPE tubing is particularly suitable for pharmaceutical bioprocessing as it can be easily welded to existing tubing lines and heat-sealed, facilitating safe and efficient fluid transport in biopharma processes.
In North America, the bioprocess technology market holds the largest share, driven by the presence of major players launching innovative products, particularly in bioprocess technology, and ongoing technological advancements. The United States accounts for the largest share of the bioprocess technology market in North America. According to a report from the Food and Drug Administration (FDA), over 30 million individuals in the US are affected by approximately 7,000 rare diseases, many of which are life-threatening and have limited treatment options. The development of drugs, biological products, and devices for rare diseases is particularly challenging due to the complexities involved in understanding these conditions and conducting clinical trials. Consequently, advancements in bioprocess technologies, such as gene and cell therapies (CGTs) and specialty pharmaceuticals, represent a significant shift in the treatment landscape for rare diseases. For example, CGTs have demonstrated substantial health benefits compared to traditional formulated drugs for rare diseases. Currently, there are over 900 investigational new drug (IND) applications targeting gene therapy products in the US, with the FDA approving 10-20 gene therapies annually. Notably, in August 2022, the FDA approved Bluebird Bio's "Zynteglo (betibeglogene autotemcel)," which became the most expensive single-application drug approval in the US for treating a rare neurological disorder known as cerebral adrenoleukodystrophy (CALD).

Advancements in Automated Real-Time Flow Cytometry (ART-FCM)
The field of flow cytometry (FCM) has seen significant advancements over the past decade, particularly as a tool for analyzing single-cell properties and population distributions in bioreactors. Recently, automated real-time flow cytometry (ART-FCM) solutions have been developed to monitor bioreactor processes without the need for operator intervention over extended periods, allowing for variable sampling frequencies.

ART-FCM facilitates long-term measurements without overlooking critical events in bioprocesses, revealing temporal phenomena that warrant further investigation. This technology allows for more frequent measurements at user-defined intervals, independent of personnel availability. Compared to traditional methods like omics, which provide limited single-cell data, ART-FCM enables multi-parameter measurements with significantly reduced labor and time requirements.

Microfluidic devices also hold great promise for ART-FCM applications on a chip. This technology could allow for the simultaneous analysis of samples from various bioreactors or different locations within a single bioreactor setup. Many aspects of ART-FCM could be adapted for other experimental setups where rapid and reproducible real-time monitoring of fluorescent process parameters is essential. In summary, ART-FCM is poised for exponential growth in the coming years.

The COVID-19 pandemic positively influenced the bioprocess technology market. By mid-May, over 215 novel and repurposed therapies were being developed for COVID-19, with increased investments from organizations like the Coalition for Epidemic Preparedness Innovations and the Bill and Melinda Gates Foundation. Biopharmaceutical companies also ramped up investments in commercial manufacturing. This surge in investment during the pandemic accelerated the adoption of bioprocessing technologies, enhancing efficiency and productivity on a large scale. Additionally, well-equipped facilities were established in various regions, ultimately boosting supply chains and bioprocessing capabilities.

Insights by Type
The bioprocess technology market is categorized by type into cell culture media bioprocess, chromatography bioprocess, consumables & accessories, and others. The cell culture media bioprocess segment held the largest market share in 2022, while the chromatography bioprocess segment is expected to exhibit the highest CAGR during the forecast period from 2023 to 2028.

Insights by Modality
The global bioprocess technology market is divided into single-use and multiple-use modalities. The single-use segment accounted for a larger market share in 2022, while the multiple-use segment is projected to grow at a higher CAGR during the forecast period.

Insights by End User
In terms of end users, the bioprocess technology market is segmented into academic & medical institutions, biopharmaceutical companies, research laboratories, and others. The biopharmaceutical companies segment held the largest market share in 2022, whereas academic & medical institutions are expected to register a higher CAGR during the forecast period.

Competitive Landscape and Key Developments in the Bioprocess Technology Market
Key players in the global bioprocess technology market include Merck KGaA, Sartorius AG, Thermo Fisher Scientific Inc, Corning Inc, STAMM Biotech, Lonza Group AG, Eppendorf SE, Repligen Corp, Danaher Corp, and BioPharma Dynamics. These leading companies are focused on expanding and diversifying their market presence to capitalize on existing business opportunities.

In June 2022, Merck collaborated with Agilent Technologies to enhance Process Analytical Technologies (PAT), which is crucial for real-time release and Bioprocessing 4.0, as encouraged by global regulatory authorities.

In March 2020, Sartorius launched the BIOSTAT STR Generation 3 single-use bioreactor and the BIOBRAIN automation platform, introducing innovations aimed at transforming biopharmaceutical process development and manufacturing, thereby simplifying biologics production.