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Merck KGaA, Sartorius AG, Thermo Fisher Scientific Inc, Corning Inc, STAMM Biotech, Lonza Group AG, Eppendorf SE, Repligen Corp, Danaher Corp, BioPharma Dynamics µîÀÌ ¼¼°è ¹ÙÀÌ¿À ÇÁ·Î¼¼½º ±â¼ú ½ÃÀå¿¡¼ Ȱµ¿ÇÏ´Â ÁÖ¿ä ±â¾÷ÀÔ´Ï´Ù. ÁÖ¿ä ±â¾÷µéÀº ½ÃÀå¿¡¼ÀÇ ÀÔÁö¿Í °í°´Ãþ È®´ë ¹× ´Ù¾çÈ¿¡ ÁýÁßÇÏ¿© ºñÁî´Ï½º ±âȸ¸¦ Æ÷ÂøÇϰí ÀÖ½À´Ï´Ù.
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The bioprocess technology market size is expected to grow from US$ 30.89 billion in 2022 to US$ 77.09 billion by 2028. The market is estimated to register a CAGR of 16.8% from 2022 to 2028.
The growth of the global bioprocess technology market growth is majorly driven by growing R&D spendings to introduce new drug compounds and increasing prevalence of chronic diseases. However, stringent regulatory policies hamper the market growth.
Bioprocess technology employs microscopic life, acting as a biological factory to benefit mankind. In bioprocess technology, microorganisms are grown in a controlled environment comprising feed with substrates such as sugar and palm oil mill waste. These ingredients transform to form commercially useful biological components such as proteins, platform chemicals, and lipids. Also, a well-executed bioprocess technology transfer plays a critical role in ensuring smooth knowledge transfer and optimal process reproducibility.
Asia Pacific region registers fastest growing CAGR for bioprocess technology market share. Among Asia Pacific region, China holds considerable share for bioprocess technology market during 2022-2028. Additionally, India will hold considerable CAGR of 21.3% for bioprocess technology market during the forecast period of 2022-2028. India is a well-known destination for bioprocess outsourcing, standing as a major supplier of active pharmaceutical ingredients (API) and raw materials. Also, India's bioprocessing capability is highly dependent on its qualified workforce and cost efficiencies, which creates growth opportunities for the market. Also, small molecule manufacturing is the strength of the pharma and biotechnology companies in the country. Small molecule pharmaceutical products are considered generics and well recognized across the international markets of the US, Europe, etc.
In addition, India comprises early-stage entrepreneurs involved in developing biosimilars in cell and gene therapy, and various top companies announced innovative product launches in the country. In May 2022, Freudenberg Medical announced the launch of a new product, "HeliFlex," in India. The product is a high-purity thermoplastic elastomer TPE tubing designed for utility in biopharmaceutical fluid transfer applications. The TPE tubing is ideal for pharmaceutical bioprocessing applications as it can be welded to existing tubing lines and heat-sealed, allowing fast, safe, and easy fluid transport in the biopharma process.
North America dominated the bioprocess technology market accounting maximum share. The bioprocess technology market growth in this region is attributed due to the presence of large players launching innovative products (particularly related to bioprocess technology), growing product introduction in the region, and technological advancements in bioprocess technology. In North America, the US records maximum share for the bioprocess technology. According to the Food and Drug Administration (FDA) report, over 30 million people in the US suffer from ~7,000 rare diseases, accounting for life-threatening conditions with low treatment options. Drug, biological, and device development in the treatment of rare diseases is challenging due to a lack of understanding of the history of rare diseases and difficulty in conducting clinical trials. Therefore, the growth of bioprocess technologies such as gene and cell therapies (CGTs) and specialty pharmaceuticals represent a radical shift in the treatment of rare diseases. For example, CGTs have revealed significant health benefits than formulated drugs for treating rare diseases. In the US, more than 900 investigational new drug (IND) applications targeting gene therapy products are underway. Also, 10-20 gene therapies are approved annually by the FDA. Likewise, in August 2022, the FDA approved Bluebird Bio's "Zynteglo (betibeglogene autotemcel)." It was the most expensive single-application drug approval in the US intended for the treatment of a rare neurological disorder-cerebral adrenoleukodystrophy (CALD).
Emergence of Automated Real?Time Flow Cytometry (ART?FCM)
Flow cytometry (FCM) and its technological possibilities have greatly advanced in the past decade as an analysis tool for single-cell properties and population distributions of different cell types in bioreactors. Along the way, a few automated real?time flow cytometry (ART?FCM) solutions were developed for monitoring bioreactor processes without operator interference over extended periods with a variable sampling frequency.
ART?FCM enables long?term measurements without missing any important events in bioprocesses and uncovers temporal phenomena that are likely unknown and should be investigated in greater detail. Also, more frequent measurements can be performed at a user-defined frequency, independent of the availability of personnel. When compared with methods such as omics that are only partially available on a single-cell level, multi-parameter measurements can be easily established without the extended effort of labor and time via ART-FCM.
Compared with conventional FCM studies, microfluidic devices great future potential as ART?FCM on a chip. In this context, parallelization might become more relevant, as samples from different bioreactors or different locations inside a bioreactor setup could be analyzed simultaneously. Many aspects might also be adapted to other experimental setups where fast and reproducible real?time monitoring of fluorescent process parameters is also of interest. In conclusion, ART?FCM will most probably advance exponentially in the upcoming years.
The COVID-19 pandemic had a positive impact on the bioprocess technology market. By mid-May, more than 215 novel and repurposed therapies were in the pipeline for the treatment of COVID-19, with rising investment from organizations such as the Coalition for Epidemic Preparedness Innovations and Melinda and Gates Foundation. Also, additional investments were made by the biopharmaceutical companies for commercial manufacturing. Amid the pandemic, the investment increased the adoption of bioprocessing technologies, enhancing efficiency and productivity at a large scale. Moreover, well-infrastructure facilities in regional markets were opened that will ultimately accelerate towards supply chain and bioprocessing facilities in the region.
Type-Based Insights
Based on type, the bioprocess technology market is segmented into cell culture media bioprocess, chromatography bioprocess, consumables & accessories, and others. The cell culture media bioprocess segment held a largest market share of bioprocess technology in 2022 whereas chromatography bioprocess is anticipated to register a highest CAGR during the forecast period (2023-2028).
Modality-Based Insights
Based on modality, the global bioprocess technology market is bifurcated into single use and multiple use. The single use segment accounted a larger market share for bioprocess technology in 2022. The multiple use segment is expected to grow at a higher CAGR during the forecast period.
End User-Based Insights
In terms of end user, the bioprocess technology market is categorized into academic & medical institutions, biopharmaceutical companies, research laboratories, and others. The biopharmaceutical companies segment held a largest market share in 2022, whereas academic & medical institutions is expected to register a higher CAGR during the forecast period.
Bioprocess Technology Market: Competitive Landscape and Key Developments
Merck KGaA, Sartorius AG, Thermo Fisher Scientific Inc, Corning Inc, STAMM Biotech, Lonza Group AG, Eppendorf SE, Repligen Corp, Danaher Corp, BioPharma Dynamics are among the key companies operating in the global bioprocess technology market. Leading players focus on expanding and diversifying their market presence and clientele, thereby tapping prevailing business opportunities.
In June 2022, Merck has entered a collaboration with Agilent Technologies to advance Process Analytical Technologies (PAT). PAT, which is strongly encouraged by global regulatory authorities, is a key enabler for real-time release and Bioprocessing 4.0.
In March 2020, Sartorius launched BIOSTAT STR Generation 3 single-use bioreactor and BIOBRAIN automation platform to introduce innovations that will change the field of biopharmaceutical process development and manufacturing. Biostat STR simplifies biologics production.