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市場調査レポート
商品コード
1384877
大規模・小規模バイオプロセシングの世界市場規模、シェア、産業動向分析レポート:規模別、使用タイプ別、モード別、用途別、ワークフロー別、製品別、地域別展望と予測、2023年~2030年Global Large And Small-scale Bioprocessing Market Size, Share & Industry Trends Analysis Report By Scale, By Use Type, By Mode (In-house, and Outsourced), By Application, By Workflow, By Product, By Regional Outlook and Forecast, 2023 - 2030 |
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大規模・小規模バイオプロセシングの世界市場規模、シェア、産業動向分析レポート:規模別、使用タイプ別、モード別、用途別、ワークフロー別、製品別、地域別展望と予測、2023年~2030年 |
出版日: 2023年10月31日
発行: KBV Research
ページ情報: 英文 425 Pages
納期: 即納可能
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大規模・小規模バイオプロセシングの市場規模は2030年までに1,596億米ドルに達すると予測され、予測期間中のCAGRは14.2%の市場成長率で上昇する見込みです。
KBV Cardinalのマトリックスに示された分析によると、F. Hoffmann-La Roche Ltd.がこの市場における主要な先駆者です。Merck KGaA、Thermo Fisher Scientific, Inc.、Boehringer Ingelheim International GmbHなどの企業は、この市場における主要なイノベーターです。2023年7月、ザルトリウスAGはプエルトリコのヤーコに細胞培養培地製造施設を新設して拡張しました。この追加により、特に南北アメリカの顧客向けの広範なポートフォリオが強化されました。
COVID-19影響分析
パンデミックにより、COVID-19ワクチンが緊急に必要となり、大規模なバイオ加工施設の迅速な拡張が必要となっています。その結果、バイオプロセス装置、シングルユース技術、大規模ワクチン製造の専門知識に対する需要が増加しました。パンデミックは、診断薬、治療薬、ワクチンの開発に関連する小規模なバイオプロセス活動を含む研究への資金増加を促しました。学術研究機関はCOVID-19関連プロジェクトに多額の資金を得た。小規模なバイオ加工研究所の多くは、社会的距離を縮める措置に対応するため、リモートワークやバーチャルコラボレーションに移行しました。このため、データ分析、実験計画、コミュニケーションのためのデジタルツールやソフトウェアの導入が加速しました。したがって、COVID-19の影響は市場全体にプラスの効果をもたらしました。
市場成長要因
バイオシミラー、ジェネリック生物製剤、個別化医療に対する需要の高まり
生物製剤の特許切れによるバイオシミラーとジェネリック生物製剤の需要は、大規模バイオプロセスに大きな影響を与えています。バイオシミラーとジェネリック生物製剤は、生物学的製剤の代替品をより安価に提供し、患者にとってより利用しやすくすることを目的としています。このような需要の高まりに対応するため、これらの生物製剤を効率的かつコスト効率よく製造する大規模なバイオプロセス施設が必要とされています。その結果、大規模なバイオプロセス事業が活発化し、生産施設や設備への投資が増加しています。したがって、これらの医薬品に対する需要の増加が市場の成長を後押ししています。
バイオプロセス技術の進歩
バイオプロセス機器、自動化、分析における絶え間ない進歩は、大規模生産の効率性と拡張性を向上させる。シングルユース・バイオプロセシング機器およびシステムは、大規模バイオプロセスにおいてますます普及しています。これらのシステムは洗浄と滅菌の必要性をなくし、ダウンタイムと汚染リスクを低減します。連続バイオプロセスは、従来のバッチ処理に代わる方法として人気を集めています。自動化されたハイスループット・スクリーニング技術は、細胞株、培養条件、プロセス・パラメーターの迅速なスクリーニングに役立ち、大規模生産のためのプロセス開発を加速します。バイオプロセス技術の進歩は市場に大きな影響を与えています。
市場抑制要因
厳しい規制遵守
小規模のバイオプロセッシングラボ、特に学術機関や新興企業では、複雑な規制要件に対応するためのリソースや専門知識が限られています。標準作業手順書(SOP)や文書化を含む品質システムの確立と維持は、人員の少ない小規模な組織にとって困難な課題です。コンプライアンスを維持しながら、小規模生産から大規模生産に移行することは、特にプロセスや設備を適合させる必要がある場合、困難な場合があります。このように、規制遵守は大規模・小規模バイオプロセシング市場における重要な課題です。
規模の展望
規模別に見ると、市場は工業規模と小規模規模に分類されます。2022年には、産業規模セグメントが市場で最も高い売上シェアを占めました。50,000リットルを超える大規模バイオプロセスは、モノクローナル抗体、ワクチン、その他のバイオ医薬品の生産に関連することが多いです。これらの製品は、世界の需要を満たすために大量に必要とされます。ステンレス製バイオリアクターは、その耐久性と高圧・高容量に耐える能力から、大規模バイオプロセス施設で頻繁に使用されています。
用途別展望
用途別に見ると、市場はマルチユースとシングルユースに細分化されます。シングルユース分野は、2022年の市場でかなりの収益シェアを占めています。シングルユースシステムは適応性が高く、変動する生産要件に対応するために容易に拡張できます。この拡張性は、大規模・小規模バイオプロセシング事業にとって貴重であり、市場の需要の変化に適応することができます。シングルユースシステムは、洗浄、滅菌、バッチ間の切り替えに関連するダウンタイムを削減することができます。その結果、ターンアラウンドタイムが短縮され、生産スケジュールへの迅速な対応や市場の需要への対応が容易になります。
モードの展望
モード別に見ると、市場はインハウスとアウトソーシングに二分されます。2022年の大規模・小規模バイオプロセシング市場では、アウトソーシング部門が大きな収益シェアを獲得しました。大手製薬企業やバイオテクノロジー企業は、バイオ医薬品を製造するために、製造受託機関(CMO)にバイオ加工を委託しています。CMOは、高い需要に対応するために生産を迅速に拡大できるインフラと専門知識を持っています。CMOは多くの場合、モノクローナル抗体製造やワクチン製造など、特定のタイプのバイオプロセスに特化しています。大企業は、こうしたサービス・プロバイダーの専門的な知識と経験から利益を得ることができます。小規模なバイオテクノロジー新興企業や研究機関には、特定のバイオ加工活動のための専門的な機器や設備が不足しています。アウトソーシングにより、高度な設備やインフラを利用することができます。
用途の展望
用途別では、市場はバイオ医薬品、特殊工業薬品、環境補助剤に区分されます。2022年には、バイオ医薬品分野が市場で最大の売上シェアを記録しました。バイオプロセスの主な用途は、バイオ医薬品の商業生産です。これには、大量のモノクローナル抗体、ワクチン、組み換えタンパク質、その他の生物製剤の製造が含まれます。モノクローナル抗体は、がん、自己免疫疾患、感染症の治療に広く使用されています。多くのバイオ製薬会社は、自社製品の大量生産を製造受託機関(CMO)に委託しています。
ワークフローの展望
ワークフローに基づき、市場は下流工程、発酵工程、上流工程に分類されます。2022年の市場では、発酵部門が大きな収益シェアを獲得しました。大規模発酵は、大量の製品の生産を可能にします。大規模発酵プロセスは、規模の経済の恩恵を受けることが多く、その結果、製品単位当たりの生産コストが低下します。これは、バイオ医薬品やその他の高価値製品のコスト効率の高い製造に不可欠です。大規模発酵槽には、一貫した製品品質を確保するための高度な監視・制御システムがあります。
製品の展望
製品別では、市場はバイオリアクター/発酵槽、細胞培養製品、ろ過アセンブリ、バイオリアクターアクセサリー、バッグ&容器、その他に分けられます。2022年には、バイオリアクター/発酵槽セグメントが最大収益シェアで市場を独占しました。大規模バイオ医薬品製造施設では、一般的にステンレス製バイオリアクターが採用されています。これらのバイオリアクターは大量生産用に設計されており、耐久性、無菌性、高圧・高温条件への耐性で知られています。大規模バイオプロセスでは、シングルユース・バイオリアクターを採用する傾向が強まっています。これらのシステムは柔軟性があり、汚染リスクを低減し、時間のかかる洗浄・滅菌工程の必要性を最小限に抑えることができます。
地域別展望
地域別に見ると、市場は北米、欧州、アジア太平洋、LAMEAで分析されます。2022年には、北米地域が最も高い収益シェアを獲得して市場をリードしました。北米には、モノクローナル抗体、ワクチン、遺伝子治療などのバイオ医薬品を生産するために大規模なバイオプロセスを使用する数多くの大手製薬企業やバイオテクノロジー企業があります。北米は、大規模なバイオリアクター、下流処理装置、品質管理システムを備えた最先端のバイオ製造施設を誇っています。北米、特に米国には、研究、開発、初期段階の製品試験のための小規模バイオ加工に従事するバイオテクノロジー新興企業のエコシステムが盛んです。
大規模・小規模バイオプロセシング市場で展開されている最近の戦略
パートナーシップ、提携、契約
製品上市と製品拡大
買収と合併
地理的拡大
The Global Large And Small-scale Bioprocessing Market size is expected to reach $159.6 billion by 2030, rising at a market growth of 14.2% CAGR during the forecast period.
The biopharmaceutical industry's expansion has spurred continuous advancements in bioprocessing technologies. Therefore, Biopharmaceuticals segment would generate $35,141.7 million revenue in the market in 2022. As a result, the constant innovation within the biopharmaceutical industry has a positive feedback loop, driving the evolution of bioprocessing technologies and equipment. As biopharmaceutical companies strive to optimize their manufacturing processes, they invest in cutting-edge equipment, automation, and process control systems.
The major strategies followed by the market participants are Geographical Expansion as the key developmental strategy to keep pace with the changing demands of end users. For instance, In September, 2022, Eppendorf Group expanded its Julich bioprocess site by constructing a new multifunctional building. Moreover, In April, 2022, Thermo Fisher Scientific set up a new single-use technology manufacturing site in Ogden, Utah, enhancing capacity for high-quality materials crucial in developing vaccines and therapies. This expansion strengthens the company's Utah presence and facilitates close collaboration with the Logan site, tapping into a skilled workforce for manufacturing intricate, customized solutions.
Based on the Analysis presented in the KBV Cardinal matrix; F. Hoffmann-La Roche Ltd. is the major forerunner in the Market. Companies such as Merck KGaA, Thermo Fisher Scientific, Inc., and Boehringer Ingelheim International GmbH are some of the key innovators in the Market. In July, 2023, Sartorius AG expanded its site in Yauco, Puerto Rico, by incorporating a new cell culture media manufacturing facility. This addition solidified their extensive portfolio, particularly catering to customers in the Americas.
COVID-19 Impact Analysis
The pandemic led to an urgent need for COVID-19 vaccines, which required rapidly scaling up large-scale bioprocessing facilities. This resulted in increased demand for bioprocessing equipment, single-use technologies, and expertise in large-scale vaccine production. The pandemic prompted increased funding for research, including small-scale bioprocessing activities related to developing diagnostics, therapeutics, and vaccines. Academic and research labs received substantial funding for COVID-19-related projects. Many small-scale bioprocessing labs shifted to remote work and virtual collaboration to comply with social distancing measures. This accelerated the adoption of digital tools and software for data analysis, experiment planning, and communication. Therefore, COVID-19 impact had an overall positive effect on the market.
Market Growth Factors
Rising demand for biosimilars, generic biologics, and personalized medicine
The demand for biosimilars and generic biologics, driven by the expiration of patents on biologic drugs, has significantly impacted the large-scale bioprocessing. Biosimilars and generic biologics aim to provide more affordable alternatives to biologic drugs, making them more accessible to patients. To meet this growing demand, large-scale bioprocessing facilities are required to produce these biologics efficiently and cost-effectively. As a result, the large-scale bioprocessing businesses have seen a boost in activity, with increased investment in production facilities and equipment. Therefore, the increasing demand for these pharmaceuticals is propelling the growth of the market.
Advancements in bioprocessing technologies
Continuous advancements in bioprocessing equipment, automation, and analytics improve the efficiency and scalability of large-scale production. Single-use bioprocessing equipment and systems have become increasingly popular in large-scale bioprocessing. These systems eliminate the need for cleaning and sterilization, reducing downtime and the risk of contamination. Continuous bioprocessing is gaining traction as an alternative to traditional batch processing. Automated high-throughput screening technologies help rapidly screen cell lines, culture conditions, and process parameters, accelerating process development for large-scale production. Advancements in bioprocessing technologies have significantly impacted the market.
Market Restraining Factors
Stringent regulatory compliance
Small-scale bioprocessing labs, especially in academic or startup settings, have limited resources and expertise to navigate complex regulatory requirements. Establishing and maintaining quality systems, including standard operating procedures (SOPs) and documentation, can be challenging for smaller organizations with fewer personnel. Transitioning from small-scale to larger-scale production while maintaining compliance can be difficult, especially when processes and equipment need to be adapted. Thus, regulatory compliance is a significant challenge in large and small-scale bioprocessing market.
Scale Outlook
By scale, the market is categorized into industrial scale and small scale. In 2022, the industrial scale segment held the highest revenue share in the market. Large-scale bioprocessing at volumes exceeding 50,000 litres is often associated with producing monoclonal antibodies, vaccines, and other biopharmaceuticals. These products require large quantities to meet global demand. Due to their durability and capacity to endure high pressures and volumes, stainless steel bioreactors are frequently used in large-scale bioprocessing facilities.
Use Type Outlook
Based on use type, the market is fragmented into multi use and single use. The single use segment covered a considerable revenue share in the market in 2022. Single use systems are highly adaptable and readily scaled to accommodate fluctuating production requirements. This scalability is valuable for large and small-scale bioprocessing operations, allowing them to adapt to evolving market demands. Single-use systems can reduce downtime associated with cleaning, sterilization, and changeover between batches. This results in faster turnaround times, making it easier to quickly meet production schedules and respond to market demands.
Mode Outlook
On the basis of mode, the market is bifurcated into in-house and outsourced. The outsourced segment acquired a substantial revenue share in the large and small-scale bioprocessing market in 2022. Large pharmaceutical and biotechnology companies outsource bioprocessing to contract manufacturing organizations (CMOs) to produce biopharmaceuticals. CMOs have the infrastructure and expertise to scale up production quickly to meet high demand. CMOs often specialize in certain types of bioprocessing, such as monoclonal antibody production or vaccine manufacturing. Large-scale companies can benefit from these service providers' specialized knowledge and experience. Small biotech startups and research institutions lack the specialized equipment and facilities for certain bioprocessing activities. Outsourcing provides access to advanced equipment and infrastructure.
Application Outlook
By application, the market is segmented into biopharmaceuticals, speciality industrial chemicals, and environmental aids. In 2022, the biopharmaceuticals segment registered the maximum revenue share in the market. The primary application of bioprocessing is the commercial production of biopharmaceuticals for the market. This includes manufacturing large quantities of monoclonal antibodies, vaccines, recombinant proteins, and other biologics. Monoclonal antibodies are widely used to treat cancer, autoimmune diseases, and infectious diseases. Many biopharmaceutical companies outsource the large-scale production of their products to contract manufacturing organizations (CMOs).
Workflow Outlook
Based on workflow, the market is classified into downstream processing, fermentation, and upstream processing. The fermentation segment acquired a substantial revenue share in the market in 2022. Large-scale fermentation allows the production of substantial quantities of products. Large-scale fermentation processes often benefit from economies of scale, resulting in lower production costs per product unit. This is critical for cost-effective manufacturing of biopharmaceuticals and other high-value products. Large-scale fermenters have advanced monitoring and control systems to ensure consistent product quality.
Product Outlook
On the basis of product, the market is divided into bioreactors/fermenters, cell culture products, filtration assemblies, bioreactors accessories, bags & containers, and others. In 2022, the bioreactors/fermenters segment dominated the market with maximum revenue share. Large-scale biopharmaceutical manufacturing facilities typically employ stainless steel bioreactors. These bioreactors are designed for high-volume production and are known for their durability, sterility, and ability to withstand high pressure and temperature conditions. There has been a growing trend in large-scale bioprocessing towards adopting single-use bioreactors. These systems offer flexibility, reduce the risk of contamination, and minimize the need for time-consuming cleaning and sterilization processes.
Regional Outlook
Region-wise, the market is analysed across North America, Europe, Asia Pacific, and LAMEA. In 2022, the North America region led the market by generating the highest revenue share. North America is home to numerous large pharmaceutical and biotechnology companies that use large-scale bioprocessing to produce biopharmaceuticals, including monoclonal antibodies, vaccines, gene therapies, and more. North America boasts state-of-the-art biomanufacturing facilities with large-scale bioreactors, downstream processing units, and quality control systems. North America, particularly the United States, has a thriving ecosystem of biotech startups that engage in small-scale bioprocessing for research, development, and early-stage product testing.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Merck KGaA, Thermo Fisher Scientific, Inc., GE healthcare, Corning Incorporated, Sartorius AG, Lonza Group AG (Capsugel), Meissner Filtration Products, Inc., Boehringer Ingelheim International GmbH, F. Hoffmann-La Roche Ltd. and Eppendorf SE.
Recent Strategies developed in Large and Small-scale Bioprocessing Market
Partnerships, Collaborations, and Agreements:
Oct-2023: Boehringer Ingelheim International GmbH collaborated with ZEISS Medical Technology, a multinational medical technology company and subsidiary of Carl Zeiss AG, to develop predictive analytics for the early detection of eye diseases and personalized treatments to prevent vision loss. The partnership, which brought together their expertise in ophthalmological technology, data analytics, algorithms, and first-in-class treatments, aimed to detect and treat retinal diseases early, preventing irreversible vision loss.
May-2023: Merck KGaA had signed a non-binding MoU with Ministry of Trade, Industry and Energy (MOTIE) and Daejeon City for an Asia-Pacific BioProcessing Center. The facility, aimed at aiding the region's healthcare ecosystem, would support commercial manufacturing for biotech and pharmaceutical clients in Asia-Pacific, serving as a vital hub for industry development in South Korea.
Apr-2023: Sartorius AG came into partnership with va-Q-tec, an innovator in thermal insulation solutions, to enhance logistics for shipping bulk drug substances (BDS). As BDS are highly temperature-sensitive and valuable, this collaboration seeks to improve efficiency and safety in their transportation within the industry. The partnership built on years of collaboration, leveraging the established positions and expertise of both Sartorius and va-Q-tec in the field.
Jan-2023: Sartorius AG extended collaboration with RoosterBio Inc., a privately held cell manufacturing platform technology company, to tackle purification challenges and set up scalable downstream manufacturing for exosome-based therapies. The partnership aimed to deliver high-quality solutions for an hMSC-based exosome production platform, emphasizing top-tier yield, purity, and potency. The collaboration also focused on developing comprehensive analytical techniques for characterizing exosomes and the entire range of extracellular vesicles (EVs), establishing quantitative strategies for quality control in exosome purification intermediates and final drug products.
Product Launches and Product Expansions:
Sep-2022: Thermo Fisher Scientific, Inc. introduced the Thermo Scientific DynaSpin Single-Use Centrifuge system, designed for large-scale cell culture harvesting. Streamlining the process in single-use bioprocessing, it reduces the required depth filtration cartridges, maintaining or improving product yield compared to traditional systems. The DynaSpin solution enhances operational efficiency, cost-effectiveness, and sustainability in biologics production.
Acquisition and Mergers:
Jun-2023: Merck KGaA completed the acquisition of Prometheus Biosciences, Inc., making it a wholly owned subsidiary. Under the acquisition, Prometheus' common stock ceased trading on the Nasdaq Global Market, furthering Merck's presence in immunology, enhancing their pipeline, and strengthening their ability to provide patient value. This strategic and decisive move aligned with Merck's commitment to science and value.
Dec-2022: Merck KGaA acquired Erbi Biosystems, a developer of the 2 ml micro-bioreactor platform technology known as "Breez", to enhance its therapeutic protein upstream portfolio with the "Breez" 2 ml micro-bioreactor platform. This supports scalable cell-based perfusion bioreactor processes from 2 mL to 2000L, aiding rapid lab-scale development. The acquisition also opens possibilities for future development in novel applications, including cell therapies.
Apr-2022: Merck KGaA acquired the MAST (Modular Automated Sampling Technology) platform from Lonza to enhance its bioprocessing portfolio. Merck utilized the MAST platform, an automated, aseptic bioreactor sampling system developed in Bend, Oregon, USA. This technology, along with data analysis and management software, enabled Merck to provide distinctive and integrated solutions, assisting customers in optimizing their bioprocesses.
Geographical Expansions:
Jul-2023: Sartorius AG expanded its site in Yauco, Puerto Rico, by incorporating a new cell culture media manufacturing facility. Now officially opened, this 21,500-square-foot (2,000 square meters) facility aimed to enhance the company's cell culture media capacities, with a specific focus on serving customers in the Americas region. This addition solidified their extensive portfolio, particularly catering to customers in the Americas.
May-2023: Thermo Fisher Scientific, Inc. broadened its sterile manufacturing and research capabilities in the Asia-Pacific by inaugurating a new sterile drug facility in Singapore. Supported by the Singapore Economic Development Board, this good manufacturing practices facility complements Thermo Fisher's existing bioprocess design and customer experience centers, enhancing their operational labs with cutting-edge life science, analytical, and bioprocessing technologies.
Sep-2022: Eppendorf Group expanded its Julich bioprocess site by constructing a new multifunctional building. The added space increased DASGIP Information and Process Technology GmbH's production capacity by up to 20%, showcasing Eppendorf's long-term commitment to its Julich production location.
Apr-2022: Thermo Fisher Scientific set up a new single-use technology manufacturing site in Ogden, Utah, enhancing capacity for high-quality materials crucial in developing vaccines and therapies. This expansion strengthens the company's Utah presence and facilitates close collaboration with the Logan site, tapping into a skilled workforce for manufacturing intricate, customized solutions.
Nov-2021: Lonza Group AG expanded its manufacturing capacity to enhance microbial development capabilities in Switzerland, by expanding laboratory space and equipment to increase capacity for development services focusing on microbial-derived proteins. This extension supports new projects in Lonza's existing manufacturing assets and complements the previously announced mid-scale microbial capacity expansion. Strengthening upstream, downstream, and process analytics support, these expanded development services address the complexities of manufacturing processes in microbial expression systems.
Sep-2021: Sartorius AG expanded its Michigan presence by opening a 130,000-square-foot facility in Ann Arbor. The center of excellence consolidated operations in Washtenaw County for laboratory and Bioprocess products and services in North America. The focus is on delivering innovative solutions to aid customers in developing drugs to cure, prevent, and halt diseases.
May-2021: Lonza Group AG expanded its mammalian drug substance manufacturing facilities in Visp (CH) and Portsmouth (US). The expansion in Visp included a new large-scale facility with six 20,000L bioreactors to address the growing demand for biologics. Encompassing approximately 27,500 m2, the state-of-the-art facility, equipped with perfusion capabilities, was designed for high-titer processes and the next generation of mammalian biologics.
Sep-2020: Thermo Fisher Scientific Inc. opened the Bioprocessing Collaboration Center (BCC) in St. Louis, Missouri, located near its expanded biologics manufacturing facility. The BCC, merging expertise from Thermo Fisher's bioproduction and pharma services, aimed to boost innovation and productivity for biopharma companies. This initiative responds to the increasing demand for flexible, scalable solutions in biologics development and manufacturing, improving workflows and expediting product launches for customers.
Market Segments covered in the Report:
By Scale
By Use Type
By Mode
By Application
By Workflow
By Product
By Geography
Companies Profiled
Unique Offerings from KBV Research