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市場調査レポート
商品コード
1654645
バイオプロセス自動化・制御ソフトウェアの世界市場(2025年~2033年)Global Bioprocess Automation and Control Software Market - 2025-2033 |
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カスタマイズ可能
適宜更新あり
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バイオプロセス自動化・制御ソフトウェアの世界市場(2025年~2033年) |
出版日: 2025年02月13日
発行: DataM Intelligence
ページ情報: 英文 179 Pages
納期: 即日から翌営業日
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世界のバイオプロセス自動化・制御ソフトウェアの市場規模は、2024年に16億米ドルに達し、2033年には27億米ドルに達すると予測され、予測期間2025年~2033年のCAGRは6.2%で成長する見通しです。
バイオプロセス自動化・制御ソフトウェアは、バイオテクノロジー、医薬品、バイオ製造などの産業におけるバイオプロセスの様々な段階を自動化、監視、制御するために設計されたソフトウェアの専門カテゴリーです。これらのソフトウェアシステムは、細胞培養や発酵から下流の精製や品質管理まで、複雑なバイオプロセスのワークフローを最適化するために使用されます。バイオプロセス自動化・制御ソフトウェアの主な目的は、プロセス効率の向上、一貫性の確保、高い製品品質の維持、規制基準の遵守です。
バイオプロセス自動化・制御ソフトウェア市場は、バイオテクノロジー、医薬品、バイオ製造における需要の高まりにより、急速に拡大しています。例えば、OECDによれば、米国はバイオテクノロジー分野で引き続き圧倒的な強さを誇っており、最も活発なバイオテクノロジー企業(2,840社)を擁し、研究開発強度の付加価値は17%に達しています。ベルギーのバイオテクノロジー研究開発付加価値35.7%や、英国の2023年第3四半期の好調は、欧州のイノベーション牽引国としての地位を確固たるものにし、これは不均衡でありつつ有望なバイオテクノロジー環境を示しています。
促進要因と抑制要因
バイオ医薬品と生物製剤の需要増加
バイオ医薬品と生物製剤に対する需要の高まりは、バイオプロセス自動化・制御ソフトウェア市場の成長を大きく牽引しており、予測期間中も牽引していくと予想されます。モノクローナル抗体、細胞・遺伝子治療、ワクチン、遺伝子組換えタンパク質などの製品を含むバイオ医薬品・生物製剤に対する需要の高まりが、バイオプロセス自動化・制御ソフトウェア市場の大きな成長を牽引しています。バイオ医薬品は非常に複雑で繊細な製品であるため、一貫した品質、正確な管理、スケーラビリティが生産の成功に不可欠です。このため、バイオプロセスでは自動化と高度な制御システムが強く推進されています。
例えば、米国研究製薬工業協会(Pharmaceutical Research and Manufacturers of America)によると、2022年末時点で40のバイオシミラー医薬品が承認され、米国では27のバイオシミラー医薬品が上市されています。また、PhRMAが発表したデータによると、世界全体で7,800以上のバイオ医薬品が臨床開発されており、そのうち1,000以上が第3相試験に到達しています。このようなバイオ医薬品や生物製剤に対する需要の高まりが、市場の成長を後押ししています。
サイバーセキュリティへの懸念
サイバーセキュリティへの懸念は、バイオプロセス自動化・制御ソフトウェア市場にとって重要な課題であり、その成長と普及を妨げる可能性があります。バイオ製造施設の自動化システム統合が進むにつれ、クラウドベースのプラットフォーム、IoTデバイス、リアルタイムモニタリングなどのデータ駆動型コネクテッドテクノロジーへの依存が、幅広いサイバーリスクにさらされるようになっています。
例えば、HHSサイバーセキュリティ・プログラムによると、ヘルスケア組織で630件以上、2,900万件の医療記録が侵害されています。これらの脆弱性は、重要なシステムをサイバー攻撃、データ漏洩、業務妨害にさらす可能性があり、製造工程と規制遵守の両方に深刻な結果をもたらす可能性があります。
The global bioprocess automation and control software market reached US$ 1.6 billion in 2024 and is expected to reach US$ 2.7 billion by 2033, growing at a CAGR of 6.2% during the forecast period 2025-2033.
Bioprocess automation and control software is a specialized category of software designed to automate, monitor and control various stages of bioprocessing in industries such as biotechnology, pharmaceuticals and bio-manufacturing. These software systems are used to optimize complex bioprocess workflows, from cell culture and fermentation to downstream purification and quality control. The primary goal of bioprocess automation and control software is to improve process efficiency, ensure consistency, maintain high product quality and comply with regulatory standards.
The bioprocess automation and control software market is expanding rapidly, driven by rising demand in biotechnology, pharmaceuticals and biomanufacturing. For instance, according to the OECD, the United States continues to be a dominant force in the biotech sector, with the most active biotech businesses (2,840) and an R&D intensity added value of 17%. Belgium's remarkable 35.7% biotech R&D added value or the UK's strong 2023 third quarter, which solidified its position as a European innovation driver, demonstrates an uneven but promising biotechnology environment.
Market Dynamics: Drivers & Restraints
Rising demand for biopharmaceuticals and biologics
The rising demand for biopharmaceuticals and biologics is significantly driving the growth of the bioprocess automation and control software market and is expected to drive over the forecast period. The rising demand for biopharmaceuticals and biologics including products like monoclonal antibodies, cell and gene therapies, vaccines and recombinant proteins drives significant growth in the bioprocess automation and control software market. Biopharmaceuticals are highly complex and sensitive products, making consistent quality, precise control and scalability essential for successful production. This has created a strong push toward automation and advanced control systems in bioprocessing.
For instance, according to the Pharmaceutical Research and Manufacturers of America, as of the end of 2022, 40 biosimilars have been approved and there are 27 biosimilars on the market in the U.S. Additionally, data published by PhRMA indicate that there are more than 7,800 biopharmaceutical products in clinical development globally, of which over 1,000 have reached phase 3 trials. This rising demand for biopharmaceuticals and biologics boosting the market growth.
Cybersecurity concerns
Cybersecurity concerns are a significant challenge for the bioprocess automation and control software market, potentially hindering its growth and adoption. As biomanufacturing facilities increasingly integrate automation systems, the reliance on data-driven, connected technologies such as cloud-based platforms, IoT devices and real-time monitoring opens them up to a wide range of cyber risks.
For instance, according to the HHS Cybersecurity Program, 630+ total healthcare organizational breaches and 29 million healthcare records were breached. These vulnerabilities can expose critical systems to cyberattacks, data breaches and operational disruptions, which can have severe consequences for both the manufacturing process and regulatory compliance.
The global bioprocess automation and control software market is segmented based on software type, deployment mode, application, end-user and region.
The bioprocess control software segment is expected to dominate the global bioprocess automation and control software market share
The bioprocess control software segment holds a major portion of the bioprocess automation and control software market share and is expected to continue to hold a significant portion of the market share over the forecast period due to its critical role in optimizing, monitoring and controlling complex biomanufacturing processes. As the demand for biologics and biopharmaceuticals continues to grow, the need for highly precise control systems becomes more vital. Bioprocess control software ensures the accuracy, repeatability and efficiency required to produce high-quality bioproducts while maintaining compliance with stringent regulatory standards.
For instance, Strict control of bioreactor conditions is necessary for the manufacture of monoclonal antibodies (mAbs), as even minor variations might result in decreased output or problems with product quality. Bioprocess control software optimizes the process to attain optimum efficiency by automating the real-time modification of critical variables such as temperature, pH and oxygen concentration.
The quality management software segment is the fastest-growing segment in the bioprocess automation and control software market
The quality management software segment is expected to be the fastest-growing segment in the bioprocess automation and control software market over the forecast period largely driven by the increasing complexity and regulatory scrutiny in the biopharmaceutical and biotechnology sectors. Quality management systems ensure that bioprocesses are executed under controlled conditions, maintain high standards of product quality and comply with stringent regulatory requirements.
For instance, according to the National Institute of Health, in a Quality Benchmarking Study (QBS), more than 200 pharmaceutical manufacturing facilities from across the world contributed information on their production performance and self-evaluations of their compliance with quality standards. These can increase the demand for quality management software in pharmaceutical manufacturing facilities.
North America is expected to hold a significant position in the global bioprocess automation and control software market
North America region is expected to hold the largest share in the bioprocess automation and control software market over the forecast period owing to the rising demand for biopharmaceuticals. The growing shift toward biopharmaceuticals as the preferred treatment option for a variety of diseases is boosting the need for advanced biomanufacturing capabilities. North America especially in the United States and Canada is the largest market and is expected to maintain this position, fueling the demand for bioprocess automation software in the region.
According to the Government of Canada, Canada is the eighth largest pharmaceutical market in the world, with a 2.2% share worldwide. In Canada, brand-name goods make up 25.7% of prescriptions by quantity and 80.5% of sales by value. Generics make up 74.3% of the share by prescriptions and 19.5% of sales by value.
Asia Pacific is growing at the fastest pace in the bioprocess automation and control software market
The Asia Pacific region is experiencing the fastest growth in the bioprocess automation and control software market. The biopharmaceutical market in APAC is experiencing rapid growth, especially in India, Japan and China. The increasing demand for biologics such as monoclonal antibodies, vaccines, biosimilars and gene therapies is driving the need for advanced biomanufacturing solutions, including automation software for both upstream and downstream processing.
For instance, according to Invest India, a total of 22 mergers and acquisitions (M&A) deals have occurred in the life sciences sector in India. The percentage share of the biotechnology segments is biopharmaceuticals at 62%, bioagriculture at 13%, bioindustry at 15% and bioIT & bioservices at 10%.
The major global players in the bioprocess automation and control software market include Thermo Fisher Scientific Inc., Merck KGaA, Sartorius AG, SECURECELL AG, Resea Biotec GmbH, Getinge AB, Vimachem, Danaher Corporation, Eppendorf SE, Waters Corporation and among others.
Emerging Players
The emerging players in the bioprocess automation and control software market include TetraScience, Inc., Korber AG, Infors AG and among others.
The global Bioprocess Automation and Control Software market report delivers a detailed analysis with 70 key tables, more than 68 visually impactful figures, and 179 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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