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市場調査レポート
商品コード
1541095
医薬品連続製造市場レポート:治療薬タイプ、製剤、用途、エンドユーザー、地域別、2024~2032年Pharmaceutical Continuous Manufacturing Market Report by Therapeutics Type, Formulation, Application, End User, and Region 2024-2032 |
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医薬品連続製造市場レポート:治療薬タイプ、製剤、用途、エンドユーザー、地域別、2024~2032年 |
出版日: 2024年08月10日
発行: IMARC
ページ情報: 英文 141 Pages
納期: 2~3営業日
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世界の医薬品連続製造市場規模は2023年に13億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに32億米ドルに達し、2024~2032年の間に10.1%の成長率(CAGR)を示すと予測しています。効果的な医薬品生産システムに対する需要の高まり、医薬品セグメントの改善、研究開発(R&D)活動の活発化、健康への関心の高まりなどが、市場を後押しする要因のひとつです。
医薬品の連続製造は、最小限の資本投資で革新的な医薬品の品質と一貫性を向上させる、医薬品とワクチン製造への総合的なアプローチです。従来のバッチ処理とは対照的に、この方法は連続フローでシームレスに動作し、拡大性、制御性の向上、自動化、物理的介入の排除を記載しています。特筆すべきは、医薬品の連続製造は、薬剤の調合時間と人的ミスの可能性を大幅に削減し、製造プロセスの監視を強化し、製品品質が厳しい規制基準に適合することを保証することです。その結果、この技術は医薬品原薬(API)や医薬品を開発する製薬会社や製造受託機関(CMO)に広く受け入れられています。医薬品連続製造の採用は、医薬品の生産効率と規制要件への準拠を推進する上で極めて重要な役割を担っていることを裏付けています。
世界市場は、いくつかの重要な要因によって力強い成長を遂げています。特に世界の健康課題の進行に伴い、医薬品とワクチンの需要が増加しているため、業界は生産効率の改善を迫られています。連続製造はプロセスを合理化し、リードタイムを短縮し、より信頼性の高い医薬品供給を可能にするため、この需要の高まりに応える魅力的なソリューションとなっています。さらに、連続製造の費用対効果は大きな推進力となっています。従来のバッチプロセスよりも設備投資が少なくて済むため、経費を最小限に抑えながら業務の最適化を図りたい製薬企業にとっては魅力的な選択肢となります。さらに、製品の品質を高め、汚染リスクを低減し、製造プロセスをリアルタイムでモニタリングできる可能性があることから、規制当局の連続製造に対する支持も高まっています。このような規制ガイドラインとの整合性により、より多くの製薬企業が連続製造方式を採用するようになっています。さらに、より一貫性と純度の高い高品質の医薬品を製造する連続製造の能力は、極めて重要な要素です。この技術は、人的ミスを最小限に抑え、重要なパラメーターを正確に制御し、交差汚染のリスクを低減します。さらに、医薬品の連続製造は、廃棄物やエネルギー消費を最小限に抑えることで、持続可能性の目標に沿うものであり、より環境に配慮した製造プロセスを目指す企業と共鳴するものです。
慢性疾患の蔓延
慢性疾患の蔓延は、市場拡大の重要な促進要因です。糖尿病、心血管疾患、各種がんなどの慢性疾患は世界的に増加しています。このような慢性的な健康問題の大幅な増加は、医薬品や薬剤に対する持続的な需要を生み出しています。連続製造は、慢性疾患に対する投薬要件の増加に対して、より効率的で迅速なソリューションを記載しています。その合理化された連続生産プロセスにより、必要不可欠な医薬品の確実で安定した供給が保証され、医薬品不足のリスクが軽減され、患者の治療へのアクセスが改善されます。さらに、製薬会社が慢性疾患用の複雑な医薬品や生物製剤の製造に努める中、連続製造は医薬品製造においてより高い管理と精度を記載しています。これは、こうした救命治療の品質と有効性を確保する上で極めて重要です。
研究開発活動の増加
研究開発(R&D)活動の重視の高まりは、医薬品連続製造の成長の強力な原動力です。製薬会社は、感染症、慢性疾患、新興の健康脅威など、さまざまな健康課題に対処するために、新薬、生物製剤、ワクチンを開発する研究開発に多額の投資を行っています。継続的製造は、より効率的で制御された製造プロセスを提供することで、こうした研究開発努力に沿うものです。製薬会社は新薬候補の製造を迅速に拡大することができ、革新的な治療法の市場投入までの時間を短縮することができます。このような生産における俊敏性は、ワクチンや治療の迅速な開発・製造が重要な、世界の健康危機やパンデミックに対応する際に特に価値があります。さらに、連続製造は、医薬品の研究開発において不可欠な製剤の最適化や、新しいドラッグデリバリー方法の探求を容易にします。製造のばらつきを抑え、重要なパラメーターを正確に制御することで、実験薬の一貫性と品質を向上させます。製薬業界が革新を続け、新たな治療法を導入する中、連続製造技術の採用は、現代の研究開発活動の要求との整合性によって後押しされ、さらに拡大すると予想されます。
人工知能(AI)ソリューションの統合の高まり
人工知能(AI)ソリューションの統合の高まりは、医薬品連続製造市場の成長を促進する有力なドライバーです。AI技術はさまざまな医薬品の研究開発、製造に革命をもたらしています。医薬品の連続製造において、AIはプロセスの最適化と自動化に利用されています。AI主導のアルゴリズムは、重要な製造パラメータをリアルタイムで監視・調整し、一貫した製品品質を確保し、逸脱のリスクを低減することができます。このレベルの自動化は効率を高め、製造プロセスにおける人的ミスを最小限に抑えます。AIは創薬や製剤にも採用されています。機械学習アルゴリズムは、膨大なデータセットを分析して潜在的な医薬品候補を特定し、その挙動を予測し、より優れた有効性と安全性のために製剤を最適化します。これにより医薬品開発が加速され、製薬会社は新しい治療法をより迅速に市場に投入できるようになります。さらに、AIを活用した予知保全は、製薬メーカーが設備の問題を事前に特定して対処し、ダウンタイムや生産中断を最小限に抑えるのに役立ちます。製薬企業が効率改善、コスト削減、製品品質向上におけるAIの可能性を認識するにつれ、継続的製造プロセスにおけるAIソリューションの採用が増加しています。このような統合は、進化する医療需要に対応するための先進技術の追求と一致し、医薬品連続製造市場の成長を促進しています。
The global pharmaceutical continuous manufacturing market size reached US$ 1.3 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 3.2 Billion by 2032, exhibiting a growth rate (CAGR) of 10.1% during 2024-2032. The rising demand for effective medicine production systems, the improvements in the pharmaceutical sector, the increasing research and development (R&D) activities, and the escalating health concerns are some of the factors propelling the market.
Pharmaceutical continuous manufacturing represents a holistic approach to drug and vaccine production that elevates the quality and consistency of innovative pharmaceuticals while requiring minimal capital investment. In contrast to traditional batch processing, this method operates seamlessly in a continuous flow, offering scalability, increased control, automation, and the elimination of physical interventions. Notably, continuous pharmaceutical manufacturing significantly reduces drug formulation time and the potential for human errors, enhances production process monitoring, and ensures product quality aligns with stringent regulatory standards. As a result, this technique is widely embraced by pharmaceutical companies and contract manufacturing organizations (CMOs) to develop active pharmaceutical ingredients (APIs) and medications. The adoption of pharmaceutical continuous manufacturing underscores its pivotal role in advancing pharmaceutical production efficiency and compliance with regulatory requirements.
The global market is experiencing robust growth driven by several key factors. The increasing demand for pharmaceuticals and vaccines, particularly with the ongoing global health challenges, has pressured the industry to improve production efficiency. Continuous manufacturing streamlines the process, reduces lead times, and ensures a more reliable supply of medicines, making it an attractive solution to meet this heightened demand. Furthermore, the cost-effectiveness of continuous manufacturing is a significant driver. It requires lower capital investments than traditional batch processes, making it an appealing choice for pharmaceutical companies looking to optimize their operations while minimizing expenses. Moreover, regulatory agencies are increasingly supportive of continuous manufacturing due to its potential to enhance product quality, reduce contamination risks, and provide real-time monitoring of the production process. This alignment with regulatory guidelines encourages more pharmaceutical companies to adopt continuous manufacturing practices. Additionally, the ability of continuous manufacturing to produce high-quality pharmaceuticals with greater consistency and purity is a crucial factor. This technology minimizes human errors, ensures precise control over critical parameters, and reduces the risk of cross-contamination. Besides, pharmaceutical continuous manufacturing aligns with sustainability goals by minimizing waste and energy consumption, which resonates with companies aiming for more environmentally responsible production processes.
The growing prevalence of several chronic ailments
The growing prevalence of chronic ailments is a significant driver behind the expanding market. Chronic diseases, such as diabetes, cardiovascular conditions, and various cancers, are rising globally. This considerable rise in chronic health issues has created a sustained demand for pharmaceuticals and medications. Continuous manufacturing offers a more efficient and responsive solution to the increasing medication requirements for chronic diseases. Its streamlined and continuous production process ensures a reliable and consistent supply of essential drugs, reducing the risk of shortages and improving patient access to treatments. Furthermore, as pharmaceutical companies strive to produce complex medications and biologics for chronic conditions, continuous manufacturing provides greater control and precision in drug production. This is crucial in ensuring the quality and efficacy of these life-saving treatments.
Increasing research and development (R&D) activities
The increasing emphasis on research and development (R&D) activities is a powerful driving force behind the growth of the pharmaceutical continuous manufacturing market. Pharmaceutical companies are investing significantly in R&D to develop new drugs, biologics, and vaccines to address various health challenges, including infectious diseases, chronic conditions, and emerging health threats. Continuous manufacturing aligns with these R&D efforts by offering a more efficient and controlled production process. It enables pharmaceutical companies to swiftly scale up the manufacturing of new drug candidates, reducing time-to-market for innovative therapies. This agility in production is particularly valuable when responding to global health crises or pandemics, where the rapid development and manufacturing of vaccines and treatments are critical. Moreover, continuous manufacturing facilitates the optimization of drug formulations and the exploration of novel drug delivery methods, both essential aspects of pharmaceutical R&D By reducing production variability and ensuring precise control over critical parameters, it enhances the consistency and quality of experimental drugs. As the pharmaceutical industry continues to innovate and introduce novel therapies, the adoption of continuous manufacturing technologies is expected to grow further, bolstered by its alignment with the demands of contemporary R&D activities.
Rising integration of artificial intelligence (AI) solutions
The rising integration of artificial intelligence (AI) solutions is a compelling driver fueling the growth of the pharmaceutical continuous manufacturing market. AI technologies are revolutionizing various pharmaceutical research, development, and manufacturing aspects. In pharmaceutical continuous manufacturing, AI is used for process optimization and automation. AI-driven algorithms can monitor and adjust critical manufacturing parameters in real time, ensuring consistent product quality and reducing the risk of deviations. This level of automation enhances efficiency and minimizes human errors in the manufacturing process. AI is also employed in drug discovery and formulation. Machine learning algorithms analyze vast datasets to identify potential drug candidates, predict their behavior, and optimize their formulations for better efficacy and safety. This accelerates drug development and enables pharmaceutical companies to bring new therapies to market more quickly. Furthermore, AI-driven predictive maintenance can help pharmaceutical manufacturers proactively identify and address equipment issues, minimizing downtime and production disruptions. As pharmaceutical companies recognize the potential of AI in improving efficiency, reducing costs, and enhancing product quality, they are increasingly adopting AI solutions in their continuous manufacturing processes. This integration aligns with the industry's pursuit of advanced technologies to meet evolving healthcare demands, thereby driving the growth of the pharmaceutical continuous manufacturing market.
IMARC Group provides an analysis of the key trends in each segment of the global pharmaceutical continuous manufacturing market report, along with forecasts at the global, regional and country levels for 2024-2032. Our report has categorized the market based on therapeutics type, formulation, application, and end user.
Large Molecules
Small Molecules
Small Molecules dominates the market
The report has provided a detailed breakup and analysis of the market based on the therapeutics type. This includes large molecules and small molecules. According to the report, small molecules represented the largest segment.
Small molecule drugs, including chemically synthesized pharmaceuticals, benefit from continuous manufacturing. It enhances the production efficiency of small molecule drugs, reduces production costs, and ensures product quality. As pharmaceutical companies seek cost-effective and efficient solutions for producing both generic and innovative small-molecule drugs, the adoption of continuous manufacturing in this segment remains robust.
Conversely, the production of large molecules, including biologics such as monoclonal antibodies and therapeutic proteins, requires highly precise and controlled manufacturing processes. Continuous manufacturing offers an advantage in producing these complex molecules with consistent quality. The biopharmaceutical industry, in particular, is increasingly turning to continuous manufacturing to meet the growing demand for biologics. This segment's adoption drives the market's growth as it aligns with the expanding biopharmaceutical sector.
Solid Formulation
Liquid and Semi-solid Formulation
Solid Formulation dominates the market
The report has provided a detailed breakup and analysis of the market based on the formulation. This includes solid formulation, and liquid and semi-solid formulation. According to the report, solid formulation represented the largest segment.
Continuous manufacturing is particularly well-suited for solid dosage forms such as tablets, capsules, and powders. This segment leverages the benefits of continuous processes, including precise control over blending, granulation, and tableting. Pharmaceutical companies adopting continuous manufacturing for solid formulations experience enhanced efficiency, reduced waste, and improved consistency in producing oral solid medications. As the demand for solid dosage forms remains high, the continuous manufacturing approach significantly caters to this demand and optimizes production processes.
On the other hand, continuous manufacturing also benefits the production of liquid and semi-solid formulations, including syrups, suspensions, and creams. In this segment, continuous manufacturing streamlines mixing, blending, and filling processes. It enables pharmaceutical companies to achieve higher levels of automation, consistency, and quality control in manufacturing liquid and semi-solid medications. The adoption of continuous manufacturing in this category addresses the demand for various delivery forms and supports the development of innovative drug formulations.
Final Drug Product Manufacturing
API Manufacturing
Final Drug Product Manufacturing dominates the market
The report has provided a detailed breakup and analysis of the market based on the application. This includes final drug product manufacturing and API manufacturing. According to the report, final drug product manufacturing represented the largest segment.
Continuous manufacturing offers a streamlined and efficient process for producing the final drug products, such as tablets, capsules, or injectables. This segment benefits from continuous processes that enhance precision and consistency in dosage form production. The adoption of continuous manufacturing in final drug product manufacturing results in cost savings, quicker time-to-market, and improved product quality, all of which drive market growth.
On the contrary, API manufacturing, the production of the active pharmaceutical ingredients that form the basis of medications, also benefits from continuous manufacturing practices. Continuous synthesis and processing of APIs ensure efficient and consistent production. Pharmaceutical companies adopting continuous manufacturing for API manufacturing experience increased yield, reduced waste, and quicker API production, thus contributing to market growth.
Pharmaceutical Companies
Contract Manufacturing Organizations
Others
Pharmaceutical Companies dominates the market
The report has provided a detailed breakup and analysis of the market based on the end user. This includes pharmaceutical companies, contract manufacturing organizations, and others. According to the report, pharmaceutical companies represented the largest segment.
Pharmaceutical companies are major drivers of the adoption of continuous manufacturing. They utilize continuous processes for in-house production, focusing on enhancing efficiency, reducing costs, and ensuring consistent product quality. Continuous manufacturing aligns with their goal of delivering innovative, cost-effective pharmaceutical products, driving market growth.
Furthermore, contract manufacturing organizations specialize in providing manufacturing services to pharmaceutical companies, often on a contract basis. Continuous manufacturing is increasingly attractive to CMOs, enabling them to offer their clients more efficient and responsive production solutions. By adopting continuous manufacturing practices, CMOs can optimize their operations, reduce production lead times, and maintain high-quality standards, thus attracting more pharmaceutical clients and contributing to market growth.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance, accounting for the largest market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
North America, comprising the United States and Canada, is a leading pharmaceutical innovation and production hub. Several factors contribute to the growth of pharmaceutical continuous manufacturing in this region. It is at the forefront of technological advancements in pharmaceutical manufacturing. Companies in this region continually invest in cutting-edge continuous manufacturing technologies, pushing the boundaries of efficiency and quality.
Regulatory bodies in North America are increasingly supportive of continuous manufacturing practices. This alignment with regulatory guidelines encourages pharmaceutical companies to adopt continuous manufacturing solutions, bolstering market growth. The region hosts numerous industry collaborations and consortiums focusing on advancing continuous manufacturing practices. These partnerships accelerate innovation and standardization within the sector.
Moreover, the pharmaceutical market in North America is vast and competitive. Companies in this region actively seek ways to improve efficiency, reduce costs, and enhance product quality, making continuous manufacturing an attractive option. Besides, pharmaceutical companies and contract manufacturing organizations have a significant global presence. Their adoption of continuous manufacturing helps disseminate these practices to other regions, further expanding the market.
Top companies are bolstering market growth through various strategic initiatives and innovations. They invest heavily in research and development to enhance continuous manufacturing technologies. They continually innovate and improve processes to offer more efficient, scalable, and precise manufacturing solutions. These companies collaborate closely with regulatory agencies to ensure that their continuous manufacturing processes meet the stringent requirements and quality standards set forth by regulatory bodies. This alignment instills trust and confidence in their solutions. Top firms form strategic partnerships with other pharmaceutical companies, contract manufacturers, and technology providers. These collaborations foster the development of integrated and standardized continuous manufacturing solutions that can be widely adopted across the industry. Furthermore, they offer educational resources and training programs to help pharmaceutical professionals effectively understand and implement continuous manufacturing technologies. This accelerates adoption and ensures the proper utilization of these systems. Leading companies expand internationally, addressing the global demand for advanced pharmaceutical manufacturing solutions. Their global reach helps in disseminating continuous manufacturing practices across regions.
The report has provided a comprehensive analysis of the competitive landscape in the pharmaceutical continuous manufacturing market. Detailed profiles of all major companies have also been provided.
Baker Perkins
Coperion GmbH (Hillenbrand Inc.)
Eli Lilly and Company
GEA Group Aktiengesellschaft
Glatt GmbH
Korsch AG
Novartis AG
Siemens
SK biotek
Thermo Fisher Scientific Inc.
Viatris Inc.
In 2023, Hillenbrand, Inc. successfully completed its acquisition of LINXIS Group, a leader in specialized equipment for the food, pharma, and cosmetics industries.
Eli Lilly and Company has successfully completed the acquisition of Versanis Bio in 2023, expanding its portfolio to include bimagrumab, a potential innovative treatment for obesity.
Viatris and Mapi Pharma have announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for GA Depot 40 mg, a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS). The FDA has set a target action date of March 8, 2024, for the NDA.