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市場調査レポート
商品コード
1629906
医薬品用シーリングマシンの世界市場 - 2025年~2033年Global Pharmaceutical Sealing Machines 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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医薬品用シーリングマシンの世界市場 - 2025年~2033年 |
出版日: 2024年12月30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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医薬品用シーリングマシンの世界市場は2024年に14億米ドルに達し、2033年には24億米ドルに達すると予測され、予測期間2025年のCAGRは6.3%で成長します。
医薬品用シーリングマシンは、製品の完全性、安全性、無菌性を確保するために、様々なタイプの医薬品包装を確実に密封するように設計された専門機器です。これらの機器は、医薬品やその他のヘルスケア製品を汚染、改ざん、湿気、空気、光などの環境要因から保護するため、医薬品製造プロセスにおいて非常に重要です。全体として、医薬品用シーリングマシンは医薬品の安全性、有効性、品質を確保する上で非常に重要であり、特に厳しい規制要件や製薬業界におけるより高品質なパッケージングソリューションへの要求の高まりの中で重要な役割を担っています。
医薬品用シーリングマシンの需要は、製品の安全性に対するニーズの高まり、厳しい規制への対応、生産量の多い製薬業界の拡大により、着実に伸びています。例えば、キャップシール機は1時間に最大36,000~1万2,000個のバイアルを生産することができます。生物製剤やバイオシミラーの成長により、繊細な包装マテリアルを扱い、気密シールを確保できる密封機への需要が高まっています。
促進要因と抑制要因
医薬品製造の成長
医薬品製造業の成長は、医薬品用シーリングマシン市場を大きく牽引しており、予測期間中も市場を牽引すると予測されています。この動向は主に、医薬品需要の増加、製造施設の拡大、厳格な規制遵守の必要性など、いくつかの要因によってもたらされています。
糖尿病、心血管疾患、がんなどの慢性疾患の世界の増加は、医薬品の生産を後押ししており、その結果、効果的な密封機のニーズが高まっています。例えば、世界保健機関(WHO)によると、2022年の世界の死亡者数の74%を慢性疾患が占めており、医薬品の必要性が高まっていることが強調されています。
生物製剤やバイオシミラーの成長は、有効性を維持し汚染を防ぐために特殊な包装・密封技術を必要とすることが多く、複雑な包装要件に対応できる密封機に対する需要の高まりにつながっています。例えば、米国研究製薬工業協会(Pharmaceutical Research and Manufacturers of America)によると、2022年末現在、米国では40のバイオシミラーが承認され、27のバイオシミラーが上市されています。
次世代シーリングマシンの採用により、特に無菌性と使い勝手の向上というメリットが得られます。これにより、ダウンタイムが短縮され、製造ライン全体で一貫した品質が保証されます。例えば、2023年10月、ヘルスケアパッケージングソリューションのリーディングプロバイダーであるTekniPlexヘルスケアは、スペインのバルセロナで開催されたCPhI見本市でPentafill A25 Filling &Sealing Machineを展示し、医薬品パッケージング技術の進歩へのコミットメントを示しました。Pentafill A25はテクニプレックス・ヘルスケアが開発した次世代型充填密封機です。主に無菌性と使いやすさの向上に重点を置き、様々な利点を提供しています。
材料適合性の問題
材料適合性の問題は、これらの機械の効率、信頼性、採用に直接影響するため、医薬品用シーリングマシン市場にとって重要な課題です。製薬会社が環境にやさしく生分解性のある包装材料を採用するにつれ、従来のシーリングマシンはこれらの材料を効果的に扱うのに苦労することが多いです。
例えば、プラスチックやアルミニウム用に最適化された従来のシーリングマシンは、生分解性プラスチックや紙ベースの素材に使用すると、必要なシール強度や一貫性が得られない場合があり、生産効率の低下や廃棄物の増加につながります。このような移行は、機械の改造や交換の必要性を高め、運用コストを増加させ、採用を遅らせる。
高感度医薬品に使われる多層フィルムのような高度な素材は、均一な熱分布とシール強度を達成する上で課題を引き起こす可能性があります。例えば、単層材料用に設計されたシーリングマシンを多層フィルムに使用すると、オーバーヒートやシール不足を引き起こし、包装不良や製品回収につながる可能性があります。これは生産性を妨げ、無駄を増やし、メーカーのコストを押し上げます。
The global pharmaceutical sealing machines market reached US$ 1.4 billion in 2024 and is expected to reach US$ 2.4 billion by 2033, growing at a CAGR of 6.3% during the forecast period 2025-2033.
Pharmaceutical sealing machines are specialized equipment designed to securely seal various types of pharmaceutical packaging to ensure the integrity, safety, and sterility of the products. These machines are critical in the pharmaceutical manufacturing process, as they protect medicines and other healthcare products from contamination, tampering, and environmental factors such as moisture, air and light. Overall, pharmaceutical sealing machines are critical in ensuring the safety, efficacy, and quality of pharmaceutical products, especially in the context of stringent regulatory requirements and the increasing demand for higher-quality packaging solutions in the pharmaceutical industry.
The demand for pharmaceutical sealing machines is steadily growing due to the increasing need for product safety, compliance with stringent regulations, and the expansion of the pharmaceutical industry in terms of high production. For instance, the cap-sealing machine can produce up to 36,000 to 12,000 vials in an hour. The growth in biologics and biosimilars has increased the demand for sealing machines capable of handling sensitive packaging materials and ensuring airtight seals.
Market Dynamics: Drivers & Restraints
Growth in pharmaceutical manufacturing
The growth in pharmaceutical manufacturing is significantly driving the pharmaceutical sealing machines market and is expected to drive the market over the forecast period. This trend is primarily driven by several factors, including increased demand for pharmaceutical products, expansion of manufacturing facilities, and the need for stringent regulatory compliance.
The global rise in chronic diseases such as diabetes, cardiovascular conditions, and cancer is boosting the production of pharmaceutical products, which in turn drives the need for effective sealing machines. For instance, according to the World Health Organization (WHO), chronic diseases accounted for 74% of global deaths in 2022, emphasizing the growing need for pharmaceuticals.
The growth of biologics and biosimilars, which often require specialized packaging and sealing technologies to maintain efficacy and prevent contamination, has led to increased demand for sealing machines capable of handling complex packaging requirements. 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 US.
The adoption of next-generation sealing machines allows advantages, especially by enhancing sterility and user-friendliness. This reduces downtime and ensures consistent quality across manufacturing lines. For instance, in October 2023, TekniPlex Healthcare, a leading provider of healthcare packaging solutions, showcased its Pentafill A25 Filling & Sealing Machine at the CPhI trade show in Barcelona, Spain, demonstrating a commitment to advancing pharmaceutical packaging technology. The Pentafill A25 is a next-generation filling and sealing machine developed by TekniPlex Healthcare. It offers various advantages, primarily focusing on enhancing sterility and user-friendliness.
Material compatibility issues
Material compatibility issues are a significant challenge for the pharmaceutical sealing machines market, as they directly affect the efficiency, reliability and adoption of these machines. As pharmaceutical companies adopt eco-friendly and biodegradable packaging materials, traditional sealing machines often struggle to handle these materials effectively.
For instance, conventional sealing machines optimized for plastic and aluminum may not provide the required seal strength or consistency when used with biodegradable plastics or paper-based materials, leading to production inefficiencies and increased waste. This transition increases the need for retrofitting or replacing machines, which adds to operational costs and delays adoption.
Advanced materials, such as multi-layer films used for sensitive drugs, can cause challenges in achieving uniform heat distribution and sealing strength. For instance, sealing machines designed for single-layer materials may cause overheating or under-sealing when used with multi-layer films, resulting in defective packaging and product recalls. This hampers productivity and increases waste, driving up costs for manufacturers.
The global pharmaceutical sealing machines market is segmented based on machine type, technology, end-user and region.
The induction sealing machines segment is expected to dominate the pharmaceutical sealing machines market share
Induction sealing provides a hermetic (airtight) seal on containers, such as plastic and glass bottles, which prevents contamination from external elements like air, moisture and light. This is critical for preserving the efficacy and shelf life of pharmaceutical products, especially sensitive ones like liquids, creams and powders by providing inspection and process analysis.
For instance, in November 2024, Yoran Imaging introduced a system that provides inspection and process analysis for induction-sealed bottles, jars and vials. Capable of operating at full production speeds, the company's i-PAM induction seal process analytical monitoring system performs non-intrusive through-the-cap thermal imaging inspection of all induction seals and provides process insights to reveal the root causes of current or foreseeable adverse issues.
Induction sealing is widely adopted because it provides tamper-evident seals that are difficult to counterfeit. This meets the regulatory requirements set by bodies such as the FDA and the EU for pharmaceutical packaging. For instance, in the U.S., the Drug Supply Chain Security Act (DSCSA) mandates tamper-evident packaging for prescription drugs, pushing manufacturers to use induction sealing machines to include tamper-evident seals on product containers.
Induction sealing machines are suitable for sealing a wide range of containers and materials, including plastic, glass, and aluminum, which makes them highly adaptable to different pharmaceutical packaging needs. For instance, companies like Uhlmann and other emerging players offer induction sealing machines that can seal PET, HDPE, and glass containers, accommodating different pharmaceutical products such as tablets, syrups, and powders.
North America is expected to hold a significant position in the pharmaceutical sealing machines market share
North America hosts many of the world's leading pharmaceutical companies, including Pfizer, Merck, Johnson & Johnson, and Eli Lilly. These companies have substantial production facilities equipped with state-of-the-art sealing machines to maintain high standards of product quality and compliance. For instance, Pfizer's manufacturing facilities in the United States use advanced sealing technologies to package drugs like biologics and vaccines, which require precise sealing for integrity and stability.
North America is known for having some of the world's most stringent regulatory requirements for pharmaceutical manufacturing. The FDA mandates compliance with cGMP (Current Good Manufacturing Practices), which includes the use of specialized sealing machines to ensure product safety and quality. For instance, pharmaceutical companies in the US use induction sealing machines for tamper-evident seals on products like OTC medications to comply with the DSCSA and EU Falsified Medicines Directive.
North American consumers and regulatory bodies prioritize product security, including anti-counterfeiting measures and serialization. This has led to the widespread use of sealing machines with advanced sealing technologies. For instance, the serialization and anti-tampering features of induction sealing machines are crucial for compliance with U.S. FDA and DSCSA regulations, particularly for prescription drugs.
Asia-Pacific is growing at the fastest pace in the pharmaceutical sealing machines market
The Asia-Pacific region is witnessing a significant expansion in pharmaceutical manufacturing facilities, driven by government initiatives and favorable economic conditions. Countries like India, China, and South Korea are major hubs for pharmaceutical production. For instance, India, often referred to as the "pharmacy of the world," is expanding its pharmaceutical manufacturing base to meet global demand for generic drugs.
The demand for biologics, vaccines, and specialized pharmaceutical products is growing rapidly in the APAC region. These products often require advanced sealing solutions to maintain product stability and prevent contamination. For instance, the production of COVID-19 vaccines, particularly in China and India, has highlighted the need for sealing machines that can handle complex packaging requirements and ensure product integrity during distribution.
As the pharmaceutical manufacturing sector expands rapidly in this region, the demand for advanced sealing technologies is set to rise, particularly with the increasing production of biopharmaceuticals and vaccines. The combination of technological advancements, favorable economic conditions and strategic government initiatives is positioning the APAC region as the fastest-growing market in the pharmaceutical sealing machines landscape.
The major global players in the pharmaceutical sealing machines market include Marchesini Group S.p.A., Uhlmann Pac-Systeme GmbH & Co. KG, MULTIVAC Group, I.M.A. Industria Macchine Automatiche S.p.A., MG2 s.r.l., PlexPack, Bausch+Strobel SE + Co. KG, Audion, Syntegon Technology GmbH, MGA Technologies and among others.
The global pharmaceutical sealing machines market report delivers a detailed analysis with 62 key tables, more than 52 visually impactful figures, and 179 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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