Stratistics MRC에 따르면 세계의 BFS(Blow-Fill-Seal) 장비 시장은 2025년에 24억 3,000만 달러를 차지하고 예측 기간 동안 CAGR은 5.3%를 나타내 2032년에는 35억 달러에 이를 전망입니다.
BFS(Blow-Fill-Seal) 장비는 액체의 무균 포장을 위해 제약, 헬스케어, 식품 산업에서 널리 사용되고 있는 첨단 무균 포장 기술입니다. 이로써 이 기술은 오염 가능성을 낮추고 제품의 안전성을 향상시키고 있습니다.
비경구 의약품 협회(PDA)에 따르면, BFS(Blow-Fill-Seal) 기술은 무균 의약품 제조에 큰 이점을 가져다주는 고급 무균 프로세스로 인식되고 있습니다.
무균 포장에 대한 증가 제약 요구
제약 업계는 특히 주사제와 흡입제와 관련하여 가장 엄격한 안전성과 위생 규제를 유지할 필요가 항상 있습니다. 미생물 오염의 가능성을 대폭 줄일 수 있기 때문에 무균액제 포장에 최적입니다.
고액의 초기 투자
BFS(Blow-Fill-Seal) 장비를 구입하고 설치하는 데 드는 초기 비용은 보급을 방해하는 주요 요인 중 하나입니다. 이러한 복잡성은 초기 투자를 증가시키고 큰 부담이 될 수 있습니다. 또한 기업은 기계 본체뿐만 아니라 클린 룸 설정, 인프라 업그레이드 및 규정 준수 인증에도 비용을 들여야하며 총 소유 비용이 더욱 상승합니다.
특수 의약품 및 생물 제제 생산의 성장
무균성과 제품의 안정성을 보장하는 첨단 포장 기술은 제약 업계가 생물 제제, 바이오시밀러, 맞춤형 의료로 전환함에 따라 점점 더 필요해지고 있습니다. 또한 BFS(Blow-Fill-Seal) 장비 제조업체는 특히 단위 용량 형식과 낮은 오염 위험을 요구하는 틈새 치료제에 대한 생물학적 제제의 승인이 세계적으로 증가한 결과, 고가치 소량 생산을 위한 맞춤형 솔루션을 만드는 큰 기회를 얻고 있습니다.
다른 무균 포장 기술과의 경쟁 격화
BFS는 유명한 무균 기술이지만, Form Fill Seal(FFS) 기술, 바이알 충전 라인, 프리필드 주사기 등 다른 최첨단 충전 마감 시스템과의 치열한 경쟁에 노출되어 있습니다. 특히, 프리필드 시린지는 사용의 용이성과 환자의 안전성에 도움이 되기 때문에 주사제 및 생물제제 시장에서 점점 인기가 높아지고 있습니다.
COVID-19의 큰 유행은 BFS(Blow-Fill-Seal) 장비 시장에 다양한 영향을 미쳤습니다. 단기적인 투자는 긴급한 헬스케어 요구에 대응하기 위해, 많은 제약 제조업체가 BFS 기반의 충전·마무리 오퍼레이션을 증가시킴으로써 촉진되었습니다.
예측 기간 동안 병 부문이 최대가 될 것으로 예상
예측 기간 동안 가장 큰 시장 점유율을 차지할 것으로 예상되는 것은 병 분야입니다. 정지, 보존 기간 연장, 오염 위험 감소 등의 장점이 있기 때문에 대량 생산에 최적입니다.
잉크젯 인쇄 분야는 예측 기간 동안 가장 높은 CAGR이 예상됩니다.
예측 기간 동안 빠르고 유연하며 합리적인 가격의 라벨링 솔루션에 대한 요구가 증가함에 따라 잉크젯 인쇄 부문이 가장 높은 성장률을 보일 것으로 예측됩니다. 제품의 추적 가능성, 배치 코딩, 위조 방지 대책이 규제상 중시되게 된 결과, 제조업체는 규정 준수를 확보해, 업무 효율을 높이기 위해서 잉크젯 인쇄를 이용하고 있습니다. 또한, 다양한 용기 형상이나 소재와의 호환성이 있기 때문에 보다 폭넓은 최종 용도 분야에 어필할 수 있습니다.
예측 기간 동안 북미는 정교한 의약품 제조 시설, 엄격한 법적 요구 사항, 무균 및 침입 불가능한 포장에 대한 높은 수요로 인해 최대 시장 점유율을 차지할 것으로 예측됩니다. 만성 질환의 높은 유병률, 단일 투여 약물에 대한 선호도가 높아지고 있습니다.
예측 기간 동안 아시아태평양이 가장 높은 CAGR을 나타낼 것으로 예측됩니다. 이는 중국, 인도 및 동남아시아와 같은 개발 도상국의 건강 관리 및 제약 업계의 폭발적인 확대로 인한 것입니다. 또, 이 지역의 정부는 현지의 의약품 생산과 헬스케어·인프라에 다액의 투자를 실시하고 있어, BFS(Blow-Fill-Seal)의 채용이 촉진될 것으로 예측됩니다.
According to Stratistics MRC, the Global Blow Fill Seal Equipment Market is accounted for $2.43 billion in 2025 and is expected to reach $3.50 billion by 2032 growing at a CAGR of 5.3% during the forecast period. Blow-fill-seal (BFS) equipment is an advanced aseptic packaging technology widely used in the pharmaceutical, healthcare, and food industries for the sterile packaging of liquids. In this automated process, plastic containers are continuously formed from polymer resin, immediately filled, and sealed in a sterile environment-all in a single machine cycle. By drastically lowering the need for human intervention, the technology lowers the possibility of contamination and improves product safety. Packaging unit-dose drugs, eye solutions, respiratory treatments, and other sterile liquid products is a special application for BFS equipment. Moreover, it is a useful tool in contemporary sterile manufacturing operations because of its capacity to expedite production while maintaining high standards of precision and hygiene.
According to the Parenteral Drug Association (PDA), Blow-Fill-Seal (BFS) technology is recognized as an advanced aseptic process that offers significant advantages in sterile pharmaceutical manufacturing. In their Technical Report No. 77, the PDA provides comprehensive guidance on the operation of BFS systems, emphasizing their role in enhancing product safety by minimizing human intervention during the filling and sealing processes.
Growing pharmaceutical need for aseptic packaging
The pharmaceutical industry is constantly under pressure to uphold the strictest safety and hygienic regulations, especially with regard to injectable and inhalable drugs. By integrating container formation, filling, and sealing into a single, continuous, automated cycle, BFS equipment guarantees a sterile fill-finish procedure. Additionally, this greatly lowers the chance of microbial contamination, making it the perfect choice for packaging sterile liquids. As more vaccines, biologics, and specialty medications are produced, there is a greater need for aseptic packaging, especially in developing nations where healthcare infrastructure is developing quickly.
High initial outlay of funds
The high initial cost of buying and setting up BFS equipment is one of the main factors preventing its widespread use. Highly specialized BFS machines combine filling, sealing, and molding processes into one automated device. For small and medium-sized manufacturers, particularly those in emerging economies, this complexity raises the initial investment, which can be a major burden. Furthermore, companies must also spend money on cleanroom settings, infrastructure upgrades, and compliance certifications in addition to the machinery itself, which raises the total cost of ownership even more.
Growth in the production of specialty drugs and biologics
Advanced packaging technologies that guarantee sterility and product stability are becoming more and more necessary as the pharmaceutical industry moves toward biologics, biosimilars, and personalized medicine. Aseptic packaging of delicate biologics, including vaccines, monoclonal antibodies, and cell-based treatments, is a good fit for BFS systems. Moreover, manufacturers of BFS equipment have a significant opportunity to create customized solutions for high-value, small-batch production as a result of the global increase in biologic drug approvals, particularly for niche therapies that demand unit-dose formats and low contamination risk.
Increasing rivalry from other aseptic packaging technologies
Although BFS is a well-established aseptic technology, it is up against fierce competition from other cutting-edge fill-finish systems like form-fill-seal (FFS) technologies, vial filling lines, and prefilled syringes. These substitutes frequently provide more flexibility, particularly for businesses with a range of packaging requirements. Because of their ease of use and benefits for patient safety, prefilled syringes in particular are becoming more and more popular in the injectable drug and biologics markets. Additionally, the market share of BFS may decline if manufacturers start choosing these substitutes due to factors like price, format, or usability.
The COVID-19 pandemic affected the blow-fill-seal (BFS) equipment market in a number of ways. The need for aseptic packaging solutions was greatly increased by the crisis, particularly for vaccines, respiratory medications, and single-dose drugs. This underscored the importance of BFS technology in maintaining sterility and reducing contamination. Short-term investments in BFS systems were fuelled by a number of pharmaceutical manufacturers increasing their BFS-based fill-finish operations to meet urgent healthcare needs. However, delays in capital expenditure in non-essential sectors, limitations on industrial operations, and disruptions in global supply chains temporarily hampered project timelines and the installation of new equipment.
The bottles segment is expected to be the largest during the forecast period
The bottles segment is expected to account for the largest market share during the forecast period. The production of sterile plastic bottles in a range of sizes for the packaging of liquid formulations, including cough syrups, rehydration solutions, and eye medications, is a highly suitable application for BFS technology. The bottle format is perfect for high-volume production because it provides benefits like tamper-evidence, longer shelf life, and a lower risk of contamination. Additionally, the bottle segment's dominance in the BFS market is still supported by the rising demand for unit-dose packaging and the move toward affordable, preservative-free alternatives.
The ink-jet printed segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the ink-jet printed segment is predicted to witness the highest growth rate, driven by the growing need for high-speed, flexible, and affordable labeling solutions. With its many benefits, such as variable data printing, on-demand customization, and short turnaround times, ink-jet printing is perfect for pharmaceutical applications that call for serialized packaging and short production runs. Manufacturers are using ink-jet printing to ensure compliance and boost operational efficiency as a result of increased regulatory emphasis on product traceability, batch coding, and anti-counterfeiting measures. Furthermore, it is more appealing to a wider range of end-use sectors due to its compatibility with various container shapes and materials.
During the forecast period, the North America region is expected to hold the largest market share because of its sophisticated pharmaceutical production facilities, strict legal requirements, and high demand for sterile, impenetrable packaging. The widespread adoption of BFS technology is fueled by the region's well-established healthcare system, high prevalence of chronic diseases, and growing preference for single-dose medications. In order to comply with FDA and USP regulations for aseptic processing, major pharmaceutical companies and contract manufacturing organizations (CMOs) in the United States and Canada have incorporated BFS systems into their production lines.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by the healthcare and pharmaceutical industries' explosive expansion in developing nations like China, India, and Southeast Asia. Cost-effective, high-volume aseptic packaging solutions are in high demand due to rising healthcare costs, easier access to necessary medications, and an increase in the production of generic drugs. The region's governments are also making significant investments in local pharmaceutical production and healthcare infrastructure, which will facilitate the adoption of BFS. Additionally, pharmaceutical companies are investing in BFS technology due to the growth of contract manufacturing organizations (CMOs), regulatory compliance, and contamination-free drug delivery.
Key players in the market
Some of the key players in Blow Fill Seal Equipment Market include Gerresheimer AG, Adinath International, Robert Bosch GmbH, Serac Group, Syntegon Technology GmbH, Recipharm AB, Marchesini Group S.p.A., Brevetti Angela S.r.l., Gea Group Aktiengesellschaft, Rommelag Kunststoff-Maschinen Vertriebsgesellschaft Gmbh, Foshan Coretamp Packaging Machinery Co. Ltd, Unither Pharmaceuticals, Takeda Pharmaceutical Company Limited, GlaxoSmithKline plc and Weiler Engineering, Inc.
In July 2024, German engineering and electronics group Robert Bosch GmbH has agreed to acquire Johnson Controls International ( JCI )'s global heating, ventilation, and air-conditioning ( HVAC ) business for residential and light commercial buildings in an all-cash deal valued at US$8.1 billion.
In June 2024, Takeda announced the signing of an option agreement with Ascentage Pharma to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers.
In May 2024, Gerresheimer Glas, a subsidiary of Gerresheimer, has entered into a purchase agreement to acquire Blitz LuxCo, the holding company of Bormioli Pharma. The acquisition is valued at approximately €800m. Bormioli Pharma, with nine production sites across Europe, offers a range of pharmaceutical primary packaging products made from glass and plastic, including closure solutions, accessories, and dispensing systems.