세계 완제(Fill-Finish) 제조 시장 규모는 2023년 117억 4,000만 달러에서 2031년까지 236억 8,000만 달러에 달할 것으로 예상되며, 2024-2031년 예측 기간 동안 연평균 9.17% 성장할 것으로 예상됩니다. 이 시장은 최근 몇 년 동안 큰 폭의 성장세를 보였으며, 앞으로도 강력한 성장세를 유지할 것으로 예상됩니다.
완제 제조는 바이알, 주사기, 카트리지, 병과 같은 1차 용기에 약물을 채우는 작업입니다. 그런 다음 라벨을 붙이고, 포장하고, 일련번호를 부착하여 사용 및 유통할 수 있도록 준비합니다. 의약품에 대한 수요 증가에 대응하고 전 세계 환자들이 고품질의 처방약을 제때에 받을 수 있도록 하기 위해서는 완제 제조 시설이 효율적이고 일관성 있게 대규모로 운영되어야 합니다. 생산성을 높이고, 다운타임을 줄이고, 제품의 품질과 안전성을 유지하기 위해서는 자동화 기술, 최첨단 제조 장비 및 공정 최적화 기술에 대한 투자가 필요합니다. 의약품 제조의 마지막 단계인 완제의약품 제조 공정은 환자에게 의약품이 전달되기 전 단계이기 때문에 의약품 수요의 증가는 이러한 공정에 큰 부담을 주고 있습니다. 전 세계적으로 만성질환과 생활습관병의 비율이 증가함에 따라 완제 제조 산업의 큰 성장이 예상됩니다. 전 세계 생물학적 제제 산업의 대폭적인 확장은 완제 제조 시장의 대폭적인 성장을 촉진하고 있습니다. 생물학적 제제는 보다 효과적이고 표적화된 치료 옵션이기 때문에 현재 기존 의약품보다 수요가 증가하고 있습니다. 또한, 단클론항체 및 백신에 대한 수요가 증가함에 따라 완제 생산 공정의 증가를 촉진하고 있습니다. 또한, 기술 발전은 시장 확대의 주요 요인으로 작용하고 있습니다.
예를 들어, Gerresheimer AG는 2023년 10월, 환자의 안전과 생산 효율을 향상시키고 보장하기 위해 유리 주사기 제품군인 Gx Elite를 발표했습니다. 이 제품군은 주로 충격에 강하고 쉽게 깨지지 않는 고품질 바이알을 제공하는 데 중점을 둡니다.
의료비 지출 증가로 시장 성장 촉진
사람들이 의료 수요를 충족시키기 위해 의료 서비스 및 치료법을 찾게 됨에 따라 의료비 증가는 의료 이용의 증가와 밀접한 관련이 있습니다. 의료 서비스에 대한 수요가 증가함에 따라 다양한 의료 질환의 예방, 관리 및 치료에 의약품을 사용하는 빈도가 증가하고 있습니다. 이에 따라 제약 산업은 의약품 수요 증가에 대응하기 위해 생산량을 늘려야 하며, 이는 완제 제조 시장에 활력을 불어넣고 있습니다. 전 세계적으로 암, 당뇨병, 심혈관 질환, 호흡기 질환과 같은 만성 질환의 유병률이 증가하면서 의료비 지출이 증가하고 있습니다. 만성질환의 장기적인 관리를 위해서는 증상 관리, 질병 관리, 합병증 예방 등 의약품 치료가 필요합니다. 만성질환 관리에 중점을 둔 의약품에 대한 수요는 만성질환 관리에 중점을 둔 변화로 인해 환자에게 안정적인 의약품 공급을 보장할 수 있는 효과적인 완제의약품 제조 공정이 요구되고 있습니다. 공공 정책, 민간 투자 및 국제 원조 활동의 목표는 의료 지출을 늘리고, 필요한 의료 서비스와 처방약에 대한 접근성을 개선하고, 선진국과 개발도상국의 의료 인프라를 개선하는 것입니다. 필수의약품 제조 증가의 주요 촉진요인 중 하나는 신약과 특수 의약품의 등장입니다. 생물학적 제제, 희귀의약품, 정밀의약품은 특정 질병이나 복잡한 의료 수요가 있는 환자군을 치료하는 데 사용되는 특수 의약품의 일종입니다.
이러한 첨단 치료제가 안정적이고 효과적이며 제품의 무결성을 유지하기 위해서는 특정 완제 제조 절차가 자주 필요합니다. 특수 의약품에 대한 수요에 대응하기 위해 제약사들은 제조 역량에 투자하고 있으며, 이는 완제 제조 시장의 성장을 촉진하고 있습니다. 예를 들어, Recro Pharma, Inc.는 2022년 2월, 위탁개발 및 제조수탁기관(CDMO)인 Recro Pharma, Inc.가 위탁생산 서비스 라인업을 확장하고 동결건조 기능을 추가했다고 발표했습니다. Recro Pharma의 완제 무균실에서 자동화된 무균 바이알 충전 플랫폼을 통해 시간당 2,000개의 멸균된 바이알을 충전할 수 있습니다. 이러한 의료 혁신과 기술 혁신은 새로운 의료기기, 진단 및 치료법을 가져와 의료 비용을 증가시키고 있습니다. 신약 개발, 유전학 및 의료 기술의 발전으로 새로운 약물과 치료법이 개발되어 완제 제조 서비스에 대한 수요가 증가하고 있습니다. 제약기업들은 기술 개발을 통해 새로운 의약품과 제제를 개발하여 완제 제조 산업에 새로운 성장 전망을 열어주고 있습니다. 제약사들은 완제 제조 사업에서 경쟁력을 유지하기 위해 규제 요건과 시장 환경의 변화에 대응하고 제조 인프라 및 생산능력에 대한 투자를 늘리고 있습니다.
이 보고서는 세계 완제 제조 시장에 대해 조사 분석했으며, 시장 규모와 예측, 시장 역학, 주요 기업 현황 및 전망 등을 제공합니다.
Global fill-finish manufacturing market is projected to witness a CAGR of 9.17% during the forecast period 2024-2031F, growing from USD 11.74 billion in 2023 to USD 23.68 billion in 2031F. The market has experienced significant growth in recent years and is expected to maintain a strong pace of expansion in the coming years.
Fill-finish manufacturing involves filling medication formulations into primary containers like vials, syringes, cartridges, and bottles. They are then labeled, packaged, and serialized to make them ready for usage and distribution. Fill-finish manufacturing facilities must run effectively, consistently, and at scale to fulfill the increasing demand for pharmaceutical products and guarantee that patients around the world receive high-quality prescriptions on time. Investments in automation technologies, state-of-the-art manufacturing equipment, and process optimization techniques are necessary to increase productivity, reduce downtime, and preserve product quality and safety. Since fill-finish manufacturing activities are the last phases of drug manufacturing before goods are delivered to patients, the growing demand for pharmaceuticals puts great strain on these operations. Globally increasing rates of chronic illness and lifestyle issues are predicted to drive significant growth in the fill-finish manufacturing industry. The substantial expansion of the worldwide biologics industry is driving considerable growth in the fill-finish manufacturing market. Biologics, nowadays are more in demand than conventional medications since they are more efficacious and targeted treatment options. Furthermore, the rise in the fill-finish manufacturing step is being aided by the growing demand for monoclonal antibodies and vaccines. Furthermore, technological advancements act as pillars in the expansion of this market.
For instance, Gerresheimer AG introduced Gx Elite, a range of glass injection vials, in October 2023 to improve and ensure patient safety and production efficiency. This line primarily focuses on providing better-quality vials that are more resistant to shocks, preventing them from breaking quickly.
Rising Healthcare Expenditure to Drive Market Growth
As people increasingly seek medical services and treatments to meet their healthcare needs, the rising healthcare costs can be easily correlated with rising healthcare utilization. Pharmaceutical items are used more frequently to prevent, manage, and treat various medical disorders because of the increasing demand for healthcare services. Consequently, the pharmaceutical industry needs to increase its output to keep up with the growing demand for drugs, fueling the market for fill-finish manufacturing. Globally, the prevalence of chronic illnesses like cancer, diabetes, cardiovascular disease, and respiratory problems is rising, which is driving up the cost of healthcare. Pharmaceutical treatments, such as those for symptom management, disease control, and complication avoidance, are necessary for the long-term management of chronic illnesses. The need for pharmaceutical products is driven by the shift in focus toward managing chronic diseases, which calls for effective fill-finish manufacturing processes to guarantee a consistent supply of medications to patients. The goals of public policy, private sector investments, and international aid activities are to raise healthcare spending, develop access to necessary medical services and prescription drugs, and upgrade healthcare infrastructure in developed and underdeveloped regions. One major factor driving the rise in fill-finish manufacturing is the emergence of novel medicines and specialty drugs. Biologics, orphan drugs, and precision medicines are examples of specialty medications used to treat certain diseases or patient populations with complicated medical demands.
Specific fill-finish manufacturing procedures are frequently needed for these cutting-edge treatments to be stable, effective, and maintain product integrity. To address the demand for specialty drugs, pharmaceutical companies invest in manufacturing capabilities, which propels the fill-finish manufacturing market's growth. For instance, a contract development and manufacturing organization (CDMO) called Recro Pharma, Inc. stated in February 2022 that it had expanded its array of contract manufacturing services to include new lyophilization capabilities. 2,000 pre-sterilized vials could be filled each hour using an automated, sterile vial filling platform in the company's fill-finish aseptic suite. Such healthcare innovation and technological breakthroughs bring new medical devices, diagnostics, and therapies, driving healthcare costs. Novel pharmaceutical products and therapeutic modalities are developed due to advances in drug discovery, genetics, and medical technology, which increases demand for fill-finish manufacturing services. Pharmaceutical firms use technological developments to create novel drugs and formulations that open new growth prospects for the fill-finish manufacturing industry. To stay competitive in the fill-finish manufacturing business, pharmaceutical companies are adjusting to changing regulatory requirements and market situations, which means they are investing more in manufacturing infrastructure and capabilities.
Increasing Demand for Pharmaceuticals Positively Impacts the Market
The global fill-finish manufacturing market is expanding due to the growing demand for pharmaceuticals, influencing industry dynamics and propelling investments in infrastructure, technologies, and skills. Numerous causes, such as population increase, changing demographics, the prevalence of chronic illnesses, and easier access to healthcare services, are contributing to this demand. Industry stakeholders must comprehend how these factors affect pharmaceutical demand, which in turn affects fill-finish manufacturing.
Demographic changes and population expansion are key factors influencing the demand for pharmaceuticals. The demand for pharmaceutical products and healthcare services rises in tandem with the global population. Demand for pharmaceuticals in a variety of therapeutic areas, such as neurological disorders, diabetes, and cardiovascular illnesses, is driven by the fact that elderly people often need more medication to manage age-related health concerns and chronic ailments. Urbanization frequently results in destructive eating patterns, sedentary lifestyles, and greater exposure to environmental toxins, all of which raise the risk of chronic illnesses and necessitate the use of pharmaceutical therapies.
Chronic illnesses, which include autoimmune disorders, cancer, diabetes, respiratory disorders, and cardiovascular diseases, place a significant burden on the world's health and must be managed over time using pharmacological treatments. The rising incidence of chronic illnesses can be attributed to various factors such as aging populations, altered lifestyle patterns, urbanization, and genetic predispositions. Additionally, there is a greater need for pharmacological therapies due to the rising prevalence of chronic illnesses and their identification, as well as improvements in medical technology and screening techniques that raise the incidence of disease detection. Therefore, pharmaceutical companies are pushed further to increase production in order to keep up with the growing demand for drugs that effectively manage chronic illnesses. A major factor in the rising demand for pharmaceuticals is the expansion of healthcare services' accessibility, especially in developing and emerging markets. More access to necessary medications and healthcare services is facilitated by programs like universal health coverage and public health insurance programs, which aim to improve healthcare spending, infrastructure, and coverage. Increasing fill-finish production capacity is one way to guarantee a steady supply of completed dosage forms, such as tablets and capsules injectables, and topical formulations, to meet the needs of diverse patient populations
Since fill-finish manufacturing activities are the last phases of drug manufacture before goods are delivered to patients, the growing demand for pharmaceuticals places a great deal of strain on these operations. Fill-finish manufacturing facilities need to run effectively, consistently, and at scale to fulfill the increasing demand for pharmaceutical products and guarantee that patients around the world receive high-quality prescriptions on time. Investments in automation technologies, state-of-the-art manufacturing equipment, and process optimization techniques are necessary to increase productivity, reduce downtime, and preserve product quality and safety.
Fill-finish manufacturing processes must follow Good Manufacturing Practices (GMP) and other strict regulatory standards to ensure product integrity, safety, and efficacy. Pharmaceutical manufacturers must strictly adhere to regulations to reduce the risks of product contamination, batch failures, and regulatory penalties, which could have serious repercussions for patient safety and public health. Pharmaceutical businesses may also get into strategic alliances, joint ventures, and outsourcing agreements with contract manufacturing organizations (CMOS) in response to growing demand to take advantage of additional manufacturing capacity and knowledge. CMOS specializes in fill-finish manufacturing services, enabling scalability, cost-effectiveness, and flexible production options for pharmaceutical industries.
For example, in February 2024, Simtra BioPharma Solutions stated that it would expand its sterile fill/finish manufacturing campus located in Bloomington, Indiana. A new, state-of-the-art, 150,000-square-foot structure would be built as part of the expansion to run two automated high-speed syringes fill lines and a new high-speed isolator vial line that will have three 30 square meter lyophilizers. By doing this, the company hopes to improve its service skills and draw in additional clients.
Increasing Dominance of Consumables Fuels the Market
Disposable parts used in fill-finish manufacturing processes, such as vials, syringes, cartridges, stoppers, seals, and labels, are included in the consumables segment. In the production of pharmaceuticals, this segment is essential for guaranteeing product integrity, regulatory compliance, and contamination control. Since disposable consumables require less cleaning, sterilizing, and validation compared to reused equipment, they are more affordable. Pharmaceutical businesses frequently prefer disposable components to reduce operating expenses and the risk of contamination. Pharmaceutical firms can adjust production numbers and product configurations in response to market demand and regulatory constraints due to flexible and scalable manufacturing operations made possible by consumables. Disposable consumables make regulatory compliance easier by lowering the possibility of cross-contamination, batch errors, and legal repercussions. Regulatory bodies like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) advise using disposable components to guarantee product safety and quality. Disposable consumables manufacturers constantly innovate and alter their goods to satisfy changing consumer demands, such as those of specific formulas, package styles, and labeling specifications. Pharmaceutical firms can develop and market their products more flexibly and uniquely when using customizable consumables. All these elements work together to support this segment's expansion.
For example, the EZ-fill Kit and a non-GMP laboratory fill and finish service at its Technology Excellence Centres (TEC), are two new products that Stevanato Group, a global supplier of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, announced on January 24, 2024. By expanding on its current ready-to-use platform of pre-sterilized containment solutions - vials, cartridges, and syringes - Stevanato Group's EZ-fill Kit enables users to screen various primary packaging along with medication items efficiently.
Similarly, in October 2023, Datwyler Holding Inc. launched its ready-for-sterilization (RFS) combi-seals designed for cartridges utilized in injectable devices, including pens and autoinjectors.
Europe to Dominate the Fill-Finish Manufacturing Market
With the most market share in terms of value, Europe emerged as the leading region in the global fill-finish manufacturing market. Europe is known for having a strong regulatory framework that prioritizes product safety, quality, and compliance. To protect the integrity of pharmaceutical manufacturing processes, strict laws and standards, such as Good Manufacturing Practices (GMP), are enforced by regulatory organizations like the European Medicines Agency (EMA) and national regulatory bodies. The Pharmaceutical Strategy for Europe and the Medical Device Regulation (MDR), which were adopted by the European Union, enhance regulatory supervision and encourage fill-finish manufacturing innovation. Following their audits, Nipro Corporation's authorized medical device manufacturers in Europe were able to successfully receive MDR certification in 2022-2023. These certified manufacturers include MTN Neubrandenburg in Germany, Nipro Pure Water (NPW) in Germany, and Nipro Renal Solutions (NRS) in Spain.
Several top pharmaceutical players, academic institutions, and technology providers in the world are based in European nations. These organizations create cutting-edge technologies, automation solutions, and high-quality products to promote innovation in fill-finish manufacturing. Personalized medicine, innovative drug delivery technologies, and biopharmaceuticals are among the areas where Europe excels in fill-finish manufacturing innovation. Europe's extensive logistics and distribution networks also make it easier to manage the global supply chain and distribute pharmaceuticals, which contributes to the region's supremacy in fill-finish production. To improve fill-finish manufacturing skills, European pharmaceutical companies frequently work with academic institutions, CMOs, and technology vendors. Pharmaceutical items have a sizable and varied market in Europe, which presents numerous chances for fill-finish manufacturing businesses to grow and attract new clients.
Fill-finish manufacturing is growing due to the region's advantageous market access conditions, which include reimbursement rules, protection for intellectual property, and adoption of novel therapies by the market. Fill-finish manufacturing enterprises benefit from Europe's dedication to international collaboration and regulatory harmonization. Pharmaceutical products can more easily access international markets thanks to initiatives like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which promotes regulatory standard harmonization. European fill-finish manufacturing businesses can improve their competitiveness in the worldwide market by streamlining their product development, registration, and commercialization procedures by complying with harmonized regulatory norms.
Future Market Scenario (2024-2031F)
One of the main factors contributing to the anticipated growth of the fill-finish manufacturing market is the increasing prevalence of chronic disorders, rising geriatric population and demand for pharmaceuticals. Rising population and sedentary lifestyles are also factors that will always propel market growth in the future. Given that technology is advancing, we can expect cutting-edge technology in this area also. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. For instance, global process and packaging technology company Syntegon Technology GmbH announced in September 2023 that it had unveiled new innovations for the filing and packing of small-micro batches from October 24 to 26, 2023, at CPHI Barcelona, Spain. There is a great demand for equipment made, especially for small batch sizes in research and development and in the manufacturing of liquid and solid medications for sale.
Key Players Landscape and Outlook
Several companies, such as Becton, Dickinson and Company, Nipro Corporation, Syntegon Technology GmbH, Datwyler Holding Inc., Stevanato Group, Recro Pharma, Inc., Gerresheimer AG, West Pharmaceutical Services, Inc., Alcami Corporation, Berry Global Inc., etc., are expanding business by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launch of newly developed fill finish technologies, to help researchers and to strengthen their foothold in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments and partnerships are a few ways in which they are trying to achieve the same.
Contract development and manufacturing organization (CDO), Alcami Corporation, announced on February 8, 2024, the strategic expansion of its sterile fill-finish manufacturing capacity by the addition of a new sterile fill-finish line with isolator and two lyophilizers at its current manufacturing campus in Charleston.
In December 2023, Datwyler Holding Inc. and Conserva UK collaborated to establish a pharmaceutical primary packaging supply chain for the United Kingdom market. By using Conserva UK as the primary interface for its significant client network, this strategic alliance aims to increase Datwyler's presence in the United Kingdom.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.