市場調查報告書
商品編碼
1370951
生物製造市場 - 2018-2028 年全球產業規模、佔有率、趨勢、機會和預測,按工作流程、按應用、最終用戶、地區和競爭細分Bio-Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Workflow, By Application, By End User, By Region and Competition |
全球生物製造市場在 2022 年實現估值 190.8 億美元,並預計在整個預測期內強勁成長,預計年複合成長率 (CAGR) 為 7.72%,預計到 2028 年將達到 296.7 億美元。生物製造市場涉及生物技術和製藥領域,包括生物製品的生產,如生物製藥、細胞療法、基因療法、疫苗和其他生物衍生產品。這個市場涵蓋了從設計和開發到擴大規模和大規模生產的整個活動範圍,以滿足患者、醫療保健系統和研究工作的需求。生物製造是生物技術和製藥行業的關鍵組成部分,有助於創造拯救生命和增強生命的產品。隨著技術和科學知識的不斷進步,生物製造領域預計將不斷發展,帶來新的療法、改進的生產過程和增強的能力,以滿足醫療保健和患者需求日益成長的要求。
採用先進技術和創新:老年人口的增加和慢性呼吸系統疾病的盛行率預計將推動呼吸器的需求。人們對肺癌症狀認知的提高以及醫療機構中患者數量的增加促進了呼吸器市場的大幅成長。然而,重要的是要考慮與機械通氣相關的潛在風險,例如感染風險增加和肺損傷。自動化、機器人技術和製程控制系統等先進技術可以簡化生物製造流程、減少人為錯誤並提高整體生產效率。這可以縮短週轉時間並提高產能,滿足對生物製劑不斷成長的需求。生物反應器設計、拋棄式技術和靈活的製造平台的創新使生產的可擴展性變得更加容易。隨著對生物製造產品的需求不斷增加,快速擴大生產規模的能力變得至關重要。與傳統的批量製程相比,連續製造方法可以實現一致的產品品質、減少浪費並提高資源利用率。這些優勢可以推動對生物製造產品的需求。
市場概況 | |
---|---|
預測期 | 2024-2028 |
2022 年市場規模 | 190.8億美元 |
2028 年市場規模 | 296.7億美元 |
2023-2028 年年複合成長率 | 7.72% |
成長最快的細分市場 | 拋棄式上游生物製造 |
最大的市場 | 北美洲 |
環境問題日益嚴重:由於人們對環境問題、污染、水資源短缺和無縫藥品製造服務的擔憂日益加劇,全球生物製造市場必將成長。此外,在植物中實施下一代生物製造將有助於增加市場需求。此外,採用拋棄式產品策略將有助於降低成本、最大限度地減少產品污染並提高靈活性,從而推動對下一代生物製造的需求。環保意識的增強和對污染的擔憂促使生物製造等行業採取更永續和環保的做法。這包括減少廢棄物產生、最佳化資源利用以及實施清潔製造流程。由於生物製造旨在最大限度地減少其環境足跡,因此對環保生物製造流程和產品的需求預計將會上升。水資源短缺是一個迫切的全球問題,影響著包括生物製造在內的各個產業。實施節水製造流程和回收技術可以幫助緩解水資源短缺問題,同時維持生物製藥和其他生物衍生產品的生產。
生物製藥企業數量不斷增加:在預測期內,下一代生物製造市場的成長預計將受到全球生物製藥公司數量不斷增加的推動。滿足患者需求的先進生物製造需求可能會推動下一代生物製造業的進步。在醫學科學進步、不斷成長的醫療保健需求和新療法開發的推動下,全球生物製藥產業一直在經歷大幅成長。隨著越來越多的生物製藥公司的出現以及現有生物製藥公司擴大其產品線,對高效、可擴展且技術先進的生物製造流程來生產這些創新療法的需求不斷成長。總體而言,生物製藥公司數量的不斷增加以及滿足患者對尖端療法的需求正在推動下一代生物製造業的進步和成長。隨著該行業不斷創新和開發先進製造解決方案,它將在塑造醫療保健的未來和改善患者治療效果方面發揮關鍵作用。
巨額資本支出:生物製造過程涉及複雜且專業的設備、設施和技術,可能需要大量的財務投資。建立生物製造設施或升級現有基礎設施需要大量的初始資本投資。這包括建造或翻新專門的無塵室,購買生物反應器、淨化設備以及生物製藥生產所需的其他複雜工具。生物製造所需的大量資本可能會將資源從研發、行銷和業務擴張等其他關鍵領域轉移出去。資源分配方面的挑戰可能會影響公司的整體成長策略。高資本支出可能導致製造能力高估或利用不足。如果製造產品的實際需求低於預期,投資可能無法產生預期回報。
缺乏熟練的專業人員:熟練的專業人員的短缺是阻礙生物製造市場成長的重大挑戰。生物製造是一個高度專業化的領域,需要各種科學、工程和技術學科的專業知識。熟練專業人員的短缺可能會影響生物製造業務的效率、品質和能力。生物製造過程的複雜性,如細胞培養、發酵、純化和品質控制,需要專門的專業知識。缺乏熟練的人力資源可能會導致生產時間延遲,從而減緩市場上生物製藥和其他生物衍生產品的供應。熟練的專業人員對於在整個製造過程中保持嚴格的品質控制和保證至關重要。缺乏熟練的專業人員可能會影響產品品質和安全。熟練的專業人員在推動生物製造領域的創新和工藝改進方面也發揮著至關重要的作用。缺乏創新可能會阻礙先進技術的採用並阻礙整體市場的成長。隨著生物製藥需求的增加,由於缺乏管理和營運新設施所需的熟練人員,公司可能難以擴大其生產能力。
連續生物製造的出現:連續生物製造的出現有可能顯著推動未來生物製造業的成長。連續生物製造透過實現生物製藥和其他生物衍生產品的無縫、不間斷生產,代表了對傳統批量製程的背離。這種創新方法具有多種優勢,可以對效率、靈活性、成本效益和整體市場擴張產生積極影響。連續生物製造允許即時連續監控和調整製程參數。這可以改善製程控制、減少變異性並增強產品一致性,從而提高製程效率並縮短生產時間。與傳統的批量系統相比,連續生物製造系統通常更緊湊並且需要更少的物理空間。設施佔地面積的減少可以節省成本並提高設施設計和選址的靈活性。連續生物製造可以透過連續運作流程來實現更高的生產能力,從而在無需大幅擴建設施的情況下增加產量。這種增加的產能可以滿足對生物製藥和其他生物衍生產品不斷成長的需求。
下一代生物製造過程的開發:下一代生物製造過程的進步使得能夠生產治療肝腎疾病、癌症和糖尿病等重大疾病的生物藥物。此外,拋棄式生物反應器和生物容器等拋棄式產品的日益普及,以及私人投資者和政府對下一代生物製造單元開發的財政支持的增加,是全球下一代生物製造市場的關鍵驅動力。預計這些趨勢將在整個預測期內持續存在。
應用見解:單株抗體是使用生物製造製程最常生產的產品之一。單株抗體 (mAb) 是一種治療性蛋白質,旨在針對體內特定抗原,例如癌細胞或免疫系統分子。它們已成為現代醫療不可或缺的一部分,其生產通常涉及生物製造技術。單株抗體廣泛用於治療癌症、自體免疫疾病和傳染病等疾病。它們是透過生物製造過程生產的,涉及培養哺乳動物細胞以表達特異性抗體。生物反應器和先進的細胞培養技術通常用於單株抗體的生產。荷爾蒙是成長最快的部分,因為胰島素、生長激素和促紅血球生成素等荷爾蒙也是透過生物製造生產的。這些治療性蛋白質可治療荷爾蒙缺乏和其他疾病。生物製造涉及使用重組DNA技術將激素基因插入宿主細胞(例如細菌或酵母)中,然後宿主細胞大量生產激素。用於治療不斷增加的糖尿病和其他激素缺乏相關疾病的激素的生產預計將增加全球對生物製造激素的需求。
工作流程見解:連續的上游生物製造可以實現生物製藥的連續穩定生產,消除了傳統批次製程的停止-啟動性質。這可以提高流程效率、減少停機時間並提高資源利用率。與間歇式製程相比,連續生物反應器的一致環境和受控條件可以帶來更高的細胞密度和更高的產品產量。連續生物製造系統通常比傳統的批量系統更緊湊,這有助於最佳化設施空間並降低營運成本。由於減少了可變性和更精確的製程控制,連續製程可以使產品品質更加一致和統一。
區域洞察:北美因其發達和先進的醫療基礎設施(包括研究機構、學術中心和醫療設施)而佔據市場主導地位。該基礎設施支持生物製造活動,並促進學術界、研究組織和產業參與者之間的合作。美國食品藥物管理局 (FDA) 等監管機構為生物製藥產品的核准和監督制定了嚴格但明確的指導方針。這種監管專業知識為投資者和消費者提供了對生物製造產品的安全和品質的信心。北美強大的創投生態系統和金融市場為生物製藥新創公司和老牌公司提供資金支持,推動創新和研究工作。包括中國和印度在內的亞太地區的生物製造業一直在經歷成長,原因包括較低的製造成本、龐大的人才庫以及該地區對生物製藥的需求不斷增加等因素。一些國家積極注重發展生物製造集群和基礎設施,以吸引投資、提升生物製藥能力。
The Global Bio-Manufacturing Market achieved a valuation of USD 19.08 Billion in 2022 and is poised for robust growth throughout the forecast period, with a projected Compound Annual Growth Rate (CAGR) of 7.72% and expected to reach USD 29.67 Billion through 2028. The bio-manufacturing market pertains to the biotechnology and pharmaceutical sector, encompassing the production of biological products such as biopharmaceuticals, cell therapies, gene therapies, vaccines, and other biologically derived products. This market covers the entire spectrum of activities, from design and development to scaling up and large-scale production, to cater to the needs of patients, healthcare systems, and research endeavors. Bio-manufacturing is a pivotal component of the biotechnology and pharmaceutical industry, contributing to the creation of life-saving and life-enhancing products. As technology and scientific knowledge continue to advance, the field of bio-manufacturing is expected to evolve, ushering in new therapies, improved production processes, and enhanced capabilities to meet the growing requirements of healthcare and patient needs.
Adoption of Advanced Technology and Innovation: The increasing geriatric population and prevalence of chronic respiratory disorders are projected to drive ventilator demand. The rise in awareness about lung cancer symptoms and the growing number of patients in medical facilities contribute to substantial growth in the ventilator market. However, it's important to consider potential risks associated with mechanical ventilation, such as increased infection risk and lung damage. Advanced technologies like automation, robotics, and process control systems can streamline biomanufacturing processes, reduce human errors, and enhance overall production efficiency. This can lead to faster turnaround times and increased production capacity, addressing the growing demand for biologics. Innovations in bioreactor design, single-use technologies, and flexible manufacturing platforms allow easier scalability of production. With increasing demand for bio-manufactured products, the ability to rapidly scale up production becomes essential. Continuous manufacturing approaches, as opposed to traditional batch processes, can lead to consistent product quality, reduced waste, and improved resource utilization. These advantages can drive demand for bio-manufactured products.
Market Overview | |
---|---|
Forecast Period | 2024-2028 |
Market Size 2022 | USD 19.08 Billion |
Market Size 2028 | USD 29.67 Billion |
CAGR 2023-2028 | 7.72% |
Fastest Growing Segment | Single-Use Upstream Biomanufacturing |
Largest Market | North America |
Rising Environmental Concerns: The global biomanufacturing market is set to grow due to mounting concerns about environmental issues, pollution, water scarcity, and seamless medication manufacturing services. Additionally, the implementation of next-generation biomanufacturing in plants will contribute to increased market demand. Furthermore, the adoption of a single-use product strategy will facilitate cost reduction, minimize product contamination, and enhance flexibility, driving demand for next-generation biomanufacturing. Heightened environmental awareness and worries about pollution have prompted industries, including biomanufacturing, to adopt more sustainable and environmentally friendly practices. This includes reducing waste generation, optimizing resource usage, and implementing cleaner manufacturing processes. As biomanufacturing aims to minimize its environmental footprint, the demand for eco-friendly biomanufacturing processes and products is expected to rise. Water scarcity is a pressing global issue that affects various industries, including biomanufacturing. Implementing water-efficient manufacturing processes and recycling technologies can help alleviate water scarcity concerns while maintaining the production of biopharmaceuticals and other biologically derived products.
Increasing Number of Biopharmaceutical Businesses: During the forecast period, the growth of the next-generation biomanufacturing market is expected to be driven by the increasing number of biopharmaceutical companies worldwide. The need for advanced biomanufacturing to meet patient demands is likely to fuel the progress of the next-generation biomanufacturing industry. The global biopharmaceutical industry has been experiencing substantial growth, driven by advancements in medical science, rising healthcare needs, and the development of novel therapies. As more biopharmaceutical companies emerge and existing ones expand their product pipelines, the demand for efficient, scalable, and technologically advanced biomanufacturing processes to produce these innovative therapies is growing. Overall, the rising number of biopharmaceutical companies and the need to meet patient demands for cutting-edge therapies are driving the progress and growth of the next-generation biomanufacturing industry. As the industry continues to innovate and develop advanced manufacturing solutions, it will play a critical role in shaping the future of healthcare and contributing to improved patient outcomes.
Growing Demand for Biopharmaceuticals: The increasing demand for biopharmaceuticals is a significant driver that is boosting the demand for biomanufacturing. Biopharmaceuticals are a class of drugs produced using living organisms or biological systems, such as bacteria, yeast, mammalian cells, or plant cells. These drugs include monoclonal antibodies, vaccines, gene therapies, cell therapies, and more. The unique nature of biopharmaceuticals and their growing prominence in medical treatments have led to a higher demand for specialized biomanufacturing processes. Biopharmaceuticals have revolutionized the treatment landscape for various diseases, offering targeted therapies with high specificity and reduced side effects. As more biopharmaceuticals enter the market and offer innovative treatment options, the demand for their production increases. The development of new and advanced therapies, such as gene therapies and cell therapies, is contributing to the growing demand for biopharmaceutical manufacturing. These therapies require complex manufacturing processes that involve genetic modification and manipulation of cells, highlighting the need for specialized biomanufacturing expertise.
Huge Capital Expenditure: The biomanufacturing process involves intricate and specialized equipment, facilities, and technologies, which can require significant financial investments. Establishing a biomanufacturing facility or upgrading existing infrastructure demands substantial initial capital investment. This encompasses constructing or renovating specialized cleanrooms, purchasing bioreactors, purification equipment, and other sophisticated tools necessary for biopharmaceutical production. The substantial capital required for biomanufacturing can divert resources away from other critical areas such as research and development, marketing, and business expansion. This challenge in resource allocation can impact a company's overall growth strategy. The high capital expenditure can result in either overestimating or underutilizing manufacturing capacity. If the actual demand for the manufactured product is lower than anticipated, the investment may not yield the expected returns.
Lack of Skilled Professionals: The shortage of skilled professionals is a significant challenge that can hinder the growth of the biomanufacturing market. Biomanufacturing is a highly specialized field that requires expertise in various scientific, engineering, and technical disciplines. The shortage of skilled professionals can impact the efficiency, quality, and capacity of biomanufacturing operations. The complexity of biomanufacturing processes, such as cell culture, fermentation, purification, and quality control, demands specialized expertise. A lack of skilled manpower can lead to delays in production timelines, slowing down the availability of biopharmaceuticals and other biologically derived products in the market. Skilled professionals are vital for maintaining rigorous quality control and assurance throughout the manufacturing process. The absence of skilled professionals can compromise product quality and safety. Skilled professionals also play a crucial role in driving innovation and process improvement within biomanufacturing. The lack of innovation can hinder the adoption of advanced technologies and hinder overall market growth. As the demand for biopharmaceuticals increases, companies may struggle to expand their manufacturing capacity due to the lack of skilled personnel required to manage and operate new facilities.
Emergence of Continuous Biomanufacturing: The emergence of continuous biomanufacturing has the potential to significantly boost the growth of the biomanufacturing industry in the future. Continuous biomanufacturing represents a departure from traditional batch processes by enabling seamless, uninterrupted production of biopharmaceuticals and other biologically derived products. This innovative approach offers several benefits that can positively impact efficiency, flexibility, cost-effectiveness, and overall market expansion. Continuous biomanufacturing allows for continuous monitoring and adjustment of process parameters in real-time. This leads to improved process control, reduced variability, and enhanced product consistency, resulting in higher process efficiency and reduced production times. Continuous biomanufacturing systems are generally more compact and require less physical space than traditional batch systems. This reduction in facility footprint can lead to cost savings and greater flexibility in facility design and location. Continuous biomanufacturing can enable higher production capacities by running processes continuously, thereby increasing output without the need for significant facility expansion. This increased capacity can meet the growing demand for biopharmaceuticals and other biologically derived products.
Development Of a Next-Generation Biomanufacturing Process: The advancement of a next-generation biomanufacturing process enables the production of biological medications for critical ailments like liver and kidney disease, cancer, and diabetes. Moreover, the growing adoption of single-use products such as single-use bioreactors and biocontainers, along with increased financial support from private investors and governments for the development of next-generation biomanufacturing units, are key drivers of the global next-generation biomanufacturing market. These trends are expected to persist throughout the forecast period.
Application Insights: Monoclonal antibodies are one of the most commonly produced products using biomanufacturing processes. Monoclonal antibodies (mAbs) are therapeutic proteins designed to target specific antigens in the body, such as cancer cells or immune system molecules. They have become integral to modern medical treatment, and their production often involves biomanufacturing techniques. Monoclonal antibodies are widely used in treating diseases including cancer, autoimmune disorders, and infectious diseases. They are produced using biomanufacturing processes that involve culturing mammalian cells to express specific antibodies. Bioreactors and advanced cell culture techniques are commonly used for mAb production. Hormones are the fastest-growing segment as hormones like insulin, growth hormone, and erythropoietin are also produced using biomanufacturing. These therapeutic proteins treat hormonal deficiencies and other medical conditions. Biomanufacturing involves using recombinant DNA technology to insert the hormone gene into host cells (e.g., bacteria or yeast), which then produce the hormone in large quantities. The manufacturing of hormones for rising cases of diabetes and other hormone deficiency-related disorders is expected to boost the demand for biomanufacturing hormones globally.
Workflow Insights: Continuous upstream biomanufacturing allows for continuous and steady production of biopharmaceuticals, eliminating the stop-start nature of traditional batch processes. This can lead to improved process efficiency, reduced downtime, and better resource utilization. The consistent environment and controlled conditions of continuous bioreactors can lead to higher cell densities and improved product yields compared to batch processes. Continuous biomanufacturing systems are often more compact than traditional batch systems, which can help in optimizing facility space and reducing operational costs. Continuous processes can result in more consistent and uniform product quality due to reduced variability and more precise process control.
Regional Insights: North America dominates the market due to its well-developed and advanced healthcare infrastructure, including research institutions, academic centers, and medical facilities. This infrastructure supports biomanufacturing activities and facilitates collaboration between academia, research organizations, and industry players. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) have established rigorous but well-defined guidelines for the approval and oversight of biopharmaceutical products. This regulatory expertise provides confidence to both investors and consumers in the safety and quality of bio-manufactured products. North America's strong venture capital ecosystem and financial markets support the funding of biopharmaceutical startups and established companies, fueling innovation and research efforts. The Asia-Pacific region, including China and India, has been experiencing growth in the biomanufacturing sector due to factors like lower manufacturing costs, a large talent pool, and increasing demand for biopharmaceuticals in the region. Some countries actively focus on developing biomanufacturing clusters and infrastructure to attract investments and boost their biopharmaceutical capabilities.
In this report, the Global Bio-Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below: