市場調查報告書
商品編碼
1466473
生物製藥契約製造市場:按產品、供應商、服務、業務規模、治療應用 - 2024-2030 年全球預測Biopharmaceuticals Contract Manufacturing Market by Product (Biologics, Biosimilar), Source (Mammalian, Non-Mammalian), Services, Scale of Operation, Therapeutic Applications - Global Forecast 2024-2030 |
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生物製藥契約製造市場規模預計2023年為182.7億美元,2024年達到191.6億美元,預計2030年將達259.5億美元,複合年成長率為5.14%。
生物藥品契約製造是指將生物藥品的製造過程委託給第三方製造商。這些專業公司擁有生產生質製藥所需的專業知識、設備和設施,包括疫苗、單株抗體、重組蛋白和其他生物來源。這種協作方法使生物製藥公司能夠利用外部能力和資源來提高擴充性、降低成本並加快新治療方法的上市時間。生物製藥契約製造市場是由生物製藥管道的不斷成長、生物學名藥需求的增加以及生物製藥製造過程日益複雜性所推動的。對專業製造能力的需求、嚴格的監管要求以及縮短時間的願望正在推動製藥公司走向外包。然而,建立生物製藥生產設施成本高昂,這可能會阻礙市場成長。然而,生物製藥研發和製造的投資不斷增加,以及全球對個人化醫療的日益關注,預計將為市場成長創造潛在機會。
主要市場統計 | |
---|---|
基準年[2023] | 182.7億美元 |
預測年份 [2024] | 191.6億美元 |
預測年份 [2030] | 259.5億美元 |
複合年成長率(%) | 5.14% |
擴大分析和品質控制測試的使用對於滿足服務監管標準至關重要
分析和品管(QC) 測試對於確保生物製藥的安全性、有效性和品質至關重要。該服務包括各種活動,包括測試方法開發、驗證、穩定性測試和批量發布測試。這些測試對於滿足監管標準並確保製造的產品符合規格至關重要。灌裝和精加工作業是生物製藥製造過程中的關鍵步驟,其中最終藥品被無菌填充到容器中,並進行貼標和包裝等精加工操作。該過程需要精確度和高標準的清潔度,以保持產品的無菌性和完整性,使其成為生物製藥契約製造的關鍵要素。生物製藥包裝服務不僅僅是封裝產品。這包括設計和開發包裝系統,保護產品免受環境因素的影響,確保儲存和運輸過程中的穩定性,並滿足監管要求。此外,先進的包裝解決方案增加了患者的便利性並支持治療計劃的遵守。製程開發是生物製藥契約製造中的關鍵服務,重點是設計、最佳化和擴大生產流程,以確保成本效益、效率並符合品質標準。這包括細胞培養製程、精製製程和整合製程分析的開發,以確保商業性製造的製程穩健性和永續性。在下游過程中,上游工程中產生的生物物質被回收和精製。此步驟對於去除雜質和濃縮產品很重要。下游加工涉及的技術包括層析法、過濾和沈澱,所有這些對於確保最終生物製藥產品的純度和品質至關重要。上游工程是指生物製藥製造的早期階段,涉及在受控條件下在反應器中培養細胞以生產所需的生物物質。這項服務需要細胞株開發、培養基製備和反應器操作方面的專業知識,並構成生產可進一步加工和最終形成治療產品的生物活性物質的基礎。
業務規模:生物製藥契約製造:不斷發展的商業性業務規模
生物藥品契約製造中的臨床規模是指以臨床試驗為目的的中小批量生物藥品的生產。在這種規模下,彈性、準確性和遵守監管標準是優先考慮的,以確保臨床實驗產品的有效性和安全性。製造流程旨在適應臨床開發過程中不斷變化的需求,促進從臨床前測試向 I、II 和 III 期臨床試驗的過渡。這種規模強調適應性以及隨著產品接近商業化而擴大流程的能力。受託製造廠商(CMO) 提供臨床規模的服務,擁有處理複雜生技藥品(包括單株抗體、重組蛋白和基因療法)的尖端技術和專業知識,確保產品為臨床研究做好準備。符合嚴格的品質標準要求。生物製藥契約製造的商業性規模涉及大規模生產,目標是在監管部門核准後進行大量銷售。此規模強調效率、成本效益以及滿足對核准生物製藥的高需求的能力。商業規模的製造需要對基礎設施、技術和品管系統進行大量投資,以確保一致的產品品質並符合全球監管要求。商業規模的受託製造公司有能力最佳化製造流程、高效管理供應鏈並及時交付大量生物製藥。這種規模的企業不斷追求卓越營運、流程最佳化和良好生產規範 (GMP) 合規性,以滿足生物製藥行業的嚴格標準並滿足世界各地人們的健康需求。
區域洞察
美洲因其先進的技術基礎設施、強力的法律規範以及對生物技術研究的大量投資而成為生物製藥契約製造的重要市場。最近的舉措主要集中在精準醫學和生技藥品上,並在生物加工和基因工程技術領域申請了多項專利。此外,對單株抗體和疫苗研究的關注促使全球合約受託製造廠商(CMO)在該國投資。隨著製造能力升級和生技藥品產量增加,亞太地區生物製藥契約製造製造業正在蓬勃發展,對細胞療法和重組蛋白藥物進行了大量投資。此外,反應器技術和再生醫學領域的重要專利,以及對國內和國際市場生物相似藥和疫苗的關注,正在推動投資和合作夥伴關係,為 CMO 提供了許多機會。在先進的醫療基礎設施和嚴格的監管標準的支持下,歐盟 (EU) 的生物製藥契約製造市場呈現成長態勢。最近的趨勢包括生技藥品的激增以及對個人化藥物和細胞療法的興趣增加。儘管在中東仍處於起步階段,但生物製藥的契約製造正在逐步進展,投資主要集中在疫苗生產和生物相似藥上,以應對不斷成長的醫療需求。非洲的生物製藥契約製造正在發展,因為該國專注於建立本地製造能力,以減少對進口藥品的依賴,並專注於疫苗和一般治療藥物。
FPNV定位矩陣
FPNV定位矩陣對於評估生物製藥契約製造市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對生物製藥契約製造市場中供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。這種詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4. 競爭評估和情報:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況和製造能力進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.生物製藥契約製造市場的市場規模和預測是多少?
2.在生物製藥契約製造市場的預測期內,需要考慮投資哪些產品、細分市場、應用和領域?
3.生物製藥契約製造市場的技術趨勢和法規結構是什麼?
4.生物製藥契約製造市場主要供應商的市場佔有率是多少?
5.進入生物製藥契約製造市場的合適型態和策略手段是什麼?
[186 Pages Report] The Biopharmaceuticals Contract Manufacturing Market size was estimated at USD 18.27 billion in 2023 and expected to reach USD 19.16 billion in 2024, at a CAGR 5.14% to reach USD 25.95 billion by 2030.
Biopharmaceutical contract manufacturing is the outsourcing of biopharmaceutical production processes to third-party manufacturers. These specialized entities possess the expertise, equipment, and facilities required to manufacture biopharmaceutical products, which include vaccines, monoclonal antibodies, recombinant proteins, and other biologically derived pharmaceuticals. This collaborative approach enables biopharmaceutical companies to leverage external capabilities and resources to enhance scalability, reduce costs, and accelerate the time to market for new therapies. The biopharmaceutical contract manufacturing market is driven by an increasing pipeline of biologic drugs, rising demand for biosimilars, and the complexity of biologic drug production processes. The need for specialized manufacturing capabilities, stringent regulatory requirements, and the desire to reduce costs and time-to-market push pharmaceutical companies toward outsourcing. However, the high price of setting up a production facility for biopharmaceuticals may hinder market growth. Nevertheless, rising investments in biopharmaceutical R&D and manufacturing, coupled with a growing emphasis on personalized medicine globally, are expected to create potential opportunities for market growth.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 18.27 billion |
Estimated Year [2024] | USD 19.16 billion |
Forecast Year [2030] | USD 25.95 billion |
CAGR (%) | 5.14% |
Services: Proliferating utilization of analytical and QC studies critical for meeting regulatory standards
Analytical and quality control (QC) studies are vital in ensuring the safety, efficacy, and quality of biopharmaceutical products. This service encompasses a range of activities, including method development, validation, stability testing, and batch release testing. These studies are critical for meeting regulatory standards and ensuring manufactured products meet specifications. Fill and finish operations are a crucial stage in the manufacturing process of biopharmaceuticals, involving the aseptic filling of the final drug into its container, followed by finishing tasks such as labeling and packaging. This process requires precision and high standards of cleanliness to maintain the sterility and integrity of the product, making it a critical component in the contract manufacturing of biopharmaceuticals. Packaging services for biopharmaceuticals go beyond simply enclosing the product. They involve designing and developing packaging systems that protect the product from environmental factors, ensure its stability during storage and transport, and comply with regulatory requirements. Sophisticated packaging solutions also provide patient convenience and support compliance with treatment regimens. Process development is a critical service in biopharmaceuticals contract manufacturing, focusing on designing, optimizing, and scaling up production processes to ensure cost-effectiveness, efficiency, and compliance with quality standards. This includes the development of cell culture processes, purification processes, and integration process analytics to ensure the process is robust and sustainable for commercial manufacturing. Downstream processing involves recovering and purifying biological substances produced during upstream processing. This phase is critical for removing impurities and concentrating the product. Techniques involved in downstream processes include chromatography, filtration, and precipitation, all of which are essential for ensuring the purity and quality of the final biopharmaceutical product. Upstream Processing refers to the initial phase of biopharmaceutical manufacturing, which involves cultivating cells in bioreactors under controlled conditions to produce the desired biological substance. This service requires expertise in cell line development, media preparation, and bioreactor operation, forming the foundation for producing biologically active substances that can be further processed and finalized as therapeutic products.
Scale of Operation: Evolving commercial scale of operation for biopharmaceuticals contract manufacturing
The clinical scale of operation in biopharmaceutical contract manufacturing refers to producing small to medium batches of biopharmaceutical products intended for clinical trials. This scale prioritizes flexibility, precision, and compliance with regulatory standards to assure the efficacy and safety of products under investigation. The production processes are designed to accommodate the evolving requirements of clinical development stages, facilitating the transition from preclinical studies to Phase I, II, and III clinical trials. At this scale, the focus is on adaptability and the ability to scale up processes as the product moves closer to commercialization. Contract manufacturing organizations (CMOs) offering services at the clinical scale are equipped with cutting-edge technology and expertise to handle complex biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, ensuring that products meet the stringent quality standards required for clinical research. The commercial scale of operation in biopharmaceutical contract manufacturing involves large-scale production intended for the mass market following regulatory approval. This scale focuses on efficiency, cost-effectiveness, and the ability to meet the high demand for approved biopharmaceutical products. Commercial-scale manufacturing requires a significant investment in infrastructure, technology, and quality control systems to assure consistent product quality and compliance with global regulatory requirements. Contract manufacturing organizations serving at the commercial scale have the capabilities to optimize production processes, manage supply chains effectively, and ensure the timely delivery of large quantities of biopharmaceuticals. This scale of operation is characterized by a continuous commitment to operational excellence, process optimization, and adherence to Good Manufacturing Practices (GMP) to meet the stringent standards of the biopharmaceutical industry and address the health needs of populations globally.
Regional Insights
The Americas represent a significant market for biopharmaceuticals contract manufacturing, attributed to its advanced technological infrastructure, robust regulatory framework, and significant investments in biotech research. Recent initiatives focus on precision medicine and biologics, with numerous patents filed in bioprocessing and genetic engineering technologies. In addition, the emphasis on research in monoclonal antibodies and vaccines has attracted global contract manufacturing organizations (CMOs) to invest in the country. The biopharmaceutical contract manufacturing sector in Asia Pacific is booming, owing to the upgrading of manufacturing capabilities and enhancement of biologics production, with considerable investments in cell therapy and recombinant protein drugs. Furthermore, significant patents in bioreactor technologies and regenerative medicine and the focus on biosimilars and vaccines for domestic and international markets propel investments and collaborations, offering numerous opportunities for CMOs. The European Union exhibits growth in the biopharmaceuticals contract manufacturing market, supported by its advanced healthcare infrastructure and strong regulatory standards. Recent trends indicate a surge in biologics production and a growing interest in personalized medicines and cell therapies. Despite being nascent, the Middle East is gradually advancing in biopharmaceutical contract manufacturing, with investments focusing on vaccine production and biosimilars to address the rising healthcare needs. Africa's biopharmaceutical contract manufacturing is developing due to the region's focus on establishing local manufacturing capabilities to reduce dependency on imported drugs, emphasizing vaccines and common therapeutics.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Biopharmaceuticals Contract Manufacturing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Biopharmaceuticals Contract Manufacturing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Biopharmaceuticals Contract Manufacturing Market, highlighting leading vendors and their innovative profiles. These include 3P Biopharmaceuticals, AbbVie, Inc., Aenova Group GmbH, AGC Biologics, Ajinomoto Co., Inc., Aurobindo Pharma Limited, Boehringer Ingelheim International GmbH, Cambrex Corporation, Catalent, Inc., Celonic AG, FUJIFILM Diosynth Biotechnologies, INCOG BioPharma Services, Inc., JRS PHARMA GmbH + Co. KG, KBI Biopharma Inc, Lonza AG, Merck KGaA, Pressure BioSciences, Inc. by Emergent Health Corp., ProBioGen AG, Rentschler Biopharma SE, Samsung Biologics, Thermo Fisher Scientific Inc., Toyobo Co., Ltd., and WuXi Biologics, Inc..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Biopharmaceuticals Contract Manufacturing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Biopharmaceuticals Contract Manufacturing Market?
3. What are the technology trends and regulatory frameworks in the Biopharmaceuticals Contract Manufacturing Market?
4. What is the market share of the leading vendors in the Biopharmaceuticals Contract Manufacturing Market?
5. Which modes and strategic moves are suitable for entering the Biopharmaceuticals Contract Manufacturing Market?
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