市場調查報告書
商品編碼
1466697
抗體契約製造市場:按抗體類型、來源、服務和最終用戶分類 - 2024-2030 年全球預測Antibodies Contract Manufacturing Market by Antibody Type (Monoclonal Antibodies, Polyclonal Antibodies), Source (Mammalian, Microbial), Services, End-User - Global Forecast 2024-2030 |
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預計2023年抗體契約製造市場規模為163.4億美元,預計2024年將達180.4億美元,2030年將達335.6億美元,複合年成長率為10.82%。
抗體契約製造涉及將抗體生產和精製過程外包給專業公司。這種方法允許生物技術和製藥公司利用外部專業知識和先進設備來生產單株、多株抗體和重組抗體,而無需對基礎設施進行大量資本投資。抗體契約製造服務通常涵蓋廣泛的流程,包括細胞株開發、上游和下游加工、精製和最終製劑。抗體藥物在癌症、自體免疫疾病和感染疾病等慢性疾病的治療中變得越來越重要,增加了對專業製造服務的需求。對創新抗體療法的監管支持增加,加上生技藥品核准的簡化,正在推動與受託製造廠商(CMO) 的合作。智慧財產權問題以及與抗體契約製造相關的品質和合規風險不斷上升正在限制市場成長。生物加工、基因工程和高通量篩檢的技術進步正在加速新型抗體的開發並創造市場成長機會。
主要市場統計 | |
---|---|
基準年[2023] | 163.4億美元 |
預測年份 [2024] | 180.4億美元 |
預測年份 [2030] | 335.6億美元 |
複合年成長率(%) | 10.82% |
抗體類型 由於單株抗體的均一性、特異性和大規模生產能力,對單株抗體的需求不斷增加。
單株抗體是針對特定抗原的抗體的相同副本。它們由單一克隆細胞或細胞株產生,具有親和性,僅與相同表位結合。在契約製造中,單株抗體是使用融合瘤開發、重組 DNA 和噬菌體展示等先進技術生產的。這些抗體有廣泛的應用,包括診斷、治療(針對癌症、自體免疫疾病和感染疾病等疾病)和研究。它們的均勻性、特異性和大量生產的能力使它們成為醫學和生物學領域的寶貴工具。多株抗體由不同 B 細胞克隆產生的混合抗體分子群組成。多株抗體可辨識並結合單一抗原上的多個表位。由於這種多樣性,多株抗體常用於免疫沉澱分析法和螢光方法中檢測各種抗原。生產涉及用抗原免疫合適的哺乳動物,例如兔子、山羊或小鼠。動物的免疫系統產生多種針對抗原的抗體,並且可以從血清中回收抗體。多株抗體因其高靈敏度和捕獲天然構象蛋白質的能力而備受讚譽,但批次間的變異性是其生產和使用中的一個重要考慮因素。
最終用戶:抗體契約製造擴大被生物技術和製藥公司採用,以利用抗體生產和精製方面的專業知識。
學術和研究機構是抗體契約製造市場最終用戶的重要組成部分。這些機構將先進的抗體開發服務用於各種研究目的,專注於闡明疾病機制、發現新的治療標靶和開發新型診斷工具。與受託製造廠商(CMO) 合作,無需對基礎設施進行大量投資,即可獲得尖端技術和專業知識,從而加快科學發現和創新的步伐。生技和製藥公司,從新新興企業到老字型大小企業,都嚴重依賴抗體契約製造服務來實現各種應用,包括開發治療性抗體和製造診斷試劑。這些公司通常專注於特定的治療領域或新穎的生物技術方法,需要高度專業、可擴展且具成本效益的抗體製造解決方案。受託製造合作夥伴關係使生物技術公司能夠應對複雜的監管環境,管理與生物製藥產品開發週期相關的風險,並加快創新的上市時間。透過與 CMO 合作,製藥和生物技術公司可以利用我們在抗體生產和精製的專業知識來最佳化製造流程並確保產品品質並符合全球監管標準。
區域洞察
美洲是全球市場格局中高度開拓的地區。該地區擁有強大的生物製藥研究、高額的醫療保健支出以及完善的法規環境。美國擁有多個重要的合約受託製造廠商(CMO),提供從早期開發到大規模製造的廣泛服務。加拿大和巴西在這一領域也出現了成長,但美國在市場規模和技術進步方面繼續處於領先地位。生物技術投資的增加、生物相似藥需求的成長以及醫療保健基礎設施的改善為亞太地區抗體契約製造市場注入了活力。中國、韓國和印度等國家處於領先地位,政府實施了有利於生物技術進步的政策。尤其是中國,由於患者數量眾多以及生物技術產業的發展,CMO和合約開發與受託製造廠商(CDMO)的建立迅速增加。該地區的產品具有成本競爭力,加上品質標準的提高,使其成為外包抗體生產的有吸引力的地點。 EMEA(歐洲、中東和非洲)地區在抗體契約製造市場擁有強大的影響力,其中歐洲因其高度發展的生物製藥產業而處於領先地位。德國、英國和瑞士等國家以其複雜的生物技術生態系統而聞名,其中包括成熟的生物技術公司和新興的生物技術公司。嚴格的監管標準的存在確保了高品質的製造流程和產量。隨著對醫療基礎設施的投資和對生物技術研究興趣的增加,中東和非洲正逐漸迎頭趕上。
FPNV定位矩陣
FPNV定位矩陣對於評估抗體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,可以對抗體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.抗體契約製造市場的市場規模與預測是多少?
2.抗體契約製造市場預測期內需要考慮投資的產品、細分市場、應用和領域有哪些?
3.抗體契約製造市場的技術趨勢和法規結構是什麼?
4.抗體契約製造市場主要廠商的市場佔有率是多少?
5.進入抗體契約製造市場的合適型態和策略手段是什麼?
[198 Pages Report] The Antibodies Contract Manufacturing Market size was estimated at USD 16.34 billion in 2023 and expected to reach USD 18.04 billion in 2024, at a CAGR 10.82% to reach USD 33.56 billion by 2030.
Antibodies contract manufacturing includes the outsourcing of antibody production and purification processes to specialized service providers. This approach allows biotechnology and pharmaceutical companies to leverage external expertise and advanced facilities for the production of monoclonal, polyclonal, and recombinant antibodies without the need for significant capital investments in infrastructure. Antibodies contract manufacturing services typically cover a broad spectrum of processes, including cell line development, upstream and downstream processing, purification, and final formulation. The growing emphasis on antibody-based drugs in the treatment of chronic diseases such as cancer, autoimmune diseases, and infectious diseases significantly fuels the need for specialized manufacturing services. Increasing regulatory support for innovative therapeutic antibodies, combined with streamlined approvals for biologics, promotes partnerships with contract manufacturing organizations (CMOs). Intellectual property concerns with rising quality and compliance risks associated with antibody contract manufacturing is restraining the growth of the market. Technological progress in bioprocessing, genetic engineering, and high-throughput screening accelerates the development of novel antibodies, creating opportunities for market growth.
KEY MARKET STATISTICS | |
---|---|
Base Year [2023] | USD 16.34 billion |
Estimated Year [2024] | USD 18.04 billion |
Forecast Year [2030] | USD 33.56 billion |
CAGR (%) | 10.82% |
Antibody Type: Growing need for monoclonal antibodies due to their uniformity, specificity, and large-scale production capabilities
Monoclonal antibodies are identical copies of an antibody that targets a specific antigen. They are produced by a single clone of cells or cell lines and have monovalent affinity, binding only to the same epitope. In the context of contract manufacturing, monoclonal antibodies are generated through sophisticated technologies such as hybridoma development, recombinant DNA, or phage display. These antibodies have a broad range of applications in diagnostics, therapeutics (for diseases such as cancer, autoimmune diseases, and infectious diseases), and research. Their uniformity, specificity, and large-scale production capabilities make them invaluable tools in medicine and biology. Polyclonal antibodies consist of a mixed population of antibody molecules that are produced by different clones of B cells. They recognize and bind to multiple epitopes on a single antigen. Due to this diversity, polyclonal antibodies are often used for detecting a wide range of antigens in immunoprecipitation and immunofluorescence assays. Production involves the immunization of a suitable mammal, such as a rabbit, goat, or mouse, with an antigen. The animal's immune system produces a wide array of antibodies against the antigen, which can then be collected from the serum. Polyclonal antibodies are appreciated for their high sensitivity and ability to capture proteins in their native conformation, but variability from batch to batch is a significant consideration in their production and use.
End-User: Rising adoption of antibodies contract manufacturing among biotechnology & pharmaceutical firms to leverage specialized expertise in antibody production and purification
Academics & research institutions constitute a significant segment of the end-users in the antibodies contract manufacturing market. Utilizing advanced antibody development services for diverse research purposes, these entities focus on understanding disease mechanisms, discovering new therapeutic targets, and developing novel diagnostics tools. The partnership with contract manufacturing organizations (CMOs) allows them to access cutting-edge technologies and expertise without the need for substantial investments in infrastructure, thereby accelerating the pace of scientific discoveries and innovations. Biotechnology & pharmaceutical companies, ranging from startups to well-established firms, heavily rely on antibody contract manufacturing services for various applications, including therapeutic antibody development, diagnostic reagent production, and more. These companies often focus on specific therapeutic areas or novel biotechnological approaches, necessitating the need for specialized, scalable, and cost-effective antibody production solutions. Contract manufacturing partnerships enable biotech companies to navigate the complex regulatory landscapes and manage the risks associated with the biopharmaceutical product development cycle, facilitating a quicker time-to-market for their innovations. The collaboration with CMOs allows pharmaceutical & biotechnology firms to leverage specialized expertise in antibody production and purification, optimize manufacturing processes, and ensure product quality and compliance with global regulatory standards, thus supporting their efforts to deliver safe and effective treatments to patients worldwide.
Regional Insights
The Americas represents a highly developing landscape for the global antibodies contract manufacturing market attributed to the region's robust biopharmaceutical research landscape, significant healthcare spending, and supportive regulatory environment. The US houses several significant contract manufacturing organizations (CMOs) that offer a wide range of services, from early-stage development to large-scale production. Canada and Brazil are also witnessing growth in this sector, though the US continues to lead in terms of market size and technological advancements. The antibody contract manufacturing market in Asia-Pacific is fueled by increasing investment in biotechnology, rising demand for biosimilars, and improving healthcare infrastructure. Countries such as China, South Korea, and India are at the forefront, with their governments implementing favorable policies for biotech advancements. China, in particular, has seen a surge in the establishment of CMOs and contract development and manufacturing organizations (CDMOs) owing to its large patient population and growing biotech industry. The region offers cost-competitive services, which, combined with improving quality standards, makes it an attractive location for outsourcing antibody production. The EMEA region exhibits a strong presence in the antibodies contract manufacturing market, with Europe leading the way due to its highly developed biopharmaceutical sector. Countries including Germany, the United Kingdom, and Switzerland are notable for their sophisticated biotech ecosystems, comprising both established players and emerging biotechs. The presence of stringent regulatory standards ensures high-quality manufacturing processes and outputs. The Middle East and Africa are gradually catching up, with investments in healthcare infrastructure and an increasing focus on biotechnology research.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Antibodies 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 Antibodies 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 Antibodies Contract Manufacturing Market, highlighting leading vendors and their innovative profiles. These include Abeomics, Absolute Antibody by LSBio, Advanced ChemTech, Inc., AGC Biologics, Antibodies, Inc., AstraZeneca, Boehringer Ingelheim Biopharmaceuticals GmbH., Bryllan LLC, Catalent, Inc., CD BioSciences, Charles River Laboratories International, Inc., Eli Lilly and Company, FUJIFILM Holdings Corporation, Fujirebio Inc. by H.U. Group Holdings, Inc., Hycult Biotechnology (H.B.T.) B.V., Labcorp Drug Development, Lonza Group Ltd., Merck KGaA, Molecular Depot LLC, Pierre Fabre S.A, Samsung Biologics, Sapphire Bioscience Pty. Ltd., Scantibodies Laboratory, Inc., Synthon International Holding B.V., The Serum Institute of India, and WuXi Biologics Co., Ltd..
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 Antibodies Contract Manufacturing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Antibodies Contract Manufacturing Market?
3. What are the technology trends and regulatory frameworks in the Antibodies Contract Manufacturing Market?
4. What is the market share of the leading vendors in the Antibodies Contract Manufacturing Market?
5. Which modes and strategic moves are suitable for entering the Antibodies Contract Manufacturing Market?