市場調查報告書
商品編碼
1470778
製備色譜和過程層析法市場:按產品類型和最終用戶 - 2024-2030 年全球預測Preparative & Process Chromatography Market by Product, Type (Gas Chromatography, Gel-permeation Chromatography, Hydrophobic Interaction Chromatography), End-User - Global Forecast 2024-2030 |
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預計2023年製備色譜和製層析法市場規模為102億美元,預計2024年將達114.9億美元,2030年將達237億美元,複合年成長率為12.80%。
層析法和製程層析法是用於以適合商業生產的規模分離和精製化合物的先進技術。製備層析法是指從混合物中分離出足夠量的特定化合物以供後續使用或分析的過程,通常用於實驗室或研究環境。另一方面,過程層析法是製備層析法的放大版本,旨在處理大規模分離和精製。過程層析法在製造業中發揮著至關重要的作用,在製造業中,一致的品質、效率和法律規章遵循至關重要。層析法和製程層析法是廣泛用於藥品、生物技術產品和特種化學品生產中化學和生化化合物分離和精製的基本技術。由於生物製藥需求不斷成長、確保產品純度的嚴格法規、層析法技術的進步以及生物技術和製藥領域的大量研發投資,製備和工藝層析法市場正在快速成長。然而,他們也面臨著挑戰,例如與先進層析法系統相關的高成本、需要熟練的操作員來管理複雜的流程以及來自其他分離技術的競爭。對客製化服務和創新的一次性層析法解決方案的需求不斷成長,為未來的市場成長提供了利潤豐厚的機會。
主要市場統計 | |
---|---|
基準年[2023] | 102億美元 |
預測年份 [2024] | 114.9億美元 |
預測年份 [2030] | 237億美元 |
複合年成長率(%) | 12.80% |
在產品藥物發現中擴大製備層析法的採用
製備層析法用於從複雜的混合物中精製和分離特定的化合物。製備層析法的主要應用是研究和開發、大規模製造和純物質的生產,特別是在製藥和生物技術領域。該方法在藥物發現、活性藥物成分 (API) 的小規模合成和新型化合物開發的學術環境中至關重要。製程層析法廣泛用於大規模製造過程中生物分子的連續精製,特別是在生物製藥產業。該技術可生產大量生物分子,如疫苗、單株抗體和治療性蛋白質。這是良好生產規範 (GMP) 環境的重要組成部分。層析法和製程層析法之間的選擇主要取決於操作規模、監管需求和純度規格。製備層析法系統必須具有高度適應性,才能實現方法開發和放大製程。製層析法系統專為堅固耐用、高通量、可自動整合到生產線中而設計,並專注於 GMP 合規性。
類型 製藥業對 HPLC 純度檢測和產品品管的需求增加
氣相層析法是分析化學中廣泛使用的方法,用於分離和分析蒸發而不分解的化合物。凝膠滲透層析法,也稱為尺寸排阻層析法,主要用於大分子和聚合物的分析。其效用基於按分子大小分離分析物。疏水交互作用層析法是蛋白質和複雜生物樣品的首選方法。它的優勢在於能夠在分離過程中維持生物分子的活性和構形。該技術在生物技術和製藥領域受到青睞,尤其是抗體精製。液相層析法是一種多功能分析技術,具有從藥物到環境分析的多種應用。親和層析法是一種基於固定配體與目標分子的特異性相互作用的選擇性精製技術。急速層析法也稱為中壓層析法,是製備型液相層析法的一種快速型態。透過在正壓下使化合物通過填充固定相(例如矽膠或氧化鋁)的管柱,將化合物從混合物中分離和精製。高效液相層析(HPLC) 是液相層析法的一種高級型態,它使用高壓迫使樣品通過填充固定相微粒的管柱。以高解析度分離複雜的混合物並處理各種樣品類型。離子交換層析法技術依賴於樣品中的帶電粒子與固定相上附著的帶相反電荷的基團之間的可逆相互作用。尺寸排阻層析法(SEC) 或凝膠過濾層析法可根據分子通過填充多孔珠的管柱時的大小和形狀來分離分子。高效液相層析(HPLC) 是一種常見的層析法,以其高靈敏度和特異性而聞名。紙層析法是一種具有成本效益的教育技術,主要用於教授層析法原理和簡單的分離。與更先進的方法相比,低解析度和效率限制了其應用。薄層層析法也是一種簡單、快速、有效的定性技術。它通常用於有機化學和生物化學中監測反應進程和分析混合物的組成。
最終用戶:經常使用層析法和製程層析法來進行製程最佳化和製造品管
在學術實驗室中,製備層析法和過程層析法主要用於教育目的和基礎研究。這些實驗室需要強大且多功能的系統來進行各種實驗和教育演示。成本效益和易用性非常重要,因為資金有限且需要專門培訓。生物技術和製藥公司在藥物發現、開發和大規模生產中廣泛使用層析法和工藝層析法。效率、可重複性、遵守監管標準以及擴大商業生產的能力至關重要。食品和營養補充食品依靠層析法和工藝層析法來提取和精製營養補充、食品食品和天然化合物。為了確保商業性可行性,系統需要能夠處理具有不同純度要求的各種天然產物,並且通常具有高通量。
區域洞察
在製藥和生物技術產業(主要在美國)擴張的推動下,美洲的製備和製程層析法市場呈現穩定成長。該地區成熟的製藥公司和強大的研發活動促進了對層析法技術不斷成長的需求。此外,FDA 等監管機構對醫藥品認證過程製定了嚴格的指導方針,推動了層析法系統的採用,以確保整個美洲的合規性。歐洲、中東和非洲地區的層析法層析法不斷發展。政府對製藥和生物技術研究的資助也支持了該地區層析法市場的成長。由於中國和印度製藥和生物技術行業的快速擴張,亞太地區是成長最快的製備和工藝層析法市場。製造成本的下降以及政府對醫療保健和藥品研發的投資增加是該地區的主要市場驅動力。學名藥產量的增加和委外研發機構(CRO) 數量的快速增加也促進了亞太地區製備和製程層析法市場的成長。
FPNV定位矩陣
FPNV 定位矩陣對於評估製備和製程層析法市場至關重要。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,可以對製備色譜和工藝層析法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.競爭評估與資訊: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、製造能力等進行全面評估。
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.製備/製程層析法市場的市場規模和預測是多少?
2.在製備層析和製程層析法市場的預測期內,有哪些產品、細分市場、應用和領域需要考慮投資?
3.製備/製層析法市場的技術趨勢和法規結構是什麼?
4.製備/製層析法市場主要供應商的市場佔有率是多少?
5.進入製備/製層析法市場的適當型態或策略手段是什麼?
[185 Pages Report] The Preparative & Process Chromatography Market size was estimated at USD 10.20 billion in 2023 and expected to reach USD 11.49 billion in 2024, at a CAGR 12.80% to reach USD 23.70 billion by 2030.
Preparative and process chromatography are advanced techniques used to separate and purify chemical compounds on a scale suitable for commercial production. Preparative chromatography refers to the process of isolating specific compounds from mixtures in sufficient quantities for further use or analysis, typically in a laboratory or research setting. Process chromatography, on the other hand, is an upscaled version of preparative chromatography designed to handle large-scale separations and purifications, often within industrial environments. It plays a crucial role in the manufacturing sector, where consistent quality, efficiency, and regulatory compliance are paramount. Preparative and process chromatography is an essential technique widely used to separate and purify chemical and biochemical compounds for the production of pharmaceuticals, biotech products, and specialty chemicals. The preparative and process chromatography market is growing rapidly, driven by increasing demands for biopharmaceuticals, stringent regulations ensuring product purity, advancements in chromatographic technologies, and significant R&D investments in the biotech and pharma sectors. However, the market also confronts challenges such as the steep costs associated with advanced chromatographic systems, the need for skilled operators to manage the complexity of the processes, and competition from other separation techniques. Growing demand for tailored services and innovative single-use chromatography solutions has been presenting lucrative opportunities for future market growth.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 10.20 billion |
Estimated Year [2024] | USD 11.49 billion |
Forecast Year [2030] | USD 23.70 billion |
CAGR (%) | 12.80% |
Product: Growing adoption of preparative chromatography for drug discovery
Preparative chromatography is leveraged to purify and isolate specific compounds from complex mixtures. Its primary application is in producing pure substances for research, development, and large-scale manufacturing, especially in the pharmaceutical and biotechnology sectors. This method is crucial in drug discovery, small-scale synthesis for active pharmaceutical ingredients (APIs), and academic settings for novel compound development. Process Chromatography is extensively used in the continual purification of biological molecules during large-scale manufacturing processes, particularly in the biopharmaceutical industry. This technique produces high volumes of biomolecules such as vaccines, monoclonal antibodies, and therapeutic proteins. It is a critical component of the good manufacturing practice (GMP) environments. The choice between preparative and process chromatography depends primarily on the scale of operation, regulatory necessities, and purity specifications. Preparative chromatography systems must be highly adaptable, allowing for method development and scale-up processes. Process chromatography systems are designed for robustness, high throughput, and integration into automatable production lines, focusing on GMP compliance.
Type: Increasing demand for HPLC in the pharmaceutical industry for purity testing and quality control of products
Gas chromatography is a prevalent method utilized in analytical chemistry for isolating and analyzing compounds that can be vaporized without decomposition. Gel-permeation chromatography, also known as size-exclusion chromatography, serves primarily for the analysis of macromolecules and polymers. Its utility is based on the separation of analytes by molecular size. Hydrophobic interaction chromatography is a method of choice for proteins and complex biological samples. Its strength lies in its capacity to maintain the activity and conformation of biomolecules during separation. This technique is favored in the biotechnological and pharmaceutical sectors, particularly for antibody purification. Liquid chromatography is a versatile analytical technique with many applications, from pharmaceutical to environmental analysis. Affinity chromatography is a selective technique used for purification based on the specific interaction between an immobilized ligand and its target molecule. Flash chromatography, also known as medium-pressure chromatography, is a rapid form of preparative liquid chromatography. It separates and purifies compounds from a mixture by passing them via a column packed with a stationary phase, typically silica gel or alumina, under positive pressure. High-performance liquid chromatography (HPLC) is an advanced form of liquid chromatography that uses high pressure to drive the sample through a column packed with fine particles of the stationary phase. It provides high-resolution separations of complex mixtures and is capable of handling a variety of sample types. Ion-exchange chromatography This technique relies on the reversible interaction between charged particles in a sample and oppositely charged groups attached to the stationary phase. Size-exclusion chromatography (SEC), or gel filtration chromatography, separates molecules based on size and shape as they pass through a column filled with porous beads. High-performance liquid chromatography (HPLC) is a popular variant known for its high sensitivity and specificity. Paper chromatography is an educational and cost-effective technique primarily used to teach chromatography principles and simple separations. Its applications are limited compared to more advanced methods due to lower resolution and efficiency. Thin-layer chromatography is another simple, quick, and effective qualitative technique. It is commonly used in organic chemistry and biochemistry to monitor the progress of reactions and analyze mixtures' composition.
End-User: Significant use of preparative and process chromatography for process optimization and production quality control
Academic research laboratories primarily use preparative and process chromatography for educational purposes and basic research. These laboratories require robust and versatile systems for various experiments and educational demonstrations. Cost-effectiveness and ease of use are often crucial, as funding can be limited, and users may need specialized training. Biotechnology & pharmaceutical companies extensively use preparative and process chromatography in drug discovery, development, and large-scale production. Efficiency, reproducibility, compliance with regulatory standards, and the ability to scale up for commercial production are essential. Food and nutraceutical companies utilize preparative and process chromatography to extract and purify nutraceuticals, food additives, and natural compounds. They require systems that can handle various natural products with varying purity requirements, often at high throughput, to ensure commercial viability.
Regional Insights
The preparative and process chromatography market in the Americas has shown a robust growth rate driven by the expanding pharmaceutical and biotechnology industries, especially in the United States. The presence of established pharmaceutical companies and a strong focus on R&D activities contribute to the higher demand for chromatography techniques in the region. Moreover, regulatory bodies, including the FDA have stringent guidelines for drug approval processes, which in turn boosts the adoption of chromatography systems to ensure compliance across the Americas. The EMEA region presents a growing market landscape for preparative and process chromatography, supported by the presence of a well-established pharmaceutical industry, a strong focus on quality control, and high standards for drug development. Government funding for pharmaceutical and biotechnological research also supports the growth of the chromatography market in the region. The Asia-Pacific region is witnessing the fastest growth in the preparative and process chromatography market, attributed to the rapid expansion of pharmaceutical and biotech industries in China and India. Lower manufacturing costs and increasing government investments in healthcare and pharmaceutical R&D are significant market drivers in the region. Increased generic drug production and a surge in the number of Contract Research Organizations (CROs) also contribute to the growth of the preparative and process chromatography market in the APAC.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Preparative & Process Chromatography 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 Preparative & Process Chromatography 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 Preparative & Process Chromatography Market, highlighting leading vendors and their innovative profiles. These include Agilent Technologies, Inc, Akzo Nobel N.V., Altmann Analytik GmbH & Co. Kg, Bio-Rad Laboratories, Inc., Biobase Biodusty(Shandong), Co., Ltd., Bruker Corporation, Centurion Scientific, Daicel Corporation, Danaher Corporation, General Electric Company, Gilson, Inc., GL Sciences Inc., Hamilton Bonaduz AG, Hitachi High-Technologies Corporation, JASCO Corporation, Merck KGaA, Perkinelmer, Inc., Repligen Corporation, Restek Corporation, Sartorius AG, Sykam GmbH, Thermo Fisher Scientific Inc., Unimicro Technologies, Waters Corporation, and Welch Materials, 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 Preparative & Process Chromatography Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Preparative & Process Chromatography Market?
3. What are the technology trends and regulatory frameworks in the Preparative & Process Chromatography Market?
4. What is the market share of the leading vendors in the Preparative & Process Chromatography Market?
5. Which modes and strategic moves are suitable for entering the Preparative & Process Chromatography Market?