市場調查報告書
商品編碼
1470815
藥物分析測試外包市場:按服務、測試方法和最終用途分類 - 2024-2030 年全球預測Pharmaceutical Analytical Testing Outsourcing Market by Services (Bioanalytical Testing, Method Development & Validation, Stability Testing), Testing Technique (Chromatography, Mass Spectrometry, Spectroscopy), End-use - Global Forecast 2024-2030 |
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預計2023年藥品分析測試外包市場規模為92.3億美元,預計2024年將達100.7億美元,2030年將達173億美元,複合年成長率為9.38%。
藥品分析測試外包是指由外部機構專門為製藥公司執行各種分析測試程序提供的專業服務。這種外包是製藥公司採取的一種策略方法,旨在提高成本效率、利用專業知識並從內部不具備的先進技術中獲益。藥物分析測試外包的需求是由以下因素推動的:對準確藥物驗證的監管要求不斷增加、需要先進分析方法的藥品複雜性不斷增加,以及製藥公司為專注於核心能力而進行的成本最佳化努力。儘管出現了預期的成長,但智慧財產權問題和遵守嚴格監管標準的需求可能會導致前置作業時間和成本增加,從而抑制市場成長。然而,人工智慧和高通量篩檢方法等技術進步正在為市場成長提供新的途徑。此外,個人化醫療和罕見疾病藥物的趨勢正在擴大專業分析測試服務的可能性,並為藥物分析測試外包市場創造重大商機。
主要市場統計 | |
---|---|
基準年[2023] | 92.3億美元 |
預測年份 [2024] | 100.7億美元 |
預測年份 [2030] | 173億美元 |
複合年成長率(%) | 9.38% |
對生物分析測試服務的需求以確定服務藥物的功效和安全性
生物分析測試服務在臨床和非臨床環境中都至關重要。臨床生物分析測試是藥物開發過程中的重要步驟,涉及生物體液中藥物的定量測量。此評估對於確定臨床試驗中藥物化合物的功效和安全性至關重要。非臨床生物分析測試是藥物開發週期早期階段的重要組成部分。這涉及使用動物模型在體內或體外測試新藥物實體,以便在將其用於人類之前對該物質的安全性和生物活性進行初步評估。
在藥物分析測試領域,方法開發和驗證是確保結果準確性和可靠性的關鍵要素。萃取性和溶出方法的自訂製化開發和嚴格驗證對於評估藥品及其包裝材料的相容性至關重要。同樣,雜質方法的開發對於識別和量化可能影響產品安全性和功效的雜質至關重要。除此之外,技術諮詢還提供專家指導,以應對複雜的監管要求並最佳化分析程序以獲得可靠的結果。
穩定性測試是藥物品管的重要組成部分,可以深入了解藥物的保存期限並確保其在整個預期保存期限內保持安全有效。加速穩定性測試模擬長期環境影響以預測產品壽命,而原料藥測試則評估不同條件下的行為。光穩定性測試評估暴露於光如何影響藥品的穩定性,並確保暴露於光的藥品不會分解到不可接受的程度。穩定性方法驗證是一個徹底的分析過程,可確認分析程序是否適合檢測藥品的效力和純度的變化。此驗證證實特定的分析方法可以準確可靠地測量原料藥和藥品可能因分解而產生的變化。
檢測技術:層析法在有效分離和定量樣品中分析物的優勢
層析法是一種通用的分離技術,廣泛應用於製藥業,用於定量和鑑定混合物的成分以及精製藥物化合物。它因其高精度、分離複雜混合物的能力以及從分析到製備應用的擴充性而受到青睞。質譜分析是一種透過質荷比來辨識化合物的分析技術。該技術對於結構解析、微量成分鑑定和雜質分析至關重要。其高特異性和靈敏度使其成為藥物動力學、代謝研究和蛋白質體學的合適方法。光譜學涵蓋了基於光與物質相互作用的各種技術。在製藥工業中,它用於結構分析、化合物鑑定和濃度測定。
最終用途製造外包對各種困難測試服務的需求不斷增加
生物製藥和製藥部門包括參與藥品開發和製造的公司,包括生物來源(生物製藥)和化學合成藥物(藥品)。這些公司所需的分析測試服務包括純度評估、穩定性測試、生物分析測試、批次放行測試等。受託製造廠商(CMO)是一家以合約為基礎向其他製藥公司提供服務的公司,提供從藥物開發到藥品製造的全套服務。這些公司通常會外包分析測試,以保持法規遵循並確保產品質量,而無需投資昂貴的實驗室基礎設施。
區域洞察
美洲的藥物分析測試外包市場呈現強勁成長。製藥業和老牌外包公司的存在加強了這種成長。以美國食品藥物管理局(FDA) 為首的嚴格監管環境,以及對成本效率、創新和縮短時間日益成長的需求正在推動外包活動。在歐洲、中東和非洲地區,歐洲仍然是藥品分析測試外包市場的主要貢獻者。該市場受益於先進的醫療保健基礎設施、對藥品研發的大量投資以及該地區完善的法律規範。儘管規模小於歐洲,但在醫療保健投資增加以及對降低成本和利用當地專業知識的製藥外包興趣不斷成長的推動下,中東和非洲地區正在緩慢擴張。在中國和印度等新興國家的推動下,亞太地區市場正經歷快速成長。這些國家因其具有成本競爭力的勞動力、藥物分析專業化程度的提高以及對國際品質標準的遵守程度的提高而成為熱點。當地製藥商的擴張和醫療保健基礎設施領域外國投資的增加繼續為該地區的藥物分析測試外包服務創造新的機會。
FPNV定位矩陣
FPNV 定位矩陣對於評估藥物分析測試外包市場至關重要。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,可以對藥物分析測試外包市場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.競爭評估及資訊: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、製造能力等進行綜合評估。
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.藥物分析檢測外包市場規模及預測是多少?
2.藥物分析測試外包市場預測期間需要考慮投資的產品、細分市場、應用和領域有哪些?
3.藥物分析測試外包市場的技術趨勢和法規結構是什麼?
4.藥物分析測試外包市場主要供應商的市場佔有率為何?
5.進入藥品分析檢測外包市場的合適型態和策略手段是什麼?
[195 Pages Report] The Pharmaceutical Analytical Testing Outsourcing Market size was estimated at USD 9.23 billion in 2023 and expected to reach USD 10.07 billion in 2024, at a CAGR 9.38% to reach USD 17.30 billion by 2030.
Pharmaceutical analytical testing outsourcing refers to the professional services provided by external organizations that specialize in performing various analytical testing procedures for pharmaceutical companies. This practice of outsourcing is a strategic approach adopted by pharmaceutical companies to attain cost efficiencies, access specialized expertise, and benefit from advanced technologies that they may not possess in-house. The demand for pharmaceutical analytical testing outsourcing is driven by factors such as increasing regulatory demands for precise drug validation, the rising complexity of drugs, which requires advanced analytical methods, and cost optimization efforts from pharmaceutical companies looking to focus on core competencies. Despite the growth prospects, intellectual property concerns and the need for compliance with stringent regulatory standards, which can lead to an increase in lead time and costs, act as a restraint for market growth. However, advancements in technology, such as AI and high-throughput screening methods, present new avenues for market growth. The trend towards personalized medicine and orphan drugs also opens up a potential for specialized analytical testing services, presenting significant opportunities for the pharmaceutical analytical testing outsourcing market.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 9.23 billion |
Estimated Year [2024] | USD 10.07 billion |
Forecast Year [2030] | USD 17.30 billion |
CAGR (%) | 9.38% |
Services: Demand for bioanalytical testing services to determine efficacy and safety of pharmaceutical products
Bioanalytical testing services are essential for both clinical and non-clinical settings. Clinical bioanalytical testing is a critical phase in the drug development process, entailing the quantitative measurement of drugs in biological fluids. This evaluation is paramount for determining the efficacy and safety of pharmaceutical compounds in clinical trials. Non-clinical bioanalytical testing is an essential early-stage component of the drug development cycle. This involves the examination of new drug entities in vivo or in vitro in animal models to establish a preliminary assessment of the safety and biological activity of a substance before it is administered to humans.
In the realm of pharmaceutical analytical testing, method development and validation are critical components that ensure accuracy and reliability in results. Custom development and rigorous validation of methods for extractable and leachable are vital for assessing the compatibility between drug products and their packaging. Similarly, the development of an impurity method is crucial for identifying and quantifying potential impurities that could affect product safety and efficacy. Alongside this, technical consulting provides expert guidance to navigate complex regulatory requirements and optimize analytical procedures for robust outcomes.
Stability testing represents an integral part of pharmaceutical quality control, offering insights into a drug's shelf life and ensuring it remains safe and effective throughout its intended storage period. Accelerated stability testing simulates long-term environmental effects to predict a product's lifespan, while tests on the drug substance evaluate its behavior under varied conditions. Photostability testing assesses how exposure to light affects the stability of pharmaceutical products to ensure drug products do not degrade to an unacceptable degree when exposed to light. Stability indicating method validation is a thorough analytical process that confirms the suitability of analytical procedures for detecting changes in a drug's potency and purity. It involves the validation of specific methods to ensure they can accurately and reliably measure changes in the drug substances and products, which could result from degradation.
Testing Technique: Significant benefits of chromatography owing to its efficiency in separating and quantifying analytes in samples
Chromatography is a versatile separation technique extensively used in the pharmaceutical industry for quantifying and identifying the components of a mixture and purifying pharmaceutical compounds. It is preferred for its high precision, ability to separate complex mixtures, and scalability from analytical to preparative applications. Mass spectrometry offers an analytical technique that identifies compounds by their mass-to-charge ratio. This technique is indispensable for structural elucidation, identification of trace components, and impurity profiling. Its high specificity and sensitivity make it a suitable method for pharmacokinetics, metabolism studies, and proteomics. Spectroscopy encompasses a range of techniques based on the interaction of light with matter. In the pharmaceutical industry, it is used for structural analysis, compound identification, and concentration determination.
End-use: Growing need for a broad range of high-complexity testing services from contract manufacturing organizations
The Biopharmaceuticals & pharmaceuticals segment encompasses companies involved in the development and manufacturing of drugs, both biologically derived products (biopharmaceuticals) and chemically synthesized drugs (pharmaceuticals). Analytical testing services required by these entities include purity assessment, stability testing, bioanalytical testing, and batch-release testing, among others. Contract manufacturing organizations (CMOs) are companies that serve other pharmaceutical businesses on a contract basis to provide a comprehensive suite of services ranging from drug development to drug manufacturing. These organizations commonly outsource analytical testing to maintain regulatory compliance and ensure product quality without needing to invest in expensive laboratory infrastructure.
Regional Insights
The pharmaceutical analytical testing outsourcing market in the Americas is demonstrating robust growth. This growth is fortified by the presence of a pharmaceutical industry, along with well-established outsourcing companies. The stringent regulatory landscape, spearheaded by the U.S. Food and Drug Administration (FDA), and the increasing demand for cost-efficiency, innovation, and faster time-to-market are driving outsourcing activities. Europe remains a major contributor to the pharmaceutical analytical testing outsourcing market within the EMEA region. The market is benefiting from advanced healthcare infrastructure, significant investment in pharmaceutical R&D, and well-defined regulatory frameworks in the region. The Middle East and Africa, while smaller in comparison to Europe, are experiencing gradual expansions fueled by growing investment in healthcare sectors and a rising interest in pharmaceutical outsourcing to reduce costs and leverage regional expertise. The APAC market is experiencing rapid growth in pharmaceutical analytical testing outsourcing, backed by emerging economies such as China and India. These countries are becoming hotspots owing to their cost-competitive labor, growing expertise in pharma analytics, and increasing compliance with international quality standards. The expansion of local pharmaceutical manufacturers, coupled with increased foreign investments in healthcare infrastructure, continues to create new opportunities for pharmaceutical analytical testing outsourcing services in the region.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Pharmaceutical Analytical Testing Outsourcing 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 Pharmaceutical Analytical Testing Outsourcing 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 Pharmaceutical Analytical Testing Outsourcing Market, highlighting leading vendors and their innovative profiles. These include Ajinomoto Bio-Pharma, Alcami Corporation, AptarGroup, Inc., Ascendia Pharmaceuticals, BioAgilytix, Cambrex Corporation, Catalent, Inc, Charles River Laboratories International, Inc., Element Materials Technology, Eurofins Scientific SE, ICON PLC, Intertek Group PLC, Laboratory Corporation of America Holdings, LGM Pharma, Medpace Holdings, Inc., Merck KGaA, Pace Analytical Services, Inc., SGS SA, Societal CDMO, Source BioScience, Syneos Health, Thermo Fisher Scientific Inc., West Pharmaceutical Services, Inc., and WuXi AppTec.
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 Pharmaceutical Analytical Testing Outsourcing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Pharmaceutical Analytical Testing Outsourcing Market?
3. What are the technology trends and regulatory frameworks in the Pharmaceutical Analytical Testing Outsourcing Market?
4. What is the market share of the leading vendors in the Pharmaceutical Analytical Testing Outsourcing Market?
5. Which modes and strategic moves are suitable for entering the Pharmaceutical Analytical Testing Outsourcing Market?