市場調查報告書
商品編碼
1463674
到 2030 年北美生物分析測試服務市場預測 - 區域分析 - 按服務分類;疾病適應症;和最終用戶North America Bioanalytical Testing Services Market Forecast to 2030 - Regional Analysis - by Services ; Disease Indication ; and End User |
2022年北美生物分析測試服務市值為17.9803億美元,預計2030年將達到39.7142億美元;預計2022年至2030年CAGR為10.4%。
製藥公司不斷增加的研發活動外包推動了北美生物分析測試服務市場
製藥公司將非其內部結構核心的研發活動外包。外包雜項活動使他們能夠有效地專注於其內部核心能力,從而使藥物開發過程更好、更具成本效益。此外,外包製造活動以及研發可以縮短週轉時間,增加他們的專業知識,並消除大量資本投資的需要,從而使他們受益。根據 BioPlan Associates 對生物製藥產能和生產的調查,分析測試/生物測定是 2022 年外包最多的服務,其次是毒性測試、驗證服務、產品表徵等。雖然發展中國家是透過合約製造對生物分析測試服務需求的最大貢獻者,但美國仍然是潛在的外包目的地。調查中 39.6% 的非美國受訪者更願意外包給美國設施。因此,外包的做法在全球範圍內越來越流行,特別是在發展中國家,從而有利於生物分析測試服務市場的成長。製藥公司正在廣泛實施品質源自於設計(QbD)概念,這進一步推動製藥公司採用外包服務,以提高其生產流程的穩健性,並確保最佳的產品品質和製造生產力。 QbD 得到美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等監管機構的支持。多年來,隨著 ICH Q9(品質風險管理)、ICH Q8(R2,藥品開發)和 ICH Q10(藥品品質系統)的發布,這一概念在製藥業獲得了廣泛關注。根據 ICH Q10 指南,分析方法對於藥品品質系統至關重要。在製造中實施分析 QbD (AQbD) 可確保產品品質和效能。外包生物分析測試服務可以幫助製藥公司避免對分析設備和熟練專業人員的大量投資,從而降低業務風險,特別是當產品處於開發的早期階段時。由於專業的分析測試服務提供者俱有快速提供優異結果的關鍵能力,製藥公司擴大考慮將生物分析測試服務外包給第三方服務供應商,這推動了市場的成長。
北美生物分析測試服務市場概況
北美佔據生物分析測試服務市場的最大佔有率,其中美國、加拿大和墨西哥是該地區市場成長的主要貢獻者。製藥業的不間斷成長、各種疾病發病率的上升對開發新藥的需求不斷增加、政府醫療保健支出的增加以及為保證藥品質量而對外包活動的日益偏好是有利的因素北美生物分析測試服務市場的成長。
北美生物分析測試服務市場收入及 2030 年預測(百萬美元)
北美生物分析測試服務市場細分
北美生物分析測試服務市場根據測試類型、疾病適應症、最終用戶和國家進行細分。
根據測試類型,北美生物分析測試服務市場分為藥物動力學、生物標記、免疫原性、病毒學測試、基於細胞的測定等。 2022 年,基於細胞的檢測領域佔據最大的市場佔有率。
根據疾病適應症,北美生物分析測試服務市場分為心血管、神經系統疾病、代謝失調、呼吸系統疾病、自體免疫疾病、腫瘤、性健康、骨骼疾病等。 2022 年,腫瘤學領域佔據最大的市場。
根據最終用戶,北美生物分析測試服務市場分為製藥和生物製藥公司、合約研究組織(CRO)、合約開發和製造組織(CDMO)等。 2022 年,製藥和生物製藥公司領域佔據最大的市場佔有率。
按國家/地區分類,北美生物分析測試服務市場分為美國、加拿大和墨西哥。 2022年,美國在北美生物分析測試服務市場佔有率中佔據主導地位。
SGS SA、康龍化成北京有限公司、Element Materials Technology Group Ltd、CD BioSciences Inc、Charles River Laboratories International Inc、Eurofins Scientific SE、Labcorp Drug Development Inc、Syneos Health Inc、KCAS Bioanalytical and Biomarker Services LLC、ICON Plc 和Intertek Group Plc 是北美生物分析測試服務市場上的一些領先公司。
表中的內容
The North America bioanalytical testing services market was valued at US$ 1,798.03 million in 2022 and is expected to reach US$ 3,971.42 million by 2030; it is estimated to grow at a CAGR of 10.4% from 2022 to 2030.
Increasing Outsourcing of R&D Activities by Pharmaceutical Companies fuel the North America Bioanalytical Testing Services Market
Pharmaceutical companies outsource research & development activities that are not core to their internal structure. Outsourcing miscellaneous activities allows them to efficiently focus on their internal core competencies for making the drug development process better and more cost effective. Moreover, outsourcing manufacturing activities, along with R&D, benefits them by lowering the turnaround period, adding to their expertise, and eliminating the need for large capital investments. According to the Survey of Biopharmaceutical Manufacturing Capacity and Production by BioPlan Associates, analytical testing/bioassay was the most outsourced service in 2022, followed by toxicity testing, validation services, product characterization, and others. While developing nations are the largest contributors to the demand for bioanalytical testing services through contract manufacturing, the US remains a potential outsourcing destination. 39.6% of non-US respondents in the survey preferred outsourcing to US-based facilities. Thus, the practice of outsourcing is gaining popularity worldwide, especially in developing countries, thereby favoring the growth of the bioanalytical testing services market. Pharmaceutical businesses are widely implementing the quality-by-design (QbD) concept, which is further propelling the adoption of outsourcing services by pharmaceutical companies to increase the robustness of their production processes and ensure optimal product quality and manufacturing productivity. QbD is supported by regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The concept has gained traction in the pharmaceutical industry over the years with the publication of ICH Q9 (Quality Risk Management), ICH Q8 (R2, Pharmaceutical Development), and ICH Q10 (Pharmaceutical Quality System). According to the ICH Q10 guidelines, analytical methods are essential to the pharmaceutical quality system. Analytical QbD (AQbD) implementation in manufacturing ensures product quality and performance. Outsourcing bioanalytical testing services helps pharmaceutical businesses reduce business risks by avoiding major investments in analytical equipment and skilled professionals, especially while the product is in the early phase of development. Due to the availability of specialized analytical testing service providers with crucial competencies to quickly provide excellent results, pharmaceutical companies are increasingly considering outsourcing bioanalytical testing services to third-party service providers, which fuels the market growth.
North America Bioanalytical Testing Services Market Overview
North America holds the largest share of the bioanalytical testing services market, with the US, Canada, and Mexico being the major contributors to the market growth in this region. The uninterrupted growth of the pharmaceuticals industry, the increasing need for developing novel drugs due to an upsurge in the incidences of various diseases, rising healthcare expenditure by governments, and a growing preference for outsourcing activities for the quality assurance of pharmaceutical products are the factors favoring the growth of the bioanalytical testing services market in North America.
North America Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Million)
North America Bioanalytical Testing Services Market Segmentation
The North America bioanalytical testing services market is segmented based on test type, disease indication, end user, and country.
Based on test type, the North America bioanalytical testing services market is segmented into pharmacokinetics, biomarkers, immunogenicity, virology testing, cell-based assays, and others. The cell-based assays segment held the largest market share in 2022.
Based on disease indication, the North America bioanalytical testing services market is segmented into cardiovascular, neurological disorders, metabolic disorders, respiratory diseases, autoimmune disorder, oncology, sexual health, bone disease, and others. The oncology segment held the largest market share in 2022.
Based on end user, the North America bioanalytical testing services market is segmented into pharmaceutical and biopharmaceutical companies, contract research organization (CRO), contract development and manufacturing organization (CDMO), and others. The pharmaceutical and biopharmaceutical companies segment held the largest market share in 2022.
Based on country, the North America bioanalytical testing services market is segmented into the US, Canada, and Mexico. The US dominated the North America bioanalytical testing services market share in 2022.
SGS SA, Pharmaron Beijing Co Ltd, Element Materials Technology Group Ltd, CD BioSciences Inc, Charles River Laboratories International Inc, Eurofins Scientific SE, Labcorp Drug Development Inc, Syneos Health Inc, KCAS Bioanalytical and Biomarker Services LLC, ICON Plc, and Intertek Group Plc are some of the leading companies operating in the North America bioanalytical testing services market.
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