市場調查報告書
商品編碼
1372028
到 2030 年的生物分析測試服務市場預測:按類型、分子、工作流程、治療、最終用戶和地區進行的全球分析Bioanalytical Testing Services Market Forecasts to 2030 - Global Analysis By Type, Molecule, Workflow, Therapeutic, End User and By Geography |
根據 Stratistics MRC 的數據,全球生物分析測試服務市場預計在預測期內將以 12.2% 的年複合成長率成長。
生物分析測試是用來測試生物和生物技術產品的分析過程的術語。分析程序在生物技術和藥品生產中至關重要。藥物研發、開發和商業化都涉及生物分析評估的使用。生物分析測試服務部門是更大的生命科學和醫療保健部門的一個子集,該部門使用組織、血液、尿液和其他體液來收集法規遵循、臨床診斷和研究的關鍵資料。生物樣本,例如。它對許多行業至關重要,包括生物技術、製藥、環境監測、食品安全和臨床研究。
印度製藥協會(IPA)的報告顯示,印度製藥業正以7-8%的成長率成長,預計2030年年度將達到80-900億美元。
製藥公司擴大利用品質源於設計 (QbD) 的概念,該概念已被 EMA 和美國FDA 等法規機構廣泛接受,以提高產品品質、製造流程的穩健性和工廠生產力。看起來像這樣。隨著ICH Q8(R2)(藥物開發)、ICH Q9(品質風險管理)和ICH Q10(藥品品質系統)的發布,製藥業的QbD方法與時俱進。未來年度,全球製藥和生物製藥企業擴大接受和使用 QbD 方法,預計將為全球市場的擴張做出重大貢獻。
生物分析測試服務市場受到高營運成本的嚴重限制。這些成本是僱用高技能員工、維護最先進的分析設備和實施嚴格的品管程序所必需的。生物分析所需的昂貴設備的購買和維護成本通常很高。此外,由於需要化學、生物學和資料處理等領域的專業人員,導致人事費用高。較小的公司尤其發現很難透過提供生物分析測試服務來擴張和獲利,並且需要持續投資以保持競爭力並遵守行業標準和立法。這可能會成為。
改進創新方法的先進、靈活平台的出現正在影響生物分析測試服務的成長。生物分析領域最近取得了進步,因為該領域的新方法可以解決所有可能的問題。這些因素預計將推動生物分析測試服務產業的整體成長。重要市場引進了乾血斑法等尖端最尖端科技來檢測藥物動力學。乾血斑法具有許多重要的優點,包括需要少量的處理樣本、易於樣本儲存、減少生物危害問題以及無需採集後處理。因此,先進技術的出現預計將簡化定量過程,從而增加預測期內生物分析測試服務的市場成長。
生物分析測試服務市場面臨客戶依賴的嚴峻挑戰。如果服務公司過度依賴某些關鍵客戶群,它們可能會在財務上變得脆弱。然而,隨著主要客戶遷移到其他提供者或降低其測試要求,可能會出現嚴重的收益短缺。為了降低這些風險,至關重要的是使您的客戶群多樣化並透過卓越的客戶服務和附加價值服務來維持牢固的客戶關係。透過客戶群多元化,公司可以減少單一客戶的潛在損失,並確保在競爭激烈的生物分析測試市場中實現更穩定和永續的成長。
COVID-19 的傳播減少了工業部門的產出,並對多家全球企業產生了重大影響,導致對有效疫苗、治療方法和其他醫療服務的需求增加。因此,疫情期間生物分析檢測服務市場呈現需求成長。醫療保健提供者依靠即時護理服務和篩檢技術來進行早期病毒診斷。此外,操作員還引入了減少處理時間的尖端方法和技術。基本技術包括自動化樣品製備、高效液相層析和質譜。機器人和條碼系統等先進技術在疫情期間已被證明是有效的。
樣品製備部分估計佔最大佔有率。分析過程中一個重要的步驟是樣品製備,這是生物分析測試服務市場的一個新興領域。在測試或分析之前,必須仔細、有條理地製備生物樣品。此外,樣品製備技術包括樣品萃取、精製、濃縮,有時還包括變性。該元素對於提高分析技術的靈敏度、特異性和精確度以及實現少量目標化合物的檢測和定量至關重要。
預計病毒檢測產業在預測期內將出現良好成長。生物樣本中病毒的分析和檢測是該市場病毒學檢測的主要焦點。對於臨床研究、藥物開發和公共衛生至關重要。由於新的病毒性疾病和流行病帶來的持續危險,對病毒檢測服務的需求正在增加。本部分對於感染疾病控制和預防至關重要,因為使用多種技術來診斷和測試病毒感染,包括 PCR、血清學和次世代定序。
由於該地區可用的設施以及美國大型大型製藥企業對研發的投資不斷增加,北美在預測期內獲得了最大的市場佔有率。此外,製藥公司正在努力開發新藥,目前有超過 1,100 種癌症治療藥物處於不同的臨床開發階段。由於輝瑞等主要市場參與者的存在,生物分析測試服務業務正在北美範圍內擴展。
預計亞太地區在預測期內將實現獲利成長。在亞太地區提供生物分析測試服務的組織投資不斷增加、採用這些服務的公司數量不斷增加、企業和法規改革是推動亞太市場的其他因素。專注於建造生技藥品管道的中國和印度小公司以及提供生物分析測試服務的公司擴大採用最尖端科技,例如一次性技術,正在推動市場發展。
According to Stratistics MRC, the Global Bioanalytical Testing Services Market is accounted for $5207.3 million in 2023 and is expected to reach $116.38 million by 2030 growing at a CAGR of 12.2% during the forecast period. Bioanalytical testing is the term for the analytical process used to examine biological and biotechnological products. In the production of biotechnology and pharmaceuticals, analytical procedures are essential. Drug discovery, development, and commercialization all involve the use of bio analytical evaluation. The bio analytical testing services sector is a subset of the larger life sciences and healthcare sectors that focuses on the examination and testing of biological samples, such as tissues, blood, urine, and other bodily fluids, in order to gather important data for regulatory compliance, clinical diagnosis, and research. It is crucial to many industries, including biotechnology, medicines, environmental monitoring, food safety, and clinical research.
According to a report from the Indian Pharmaceutical Alliance (IPA), the Indian pharmaceutical industry was growing at a rate of 7-8% and is estimated to register USD 80-90 billion in annual revenue by 2030.
Pharmaceutical companies are increasingly using the Quality-by-Design (QbD) concept, which has been widely embraced by regulatory bodies like the EMA and US FDA, to improve the quality of their products, the robustness of their manufacturing processes, and the productivity of their factories. With the release of ICH Q8 (R2) (pharmaceutical development), ICH Q9 (quality risk management), and ICH Q10 (pharmaceutical quality system), the QbD method in the pharmaceutical business has evolved throughout time. In the upcoming years, it is anticipated that the growing acceptance and use of the QbD approach among pharmaceutical and biopharmaceutical operations around the world will significantly contribute to the expansion of the global market.
The market for bio analytical testing services is significantly constrained by high operational costs. These costs are required in order to hire highly skilled employees, maintain cutting-edge analytical equipment, and implement strict quality control procedures. The pricey equipment needed for bio analysis is frequently expensive to buy and keep up. Furthermore, high labour expenses are a result of the demand for specialised talent in sectors like chemistry, biology, and data processing. Smaller companies in particular may find it challenging to scale their businesses and make a profit from offering bio analytical testing services, and they may need to make continual investments to stay competitive and comply with industry standards and laws.
The emergence of sophisticated and flexible platforms that improve innovative methods has had an impact on the growth of bio analytical testing services. The discipline of bio analysis has advanced recently since new approaches in the sector are capable of handling any issues that can arise. These elements are anticipated to boost the industry's overall growth for bio analytical testing services. Prominent markets are implementing cutting-edge technologies, like dry blood spot technology, to measure pharmacokinetics because it has more benefits than other traditional methods. The dry blood spot method has a number of important advantages, including the need for a small processing sample, easy sample storage, reduced biohazard concerns, the lack of post-collection processing, and many more. Therefore, the presence of advanced technologies is simplifying the quantification process and thereby expected to increase the bio analytical testing services market growth during the forecast period.
The market for bio analytical testing services faces a serious challenge from client dependence. Services companies may be financially vulnerable if they rely excessively on a select group of important customers. However, a significant revenue shortfall could come from a key client shifting to another provider or reducing their testing requirements. It is crucial to reducing this danger to diversify the client base and retain solid client relationships through outstanding customer service and value-added services. By diversifying their clientele, businesses can reduce their exposure to the potential loss of a single customer and assure steadier, sustainable growth in the competitive bio analytical testing market.
The spread of COVID-19 has reduced the output of the industrial sectors, and as a result of its significant impact on several worldwide operations, there has been a rise in demand for effective vaccines, treatments, and other medical services. As a result, the market for bio analytical testing services saw an increase in demand during the epidemic. Healthcare providers relied on point of care services and screening techniques for early viral diagnosis in people. Additionally, the businesses have introduced cutting-edge methodologies and technology that have reduced processing time. The essential techniques include automated sample preparation, ultra-performance liquid chromatography, mass spectrometry, and others. Such advanced technologies as robotics and barcode systems have proved efficient during the pandemic.
The sample preparation segment is estimated to hold the largest share. An essential step in the analysis process is sample preparation, which is an emerging area in the bio analytical testing services market. Before being tested or analysed, biological samples must be carefully and methodically prepared. Moreover, techniques for sample preparation include sample extraction, purification, concentration, and occasionally alteration. This component is essential for improving the sensitivity, specificity, and accuracy of analytical techniques and allowing the detection and quantification of small amounts of target compounds.
The virology testing segment is anticipated to have lucrative growth during the forecast period. The analysis and detection of viruses in biological samples is the primary focus of the virology testing component of the market. It is essential to clinical research, pharmaceutical development, and public health. The need for virology testing services has grown due to the persistent hazards posed by new viral illnesses and pandemics. This section is crucial for the management and prevention of infectious diseases because it uses a variety of techniques to diagnose and examine viral infections, including PCR, serology, and next-generation sequencing.
North America commanded the largest market share during the extrapolated period due to the facilities available across the region and increasing investment for the R&D from US pharmaceutical titans. Additionally, pharmaceuticals are working very hard to create new medicines and they have developed over 1100 oncology treatments that are in various phases of clinical development. The business for bio analytical testing services is expanding across North America because of the presence of major market players like Pfizer.
Asia Pacific is expected to witness profitable growth over the projection period. A rise in investments made by organisations offering bio analytical testing services in the region, an increase in the number of companies adopting these services, and corporate and regulatory reforms are other factors driving the market in Asia Pacific. Small enterprises in China and India that are focused on building biologics pipelines, as well as an increase in the pace of adoption of cutting-edge technologies, like single-use technologies, by businesses that provide bio analytical testing services, have boosted the market.
Some of the key players in the Bioanalytical Testing Services Market include: Syneos Health, Intertek Group, Med pace, PPD, Inc., Euro fins Scientific, Laboratory Corporation of America, Pace Analytical Services, ICON plc, PRA Health Sciences , Charles River Laboratories International, Inc., WuXi App Tec, SGS SA Toxikon, Inc., IQVIA, Pharmaceutical Product Development, Frontage Labs, Covance Inc., Alta sciences, BioAgilytix Labs, Vipragen Biosciences and Bio needs India Private Limited.
In June 2023, ICON plc, one of the world leaders in CRO and healthcare intelligence, announced the release of its new ICON Digital Platform. The platform facilitates seamless integration of ICON site, patient, site, and sponsor services along with harmonized and customizable data delivery.
In June 2023, Syneos Health, one of the leading companies in biopharmaceutical solutions, announced a patient-centric partnership with uMotif, a clinical trial solutions organization. The collaboration is aimed at aiding the acceleration of clinical trials and introducing new therapies to patients via an end-to-end and more effective digital platform. This platform comprises robust Electronic Patient-reported Outcomes (ePRO) and Electronic Clinical Outcome Assessment (eCOA) capabilities
In May 2023, IQVIA a significant provider of advanced analytics, clinical research services, and technology solutions in the world, announced a strategic partnership RED, to battle against AIDS and the injustices that permit pandemics to thrive. This partnership supports laboratory system strengthening.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.