首頁 > 市場調查報告書 > 製藥

藥物開發臨床實驗開發業務受託機關

市場調查報告書

商品編碼

1618418

全球臨床前 CRO 市場規模：按服務、按應用、按最終用戶、按地區、範圍和預測

Global Preclinical CRO Market Size By Service, By Application, By End User, By Geographic Scope And Forecast

出版日期: 2024年10月29日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

臨床前CRO市場規模及預測

2023年臨床前CRO市場規模為54.4億美元，預計2024年至2031年複合年增長率為8.03%，到2031年達到101億美元。臨床前合約組織 (CRO) 是製藥和生物技術研究領域的專業服務提供商，他們在將新藥物和治療方法投入人體臨床試驗之前對其進行研究和試驗。臨床前 CRO 在藥物開發的早期階段發揮關鍵作用，專注於非人體測試以確定新化合物的安全性、有效性和潛在毒性。這些組織提供各種服務，包括體外和體內測試、藥物動力學和毒理學研究。

此外，將臨床前研究外包給 CRO 的製藥和生技公司提供的服務包括：

臨床前 CRO 市場動態

塑造臨床前 CRO 市場的關鍵市場動態

主要市場驅動因子

藥物開發的複雜性：

藥物開發的複雜性日益增加：為了更好地瞭解複雜的疾病和治療靶點，製藥業正在專注於專業的臨床前研究服務。因此，臨床前 CRO 擁有先進的設備和專業團隊，在解決藥物開發的複雜性和提供加速早期研究的新穎解決方案方面發揮關鍵作用。因此，藥物開發日益複雜已成為推動臨床前CRO市場擴張的關鍵因素。

外包效率：

製藥和生物技術公司越來越多地使用 CRO（合約研究組織）來簡化藥物開發流程。這種策略性外包使這些公司能夠專注於自己的核心優勢，同時利用臨床前 CRO 的獨特技能和成本效率。這種外包趨勢表明，產業正在認識到 CRO 帶來的價值，從而實現更有效率的資源配置和更快的周轉。

調查工具的技術進步：

研究方法的不斷發展，以及影像技術和分子生物學工具的進步，正在增強臨床前 CRO 的能力，並推動臨床前 CRO 市場的成長。尖端技術的使用使這些公司能夠進行更準確、更有效率的臨床前測試並改善藥物開發流程。因此，研究儀器的技術發展是決定臨床前 CRO 格局的關鍵因素。

主要挑戰

漫長的監管審批時間表：

監管審批所需的額外時間阻礙了尋求快速進入臨床前階段的公司。批准延遲會減慢開發過程，增加製藥公司的成本和不確定性，並嚴重限製藥物開發時間表。

資料安全與保密問題：

臨床前研究資料的敏感性是一個主要阻礙因素，因為對資料安全和保密性的擔憂阻礙了公司外包藥物開發的關鍵階段。智慧財產權盜竊和未經授權存取敏感資訊的威脅是臨床前 CRO 市場的主要障礙。

能力和資源有限：

無法滿足製藥業對臨床前 CRO 服務不斷增長的資源需求，預計將阻礙臨床前 CRO 服務的採用。可用性限制和延遲也對製藥業務產生重大影響。此外，某些專業 CRO 的稀缺性限制了合作機會，特別是在需要獨特的專業知識時。

主要趨勢

擴大治療範圍：

治療領域的擴大可能會大幅增加對臨床前CRO服務的需求。臨床前 CRO 正在將其專業知識擴展到癌症等傳統重點領域之外，擴展到神經病學和不太常見的疾病，這是一個主要的市場趨勢。此外，臨床前 CRO 正在適應不同的治療領域並提高其專業化程度，加強其作為整體藥物開發策略中策略合作夥伴的角色。

生物標記開發：

對生物標記開發的重視是一種變革趨勢，它響應了人們對個人化患者治療反應的日益認識。臨床前 CRO 處於這場革命的最前沿，積極致力於識別和驗證生物標記。這項策略策略能夠實現更有針對性的藥物研究，並將這些企業定位為未來個人化醫療保健的重要參與者，從而對臨床前 CRO 產生更高的需求。

臨床前 CRO 市場的區域分析

臨床前 CRO 市場的詳細區域分析如下：

北美

根據經過驗證的市場研究，亞太地區預計將在預測期內主導臨床前 CRO 市場。製藥公司專注於藥物和治療的開發以及遵守嚴格監管結構的臨床前 CRO 服務的實施，從而在北美實現了廣泛的臨床前應用。

該地區嚴格的藥物開發法規對臨床前 CRO 服務產生了巨大的需求。這些服務對於確保遵守嚴格的監管標準、展示對患者安全的奉獻精神以及保持藥物研究的最高功效至關重要。嚴格的監管框架使北美成為臨床前研究的重要中心，吸引了尋求監管和透明的藥物開發方法的公司。

此外，眾多製藥和生物技術公司的存在也有助於該地區的臨床前研究優勢。這些行業參與者的接近創造了一個動態的生態系統，其中臨床前研究活動集中。這種集聚效應促進了製藥公司與已建立的臨床前 CRO 之間的互動。

歐洲

歐洲的臨床前 CRO 市場處於藥物發現和治療領域創新的前沿，從而推動了藥物研究的進步。由於生物技術產業的蓬勃發展、積極的政府舉措以及臨床前 CRO 市場不斷增長的外包趨勢，歐洲已成為決定臨床前研究軌蹟的關鍵參與者。

該地區對新藥和生物製藥的日益關注正在推動對臨床前專業服務的需求。隨著歐洲公司專注於尖端生物技術的進步，對全面的臨床前研究的需求不斷增加。因此，歐洲的治療方法有望取得進展。

此外，製藥公司對臨床前CRO外包的需求不斷增長，為開拓歐洲市場創造了機會。歐洲製藥公司認識到藥物開發早期階段專業知識和成本效益的好處，越來越多地與臨床前 CRO 合作。這項策略性舉措使公司能夠專注於核心能力並簡化運營，同時利用 CRO 提供的專業服務。

亞太地區

預計在預測期內，亞太地區的臨床前 CRO 市場複合年增長率最高。由於慢性病的高盛行率，亞太地區的臨床前CRO市場正在迅速擴大，促使對高效治療和生物製藥的需求激增。除此之外，隨著生物製藥公司的發展，醫療保健支出不斷增加，吸引了多樣化的患者群體，擴大了臨床前CRO服務的採用範圍。

亞太地區的醫療保健支出大幅增加，尤其是在中國和印度等人口大國。這種投資的增加正在推動製藥和生物技術行業的崛起。隨著這些產業在該地區的擴張，對臨床前 CRO 服務的需求也不斷增加。

此外，亞太國家多樣化的種族和人口結構為臨床前研究提供了寶貴的資源。與該地區臨床前 CRO 合作的製藥公司受益於測試跨種族藥物反應的能力，從而更深入地瞭解新候選藥物的功效和安全性。因此，亞太地區因其多樣化的患者群體而成為擴大臨床前 CRO 市場的沃土，並可能影響全球藥物開發方法。

Preclinical CRO Market size was valued at USD 5.44 Billion in 2023 and is projected to reach USD 10.1 Billion by 2031, growing at a CAGR of 8.03% from 2024 to 2031. A preclinical Contract Research Organization (CRO) is a specialist service provider in pharmaceutical and biotechnological research that conducts investigations and experiments before moving a new medicine or medical treatment into human clinical trials. Preclinical CROs serve an important role in the early stages of drug development, focusing on non-human testing to determine the safety, effectiveness, and possible toxicity of novel compounds. These organizations offer a variety of services, including in vitro and in vivo testing, pharmacokinetics, and toxicological research.

Furthermore, pharmaceutical and biotech companies that outsource preclinical research to CROs

Preclinical CRO Market Dynamics

The key market dynamics that are shaping the Preclinical CRO Market include:

Key Market Drivers

Increasing Complexity in Drug Development:

To gain a better understanding of complex diseases and treatment targets, the pharmaceutical industries are focusing on specialized preclinical research services. Thus, preclinical CROs, equipped with advanced equipment and professional teams, play a critical role in resolving the complexity of drug development, providing novel solutions to speed up the early stages of research. As a result, the increasing complexity of drug development is a significant driver fueling the expansion of the Preclinical CRO Market.

Outsourcing Efficiency:

Pharmaceutical and biotech companies are increasingly using contract research organizations (CROs) to streamline the drug development process. This strategic outsourcing enables these businesses to focus on their core strengths while taking advantage of preclinical CROs' specific skills and cost-effectiveness. This inclination toward outsourcing demonstrates the industry's recognition of the value that CROs bring to the table, allowing for more efficient resource allocation and faster turnaround.

Technological Advancements in Research Tools:

The constant evolution of research methodology, together with advances in imaging techniques and molecular biology tools is enhancing the capabilities of preclinical CROs, propelling the growth of the Preclinical CRO Market. The use of cutting-edge technologies enables these firms to undertake more precise and efficient preclinical examinations to improve their drug development processes. Thus, technological developments in research instruments are an important factor defining the preclinical CRO landscape.

Key Challenges

Long Regulatory Approval Timelines:

The additional period required for regulatory clearance hampers companies looking to move fast through the preclinical phase. Delays in approvals delay the development process and also increase pharmaceutical companies' costs and uncertainties, posing a significant constraint on the total drug development timetable.

Data Security and Confidentiality Issues:

The delicate nature of preclinical research data creates a significant constraint as concerns regarding data security and confidentiality discourage corporations from outsourcing vital stages of drug development. This threat of intellectual property theft or illegal access to confidential information poses a significant impediment in the Preclinical CRO Market.

Limited Capacity and Resources:

The inability to meet the rising demand for resources for preclinical CRO services in the pharmaceutical industry is projected to inhibit the adoption of preclinical CRO services. Also, the limited availability or delays further have a huge impact on the pharmaceutical businesses. Furthermore, the scarcity of certain specialized CROs limits collaboration opportunities, particularly when unique expertise is required.

Key Trends

Expansion of Therapeutic Areas:

The growth of therapeutic domains is likely to surge the demand for preclinical CRO services. Preclinical CROs are expanding their expertise beyond conventional emphasis areas like cancer and into neurology and uncommon disorders representing a significant trend in the market. Also, preclinical CROs' ability to adapt to and increase their expertise in a variety of therapeutic areas strengthens their role as strategic partners in overall drug development strategy.

Biomarker Development:

The emphasis on biomarker development is a transformative trend that corresponds to the growing awareness of personalized patient responses to therapies. Preclinical CROs are at the vanguard of this revolution, actively identifying and validating biomarkers. This strategic strategy allows for more targeted and successful medication research and also places these businesses as essential actors in the future of customized healthcare, creating higher demand for preclinical CRO.

What's inside a VMR industry report?

Our reports include actionable data and forward-looking analysis that help you craft pitches, create business plans, build presentations and write proposals.

Preclinical CRO Market Regional Analysis

Here is a more detailed regional analysis of the Preclinical CRO Market:

North America

According to Verified Market Research, Asia Pacific is estimated to dominate in Preclinical CRO Market over the forecast period. The focus of pharmaceutical companies on developing drugs, treatments, and implementing preclinical CRO services compliant with strict regulatory structure is enabling in creating vast application of preclinical in North America..

The region is experiencing significant demand for preclinical CRO services due to the strict regulations governing drug development. These services are critical in guaranteeing compliance with stringent regulatory standards, demonstrating dedication to patient safety and maintaining the highest levels of efficacy in pharmaceutical research. The tight regulatory framework distinguishes North America as a prominent hub for preclinical research, attracting companies seeking a regulatory-compliant and transparent approach for drug development.

Furthermore, the concentration of a large number of pharmaceutical and biotech companies contributes to the region's preclinical research dominance. The proximity of these industry participants has resulted in a dynamic ecosystem, with a high concentration of preclinical research activity. This clustering effect allows for easy interactions between pharmaceutical corporations and established preclinical CROs.

Europe

Europe's Preclinical CRO Market is at the forefront of generating innovation in the field of drug discovery and treatment, thereby leading to the progression of pharmaceutical research. Europe has emerged as an important player in defining the trajectory of preclinical research, owing to a thriving biotechnology sector, favorable government efforts, and an expanding tendency of outsourcing in the Preclinical CRO Market.

The region's increased focus on novel medicines and biopharmaceuticals has increased demand for specialist preclinical services. As European corporations focus more on cutting-edge biotechnological advancements, the need for comprehensive preclinical research grows. This is likely to result in the advancements of therapeutics in Europe.

Furthermore, the growing demand for outsourcing of preclinical CRO in pharmaceutical companies is creating development opportunities for the market in Europe. Recognizing the benefits of specialized expertise and cost-effectiveness in the early stages of drug development, European pharmaceutical companies are actively collaborating with preclinical CROs. This strategic move enables businesses to streamline their operations, focusing on core capabilities while leveraging the specialized services provided by CRO.

Asia Pacific

Asia Pacific is estimated to grow at the highest CAGR in the Preclinical CRO Market during the forecast period. The Preclinical CRO Market in Asia Pacific is expanding rapidly owing to the high prevalence of chronic illnesses, which is surging the demand for efficient treatment and biopharmaceuticals. In addition to this, the increasing healthcare spending along with the development of biopharmaceutical companies is attracting diverse patient population, creating a wider scope of adoption for the preclinical CRO services.

Healthcare expenditure in Asia-Pacific is increasing significantly, particularly in populous countries like China and India. This increasing investment has fueled the rise of the pharmaceutical and biotech industries. This demand for preclinical CRO services increases in parallel with the expansion of these sectors in this region.

Furthermore, the diverse ethnicities and demographics that exist in Asia Pacific countries provide an invaluable resource for preclinical research. Pharmaceutical companies that work with preclinical CROs in this region benefit from the capacity to test medication reactions across ethnicities, resulting in a more thorough understanding of a drug candidate's efficacy and safety profile. Because of the diversity of patient populations, Thus, Asia Pacific is turning into a fertile ground for the expansion of the Preclinical CRO Market that is likely to influence worldwide drug development methods.

Global Preclinical CRO Market Segmentation Analysis

The Global Preclinical CRO Market is segmented on the basis of Service, Application, End-User, And Geography.

Preclinical CRO Market, By Service

Bioanalysis and Drug Metabolism and Pharmacokinetics (DMPK) Studies
Toxicology Testing

Based on Service, the market is segmented into Bioanalysis & DMPK Studies and Toxicology Testing. The Toxicology Testing segment is estimated to dominate the Preclinical CRO Market due to its critical role in assessing the safety and potential toxicity of new drug candidates. Toxicology testing is an essential part of the preclinical review process, providing critical information on the negative effects a substance may have on biological systems. As regulatory authorities prioritize comprehensive safety assessments before clinical trials, pharmaceutical and biotech businesses are increasingly relying on CROs for specialist toxicology testing services. These services cover a wide range of investigations, including acute, sub-chronic, and chronic toxicity assessments, as well as reproductive and developmental toxicology research. The importance of toxicological testing reflects its critical role in guaranteeing the overall safety profile of drug candidates, reducing risks and increasing the possibility of achieving regulatory approval in later clinical phases.

Preclinical CRO Market, By Application

Oncology
Central Nervous System (CNS) Disorders
Cardiovascular Diseases
Immunological Disorders
Respiratory Diseases
Infectious Diseases
Diabetes
Others

Based on Application, the market is segmented into Oncology, Central Nervous System (CNS) Disorders, Cardiovascular Diseases, Immunological Disorders, Respiratory Diseases, Infectious Diseases, Diabetes, and Others. The Oncology segment is estimated to dominate the Preclinical CRO Market. Oncology has seen an increase in demand for preclinical CRO services because of the complexities and obstacles of finding effective cancer medicines is increasing the application of preclinical CRO in oncology.

Preclinical CROs that specialize in oncology conduct critical research such as efficacy assessments, toxicity evaluations, and biomarker discovery to help create innovative and tailored medicines. The complexities of cancer biology require specialized expertise, cutting-edge technologies, and a thorough understanding of regulatory regulations, all of which is likely to be provided by preclinical CROs. Their ability to manage the complexities of oncology research, combined with the rising worldwide cancer incidence and the ongoing hunt for novel treatments, positions the oncology application segment as the primary driver driving the growth and significance of the entire Preclinical CRO Market.

Preclinical CRO Market, By End-User

Pharmaceutical and Biopharmaceutical Industries
Medical Device Companies
Academic Institutes

Based on End-User, the market is segmented into Pharmaceutical & Biopharmaceutical Industries, Medical Device Companies, and Academic Institutes. The pharmaceutical and biopharmaceutical industries end-user segment is estimated to dominate the market over the forecast period. Pharmaceutical and biopharmaceutical companies are depending more and more on the specialized services provided by preclinical CROs to help them negotiate the challenging early stages of drug development as the market for innovative and focused therapeutics grows. These sectors necessitate extensive preclinical testing, including efficacy, safety, and toxicity investigations, to guarantee that new drug candidates meet tight regulatory requirements. Outsourcing preclinical research efforts to CROs enables pharmaceutical and biopharmaceutical companies to benefit from external knowledge, cutting-edge technologies, and cost-effective solutions, accelerating the drug development process.

Key Players

The "Global Preclinical CRO Market" study report will provide valuable insight with an emphasis on the global market including some of the major players such as
Charles River Laboratories, Syneos Health, WuXi AppTec, Eurofins Scientific, Envigo, Covance, Parexel, Labcorp Drug Development, Emmes Corporation, Albany Molecular Research Inc., Aptuit LLC, Bio-Bridge Laboratories Inc., Stelis Biopharma, ToxStrategies Inc., Epredia, Marshall BioResources, Taconic Biosciences, Xenotech and Evotec.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Key Developments

In January 2024, WuXi AppTec, a renowned Chinese CRO, collaborated with Personalis, a genomics data business, to develop AI-powered drug discovery solutions. The collaboration hopes to use Personalis' AI technology to scan massive amounts of genomic data and find new therapeutic targets.
In January 2024, Charles River Laboratories, a global leader in preclinical CRO services, announced an expansion of its bioanalytical capabilities in Europe. The company bought a bioanalytical laboratory in the United Kingdom, expanding its drug development support services.
In January 2024, Syneos Health, a well-known clinical CRO, partnered with Huma Therapeutics, a digital health business, to create digital biomarkers for Parkinson's disease. This cooperation intends to use wearable technologies and artificial intelligence to monitor illness development and improve clinical trial design.
In January 2024, Eurofins Scientific, a prominent provider of analytical testing services, acquired Bio-Alternatives, a preclinical drug discovery CRO. This acquisition broadens Eurofins' expertise in fields such as in vitro toxicity and ADME investigations.

1 INTRODUCTION OF GLOBAL PRECLINICAL CRO MARKET

1.1 Overview of the Market
1.2 Scope of Report
1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4 GLOBAL PRECLINICAL CRO MARKET OUTLOOK

4.1 Overview
4.2 Market Dynamics
- 4.2.1 Drivers
- 4.2.2 Restraints
- 4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis

5 GLOBAL PRECLINICAL CRO MARKET, BY SERVICE

5.1 Overview
5.2 Bioanalysis and Drug Metabolism and Pharmacokinetics (DMPK) Studies
5.3 Toxicology Testing

6 GLOBAL PRECLINICAL CRO MARKET, BY END-USER

6.1 Overview
6.2 Pharmaceutical and Biopharmaceutical Industries
6.3 Medical Device Companies
6.4 Academic Institutes

7 GLOBAL PRECLINICAL CRO MARKET, BY APPLICATION

7.1 Overview
7.2 Oncology
7.3 Central Nervous System (CNS) Disorders
7.4 Cardiovascular Diseases
7.5 Immunological Disorders
7.6 Respiratory Diseases
7.7 Infectious Diseases
7.8 Diabetes
7.9 Others

8 GLOBAL PRECLINICAL CRO MARKET, BY GEOGRAPHY

8.1 Overview
8.2 North America
- 8.2.1 U.S.
- 8.2.2 Canada
- 8.2.3 Mexico
8.3 Europe
- 8.3.1 Germany
- 8.3.2 U.K.
- 8.3.3 France
- 8.3.4 Rest of Europe
8.4 Asia Pacific
- 8.4.1 China
- 8.4.2 Japan
- 8.4.3 India
- 8.4.4 Rest of Asia Pacific
8.5 Rest of the World
- 8.5.1 Latin America
- 8.5.2 Middle East & Africa

9 GLOBAL PRECLINICAL CRO MARKET COMPETITIVE LANDSCAPE

9.1 Overview
9.2 Company Market Ranking
9.3 Key Development Strategies

10 COMPANY PROFILES

10.1 Charles River Laboratories
- 10.1.1 Overview
- 10.1.2 Financial Performance
- 10.1.3 Product Outlook
- 10.1.4 Key Developments
10.2 Syneos Health
- 10.2.1 Overview
- 10.2.2 Financial Performance
- 10.2.3 Product Outlook
- 10.2.4 Key Developments
10.3 WuXi AppTec
- 10.3.1 Overview
- 10.3.2 Financial Performance
- 10.3.3 Product Outlook
- 10.3.4 Key Developments
10.4 Eurofins Scientific
- 10.4.1 Overview
- 10.4.2 Financial Performance
- 10.4.3 Product Outlook
- 10.4.4 Key Developments
10.5 Envigo
- 10.5.1 Overview
- 10.5.2 Financial Performance
- 10.5.3 Product Outlook
- 10.5.4 Key Developments
10.6 Covance
- 10.6.1 Overview
- 10.6.2 Financial Performance
- 10.6.3 Product Outlook
- 10.6.4 Key Developments
10.7 Parexel
- 10.7.1 Overview
- 10.7.2 Financial Performance
- 10.7.3 Product Outlook
- 10.7.4 Key Developments
10.8 Labcorp Drug Development
- 10.8.1 Overview
- 10.8.2 Financial Performance
- 10.8.3 Product Outlook
- 10.8.4 Key Developments
10.9 Emmes Corporation
- 10.9.1 Overview
- 10.9.2 Financial Performance
- 10.9.3 Product Outlook
- 10.9.4 Key Developments