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市場調査レポート
商品コード
1378981
前臨床CRO市場:世界の産業動向、シェア、規模、成長、機会、2023-2028年予測Preclinical CRO Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028 |
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前臨床CRO市場:世界の産業動向、シェア、規模、成長、機会、2023-2028年予測 |
出版日: 2023年11月02日
発行: IMARC
ページ情報: 英文 147 Pages
納期: 2~3営業日
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世界の前臨床CRO市場規模は2022年に56億米ドルに達しました。今後、IMARC Groupは、2022年から2028年にかけての成長率(CAGR)は7.6%を示し、2028年には87億米ドルに達すると予測しています。研究開発(R&D)活動への支出の増加、規制環境の複雑化、企業でのコアコンピタンスへの注力の高まり、特殊な治療法における最近の進歩などは、市場を推進する主な要因の一部です。
前臨床試験受託機関(CRO)とは、バイオテクノロジー、製薬、医療機器業界に様々な研究開発(R&D)サービスを提供する企業を指します。毒性試験、薬物動態、製剤開発、薬事サポート、薬力学試験など、さまざまなサービスを提供しています。前臨床CROは、創薬、医療機器試験、生体適合性、疾患モデリング、安全性薬理学、剤形選択など、広範な用途に利用されています。製品開発の迅速化、規制遵守の強化、専門知識の活用、リソース管理の最適化、スケーラブルな研究ソリューションの提供などを支援します。
企業間でコアコンピテンシーへの注目が高まっているため、前臨床CROは専門的な前臨床業務を軽減し、後期臨床試験やマーケティングなどの主要分野に多くのリソースを割くことが求められています。加えて、新興諸国における製薬セクターの急速な拡大による前臨床CROへの需要の高まりは、独自のヘルスケア課題に対処するためであり、患者数の増加が市場の成長を支えています。さらに、個別化医療、生物製剤、遺伝子治療など、微妙な前臨床試験を必要とする特殊な治療法における最近の進歩が、もう一つの成長促進要因として作用しています。これとは別に、医薬品開発の高い失敗率に起因するリスクバランスの取れたアプローチを企業に提供するために前臨床CROが広く採用されていることも、市場の成長に寄与しています。これに加えて、前臨床試験の成功に極めて重要な役割を果たす最先端技術のイントロダクションが市場の成長を支えています。
研究開発(R&D)活動への支出の増大
製薬・バイオ医薬品セクターの成長と活力は、研究開発への取り組みと表裏一体です。斬新な治療薬、より効果的な治療法、画期的な医療ソリューションの探求により、企業は研究開発活動に多額の投資を行うようになっています。病気が変異し、新たな健康上の懸念が出現するにつれ、革新的な医薬品や医療機器が常に必要とされます。このような絶え間ない技術革新の推進には、大規模な前臨床試験が必要であり、一般的にCROに委託して専門的な知識や施設を活用しています。加えて、市場先行競争は研究開発努力をさらに激化させています。これに伴い、前臨床研究をアウトソーシングすることで、企業は医薬品開発の初期段階を迅速に進めることができ、研究室から患者までタイムリーかつ効率的な経路を確保することができます。
複雑化する規制環境
世界の製薬状況は、多面的で厳格な規制の枠組みの監視下にあります。これらの規制機関は、様々な製品の品質、安全性、有効性を確保するために厳しい基準を義務付けています。これらの包括的な要件を満たすには、専門知識、正確さ、広範な文書化が要求され、多くの企業にとって圧倒されることが多いです。そこで、前臨床CROの専門知識が貴重なものとなります。これらの組織は、このような複雑な規制を理解し、ナビゲートし、確実に遵守することに長けています。前臨床研究に専念することで、最新の規制変更に対応し、ベストプラクティスを採用し、世界スタンダードに準拠した最先端の施設を維持しています。さらに、これにより製薬会社は規制上の義務を遵守し、潜在的な後退を最小限に抑え、時間とリソースの両方を節約することができます。
医薬品開発プロセスのコスト増加
医薬品開発は資本集約的な取り組みであり、企業は医薬品のライフサイクルに多額の投資を行う。前臨床試験を含む初期段階は、その後の臨床段階への土台を築くため、特に重要です。しかし、これらの初期段階のために社内に施設、技術、専門知識を確立し、維持することは、高額になる可能性があります。前臨床CROにアウトソーシングすることで、企業は大幅なコスト効率を達成することができます。CROはスケーラブルなソリューションを提供するため、企業は必要な特定のサービスに対して費用を支払うことができます。さらに、CROはその集中的な性質から、しばしば規模の経済があり、そのコストメリットを顧客に還元します。財務的な慎重さが最優先される世界において、前臨床研究のアウトソーシングは、質の高い研究と経済的な配慮のバランスを取る手段を提供します。
The global preclinical CRO market size reached US$ 5.6 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 8.7 Billion by 2028, exhibiting a growth rate (CAGR) of 7.6% during 2022-2028. The growing expenditure on research and development (R&D) activities, rising complexity of regulatory environment, increasing focus on core competencies among companies, and recent advancements in specialized treatments are some of the major factors propelling the market.
A preclinical contract research organization (CRO) refers to a company that provides various research and development (R&D) services to the biotechnology, pharmaceutical, and medical device industries. It offers a range of services, such as toxicology studies, pharmacokinetics, formulation development, regulatory support, and pharmacodynamics studies. Preclinical CRO finds extensive applications in drug discovery, medical device testing, biocompatibility, disease modeling, safety pharmacology, and dosage form selection. It aids in expediting product development, enhancing regulatory compliance, leveraging specialized expertise, optimizing resource management, and offering scalable research solutions.
The increasing focus on core competencies among companies is facilitating the demand for preclinical CROs to offload specialized preclinical tasks and dedicate more resources to their primary areas, such as late-phase clinical trials or marketing. Additionally, the rising demand for preclinical CRO due to the rapid expansion of the pharmaceutical sector in developing countries to address unique healthcare challenges and the growing patient population is supporting the market growth. Furthermore, the recent advancements in specialized treatments, such as personalized medicine, biologics, and gene therapies, which require nuanced preclinical testing, are acting as another growth-inducing factor. Apart from this, the widespread adoption of preclinical CROs to provide companies with a risk-balanced approach owing to the high failure rate of drug development is contributing to the market growth. Besides this, the introduction of cutting-edge technologies that play a pivotal role in successful preclinical studies is supporting the market growth.
The growing expenditure on research and development (R&D) activities
The growth and vitality of the pharmaceutical and biopharmaceutical sectors are inextricably linked to their commitment to R&D. The quest for novel therapeutics, more efficacious treatments, and groundbreaking medical solutions has propelled companies to invest heavily in R&D activities. As diseases mutate and new health concerns emerge, there's a perpetual need for innovative medications and medical devices. This continuous drive for innovation necessitates extensive preclinical studies, which are generally outsourced to CROs to harness their specialized expertise and facilities. Additionally, the competition to be first-to-market further intensifies R&D endeavours. In line with this, outsourcing preclinical research allows companies to swiftly navigate the initial stages of drug development, thus ensuring a timely and efficient path from the lab to the patient.
The rising complexity of regulatory environment
The global pharmaceutical landscape is under the scrutiny of multifaceted and rigorous regulatory frameworks. These regulatory bodies mandate stringent standards to ensure the quality, safety, and efficacy of various products. Meeting these comprehensive requirements demands expertise, precision, and extensive documentation, often overwhelming for many companies. This is where the specialized knowledge of preclinical CROs becomes invaluable. These organizations are adept at understanding, navigating, and ensuring compliance with such intricate regulations. Their dedicated focus on preclinical research ensures they remain updated with the latest regulatory changes, employ best practices, and maintain state-of-the-art facilities that adhere to global standards. Additionally, this helps pharmaceutical companies adhere to regulatory mandates and also minimizes potential setbacks, saving both time and resources.
The increasing cost of drug development process
Drug development is a capital-intensive endeavor, with companies investing heavily in the lifecycle of a drug. The initial stages, including preclinical studies, are especially critical as they set the foundation for subsequent clinical phases. However, establishing and maintaining in-house facilities, technologies, and expertise for these early stages can be expensive. By outsourcing to preclinical CROs, companies can achieve significant cost efficiencies. CROs offer scalable solutions, allowing companies to pay for the specific services they need. Additionally, CROs often have economies of scale due to their focused nature, passing on the cost benefits to their clients. In a world where financial prudence is paramount, outsourcing preclinical research provides an avenue to balance quality research with economic considerations.
IMARC Group provides an analysis of the key trends in each segment of the global preclinical CRO market report, along with forecasts at the global, regional and country levels from 2023-2028. Our report has categorized the market based on service and end use.
Bioanalysis and DMPK Studies
Toxicology Testing
Others
Toxicology testing dominates the market
The report has provided a detailed breakup and analysis of the market based on the service. This includes bioanalysis and DMPK studies, toxicology testing, and others. According to the report, toxicology testing represented the largest market segment.
Toxicology testing is dominating the market due to the stringent regulatory requirements set by health authorities across the globe to ensure that potential adverse effects on human health are identified. Furthermore, as pharmaceuticals become more complex, understanding potential toxic interactions with biological systems becomes even more critical. Modern drugs, especially those based on novel mechanisms of action or biologics, require thorough toxicological evaluations. Additionally, many drug candidates fail during the development process due to safety concerns. Toxicology testing in the preclinical stage helps identify potential red flags early on, saving companies significant time and financial resources by preventing the progression of unsuitable candidates. Besides this, the advent of advanced technologies, such as in vitro toxicology, computational modeling, and high-throughput screening, which are enhancing the capabilities of toxicological studies and providing more detailed and rapid insights, is boosting the market growth.
Biopharmaceutical Companies
Government and Academic Institutes
Medical Device Companies
Biopharmaceutical companies dominate the market
The report has provided a detailed breakup and analysis of the market based on the end use. This includes biopharmaceutical companies, government and academic institutes, and medical device companies. According to the report, biopharmaceutical companies represented the largest market segment.
Biopharmaceutical companies are dominating the market due to the increasing development of biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, which require thorough preclinical evaluation, often necessitating specialized expertise that CROs provide. Furthermore, biopharmaceutical entities are investing heavily in R&D, which translates to a multitude of preclinical activities, many of which are outsourced to CROs for efficiency and expertise. Apart from this, the development of biologics involves intricate production processes using living cells. The complexity warrants specialized preclinical studies, including assessments of potential impurities or contaminants. Moreover, biopharmaceutical drugs are under intense regulatory scrutiny due to their potential immunogenicity and unique mechanisms of action, which often demand the detailed and specialized services of preclinical CROs.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance in the market, accounting for the largest preclinical CRO market share
The report has also provided a comprehensive analysis of all the major regional markets, which includes North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represented the largest market segment.
North America is dominating the preclinical CRO market owing to the presence of many leading pharmaceutical and biotech companies, which directly correlates with heightened demand for preclinical research services. Additionally, the regional firms consistently lead in terms of research and development (R&D) investments. This commitment to innovation drives a considerable need for preclinical studies, pushing the demand for specialized CRO services. Furthermore, leading universities and research institutions in North America provide state-of-the-art infrastructure and generate cutting-edge research. This sophisticated ecosystem often collaborates with and complements the services of CROs. Apart from this, the imposition of stringent regulatory requirements by regional governments regarding drug safety is facilitating the demand for preclinical CROs to meet rigorous requirements and navigate the intricate approval process.
The top companies in the preclinical CRO market are broadening their portfolio to provide end-to-end solutions, encompassing everything from early-stage discovery to preclinical development, which ensures clients can access a full suite of services under one roof. Additionally, companies are investing in technologies, such as in vitro toxicology, high-throughput screening, and computational modeling, to enhance their preclinical study capabilities. Furthermore, they are expanding their operations globally by setting up new facilities, upgrading existing ones, or acquiring regional players. Apart from this, several market players are attracting top talent and focusing on ongoing training to ensure their teams stay updated on the latest scientific advances and regulatory changes. Moreover, they are entering into long-term collaborations with pharmaceutical companies to streamline the drug development process, reduce redundancies, and foster deeper understanding between parties.
Charles River Laboratories Inc.
Covance Inc. (Laboratory Corporation of America Holdings)
Eurofins Scientific
ICON Plc
MD Biosciences Inc. (MLM Medical Labs)
Medpace
Parexel International Corporation
PPD Inc.
Wuxi AppTec
In March 2021, Charles River Laboratories Inc. acquired Retrogenix, an early-stage CRO providing specialized bioanalytical services.
In October 2020, Covance Inc. (Laboratory Corporation of America Holdings) announced it is transforming into a decentralized CRO.
In February 2021, ICON Plc announced that it is acquiring PRA Health Sciences to consolidate itself as a CRO.