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表紙：非臨床試験の世界市場-2023年～2030年
市場調査レポート
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1345440

非臨床試験の世界市場-2023年～2030年

Global Non-Clinical Trials Market - 2023-2030

出版日
ページ情報
英文 186 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.03円
非臨床試験の世界市場-2023年～2030年
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
GIIご利用のメリット
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  • 概要
  • 目次
概要

概要

世界の非臨床試験市場は2022年に115億米ドルに達し、2030年には153億米ドルに達すると予測され、予測期間2023-2030年のCAGRは4.5%で成長する見込みです。

非臨床試験を実施することで、研究者は医薬品開発プロセスの早い段階で安全性の問題を特定し対処することができ、後の臨床試験で被験者に危害が及ぶリスクを低減することができます。非臨床試験は、化合物の薬物動態学（体内で化合物がどのように処理されるか）と薬力学（化合物が体にどのような影響を与えるか）を研究することで、臨床試験の適切な投与量を決定するのに役立ちます。

世界の非臨床試験市場は、製薬業界やバイオテクノロジー業界が医療上のアンメットニーズに対応するため、常に革新的な新薬を探していることなどの要因によって牽引されています。非臨床試験は医薬品開発プロセスにおいて重要であり、FDAやEMAのような規制機関は、臨床試験に移行する前に医薬品の安全性と有効性を確認するため、徹底的な前臨床試験を義務付けています。規制の遵守が非臨床試験市場の成長につながっており、技術の進歩によってこれらの試験はより効率的で正確なものとなり、製薬会社や研究者からの投資を集めています。

ダイナミクス

非臨床試験受託機関の概略

企業は非臨床試験に投資することで、医薬品や治療法を臨床試験に進めるかどうかを決めることができます。企業は、前臨床段階で安全性の問題や有効性の問題が発見された場合、効かないかもしれない商品の臨床試験に多くのリソースを投資しないことで、多くの費用を節約することができます。

非臨床試験を行う研究所は、技術革新と科学的発見の中心でもあります。非臨床試験は、様々な分野の知識を高めるのに役立っており、試験の当初の目標を超えた予期せぬ発見をもたらす可能性があります。さらに、新たなCROの成長が市場の拡大に寄与しています。

例えば、2023年6月6日、大手バイオテクノロジー企業のRonawkは、ライフサイエンス分野のイノベーションを促進することを任務とする最先端の非臨床試験受託機関（CRO）であるSTELLの設立を発表しました。ロナークのポートフォリオにSTELLが加わったことは、事業の発展と拡大における重要な転換点であり、拡大するバイオテクノロジー・エコシステムにおける戦略的プレーヤーとしての地位をさらに再確認するものです。前述のような背景から、この業界は成長を続けています。

非臨床試験と動物実験への依存度の低減

非臨床試験の予測性を高め、動物実験への依存を減らすFDAの取り組みは、市場を牽引する最も重要な要因の一つです。2021年1月、FDAは、動物実験への依存を最小限に抑えつつ、非臨床試験の予測性を高めるための取り組みを概説した報告書を発表しました。FDAの規制対象製品に対するヒトと動物の反応予測性を高めるためのFDAの行動や、代替法の開発と検証を促進するための他の組織とのパートナーシップを紹介しています。

FDAは、FDA規制製品に対するヒトと動物の反応予測精度を向上させることに専念しています。これを達成するために、代替法の開発と検証を促進するために様々な組織と協力しています。FDAは、製品の安全性と有効性の評価が可能な限り効率的かつ倫理的に実施され、同時に最高水準の科学的完全性が維持されるよう尽力しています。

広範な試験と文書化は、しばしば遅延をもたらすことがある

医薬品開発において、患者の安全性を確保することは最も重要です。しかし、広範な試験と文書化のプロセスは、しばしば遅れをもたらすことがあります。さらに、動物実験の使用は倫理的な議論のテーマとなっており、世間の厳しい目にさらされています。そのため、より厳しい規制を求める声が高まっています。こうした懸念を受け、米国では2023年までに医薬品開発における動物実験の要件を撤廃する新法が成立しました。この動きは、患者の安全性と倫理的配慮を確保しつつ、より革新的で効率的な医薬品開発プロセスへの道を開くものと期待されています。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • B群溶血性レンサ球菌の有病率の上昇
      • B群溶血性レンサ球菌に関する臨床試験の増加
  • 抑制要因
      • 膨大な検査と文書化により、しばしば遅延が生じる可能性があります。
    • 機会
    • 影響分析

第5章 産業分析

  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 価格分析
  • 規制分析
  • ロシア・ウクライナ戦争の影響分析
  • DMI意見

第6章 COVID-19分析

第7章 試験タイプ別

  • 薬力学（PD）試験
  • 薬物動態（PK）試験
  • 毒性試験

第8章 試験別

  • インシリコ
  • in vitro
  • In vivo

第9章 治療領域別

  • がん領域
  • 循環器
  • 神経
  • 免疫学
  • その他

第10章 エンドユーザー別

  • 製薬・バイオテクノロジー企業
  • 開発業務受託機関（CRO）
  • 学術・政府研究機関
  • その他

第11章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • オーストラリア
    • その他アジア太平洋地域
  • 中東・アフリカ

第12章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第13章 企業プロファイル

  • Labcorp Drug Development
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な発展
  • Charles River Laboratories
  • PPD（Pharmaceutical Product Development）
  • ICON plc
  • Novartis AG
  • Merck & Co., Inc.
  • AstraZeneca plc
  • CMIC HOLDINGS Co., LTD
  • ProPharma
  • MorphoSys AG

第14章 付録

目次
Product Code: OT6783

Overview

Global Non-Clinical Trials Market reached US$ 11.5 billion in 2022 and is expected to reach US$ 15.3 billion by 2030, growing with a CAGR of 4.5% during the forecast period 2023-2030.

By conducting non-clinical trials, researchers can identify and address safety issues early in the drug development process, reducing the risk of harm to human participants in later clinical trials. Non-clinical trials help determine appropriate dosages for clinical trials by studying the compound's pharmacokinetics (how the body processes the compound) and pharmacodynamics (how the compound affects the body).

The global non-clinical trials market is driven by factors such as pharmaceutical and biotechnology industries are always searching for new and innovative drugs to address unmet medical needs. Non-clinical trials are important in the drug development process, and regulatory agencies like the FDA and EMA require thorough preclinical testing to ensure drugs are safe and effective before moving on to clinical trials. Compliance with regulations has led to growth in the non-clinical trial market, and advances in technology have made these trials more efficient and accurate, attracting investment from pharmaceutical companies and researchers.

Dynamics

Introduction on Non-Clinical Contract Research Organization

Companies can decide whether to forward a medicine or therapy into clinical trials by investing in non-clinical trials. Companies can save a lot of money by not investing a lot of resources in clinical trials for goods that might not work if safety issues or efficacy issues are discovered in preclinical stages.

Labs conducting non-clinical studies are also centres of innovation and scientific discovery. They help to enhance knowledge in a variety of sectors and could result in unanticipated discoveries that go beyond the initial goals of the study. Additionally, the growth of new CROs contributes to market expansion.

For instance, Jun 06, 2023, leading biotechnology business Ronawk announced the establishment of STELL, a cutting-edge non-clinical contract research organisation (CRO) tasked with fostering innovation in the life sciences sector. The addition of STELL to Ronawk's portfolio marks an important turning point in the business' development and expansion, further reaffirming its position as a strategic player in the expanding biotech ecosystem of the area. Because of the aforementioned considerations, the industry is growing.

Non-clinical Studies and Reduce Reliance on Animal Testing

The FDA's efforts to enhance predictivity of non-clinical studies and reduce reliance on animal testing is one of the most important factors driving the market. In January 2021, the FDA released a report outlining its efforts to boost the predictivity of non-clinical studies while minimizing reliance on animal testing. FDA's actions to advance human and animal response predictivity to FDA-regulated products, as well as their partnerships with other organizations to promote the development and validation of alternative methods.

The FDA is dedicated to improving the accuracy of human and animal response predictivity to FDA-regulated products. To achieve this, they are collaborating with various organizations to foster the development and validation of alternative methods. The FDA is committed to ensuring that the evaluation of product safety and efficacy is conducted most efficiently and ethically possible, while simultaneously upholding the highest standards of scientific integrity.

Extensive Testing and Documentation can Often Result in Delays

Ensuring patient safety is of utmost importance when it comes to drug development. However, the process of conducting extensive testing and documentation can often result in delays. Furthermore, the use of animal testing has been a topic of ethical debate and has faced public scrutiny. This has led to calls for more stringent regulations. In response to these concerns, a new U.S. law has been passed, which will eliminate the requirement for animal testing in drug development by the year 2023. This move is expected to pave the way for more innovative and efficient drug development processes, while still ensuring patient safety and ethical considerations.

Segment Analysis

The global non-clinical trials market is segmented based on study type, test, therapeutic area, end user and region.

Multiple Medications are often used in Novel Oncology Treatments

At every stage of the development of oncology medications, non-clinical studies are required. To study carcinogenesis, cancer progression, metastasis, and other aspects of cancer biology, numerous experimental cancer models have been created. These models have been helpful in assessing the efficacy and predicting the safety of oncology medicines. Although the diversity and degree of genetic involvement in the start of cancer cell growth and progression are well acknowledged, it is also becoming more and more obvious that host cells, the tissue microenvironment, and the immune system play significant roles in the development of cancer.

Multiple medications are often used in novel cancer treatments to improve results. The most efficient pharmacological combinations and any potential synergistic effects are determined by preclinical trials. Before approving the progression of a new drug or treatment strategy to human trials, regulatory organisations like the U.S. Food and Drug Administration (FDA) frequently need a solid preclinical base. Thus, the increase in cancer cases contributes to the segment's growth.

For instance, The American Cancer Society projects that there will be 609,360 cancer fatalities and 1,918,030 new cancer cases in the US in 2022, with lung cancer accounting for about 350 of those deaths daily, making it the top cause of cancer death. Thus, the incidence of diseases and prospects for pharmaceutical businesses contribute to the segment's faster growth.

Geographical Penetration

Expanding the Research Organization in the Region

North America, particularly the United States, is a major hub for pharmaceutical and biotechnology research. The pharmaceutical and biotechnology industry in North America is thriving, with numerous companies, research institutions, and contract research organizations (CROs) present. This has resulted in an increased demand for non-clinical trials to support drug development activities. The region is also home to prestigious research and educational organizations dedicated to advancing biomedical research. These institutions frequently collaborate with pharmaceutical firms to meet the growing need for non-clinical trials.

For instance, on October 6, 2022, Merck, also known as MSD outside of the US and Canada, and Ridgeback Biotherapeutics announced data from two real-world evidence studies investigating the effectiveness of LAGEVRIO (molnupiravir), an investigational oral antiviral COVID-19 medicine. The first study, PANORAMIC, was conducted by the University of Oxford in the UK on highly-vaccinated adults mostly under the age of 65 during the period when the Omicron SARS-CoV-2 variant was predominantly circulating.

COVID-19 Impact Analysis

The non-clinical trials market has been moderately affected by the outbreak of COVID-19. The pandemic has brought to light the ethical considerations surrounding animal testing and has resulted in heightened public scrutiny. Additionally, conducting experiments with animals has proven to be logistically complicated due to health and safety protocols. For instance, protests against animal testing have surged during the pandemic, drawing attention to the moral implications of using animals for research purposes.

The Europe Animal Research Organization has been particularly vocal about the need to reassess the role of animal testing in research, given the current circumstances. Overall, the pandemic has underscored the importance of responsible and ethical research practices, especially in the context of animal testing.

By Study Type

  • Pharmacodynamics (PD) studies
  • Pharmacokinetics (PK) studies
  • Toxicology studies

By Test

  • In silico
  • In vitro
  • In vivo

By Therapeutic Area

  • Oncology
  • Cardiovascular
  • Neurology
  • Immunology
  • Others

By End User

  • Pharmaceutical and Biotechnology Companies
  • Contract Research Organizations (CROs)
  • Academic and Government Research Institutes
  • Others

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Russia
    • Rest of Europe
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa

Key Developments

  • On March 02, 2023, in order to improve its cost structure, MorphoSys AG announced that it would halt working on its pre-clinical research programmes. Although the results from these pre-clinical programmes are encouraging, MorphoSys would need to invest a lot of money to bring them to patients. As a result, MorphoSys will lay off roughly 17% of its employees at its Planegg, Germany, headquarters. MorphoSys is currently able to concentrate resources on its mid- to late-stage cancer pipeline as a result of this decision and others that have been taken over last year.
  • On January 10, 2022, Pfizer Inc. and Beam Therapeutics Inc., a biotechnology company developing precision genetic medicines through base editing,announced an exclusive four-year research collaboration focused on in vivo base editing programs for three targets for rare genetic diseases of the liver, muscle and central nervous system.
  • In August 2023, the groundbreaking multi-epitope mRNA vaccine against tuberculosis was the subject of preclinical experiments, the results of which were just made public by Sirius University's Scientific Centre for Translational Medicine. According to the educational center's press office, the medication displayed exceptional effectiveness in rodent study.

Competitive Landscape

The major global players in the market include: Labcorp Drug Development, Charles River Laboratories, PPD (Pharmaceutical Product Development), ICON plc, Novartis AG, Merck & Co., Inc., AstraZeneca plc, CMIC HOLDINGS Co., LTD, ProPharma, MorphoSys AG and among others.

Why Purchase the Report?

  • To visualize the global non-clinical trials market segmentation based on study type, test, therapeutic area, end user and region,as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of non-clinical trials market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as excel consisting of key products of all the major players.

The global Non-Clinical Trials market report would provide approximately 61tables, 58figures and 186 Pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Study Type
  • 3.2. Snippet by Test
  • 3.3. Snippet by Therapeutic Area
  • 3.4. Snippet by End User
  • 3.5. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. The rising prevalence of Group B Streptococcus
      • 4.1.1.2. The rising the clinical trials on Group B Streptococcus
  • 4.2. Restraints
      • 4.2.1.1. Extensive testing and documentation can often result in delays
    • 4.2.2. Opportunity
    • 4.2.3. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Force Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis
  • 5.5. Russia-Ukraine War Impact Analysis
  • 5.6. DMI Opinion

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID
    • 6.1.2. Scenario During COVID
    • 6.1.3. Scenario Post COVID
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Study Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 7.1.2. Market Attractiveness Index, By Study Type
  • 7.2. Pharmacodynamics (PD) studies *
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Pharmacokinetics (PK) studies
  • 7.4. Toxicology studies

8. By Test

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test
    • 8.1.2. Market Attractiveness Index, By Test
  • 8.2. In silico *
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. In vitro
  • 8.4. In vivo

9. By Therapeutic Area

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
    • 9.1.2. Market Attractiveness Index, By Therapeutic Area
  • 9.2. Oncology *
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Cardiovascular
  • 9.4. Neurology
  • 9.5. Immunology
  • 9.6. Others

10. By End User

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.1.2. Market Attractiveness Index, By End User
  • 10.2. Pharmaceutical and Biotechnology Companies s*
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Contract Research Organizations (CROs)
  • 10.4. Academic and Government Research Institutes
  • 10.5. Others

11. By Region

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 11.1.2. Market Attractiveness Index, By Region
  • 11.2. North America
    • 11.2.1. Introduction
    • 11.2.2. Key Region-Specific Dynamics
    • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
      • 11.2.6.1. U.S.
      • 11.2.6.2. Canada
      • 11.2.6.3. Mexico
  • 11.3. Europe
    • 11.3.1. Introduction
    • 11.3.2. Key Region-Specific Dynamics
    • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
    • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.8.1. Germany
      • 11.3.8.2. UK
      • 11.3.8.3. France
      • 11.3.8.4. Italy
      • 11.3.8.5. Spain
      • 11.3.8.6. Rest of Europe
  • 11.4. South America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.7.1. Brazil
      • 11.4.7.2. Argentina
      • 11.4.7.3. Rest of South America
  • 11.5. Asia-Pacific
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.7.1. China
      • 11.5.7.2. India
      • 11.5.7.3. Japan
      • 11.5.7.4. Australia
      • 11.5.7.5. Rest of Asia-Pacific
  • 11.6. Middle East and Africa
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Type
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Area
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

  • 13.1. Labcorp Drug Development *
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Financial Overview
    • 13.1.4. Key Developments
  • 13.2. Charles River Laboratories
  • 13.3. PPD (Pharmaceutical Product Development)
  • 13.4. ICON plc
  • 13.5. Novartis AG
  • 13.6. Merck & Co., Inc.
  • 13.7. AstraZeneca plc
  • 13.8. CMIC HOLDINGS Co., LTD
  • 13.9. ProPharma
  • 13.10. MorphoSys AG

LIST NOT EXHAUSTIVE

14. Appendix

  • 14.1. About Us and Services
  • 14.2. Contact Us