バイオ分析試験サービスの市場規模および予測（2020年～2030年）、世界および地域シェア、動向、成長機会分析レポートの対象範囲サービス別（薬物動態学、バイオマーカー、免疫原性、ウイルス学試験、細胞ベースアッセイ、その他）；適応疾患別（心血管疾患、神経疾患、代謝性疾患、自己免疫疾患、呼吸器疾患、腫瘍学、性の健康、骨疾患、その他）；エンドユーザー[製薬・バイオ医薬品企業、医薬品開発業務受託機関（CRO）、医薬品開発・製造業務受託機関（CDMO）、その他]、地域（北米、欧州、アジア太平洋、中東・アフリカ、中南米）

Bioanalytical Testing Services Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Services (Pharmacokinetics, Biomarkers, Immunogenicity, Virology Testing, Cell-based assays, and Others); Disease Indication (Cardiovascular, Neurological Disorders, Metabolic Disorders, Autoimmune Disorders, Respiratory Diseases, Oncology, Sexual Health, Bone Disease, and Others); End User [Pharmaceutical and Biopharmaceutical Companies, Contract Research Organization (CRO), Contract Development And Manufacturing Organization (CDMO), and Others], and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

バイオ分析検査サービスの世界市場は、2022年の46億4,113万米ドルから2030年には101億8,082万米ドルに達すると予測されている。2022年から2030年までの年平均成長率は10.2%と推定される。市場の成長を促す主... もっと見る

出版社	出版年月	電子版価格	ページ数	言語
The Insight Partners ザ・インサイトパートナーズ	2023年9月14日	US$4,550 シングルユーザライセンスライセンス・価格情報注文方法はこちら	202	英語

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バイオ分析検査サービスの世界市場は、2022年の46億4,113万米ドルから2030年には101億8,082万米ドルに達すると予測されている。2022年から2030年までの年平均成長率は10.2%と推定される。

市場の成長を促す主な要因は、製薬企業による研究開発活動のアウトソーシングの増加、バイオシミラーや生物製剤の分析試験に対する需要の高さである。しかし、バイオ分析法の開発と検証における課題が、市場の成長をある程度妨げている。

バイオ分析試験サービス市場の市場機会

医薬品やその他の医薬品の研究開発、生産、流通は製薬産業の主要分野である。世界の医薬品消費量は、加齢関連疾患や慢性疾患の治療薬に対するニーズの高まりとともに増加している。WHOによると、60歳以上の高齢者人口は2020年から2050年にかけて倍増し、2050年には21億人に達すると予測されている。高齢者人口の増加は、心血管疾患、癌、高血圧、変形性関節症、糖尿病などの慢性疾患の発生を急増させる。そのため、慢性疾患は製薬会社の主要な注力分野となっている。

新薬開発は、資源、コスト、時間の集約的なプロセスであり、後期臨床段階では多大なコストがかかる。米国議会予算局（CBO）によれば、医薬品を発見し、規制当局の承認を得るまでには10〜15年以上かかり、およそ1〜20億米ドルの費用がかかる。そのため、医薬品の研究開発における消耗率を下げるため、製薬会社は米国FDAやその他の主要な規制機関が定めた適正製造規範（GMP）に従うことに注力している。いくつかの製薬会社は、臨床段階と前臨床段階の両方で、医薬品開発とアッセイのバリデーションのためにバイオ分析試験サービスを選択している。ジェネリック医薬品と先発医薬品は、ほとんどが低分子化合物である。ジェネリック医薬品メーカーは、特許失効の問題を克服するためにバイオ分析試験結果を実施し、提出する。このように、製薬業界の絶え間ない増殖に伴い、バイオ分析試験サービスプロバイダーは、将来的にそのサービスに対する需要が継続的に増加する可能性が高く、バイオ分析試験サービス市場の新たな成長機会につながるだろう。

バイオ分析検査サービス市場を阻害する要因

バイオ分析法の開発は複雑なプロセスであり、熟練した専門家による器用なアプローチが必要である。その結果、生物学的分析法の開発とバリデーションにはいくつかの課題が伴う。複雑な臨床試験を行う英国の臨床研究機関Simbec-Orionによると、FDAの審査官は、生物学的分析試験法に関する分析上の問題、抽出技術の欠陥、計算上の問題、報告上の問題、サンプル出荷の問題などの課題を概説している。HPLCにおける分析カラムの劣化、移動相の汚染、LCMSにおけるサンプルマトリックスの複雑さから生じる問題、LCMSの他の段階における汚染などである。これらはバイオ分析試験のバリデーションを妨げ、同時に品質基準にも影響を与えるため、バイオ分析試験サービス市場の成長を制限している。

バイオ分析試験サービス市場セグメント別概要

バイオ分析試験サービス市場は、サービスに基づき、薬物動態学、バイオマーカー、免疫原性、ウイルス学試験、細胞ベースアッセイ、その他に区分される。セルベースアッセイ分野は2022年に最大の市場シェアを占めた。さらに、同セグメントは2022年から2030年にかけて最も高いCAGRを記録すると予測されている。細胞ベースアッセイは、医薬品や原薬の生物学的活性（力価）を測定し、作用機序（MOA）を発見するため、また細胞毒性試験や初期段階の原理実証試験に一般的に使用される。免疫原性試験では、患者の体内で産生される抗体の薬物中和効果を測定するのに役立ちます。

生物学的分析試験サービス市場は、適応疾患に基づいて、心血管、神経障害（CNS）、代謝障害、腫瘍学、性の健康、骨疾患、その他に区分される。2022年には、腫瘍学セグメントが市場最大のシェアを占めた。また、疼痛緩和、化学療法、その他の治療における腫瘍学の進歩により、同分野は2022年から2030年にかけて最も速いCAGRで需要が伸びると予測されている。

バイオ分析試験サービス市場は、エンドユーザーに基づき、製薬・バイオ医薬品企業、医薬品開発業務受託機関（CRO）、医薬品開発・製造業務受託機関（CDMO）、その他に区分される。2022年には、製薬・バイオ医薬品企業が最大の市場シェアを占めている。さらに、同セグメントは2022年から2030年にかけて最も速いCAGRで需要が伸びると予想されている。バイオ分析試験サービスは、医薬品製造の開始から最終製品リリースまでに関わるリスクを排除することを目的としている。したがって、創薬および医薬品開発におけるバイオ分析試験サービスの重要性は、製薬会社およびバイオ製薬会社セグメントのバイオ分析試験サービス市場を牽引している。

バイオ分析試験サービス市場地域別概要

世界のバイオ分析検査サービス市場では、北米が最大のシェアを占めており、アジア太平洋地域は急成長地域である。北米市場は、製薬産業の絶え間ない成長、様々な疾病の急増による新薬開発ニーズの高まり、政府による医療費の増加、医薬品の品質保証のためのアウトソーシング志向の高まりにより、予測期間中に成長すると予想される。アジア太平洋地域は、世界の生物分析試験サービス試験市場において最も高いCAGRを記録した。同地域の市場は、中国、インド、日本を含む国々で今後数年間に大きく成長すると予想される。アジア太平洋市場は、低コストの労働市場におけるアウトソーシングサービスの需要増加により成長が見込まれている。したがって、この地域は予測期間中にバイオ分析検査サービス市場プレーヤーが成長する大きな可能性を秘めている。

バイオ分析検査サービス市場に関するレポート作成時に参照した主な一次および二次情報源には、世界銀行データ、国民保健サービス（NHS）、FDA（食品医薬品局）、EMA（欧州医薬品庁）、EPA（環境保護庁）などがある。

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TABLE OF CONTENTS

1. Introduction
1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation
2. Executive Summary
2.1 Key Insights
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. Bioanalytical Testing Services Market Landscape
4.1 Overview
4.2 PEST Analysis
4.2.1 North America PEST Analysis
4.2.2 Europe PEST Analysis
4.2.3 Asia Pacific PEST Analysis
4.2.4 South & Central America PEST Analysis
4.2.5 Middle East & Africa PEST Analysis
5. Bioanalytical Testing Services Market - Key Industry Dynamics
5.1 Key Market Drivers:
5.1.1 Increasing Outsourcing of R&D Activities by Pharmaceutical Companies
5.1.2 High Demand for Analytical Testing of Biosimilars and Biologics
5.2 Key Market Restraints:
5.2.1 Challenges in Development and Validation of Bioanalytical Methods
5.3 Key Market Opportunities
5.3.1 Uninterrupted Growth of Pharmaceuticals Industry
5.4 Future Trends
5.4.1 Rising Drug Discovery and Development Activities for Emerging and Rare Diseases
5.5 Impact Analysis:
6. Bioanalytical Testing Services Market - Global Market Analysis
6.1 Bioanalytical Testing Services Market Revenue (US$ Mn), 2022 – 2030
7. Global Bioanalytical Testing Services Market – Revenue and Forecast to 2030 – by Services
7.1 Overview
7.2 Bioanalytical Testing Services Market Revenue Share, by Services 2022 & 2030 (%)
7.3 Pharmacokinetics
7.3.1 Overview
7.3.2 Pharmacokinetics: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.4 Biomarkers
7.4.1 Overview
7.4.2 Biomarkers: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.5 Immunogenicity
7.5.1 Overview
7.5.2 Immunogenicity: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.6 Virology Testing
7.6.1 Overview
7.6.2 Virology Testing: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.6.2.1 In-Vitro Virology Testing
7.6.2.1.1 Overview
7.6.2.1.2 In-Vitro Virology Testing: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.6.2.2 In-Vivo Virology Testing
7.6.2.2.1 Overview
7.6.2.2.2 In-Vivo Virology Testing: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.7 Cell-Based Assays
7.7.1 Overview
7.7.2 Cell-Based Assays: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
7.8 Others
7.8.1 Overview
7.8.2 Others: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8. Global Bioanalytical Testing Services Market – Revenue and Forecast to 2030 – by Disease Indication
8.1 Overview
8.2 Bioanalytical Testing Services Market Revenue Share, by Disease Indication 2022 & 2030 (%)
8.3 Cardiovascular
8.3.1 Overview
8.3.2 Cardiovascular: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.4 Neurological Diseases
8.4.1 Overview
8.4.2 Neurological Diseases: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.5 Autoimmune Disorders
8.5.1 Overview
8.5.2 Autoimmune Disorders: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.6 Respiratory Diseases
8.6.1 Overview
8.6.2 Respiratory Diseases: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.7 Metabolic Disorders
8.7.1 Overview
8.7.2 Metabolic Disorders: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.8 Oncology
8.8.1 Overview
8.8.2 Oncology: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.9 Sexual Health
8.9.1 Overview
8.9.2 Sexual Health: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.10 Bone Disease
8.10.1 Overview
8.10.2 Bone Disease: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
8.11 Others
8.11.1 Overview
8.11.2 Others: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
9. Global Bioanalytical Testing Services Market – Revenue and Forecast to 2030 – by End User
9.1 Overview
9.2 Bioanalytical Testing Services Market Revenue Share, by End User 2022 & 2030 (%)
9.3 Pharmaceutical and Biopharmaceutical Companies
9.3.1 Overview
9.3.2 Pharmaceutical and Biopharmaceutical Companies: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
9.4 Contract Research Organization (CRO)
9.4.1 Overview
9.4.2 Contract Research Organization (CRO): Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
9.5 Contract Development And Manufacturing Organization (CDMO)
9.5.1 Overview
9.5.2 Contract Development And Manufacturing Organization (CDMO): Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
9.6 Others
9.6.1 Overview
9.6.2 Others: Bioanalytical Testing Services Market – Revenue and Forecast to 2030 (US$ Million)
10. Bioanalytical Testing Services Market - Geographical Analysis
10.1 North America Bioanalytical Testing Services Market, Revenue And Forecast To 2030
10.1.1 Overview
10.1.2 North America Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.1.2.1 North America Bioanalytical Testing Services Market, by Services
10.1.2.1.1 North America Bioanalytical Testing Services Market, by Virology Testing
10.1.2.2 North America Bioanalytical Testing Services Market, by Disease Indication
10.1.2.3 North America Bioanalytical Testing Services Market, by End User
10.1.2.4 North America Bioanalytical Testing Services Market, by Country
10.1.2.5 US
10.1.2.5.1 Overview
10.1.2.5.2 US Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.1.2.5.3 US Bioanalytical Testing Services Market, by Services
10.1.2.5.3.1 US Bioanalytical Testing Services Market, by Virology Testing
10.1.2.5.4 US Bioanalytical Testing Services Market, by Disease Indication
10.1.2.5.5 US Bioanalytical Testing Services Market, by End User
10.1.2.6 Canada
10.1.2.6.1 Overview
10.1.2.6.2 Canada Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.1.2.6.3 Canada Bioanalytical Testing Services Market, by Services
10.1.2.6.3.1 Canada Bioanalytical Testing Services Market, by Virology Testing
10.1.2.6.4 Canada Bioanalytical Testing Services Market, by Disease Indication
10.1.2.6.5 Canada Bioanalytical Testing Services Market, by End User
10.1.2.7 Mexico
10.1.2.7.1 Overview
10.1.2.7.2 Mexico Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.1.2.7.3 Mexico Bioanalytical Testing Services Market, by Services
10.1.2.7.3.1 Mexico Bioanalytical Testing Services Market, by Virology Testing
10.1.2.7.4 Mexico Bioanalytical Testing Services Market, by Disease Indication
10.1.2.7.5 Mexico Bioanalytical Testing Services Market, by End User
10.2 Europe Bioanalytical Testing Services Market, Revenue And Forecast to 2030
10.2.1 Overview
10.2.2 Europe Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.2.2.1 Europe Bioanalytical Testing Services Market, by Services
10.2.2.1.1 Europe Bioanalytical Testing Services Market, by Virology Testing
10.2.2.2 Europe Bioanalytical Testing Services Market, by Disease Indication
10.2.2.3 Europe Bioanalytical Testing Services Market, by End User
10.2.2.4 Europe Bioanalytical Testing Services Market by Country
10.2.2.5 Germany
10.2.2.5.1 Overview
10.2.2.5.2 Germany Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.2.2.5.3 Germany Bioanalytical Testing Services Market, by Services
10.2.2.5.3.1 Germany Bioanalytical Testing Services Market, by Virology Testing
10.2.2.5.4 Germany Bioanalytical Testing Services Market, by Disease Indication
10.2.2.5.5 Germany Bioanalytical Testing Services Market, by End User
10.2.2.6 UK
10.2.2.6.1 Overview
10.2.2.6.2 UK Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.2.2.6.3 UK Bioanalytical Testing Services Market, by Services
10.2.2.6.3.1 UK Bioanalytical Testing Services Market, by Virology Testing
10.2.2.6.4 UK Bioanalytical Testing Services Market, by Disease Indication
10.2.2.6.5 UK Bioanalytical Testing Services Market, by End User
10.2.2.7 France
10.2.2.7.1 Overview
10.2.2.7.2 France Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.2.2.7.3 France Bioanalytical Testing Services Market, by Services
10.2.2.7.3.1 France Bioanalytical Testing Services Market, by Virology Testing
10.2.2.7.4 France Bioanalytical Testing Services Market, by Disease Indication
10.2.2.7.5 France Bioanalytical Testing Services Market, by End User
10.2.2.8 Italy
10.2.2.8.1 Overview
10.2.2.8.2 Italy Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.2.2.8.3 Italy Bioanalytical Testing Services Market, by Services
10.2.2.8.3.1 Italy Bioanalytical Testing Services Market, by Virology Testing
10.2.2.8.4 Italy Bioanalytical Testing Services Market, by Disease Indication
10.2.2.8.5 Italy Bioanalytical Testing Services Market, by End User
10.2.2.9 Spain
10.2.2.9.1 Overview
10.2.2.9.2 Spain Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.2.2.9.3 Spain Bioanalytical Testing Services Market, by Services
10.2.2.9.3.1 Spain Bioanalytical Testing Services Market, by Virology Testing
10.2.2.9.4 Spain Bioanalytical Testing Services Market, by Disease Indication
10.2.2.9.5 Spain Bioanalytical Testing Services Market, by End User
10.2.2.10 Rest of Europe
10.2.2.10.1 Overview
10.2.2.10.2 Rest of Europe Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.2.2.10.3 Rest of Europe Bioanalytical Testing Services Market, by Services
10.2.2.10.3.1 Rest of Europe Bioanalytical Testing Services Market, by Virology Testing
10.2.2.10.4 Rest of Europe Bioanalytical Testing Services Market, by Disease Indication
10.2.2.10.5 Rest of Europe Bioanalytical Testing Services Market, by End User
10.3 Asia Pacific Bioanalytical Testing Services Market, Revenue And Forecast to 2030
10.3.1 Overview
10.3.2 Asia Pacific Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.3.2.1 Asia Pacific Bioanalytical Testing Services Market, by Services
10.3.2.1.1 Asia Pacific Bioanalytical Testing Services Market, by Virology Testing
10.3.2.2 Asia Pacific Bioanalytical Testing Services Market, by Disease Indication
10.3.2.3 Asia Pacific Bioanalytical Testing Services Market, by End User
10.3.2.4 Asia Pacific Bioanalytical Testing Services Market by Country
10.3.2.5 China
10.3.2.5.1 Overview
10.3.2.5.2 China Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.3.2.5.3 China Bioanalytical Testing Services Market, by Services
10.3.2.5.3.1 China Bioanalytical Testing Services Market, by Virology Testing
10.3.2.5.4 China Bioanalytical Testing Services Market, by Disease Indication
10.3.2.5.5 China Bioanalytical Testing Services Market, by End User
10.3.2.6 Japan
10.3.2.6.1 Overview
10.3.2.6.2 Japan Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.3.2.6.3 Japan Bioanalytical Testing Services Market, by Services
10.3.2.6.3.1 Japan Bioanalytical Testing Services Market, by Virology Testing
10.3.2.6.4 Japan Bioanalytical Testing Services Market, by Disease Indication
10.3.2.6.5 Japan Bioanalytical Testing Services Market, by End User
10.3.2.7 India
10.3.2.7.1 Overview
10.3.2.7.2 India Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.3.2.7.3 India Bioanalytical Testing Services Market, by Services
10.3.2.7.3.1 India Bioanalytical Testing Services Market, by Virology Testing
10.3.2.7.4 India Bioanalytical Testing Services Market, by Disease Indication
10.3.2.7.5 India Bioanalytical Testing Services Market, by End User
10.3.2.8 Australia
10.3.2.8.1 Overview
10.3.2.8.2 Australia Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.3.2.8.3 Australia Bioanalytical Testing Services Market, by Services
10.3.2.8.3.1 Australia Bioanalytical Testing Services Market, by Virology Testing
10.3.2.8.4 Australia Bioanalytical Testing Services Market, by Disease Indication
10.3.2.8.5 Australia Bioanalytical Testing Services Market, by End User
10.3.2.9 South Korea
10.3.2.9.1 Overview
10.3.2.9.2 South Korea Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.3.2.9.3 South Korea Bioanalytical Testing Services Market, by Services
10.3.2.9.3.1 South Korea Bioanalytical Testing Services Market, by Virology Testing
10.3.2.9.4 South Korea Bioanalytical Testing Services Market, by Disease Indication
10.3.2.9.5 South Korea Bioanalytical Testing Services Market, by End User
10.3.2.10 Rest of Asia Pacific
10.3.2.10.1 Overview
10.3.2.10.2 Rest of Asia Pacific Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.3.2.10.3 Rest of Asia Pacific Bioanalytical Testing Services Market, by Services
10.3.2.10.3.1 Rest of Asia Pacific Bioanalytical Testing Services Market, by Virology Testing
10.3.2.10.4 Rest of Asia Pacific Bioanalytical Testing Services Market, by Disease Indication
10.3.2.10.5 Rest of Asia Pacific Bioanalytical Testing Services Market, by End User
10.4 Middle East & Africa Bioanalytical Testing Services Market, Revenue And Forecast to 2030
10.4.1 Overview
10.4.2 Middle East & Africa Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.4.2.1 Middle East & Africa Bioanalytical Testing Services Market, by Services
10.4.2.1.1 Middle East & Africa Bioanalytical Testing Services Market, by Virology Testing
10.4.2.2 Middle East & Africa Bioanalytical Testing Services Market, by Disease Indication
10.4.2.3 Middle East & Africa Bioanalytical Testing Services Market, by End User
10.4.2.4 Middle East & Africa Bioanalytical Testing Services Market by Country
10.4.2.5 UAE
10.4.2.5.1 Overview
10.4.2.5.2 UAE Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.4.2.5.3 UAE Bioanalytical Testing Services Market, by Services
10.4.2.5.3.1 UAE Bioanalytical Testing Services Market, by Virology Testing
10.4.2.5.4 UAE Bioanalytical Testing Services Market, by Disease Indication
10.4.2.5.5 UAE Bioanalytical Testing Services Market, by End User
10.4.2.6 Saudi Arabia
10.4.2.6.1 Overview
10.4.2.6.2 Saudi Arabia Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.4.2.6.3 Saudi Arabia Bioanalytical Testing Services Market, by Services
10.4.2.6.3.1 Saudi Arabia Bioanalytical Testing Services Market, by Virology Testing
10.4.2.6.4 Saudi Arabia Bioanalytical Testing Services Market, by Disease Indication
10.4.2.6.5 Saudi Arabia Bioanalytical Testing Services Market, by End User
10.4.2.7 South Africa
10.4.2.7.1 Overview
10.4.2.7.2 South Africa Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.4.2.7.3 South Africa Bioanalytical Testing Services Market, by Services
10.4.2.7.3.1 South Africa Bioanalytical Testing Services Market, by Virology Testing
10.4.2.7.4 South Africa Bioanalytical Testing Services Market, by Disease Indication
10.4.2.7.5 South Africa Bioanalytical Testing Services Market, by End User
10.4.2.8 Rest of Middle East & Africa
10.4.2.8.1 Overview
10.4.2.8.2 Rest of Middle East & Africa Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.4.2.8.3 Rest of Middle East & Africa Bioanalytical Testing Services Market, by Services
10.4.2.8.3.1 Rest of Middle East & Africa Bioanalytical Testing Services Market, by Virology Testing
10.4.2.8.4 Rest of Middle East & Africa Bioanalytical Testing Services Market, by Disease Indication
10.4.2.8.5 Rest of Middle East & Africa Bioanalytical Testing Services Market, by End User
10.5 South & Central America Bioanalytical Testing Services Market, Revenue And Forecast to 2030
10.5.1 Overview
10.5.2 South & Central America Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.5.2.1 South & Central America Bioanalytical Testing Services Market, by Services
10.5.2.1.1 South & Central America Bioanalytical Testing Services Market, by Virology Testing
10.5.2.2 South & Central America Bioanalytical Testing Services Market, by Disease Indication
10.5.2.3 South & Central America Bioanalytical Testing Services Market, by End User
10.5.2.4 South & Central America Bioanalytical Testing Services Market by Country
10.5.2.5 Brazil
10.5.2.5.1 Overview
10.5.2.5.2 Brazil Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.5.2.5.3 Brazil Bioanalytical Testing Services Market, by Services
10.5.2.5.3.1 Brazil Bioanalytical Testing Services Market, by Virology Testing
10.5.2.5.4 Brazil Bioanalytical Testing Services Market, by Disease Indication
10.5.2.5.5 Brazil Bioanalytical Testing Services Market, by End User
10.5.2.6 Argentina
10.5.2.6.1 Overview
10.5.2.6.2 Argentina Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.5.2.6.3 Argentina Bioanalytical Testing Services Market, by Services
10.5.2.6.3.1 Argentina Bioanalytical Testing Services Market, by Virology Testing
10.5.2.6.4 Argentina Bioanalytical Testing Services Market, by Disease Indication
10.5.2.6.5 Argentina Bioanalytical Testing Services Market, by End User
10.5.2.7 Rest of South & Central America
10.5.2.7.1 Overview
10.5.2.7.2 Rest of South & Central America Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
10.5.2.7.3 Rest of South & Central America Bioanalytical Testing Services Market, by Services
10.5.2.7.3.1 Rest of South & Central America Bioanalytical Testing Services Market, by Virology Testing
10.5.2.7.4 Rest of South & Central America Bioanalytical Testing Services Market, by Disease Indication
10.5.2.7.5 Rest of South & Central America Bioanalytical Testing Services Market, by End User
11. Pre & Post Covid-19 Impact
11.1 Pre & Post Covid-19 Impact
12. Bioanalytical Testing Services Market Industry Landscape
12.1 Overview
12.2 Growth Strategies in the Bioanalytical Testing Services Market
12.3 Inorganic Growth Strategies
12.3.1 Overview
12.4 Organic Growth Strategies
12.4.1 Overview
13. Company Profiles
13.1 SGS SA
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Pharmaron Beijing Co Ltd
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Element Materials Technology Group Ltd
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 CD BioSciences Inc
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 Charles River Laboratories International Inc
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 Eurofins Scientific SE
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 Labcorp Drug Development Inc
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 Syneos Health Inc
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 KCAS Bioanalytical and Biomarker Services LLC
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 ICON Plc
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
13.10.6 Key Developments
13.11 Intertek Group Plc
13.11.1 Key Facts
13.11.2 Business Description
13.11.3 Products and Services
13.11.4 Financial Overview
13.11.5 SWOT Analysis
13.11.6 Key Developments
14. Appendix
14.1 About Us
14.2 Glossary of Terms

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Table of Contents

Summary

The global bioanalytical testing services market is expected to reach US$ 10,108.82 million in 2030 from US$ 4,641.13 million in 2022. The market is estimated to grow with a CAGR of 10.2% from 2022 to 2030.

The key factors driving the market's growth are increasing outsourcing of R&D activities by pharmaceutical companies and the high demand for analytical testing of biosimilars and biologics. However, challenges in developing and validating bioanalytical methods are hampering the market's growth to a certain extent.

Market Opportunities of Bioanalytical Testing Services Market

The research & development, production, and distribution of medicinal drugs and other pharmaceutical products are the major areas of the pharmaceutical industry. Global pharmaceutical consumption is rising with the increasing need for drugs to treat age-related diseases and chronic diseases. According to the WHO, the elderly population aged 60 or above is projected to double from 2020 to 2050, reaching ~2.1 billion by 2050. A rise in the geriatric population would contribute to a surge in incidences of chronic diseases, such as cardiovascular diseases, cancer, hypertension, osteoarthritis, and diabetes mellitus. Thus, chronic diseases have been a major area of focus for pharmaceutical companies.

New drug development is a resource-, cost-, and time-intensive process, where later clinical stages result in significant costs. As per the United States Congressional Budget Office (CBO), it takes over 10–15 years and costs around US$ 1–2 billion to discover a drug and obtain regulatory approval. Therefore, to lower the attrition rate in drug research & development, pharmaceutical companies are focusing on following the good manufacturing practices (GMP) set by the US FDA and other major regulatory organizations. Several pharmaceutical companies are opting for bioanalytical testing services for drug development and validation of assays in both clinical and preclinical stages. Generics and branded drug compounds are mostly small molecules. Generics manufacturers conduct and submit bioanalytical testing results to overcome the issue of patent expiration. Thus, with the uninterrupted proliferation of the pharmaceutical industry, bioanalytical testing service providers are likely to experience a continuous rise in demand for their services in the future, which would lead to new growth opportunities in the bioanalytical testing services market.

Factors Hampering Bioanalytical Testing Services Market

Developing bioanalytical methods is a complex process that necessitates a dexterous approach by skilled professionals. As a result, several challenges are associated with the development and validation of biological analysis methods. According to Simbec-Orion, a UK-based clinical research organization for complex clinical studies, FDA reviewers have outlined challenges such as analytical issues, flawed extraction techniques, calculation problems, reporting issues, and sample shipping issues related to bioanalytical testing methods. Various analytical issues may arise during the sample preparation and analysis stage; these include deterioration of analytical columns in HPLC; contamination in the mobile phase; issues arising from the complexity of sample matrices in LCMS; and contamination of other stages of LCMS. These hamper the bioanalytical test validation and simultaneously affect the quality standards, thereby limiting the growth of the bioanalytical testing services market.

Bioanalytical Testing Services Market: Segmental Overview

Based on services, the 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. Furthermore, the same segment is anticipated to register the highest CAGR from 2022 to 2030. Cell-based assays are commonly used to determine the biological activity (potency) of the drug product or drug substance and discover the mechanism of action (MOA), as well as for cytotoxicity testing and early-stage proof-of-principal studies. While in immunogenicity studies, it helps in determining drug neutralization effect of antibodies produced in the patient's body.

Based on disease indication, the bioanalytical testing services market is segmented into cardiovascular, neurological disorders (CNS), metabolic disorders, oncology, sexual health, bone disease, and others. In 2022, the oncology segment held the market's largest share. Also, the same segment is expected to grow in demand at the fastest CAGR from 2022 to 2030, owing to the advances in oncology for pain relief, chemotherapy, and other therapies.

Based on end users, the bioanalytical testing services market is segmented into pharmaceutical and biopharmaceutical companies, contract research organizations (CRO), contract development and manufacturing organization (CDMO), and others. In 2022, the pharmaceutical and biopharmaceutical companies segment held the largest market share. Furthermore, the same segment is expected to witness growth in demand at the fastest CAGR from 2022 to 2030. The bioanalytical test services aim to eliminate the risks involved from the beginning of the pharmaceutical production to the final product release. Thus, the cruciality of bioanalytical testing services in drug discovery and development drives the bioanalytical testing services market for the pharmaceutical and biopharmaceutical companies segment.

Bioanalytical Testing Services Market: Geographical Overview

North America holds the largest share of the global bioanalytical testing services market, whereas the Asia Pacific is the fastest-growing region. The market in North America is expected to grow during the forecast period owing to 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. Asia Pacific registered the highest CAGR in the global bioanalytical testing services testing market. The market in the region is expected to grow significantly in countries, including China, India, and Japan, in the coming years. The Asia Pacific market is expected to grow due to the increasing demand for outsourcing services in the low-cost labor markets. Therefore, the region holds huge potential for the bioanalytical testing services market players to grow during the forecast period.

A few of the major primary and secondary sources referred to while preparing the report on the bioanalytical testing services market are the World Bank Data, National Health Service (NHS), FDA (Food and Drug Administration), EMA (European Medicines Agency), and EPA (Environmental Protection Agency).

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ご注文は、お電話またはWEBから承ります。お見積もりの作成もお気軽にご相談ください。

本レポートと同分野（医療機器）の最新刊レポート

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