生物製剤の安全性試験市場：製品タイプ、用途、エンドユーザー別-2025-2030年の世界予測

生物製剤の安全性試験市場は、2023年に56億2,000万米ドルと評価され、2024年には64億3,000万米ドルに達すると予測され、CAGR 14.71％で成長し、2030年には147億米ドルに達すると予測されています。

調査手法には、ワクチン、血液製剤、その他のバイオテクノロジー由来の治療薬など、生物学的製剤の安全性を確保するために利用される手順や手法が含まれます。公衆衛生を守るために不可欠なこれらの検査は、製品の承認や流通の前に、細菌、ウイルス、その他の汚染物質がないことを確認するために不可欠です。生物製剤の安全性試験のアプリケーションは、細胞バンクの特性評価、原料試験、プロセス不純物分析、最終製品試験など複数の段階にまたがり、主に製薬業界やバイオテクノロジー業界にサービスを提供しています。市場成長の大きな原動力は、バイオ医薬品に対する需要の高まりと、厳格な安全性試験を義務付ける厳しい規制の枠組みです。迅速な検出テストの開発や検査プロセスの自動化などの技術的進歩は、大きな潜在機会を提供します。企業は、検査能力を拡大し、進化する規制要件に対応するために、既存技術の強化や他のバイオテクノロジー企業との提携に注力すべきです。バイオシミラーと個別化医療の拡大も、潜在的な成長の可能性を浮き彫りにしています。しかし、高度な検査手法に伴う高コストや専門人材の必要性による制約があり、特に中小企業の成長を妨げています。地域間の規制の違いが世界の検査の標準化をさらに複雑にしており、国際的な市場プレーヤーにとって課題となっています。イノベーションの中心は、プロセスを合理化し、市場投入までの時間を短縮するための、費用対効果の高い、迅速な、マルチパラメーター検査であるべきです。新規診断ツール、バイオセンサー、予測分析のためのAIの統合に焦点を当てた調査への投資は、安全性の結果を向上させ、市場のプレゼンスを強化することができます。市場力学はダイナミックで高度に規制されているため、その複雑性を乗り切るための適応戦略が必要です。規制の変化、技術革新、市場の需要を継続的に評価することは、この重要な分野で競争力を維持し、成長を促進する上で極めて重要です。

市場力学：急速に進化する生物製剤の安全性試験市場の主要市場インサイトを公開

生物製剤の安全性試験市場は、需要と供給のダイナミックな相互作用によって変貌を遂げています。このような市場力学の進化を理解することで、企業は十分な情報に基づいた投資決定、戦略的意思決定、新たなビジネスチャンスの獲得を行うことができます。これらの動向を包括的に把握することで、企業は政治的、地理的、技術的、社会的、経済的な領域にわたる様々なリスクを軽減することができ、また、消費者行動とそれが製造コストや購買動向に与える影響をより明確に理解することができます。

• 市場促進要因
  • 臨床試験における安全性モニタリングと試験のニーズの急増
  • 医薬品リコールの増加、生物製剤の安全性に関する政府の取り組みと基準
  • 医療機器の生産と取引の増加と品質評価
• 市場抑制要因
  • 医薬品開発における安全性試験の高コスト化
• 市場機会
  • 生物学的製剤の安全性試験における技術革新と進歩
  • 安全性向上のための組換えタンパク質や細胞・遺伝子治療の調査拡大
• 市場の課題
  • 正確な試験を実施する熟練した専門家の不足

ポーターのファイブフォース：生物製剤の安全性試験市場をナビゲートする戦略ツール

ポーターのファイブフォースフレームワークは、市場情勢の競合情勢を理解するための重要なツールです。ポーターのファイブフォース・フレームワークは、企業の競争力を評価し、戦略的機会を探るための明確な手法を提供します。このフレームワークは、企業が市場内の勢力図を評価し、新規事業の収益性を判断するのに役立ちます。これらの洞察により、企業は自社の強みを活かし、弱みに対処し、潜在的な課題を回避することができ、より強靭な市場でのポジショニングを確保することができます。

PESTLE分析：生物製剤の安全性試験市場における外部からの影響の把握

外部マクロ環境要因は、生物製剤の安全性試験市場の業績ダイナミクスを形成する上で極めて重要な役割を果たします。政治的、経済的、社会的、技術的、法的、環境的要因の分析は、これらの影響をナビゲートするために必要な情報を提供します。PESTLE要因を調査することで、企業は潜在的なリスクと機会をよりよく理解することができます。この分析により、企業は規制、消費者の嗜好、経済動向の変化を予測し、先を見越した積極的な意思決定を行う準備ができます。

市場シェア分析生物製剤の安全性試験市場における競合情勢の把握

生物製剤の安全性試験市場の詳細な市場シェア分析により、ベンダーの業績を包括的に評価することができます。企業は、収益、顧客ベース、成長率などの主要指標を比較することで、競争上のポジショニングを明らかにすることができます。この分析により、市場の集中、断片化、統合の動向が明らかになり、ベンダーは競争が激化する中で自社の地位を高める戦略的意思決定を行うために必要な知見を得ることができます。

FPNVポジショニング・マトリックス生物製剤の安全性試験市場におけるベンダーのパフォーマンス評価

FPNVポジショニングマトリックスは、生物製剤の安全性試験市場においてベンダーを評価するための重要なツールです。このマトリックスにより、ビジネス組織はベンダーのビジネス戦略と製品満足度に基づき評価することで、目標に沿った十分な情報に基づいた意思決定を行うことができます。4つの象限によってベンダーを明確かつ正確にセグメント化し、戦略目標に最適なパートナーやソリューションを特定することができます。

戦略分析と推奨生物製剤の安全性試験市場における成功への道筋を描く

生物製剤の安全性試験市場の戦略分析は、世界市場でのプレゼンス強化を目指す企業にとって不可欠です。主要なリソース、能力、業績指標を見直すことで、企業は成長機会を特定し、改善に取り組むことができます。このアプローチにより、競合情勢における課題を克服し、新たなビジネスチャンスを活かして長期的な成功を収めるための体制を整えることができます。

本レポートでは、主要な注目分野を網羅した市場の包括的な分析を提供しています：

1.市場の浸透度：現在の市場環境の詳細なレビュー、主要企業による広範なデータ、市場でのリーチと全体的な影響力の評価。

2.市場の開拓度：新興市場における成長機会を特定し、既存分野における拡大可能性を評価し、将来の成長に向けた戦略的ロードマップを提供します。

3.市場の多様化：最近の製品発売、未開拓の地域、業界の主要な進歩、市場を形成する戦略的投資を分析します。

4.競合の評価と情報：競合情勢を徹底的に分析し、市場シェア、事業戦略、製品ポートフォリオ、認証、規制当局の承認、特許動向、主要企業の技術進歩などを検証します。

5.製品開発およびイノベーション：将来の市場成長を促進すると期待される最先端技術、研究開発活動、製品イノベーションをハイライトしています。

また、利害関係者が十分な情報を得た上で意思決定できるよう、重要な質問にも答えています：

1.現在の市場規模と今後の成長予測は？

2.最高の投資機会を提供する製品、セグメント、地域はどこか？

3.市場を形成する主な技術動向と規制の影響とは？

4.主要ベンダーの市場シェアと競合ポジションは？

5.ベンダーの市場参入・撤退戦略の原動力となる収益源と戦略的機会は何か？

目次

第1章 序文

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 市場の概要

第5章 市場洞察

• 市場力学
  • 促進要因
    • 臨床試験活動における安全性の監視とテストの必要性が急増
    • 医薬品の回収件数の増加と、生物学的製剤の安全性に関する政府の取り組みと基準
    • 医療機器の生産と貿易の増加と品質評価
  • 抑制要因
    • 医薬品開発における安全性試験の高コスト要件
  • 機会
    • 生物学的安全性試験における技術革新と進歩
    • 安全性向上のための組み換えタンパク質および細胞・遺伝子治療の調査拡大
  • 課題
    • 正確な検査を実施できる熟練した専門家の不足
• 市場セグメンテーション分析
  • 製品：バイオ医薬品企業が複雑な規制環境を乗り越えるためのサービスの重要性
  • 用途：ワクチンと新治療薬の有効性と安全性を検証するためのワクチンおよび治療薬開発における採用の増加
• ポーターのファイブフォース分析
• PESTEL分析
  • 政治的
  • 経済
  • 社交
  • 技術的
  • 法律上
  • 環境

第6章 生物製剤の安全性試験市場：製品別

• 消耗品
• 機器
• サービス

第7章 生物製剤の安全性試験市場テストタイプ別

• バイオバーデン試験
• エンドトキシン検査
• マイコプラズマ検査
• 残留宿主細胞タンパク質およびDNA検出テスト
• 無菌試験
• ウイルス安全性試験

第8章 生物製剤の安全性試験市場：用途別

• 血液および血液関連製品の開発
• 細胞・遺伝子治療製品の開発
• モノクローナル抗体の開発
• ワクチンと治療薬の開発

第9章 生物製剤の安全性試験市場：エンドユーザー別

• 学術調査機関
• 契約調査機関/契約製造機関
• 製薬・バイオテクノロジー企業

第10章 南北アメリカの生物製剤の安全性試験市場

• アルゼンチン
• ブラジル
• カナダ
• メキシコ
• 米国

第11章 アジア太平洋地域の生物製剤の安全性試験市場

• オーストラリア
• 中国
• インド
• インドネシア
• 日本
• マレーシア
• フィリピン
• シンガポール
• 韓国
• 台湾
• タイ
• ベトナム

第12章 欧州・中東・アフリカの生物製剤の安全性試験市場

• デンマーク
• エジプト
• フィンランド
• フランス
• ドイツ
• イスラエル
• イタリア
• オランダ
• ナイジェリア
• ノルウェー
• ポーランド
• カタール
• ロシア
• サウジアラビア
• 南アフリカ
• スペイン
• スウェーデン
• スイス
• トルコ
• アラブ首長国連邦
• 英国

第13章 競合情勢

• 市場シェア分析2023
• FPNVポジショニングマトリックス, 2023
• 競合シナリオ分析
  • オックスフォード・ナノポア・テクノロジーズとパソクエストが画期的なバイオ医薬品安全性試験で協力
  • バイオ医薬品生産の拡大：テバのウルム工場の戦略的展望と将来計画
  • クリーンセルの拡張により、欧州におけるバイオ医薬品の試験能力が向上
• 戦略分析と提言

企業一覧

• Accugen Laboratories, Inc.
• Agilent Technologies, Inc.
• Almac Group Limited
• Associates of Cape Cod, Inc.
• Becton, Dickinson and Company
• Bio-Rad Laboratories, Inc.
• bioMerieux SA
• BSL Bioservice Scientific Laboratories Munich GmbH
• Charles River Laboratories International, Inc.
• Creative Biolabs, Inc.
• Eagle Analytical Services
• Eurofins Scientific Limited
• F. Hoffmann-La Roche Ltd.
• FUJIFILM Wako Pure Chemical Corporation
• Laboratory Corporation of America Holdings
• Lonza Group AG
• Maravai Lifesciences
• Merck KGaA
• Microcoat Biotechnologie GmbH
• Nelson Laboratories, LLC by Sterigenics International LLC
• Pacific BioLabs by Northview Biosciences, Inc.
• Promega Corporation
• PromoCell GmbH
• QIAGEN GmbH
• Rockland Immunochemicals, Inc.
• Samsung Biologics
• Sartorius AG
• SGS S.A.
• SGS Societe Generale de Surveillance SA
• Thermo Fisher Scientific, Inc.

LIST OF FIGURES

• FIGURE 1. BIOLOGICS SAFETY TESTING MARKET RESEARCH PROCESS
• FIGURE 2. BIOLOGICS SAFETY TESTING MARKET SIZE, 2023 VS 2030
• FIGURE 3. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, 2018-2030 (USD MILLION)
• FIGURE 4. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY REGION, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 5. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 6. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2023 VS 2030 (%)
• FIGURE 7. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 8. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2023 VS 2030 (%)
• FIGURE 9. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 10. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2023 VS 2030 (%)
• FIGURE 11. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 12. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2023 VS 2030 (%)
• FIGURE 13. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 14. AMERICAS BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
• FIGURE 15. AMERICAS BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 16. UNITED STATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY STATE, 2023 VS 2030 (%)
• FIGURE 17. UNITED STATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY STATE, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 18. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
• FIGURE 19. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 20. EUROPE, MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
• FIGURE 21. EUROPE, MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
• FIGURE 22. BIOLOGICS SAFETY TESTING MARKET SHARE, BY KEY PLAYER, 2023
• FIGURE 23. BIOLOGICS SAFETY TESTING MARKET, FPNV POSITIONING MATRIX, 2023

LIST OF TABLES

• TABLE 1. BIOLOGICS SAFETY TESTING MARKET SEGMENTATION & COVERAGE
• TABLE 2. UNITED STATES DOLLAR EXCHANGE RATE, 2018-2023
• TABLE 3. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, 2018-2030 (USD MILLION)
• TABLE 4. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY REGION, 2018-2030 (USD MILLION)
• TABLE 5. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2018-2030 (USD MILLION)
• TABLE 6. BIOLOGICS SAFETY TESTING MARKET DYNAMICS
• TABLE 7. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 8. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY CONSUMABLE, BY REGION, 2018-2030 (USD MILLION)
• TABLE 9. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY INSTRUMENTS, BY REGION, 2018-2030 (USD MILLION)
• TABLE 10. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY SERVICES, BY REGION, 2018-2030 (USD MILLION)
• TABLE 11. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 12. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY BIOBURDEN TESTS, BY REGION, 2018-2030 (USD MILLION)
• TABLE 13. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY ENDOTOXIN TESTS, BY REGION, 2018-2030 (USD MILLION)
• TABLE 14. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY MYCOPLASMA TESTS, BY REGION, 2018-2030 (USD MILLION)
• TABLE 15. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS, BY REGION, 2018-2030 (USD MILLION)
• TABLE 16. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY STERILITY TESTS, BY REGION, 2018-2030 (USD MILLION)
• TABLE 17. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY VIRUS SAFETY TESTS, BY REGION, 2018-2030 (USD MILLION)
• TABLE 18. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 19. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY BLOOD & BLOOD-RELATED PRODUCTS DEVELOPMENT, BY REGION, 2018-2030 (USD MILLION)
• TABLE 20. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT, BY REGION, 2018-2030 (USD MILLION)
• TABLE 21. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY MONOCLONAL ANTIBODIES DEVELOPMENT, BY REGION, 2018-2030 (USD MILLION)
• TABLE 22. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY VACCINE & THERAPEUTICS DEVELOPMENT, BY REGION, 2018-2030 (USD MILLION)
• TABLE 23. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 24. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY ACADEMIC & RESEARCH INSTITUTES, BY REGION, 2018-2030 (USD MILLION)
• TABLE 25. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY CONTRACT RESEARCH ORGANIZATION/ CONTRACT MANUFACTURING ORGANIZATION, BY REGION, 2018-2030 (USD MILLION)
• TABLE 26. GLOBAL BIOLOGICS SAFETY TESTING MARKET SIZE, BY PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY REGION, 2018-2030 (USD MILLION)
• TABLE 27. AMERICAS BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 28. AMERICAS BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 29. AMERICAS BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 30. AMERICAS BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 31. AMERICAS BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2018-2030 (USD MILLION)
• TABLE 32. ARGENTINA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 33. ARGENTINA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 34. ARGENTINA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 35. ARGENTINA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 36. BRAZIL BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 37. BRAZIL BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 38. BRAZIL BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 39. BRAZIL BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 40. CANADA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 41. CANADA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 42. CANADA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 43. CANADA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 44. MEXICO BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 45. MEXICO BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 46. MEXICO BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 47. MEXICO BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 48. UNITED STATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 49. UNITED STATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 50. UNITED STATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 51. UNITED STATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 52. UNITED STATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY STATE, 2018-2030 (USD MILLION)
• TABLE 53. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 54. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 55. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 56. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 57. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2018-2030 (USD MILLION)
• TABLE 58. AUSTRALIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 59. AUSTRALIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 60. AUSTRALIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 61. AUSTRALIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 62. CHINA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 63. CHINA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 64. CHINA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 65. CHINA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 66. INDIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 67. INDIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 68. INDIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 69. INDIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 70. INDONESIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 71. INDONESIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 72. INDONESIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 73. INDONESIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 74. JAPAN BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 75. JAPAN BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 76. JAPAN BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 77. JAPAN BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 78. MALAYSIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 79. MALAYSIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 80. MALAYSIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 81. MALAYSIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 82. PHILIPPINES BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 83. PHILIPPINES BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 84. PHILIPPINES BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 85. PHILIPPINES BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 86. SINGAPORE BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 87. SINGAPORE BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 88. SINGAPORE BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 89. SINGAPORE BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 90. SOUTH KOREA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 91. SOUTH KOREA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 92. SOUTH KOREA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 93. SOUTH KOREA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 94. TAIWAN BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 95. TAIWAN BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 96. TAIWAN BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 97. TAIWAN BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 98. THAILAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 99. THAILAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 100. THAILAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 101. THAILAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 102. VIETNAM BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 103. VIETNAM BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 104. VIETNAM BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 105. VIETNAM BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 106. EUROPE, MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 107. EUROPE, MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 108. EUROPE, MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 109. EUROPE, MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 110. EUROPE, MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY, 2018-2030 (USD MILLION)
• TABLE 111. DENMARK BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 112. DENMARK BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 113. DENMARK BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 114. DENMARK BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 115. EGYPT BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 116. EGYPT BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 117. EGYPT BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 118. EGYPT BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 119. FINLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 120. FINLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 121. FINLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 122. FINLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 123. FRANCE BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 124. FRANCE BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 125. FRANCE BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 126. FRANCE BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 127. GERMANY BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 128. GERMANY BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 129. GERMANY BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 130. GERMANY BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 131. ISRAEL BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 132. ISRAEL BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 133. ISRAEL BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 134. ISRAEL BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 135. ITALY BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 136. ITALY BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 137. ITALY BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 138. ITALY BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 139. NETHERLANDS BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 140. NETHERLANDS BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 141. NETHERLANDS BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 142. NETHERLANDS BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 143. NIGERIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 144. NIGERIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 145. NIGERIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 146. NIGERIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 147. NORWAY BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 148. NORWAY BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 149. NORWAY BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 150. NORWAY BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 151. POLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 152. POLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 153. POLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 154. POLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 155. QATAR BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 156. QATAR BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 157. QATAR BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 158. QATAR BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 159. RUSSIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 160. RUSSIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 161. RUSSIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 162. RUSSIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 163. SAUDI ARABIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 164. SAUDI ARABIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 165. SAUDI ARABIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 166. SAUDI ARABIA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 167. SOUTH AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 168. SOUTH AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 169. SOUTH AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 170. SOUTH AFRICA BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 171. SPAIN BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 172. SPAIN BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 173. SPAIN BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 174. SPAIN BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 175. SWEDEN BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 176. SWEDEN BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 177. SWEDEN BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 178. SWEDEN BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 179. SWITZERLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 180. SWITZERLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 181. SWITZERLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 182. SWITZERLAND BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 183. TURKEY BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 184. TURKEY BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 185. TURKEY BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 186. TURKEY BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 187. UNITED ARAB EMIRATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 188. UNITED ARAB EMIRATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 189. UNITED ARAB EMIRATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 190. UNITED ARAB EMIRATES BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 191. UNITED KINGDOM BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2018-2030 (USD MILLION)
• TABLE 192. UNITED KINGDOM BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST TYPE, 2018-2030 (USD MILLION)
• TABLE 193. UNITED KINGDOM BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2018-2030 (USD MILLION)
• TABLE 194. UNITED KINGDOM BIOLOGICS SAFETY TESTING MARKET SIZE, BY END-USER, 2018-2030 (USD MILLION)
• TABLE 195. BIOLOGICS SAFETY TESTING MARKET SHARE, BY KEY PLAYER, 2023
• TABLE 196. BIOLOGICS SAFETY TESTING MARKET, FPNV POSITIONING MATRIX, 2023

The Biologics Safety Testing Market was valued at USD 5.62 billion in 2023, expected to reach USD 6.43 billion in 2024, and is projected to grow at a CAGR of 14.71%, to USD 14.70 billion by 2030.

Biologics safety testing encompasses the procedures and methodologies utilized to ensure the safety of biological products, which include vaccines, blood products, and other biotechnology-derived therapeutics. Essential for safeguarding public health, these tests are imperative to confirm the absence of bacterial, viral, and other contaminants before product approval and distribution. The application of biologics safety testing spans across multiple stages, including cell bank characterization, raw materials testing, process impurities analysis, and final product testing, primarily serving the pharmaceutical and biotechnology industries. Market growth is largely driven by the escalating demand for biopharmaceuticals, coupled with stringent regulatory frameworks mandating rigorous safety studies. Technological advancements, such as the development of rapid detection tests and automation in testing processes, offer substantial potential opportunities. Businesses should focus on enhancing existing technologies and collaborating with other biotech firms to broaden their testing capabilities and meet evolving regulatory requirements. The expansion of biosimilars and personalized medicine also highlights potential growth avenues. However, the market faces limitations due to high costs associated with sophisticated testing methodologies and the requirement for expert personnel, impeding growth, especially in smaller companies. Regulatory differences across regions further complicate global test standardization, posing challenges for international market players. Innovation should center around cost-effective, rapid, and multi-parameter tests to streamline processes and reduce time-to-market. Investment in research focusing on novel diagnostic tools, biosensors, and integrating AI for predictive analysis can enhance safety outcomes, thus fortifying market presence. Given its dynamic and highly regulated nature, the biologics safety testing market necessitates adaptive strategies to navigate its complexities. Continual assessment of regulatory changes, technical innovation, and market demands is crucial to maintaining competitiveness and fostering growth in this vital sector.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biologics Safety Testing Market

The Biologics Safety Testing Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Exponential need for safety monitoring & testing in clinical trials activities
  • Growing number of drug recalls and government initiatives and standards for biologics product safety
  • Increasing production and trade of medical devices and their quality evaluation
• Market Restraints
  • High-cost requirement of safety testing for the development of drugs
• Market Opportunities
  • Technological innovation and advancements in biologic safety testing
  • Expanding research for improved safety recombinant protein and cell & gene therapy
• Market Challenges
  • Lack of skilled professionals to perform accurate testing

Porter's Five Forces: A Strategic Tool for Navigating the Biologics Safety Testing Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Biologics Safety Testing Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Biologics Safety Testing Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Biologics Safety Testing Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Biologics Safety Testing Market

A detailed market share analysis in the Biologics Safety Testing Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Biologics Safety Testing Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Biologics Safety Testing Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Biologics Safety Testing Market

A strategic analysis of the Biologics Safety Testing Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Biologics Safety Testing Market, highlighting leading vendors and their innovative profiles. These include Accugen Laboratories, Inc., Agilent Technologies, Inc., Almac Group Limited, Associates of Cape Cod, Inc., Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., bioMerieux SA, BSL Bioservice Scientific Laboratories Munich GmbH, Charles River Laboratories International, Inc., Creative Biolabs, Inc., Eagle Analytical Services, Eurofins Scientific Limited, F. Hoffmann-La Roche Ltd., FUJIFILM Wako Pure Chemical Corporation, Laboratory Corporation of America Holdings, Lonza Group AG, Maravai Lifesciences, Merck KGaA, Microcoat Biotechnologie GmbH, Nelson Laboratories, LLC by Sterigenics International LLC, Pacific BioLabs by Northview Biosciences, Inc., Promega Corporation, PromoCell GmbH, QIAGEN GmbH, Rockland Immunochemicals, Inc., Samsung Biologics, Sartorius AG, SGS S.A., SGS Societe Generale de Surveillance SA, and Thermo Fisher Scientific, Inc..

Market Segmentation & Coverage

This research report categorizes the Biologics Safety Testing Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Product, market is studied across Consumable, Instruments, and Services.
• Based on Test Type, market is studied across Bioburden Tests, Endotoxin Tests, Mycoplasma Tests, Residual Host-Cell Proteins & DNA Detection Tests, Sterility Tests, and Virus Safety Tests.
• Based on Application, market is studied across Blood & Blood-Related Products Development, Cellular & Gene Therapy Products Development, Monoclonal Antibodies Development, and Vaccine & Therapeutics Development.
• Based on End-User, market is studied across Academic & Research Institutes, Contract Research Organization/ Contract Manufacturing Organization, and Pharmaceutical & Biotechnology Companies.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Exponential need for safety monitoring & testing in clinical trials activities
    • 5.1.1.2. Growing number of drug recalls and government initiatives and standards for biologics product safety
    • 5.1.1.3. Increasing production and trade of medical devices and their quality evaluation
  • 5.1.2. Restraints
    • 5.1.2.1. High-cost requirement of safety testing for the development of drugs
  • 5.1.3. Opportunities
    • 5.1.3.1. Technological innovation and advancements in biologic safety testing
    • 5.1.3.2. Expanding research for improved safety recombinant protein and cell & gene therapy
  • 5.1.4. Challenges
    • 5.1.4.1. Lack of skilled professionals to perform accurate testing
• 5.2. Market Segmentation Analysis
  • 5.2.1. Product: Cruciality of services for biopharmaceutical companies to navigate the complex regulatory landscapes
  • 5.2.2. Application: Increasing adoption in vaccine & therapeutics development to validate the effectiveness and safety of vaccines and new therapeutic drugs
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Biologics Safety Testing Market, by Product

• 6.1. Introduction
• 6.2. Consumable
• 6.3. Instruments
• 6.4. Services

7. Biologics Safety Testing Market, by Test Type

• 7.1. Introduction
• 7.2. Bioburden Tests
• 7.3. Endotoxin Tests
• 7.4. Mycoplasma Tests
• 7.5. Residual Host-Cell Proteins & DNA Detection Tests
• 7.6. Sterility Tests
• 7.7. Virus Safety Tests

8. Biologics Safety Testing Market, by Application

• 8.1. Introduction
• 8.2. Blood & Blood-Related Products Development
• 8.3. Cellular & Gene Therapy Products Development
• 8.4. Monoclonal Antibodies Development
• 8.5. Vaccine & Therapeutics Development

9. Biologics Safety Testing Market, by End-User

• 9.1. Introduction
• 9.2. Academic & Research Institutes
• 9.3. Contract Research Organization/ Contract Manufacturing Organization
• 9.4. Pharmaceutical & Biotechnology Companies

10. Americas Biologics Safety Testing Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Biologics Safety Testing Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Biologics Safety Testing Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Oxford Nanopore Technologies and PathoQuest Collaborate on Groundbreaking Biopharmaceutical Safety Test
  • 13.3.2. Expanding Biologics Production: A Strategic Look at Teva's Ulm Facility and Future Plans
  • 13.3.3. Expansion of Clean Cells Advances Biopharmaceutical Testing Capabilities in Europe
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Accugen Laboratories, Inc.
• 2. Agilent Technologies, Inc.
• 3. Almac Group Limited
• 4. Associates of Cape Cod, Inc.
• 5. Becton, Dickinson and Company
• 6. Bio-Rad Laboratories, Inc.
• 7. bioMerieux SA
• 8. BSL Bioservice Scientific Laboratories Munich GmbH
• 9. Charles River Laboratories International, Inc.
• 10. Creative Biolabs, Inc.
• 11. Eagle Analytical Services
• 12. Eurofins Scientific Limited
• 13. F. Hoffmann-La Roche Ltd.
• 14. FUJIFILM Wako Pure Chemical Corporation
• 15. Laboratory Corporation of America Holdings
• 16. Lonza Group AG
• 17. Maravai Lifesciences
• 18. Merck KGaA
• 19. Microcoat Biotechnologie GmbH
• 20. Nelson Laboratories, LLC by Sterigenics International LLC
• 21. Pacific BioLabs by Northview Biosciences, Inc.
• 22. Promega Corporation
• 23. PromoCell GmbH
• 24. QIAGEN GmbH
• 25. Rockland Immunochemicals, Inc.
• 26. Samsung Biologics
• 27. Sartorius AG
• 28. SGS S.A.
• 29. SGS Societe Generale de Surveillance SA
• 30. Thermo Fisher Scientific, Inc.