市場調査レポート

商品コード

1525466

生物製剤安全性試験の世界市場の評価：製品・サービス別、試験タイプ別、用途別、エンドユーザー別、地域別、機会、予測、2017年～2031年

Biologics Safety Testing Market Assessment, By Product and Services, By Test Type, By Application, By End-user, By Region, Opportunities and Forecast, 2017-2031F

出版日: 2024年08月02日
発行: Markets & Data
ページ情報: 英文 225 Pages
納期: 3～5営業日

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全表示
概要
図表
目次

概要

サンプル依頼リストに入れる

世界の生物製剤安全性試験の市場規模は、予測期間の2024年～2031年に11.80％のCAGRで拡大し、2023年の40億1,000万米ドルから2031年には97億9,000万米ドルに成長すると予測されています。この市場はバイオテクノロジー市場の重要な一部であり、慢性疾患の有病率の上昇、技術の進歩、投資と資金の増加などの要因によって牽引されています。

生物製剤の安全性試験は、治療用生物製剤の有効性と安全性を保証するために極めて重要です。近代的な分子技術が確立されて久しいが、実験室ではいまだに1970年代の動物実験プロトコルが主流です。最近のガイドラインの変更により、バイオ医薬品部門は、次世代シーケンシング（NGS）ベースの試験など、生物製剤の品質管理（QC）における新しい基準に移行し、動物の使用をやめるよう促されています。モノクローナル抗体、ワクチン、組換えタンパク質、ウイルスベクター、細胞・遺伝子治療は、治療用生物製剤という広いカテゴリーに分類される数多くの手法のほんの一部に過ぎません。医薬品開発における動物の使用を減らすという世界の合意がなされた後も、生物製剤の品質管理試験において動物は広範囲に利用されています。この合意は、3R（代替、削減、改良）の理念や、米国や欧州連合（EU）で実施された指令に表れています。動物実験にはコストがかかり、倫理的な懸念に加え、完了までに数週間から数ヶ月を要します。

当レポートでは、世界の生物製剤安全性試験市場について調査し、市場の概要とともに、製品・サービス別、試験タイプ別、用途別、エンドユーザー別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。

市場リーダートップ5の競合マトリックス
参入企業トップ5のSWOT分析
市場の主要参入企業トップ10の情勢
- Charles River Laboratories International Inc
- BSL BIOSERVICE Scientific Laboratories Munich GmbH
- Merck KGaA
- Thermo Fisher Scientific Inc.
- Sartorious AG
- F.Hoffman-La Roche Ltd
- Biomerieux SA
- Eurofins Scientific SE
- Lonza Group AG
- Maravai LifeSciences Holdings, Inc.

図表

List of Tables

Table 1. Pricing Analysis of Products from Key Players
Table 2. Competition Matrix of Top 5 Market Leaders
Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

Figure 1. Global Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 2. Global Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 3. Global Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 4. Global Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 5. Global Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 6. Global Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 7. Global Biologics Safety Testing Market Share (%), By Region, 2017-2031F
Figure 8. North America Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 9. North America Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 10. North America Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 11. North America Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 12. North America Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 13. North America Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 14. North America Biologics Safety Testing Market Share (%), By Country, 2017-2031F
Figure 15. United States Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 16. United States Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 17. United States Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 18. United States Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 19. United States Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 20. United States Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 21. Canada Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 22. Canada Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 23. Canada Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 24. Canada Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 25. Canada Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 26. Canada Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 27. Mexico Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 28. Mexico Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 29. Mexico Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 30. Mexico Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 31. Mexico Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 32. Mexico Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 33. Europe Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 34. Europe Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 35. Europe Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 36. Europe Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 37. Europe Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 38. Europe Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 39. Europe Biologics Safety Testing Market Share (%), By Country, 2017-2031F
Figure 40. Germany Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 41. Germany Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 42. Germany Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 43. Germany Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 44. Germany Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 45. Germany Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 46. France Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 47. France Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 48. France Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 49. France Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 50. France Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 51. France Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 52. Italy Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 53. Italy Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 54. Italy Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 55. Italy Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 56. Italy Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 57. Italy Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 58. United Kingdom Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 59. United Kingdom Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 60. United Kingdom Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 61. United Kingdom Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 62. United Kingdom Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 63. United Kingdom Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 64. Russia Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 65. Russia Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 66. Russia Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 67. Russia Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 68. Russia Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 69. Russia Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 70. Netherlands Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 71. Netherlands Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 72. Netherlands Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 73. Netherlands Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 74. Netherlands Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 75. Netherlands Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 76. Spain Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 77. Spain Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 78. Spain Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 79. Spain Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 80. Spain Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 81. Spain Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 82. Turkey Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 83. Turkey Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 84. Turkey Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 85. Turkey Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 86. Turkey Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 87. Turkey Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 88. Poland Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 89. Poland Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 90. Poland Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 91. Poland Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 92. Poland Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 93. Poland Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 94. South America Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 95. South America Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 96. South America Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 97. South America Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 98. South America Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 99. South America Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 100. South America Biologics Safety Testing Market Share (%), By Country, 2017-2031F
Figure 101. Brazil Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 102. Brazil Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 103. Brazil Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 104. Brazil Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 105. Brazil Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 106. Brazil Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 107. Argentina Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 108. Argentina Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 109. Argentina Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 110. Argentina Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 111. Argentina Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 112. Argentina Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 113. Asia-Pacific Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 114. Asia-Pacific Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 115. Asia-Pacific Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 116. Asia-Pacific Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 117. Asia-Pacific Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 118. Asia-Pacific Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 119. Asia-Pacific Biologics Safety Testing Market Share (%), By Country, 2017-2031F
Figure 120. India Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 121. India Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 122. India Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 123. India Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 124. India Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 125. India Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 126. China Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 127. China Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 128. China Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 129. China Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 130. China Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 131. China Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 132. Japan Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 133. Japan Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 134. Japan Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 135. Japan Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 136. Japan Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 137. Japan Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 138. Australia Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 139. Australia Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 140. Australia Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 141. Australia Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 142. Australia Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 143. Australia Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 144. Vietnam Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 145. Vietnam Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 146. Vietnam Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 147. Vietnam Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 148. Vietnam Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 149. Vietnam Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 150. South Korea Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 151. South Korea Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 152. South Korea Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 153. South Korea Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 154. South Korea Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 155. South Korea Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 156. Indonesia Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 157. Indonesia Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 158. Indonesia Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 159. Indonesia Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 160. Indonesia Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 161. Indonesia Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 162. Philippines Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 163. Philippines Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 164. Philippines Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 165. Philippines Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 166. Philippines Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 167. Philippines Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 168. Middle East & Africa Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 169. Middle East & Africa Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 170. Middle East & Africa Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 171. Middle East & Africa Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 172. Middle East & Africa Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 173. Middle East & Africa Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 174. Middle East & Africa Biologics Safety Testing Market Share (%), By Country, 2017-2031F
Figure 175. Saudi Arabia Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 176. Saudi Arabia Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 177. Saudi Arabia Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 178. Saudi Arabia Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 179. Saudi Arabia Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 180. Saudi Arabia Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 181. UAE Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 182. UAE Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 183. UAE Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 184. UAE Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 185. UAE Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 186. UAE Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 187. South Africa Biologics Safety Testing Market, By Value, In USD Billion, 2017-2031F
Figure 188. South Africa Biologics Safety Testing Market, By Volume, In Thousand Units, 2017-2031F
Figure 189. South Africa Biologics Safety Testing Market Share (%), By Product and Services, 2017-2031F
Figure 190. South Africa Biologics Safety Testing Market Share (%), By Test Type, 2017-2031F
Figure 191. South Africa Biologics Safety Testing Market Share (%), By Application, 2017-2031F
Figure 192. South Africa Biologics Safety Testing Market Share (%), By End-user, 2017-2031F
Figure 193. By Product and Services Map-Market Size (USD Billion) & Growth Rate (%), 2023
Figure 194. By Test Type Map-Market Size (USD Billion) & Growth Rate (%), 2023
Figure 195. By Application Map-Market Size (USD Billion) & Growth Rate (%), 2023
Figure 196. By End-user Map-Market Size (USD Billion) & Growth Rate (%), 2023
Figure 197. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2023

Product Code: MX11687

Global biologics safety testing market is projected to witness a CAGR of 11.80% during the forecast period 2024-2031, growing from USD 4.01 billion in 2023 to USD 9.79 billion in 2031. This market is an important part of the biotechnology market and is driven by factors such as the increasing prevalence of chronic diseases, technological advancements, and increased investments and funding.

Testing for biologics safety is crucial to guarantee the effectiveness and safety of therapeutic biologics. Modern molecular techniques have been around for a while, yet laboratories still mostly use protocols from the 1970s for animal testing. A recent change to guidelines urges the biopharmaceutical sector to transition to new standards in biologics quality control (QC), such as next-generation sequencing (NGS)-based tests, and to stop using animals. Monoclonal antibodies, vaccines, recombinant proteins, viral vectors, and cell and gene therapies are just a few of the many modalities that fall under the broad category of therapeutic biologics. Animals are still extensively utilized in biologics quality control testing even after there was a global agreement to reduce the use of animals in medication development. This agreement is represented in the 3R (replace, reduce, refine) philosophy and directives put in place in the United States and European Union. Animal-based operations come with a price tag and need weeks or even months to complete, in addition to ethical concerns.

Leading science and technology organization Merck finished the second phase of its new USD 31.41 million Biologics Testing Center expansion in China in November 2023, adding 1,500 square meters to the lab. These are Merck's first biosafety labs in this market, giving customers local access to a wide variety of testing services and cell line characterization from pre-clinical research to commercialization.

Increasing Prevalence of Chronic Diseases

The need for biologics testing is driven mostly by the rising incidence of chronic illnesses. Advanced treatment alternatives, especially biologics like monoclonal antibodies and other targeted medicines, are needed as chronic illnesses like diabetes, cancer, and autoimmune disorders grow increasingly prevalent. Extensive testing is frequently necessary to guarantee the safety and effectiveness of biologics across a range of patient groups. The increasing number of patients related to chronic diseases calls for improved biological testing capacities in order to facilitate the development of customized medicine strategies that address individual patient demands and eventually lead to better treatment results.

According to the British Heart Foundation Report 2024, more than 200 million people globally are living with coronary heart disease. Out of 200 million coronary heart patients, 110 million are men, and 90 million are women. As per the World Health Organization (WHO), in 2022, there were 20 million new cancer patients, and close to 9.7 million patients died due to cancer.

Rising Adoption of Advanced Analytics Solutions in Biologics Safety Testing and Clinical Trials

Healthcare leaders see a wide range of opportunities to improve patient care by bringing data from disparate sources together in a meaningful way. Healthcare professionals believe data-driven insights could help optimize treatment plans and care pathways, identify evidence-based practices, and reduce waiting lists for diagnostic and elective procedures. However, to deliver on these possibilities, healthcare leaders recognize they first need to get the foundations right. The foundation of seamless data integration can be done by improving the accuracy of patient data, improving drug efficacy in biologics testing, enhancing interoperability among different platforms and healthcare settings, and strengthening data security and privacy. Healthcare executives see several chances to enhance patient care via the integration of data from various sources. Healthcare practitioners think data-driven insights might assist in finding evidence-based treatments, streamline treatment plans and care pathways, and shorten waiting lists for elective and diagnostic procedures. Healthcare executives understand that, in order to fully realize these opportunities, they must first lay the necessary groundwork. Improving patient data accuracy, boosting platform and healthcare setting interoperability, and fortifying data security and privacy are the cornerstones of a smooth data integration process.

In 2024, Yotta Data Services Pvt Ltd. announced a partnership with Partex NV to improve healthcare services in drug discovery and patient care. The partnership will leverage Yotta's Shakti-Cloud platform, backed by Nvidia H100 GPU processing infrastructure, to enable Partex's AI-driven healthcare solutions. The collaboration intends to create AI-based solutions that will improve healthcare services' efficacy and efficiency, especially in the areas of patient care and drug development.

Residual Host Contamination Detection Tests Dominate the Market

Biologics safety testing can be divided into the following categories - residual host contamination detection tests, adventitious agent detection tests, bioburden tests, cell line authentication & characterization tests, sterility tests, endotoxin tests, and many others. Assays for detecting residual host contamination are crucial to the biopharmaceutical industry and testing for residual host cell DNA (HCDNA) is one area of particular importance. These tests aim to locate and quantify any host cell DNA that is still needed to produce biologics, such as therapeutic proteins and vaccines. These tests usually employ sensitive techniques, such as Polymerase Chain Reaction (PCR), to identify and measure any leftover DNA remains. Modern technologies enable the identification of even minute amounts, which is crucial for ensuring the safety of products. Tests for residual host contamination provide strong regulatory compliance, enhanced safety, and quality assurance, among other clinical benefits.

Pharmaceutical and Biotechnology Companies Dominate the Market

To guarantee the effectiveness and safety of biologics such as therapeutic proteins and vaccines, pharmaceutical and biotechnology businesses are essential to the safety testing process of biologics. Throughout the development process, these businesses oversee carrying out thorough evaluations that involve testing for toxins, leftover host cell proteins, and viral safety. Advanced testing procedures are necessary to address specific safety issues related to various biologics products because of the complexity and variety of biologics. For instance, Skan AG, a leader in cleanroom technology, decontamination procedures, and isolators for the aseptic manufacturing of biopharmaceuticals launched Claire Neo in June 2024. Claire Neo is a new line of safety cabinets designed to suit future laboratory standards in the pharmaceutical, medical, and biological sectors. Users may be as flexible as possible with the new safety cabinets. The manufacture in metric increments of 30 cm is the main emphasis of this new flexibility.

Future Market Scenario (2024-2031F)

Integration of Bioinformatics and Data Analytics: Bioinformatics will enable the integration and analysis of large datasets generated during biologics safety testing. This will help identify trends, understand complex interactions, and ensure compliance with regulatory standards, ultimately enhancing the overall safety profile of biologic therapies.

Introduction of Rapid Microbiological Methods: The development and implementation of rapid microbiological testing techniques will facilitate quicker detection of microbial contamination in biologics. These methods can provide results in real-time, which is crucial for maintaining the safety and quality of biologic products during manufacturing.

NGS Will Become an Important Part of Biologics Testing: The adoption of NGS in safety testing will allow for comprehensive analysis of genetic material in biologics, enabling the detection of contaminants and residual host cell DNA with greater precision. This technology can significantly improve the reliability of safety assessments.

Key Player Landscape and Outlook

Key players in this sector, including Charles River Laboratories International, Inc., BSL BIOSERVICE Scientific Laboratories Munich GmbH, Merck KGaA, Thermo Fisher Scientific Inc., Sartorious AG, F.Hoffman-La Roche Ltd, Biomerieux SA, Eurofins Scientific SE, Lonza Group AG, Maravai LifeSciences Holdings, Inc. are actively enhancing their service offerings and expanding their technological capabilities to meet stringent regulatory standards and ensure the safety of biologics. Companies are also engaging in strategic acquisitions and partnerships to bolster their market positions and improve testing methodologies, thereby addressing the increasing demand for comprehensive safety evaluations in the biopharmaceutical industry.

SAMDI Tech, Inc., a provider of high-throughput screening (HTS) technologies, was acquired by Charles River Laboratories, Inc. in January 2023. By utilizing SAMDI Tech's technology to speed up the identification of viable drug candidates, this acquisition seeks to improve drug discovery procedures.

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Biologics Safety Testing Market Outlook, 2017-2031F

4.1. Market Size Analysis & Forecast
- 4.1.1. By Value
- 4.1.2. By Volume
4.2. Market Share Analysis & Forecast
- 4.2.1. By Product and Services
  - 4.2.1.1. Consumables
  - 4.2.1.2. Instruments
  - 4.2.1.3. Services
    - 4.2.1.3.1. Mycoplasma Testing Services
    - 4.2.1.3.2. Sterility Testing Services
    - 4.2.1.3.3. Endotoxin Testing Services
    - 4.2.1.3.4. Virus Safety Testing Services
    - 4.2.1.3.5. Bioburden Testing Services
    - 4.2.1.3.6. Others
- 4.2.2. By Test Type
  - 4.2.2.1. Residual Host Contamination Detection Tests
  - 4.2.2.2. Adventitious Agent Detection Tests
  - 4.2.2.3. Bioburden Tests
  - 4.2.2.4. Cell Line Authentication and Characterization Tests
  - 4.2.2.5. Sterility Tests
  - 4.2.2.6. Endotoxin Tests
  - 4.2.2.7. Others
- 4.2.3. By Application
  - 4.2.3.1. Vaccines and Therapeutics
  - 4.2.3.2. Blood and Blood-based Products
  - 4.2.3.3. Gene Therapy
  - 4.2.3.4. Tissue and Tissue-based Products
  - 4.2.3.5. Stem Cell
- 4.2.4. By End-user
  - 4.2.4.1. Pharmaceutical and Biotechnology Companies
  - 4.2.4.2. CRO and CDMOs
  - 4.2.4.3. Academic and Research Institutes
- 4.2.5. By Region
  - 4.2.5.1. North America
  - 4.2.5.2. Europe
  - 4.2.5.3. Asia-Pacific
  - 4.2.5.4. South America
  - 4.2.5.5. Middle East and Africa
- 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
4.3. Market Map Analysis, 2023
- 4.3.1. By Product and Services
- 4.3.2. By Test Type
- 4.3.3. By Application
- 4.3.4. By End-user
- 4.3.5. By Region

5. North America Biologics Safety Testing Market Outlook, 2017-2031F*

5.1. Market Size Analysis & Forecast
- 5.1.1. By Value
- 5.1.2. By Volume
5.2. Market Share Analysis & Forecast
- 5.2.1. By Product and Services
  - 5.2.1.1. Consumables
  - 5.2.1.2. Instruments
  - 5.2.1.3. Services
    - 5.2.1.3.1. Mycoplasma Testing Services
    - 5.2.1.3.2. Sterility Testing Services
    - 5.2.1.3.3. Endotoxin Testing Services
    - 5.2.1.3.4. Virus Safety Testing Services
    - 5.2.1.3.5. Bioburden Testing Services
    - 5.2.1.3.6. Others
- 5.2.2. By Test Type
  - 5.2.2.1. Residual Host Contamination Detection Tests
  - 5.2.2.2. Adventitious Agent Detection Tests
  - 5.2.2.3. Bioburden Tests
  - 5.2.2.4. Cell Line Authentication and Characterization Tests
  - 5.2.2.5. Sterility Tests
  - 5.2.2.6. Endotoxin Tests
  - 5.2.2.7. Others
- 5.2.3. By Application
  - 5.2.3.1. Vaccines and Therapeutics
  - 5.2.3.2. Blood and Blood-based Products
  - 5.2.3.3. Gene Therapy
  - 5.2.3.4. Tissue and Tissue-based Products
  - 5.2.3.5. Stem Cell
- 5.2.4. By End-user
  - 5.2.4.1. Pharmaceutical and Biotechnology Companies
  - 5.2.4.2. CRO and CDMOs
  - 5.2.4.3. Academic and Research Institutes
- 5.2.5. By Country Share
  - 5.2.5.1. United States
  - 5.2.5.2. Canada
  - 5.2.5.3. Mexico
5.3. Country Market Assessment
- 5.3.1. United States Biologics Safety Testing Market Outlook, 2017-2031F*
  - 5.3.1.1. Market Size Analysis & Forecast
    - 5.3.1.1.1. By Value
    - 5.3.1.1.2. By Volume
  - 5.3.1.2. Market Share Analysis & Forecast
    - 5.3.1.2.1. By Product and Services
      - 5.3.1.2.1.1. Consumables
      - 5.3.1.2.1.2. Instruments
      - 5.3.1.2.1.3. Services
      - 5.3.1.2.1.3.1. Mycoplasma Testing Services
      - 5.3.1.2.1.3.2. Sterility Testing Services
      - 5.3.1.2.1.3.3. Endotoxin Testing Services
      - 5.3.1.2.1.3.4. Virus Safety Testing Services
      - 5.3.1.2.1.3.5. Bioburden Testing Services
      - 5.3.1.2.1.3.6. Others
    - 5.3.1.2.2. By Test Type
      - 5.3.1.2.2.1. Residual Host Contamination Detection Tests
      - 5.3.1.2.2.2. Adventitious Agent Detection Tests
      - 5.3.1.2.2.3. Bioburden Tests
      - 5.3.1.2.2.4. Cell Line Authentication and Characterization Tests
      - 5.3.1.2.2.5. Sterility Tests
      - 5.3.1.2.2.6. Endotoxin Tests
      - 5.3.1.2.2.7. Others
    - 5.3.1.2.3. By Application
      - 5.3.1.2.3.1. Vaccines and Therapeutics
      - 5.3.1.2.3.2. Blood and Blood-based Products
      - 5.3.1.2.3.3. Gene Therapy
      - 5.3.1.2.3.4. Tissue and Tissue-based Products
      - 5.3.1.2.3.5. Stem Cell
    - 5.3.1.2.4. By End-user
      - 5.3.1.2.4.1. Pharmaceutical and Biotechnology Companies
      - 5.3.1.2.4.2. CRO and CDMOs
      - 5.3.1.2.4.3. Academic and Research Institutes
- 5.3.2. Canada
- 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Biologics Safety Testing Market Outlook, 2017-2031F

6.1.1. Germany
6.1.2. France
6.1.3. Italy
6.1.4. United Kingdom
6.1.5. Russia
6.1.6. Netherlands
6.1.7. Spain
6.1.8. Turkey
6.1.9. Poland

7. Asia-Pacific Biologics Safety Testing Market Outlook, 2017-2031F

7.1.1. India
7.1.2. China
7.1.3. Japan
7.1.4. Australia
7.1.5. Vietnam
7.1.6. South Korea
7.1.7. Indonesia
7.1.8. Philippines

8. South America Biologics Safety Testing Market Outlook, 2017-2031F

8.1.1. Brazil
8.1.2. Argentina

9. Middle East and Africa Biologics Safety Testing Market Outlook, 2017-2031F

9.1.1. Saudi Arabia
9.1.2. UAE
9.1.3. South Africa

10. Demand Supply Analysis

11. Import and Export Analysis

12. Value Chain Analysis

13. Porter's Five Forces Analysis

14. PESTLE Analysis

15. Pricing Analysis

16. Market Dynamics

16.1. Market Drivers
16.2. Market Challenges

17. Market Trends and Developments

18. Regulatory Framework and Innovation

18.1. Clinical Trials
18.2. Regulatory Approvals

19. Patent Landscape20. Case Studies

21. Competitive Landscape

1.1. Competition Matrix of Top 5 Market Leaders
1.2. SWOT Analysis for Top 5 Players
1.3. Key Players Landscape for Top 10 Market Players
- 1.3.1. Charles River Laboratories International Inc
  - 1.3.1.1. Company Details
  - 1.3.1.2. Key Management Personnel
  - 1.3.1.3. Products and Services
  - 1.3.1.4. Financials (As Reported)
  - 1.3.1.5. Key Market Focus and Geographical Presence
  - 1.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
- 1.3.2. BSL BIOSERVICE Scientific Laboratories Munich GmbH
- 1.3.3. Merck KGaA
- 1.3.4. Thermo Fisher Scientific Inc.
- 1.3.5. Sartorious AG
- 1.3.6. F.Hoffman-La Roche Ltd
- 1.3.7. Biomerieux SA
- 1.3.8. Eurofins Scientific SE
- 1.3.9. Lonza Group AG
- 1.3.10. Maravai LifeSciences Holdings, Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.22. Strategic Recommendations23. About Us and Disclaimer

生物製剤安全性試験の世界市場の評価：製品・サービス別、試験タイプ別、用途別、エンドユーザー別、地域別、機会、予測、2017年～2031年

Biologics Safety Testing Market Assessment, By Product and Services, By Test Type, By Application, By End-user, By Region, Opportunities and Forecast, 2017-2031F

目次

第1章 プロジェクトの範囲と定義

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 世界の生物製剤安全性試験市場の見通し、2017年～2031年

第5章 北米の生物製剤安全性試験市場の見通し、2017年～2031年

第6章 欧州の生物製剤安全性試験市場の見通し、2017年～2031年

第7章 アジア太平洋の生物製剤安全性試験市場の見通し、2017年～2031年

第8章 南米の生物製剤安全性試験市場の見通し、2017年～2031年

第9章 中東・アフリカの生物製剤安全性試験市場の見通し、2017年～2031年

第10章 需要供給分析

第11章輸出入分析

第12章 バリューチェーン分析

第13章 ポーターのファイブフォース分析

第14章 PESTLE分析

第15章 価格分析

第16章 市場力学

第17章 市場の動向と発展

第18章 規制枠組みとイノベーション

第19章 特許の現状

第20章 ケーススタディ

第21章 競合情勢

List of Tables

List of Figures

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Biologics Safety Testing Market Outlook, 2017-2031F

5. North America Biologics Safety Testing Market Outlook, 2017-2031F*

6. Europe Biologics Safety Testing Market Outlook, 2017-2031F

7. Asia-Pacific Biologics Safety Testing Market Outlook, 2017-2031F

8. South America Biologics Safety Testing Market Outlook, 2017-2031F

9. Middle East and Africa Biologics Safety Testing Market Outlook, 2017-2031F

10. Demand Supply Analysis

11. Import and Export Analysis

12. Value Chain Analysis

13. Porter's Five Forces Analysis

14. PESTLE Analysis

15. Pricing Analysis

16. Market Dynamics

17. Market Trends and Developments

18. Regulatory Framework and Innovation

19. Patent Landscape20. Case Studies

21. Competitive Landscape

第1章プロジェクトの範囲と定義

第2章調査手法

第3章エグゼクティブサマリー

第4章世界の生物製剤安全性試験市場の見通し、2017年～2031年

第5章北米の生物製剤安全性試験市場の見通し、2017年～2031年

第6章欧州の生物製剤安全性試験市場の見通し、2017年～2031年

第7章アジア太平洋の生物製剤安全性試験市場の見通し、2017年～2031年

第8章南米の生物製剤安全性試験市場の見通し、2017年～2031年

第9章中東・アフリカの生物製剤安全性試験市場の見通し、2017年～2031年

第10章需要供給分析

第12章バリューチェーン分析

第13章ポーターのファイブフォース分析

第15章価格分析

第16章市場力学

第17章市場の動向と発展

第18章規制枠組みとイノベーション

第19章特許の現状

第20章ケーススタディ

第21章競合情勢