市場調査レポート
商品コード
1141910

GMP試験サービスの2028年までの市場予測-世界分析- サービスタイプ別、エンドユーザー別

GMP Testing Service Market Forecast to 2028 - COVID-19 Impact and Global Analysis - by Service Type and End User

出版日: | 発行: The Insight Partners | ページ情報: 英文 250 Pages | 納期: 即納可能 即納可能とは

価格
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本日の銀行送金レート: 1USD=158.97円
GMP試験サービスの2028年までの市場予測-世界分析- サービスタイプ別、エンドユーザー別
出版日: 2022年09月27日
発行: The Insight Partners
ページ情報: 英文 250 Pages
納期: 即納可能 即納可能とは
  • 全表示
  • 概要
  • 図表
  • 目次
概要

GMP試験サービス市場は、2021年の18億3,057万米ドルから2028年には28億6,342万米ドルに成長すると予測され、2022年から2028年までのCAGRは6.7%と推定されています。

本レポートでは、市場の動向と成長を促進する要因を明らかにしています。市場の成長は、医薬品および医療機器製造業の普及に起因しています。また、GMP試験サービスに関連する進歩は、予測期間中に市場の重要な動向として現れると思われます。しかし、GMP試験サービスに関する統一された規制の枠組みがないことが、市場の成長を妨げています。

医療機器業界は、さまざまな病気の診断や治療に役立つ医療技術の開発を促進する主要な存在です。この業界は、手術用マスクのような一般的な消耗品からハイテク画像機器に至るまで、さまざまな製品を製造しています。インスリン投与システム、血糖値モニター、酸素濃縮器、ネブライザーなどの医療機器は、いくつかの医療疾患の自宅での診断や治療にますます使用されるようになってきています。これらのデバイスは、患者のEMR、ウェアラブル、携帯電話、遠隔医療プラットフォームと統合され、臨床および運用上の意思決定を強化するための重要な洞察を提供します。PRODSMARTが提供するデータによると、医療機器製造業は2020年に~42億米ドルと評価されました。慢性疾患の発生率の上昇と老年人口の増加が、今後数年間の医療機器産業の進展に影響を及ぼすと予想される主な要因です。医療機器とInternet of Medical Things(IoMT)システムの統合には、スマートガジェット、スマートセンサー、その他の軽量通信デバイスが含まれます。このようなイノベーションは、医療従事者が患者の転帰を改善し、コストを削減し、効率を向上させることを支援します。

医療機器の製造において、GMPは非常に重要です。なぜなら、GMPは、一般に公開される製品の品質、安全性、純度、強度を保証するものだからです。GMPの遵守は、副作用、製品回収、欠陥の防止に役立ち、将来的に高額な賠償責任訴訟につながる可能性があります。品質管理と一貫した試験環境が製造サイクルの成功に不可欠であることから、製品の汚染、不具合、品質逸脱を回避するためにGMPへの注目度は高まっています。

GMP試験サービスに関する統一された規制の枠組みがないことが、GMP試験サービス市場全体の成長を阻害しています。GMP試験サービスの規制遵守基準は、製薬・バイオテクノロジー企業の所在地や流通経路の地理的範囲に依存します。北米ではFDAがGMP試験サービス市場を規制していますが、欧州では欧州医薬品庁(EMA)がGMP試験サービス市場を規制しています。東南アジア諸国連合(ASEAN)や医薬品検査条約も、GMP試験サービスを規制するその他の機関のひとつです。これらの規制機関は、製薬会社によって製品が製造、流通、販売される場所によって、適切なコンプライアンスを確保する必要があります。規制機関は、医薬品の製造に関わるすべての施設を評価します。この評価には、原材料/API製造の初期段階から最終的な包装設備に至るまで、すべての段階が含まれます。さらに、特定の製造工程に関わるステップによって、規制が変更されることもあります。もし、企業が特定の国や地域の規制機関の仕様に従わない場合、その製品は法律上、粗悪品とみなされ、FDAはそのような薬を服用しないよう患者に勧告し、健康に深刻な影響を与える可能性があります。このように、地域によって異なるGMP試験サービスに対する厳しい規制の枠組みが、GMP試験サービス市場の成長を妨げています。

サービスタイプに基づき、GMP試験サービス市場は、製品バリデーション試験、バイオ分析サービス、包装および保存性試験、およびその他のサービスタイプに区分されます。2021年の市場シェアは、製品バリデーション試験部門が最も大きいです。このセグメントの市場は、予測期間中に最も速いCAGRで成長すると予想されます。GMP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、医療機器企業に区分されます。2021年の市場シェアは、製薬・バイオ製薬会社セグメントが大きくなっています。さらに、予測期間中はより高いCAGRを記録すると予想されます。

GMP試験サービス市場では、さまざまな有機的および無機的戦略が企業によって採用されています。有機的戦略には主に製品の上市や製品承認が含まれ、一方、無機的成長戦略には買収、共同研究、パートナーシップなどが含まれます。これらの成長戦略により、市場参加者は事業を拡大し、地理的プレゼンスを高めることができ、それによって市場全体の成長に貢献することができます。さらに、買収とパートナーシップ戦略は、市場参加者が顧客基盤を強化し、製品ポートフォリオを拡大するのに役立ちます。GMP検査サービス市場における主要企業の重要な発展のいくつかを以下に示します。

2022年6月、Almacグループの一員であるAlmac Diagnostic Servicesは、AstraZenecaと複数のコンパニオン診断薬(CDx)製品の開発および商業化に関するマスターコラボレーション契約(MCA)を締結しました。アルマックは、アンメットメディカルニーズの高い地域に住む患者さんに新しい治療法を提供するために、アストラゼネカを支援していきます。

GMP試験サービス市場に関する報告書の作成にあたり、米国疾病対策予防センター(CDC)、欧州医療機関(EMA)、世界保健機関(WHO)、国際糖尿病連合(IDF)などが、参照した主な一次情報および二次情報の一部となっています。

目次

第1章 イントロダクション

  • 調査範囲
  • インサイトパートナーズの調査報告書ガイダンス
  • 市場セグメンテーション
    • GMP試験サービスの世界市場- サービスタイプ別
    • GMP試験サービスの世界市場-エンドユーザー別
    • GMP試験サービスの世界市場-地域別

第2章 重要なポイント

第3章 調査手法

  • 調査対象
  • 2次調査
  • 1次調査

第4章 GMP試験サービス市場- 市場情勢

  • PEST分析
    • 北米PEST分析
    • 欧州PEST分析
    • アジア太平洋地域のPEST分析
    • 中南米PEST分析
    • 中東・アフリカPEST分析
  • 専門家の見解

第5章 GMP試験サービス市場-主要な市場力学

  • 市場促進要因
    • 製薬業界の継続的な成長
    • 医療機器産業の発展
  • 市場抑制要因
    • GMP試験サービスに関連する統一された規制枠組みの欠如
  • 市場機会
    • 研究開発におけるGMP試験サービスの採用
  • 今後の動向
    • GMP検査サービス製品に関連する技術的進歩
  • インパクト分析

第6章 GMP検査サービス市場-世界分析

  • GMP試験サービスの世界市場収益と予測・分析
    • GMP試験サービスの世界市場:地域別予測・分析
    • GMP試験サービスの世界市場-地域別市場ポテンシャル分析
  • 企業分析
    • 主要プレイヤーの市場ポジショニング
    • 企業比較分析
  • 成長戦略分析
    • 主要プレイヤーの業績
    • ユーロフィンズサイエンティフィック
    • サーモフィッシャーサイエンティフィックPPD Inc.
    • 主な発展状況

第7章 GMP試験サービスの世界市場収益と2028年までの予測- サービスタイプ別

  • GMP試験サービス市場の収益シェア(サービスタイプ別)(2021年、2028年
  • 製品バリデーション試験
  • バイオ分析サービス
  • 包装・賞味期限試験
  • その他のサービスタイプ

第8章 GMP試験サービス市場- エンドユーザー別

  • GMP検査サービス市場:エンドユーザー別、2021年・2028年(%)
  • 製薬会社、バイオ製薬会社
  • 医療機器企業

第9章 GMP試験サービス市場収益と2028年までの予測-地域別分析

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • アジア太平洋地域
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • その他アジア太平洋地域
  • 中東・アフリカ地域
    • UAE
    • サウジアラビア
    • 南アフリカ
    • その他の中東・アフリカ地域
  • 中南米
    • ブラジル
    • アルゼンチン
    • その他の中南米地域

第10章 GMP試験サービス市場におけるCOVID-19のパンデミック別影響

  • 北米
  • 欧州
  • アジア太平洋地域
  • 中東とアフリカ
  • 中南米

第11章 GMP試験サービス市場- 業界情勢

  • 市場参入企業が行った成長戦略(%)
  • 有機的な展開
  • インオーガニック開発

第12章 企業プロファイル

  • Eurofins Scientific
  • Almac Group
  • INTERTEK GROUP PLC
  • WuXi AppTec
  • Sartorius AG
  • North American Science Associates, Inc.
  • Nelson Laboratories, LLC
  • Boston Analytical
  • Pace Analytical Services
  • Thermo Fisher Scientific Inc.(PPD Inc.)

第13章 付録

  • The Insight Partners について
  • GMP試験サービス市場の用語解説
図表

List Of Tables

  • Table 1. North America GMP Testing Service Market, by Service Type- Revenue and Forecast to 2028 (USD Million)
  • Table 2. North America GMP Testing Service Market, by End User - Revenue and Forecast to 2028 (US$ Million)
  • Table 3. US GMP Testing Service Market, by Service Type- Revenue and Forecast to 2028 (US$ Million)
  • Table 4. US GMP Testing Service Market, by End User - Revenue and Forecast to 2028 (US$ Million)
  • Table 5. Canada GMP Testing Service Market, by Service Type- Revenue and Forecast to 2028 (US$ Million)
  • Table 6. Canada GMP Testing Service Market, by End User - Revenue and Forecast to 2028 (US$ Million)
  • Table 7. Mexico GMP Testing Service Market, by Service Type- Revenue and Forecast to 2028 (US$ Million)
  • Table 8. Mexico GMP Testing Service Market, by End User - Revenue and Forecast to 2028 (US$ Million)
  • Table 9. Europe GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (US$ Million)
  • Table 10. Europe GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 11. Germany GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 12. Germany GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 13. UK GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 14. UK GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 15. France GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 16. France GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 17. Italy GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 18. Italy GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 19. Spain GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 20. Spain GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 21. Rest of Europe GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 22. Rest of Europe GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 23. Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million).
  • Table 24. Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
  • Table 25. China: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
  • Table 26. China: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
  • Table 27. Japan: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
  • Table 28. Japan: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
  • Table 29. India: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
  • Table 30. India: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
  • Table 31. South Korea: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
  • Table 32. South Korea: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
  • Table 33. Australia: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
  • Table 34. Australia: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
  • Table 35. Rest of Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
  • Table 36. Rest of Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
  • Table 37. Middle East & Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
  • Table 38. Middle East & Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
  • Table 39. UAE: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
  • Table 40. UAE: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
  • Table 41. Saudi Arabia: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
  • Table 42. Saudi Arabia: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
  • Table 43. South Africa GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
  • Table 44. South Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
  • Table 45. Rest of Middle East & Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
  • Table 46. Rest of Middle East & Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
  • Table 47. South and Central America: GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 48. South and Central America GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 49. Brazil: GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 50. Brazil GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 51. Argentina: GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 52. Argentina GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 53. Rest of South and Central America: GMP Testing Services Market, by Service Type - Revenue and Forecast to 2028 (USD Million)
  • Table 54. Rest of South and Central America GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
  • Table 55. Organic Developments Done By Companies
  • Table 56. Inorganic Developments Done By Companies
  • Table 57. Glossary of Terms

List Of Figures

  • Figure 1. GMP Testing Service Market Segmentation
  • Figure 2. GMP Testing Service Market, By Region
  • Figure 3. Global GMP Testing Service Market Overview
  • Figure 4. Product Validation Testing Segment Held Largest Share of Surgery Type Segment in GMP Testing Service Market
  • Figure 5. Asia Pacific is Expected to Show Remarkable Growth During the Forecast Period
  • Figure 6. GMP Testing Service Market, by Geography (US$ Million)
  • Figure 7. Global GMP Testing Service Market- Leading Country Markets (US$ Million)
  • Figure 8. Global GMP Testing Service Market, Industry Landscape
  • Figure 9. North America: PEST Analysis
  • Figure 10. Europe: PEST Analysis
  • Figure 11. Asia Pacific: PEST Analysis
  • Figure 12. South And Central America: PEST Analysis
  • Figure 13. Middle East and Africa: PEST Analysis
  • Figure 14. Experts Opinion
  • Figure 15. Global GMP Testing Service Market - Revenue Forecasts and Analysis - 2020- 2028
  • Figure 16. Global GMP Testing Service Market - By Geography Forecasts and Analysis - 2022- 2028
  • Figure 17. Global GMP Testing Service Market - Market Potential Analysis, By Region
  • Figure 18. Market Positioning of Key Players in Global GMP Testing Service Market
  • Figure 19. Global GMP Testing Service Market - Comparative Company Analysis
  • Figure 20. Global GMP Testing Service Market - Growth Strategy Analysis
  • Figure 21. GMP Testing Services Market Revenue Share, by Service Type (2021 and 2028)
  • Figure 22. Product Validation Testing: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 23. Bioanalytical Services: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 24. Packaging and Shelf-Life Testing: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 25. Other Service Types: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 26. GMP Testing Services Market, by End User, 2021 and 2028 (%)
  • Figure 27. Pharmaceutical and Biopharmaceutical Companies: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 28. Medical Devices Companies: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 29. North America: GMP Testing Service Market, by Key Country - Revenue (2022) (US$ Million)
  • Figure 30. North America GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
  • Figure 31. North America: GMP Testing Service Market, by Country, 2022 & 2028 (%)
  • Figure 32. US: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 33. Canada: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 34. Mexico: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 35. Europe: GMP Testing Services Market, by Key Country - Revenue (2022) (US$ Million)
  • Figure 36. Europe GMP Testing Services Market Revenue and Forecast to 2028 (US$ Million)
  • Figure 37. Europe: GMP Testing Services Market, by Country, 2021 & 2028 (%)
  • Figure 38. Germany: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 39. UK: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 40. France: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 41. Italy: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 42. Spain: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 43. Rest of Europe: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 44. Asia Pacific GMP Testing Service Market Overview, by Country (2021)
  • Figure 45. Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
  • Figure 46. Asia Pacific: GMP Testing Service Market, by Country, 2022 & 2028 (%)
  • Figure 47. China: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
  • Figure 48. Japan: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
  • Figure 49. India: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
  • Figure 50. South Korea: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
  • Figure 51. Australia: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
  • Figure 52. Rest of Asia Pacific: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 53. Middle East & Africa GMP Testing Service Market Revenue Overview, by Country, 2021 (US$ Million)
  • Figure 54. Middle East & Africa GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
  • Figure 55. Middle East & Africa GMP Testing Service Market Revenue and Forecasts to 2028, By Country (%)
  • Figure 56. UAE: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
  • Figure 57. Saudi Arabia: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
  • Figure 58. South Africa: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
  • Figure 59. Rest of Middle East and Africa: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
  • Figure 60. South and Central America: GMP Testing Services Market, by Key Country - Revenue (2022) (USD Million)
  • Figure 61. South and Central America GMP Testing Services Market Revenue and Forecast to 2028 (USD Million)
  • Figure 62. South and Central America: GMP Testing Services Market, by Country, 2022 & 2028 (%)
  • Figure 63. Brazil: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
  • Figure 64. Argentina: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
  • Figure 65. Rest of South and Central America: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
  • Figure 66. Impact of COVID-19 Pandemic in North America Country Markets
  • Figure 67. Impact of COVID-19 Pandemic in European Country Markets
  • Figure 68. Impact of COVID-19 Pandemic in Asia Pacific Country Markets
  • Figure 69. Impact of COVID-19 Pandemic in Middle East & Africa Country Markets
  • Figure 70. Impact of COVID-19 Pandemic in South & Central American Country Markets
  • Figure 71. Growth Strategies Done by the Companies in the Market, (%)
目次
Product Code: TIPRE00029684

The GMP testing service market is expected to grow from US$ 1,830.57 million in 2021 to US$ 2,863.42 million by 2028; it is estimated to grow at a CAGR of 6.7% from 2022 to 2028.

The report highlights trends prevailing in the market and factors driving its growth. The market growth is attributed to the proliferation of pharmaceuticals and medical device manufacturing industries. Additionally, advancements related to GMP testing services are likely to emerge as a significant trend in the market during the forecast period. However, the lack of a uniform regulatory framework related to GMP testing services hampers the growth of the market.

The medical device industry is a prime enabler of the development of medical technologies that help diagnose and treat various illnesses. This industry produces products ranging from common supplies such as surgical masks to high-tech imaging equipment. Medical devices such as insulin delivery systems, glucose monitors, oxygen concentrators, and nebulizers are increasingly being used for the at-home diagnosis and treatment of a few medical disorders. These devices are integrated with the patient's EMR, wearables, cellphones, and telehealth platforms to provide critical insights for enhanced clinical and operational decision-making. According to the data provided by PRODSMART, the medical devices manufacturing industry was valued at ~US$ 4.2 billion in 2020. A rise in the incidence of chronic diseases and the growth of the geriatric population are the major factors that are expected to influence the progress of the medical device industry in the coming years. The integration of medical devices with Internet of Medical Things (IoMT) systems involve smart gadgets, smart sensors, and other lightweight communication devices. Such innovations assist healthcare providers in improving patient outcomes, lowering costs, and increasing efficiency.

GMPs are enormously important in the manufacturing of medical devices because they ensure a level of quality, safety, purity, and strength in any products that are released to the public. Adhering to these practices helps manufacturers in preventing adverse effects, product recalls, and defects, which may lead to costly liability lawsuits in the future. As quality control and consistent testing environments are pivotal for a successful manufacturing cycle, the focus on GMPs is increasing for avoiding product contamination, failure, and quality deviation.

The lack of a uniform regulatory framework related to GMP testing service hinders the overall GMP testing service market growth. The regulatory compliance criteria for GMP testing services depend on the location of pharmaceutical and biotechnology companies, and the geographic reach of their distribution channels. In North America, FDA regulates the GMP testing services market, whereas, in Europe, European Medicines Agency (EMA) regulates the GMP testing services market. The Association of South-East Asian Nations (ASEAN) and the Pharmaceutical Inspection Convention are among the other agencies that regulate GMP testing services. These regulatory agencies need to ensure appropriate compliance depending on where the product is manufactured, distributed, and marketed by the pharmaceutical companies. The regulatory agencies evaluate all sites involved in the manufacturing of a drug. This evaluation includes all the steps ranging from the initial steps of the raw materials/API manufacturing to the final packaging facilities. Moreover, regulations may change depending on the steps involved in a particular manufacturing process. If a company fail to comply with the specifications of a regulatory body in a particular country or region, its products are considered adulterated under the law, and the FDA advises patients not to take such medications, which could have serious consequences on their health. Thus, stringent regulatory frameworks for GMP testing services in different regions are hampering the growth of the GMP testing services market.

Based on service type, the GMP testing service market is segmented into product validation testing, bioanalytical services, packaging and shelf-life testing, and other service types. The product validation testing segment held the largest market share in 2021. The market for this segment is expected to grow at the fastest CAGR during the forecast period. Based on end user, the GMP testing service market is segmented into pharmaceutical and biopharmaceutical companies, and medical devices companies. The pharmaceutical and biopharmaceutical companies segment held a larger market share in 2021. Moreover, it is expected to register a higher CAGR during the forecast period.

Various organic and inorganic strategies are adopted by companies in the GMP testing service market. The organic strategies mainly include product launches and product approvals, whereas the inorganic growth strategies include acquisitions, collaborations, and partnerships. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall market growth. Further, acquisition and partnership strategies help the market players strengthen their customer base and expand their product portfolios. A few of the significant developments by key players in the GMP testing service market are listed below.

In June 2022, Almac Diagnostic Services, a member of the Almac Group, signed a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialize multiple companion diagnostic (CDx) products. Almac will support AstraZeneca in bringing new therapies to patients residing in areas of high unmet medical needs. 

The Centers for Disease Control and Prevention (CDC), European Medical Agency (EMA), World Health Organization (WHO), and International Diabetes Federation (IDF) are a few of the major primary and secondary sources referred to while preparing the report on the GMP testing service market.

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Table Of Contents

1. Introduction

  • 1.1 Study Scope
  • 1.2 The Insight Partners Research Report Guidance
  • 1.3 Market Segmentation
    • 1.3.1 Global GMP Testing Service Market - By Service Type
    • 1.3.2 Global GMP Testing Service Market - By End User
    • 1.3.3 Global GMP Testing Service Market - By Geography

2. Key Takeaways

3. Research Methodology

  • 3.1 Coverage
  • 3.2 Secondary Research
  • 3.3 Primary Research

4. GMP Testing Service Market - 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 And Central America PEST Analysis
    • 4.2.5 Middle East and Africa PEST Analysis
  • 4.3 Experts Opinion

5. GMP Testing Service Market- Key Market Dynamics

  • 5.1 Market Drivers
    • 5.1.1 Continuous Proliferation of Pharmaceuticals Industry
    • 5.1.2 Flourishment of Medical Device Industry
  • 5.2 Market Restraints
    • 5.2.1 Lack of Uniform Regulatory Framework Related to GMP Testing Services
  • 5.3 Market Opportunities
    • 5.3.1 Adoption of GMP Testing Services in R&D
  • 5.4 Future Trends
    • 5.4.1 Technological Advancements Related to GMP Testing Services Products
  • 5.5 Impact Analysis

6. GMP Testing Service Market- Global Analysis

  • 6.1 Global GMP Testing Service Market Revenue Forecasts and Analysis
    • 6.1.1 Overview
    • 6.1.2 Global GMP Testing Service Market, By Geography - Forecasts and Analysis
    • 6.1.3 Global GMP Testing Service Market - Market Potential Analysis, By Region
  • 6.2 Company Analysis
    • 6.2.1 Market Positioning of Key Players
    • 6.2.2 Comparative Company Analysis
  • 6.3 Growth Strategy Analysis
    • 6.3.1 Performance of Key Players
    • 6.3.2 Eurofins Scientific
    • 6.3.3 Thermo Fisher Scientific. PPD Inc.
    • 6.3.4 Key Developments

7. Global GMP Testing Service Market Revenue and Forecast To 2028 - by Service Type

  • 7.1 Overview
  • 7.2 GMP Testing Services Market Revenue Share, by Service Type (2021 and 2028)
  • 7.3 Product Validation Testing
    • 7.3.1 Overview
    • 7.3.2 Product Validation Testing: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.4 Bioanalytical Services
    • 7.4.1 Overview
    • 7.4.2 Bioanalytical Services: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.5 Packaging and Shelf-Life Testing
    • 7.5.1 Overview
    • 7.5.2 Packaging and Shelf-Life Testing: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.6 Other Service Types
    • 7.6.1 Overview
    • 7.6.2 Other Service Types: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)

8. GMP Testing Services Market - By End User

  • 8.1 Overview
  • 8.2 GMP Testing Services Market, by End User, 2021 and 2028 (%)
  • 8.3 Pharmaceutical and Biopharmaceutical Companies
    • 8.3.1 Overview
    • 8.3.2 Pharmaceutical and Biopharmaceutical Companies: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
  • 8.4 Medical Devices Companies
    • 8.4.1 Overview
    • 8.4.2 Medical Devices Companies: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)

9. GMP Testing Service Market Revenue and Forecast to 2028 - Geographical Analysis

  • 9.1 North America: GMP Testing Service Market
    • 9.1.1 Overview
    • 9.1.2 North America: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
    • 9.1.3 North America: GMP Testing Service Market, by Service Type, 2019-2028 (US$ Million)
    • 9.1.4 North America: GMP Testing Service Market, by End User, 2019-2028 (US$ Million)
    • 9.1.5 North America: GMP Testing Service Market, by Country, 2022 & 2028 (%)
      • 9.1.5.1 US: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.5.1.1 Overview
        • 9.1.5.1.2 US: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.5.1.3 US: GMP Testing Service Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.5.1.4 US: GMP Testing Service Market, by End User, 2019-2028 (US$ Million)
      • 9.1.5.2 Canada: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.5.2.1 Overview
        • 9.1.5.2.2 Canada: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.5.2.3 Canada: GMP Testing Service Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.5.2.4 Canada: GMP Testing Service Market, by End User, 2019-2028 (US$ Million)
      • 9.1.5.3 Mexico: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.5.3.1 Overview
        • 9.1.5.3.2 Mexico: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.5.3.3 Mexico: GMP Testing Service Market, by Service Type, 2019-2028 (US$ Million)
        • 9.1.5.3.4 Mexico: GMP Testing Service Market, by End User, 2019-2028 (US$ Million)
  • 9.2 Europe: GMP Testing Services Market
    • 9.2.1 Overview
    • 9.2.2 Europe: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
    • 9.2.3 Europe: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
    • 9.2.4 Europe: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
    • 9.2.5 Europe: GMP Testing Services Market, by Country, 2021 & 2028 (%)
      • 9.2.5.1 Germany: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.1.1 Overview
        • 9.2.5.1.2 Germany: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.1.3 Germany: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.2.5.1.4 Germany: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.2.5.2 UK: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.2.1 Overview
        • 9.2.5.2.2 UK: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.2.3 UK: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.2.5.2.4 UK: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.2.5.3 France: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.3.1 Overview
        • 9.2.5.3.2 France: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.3.3 France: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.2.5.3.4 France: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.2.5.4 Italy: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.4.1 Overview
        • 9.2.5.4.2 Italy: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.4.3 Italy: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.2.5.4.4 Italy: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.2.5.5 Spain: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.5.1 Overview
        • 9.2.5.5.2 Spain: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.5.3 Spain: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.2.5.5.4 Spain: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
      • 9.2.5.6 Rest of Europe: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.6.1 Overview
        • 9.2.5.6.2 Rest of Europe: GMP Testing Services Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.2.5.6.3 Rest of Europe: GMP Testing Services Market, by Service Type, 2019-2028 (US$ Million)
        • 9.2.5.6.4 Rest of Europe: GMP Testing Services Market, by End User, 2019-2028 (US$ Million)
  • 9.3 Asia Pacific GMP Testing Service Market Revenue and Forecast To 2028
    • 9.3.1 Overview
    • 9.3.2 Asia Pacific GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
    • 9.3.3 Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
    • 9.3.4 Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
    • 9.3.5 Asia Pacific: GMP Testing Service Market, by Country, 2022 & 2028 (%)
      • 9.3.5.1 China: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.1.1 Overview
        • 9.3.5.1.2 China: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.1.3 China: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
        • 9.3.5.1.4 China: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
      • 9.3.5.2 Japan: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.2.1 Overview
        • 9.3.5.2.2 Japan: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.2.3 Japan: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
        • 9.3.5.2.4 Japan: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
      • 9.3.5.3 India GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.3.1 Overview
        • 9.3.5.3.2 India: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.3.3 India: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
        • 9.3.5.3.4 India: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
      • 9.3.5.4 South Korea: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.4.1 Overview
        • 9.3.5.4.2 South Korea: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.4.3 South Korea: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
        • 9.3.5.4.4 South Korea: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
      • 9.3.5.5 Australia: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.5.1 Overview
        • 9.3.5.5.2 Australia: GMP Testing Service Market Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.5.3 Australia: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
        • 9.3.5.5.4 Australia: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
      • 9.3.5.6 Rest of Asia Pacific: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.6.1 Overview
        • 9.3.5.6.2 Rest of Asia Pacific: GMP Testing Service Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.3.5.6.3 Rest of Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028, By Service Type (US$ Million)
        • 9.3.5.6.4 Rest of Asia Pacific: GMP Testing Service Market Revenue and Forecast to 2028, By End User (US$ Million)
  • 9.4 Middle East & Africa GMP Testing Service Market Revenue and Forecasts To 2028
    • 9.4.1 Overview
    • 9.4.2 Middle East & Africa GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
    • 9.4.3 Middle East & Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
    • 9.4.4 Middle East & Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
    • 9.4.5 Middle East & Africa GMP Testing Service Market Revenue and Forecasts to 2028, By Country (%)
      • 9.4.5.1 UAE: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
        • 9.4.5.1.1 Overview
        • 9.4.5.1.2 UAE: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
        • 9.4.5.1.3 UAE: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
        • 9.4.5.1.4 UAE: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
      • 9.4.5.2 Saudi Arabia: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
        • 9.4.5.2.1 Overview
        • 9.4.5.2.2 Saudi Arabia: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
        • 9.4.5.2.3 Saudi Arabia: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
        • 9.4.5.2.4 Saudi Arabia: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
      • 9.4.5.3 South Africa: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
        • 9.4.5.3.1 Overview
        • 9.4.5.3.2 South Africa GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
        • 9.4.5.3.3 South Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
        • 9.4.5.3.4 South Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
      • 9.4.5.4 Rest of Middle East and Africa: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
        • 9.4.5.4.1 Overview
        • 9.4.5.4.2 Rest of Middle East and Africa: GMP Testing Service Market Revenue and Forecasts to 2028 (US$ Million)
        • 9.4.5.4.3 Rest of Middle East & Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By Service Type (US$ Million)
        • 9.4.5.4.4 Rest of Middle East & Africa: GMP Testing Service Market Revenue and Forecasts to 2028, By End User (US$ Million)
  • 9.5 South and Central America GMP Testing Services Market Revenue and Forecasts To 2028
    • 9.5.1 Overview
    • 9.5.2 South and Central America: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
    • 9.5.3 South and Central America: GMP Testing Services Market, by Service Type, 2019-2028 (USD Million)
    • 9.5.4 South and Central America GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
    • 9.5.5 South and Central America: GMP Testing Services Market, by Country, 2022 & 2028 (%)
      • 9.5.5.1 Brazil: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
        • 9.5.5.1.1 Overview
        • 9.5.5.1.2 Brazil: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
        • 9.5.5.1.3 Brazil: GMP Testing Services Market, by Service Type, 2019-2028 (USD Million)
        • 9.5.5.1.4 Brazil GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
      • 9.5.5.2 Argentina: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
        • 9.5.5.2.1 Overview
        • 9.5.5.2.2 Argentina: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
        • 9.5.5.2.3 Argentina: GMP Testing Services Market, by Service Type, 2019-2028 (USD Million)
        • 9.5.5.2.4 Argentina GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)
      • 9.5.5.3 Rest of South and Central America: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
        • 9.5.5.3.1 Overview
        • 9.5.5.3.2 Rest of South and Central America: GMP Testing Services Market - Revenue and Forecast to 2028 (USD Million)
        • 9.5.5.3.3 Rest of South and Central America: GMP Testing Services Market, by Service Type, 2019-2028 (USD Million)
        • 9.5.5.3.4 Rest of South and Central America GMP Testing Services Market, by End User - Revenue and Forecast to 2028 (USD Million)

10. Impact Of COVID-19 Pandemic on GMP Testing Service Market

  • 10.1 North America: Impact Assessment of COVID-19 Pandemic
  • 10.2 Europe: Impact Assessment of COVID-19 Pandemic
  • 10.3 Asia Pacific: Impact Assessment of COVID-19 Pandemic
  • 10.4 Middle East and Africa: Impact Assessment of COVID-19 Pandemic
  • 10.5 South and Central America: Impact Assessment of COVID-19 Pandemic

11. GMP Testing Service Market - Industry Landscape

  • 11.1 Overview
  • 11.2 Growth Strategies Done by the Companies in the Market, (%)
  • 11.3 Organic Developments
    • 11.3.1 Overview
  • 11.4 Inorganic Developments
    • 11.4.1 Overview

12. Company Profiles

  • 12.1 Eurofins Scientific
    • 12.1.1 Key Facts
    • 12.1.2 Business Description
    • 12.1.3 Products and Services
    • 12.1.4 Financial Overview
    • 12.1.5 SWOT Analysis
    • 12.1.6 Key Developments
  • 12.2 Almac Group
    • 12.2.1 Key Facts
    • 12.2.2 Business Description
    • 12.2.3 Products and Services
    • 12.2.4 Financial Overview
    • 12.2.5 SWOT Analysis
    • 12.2.6 Key Developments
  • 12.3 INTERTEK GROUP PLC
    • 12.3.1 Key Facts
    • 12.3.2 Business Description
    • 12.3.3 Products and Services
    • 12.3.4 Financial Overview
    • 12.3.5 SWOT Analysis
    • 12.3.6 Key Developments
  • 12.4 WuXi AppTec
    • 12.4.1 Key Facts
    • 12.4.2 Business Description
    • 12.4.3 Products and Services
    • 12.4.4 Financial Overview
    • 12.4.5 SWOT Analysis
    • 12.4.6 Key Developments
  • 12.5 Sartorius AG
    • 12.5.1 Key Facts
    • 12.5.2 Business Description
    • 12.5.3 Products and Services
    • 12.5.4 Financial Overview
    • 12.5.5 SWOT Analysis
    • 12.5.6 Key Developments
  • 12.6 North American Science Associates, Inc.
    • 12.6.1 Key Facts
    • 12.6.2 Business Description
    • 12.6.3 Products and Services
    • 12.6.4 Financial Overview
    • 12.6.5 SWOT Analysis
    • 12.6.6 Key Developments
  • 12.7 Nelson Laboratories, LLC
    • 12.7.1 Key Facts
    • 12.7.2 Business Description
    • 12.7.3 Products and Services
    • 12.7.4 Financial Overview
    • 12.7.5 SWOT Analysis
    • 12.7.6 Key Developments
  • 12.8 Boston Analytical
    • 12.8.1 Key Facts
    • 12.8.2 Business Description
    • 12.8.3 Products and Services
    • 12.8.4 Financial Overview
    • 12.8.5 SWOT Analysis
    • 12.8.6 Key Developments
  • 12.9 Pace Analytical Services
    • 12.9.1 Key Facts
    • 12.9.2 Business Description
    • 12.9.3 Products and Services
    • 12.9.4 Financial Overview
    • 12.9.5 SWOT Analysis
    • 12.9.6 Key Developments
  • 12.10 Thermo Fisher Scientific Inc. (PPD Inc.)
    • 12.10.1 Key Facts
    • 12.10.2 Business Description
    • 12.10.3 Products and Services
    • 12.10.4 Financial Overview
    • 12.10.5 SWOT Analysis
    • 12.10.6 Key Developments

13. Appendix

  • 13.1 About The Insight Partners
  • 13.2 Glossary of Terms for GMP Testing Services Market