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Healthcare IT South America Healthcare Regulatory Affairs Outsourcing Market...

南美洲医疗保健监管事务外包市场预测至 2028 年 - 按服务类型划分的 COVID-19 影响和区域分析 [监管和科学战略制定、医学和科学写作、eCTD 和电子提交、数据管理服务、生命周期管理服务、药物警戒、化学制造和控制 (CMC) 服务、监管标签和监管图稿服务] 和最终用户（制药公司、生物技术公司和医疗器械公司）

TIPRE00026215 | Pages: 115 | Healthcare IT | Dec 2021 | Type: Regional | Status: Published

市场介绍

南美地区医疗监管事务外包市场估算包括巴西、阿根廷和南美洲其他国家等国家。在全球分析中，该地区所占市场份额最小。由于节省成本的优势和提高临床试验的效率，市场可能会在预测期内得到推动。此外，发展医疗保健基础设施，增加对临床研究的公私投资，以及提高医疗保健行业对监管事务外包好处的认识。巴西是世界上面积和人口第五大国，技术进步最快，预计将为市场增长提供更广泛的增长机会。在巴西，生物技术和制药市场在工业规模活动和医疗保健方面经历了多次活动。巴西以其工业生物技术的研究和投资而闻名，主要涉及临床试验服务。巴西利益相关者、政策制定者和公共投资者推动了巴西医疗保健研究的进步。巴西的贸易团体旨在通过增加培训活动来加强现行专利法，以支持发展、医疗保健基础设施和知识转让。预计这些因素将在预测年内为医疗保健监管事务外包市场提供一些机会。医疗保健公司面临的监管压力不断加大是推动 SAM 医疗保健监管事务外包市场增长的主要因素。

南美国家的 COVID-19 病例数量不断增加自疫情在全球爆发以来。根据 Worldometer 的数据，截至 2021 年 10 月，巴西的病例数达到 21,781,436 例，阿根廷的病例数达到 5,286,074 例。预计疫情将导致该地区陷入迄今为止最严重的衰退，导致 2020 年地区 GDP 萎缩 9.1%。南美洲已经负担过重且资金不足的公共医疗保健系统面临着挑战。这些国家的政府已通过关闭边境、下令隔离以及实施一系列限制措施来应对这种情况，以将人们限制在家里。目前，各国政府正在迅速增加抗击新型冠状病毒的临床项目。许多制造工厂在大流行期间被关闭。该地区的大多数制造公司都专注于开发该疾病的治疗方法。虽然临床试验中的监管外包方法对该地区来说并不新鲜，但大流行加速了它们的采用。随着医生和患者对数字技术和电话会议的接受程度越来越高，远程监控领域的发展也产生了更多机会。药物开发商面临的挑战是快速评估现有疫苗针对因病毒突变而不断演变的 SARS-CoV-2 毒株的有效性。因此，提高数据收集的可见性和监督、更快的试验实施和实时数据共享已成为制药公司的首要任务。这些因素对南美医疗监管事务外包市场的潜在增长产生积极影响。

市场概况和动态

SAM的医疗监管事务外包市场预计将从2021年的6.5836亿美元增长到2028年的12.8519亿美元；预计 2021 年至 2028 年复合年增长率为 10.0%。开发有助于治疗特定疾病和病症的重磅疗法，如靶向基因疗法、特殊药物和精准医学，一直是医疗保健行业的主要关注点。很长一段时间。其中一些疗法还与医疗设备相结合，以提高药物输送、剂量和患者监测或依从性的质量，预计这将增加相关监管策略的复杂性和上市难度。因此，在预测期内，专业治疗、孤儿药和个性化药物等医疗保健领域新兴领域的发展预计将为医疗保健监管事务外包市场参与者提供重大增长机会。

主要市场细分

SAM 医疗保健监管事务外包市场已根据服务类型、最终目的进行细分用户和国家。根据服务类型，SAM 医疗监管事务外包市场分为医疗和医疗服务。科学写作、药物警戒、数据管理服务、生命周期管理服务、eCTD 和电子提交、监管和科学策略开发、化学制造和控制 (CMC) 服务、监管标签和监管艺术品服务。医疗与科学写作领域在 2020 年占据市场主导地位，药物警戒领域预计将在预测期内增长最快。根据最终用户，市场分为制药公司、生物技术公司和医疗器械公司。制药公司细分市场在 2020 年占据主导地位，预计将在预测期内增长最快。同样，细分的医疗器械公司分为医疗器械材料和医疗器械。生物材料、医疗器械、生物标志物和体外诊断（IVD）、医疗器械软件（SaMD）、医疗器械机电、基于物质的医疗器械以及组合产品的医疗器械。

< span>主要来源和上市公司

准备本医疗保健报告时参考的一些主要一手和二手来源SAM监管事务外包市场包括公司网站、年报、财务报告、国家政府文件、统计数据库等。报告中列出的主要公司包括 Arriello Ireland Ltd.、Azierta Contract Science Support Consulting、IQVIA Inc.、PAREXEL INTERNATIONAL CORPORATION、PHARMALEX GMBH 和 ProductLife Group 等。

购买报告的理由

  • 了解 SAM 医疗保健监管事务外包市场格局，并确定最有可能保证丰厚回报的细分市场
  • 通过理解来保持竞争优势SAM医疗监管事务外包市场不断变化的竞争格局
  • 通过识别最有前景的细分市场，有效规划SAM医疗监管事务外包市场的并购和合作交易可能的销售额
  • 通过对 SAM 医疗监管事务外包市场各个细分市场的市场表现进行敏锐而全面的分析，帮助做出明智的业务决策
  • 获取 SAM 地区 2021-2028 年各细分市场的市场收入预测。

< span>SAM 医疗保健监管事务外包市场细分

SAM 医疗保健监管事务外包市场 –按 服务类型

  • 医疗与医疗科学写作
  • 药物警戒
  • 数据管理服务
  • 生命周期管理服务
  • eCTD 和电子提交
  • 监管和科学战略制定
  • 化学制造和控制 (CMC) 服务
  • 监管标签
  • 监管艺术品服务

SAM 医疗保健监管事务外包市场 - 按最终用户划分

  • 制药公司
  • 生物技术公司
  • 医疗器械公司
    • 医疗器械材料及技术生物材料
    • 医疗器械生物标志物和体外诊断（IVD）
    • 医疗器械软件（SaMD）
    • 医疗器械机电
    • 基于物质的医疗器械
    • 组合产品的医疗器械

SAM 医疗保健监管事务外包市场 - 按国家/地区

  • 巴西
  • 阿根廷
  • SAM 其余地区

SAM 医疗保健监管事务外包市场 -公司简介

  • Arriello Ireland Ltd.
  • Azierta 合同科学支持咨询
  • IQVIA Inc.
  • PAREXEL INTERNATIONAL CORPORATION
  • PHARMALEX GMBH
  • ProductLife 集团

TABLE OF CONTENTS

1.           Introduction

1.1         Scope of the Study

1.2         The Insight Partners Research Report Guidance

1.3         Market Segmentation

1.3.1        SAM Healthcare Regulatory Affairs Outsourcing Market – By Service Type

1.3.2        SAM Healthcare Regulatory Affairs Outsourcing Market – By End User

1.3.3        SAM Healthcare Regulatory Affairs Outsourcing Market – By Country

2.           SAM Healthcare Regulatory Affairs Outsourcing Market – Key Takeaways

3.        Research Methodology

3.1         Coverage

3.2         Secondary Research

3.3         Primary Research

4.           SAM Healthcare Regulatory Affairs Outsourcing Market – Market Landscape

4.1         Overview

4.1.1        South America – PEST Analysis

4.2         Expert Opinions

5.           SAM Healthcare Regulatory Affairs Outsourcing Market– Key Market Dynamics

5.1         Market Drivers

5.1.1        Accelerating Regulatory Pressure on Healthcare Companies

5.1.2        Escalating Demand for Speedy Approval of New Products

5.2         Market Restraints

5.2.1        Dearth of Skilled Professionals

5.3         Market Opportunities

5.3.1        Advancements in Specialty Therapies, Orphan Drugs, and Personalized Medicines

5.4         Future Trends

5.4.1        Surging Market Consolidation Activities

5.5         Impact Analysis

6.           Healthcare Regulatory Affairs Outsourcing Market – SAM Analysis

6.1         SAM Healthcare Regulatory Affairs Outsourcing Market Revenue Forecast and Analysis

7.           SAM Healthcare Regulatory Affairs Outsourcing Market Analysis – By Service Type

7.1         Overview

7.2         Healthcare Regulatory Affairs Outsourcing Market, by Service Type (2021 and 2028)

7.3         Regulatory and Scientific Strategy Development

7.3.1        Overview

7.3.2        Regulatory and Scientific Strategy Development: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.4         Medical and Scientific Writing

7.4.1        Overview

7.4.2        Medical and Scientific Writing: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.5         eCTD and E-Submissions

7.5.1        Overview

7.5.2        eCTD and E-Submissions: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.6         Data Management Services

7.6.1        Overview

7.6.2        Data Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.7         Life Cycle Management Services

7.7.1        Overview

7.7.2        Life Cycle Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.8         Pharmacovigilance

7.8.1        Overview

7.8.2        Pharmacovigilance : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.9         Chemistry Manufacturing and Controls (CMC) Services

7.9.1        Overview

7.9.2        Chemistry Manufacturing & Controls ((CMC) Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.10      Regulatory Labelling

7.10.1     Overview

7.10.2     Regulatory Labelling : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.11      Regulatory Artwork Services

7.11.1     Overview

7.11.2     Regulatory Artwork Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

8.           SAM Healthcare Regulatory Affairs Outsourcing Market Analysis – By End User

8.1         Overview

8.2         Healthcare Regulatory Affairs Outsourcing Market, by End-User (2020 and 2028)

8.3         Pharmaceutical Companies

8.3.1        Overview

8.3.2        Pharmaceutical Companies: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

8.4         Biotechnology Companies

8.4.1        Overview

8.4.2        Biotechnology Companies : Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

8.5         Medical Device Companies

8.5.1        Overview

8.5.2        Medical Device Companies: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

8.5.2.1          Medical Device Software (SaMD) Market

8.5.2.1.1          Overview

8.5.2.1.2          Medical Device Software (SaMD) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.2          Medical Device Materials & Biomaterials Market

8.5.2.2.1          Overview

8.5.2.2.2          Medical Device Materials & Biomaterials Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.3          Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market

8.5.2.3.1          Overview

8.5.2.3.2          Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.4          Medical Device Electro mechanics Market

8.5.2.4.1          Overview

8.5.2.4.2          Medical Device Electro mechanics Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.5          Medical Device Substance Based Market

8.5.2.5.1          Overview

8.5.2.5.2          Medical Device Substance Based Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.6          Medical Device of Combination Product (DDC) Market

8.5.2.6.1          Overview

8.5.2.6.2          Medical Device of Combination Product (DDC) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

9.           SAM Healthcare Regulatory Affairs Outsourcing Market – Country Analysis

9.1         Overview

9.1.1        South America: Healthcare Regulatory Affairs Outsourcing Market Share by Country – 2021 & 2028, (%)

9.1.1.1          Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

9.1.1.1.1          Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

9.1.1.1.2          Brazil Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

9.1.1.1.3          Brazil Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

9.1.1.1.3.1       Brazil Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

9.1.1.2          Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

9.1.1.2.1          Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

9.1.1.2.2          Argentina Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

9.1.1.2.3          Argentina Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

9.1.1.2.3.1       Argentina Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

9.1.1.3          Rest of South America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

9.1.1.3.1          Rest of South America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

9.1.1.3.2          Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

9.1.1.3.3          Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

9.1.1.3.3.1       Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

10.        Impact Of COVID-19 Pandemic on SAM Healthcare Regulatory Affairs Outsourcing Market

10.1      Overview

11.        Industry Landscape

11.1      Overview

11.2      Organic Developments

11.2.1     Overview

11.3      Inorganic Developments

11.3.1     Overview

12.        Company Profiles

12.1      Arriello Ireland Ltd.

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      PAREXEL INTERNATIONAL CORPORATION

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      IQVIA Inc.

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      PHARMALEX GMBH

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      ProductLife Group

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      Azierta Contract Science Support Consulting

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

13.        Appendix

13.1      About The Insight Partners

13.2      Glossary of Terms

 


LIST OF TABLES

Table 1.             SAM Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecast to 2028 (US$ Million)

Table 2.             Brazil Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

Table 3.             Brazil Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

Table 4.             Brazil Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

Table 5.             Argentina Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

Table 6.             Argentina Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

Table 7.             Argentina Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

Table 8.             Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

Table 9.             Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

Table 10.          Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

Table 11.          Organic Developments in the Healthcare Regulatory Affairs Outsourcing Market

Table 12.          Inorganic Developments in the Healthcare Regulatory Affairs Outsourcing Market

Table 13.          Glossary of Terms, Healthcare Regulatory Affairs Outsourcing Market

 


LIST OF FIGURES

Figure 1.           SAM Healthcare Regulatory Affairs Outsourcing Market Segmentation

Figure 2.           SAM Healthcare Regulatory Affairs Outsourcing Market Segmentation, By Country

Figure 3.           SAM Healthcare Regulatory Affairs Outsourcing Market Overview

Figure 4.           Medical & Scientific Writing Segment Held the Largest Share of the Service Type Segment in SAM Healthcare Regulatory Affairs Outsourcing Market

Figure 5.           Brazil to Show Significant Growth During Forecast Period

Figure 6.           SAM PEST Analysis

Figure 7.           SAM Healthcare Regulatory Affairs Outsourcing Market Impact Analysis of Driver and Restraints

Figure 8.           SAM Healthcare Regulatory Affairs Outsourcing Market – Revenue Forecast and Analysis – 2019- 2028

Figure 9.           SAM Healthcare Regulatory Affairs Outsourcing Market Revenue Share, by Service Type (2020 and 2028)

Figure 10.        SAM Regulatory and Scientific Strategy Development: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 11.        SAM Medical and Scientific Writing: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 12.        SAM eCTD and E-Submissions: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 13.        SAM Data Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 14.        SAM Life Cycle Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 15.        SAM Pharmacovigilance : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 16.        SAM Chemistry Manufacturing & Controls ((CMC) Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 17.        SAM Regulatory Labelling: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 18.        SAM Regulatory Artwork Services : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 19.        SAM Healthcare Regulatory Affairs Outsourcing Market Revenue Share, by End-User (2020 and 2028)

Figure 20.        SAM Pharmaceutical Companies : Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 21.        SAM Biotechnology Companies: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 22.        SAM Medical Device Companies: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 23.        SAM Medical Device Software (SaMD) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 24.        SAM Medical Device Materials & Biomaterials Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 25.        SAM Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 26.        SAM Medical Device Electro mechanics Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 27.        SAM Medical Device Substance Based Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 28.        SAM Medical Device of Combination Product (DDC) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 29.        South America: Healthcare Regulatory Affairs Outsourcing Market, By Key Country – Revenue (2021) (USD Million)

Figure 30.        South America: Healthcare Regulatory Affairs Outsourcing Market Share by Country – 2021 & 2028, (%)

Figure 31.        Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

Figure 32.        Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

Figure 33.        Rest of South America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

Figure 34.        Impact Of COVID-19 Pandemic in South America Country Markets

  1. Arriello Ireland Ltd.
  2. Azierta Contract Science Support Consulting
  3. IQVIA Inc.
  4. PAREXEL INTERNATIONAL CORPORATION
  5. PHARMALEX GMBH
  6. ProductLife Group
  • Save and reduce time carrying out entry-level research by identifying the growth, size, leading players and segments in the SAM Healthcare Regulatory Affairs Outsourcing market.
  • Highlights key business priorities in order to assist companies to realign their business strategies
  • The key findings and recommendations highlight crucial progressive industry trends in the SAM Healthcare Regulatory Affairs Outsourcing market, thereby allowing players across the value chain to develop effective long-term strategies
  • Develop/modify business expansion plans by using substantial growth offering developed and emerging markets
  • Scrutinize in-depth SAM market trends and outlook coupled with the factors driving the Healthcare Regulatory Affairs Outsourcing market, as well as those hindering it
  • Enhance the decision-making process by understanding the strategies that underpin commercial interest with respect to client products, segmentation, pricing and distribution
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