The report features an extensive study on the current market landscape and future of companies offering services for HFE and usability testing for medical devices. The study includes an in-depth analysis, highlighting the capabilities of various service providers engaged in this market. Amongst other elements, the report includes:

·        A detailed assessment of the overall landscape of companies offering human factors engineering and usability testing services for medical devices.

·        A detailed company competitiveness analysis of HFE and usability testing service providers, taking into consideration the supplier power (based on the year of establishment of developer) and key specifications, such as core services offered, other services offered and types of medical devices they have designed till date.

·        An elaborate discussion on the various guidelines established by major regulatory bodies, governing medical device HFE and usability testing services, across different regions.

·        A detailed discussion on the cost implications across various steps of the HFE and usability testing process.

·        Elaborate profiles of key players that claim to provide human factors engineering and usability testing services for medical devices.

·        A discussion on important industry-specific trends, key market drivers and challenges, under a SWOT framework.

A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Type of tools used

·        Generative tools

·        Evaluative tools

Type of steps involved

·        Contextual analysis

·        Task analysis

·        Design analysis

·        Formative studies

·        Use risk analysis

·        Known use error analysis

·        Summative studies

·        Regulatory document preparation’

Device class

·        Class I medical devices

·        Class II medical devices

·        Class III medical devices

Key geographical regions

·        North America

·        Europe

·        Asia Pacific

Key companies covered in the report

·        Agilis

·        Human Factors Consulting Service

·        Human Factors MD

·        User wise

·        Ximedica

·        Austrian Center for Medical Innovation and Technology (ACIMT)

·        Auxergo

·        THAY Medical

·        Ergotech

·        Jonathan Bar-Or Industrial Design

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/human-factors-engineering-and-usability-testing-services.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

Key Market Insights

·        Presently, over 100 service providers across the globe have capabilities to handle high energy / hazardous chemistry conditions, offering contract and custom manufacturing services for pharmaceutical APIs

·        The market landscape is highly fragmented, featuring the presence of both established players and new entrants; majority of the companies have presence in Europe and Asia Pacific regions

·        API manufacturing facilities of service providers are well equipped to handle / maintain a wide range of temperature and pressure conditions to carry out HEC reactions

·        Industry stakeholders are actively expanding their existing capabilities through installation of advanced equipment at their manufacturing facilities, in order to maintain a competitive edge in the market

·        Service Providers are offering a diverse portfolio of reactions for manufacturing of synthetic APIs; Hydrogenation and Grignard reactions are the most popular types of reactions offered by players

·        Case In Point: Contract research service providers cater to the needs related to process development and small scale synthesis of APIs based on HEC / hazardous chemistry

·        In the long-term, the projected opportunity is anticipated to be worth USD 29 billion by 2030; the opportunity is anticipated to be well distributed across companies of varying sizes, scale of operation and geographies

Table of Contents

1.   PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2.   EXECUTIVE SUMMARY

3.   INTRODUCTION

3.1. Chapter Overview

3.2. Overview of High Energy Chemistry (HEC) / Hazardous Chemistry for Small Molecule API Manufacturing

3.3. Low Temperature / Cryogenic Chemistry

3.3.1.   Reaction Conditions

3.3.2.   Advantages

3.3.3.   Affiliated Production Processes

3.3.4.   Other Specific Requirements / Equipment

3.3.5.   List of Reactions

3.4. High Temperature Chemistry

3.4.1.   Reaction Conditions

3.4.2.   Advantages

3.4.3.   Affiliated Production Processes

3.4.4.   Other Specific Requirements / Equipment

3.4.5.   List of Reactions

3.5. High Pressure Chemistry

3.5.1.   Reaction Conditions

3.5.2.   Advantages

3.5.3.   Affiliated Production Processes

3.5.4.   Other Specific Requirements / Equipment

3.5.5.   List of Reactions

3.6. Need for Outsourcing HEC / Hazardous Chemistry-Based API Manufacturing in the Pharmaceutical Industry

3.7. Shift Towards Continuous Flow Chemistry

4.   CASE STUDY: COMPARISON OF SMALL MOLECULES AND LARGE MOLECULES

4.1. Chapter Overview

4.2. Small Molecule and Large Molecule Drugs / Therapies

4.2.1.   Comparison of Key Characteristics

4.2.2.   Comparison of Manufacturing Processes

4.2.3.   Comparison of Key Manufacturing-related Challenges

4.3 HEC / Hazardous Chemistry for Small Molecule Manufacturing

5.   CURRENT MARKET LANDSCAPE

5.1. Chapter Overview

5.2. API Manufacturers with HEC Capability: Overall Market Landscape

5.2.1.   Analysis by Type of Manufacturing Service

5.2.2.   Analysis by Year of Establishment

5.2.3.   Analysis by Company Size

5.2.4.   Analysis by Geographical Location

5.2.5.   Analysis by Location of Manufacturing Facilities

5.2.6.   Analysis by General Pharmaceutical Manufacturing Portfolio

5.2.6.1.      Analysis by Type of Product (API and FDF)

5.2.6.2.      Analysis by HPAPI Manufacturing Capability

5.2.7.   Analysis by Type of HEC Services Offered

5.2.7.1.      Analysis by Temperature Conditions Handled

5.2.7.2.      Analysis by Pressure Conditions Handled

5.2.8.   Analysis by Availability of Continuous Flow Technology

6.   REGIONAL CAPABILITY ASSESSMENT

6.1. Chapter Overview

6.2. List of Manufacturing Facilities having HEC Capabilities

6.2.1.   Manufacturing Facilities in North America

6.2.1.1.      Geographical Map Representation: Manufacturing Facilities with HEC Capabilities in North America

6.2.1.2.      Analysis by Type of Reaction Conditions Handled

6.2.1.3.      Analysis by Range of Reaction Conditions Handled

6.2.1.3.1.          Analysis by Temperature Conditions Handled

6.2.1.3.2.          Analysis by Pressure Conditions Handled

6.2.2.   Manufacturing Facilities in Europe

6.2.2.1.      Geographical Map Representation: Manufacturing Facilities with HEC Capabilities in Europe

6.2.2.2.      Analysis by Type of Reaction Conditions Handled

6.2.2.3.      Analysis by Range of Reaction Conditions Handled

6.2.2.3.1.          Analysis by Temperature Conditions Handled

6.2.2.3.2.          Analysis by Pressure Conditions Handled

6.2.3.   Manufacturing Facilities in Asia Pacific

6.2.3.1.      Geographical Map Representation: Manufacturing Facilities with HEC Capabilities in Asia Pacific

6.2.3.2.      Analysis by Type of Reaction Conditions Handled

6.2.3.3.      Analysis by Range of Reaction Conditions Handled

6.2.3.3.1.          Analysis by Temperature Conditions Handled

6.2.3.3.2.          Analysis by Pressure Conditions Handled

6.3. Regional Capability Assessment Summary

7.   COMPANY COMPETITIVENESS ANALYSIS

7.1. Chapter Overview

7.2. Key Parameters

7.3. Methodology

7.4. Competitiveness Analysis: Companies in North America

7.4.1.   Companies in North America Offering HEC-based Contract Manufacturing

7.4.2.   Companies in North America Offering HEC-based Custom Manufacturing

7.5. Competitiveness Analysis: Companies in Europe

7.5.1.   Companies in Europe Offering HEC-based Contract Manufacturing

7.5.2.   Companies in Europe Offering HEC-based Custom Manufacturing

7.6. Competitiveness Analysis: Companies in Asia Pacific

7.6.1.   Companies in Asia Pacific Offering HEC-based Contract Manufacturing

7.6.2.   Companies in Asia Pacific HEC-based Offering Custom Manufacturing

7.7. Spider Web Analysis

8.   COMPANY PROFILES

8.1. Chapter Overview

8.2. AGC Chemicals

8.2.1.   Company Overview

8.2.2.   Financial Information

8.2.3.   Manufacturing Facility Details

8.2.4.   HEC Specific Service Offerings

8.2.5.   Recent Developments and Future Outlook

8.3. Beijing Mediking Biopharm

8.3.1 Company Overview

8.3.2 Manufacturing Facility Details

8.3.3 HEC Specific Service Offerings

8.3.4. Recent Developments and Future Outlook

8.4. Cambrex

8.4.1.   Company Overview

8.4.2.   Financial Information

8.4.3.   Manufacturing Facility Details

8.4.4.   HEC Specific Service Offerings

8.4.5.   Recent Developments and Future Outlook

8.5. Corden Pharma

8.5.1 Company Overview

8.5.2 Manufacturing Facility Details

8.5.3 HEC Specific Service Offerings

8.5.4 Recent Developments and Future Outlook

8.6. Evonik

8.6.1.   Company Overview

8.6.2.   Financial Information

8.6.3.   Manufacturing Facility Details

8.6.4.   HEC Specific Service Offerings

8.6.5.   Recent Developments and Future Outlook

8.7. Hovione

8.7.1.   Company Overview

8.7.2.   Manufacturing Facility Details

8.7.3.   HEC Specific Service Offerings

8.7.4.   Recent Developments and Future Outlook

8.8. Patheon

8.8.1.   Company Overview

8.8.2.   Manufacturing Facility Details

8.8.3.   HEC Specific Service Offerings

8.8.4.   Recent Developments and Future Outlook

8.9. PCI Synthesis

8.9.1.   Company Overview

8.9.2.   Manufacturing Facility Details

8.9.3.   HEC Specific Service Offerings

8.9.4.   Recent Developments and Future Outlook

8.10.            Siegfried

8.10.1.               Company Overview

8.10.2.               Manufacturing Facility Details

8.10.3.               HEC Specific Service Offerings

8.10.4.               Financial Information

8.10.5.               Recent Developments and Future Outlook

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/high-energy-chemistry.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

The report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of endocannabinoid system targeting drugs, over the next decade. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. In addition to other elements, the study includes:

·        A detailed assessment of the current market landscape of drug developers engaged in the development of endocannabinoid system targeted therapeutics.

·        Detailed profiles of developers of endocannabinoid system targeted therapeutics (shortlisted on the basis of the number of development programs).

·        An in-depth analysis of nearly 600 grants that have been awarded to research institutes engaged in endocannabinoid system targeted therapeutics projects.

·        An analysis of the partnerships that have been established in this domain, in the recent past.

·        A detailed analysis of the various mergers and acquisitions that have taken place in this domain, between 2016-2020

·        An insightful chessboard analysis highlighting the most popular drug development strategies / paths adopted by various drug developers in the domain of endocannabinoid system targeted therapeutics.

A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Target Disease Indication

·        Cancer

·        Genetic Disorders

·        Neurological Indications

·        Others

Route of Administration

·        Oral

·        Inhalation

Key Geographies

·        North America

·        Europe

·        Asia-Pacific and the Rest of the World

Key companies covered in the report

·        GW Pharmaceuticals

·        Corbus Pharmaceuticals

·        Tilray

·        Tetra Bio-Pharma

·        Botanix Pharmaceuticals

·        Kalytera Therapeutics

·        Therapix Biosciences

·        Echo Pharmaceuticals

·        Avicanna

·        GB Sciences

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/endocannabinoid-therapeutics/316.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

Key Market Insights

·        Over 400 companies claim to possess the required expertise to offer regulatory affairs management-related services to medical device-focused business entities

·        The market landscape is highly fragmented, featuring the presence of both established players and new entrants; majority of such firms are located in the developed geographies

·        Service providers are catering to a diverse clientele, enabling sponsors to compliance to the standards of both regional and international regulators

·        Owing to the high competition, companies involved in this domain are steadily expanding their capabilities in order to augment their respective service portfolios and comply to evolving industry benchmarks

·        CROs are actively engaged in expanding their global footprint in order to enable their clients to navigate the technical and regulatory complexities across various geographies

·        The medical device regulatory affairs outsourcing market is anticipated to grow at an annualized rate of 6.8%; the opportunity is likely to be distributed across different therapeutic areas and geographies

·        Based on prevalent and anticipated trends, the revenue share will vary across important market segments, such as different types of services, size of service provider and device class

Table of Contents

1.   PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2.   EXECUTIVE SUMMARY

3.   INTRODUCTION

3.1. Chapter Overview

3.2. Contract Research Organizations (CROs)

3.2.1.   Evolution of CROs

3.3. Role of CROs in the Medical Device Industry

3.4. Types of Medical Device CROs

3.5. Types of Services Offered by CROs

3.5.1.   Types of Regulatory Affairs-Related Services Offered by CROs

3.6. Need for Outsourcing Regulatory Affairs-Related Operations for Medical Devices

3.7. Key Considerations for Selecting a Suitable CRO Partner

3.8. Advantages of Working with CROs

3.9. Risks and Challenges Related to Working with CROs

3.10.            Concluding Remarks

4.   ROLE OF REGULATORY AFFAIRS IN MEDICAL DEVICE SUPPLY CHAIN

4.1. Chapter Overview

4.2. Overview of Medical Device Supply Chain

4.2.1.   Importance of Regulatory Affairs in Medical Device Supply Chain

4.2.1.1.      Concept and Feasibility Assessment Stage

4.2.1.2.      Preclinical Stage

4.2.1.3.      Manufacturing / Production Stage

4.2.1.4.      Marketing Stage

4.2.1.5.      Post-Marketing Stage

4.3. Factors Affecting the Medical Device Supply Chain

4.4. Key Performance Indicators for Medical Device Supply Chain Management

4.5. Optimization of Regulatory Affairs in the Medical Device Supply Chain

4.5.1.   Digitalization of the Medical Device Supply Chain

5.   REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES

5.1. Chapter Overview

5.2. General Regulatory and Reimbursement Guidelines for Medical Devices

5.3. Regulatory and Reimbursement Landscape in North America

5.3.1.   The US Scenario

5.3.1.1.      Regulatory Authority

5.3.1.2.      Review / Approval Process

5.3.1.3.      Reimbursement Landscape

5.3.1.3.1.          Payer Mix

5.3.1.3.2.          Reimbursement Process

5.3.2.   The Canadian Scenario

5.3.2.1.      Regulatory Authority

5.3.2.2.      Review / Approval Process

5.3.2.3.      Reimbursement Landscape

5.3.2.3.1.          Payer Mix

5.3.2.3.2.          Reimbursement Process

5.3.3.   The Mexican Scenario

5.3.3.1.      Regulatory Authority

5.3.3.2.      Review / Approval Process

5.3.3.3.      Reimbursement Landscape

5.3.3.3.1.          Payer Mix

5.4. Regulatory and Reimbursement Landscape in Europe

5.4.1.   Overall Scenario

5.4.1.1.      Overall Regulatory Authority

5.4.1.2.      Overall Review / Approval Process

5.4.2.   The UK Scenario

5.4.2.1.      Regulatory Authority

5.4.2.2.      Review / Approval Process

5.4.2.3.      Reimbursement Landscape

5.4.2.3.1.          Payer Mix

5.4.2.3.2.          Reimbursement Process

5.4.3.   The French Scenario

5.4.3.1.      Regulatory Authority

5.4.3.2.      Review / Approval Process

5.4.3.3.      Reimbursement Landscape

5.4.3.3.1.          Payer Mix

5.4.3.3.2.          Reimbursement Process

5.4.4.   The German Scenario

5.4.4.1.      Regulatory Authority

5.4.4.2.      Review / Approval Process

5.4.4.3.      Reimbursement Landscape

5.4.4.3.1.          Payer Mix

5.4.4.3.2.          Reimbursement Process

5.4.5.   The Italian Scenario

5.4.5.1.      Regulatory Authority

5.4.5.2.      Review / Approval Process

5.4.5.3.      Reimbursement Landscape

5.4.5.3.1.          Payer Mix

5.4.5.3.2.          Reimbursement Process

5.4.6.   The Spanish Scenario

5.4.6.1.      Regulatory Authority

5.4.6.2.      Review / Approval Process

5.4.6.3.      Reimbursement Landscape

5.4.6.3.1.          Payer Mix

5.4.6.3.2.          Reimbursement Process

5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World

5.5.1.   The Australian Scenario

5.5.1.1.      Regulatory Authority

5.5.1.2.      Review / Approval Process

5.5.1.3.      Reimbursement Landscape

5.5.1.3.1.          Payer Mix

5.5.1.3.2.          Reimbursement Process

5.5.2.   The Brazilian Scenario

5.5.2.1.      Regulatory Authority

5.5.2.2.      Review / Approval Process

5.5.2.3.      Reimbursement Landscape

5.5.2.3.1.          Payer Mix

5.5.2.3.2.          Reimbursement Process

5.5.3.   The Chinese Scenario

5.5.3.1.      Regulatory Authority

5.5.3.2.      Review / Approval Process

5.5.3.3.      Reimbursement Landscape

5.5.3.3.1.          Payer Mix

5.5.3.3.2.          Reimbursement Process

5.5.4.   The Indian Scenario

5.5.4.1.      Regulatory Authority

5.5.4.2.      Review / Approval Process

5.5.4.3.      Reimbursement Landscape

5.5.4.3.1.          Payer Mix

5.5.5.   The Israeli Scenario

5.5.5.1.      Regulatory Authority

5.5.5.2.      Review / Approval Process

5.5.5.3.      Reimbursement Landscape

5.5.5.3.1.          Payer Mix

5.5.6.   The Japanese Scenario

5.5.6.1.      Regulatory Authority

5.5.6.2.      Review / Approval Process

5.5.6.3.      Reimbursement Landscape

5.5.6.3.1.          Payer Mix

5.5.6.3.2.          Reimbursement Process

5.5.7.   The New Zealand Scenario

5.5.7.1.      Regulatory Authority

5.5.7.2.      Review / Approval Process

5.5.7.3.      Reimbursement Landscape

5.5.7.3.1.          Payer Mix

5.5.7.3.2.          Reimbursement Process

5.5.8.   The Singaporean Scenario

5.5.8.1.      Regulatory Authority

5.5.8.2.      Review / Approval Process

5.5.8.3.      Reimbursement Landscape

5.5.8.3.1.          Payer Mix

5.5.8.3.2.          Reimbursement Process

5.5.9.   The South Korea Scenario

5.5.9.1.      Regulatory Authority

5.5.9.2.      Review / Approval Process

5.5.9.3.      Reimbursement Landscape

5.5.9.3.1.          Payer Mix

5.5.9.3.2.          Reimbursement Process

5.5.10.               The South African Scenario

5.5.10.1.    Regulatory Authority

5.5.10.2.    Review / Approval Process

5.5.10.3.    Reimbursement Landscape

5.5.11.               The Taiwanese Scenario

5.5.11.1.    Regulatory Authority

5.5.11.2.    Review / Approval Process

5.5.11.3.    Reimbursement Landscape

5.5.11.3.1.       Payer Mix

5.5.11.3.2.       Reimbursement Process

5.5.12.               The Thailand Scenario

5.5.12.1.    Regulatory Authority

5.5.12.2.    Review / Approval Process

5.5.12.3.    Reimbursement Landscape

5.6. Comparison of Regional Regulatory Environment

5.7. Concluding Remarks

6.   COMPETITIVE LANDSCAPE

6.1. Chapter Overview

6.2. CROs Offering Regulatory Affairs-Related Services for Medical Devices: List of Companies

6.2.1.   Analysis by Year of Establishment

6.2.2.   Analysis by Size of Employee Base

6.2.3.   Analysis by Location of Headquarters

6.2.4.   Analysis by Company Size and Geography

6.3. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Area of Specialization

6.3.1.   Analysis by Area of Specialization

6.4. CROs Offering Medical Device Regulatory Services: Information on Type of Regulatory Affairs-Related Services Offered

6.4.1.   Analysis by Type of Regulatory Affairs-Related Service Offered

6.4.2. Analysis by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered

6.5. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type of Additional Services Offered

6.5.1.   Analysis by Type of Additional Services Offered

6.6. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Device Class

6.6.1.   Analysis by Device Class

6.7. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type and Size of Clientele

6.7.1.   Analysis by Type and Size of Clientele

6.8. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Medical Device Regulatory Compliance Authorities

6.8.1.   Analysis by Medical Device Regulatory Compliance Authorities

6.9. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Region-wise)

6.9.1.   Analysis by Geographical Reach (Region-Wise)

6.10.            CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Country-wise)

6.10.1.               Analysis by Geographical Reach (Country-Wise)

7.   COMPANY PROFILES

7.1. Chapter Overview

7.2. CROs Headquartered in North America

7.2.1.   CTI Clinical Trial and Consulting (CTI)

7.2.1.1.      Company Overview

7.2.1.2.      Service Portfolio

7.2.1.3.      Future Outlook

7.2.2.   Medpace

7.2.2.1.      Company Overview

7.2.2.2 Financial Information

7.2.2.2.      Service Portfolio

7.2.2.3.      Future Outlook

7.2.3.   NAMSA

7.2.3.1.      Company Overview

7.2.3.2.      Service Portfolio

7.2.3.3.      Future Outlook

7.2.4.   PAREXEL

7.2.4.1.      Company Overview

7.2.4.2 Financial Information

7.2.4.2.      Service Portfolio

7.2.4.3.      Future Outlook

7.2.5.   Premier Research

7.2.5.1.      Company Overview

7.2.5.2.      Service Portfolio

7.2.5.3.      Future Outlook

7.2.6.   Underwriters Laboratory (UL)

7.2.6.1.      Company Overview

7.2.6.2.      Service Portfolio

7.2.6.3.      Future Outlook

7.3. CROs Headquartered in Europe

7.3.1.   CROMSOURCE

7.3.1.1.      Company Overview

7.3.1.2.      Service Portfolio

7.3.1.3 Future Outlook

7.3.2.   ICON

7.3.2.1.      Company Overview

7.3.2.2 Financial Information

7.3.2.2.      Service Portfolio

7.3.2.3.      Future Outlook

7.3.3.   Intertek

7.3.3.1.      Company Overview

7.3.3.2 Financial Information

7.3.3.2.      Service Portfolio

7.3.3.3.      Future Outlook

7.3.4.   PharmaLex

7.3.4.1.      Company Overview

7.3.4.2.      Service Portfolio

7.3.4.3 Future Outlook

7.3.5.   Société Générale de Surveillance (SGS)

7.3.5.1.      Company Overview

7.3.5.2.      Service Portfolio

7.3.5.3 Future Outlook

7.3.4. SteriPack

7.3.4.1. Company Overview

7.3.4.2. Service Portfolio

7.3.4.3 Future Outlook

7.4. CROs Headquartered in Asia-Pacific and Rest of the World

7.4.1.   MIC Medical

7.4.1.1.      Company Overview

7.4.1.2.      Service Portfolio

7.4.1.3 Recent Developments

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

Key Market Insights

·        Several players are currently engaged in the development and / or manufacturing of different types of cobots for a wide variety of operations, including both simple and precision tasks

·        Over 230 cobots, having variable payload capacities and degrees of freedom, have already been deployed, or are being actively adopted across various industries, including the life sciences and pharmaceutical industry

·        In order to achieve a competitive edge, several manufacturers are presently focusing on the integration of advanced technical features into their cobots portfolio for performing a variety of industrial task(s)

·        Companies involved in the development of industrial cobots are evenly distributed across the globe; it is worth noting that a number of start-ups claim to be working on cobots with advanced safety and hand guiding features

·        Stakeholders have already established strong brand positions; in fact, players are steadily expanding their respective portfolios, in order to maintain a competitive edge in this upcoming industry

·        Future growth of the market is likely to be driven by the need of automation in various industries; the opportunity is expected to be distributed across industrial operations, end-users, payload capacities and regions

Table of Contents

1.   PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2.   EXECUTIVE SUMMARY

3.   INTRODUCTION

3.1. Chapter Overview

3.2. Collaborative Robots (Cobots)

3.2.1.   History of Cobots

3.2.2.   Cobots versus Traditional Industrial Robots

3.3. Types of Cobots

3.4. Advantages of Cobots

3.5. Limitations of Cobots

3.6. Type of End-Users

3.7. Key Industrial Operation(s) Performed

3.8. Regulatory Standards

3.9. Key Considerations for Selection of a Cobot

3.10.            Estimation of Return on Investment (ROI) and Payback Period for Cobots

3.11.            Future Prospects

4.   CURRENT MARKET LANDSCAPE

4.1. Chapter Overview

4.2. Industrial Cobots: Overall Market Landscape

4.2.1.   Analysis by Market Availability

4.2.2.   Analysis by Type of Industrial Operation(s)

4.2.3.   Analysis by Weight of Cobot

4.2.4.   Analysis by Payload Capacity

4.2.5.   Analysis by Degrees of Freedom

4.2.6.   Analysis by Maximum Horizontal Reach

4.2.7.   Analysis by Positional Repeatability

4.2.8.   Analysis by Number of Arms

4.2.9.   Analysis by Type of Mounting

4.2.10.               Analysis by Temperature of Operational Environment

4.2.11.               Analysis by Type of End-User (Industry)

4.2.12.               Analysis by Cost of Cobot

4.3. Industrial Cobots: Additional Information

4.4. Industrial Cobots: Developer Landscape

4.4.1.   Analysis by Year of Establishment

4.4.2.   Analysis by Company Size

4.4.3.   Analysis by Location of Headquarters

4.4.4.   Analysis by Company Size and Location of Headquarters

4.5. Leading Manufacturers: Analysis by Number of Cobots

4.6. Heat Map Representation: Analysis by Payload Capacity and Industrial Operations

4.7. Tree Map Representation: Analysis by Company Size and End-User

4.8. World Map Representation: Analysis by Location of Headquarters

5.   COMPANY PROFILES

5.1. Chapter Overview

5.2. Leading Players based in North America

5.2.1.   Kinova

5.2.1.1.      Company Overview

5.2.1.2.      Product Portfolio

5.2.1.3.      Recent Developments and Future Outlook

5.2.2.   Precise Automation

5.2.2.1.      Company Overview

5.2.2.2.      Product Portfolio

5.2.2.3.      Recent Developments and Future Outlook

5.2.3.   Robotics Systems Integration

5.2.3.1.      Company Overview

5.2.3.2.      Product Portfolio

5.2.3.3.      Recent Developments and Future Outlook

5.3. Leading Players based in Europe

5.3.1.   ABB

5.3.1.1.      Company Overview

5.3.1.2.      Product Portfolio

5.3.1.3.      Recent Developments and Future Outlook

5.3.2.   Comau

5.3.2.1.      Company Overview

5.3.2.2.      Product Portfolio

5.3.2.3.      Recent Developments and Future Outlook

5.3.3.   FANUC

5.3.3.1.      Company Overview

5.3.3.2.      Product Portfolio

5.3.3.3.      Recent Developments and Future Outlook

5.3.4.   KUKA

5.3.4.1.      Company Overview

5.3.4.2.      Product Portfolio

5.3.4.3.      Recent Developments and Future Outlook

5.3.5.   Staubli

5.3.5.1.      Company Overview

5.3.5.2.      Product Portfolio

5.3.5.3.      Recent Developments and Future Outlook

5.3.6.   Universal Robots

5.3.6.1.      Company Overview

5.3.6.2.      Product Portfolio

5.3.6.3.      Recent Developments and Future Outlook

5.4. Leading Players based in Asia-Pacific

5.4.1.   Yaskawa Electric

5.4.1.1.      Company Overview

5.4.1.2.      Product Portfolio

5.4.1.3.      Recent Developments and Future Outlook

6.   COMPANY COMPETITIVENESS ANALYSIS

6.1. Chapter Overview

6.2. Assumptions / Key Parameters

6.3. Methodology

6.4. Company Competitiveness Analysis: Cobot Manufacturers in North America

6.5. Company Competitiveness Analysis: Cobot Manufacturers in Europe

6.6. Company Competitiveness Analysis: Cobot Manufacturers in Asia-Pacific and Rest of the World

7.   BRAND POSITIONING ANALYSIS OF LEADING PLAYERS

7.1. Chapter Overview

7.2. Key Parameters and Methodology

7.3. Brand Positioning Matrix: ABB

7.4. Brand Positioning Matrix: FANUC

7.5. Brand Positioning Matrix: KUKA

7.6. Brand Positioning Matrix: Staubli

7.7. Brand Positioning Matrix: Universal Robots

7.8. Brand Positioning Matrix: Yaskawa Electric

8.   PRODUCT COMPETITIVENESS ANALYSIS

8.1. Chapter Overview

8.2. Assumptions / Key Parameters

8.3. Methodology

8.4. Product Competitiveness Analysis: Cobots with Less than Six Degrees of Freedom

8.5. Product Competitiveness Analysis: Cobots with Six Degrees of Freedom

8.6. Product Competitiveness Analysis: Cobots with More than Six Degrees of Freedom

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/collaborative-robots-market.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

Key Market Insights

·        Presently, over 100 CMOs across the globe claim to have manufacturing facilities in China, offering services for pharmaceutical API, intermediates and FDF manufacturing

·        CMOs have established manufacturing facilities across different regions of China; Eastern China has emerged as a popular hub, serving as a base of operations for many contract service providers

·        The current, installed manufacturing capacity of pharmaceutical CMOs in China is estimated to be over 46 million liters; interestingly, capacity utilization has been observed to be ~75% over the last few years

·        Big pharma players have also invested significantly in this region for initiatives related to the establishment or expansion of R&D centers and manufacturing facilities focused on pharmaceutical products

·        Innovator companies are expected to continue outsourcing clinical and commercial manufacturing operations to China-based CMOs; the contract services industry in the region is likely to grow at a CAGR of ~8.9%

·        In the long-term, the projected future opportunity is anticipated to be well distributed across various market segments, such as different types of products (APIs and FDFs), region (eastern china, southern china, western china) and others

Table of Contents

1.   PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2.   EXECUTIVE SUMMARY

3.   INTRODUCTION

3.1. Chapter Overview

3.2. Need for Outsourcing in the Pharmaceutical Industry

3.3. Overview of the Pharmaceutical Contract Manufacturing

3.4. Evolution of the Pharmaceutical Contract Manufacturing Industry

3.4.1.   Traditional Contract Manufacturing Organizations (CMOs)

3.4.2.   Modern CMOs

3.5. Services Offered by CMOs

3.6. Pharmaceutical Contract Manufacturing Scenario in China

3.7. Advantages and Challenges associated with Outsourcing Pharmaceutical Manufacturing to China-based CMOs

4.   CASE STUDY: COMPARISON OF SMALL MOLECULES AND LARGE MOLECULES

4.1. Chapter Overview

4.2. Small Molecule and Large Molecule Drugs / Therapies

4.2.1.   Comparison of General Characteristics

4.2.2.   Comparison of Manufacturing Processes

4.2.3.   Comparison of Key Manufacturing-related Challenges

5.   MARKET OVERVIEW

5.1. Chapter Overview

5.2. Chinese Pharmaceutical CMOs with Manufacturing Facilities in China: List of Companies

5.2.1.   Analysis by Year of Establishment

5.2.2.   Analysis by Company Size

5.2.3.   Analysis by Location of Headquarters

5.2.4.   Analysis by Type of Product (API and FDF)

5.2.5.   Analysis by Type of FDF

5.2.6.   Analysis by Type of Packaging

5.2.7.   Analysis by Manufacturing Facilities

5.3. Non-Chinese Pharmaceutical CMOs with Manufacturing Facilities in China: List of Companies

5.3.1.   Analysis by Year of Establishment

5.3.2.   Analysis by Company Size

5.3.3.   Analysis by Location of Headquarters

5.3.4.   Analysis by Type of Product (API and FDF)

5.3.5.   Analysis by Type of FDF

5.3.6.   Analysis by Type of Packaging

5.3.7 Analysis by Manufacturing Facilities

6.   MANUFACTURING FACILITIES OF PHARMACEUTICAL CMOs IN CHINA

6.1. Chapter Overview

6.2. Chinese Pharmaceutical CMOs: List of Manufacturing Facilities

6.2.1.   Analysis by CMO Manufacturing Facilities in Eastern China

6.2.2.   Analysis by CMO Manufacturing Facilities in Southern China

6.2.3.   Analysis by CMO Manufacturing Facilities in Northern China

7.   PHARMACEUTICAL MANUFACTURING REGULATIONS IN CHINA

7.1. Chapter Overview

7.1.1.   Health Authorities in China

7.1.2.   Overview of Regulatory Guidelines in China

8.   COMPANY PROFILES

8.1. Chapter Overview

8.2. 2Y-Chem

8.2.1.   Company Overview

8.2.2.   Service Portfolio

8.2.3.   China-based Manufacturing Facilities and Capabilities

8.2.4.   Recent Developments and Future Outlook

8.3. Aurisco Pharmaceutical

8.3.1.   Company Overview

8.3.2.   Service Portfolio

8.3.3.   China-based Manufacturing Facilities and Capabilities

8.3.4.   Recent Developments and Future Outlook

8.4. ChemPartner

8.4.1.   Company Overview

8.4.2.   Service Portfolio

8.4.3.   China-based Manufacturing Facilities and Capabilities

8.4.4.   Recent Developments and Future Outlook

8.5. Dorrapharma

8.5.1.   Company Overview

8.5.2.   Service Portfolio

8.5.3.   China-based Manufacturing Facilities and Capabilities

8.5.4.   Recent Developments and Future Outlook

8.6. Hubei Biocause Pharmaceutical

8.6.1.   Company Overview

8.6.2.   Service Portfolio

8.6.3.   China-based Manufacturing Facilities and Capabilities

8.6.4.   Recent Developments and Future Outlook

8.7. Infoark

8.7.1.   Company Overview

8.7.2.   Service Portfolio

8.7.3.   China-based Manufacturing Facilities and Capabilities

8.7.4.   Recent Developments and Future Outlook

8.8. Ningbo Menovo Pharmaceutical

8.8.1.   Company Overview

8.8.2.   Service Portfolio

8.8.3.   China-based Manufacturing Facilities and Capabilities

8.8.4.   Recent Developments and Future Outlook

8.9. Shandong Xinhua Pharmaceutical

8.9.1.   Company Overview

8.9.2.   Service Portfolio

8.9.3.   China-based Manufacturing Facilities and Capabilities

8.9.4.   Recent Developments and Future Outlook

8.10.            Shanghai Acebright Pharmaceuticals

8.10.1.               Company Overview

8.10.2.               Service Portfolio

8.10.3.               China-based Manufacturing Facilities and Capabilities

8.10.4.               Recent Developments and Future Outlook

8.11.            STA Pharmaceutical

8.11.1.               Company Overview

8.11.2.               Service Portfolio

8.11.3.               China-based Manufacturing Facilities and Capabilities

8.11.4.               Recent Developments and Future Outlook

8.12.            Zhejiang Huahai Pharmaceutical

8.12.1.               Company Overview

8.12.2.               Service Portfolio

8.12.3.               China-based Manufacturing Facilities and Capabilities

8.12.4.               Recent Developments and Future Outlook

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/china-pharmaceutical-contract-manufacturing/312.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

The USD 3.7 billion (by 2030) financial opportunity within the encapsulated Cell Therapies and Encapsulation Technologies Market has been analyzed across the following segments:

Type of licensing deal payment

·        Upfront payment

·        Milestone payment

Therapeutic area

·        Metabolic disorder

·        Neurological disorder

·        Ophthalmic disorder

·        Oncological disorder

Target disease indication

·        Ataxia telangiectasia

·        Breast cancer

·        Diabetes

·        Glaucoma

·        Head and neck cancer

·        Macular telangectasia

·        Pancreatic cancer

·        Parkinson's disease

·        Retinitis pigmentosa

Type of encapsulation material used

·        Alginate-based microcapsule

·        Cellulose hydrogel

·        Medical-grade plastic

·        Red blood cell

Key geographical region

·        North America

·        Europe

·        Asia-Pacific and rest of the world

The Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030 report features the following companies, which we identified to be key players in this domain:

·        ALTuCELL

·        Azellon Cell Therapeutics

·        Beta-Cell

·        Betalin Therapeutics

·        CellProtect Biotechnology

·        Diatranz Otsuka

·        Encellin

·        EryDel

·        Gloriana Therapeutics

·        Living Cell Technologies

·        MaxiVAX

·        Neurotech Pharmaceuticals

·        PharmaCyte Biotech

·        Semma Therapeutics

·        Sernova

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/cell-encapsulation-focus-on-therapeutics-and-technologies-2019-2030/249.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

Key Market Insights

·        Several novel biomarkers are presently under investigation for a variety of cancer indications; the initiatives of big pharmaceutical companies are indicative of the growing interest in this domain

·        Presently, close to 50 companies are offering a variety of analytical testing solutions for the assessment of novel cancer biomarkers; majority of these tests are intended to facilitate important therapy-related decisions

·        Multiple tests are currently available for specific diseases indications; next generation sequencing has emerged as a key driver, enabling high throughput results and faster turnaround times

·        Companies involved in this domain are putting in significant efforts to develop efficient tests and differentiate their offerings, from those of other stakeholders, to maintain a competitive edge

·        Till date, close to 200 trials, evaluating the expression of novel biomarkers have been registered across different cancer indications, phases of development and geographical locations

·        The growing research activity in this domain is also evident across published scientific literature; several biomarker-focused studies are evaluating different types of immunotherapies

·        The growing interest in this field is also reflected by the 120+ partnerships have been signed in the last two years, involving both international and indigenous stakeholders

·        The opportunity is likely to be driven by the applicability of these tests across multiple cancer indications; the market is anticipated to grow as more biomarker based drugs get approved in the coming decade

·        The projected future opportunity is expected to be distributed across different application areas, types of analytical techniques used and various global regions

Table of Contents

1. PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview

3.2. Cancer Immunotherapy

3.2.1. Cancer Immunotherapy Biomarkers

3.2.2. Identification of a Candidate Biomarker

3.2.3. Need for Novel Cancer Biomarkers

3.3. Tumor Mutation Burden (TMB)

3.3.1. Overview

3.3.2. Variation of TMB across Multiple Indications

3.3.3. Methods for Measurement of TMB

3.3.4. Factors Affecting Measurement of TMB

3.3.5. Initiatives for Assessment of TMB as a Potential Biomarker

3.4. Microsatellite Instability / Mismatch Repair Deficiency (MSI / MMR)

3.4.1. Overview

3.4.2. Variation of MSI across Multiple Indications

3.4.3. Methods of Measurement of MSI

3.5. Tumor Infiltrating Lymphocytes and Other Novel Biomarkers

4 CURRENT MARKET LANDSCAPE

4.1. Chapter Overview

4.2. Cancer Biomarkers Testing Services: Overall Market Landscape

4.2.1. Analysis by Year of Establishment

4.2.2. Analysis by Company Size

4.2.3. Analysis by Geographical Location

4.2.4. Analysis by Test Availability

4.2.5. Analysis by Type of Biomarker

4.2.6. Analysis by Application Area

4.2.7. Analysis by Disease Indication

4.2.8. Analysis by Analytical Technique Used

4.2.9. Analysis by Turnaround Time

4.2.10. Analysis by Sample Input

4.2.11. Analysis by Nucleic Acid Tested

4.2.12. Key Players: Analysis by Type of Biomarker

4.3. TMB Tests

4.3.1. Analysis by Application Area

4.3.2. Analysis by Disease Indication

4.3.3. Analysis by Analytical Technique Used

4.3.4. Analysis by Turnaround Time

4.4. MSI / MMR Tests

4.4.1. Analysis by Application Area

4.4.2. Analysis by Disease Indication

4.4.3. Analysis by Analytical Technique Used

4.4.4. Analysis by Turnaround Time

4.5. TIL-based Tests

4.5.1. Analysis by Application Area

4.5.2. Analysis by Disease Indication

4.5.3. Analysis by Analytical Technique Used

4.5.4. Analysis by Turnaround Time

5 PRODUCT COMPETITIVENESS ANALYSIS

5.1. Chapter Overview

5.2. Product Competitiveness Analysis: Key Assumptions and Methodology

5.2.1. Tests for the Assessment of TMB

5.2.2. Tests for the Assessment of MSI / MMR

5.2.3. Tests for the Assessment of TILs

6 COMPANY PROFILES

6.1. Chapter Overview

6.2. Dr Lal PathLabs

6.2.1. Company Overview

6.2.2. Financial Information

6.2.3. Product / Service Portfolio

6.2.3.1. Biomarkers Testing Portfolio

6.2.3.1.1. Microsatellite Instability (MSI) by PCR

6.2.3.1.2. OncoPro NCCN Lung Cancer Panel (*9 Genes *MSI)

6.2.3.1.3. OncoPro Liquid Biopsy 73 Gene Panel with MSI

6.2.4. Recent Developments and Future Outlook

6.3. Foundation Medicine

6.3.1. Company Overview

6.3.2. Financial Information

6.3.3. Product / Service Portfolio

6.3.3.1. Biomarkers Testing Portfolio

6.3.3.1.1. FoundationOne CDx

6.3.3.1.2. FoundationOne Liquid

6.3.3.1.3. FoundationOne Heme

6.3.4. Recent Developments and Future Outlook

6.4. NeoGenomics Laboratories

6.4.1. Company Overview

6.4.2. Financial Information

6.4.3. Product / Service Portfolio

6.4.3.1. Biomarkers Testing Portfolio

6.4.3.1.1. NeoTYPE Discovery Profile for Solid Tumors

6.4.3.1.2. MSI Analysis / MMR Panel by IHC

6.4.3.1.3. MultiOmyx Tumor Infiltrating Lymphocyte Panel

6.4.4. Recent Developments and Future Outlook

6.5. Novogene

6.5.1. Company Overview

6.5.2. Product / Service Portfolio

6.5.2.1. Biomarkers Testing Portfolio

6.5.2.1.1. NovoPM Cancer Panel

6.5.2.1.2. NovoPM TMB

6.5.2.1.3. NovoPM bTMB

6.5.2.1.4. NovoPM MSI

6.5.3. Recent Developments and Future Outlook

6.6. Q2 Solutions

6.6.1. Company Overview

6.6.2. Product / Service Portfolio

6.6.2.1. Biomarkers Testing Portfolio

6.6.2.1.1. TMB Assay

6.6.2.1.2. MSI Assay

6.6.2.1.3. TILs Testing

6.6.3. Recent Developments and Future Outlook

6.7. Personal Genome Diagnostics

6.7.1. Company Overview

6.7.2. Product / Service Portfolio

6.7.2.1. Biomarkers Testing Portfolio

6.7.2.1.1. PGDx elio Tissue Complete Assay

6.7.2.1.2. PlasmaSELECT-R 64

6.7.2.1.3. CancerXOME-R

6.7.2.1.4. CancerSELECT-R 125

6.7.2.1.5. MutatorDETECT

6.7.3. Recent Developments and Future Outlook

6.8. Shenzhen Yuce Biotechnology

6.8.1. Company Overview

6.8.2. Product / Service Portfolio

6.8.2.1. Biomarkers Testing Portfolio

6.8.2.1.1. YuceOne Plus

6.8.2.1.2. YuceOne ICIs

6.8.2.1.3. ct-DNA TMB

6.8.2.1.4. Microsatellite (MSI) Test

6.8.3. Recent Developments and Future Outlook

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/cancer-biomarkers-market-focus-on-tmb-msi--mmr-and-tils-testing-2019--2030/253.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

Key Market Insights

·        More than 110 drugs, capable of penetrating this elusive barrier are currently being evaluated for the treatment of CNS disorders; there are 35+ technology platforms for the development of BBB penetrant drugs

·        Majority of drug candidates are currently in the early stages of development, and are intended for the treatment of neurological conditions; a large proportion of the existing pipeline molecules are biologics

·        In order to achieve a competitive edge, several technology developers are presently focusing on the integration of advanced technical features into their proprietary drug development / delivery platforms

·        An assessment of 240+ drug developers, focused on Parkinson’s and Alzheimer’s diseases, revealed that many such firms are likely to partner with technology providers in order to leverage their BBB penetration expertise

·        Over the years, more than 16,700 patents related to BBB technologies have been filed / granted to various industry and non-industry players, indicating the pace of R&D activity in this burgeoning field of research

·        Foreseeing a lucrative future, several private and public investors have invested close to USD 1 billion, across more than 70 funding instances

·        Revenues generated from the sales of BBB penetrating drugs are anticipated to be well distributed across different types of molecules, target disease indications and various global regions over time

·        In the near-term, the opportunity is likely to be driven by licensing activity driven by the capability of leading BBB penetrating technologies to successfully facilitate drug delivery into the brain

Table of Contents

1.   PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2.   EXECUTIVE SUMMARY

3.   INTRODUCTION

3.1. Chapter Overview

3.2. Structure of the Human Brain

3.3. Global Burden on Neurological Disorders and Impact of Coronavirus Disease (COVID-19)

3.4. Strategies for Drug Delivery to the Central Nervous System (CNS)

3.4.1.   Invasive Techniques

3.4.1.1.      Systemic Administration of Therapeutics

3.4.1.2.      Direct Administration of Therapeutics

3.4.1.3.      Intracerebral Devices and Implants

3.4.2.   Non-Invasive Techniques / Approaches

3.4.2.1.      Liposomes

3.4.2.2.      Exosomes

3.4.2.3.      Prodrugs

3.4.2.4.      Nanoparticles and Microspheres

3.4.2.5.      Novel Formulations and Conjugates

3.4.3.   Chemical Delivery Systems

3.5. Blood-Brain Barrier (BBB)

3.5.1.   Key Historical Milestones

3.5.2.   Structure and Key Components

3.5.3.   Key Functions

3.6. Strategies for Drug Delivery across the BBB

3.6.1.   Increasing Permeability by Temporary Disruption of the BBB

3.6.2.   Pharmacological Strategies to Facilitate Transport Across the BBB

3.7. Challenges Associated with BBB Penetration and CNS Drug Delivery

3.8. Prevalent Trends Related to Non-Invasive BBB Penetration Technologies

3.8.1.   Emerging Focus Areas

3.8.2.   Key Historical Trends

3.8.3.   Geographical Activity

3.9. Concluding Remarks

4.   MARKET LANDSCAPE: NON-INVASIVE BBB PENETRATION

4.1. Chapter Overview

4.2. Non-Invasive BBB Penetration Technologies: Overall Market Landscape

4.2.1.   Analysis by Status of Development

4.2.2.   Analysis by Underlying Principle

4.2.3.   Analysis by Compatible Pharmacological Molecule(s)

4.2.4.   Analysis by Target Receptor(s)

4.2.5.   Analysis by Target Disease Indication(s)

4.2.6.   Analysis by Patent Availability

4.2.7.   Analysis by Licensing Activity

4.3. Non-Invasive BBB Penetration Technology Providers: Overall Market Landscape

4.3.1.   Analysis by Year of Establishment

4.3.2.   Analysis by Company Size

4.3.3.   Analysis by Location of Headquarters

5.   MARKET LANDSCAPE: BBB PENETRATING DRUGS

5.1. Chapter Overview

5.2. BBB Penetrating Drugs: Development Pipeline

5.2.1.   Analysis by Phase of Development

5.2.2.   Analysis by Type of Molecule

5.2.3.   Analysis by Affiliated BBB Penetration Technology

5.2.4.   Analysis by Route of Administration

5.2.5.   Analysis by Target Disease Indication(s)

5.2.6.   Analysis by Therapeutic Area(s)

5.3. BBB Penetrating Drugs: Additional Information

5.4. BBB Penetrating Drug Developers: Overall Market Landscape

5.4.1.   Analysis by Year of Establishment

5.4.2.   Analysis by Company Size

5.4.3.   Analysis by Location of Headquarters

5.4.4.   Leading Drug Developers: Analysis by Number of Drugs

5.4.5.   Leading Drug Developers: 4D Bubble Analysis based on Pipeline Strength, Target Disease Indication and Company Size

5.4.6.   Heptagon Representation: Analysis by Phase of Development and Key Disease Indications

5.4.7.   Tree Map Representation: Analysis by Key Disease Indications and Size of the Company

6.   COMPANY PROFILES

6.1. Chapter Overview

6.2. Leading Players based in North America

6.2.1.   Angiochem

6.2.1.1.      Company Overview

6.2.1.2.      Technology Overview

6.2.1.3.      Product Portfolio

6.2.1.4.      Recent Developments and Future Outlook

6.2.2.   ArmaGen

6.2.2.1.      Company Overview

6.2.2.2.      Technology Overview

6.2.2.3.      Product Portfolio

6.2.2.4.      Recent Developments and Future Outlook

6.2.3.   Denali Therapeutics

6.2.3.1.      Company Overview

6.2.3.2.      Technology Overview

6.2.3.3.      Product Portfolio

6.2.3.4.      Recent Developments and Future Outlook

6.2.4.   ICB International

6.2.4.1.      Company Overview

6.2.4.2.      Technology Overview

6.5.4.3. Product Portfolio

6.2.4.3.      Recent Developments and Future Outlook

6.2.5.   Lauren Sciences

6.2.5.1.      Company Overview

6.2.5.2.      Technology Overview

6.2.5.3.      Product Portfolio

6.2.5.4.      Recent Developments and Future Outlook

6.3. Leading Players based in Europe

6.3.1.   BioArctic

6.3.1.1.      Company Overview

6.3.1.2.      Technology Overview

6.3.1.3.      Product Portfolio

6.3.1.4.      Recent Developments and Future Outlook

6.3.2.   Cyclenium Pharma

6.3.2.1.      Company Overview

6.3.2.2.      Technology Overview

6.3.2.3.      Product Portfolio

6.3.2.4.      Recent Developments and Future Outlook

6.3.3.   Iproteos

6.3.3.1.      Company Overview

6.3.3.2.      Technology Overview

6.3.3.3.      Product Portfolio

6.3.3.4.      Recent Developments and Future Outlook

6.3.4.   Medesis Pharma

6.3.4.1.      Company Overview

6.3.4.2.      Technology Overview

6.3.4.3.      Product Portfolio

6.3.4.4.      Recent Developments and Future Outlook

6.3.5.   Ossianix

6.3.5.1.      Company Overview

6.3.5.2.      Technology Overview

6.3.5.3.      Product Portfolio

6.3.5.4.      Recent Developments and Future Outlook

6.3.6.   Vect-Horus

6.3.6.1.      Company Overview

6.3.6.2.      Technology Overview

6.3.6.3.      Product Portfolio

6.3.6.4.      Recent Developments and Future Outlook

6.4. Leading Players based in Asia-Pacific

6.4.1.   JCR Pharmaceuticals

6.4.1.1.      Company Overview

6.4.1.2.      Technology Overview

6.4.1.3.      Product Portfolio

6.4.1.4.      Recent Developments and Future Outlook

7.   TECHNOLOGY COMPETITIVENESS ANALYSIS

7.1. Chapter Overview

7.2. Methodology and Key Parameters

7.3. BBB Penetration Technologies: Platform Competitiveness Analysis

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/blood-brain-barrier-drug-delivery/310.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

Key Market Insights

·        Over 115 companies located in various regions across the globe claim to provide Biologics Fill / finish services for various types of biopharmaceutical drug / therapy products

·        The market landscape features a mix of both established players and new entrants; multiple biologics fill / finish service providers based in developed geographies have already adopted advanced fill / finish technologies

·        Vials represent the most prominent form of packaging used for biopharmaceutical interventions; with increasing demand for self-administration devices, syringes have also garnered significant attention

·        In fact, to acquire competencies across the value chain, stakeholders have actively invested in expanding their existing infrastructure and capabilities to cater to the evolving needs of both indigenous and international clients

·        Over the past six years, the fill / finish services domain has also witnessed significant partnership activity, with companies building strategic business relationships to consolidate their positions in the market

·        The outcome of consolidation is evident from our proprietary competitiveness analysis, based on several relevant parameters highlighting service and supplier strengths

·        Presently, the installed global Biologics Fill / finish capacity, across various geographies, is estimated to be over 17 million units (in term of packaging containers)

·        The demand for Biologics Fill / finish services for biologics is expected to increase in the coming years; it is likely that stakeholders will have to expand their respective capacities to ensure consistent supply

·        We expect biopharmaceutical developers to continue to outsource their fill / finish operations in the short to mid-term, resulting in an annualized growth rate of more than 10%

·        In the long-term, the projected opportunity is anticipated to be well distributed across various types of primary packaging, biological interventions and target disease indications

Table of Contents

1.   PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2.   EXECUTIVE SUMMARY

3.   INTRODUCTION

3.1. Chapter Overview

3.2. Introduction to Biologics

3.3. Need for Outsourcing Biologics-related Operations

3.4. Introduction to Contract Manufacturing

3.5. Commonly Outsourced Operations in the Biopharmaceutical Industry

3.5.1.   Biologics Fill / Finish Operations

3.6. Basic Guidelines for Selecting a Fill / Finish Service Provider

3.7. Advantages of Outsourcing Fill / Finish Services

3.8. Risks and Challenges of Outsourcing Fill / Finish Operations

4.   COMPETITIVE LANDSCAPE

4.1. Chapter Overview

4.2. Biologics Fill / Finish Service Providers: Overall Market Landscape

4.2.1.   Analysis by Year of Establishment

4.2.2.   Analysis by Company Size

4.2.3.   Analysis by Location of Headquarters

4.2.4.   Analysis by Location of Fill / Finish Facilities

4.2.5.   Analysis by Type of Packaging

4.2.6.   Analysis by Additional Services Offered

4.2.7.   Analysis by Scale of Operation

4.2.8.   Analysis by Type of Biologics Filled

5.   COMPANY COMPETITIVENESS ANALYSIS

5.1. Chapter Overview

5.2. Methodology

5.3. Assumptions and Key Input Parameters

5.4. Competitiveness Analysis: Biologics Fill / Finish Service Providers in North America

5.4.1.   Companies Offering Fill / Finish Services for Ampoules

5.4.2.   Companies Offering Fill / Finish Services for Cartridges

5.4.3.   Companies Offering Fill / Finish Services for Syringes

5.4.4.   Companies Offering Fill / Finish Services for Vials

5.5. Competitiveness Analysis: Fill / Finish Service Providers in Europe

5.5.1.   Companies Offering Fill / Finish Services for Ampoules

5.5.2.   Companies Offering Fill / Finish Services for Cartridges

5.5.3.   Companies Offering Fill / Finish Services for Syringes

5.5.4.   Companies Offering Fill / Finish Services for Vials

5.6. Competitiveness Analysis: Fill / Finish Service Providers of Asia-Pacific

5.6.1.   Companies Offering Fill / Finish Services for Ampoules

5.6.2.   Companies Offering Fill / Finish Services for Cartridges

5.6.3.   Companies Offering Fill / Finish Services for Syringes

5.6.4.   Companies Offering Fill / Finish Services for Vials

6.   BIOLOGICS FILL / FINISH SERVICE PROVIDERS IN NORTH AMERICA: COMPANY PROFILES

6.1. Chapter Overview

6.2. Advanced BioScience Laboratories (ABL)

6.2.1.   Company Overview

6.2.2.   Service Portfolio

6.2.3.   Recent Developments

6.2.4.   Future Outlook

6.3. Albany Molecular Research (AMRI)

6.3.1.   Company Overview

6.3.2.   Service Portfolio

6.3.3.   Financial Information

6.3.4.   Recent Developments

6.3.5.   Future Outlook

6.4. BioPharma Solutions

6.4.1.   Company Overview

6.4.2.   Service Portfolio

6.4.3.   Financial Information

6.4.4.   Recent Developments

6.4.5.   Future Outlook

6.5. BioReliance

6.5.1.   Company Overview

6.5.2.   Service Portfolio

6.5.3.   Financial Information

6.5.4.   Recent Developments

6.5.5.   Future Outlook

6.6. Emergent BioSolutions

6.6.1.   Company Overview

6.6.2.   Service Portfolio

6.6.3.   Financial Information

6.6.4.   Recent Developments

6.6.5.   Future Outlook

6.7. Patheon

6.7.1.   Company Overview

6.7.2.   Services Portfolio

6.7.3.   Financial Information

6.7.4.   Recent Developments

6.7.5.   Future Outlook

7.   BIOLOGICS FILL / FINISH SERVICE PROVIDERS IN EUROPE: COMPANY PROFILES

7.1. Chapter Overview

7.2. Boehringer Ingelheim BioXcellence

7.2.1.   Company Overview

7.2.2.   Service Portfolio

7.2.3.   Financial Information

7.2.4.   Recent Developments

7.2.5.   Future Outlook

7.3. IDT Biologika

7.3.1.   Company Overview

7.3.2.   Service Portfolio

7.3.3.   Recent Developments

7.3.4.   Future Outlook

7.4. Lonza

7.4.1.   Company Overview

7.4.2.   Service Portfolio

7.4.3.   Financial Information

7.4.4.   Recent Developments

7.4.5.   Future Outlook

7.5. Recipharm

7.5.1.   Company Overview

7.5.2.   Service Portfolio

7.5.3.   Financial Information

7.5.4.   Recent Developments

7.5.5.   Future Outlook

7.6. Vetter Pharma

7.6.1.   Company Overview

7.6.2.   Service Portfolio

7.6.3.   Recent Developments

7.6.4.   Future Outlook

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/biologics-fill--finish-services-market-2019-2030/256.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com