The pre-sterilized / ready-to-use primary packaging market is projected to grow at an annualized rate of ~8%, till 2030

Roots Analysis has done a detailed study on Pre-Sterilized / Ready-to-Use Primary Packaging Market, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

 

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Key Market Insights

  • A variety of pre-sterilized / ready-to-use primary packaging systems are available / being developed by close to 50 dedicated manufacturers; these systems cater to both small molecules and biologics
  • RTU vials and syringes are primarily fabricated using either glass or certain specialized types of plastics; steam sterilization and gamma irradiation are amongst the preferred sterilization techniques used for such containers
  • The current market landscape is fragmented, featuring the presence of established players as well as new entrants, which are well distributed across different geographical regions
  • Industry stakeholders are steadily expanding their existing capabilities in order to enhance their respective product portfolios and, thereby, maintain a competitive edge in this steadily evolving market
  • The rising interest is also reflected in the number of partnerships inked in the recent past, featuring the participation of both indigenous and international stakeholders
  • In order to mitigate the challenges associated with the ongoing COVID-19 pandemic, various strategic initiatives have been undertaken to support current packaging and distribution needs
  • Owing to the inherent benefits offered by pre-sterilized / ready-to-use primary packaging systems, including high quality output and substantial cost savings, the demand for such components is likely to rise in the coming years
  • Current industry trends support the growing need for RTU packaging solutions, primarily to accommodate larger scale, and specialized production / packaging requirements of increasingly complex drug products
  • Case Study: Close to 40 players claim to offer a wide range of robotic machinery, having different degrees of freedom, offering notable productivity and cost optimization opportunities
  • The market is anticipated to grow at a CAGR of 10%, till 2030, and the projected opportunity is likely to be distributed across various primary packaging systems, fabrication materials used and geographical regions

 

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Table of Contents

 

  1. PREFACE
    1.1. Scope of the Report

1.2.       Research Methodology

1.3.       Key Questions Answered

1.4.       Chapter Outlines

 

  1. EXECUTIVE SUMMARY

 

  1. INTRODUCTION

3.1.       Chapter Overview

3.2.       T-Cell Immunotherapies

3.2.1.    Types of Novel T-Cell Immunotherapies

3.2.1.1. Fucosylated T-Cell Therapies

3.2.1.2. Gamma Delta T-Cell Therapies

3.2.1.3. PD-1 Knockout Engineered T-Cell Therapies

3.2.1.4. TAC T-Cell Therapies

3.2.1.5. T-Cell Vaccines

3.2.1.6. Treg Cell Therapies

3.2.1.7. Virus-Driven T-Cell Therapies

 

3.3.       Key Considerations for Developing T-Cell Immunotherapies

3.4.       Concluding Remarks

 

  1. MARKET LANDSCAPE

4.1.       Chapter Overview

4.2.       Novel T-Cell Immunotherapies: Overall Market Landscape

4.2.1.    Analysis by Type of T-Cell Therapy

4.2.2.    Analysis by Phase of Development

4.2.3.    Analysis by Therapeutic Area

4.2.4.    Analysis by Popular Target Indications

4.2.5.    Analysis by Source of T-Cell

4.2.6.    Analysis by Route of Administration

4.2.7.    Analysis by Dose Frequency

4.2.8.    Analysis by Target Patient Segment

4.2.9.    Analysis by Type of Therapy

4.2.10.  Analysis by Type of Developer

 

4.3.       Novel T-cell Immunotherapies: List of Developers

4.3.1.    Analysis by Year of Establishment

4.3.2.    Analysis By Company Size

4.3.3.    Analysis By Location of Headquarters

4.3.4.    Key Industry Players: Analysis by Number of Pipeline Candidates

4.3.5.    Key Non-Industry Players: Distribution by Number of Pipeline Candidates

 

  1. NOVEL T-CELL IMMUNOTHERAPY PROFILES

5.1.       Chapter Overview

5.2.       Immuncell-LC (GC Pharma)

5.2.1.    Therapy Overview

5.3.       Cytovir CMV T-Cells (Kuur Therapeutics)

5.3.1.    Therapy Overview

 

5.4.       TT10: EB-VST (Tessa Therapeutics)

5.4.1.    Therapy Overview

5.5.       Tab-cel (tabelecleucel) (Atara Biotherapeutics)

5.5.1.    Therapy Overview

5.6.       Viralym-M (ALVR105) (AlloVir)

5.6.1.    Therapy Overview

 

5.7.       CLBS03 (Caladrius Biosciences)

5.7.1.    Therapy Overview

5.8.       TVI-Brain-1 (TVAX Biomedical)

5.8.1.    Therapy Overview

 

5.9.       ATA230 (Atara Biotherapeutics)

5.9.1.    Therapy Overview

5.10.     MILs (WindMIL Therapeutics)

5.10.1.  Therapy Overview

5.11.     Tcelna (Opexa Therapeutics)

5.11.1.  Therapy Overview

 

  1. CLINICAL TRIAL ANALYSIS

6.1.       Chapter Overview

6.2.       Scope and Methodology

6.3.       Novel T-Cell Immunotherapies: Clinical Trial Analysis

6.3.1.    Analysis by Trial Registration Year

6.3.2.    Analysis by Trial Registration Year and Enrolled Patient Population

6.3.3.    Analysis by Trial Phase

6.3.4.    Analysis by Trial Recruitment Status

6.3.5.    Analysis by Study Design

6.3.6.    Analysis by Type of Sponsor / Collaborator

6.3.7.    Leading Industry Players: Analysis by Number of Registered Trials

6.3.8.    Leading Non-Industry Players: Analysis by Number of Registered Trials

6.3.9.    Analysis by Number of Registered Trials and Geography

6.3.10.  Analysis by Enrolled Patient Population and Geography

6.3.11.  Analysis by Trial Recruitment Status and Geography

 

  1. PARTNERSHIPS AND COLLABORATIONS

7.1.       Chapter Overview

7.2.       Partnership Models

7.3.       Novel T-Cell Immunotherapies Market: Partnerships and Collaborations

7.3.1.    Analysis by Year of Partnership

7.3.2.    Analysis by Type of Partnership

7.3.3.    Analysis by Year and Type of Partnership

7.3.4.    Analysis by Type of Partnership and Type of T-Cell Therapy

7.3.5.    Analysis by Target Therapeutic Area

7.3.6.    Most Active Players: Analysis by Number of Partnerships

7.3.7.    Analysis by Geography

7.3.7.1. Region-wise Distribution

7.3.7.2. Country-wise Distribution

 

  1. FUNDING AND INVESTMENT ANALYSIS

8.1.       Chapter Overview

8.2.       Type of Funding

8.3.       Novel T-Cell Immunotherapies Market: Funding and Investment Analysis

8.3.1.    Analysis by Year of Investment

8.3.2.    Analysis by Amount Invested

8.3.3.    Analysis by Type of Funding

8.3.4.    Analysis by Type of T-Cell Therapy

8.3.5.    Most Active Players: Analysis by Number of Funding Instances

8.3.6.    Most Active Investors: Analysis by Number of Funding Instances

8.3.7.    Analysis by Type of Investor

8.3.8.    Analysis by Geography

 

  1. CASE STUDY ON CELL THERAPY MANUFACTURING

9.1.       Chapter Overview

9.2.       Overview of Cell Therapy Manufacturing

9.3.       Cell Therapy Manufacturing Models

9.3.1.    Centralized Manufacturing Model

9.3.2.    Decentralized Manufacturing Model

9.4.       Scalability of Cell Therapy Manufacturing Processes

9.4.1.    Scale-Up

9.4.2.    Scale-Out

9.5.       Types of Cell Therapy Manufacturers

9.6.       Key Challenges associated with Manufacturing of Cell Therapies

9.7.       Factors Affecting the Cell Therapy Manufacturing Process

9.7.1.    Characterization

9.7.2.    Cost of Goods

9.8.       Automation of Cell Therapy Manufacturing Process

9.9.       Cell Therapy Manufacturing Supply Chain

9.10.     Companies with In-House Capabilities and Contract Manufacturers

9.11.     Regulatory Landscape

 

  1. COMPANY PROFILES

10.1.     Chapter Overview

10.2.     Atara Biotherapeutics

10.3.     AlloVir

10.4.     Eureka Therapeutics

10.5.     Eutilex

10.6.     GammaDelta Therapeutics

10.7.     NexImmune

10.8.     OSE Immunotherapeutics

10.9.     Tevogen Bio

10.10.   WindMIL Therapeutics

 

  1. CASE STUDY ON RECENT DEVELOPMENTS IN TREG TARGETTING THERAPIES

11.1.     Chapter Overview

11.2.     Treg Targeting Therapies

11.2.1.  Mechanism of Action of Tregs

11.3      Recent Developments Related to Treg Targeting Therapies

 

  1. MARKET SIZING AND OPPORTUNITY ANALYSIS

12.1.     Chapter Overview

12.2.     Scope and Limitations

12.3.     Key Assumptions and Forecast Methodology

 

12.4.     Global Novel T-Cell Immunotherapies Market

12.4.1.  Novel T-Cell Immunotherapies Market: Distribution by Type of T-Cell Therapy

12.4.2.  Novel T-Cell Immunotherapies Market: Distribution by Target Indications

12.4.3.  Novel T-Cell Immunotherapies Market: Distribution by Key Players

12.4.4.  Novel T-Cell Immunotherapies Market: Distribution by Geography

12.5.     Novel T-Cell Immunotherapies Market: Value Creation Analysis

 

12.6.     Novel T-Cell Immunotherapies Market: Product Wise Sales Forecast

12.6.1.  Cytovir CMV T-Cells (Kuur Therapeutics)

12.6.1.1. Target Patient Population

12.6.1.2. Sales Forecast

12.6.1.3. Net Present Value

12.6.1.4. Value Creation Analysis

 

12.6.2.  Immuncell-LC (GC Pharma)

12.6.2.1. Target Patient Population

12.6.2.2. Sales Forecast

12.6.2.3. Net Present Value

12.6.2.4. Value Creation Analysis

 

12.6.3.  TT10: EB-VST (Tessa Therapeutics)

12.6.3.1. Target Patient Population

12.6.3.2. Sales Forecast

12.6.3.3. Net Present Value

12.6.3.4. Value Creation Analysis

 

12.6.4.  TVI-Brain-1 (TVAX Biomedical)

12.6.4.1. Target Patient Population

12.6.4.2. Sales Forecast

12.6.4.3. Net Present Value

12.6.4.4. Value Creation Analysis

 

12.6.5.  PD-1 Knockout Engineered T-Cells (Chengdu MedGenCell / Anhui Province Hospital)

12.6.5.1. Target Patient Population

12.6.5.2. Sales Forecast

12.6.5.3. Net Present Value

12.6.5.4. Value Creation Analysis

 

12.6.6.  CLBS03 (Caladrius Biosciences)

12.6.6.1. Target Patient Population

12.6.6.2. Sales Forecast

12.6.6.3. Net Present Value

12.6.6.4. Value Creation Analysis

 

12.6.7.  ATA230 (Atara Biotherapeutics)

12.6.7.1. Target Patient Population

12.6.7.2. Sales Forecast

12.6.7.3. Net Present Value

12.6.7.4. Value Creation Analysis

 

12.6.8.  MILs (WindMIL Therapeutics / Bristol-Myers Squibb)

12.6.8.1. Target Patient Population

12.6.8.2. Sales Forecast

12.6.8.3. Net Present Value

12.6.8.4. Value Creation Analysis

 

12.6.9.  Cytovir ADV T-Cells (Kuur Therapeutics)

12.6.9.1. Target Patient Population

12.6.9.2. Sales Forecast

12.6.9.3. Net Present Value

12.6.9.4. Value Creation Analysis

 

12.6.10. TAC01-CD19 (Triumvira Immunologics)

12.6.10.1. Target Patient Population

12.6.10.2. Sales Forecast

12.6.10.3. Net Present Value

12.6.10.4. Value Creation Analysis

 

12.6.11. PD-1 Knockout T Cells (Guangzhou Anjie Biomedical Technology)

12.6.11.1. Target Patient Population

12.6.11.2. Sales Forecast

12.6.11.3. Net Present Value

12.6.11.4. Value Creation Analysis

 

12.6.12. NEXI-0002 (NexImmune)

12.6.12.1. Target Patient Population

12.6.12.2. Sales Forecast

12.6.12.3. Net Present Value

12.6.12.4. Value Creation Analysis

 

12.6.13. ET140203 (Eureka Therapeutics)

12.6.13.1. Target Patient Population

12.6.13.2. Sales Forecast

12.6.13.3. Net Present Value

12.6.13.4. Value Creation Analysis

 

  1. CONCLUDING REMARKS

 

  1. EXECUTIVE INSIGHTS

14.1.     Chapter Overview

14.2.     Marker  Biotherapeutics

14.2.1. Interview Transcript: Peter Hoang, Chief Executive Officer

14.3.     WindMIL Therapeutics

14.3.1. Interview Transcript: Patrick Dougherty, Senior Vice President, Strategy, Planning and Operations

 

  1. APPENDIX 1: TABULATED DATA

 

  1. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

 

 

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com