The State of Personalized/Precision Medicine

Pages: 119 Published: October 31, 2019 Report Code: GDHCHT027

Personalized/Precision medicine is a field of medicine that uses information about a person’s genes, proteins, and environment to prevent, diagnose, and treat diseases. In cancer, personalized medicine uses specific information about an individual to help diagnose, plan treatment, find out how well treatment is working, or make a prognosis.

The state of personalized/precision medicines market research report covers current and future challenges for the development and launch of these medicines.

Key Findings

  • More randomized controlled prospective clinical trials are needed to identify proven diagnostic tests that will be reimbursed alongside the use of personalized medicine.
  • The biggest challenge in developing personalized medicine is meeting the regulatory standards of the FDA and EMA.
  • Personalized medicine’s sole purpose is to provide treatments that better fit specific patient populations, rather than providing inconsistent results in a broader patient population.
  • Pricing and reimbursement are among the biggest challenges in personalized medicine, as for the treatment to be available for patients, the diagnostic must also be reimbursed.

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Personalized/Precision Medicines Market Drivers

Some of the market drivers of the personalized/precision medicines market include:

  • Rising aging population
  • Increased emphasis on cost-effective healthcare
  • Availability of new technologies
  • Significant investments in personalized medicine
  • Increased focus on value-based healthcare models
  • Focus on preventative medicine
  • The popularity of targeted therapies
  • Evolving regulations
  • Increased biomarker and targeted therapy R&D

The global population is aging due to improvements in life expectancy because of better healthcare, medical advances in treating diseases, and improved sanitation. However, the overall level of health has not improved, and the burden of disease has moved from tackling infectious diseases to managing long-term conditions such as diabetes, cardiovascular diseases, and cancer.

Advantages of Personalized Medicine

Some of the advantages that personalized medicines can bring to patients are listed below:

  • More efficient selection of the right treatment path
  • Cost-effectiveness for the healthcare system
  • Better optimal dosing regimens
  • Enhancement of quality of life
  • Minimization of adverse drug reactions
  • Increased prevention and earlier intervention possibilities
  • Increased treatment options

The main advantage of personalized medicine is that it allows more efficient selection of the right treatment path. By enabling each patient to receive earlier risk assessment and a more efficacious tailored treatment, personalized medicine is expected to transform healthcare.

Key Therapy Areas in the Personalized/Precision Medicines Market

The key therapy areas in the personalized/precision medicines market are oncology, respiratory, hematology, infectious diseases, ophthalmology, metabolic, central nervous system, cardiovascular, gastrointestinal, musculoskeletal & rheumatology, and dermatology. Oncology is the largest segment in the personalized/precision medicine market followed by respiratory and hematology.

Personalized/Precision Medicines Market Analysis by Therapy Areas

Personalized/Precision Medicines Market Analysis by Therapy Areas

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Key Players in the Personalized/Precision Medicines Market

Some of the key players in the personalized/precision medicines market are 23andMe, Adaptive Biotechnologies, Ambry Genetics Corp, Astellas, AstraZeneca, Baxalta, BeiGene, Berg Health, BrainStorm Cell Therapeutics, Bristol-Myers Squibb, Catabasis, Clovis Oncology, Denovo Biopharma, Eli Lilly, Foundation Medicine, GenSight Biologics, and IgDraSol.

Personalized/Precision Medicines Market Report Overview

Key Therapy Areas Oncology, Respiratory, Hematology, Infectious Diseases, Ophthalmology, Metabolic, Central Nervous System, Cardiovascular, Gastrointestinal, Musculoskeletal & Rheumatology, and Dermatology
Key Players 23andMe, Adaptive Biotechnologies, Ambry Genetics Corp, Astellas, AstraZeneca, Baxalta, BeiGene, Berg Health, BrainStorm Cell Therapeutics, Bristol-Myers Squibb, Catabasis, Clovis Oncology, Denovo Biopharma, Eli Lilly, Foundation Medicine, GenSight Biologics, and IgDraSol

Scope

GlobalData’s The State of Personalized/Precision Medicine combines key opinion leader insight with in-house analyst expertise and research to provide an insight-rich look at personalized and precision medicine in the US, Europe, and Asia.

Components of the report include:

  • Definition of Personalized/Precision Medicine—Key attributes of personalized/precision medicine, examining and contrasting definitions by regulatory bodies and KOL respondents.
  • Personalized Medicine—Impact on Healthcare—Key factors to impacting healthcare for patients and stakeholders providing respondent mix by region and organization size.
  • Marketed products—Detailed information is provided for key personalized/precision medicines, including case studies for marketed oncology and rare disease therapeutics.
  • Pipeline products—The diverse Phase III pipeline is presented, including detailed information on the key candidate’s mechanism of action and clinical trial parameters.
  • Investment in Personalized Medicine—Investment in personalized medicine by indication and clinical trial design and approaches are presented, with case studies for three ongoing oncology trials being considered.
  • Market Opportunities and Challenges—Key areas of opportunity and roadblocks in developing, launching, and gaining reimbursement are analyzed by geography, company size, and seniority level.
  • Emerging Trends—Critical new trends, including the use of advanced digital technologies, are examined.

Reasons to Buy

  • Develop business strategies by understanding the global trends shaping and driving the personalized/precision medicines market
  • Formulate effective sales and marketing strategies by understanding the competitive landscape of various competitors in a niche therapeutic space.
  • Identify areas of unmet need within the personalized/precision market to help drive research and development towards future market opportunities.
  • Gain insights to help plan and design your clinical trials.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
  • Identify key funding and partnership strategies.

Key Players

23andMe
Adaptive Biotechnologies
Ambry Genetics Corp
Astellas
AstraZeneca
Baxalta
BeiGene
Berg Health
BrainStorm Cell Therapeutics
Bristol-Myers Squibb
Catabasis
Clovis Oncology
Denovo Biopharma
Eli Lilly
Foundation Medicine
GenSight Biologics
IgDraSol
Ignyta
Kiadis
Konica Minolta
Loxo Oncology
Marinus
Merck & Co.
NantPharma
Nebula Genomics
Novartis
Pfizer
Precision Biosciences
Retrophin
Revolution Medicines
Rhythm Pharmaceuticals
Roche
Sanofi
Sarepta
Sutro Biopharma
Takeda
Vertex
Visterra
Voluntis

Table of Contents

Table of Contents (PowerPoint Deck)

1. Preface

1.1 Table of Concents

1.2 Abbreviations

1.3 Related Reports

1.4 Upcoming Related Reports

2. Executive Summary

2.1 Key Findings

2.2 KOL and Payer Insights

3. Overview of Personalized/Precision Medicine

3.1 Definition

3.2 Definition of Personalized/Precision Medicine

3.3 KOL and Payer Perspecive

3.4 Key Attributes of Personalized Medicine Therapy

3.5 Types of Biomarkers and Diagnostics

4. Impact of Personalized Medicine on Healthcare

4.1 Personalized Medicine – Impact on Healthcare – Patients

4.2 Advantages of Personalized Medicine – Patients

4.3 Role of Personalized Medicine in Clinical Unmet Needs

4.4 Personalized Medicine – Impact on Healthcare – Drug Developers’ Perspective

4.5 Advantages of Personalized Medicine to Drug Developers

4.6 Personalized Medicine – Impact on Healthcare – Health System

5. Key Marketed Products

5.1 Leading Marketed Products

5.2 Pfizer’s Xalkori

5.3 Sarepta’s Exondys 51

5.4 Roche/Genentech’s Tarceva

5.5 Vertex’s Symdeko

5.6 AstraZeneca’s Imfinzi

5.7 Roche’s Herceptin

5.8 AstraZeneca’s Lynparza

5.9 Merck & Co.’s Keytruda

5.10 Novartis’ Tafinlar + Mekinist

6. Pipeline Products

6.1 Personalized Medicine Pipeline Candidates

6.2 BeiGene’s Pamiparib

6.3 Rhythm’s Setmelanotide

6.4 Denovo’s Enzastaurin

6.5 Roche/Genentech’s Ipatasertib

6.6 GenSight’s Lenadogene Nolparvovec

6.7 Catabasis’ Edasalonexent

6.8 Marinus’ Ganaxolone

6.9 Kiadis’ ATIR-101

6.10 Retrophin’s Fosmetpantotenate

6.11 BrainStorm’s NurOwn

6.12 AstraZeneca’s Savolitinib

7. Investment in Personalized Medicine

7.1 Involvement with Personalized Medicine

7.2 Investment in Personalized Medicine

7.3 Clinical Trial Activity

7.4 Personalized Medicine Clinical Trial Design

7.5 NCI-MATCH Clinical Trial

7.6 NAVIGATE Clinical Trial

7.7 BATTLE‐2 Clinical Trial

8. Deal-Making Landscape

8.1 Personalized Medicine Deals

9. Market Opportunities and Challenges

9.1 Market Drivers

9.2 Market Barriers

9.3 Major Challenges in Developing Personalized Medicine

9.4 Major Challenges in Launching Personalized Medicine

9.5 Challenges in Transitioning Personalized Medicine from Bench to Bedside

9.6 Major Challenges in Developing and Launching Personalized Medicine

10. Pricing, Reimbursement, and Regulatory Strategy

10.1 Personalized Medicine Regulation and Reimbursement

10.2 Personalized Medicine Regulation in the US

10.3 Obama’s Precision Medicine Initiative

10.4 Pricing and Reimbursement in the US

10.5 Personalized Medicine Regulation in the EU

10.6 Personalized Medicine Reimbursement in the EU

10.7 Personalized Medicine Regulation and Reimbursement in Japan

10.8 Personalized Medicine Regulation and Reimbursement in China

10.9 Currently Marketed Personalized Medicine Products

11. Personalized Medicine – Emerging Trends

11.1 Personalized Medicine and AI

11.2 Personalized Medicine and AI – Case Study

11.3 Personalized Medicine and Big Data

11.4 Personalized Medicine and Big Data – Case Study

11.5 Personalized Medicine and Blockchain

11.6 Personalized Medicine and Blockchain – Case Study

11.7 Personalized Medicine and Digital Therapeutics

11.8 Personalized Medicine and Digital Therapeutics – Case Study

12. Summary of Key Findings

12.1 Market Outlook

12.2 Recommendations

12.3 Future Implications for Personalized Medicine

13. Appendix

13.1 Personalized Medicine Sources

13.2 Methodology

13.3 Study Design

13.4 Primary Research – Online Survey

13.5 Primary Research – KOLs and Payers

13.6 About the Authors

13.7 About GlobalData

13.8 Contact Us

13.9 Disclaimer

Frequently Asked Questions

The key therapy areas in the personalized/precision medicines market are oncology, respiratory, hematology, infectious diseases, ophthalmology, metabolic, central nervous system, cardiovascular, gastrointestinal, musculoskeletal & rheumatology, and dermatology.

Some of the key players in the personalized/precision medicines market are 23andMe, Adaptive Biotechnologies, Ambry Genetics Corp, Astellas, AstraZeneca, Baxalta, BeiGene, Berg Health, BrainStorm Cell Therapeutics, Bristol-Myers Squibb, Catabasis, Clovis Oncology, Denovo Biopharma, Eli Lilly, Foundation Medicine, GenSight Biologics, and IgDraSol.

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