Please enable JavaScript.
Coggle requires JavaScript to display documents.
Category Intelligence on Early Phase Clinical Trials (Porter's Five…
Category Intelligence on Early Phase Clinical Trials
Market Landscape
Trends
Regulations
Regulations are revised frequently
Adaptive Trial Design
Leads to increased flexibility of clinical trials enabling parameters such as sample size, patient population, dosing to be adjusted as the trial progresses
Biomarker Technology
Growing trend to evaluate predictive biomarkers in enriched patient populations in early phase trials
Rapid evaluation of drugs, validate multiple predictive biomarkers, minimized exposure of patients to ineffective therapies, accelerated drug approval in molecularly defined populations
Outsourcing
Outsourcing on a full service basis based on therapeutic area and functions
Specialist CROs
Open up or acquire specialized Phase I units based on therapeutic areas to match up the competency of these niche players and drive revenues
Emerging Markets
Contribution of trials from Russia, South Korea etc., will increase in the future due to competitive price and patient availability.
Clinical trials which test drugs for Indian market must include Indian subject in their trial. This will affect the recruitment procedures by CROs for drug trials that are intended for the Indian market.
Overview
CAGR 3-4%
Slow growth rate due to trials being conducted on a smaller population (20 -40) of volunteers
Segmentation
Geographic Segmentation
South Korea is found to be the most attractive early phase destination (CAGR 8.2%) based on
The availability of global and regional suppliers patient pool
Regulatory scenario of the country
Porter's Five Force Analysis
Bargaining Power of Suppliers (Medium)
Several acquisitions by established early phase providers of niche specialists shows the supplier base consolidation, growth in patient pool availability and the growing demand for Phase I studies among pharmaceutical companies
Power of niche specialists is comparatively lesser
than that of established players
Bargaining Power of Buyers (High)
Multiple Suppliers
Pharma companies have a greater choice and ability to switch between suppliers, hence increasing the buyer power
Barriers to New Entrants (High)
Increased regulatory demand, varying regional regulatory compliance and high cost of conducting phase I Trials
Niche specialists have a medium level of barrier as they access to specialists population focusing on a specific therapeutic area
Threat of Substitutes (Low)
For bath established and niche specialists, the patient pool availability and number of CPU beds will be the key differentiation with experience and risk considered along side
Intensity of Rivalry (High)
Immense competition among suppliers
The suppliers are leveraging market price through competitive discount structure, ability to provide specific patient pool to beat competition
Supplier Analysis
Supplier
Types
Generic
CROs with maturity in other functions of clinical trials and new entrants to early phase could be explored for cost effective tactical sourcing.
Examples: Global Clinical Trials.
Specialists
These suppliers are the best in class for specialist oncology portfolio and rare diseases which requires a specialized physician and access to relevant patients.
Examples: DaVita, Profil, Quotient etc.
Emerging Full Service
These suppliers also have their own CPU units, however, during spike in demand they rely on partners for CPU capacities.
Examples: Nuvisan, SGS, WWC, WCT etc.
Established Full Service
They have their own CPU units to manage multiple studies.
Examples: LabCorp CRS, Parexel, PPD, PRA, INC research – inventiv Health etc.
Mergers & Acquisition Trends
Key Suppliers
Celerion
Parexel
Covance
PPD
CRS
PRAHS
Market Share of Suppliers
Sourcing
Practices
Engagement
Model
Global CROs
Most Preferred CRO engagement Model: Project based
Transformation to Strategic partnership
Adoption rate: 56%
Specialists
Most Preferred: Project Based
Adoption Rate: 44%
Cost Break Up Analysis
Sourcing Overview
Pricing Model
Global CROs
Most preferred Pricing Model by Pharma and Global CROs: Fee for Service Pricing Model
Adoption Rate: 49%
Specialists
Most Preferred: Fee for Service
Adoption Rate: 54%
Drivers
#
High Trial Complexity
High work burden
In- house facility needs to have beds, equipment's and access to patients
Patient Recruitment and Regulations
Country Specific Regulations leading to outsourcing
Cost Reduction
Constraints
High Supplier Fees
Unforeseen Events
Could cause a sudden pause in trials creating a major delay in trial conduct
Quality Issues
Supplier without right operational capability will be unable to meet quality standards
