Pharmaceutical Services: Spotlight on Tech-Enabled Clinical Development
Published January 2020
The pharmaceutical market has evolved from a traditional “one-size-fits-all” blockbuster medicines model to a market that includes a significant number of specialty and precision medicines. In 2018, the FDA approved a record 59 novel drugs. Of such approvals, 16 of the drugs (27%) were for specialty medicines and 25 of the drugs (42%) were for precision medicines. Meanwhile, only 31% were for traditional medicines.
This evolution has broad implications for both the pharma services market and the clinical development providers who partner with pharma services stakeholders. Provident has analyzed the following ramifications:
• Speed has become increasingly important to pharma sponsors due to the limited Total Addressable Market (TAM) for targeted patient sets in select cell, gene and immunotherapy markets. The market does not always justify competitive therapies for rare diseases
• The need to reduce cost and time between development phases and increased preference for data centric approaches by sponsors driving the eClinical market
• As payers transition to value-based care, particularly for costly specialty and precision therapeutic approaches, there is an increased need to track outcomes and harvest post-approval data
• Increased need for data from the FDA due to the Technology Modernization Action Plan (TMAP) and post approval regulatory requirements with the analysis of real-world evidence (RWE)
• Outside of traditional eClinical consolidators, traditional CROs can often have a strong interest in acquiring technologies that supplement existing service offerings
Report Summary
- Introduction
- Key Trends & Observations
- Consequences for M&A Activity
- Concluding Thoughts
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