Global Market Outlook on Drug Development Biometrics Services

CDM

  • The future growth would be driven by the increasing demand for adaptive trials, which, in turn, will increase the data points and use of EDC
  • The increased outsourcing by pharma has resulted in the highest revenue generation of 50–60 percent to the CDM market, followed by biotech companies (20–30 percent)

Biostatistics

  • On an average, large pharmaceuticals spend 5–7 percent of the overall clinical trials budget for biostatistics function
  • Due to the increased data scrutiny by the USFDA, the Biostatistics market is expected to grow at 14–15 percent for the next 3–5 years

SAS Programming

  • SAS Programming has been bundled with the biostatistics. Large number of institutions have been opened in Southern India to cater to the increasing outsourced demand

Medical Writing

  • Medical writing is bundled with Biostatistics and is performed largely, based on the specific skill required per project. Large CROs have third-party network to sub-contract services
  •  This is a highly fragmented market, with the entrant of new players, as pharmaceutical companies have been outsourcing their non-core activities

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Market Share by Trial Phases and Therapeutic Area

  • Phase II and III constitute the major part of the biostatistics services, as voluminous data are analyzed in these stages. This is expected to be the same, as the USFDA requirements are increasing
  • Biometrics outsourcing has become a trend. Novartis has signed a deal with Covance for preclinical and CDM services. This will further strengthen the biometrics outsourcing market
  • Data management services have witnessed a positive trend, due to the increased adoption of phase IV trials across the globe
  • The therapeutic area constitutes a minor portion of outsourcing biostatistics services. The only change noticed in the therapeutic area is the volume of data analyzed from Oncology, which has increased from 11 percent to 27 percent, and other major therapeutic areas have not seen much changes

Outsourcing Peneteration

CDM

  • Buyers off-shore CDM to India, due to cost-saving opportunities and large number of skilled resources
  • Increase in e-CRF complexities, demand for adaptive trials, and increased data points during the clinical trials leads to further outsourcing of CDM

Biostatistics

  • Increased outsourcing adoption and manpower rationalization by large pharma to low-cost countries
  • Bundling of biostatistics services with CDM to leverage further cost savings
  • Increased data scrutiny by regulators lead to increase in in-house FTEs and technology cost, resulting in further outsourcing

SAS Programming

  • Among the biometrics outsourcing, statistical programming requires niche skill for service delivery
  • More reliance on data from clinical and real world will drive the market

Medical writing

  • Fourth most frequently outsourced clinical study function. It has seen a change from near shoring to offshoring in the past few years
  • CROs have been the prime preference, due to the niche clinical knowledge. CROs still hold 70 percent of the market
  • Lack of quality resources in emerging markets is still a concern for large pharma, which requires rework
  • Crowd sourcing is one of the alternatives being followed through medical writing expert networks