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Speciality CROs Market, 2016 - 2025

Speciality CROs Market, 2016 - 2025

  • February 2016
  • 321 pages
  • ID: 3692407
  • Format: PDF
  • Roots Analysis Private Ltd.


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The biopharmaceutical industry has been witnessing a significant paradigm shift in R&D outsourcing over the last few years. Speciality CROs have emerged as credible players in the market to overcome the shortcomings of full service / traditional CROs. Often, these full service providers offer a wider portfolio of services but fail to align their efforts to meet the requirements of sponsors, primarily the smaller biotech organisations / start-ups. Speciality CROs, on the other hand, specialise in niche areas catering to either specific clinical / preclinical services or providing services in a particular disease area. Oncology, cardiovascular, metabolic disorders and CNS are some of the popular therapeutic areas that have witnessed a rise in the number of speciality CROs. Typically outsourced services include data management, site monitoring and project management but nowadays core services such as pharmacovigilance, target evaluation, formulation development, cell line development, toxicology studies and medical imaging are also being outsourced to these CROs. Speciality CROs are increasingly adopting the strategic CRO model to expand their services and geographical presence in an effort to broaden the scope of serving the global biopharmaceutical industry.

Despite the widening array of services offered by these CROs, they have found it challenging to gain a higher share in the market, which is currently dominated by larger and more well-established players. Considering that a major proportion of revenues for large CROs is generated by big pharma companies, gaps exist when it comes to providing services to smaller pharma / biotech companies. This provides an opportunity to speciality CROs to offer improved, customised and relatively economical services to newer / smaller clients in the sector.
As the demand of novel therapies for various therapeutic areas is expected to rise steadily, we are optimistic about the future of these smaller research firms, which have driven an innovative approach to drug research and development. There are a number of upcoming opportunities that can enrich the service portfolio of speciality CROs gradually strengthening their presence in an otherwise consolidated market.

The “Speciality CROs Market, 2016-2025” report delivers a comprehensive study on Contract Research Organisations (CROs) that provide a specialised set of research capabilities centred on a particular stage of clinical development or a range of services in a focused therapeutic area. The outsourcing model has proven to be extremely beneficial to drug developers catering to the unmet research, clinical development and even regulatory needs of both established players and start-ups in the market. The concept of speciality CROs continues to evolve as these organisations adopt new strategies to provide their sponsors improved services in terms of both quality and efficiency. Novel business models and strategic partnerships among established and emerging players have opened new avenues to effectively tackle issues such as rising development costs, inefficient protocols and unorganised business processes.

The report assesses key drivers that have governed the evolution of speciality CROs over the past several years, along with an elaborate discussion on the upcoming trends that will likely shape the market in the coming years. In fact, one of the primary objectives of this study is to develop an understanding of the likely future evolution of the market for speciality CROs over the short-term and long-term.

The study presents an in-depth analysis of a diverse set of speciality CROs on some of the key parameters such as geographical location, types of services being offered and focused therapeutic areas. In addition, it captures the potential growth areas that will likely present opportunities for these companies and sustain the pace of growth. It is worth highlighting that despite the fact that established pharmaceutical companies have in-house R&D and clinical development capabilities, the opportunity for speciality CROs is growing. The future evolution of this market will be primarily driven by the relatively fast paced growth of the overall pharma industry and the innovations / developments taking place in R&D. The report provides short-midterm and long-term market forecasts for the period 2016-2020 and 2020-2025, respectively. To add robustness to our forecast model, we have provided three market scenarios. The conservative, base and optimistic scenarios represent three different tracks of market evolution. The research, analysis and insights presented in this report are backed by a comprehensive survey on capabilities of several speciality CROs. For the purposes of our analysis, we also interviewed important stakeholders in this market to solicit their opinions around the future opportunities and challenges that must be considered for a more inclusive growth.

Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

Chapter 2 provides an executive summary of the insights captured during our research. The summary offers a high level view on the present scenario of the speciality CRO market and where it is headed in the mid-long term.

Chapter 3 provides a general introduction to CROs. In this chapter, we have discussed, in detail, the evolution of CROs. We have also presented a highly comprehensive CRO services map to highlight the range of services being offered by a large number of CROs operating in different locations worldwide.

Chapter 4 presents specific details on speciality CROs. It provides information about the functioning of speciality CROs along with the specific areas of specialisation. We have also discussed the advantages that speciality CROs bring over conventional CROs, focusing on new business models, strategic partnerships and relatively more efficient / integrated business processes.

Chapter 5 provides a holistic global landscape of speciality CROs that we identified in our research. This chapter highlights key aspects of these companies such as their geographical location, year of establishment and R&D capabilities (categorised in terms of specific therapeutic areas and services capabilities offered).

Chapter 6 provides profiles of 18 speciality CROs focused on specialised preclinical / clinical service offering. Each company profile includes an overview of the company, service portfolio, collaborations and associated developments that have recently taken place.

Chapter 7 provides profiles of 12 speciality CROs focused on a particular therapeutic area. Each company profile includes an overview of the company, service portfolio, collaborations and associated developments that have recently taken place.

Chapter 8 is a case study on virtual CROs. We have discussed, in detail, the virtually integrated, cross-functional outsourcing approach implemented by these organisations. In this chapter, we have also focused on various clinical research partnership models that are applied by CROs and their sponsors. The case study also includes profiles of six virtual CROs, some of which are leading players in the market.

Chapter 9 is a case study on full-service CROs. The one-stop-shop approach followed by traditional CROs has been captured in detail in this section. The case study includes profiles of four CROs, some of which are leading players in the market.

Chapter 10 presents a detailed ten year forecast highlighting the future potential for speciality CROs. Due to the uncertainty surrounding some of the key assumptions, we have presented three different evolution scenarios for the overall market.

Chapter 11 highlights important trends that provide opportunities to speciality CRO to consolidate their presence in this competitive market; amongst others, these include Health Economics and Outcomes Research (HEOR) studies, adaptive trials, eClinical solutions and risk-based monitoring (RBM).

Chapter 12 is a collection of transcript of interviews conducted with key players during the course of this study.

Chapter 13 summarises the overall report. In this chapter, we have provided a recap of the key takeaways and our overall opinion on where the market is headed in the mid-long term.
Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 15 is an appendix, which provides a list of companies and organisations mentioned in the report.

Chapter 16 is an appendix, which provides a glossary of the CRO services map.

1. Over the last few years, a structural transformation in the primary CRO business model to a more strategic approach has revolutionised R&D outsourcing. Newer players providing specific capabilities in the R&D value chain have witnessed a gradual acceptance.
2. During our research, we have identified over 200 speciality CROs after detailed due diligence of more than 1,000 CROs based on their specific capabilities and the range of services they provide. These speciality CROs collectively cater to the multitude of research services required by drug developers.
3. The US, with ~115 speciality CROs, has emerged as the primary hub of speciality CROs; this is followed by Europe with ~60 CROs. India and China, where CROs offer a relatively higher cost optimised service portfolio, are emerging as new destinations; the level of activity, however, has been fairly limited so far.
4. Though the broader contract research market is highly consolidated and dominated by a handful of bigger CROs, the market within the speciality CRO segment is highly fragmented. This is unlikely to change as biotech companies will continue to prefer outsourcing specific requirements of the clinical trials instead of outsourcing the entire clinical trial programme to an individual CRO.
5. We expect the overall market of speciality CROs to more than double in the coming decade, growing at a CAGR of 8.6%. Specific areas of growth are likely to be driven by novel services and upcoming technologies resulting in cost optimisation and improved outputs.
6. Some of the niche opportunity areas/approaches include Health Economics and Outcomes Research (HEOR), adaptive trial designs, and eClinical solutions. Specifically, these areas typify a growing unmet need and represent untapped areas making outsourcing an attractive option.

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