Biopharmas are looking at CROs to help in their research and development, not just to cut costs but also as a strategic partner to help throughout the complete lifecycle of a drug. With reduced R&D budgets, not great pipelines and reducing number of NCEs, patent expiry looming large in the horizon and generic competition, pharmaceuticals need a strategic partner to help plan the development and market their molecules.
It is estimated that the Global CRO market was about US$ 27 billion in 2014, with another report estimating the current market at US$ 40 billion. Various reports and analysis estimate the growth at an annual rate ranging from six per cent to almost 10 per cent with projections of nearly US$ 59.4 billion by 2020. By comparison, Indian CRO market is around US$ 1.3 billion, about 3.1 per cent of the global market.
One of the challenges facing the industry in India was government policies, which have developed over time in consultation with industry and DCGI is back to providing approvals for clinical studies. Mushrooming of many small companies have made the industry very competitive and pose a challenge. But CROs are also receiving funds from venture capitalists that see a large growth in the industry with consolidations, mergers and acquisitions taking place.
Talent pool is both an advantage and a challenge in India as English language - proficient life science, pharma and medical graduates and postgraduates are available. However they need to be adequately trained in GCP and other regulatory guidelines regularly to keep them updated with the latest developments in the industry.
Though initially CROs started with only clinical trials outsourcing, they have moved on to other business models partnering their sponsors to offer services right from drug discovery models, in vitro testing, small animal in vivo testing, BA /BE studies, to late phase clinical trial management, central lab facilities, clinical trial supplies management, bioanalytics, proteomics, pharmacovigilance, medical and scientific writing (protocols, study reports, eCTD modules, publications, RMPs, DSURs etc), branding and launch activities, and post marketing studies.
Though, it is tough to find an Indian CRO offering all these services, this is an important area to look into for the Indian CROs and build their capabilities so that they can offer a one stop solution for their sponsors and become a strategic partner.
Lambda Therapeutic Research is a leading full service CRO in the clinical research domain. head-quartered in Ahmedabad (India). Its global footprint encompasses strategically located offices in Mumbai (India), Poland (Europe), London (UK) & Canada. Incepted in 1999, it has conducted over 5000 BA-BE studies of over 300 different chemical entities. Under the dynamic leadership of its MD - Bindi Chudgar, engaging and motivating policies have been implemented that makes Lambda an employer of choice across its offices globally.