A Contract Research Organization (CRO) is a service provider, which offers end-to-end solutions in conducting clinical trials for biopharmaceutical and medical device companies. The core services offered by CROs to biopharmaceutical companies include initial drug discovery solutions, toxicology studies, bio-analytical services, central laboratory, site monitoring, data management services, vigilance, bio-statistics, study and development program design and consulting, regulatory affairs and a variety of post-marketing surveillance services. Many pharmaceutical companies often outsource their R&D activities to CROs and is expected that these companies will increase their outsourcing activities for drug development process to CROs in future.
The markets included under CRO are oncology based CRO market, cardiovascular disease drug market, CNS therapeutics market, metabolic disorders therapeutics market, and infectious disease & vaccine CRO.
The top five companies covered are IQVIA, Laboratory Corporation of America Holdings, ICON Plc, PAREXEL and PPD. IQVIA was the largest player in the global CRO market in 2017.
The countries covered are USA, UK, Germany, France, Italy, Spain, Russia, Brazil, Australia, China, India, and Japan.
The global contract research organization market was valued at $44.4 billion in 2017. North America was the largest region in the global CRO market accounting for less than 45% share of the market. The USA was the largest country in the global CRO market, with around 33% share of the market.
This report also includes the healthcare CRO market, preclinical CRO market, and the preclinical research market.
CROs are focusing on conducting clinical trials in emerging countries such as China, India and Brazil to reduce drug development costs. As the sponsors of the CROs struggle with the rising cost of drug/device development, they are also challenged to improve productivity and efficiency, streamline clinical trials, and meet more rigorous regulatory and quality assurance requirements in order to sustain profitability. The cost of conducting clinical trials in developing countries is around 50% lesser than that of developed countries, with the potential of less costly clinical trial enrollment and more cost-effective trial conduct. Apart from the cost factor, developing countries also prove to be the ideal place for CROs to conduct their clinical trials in order to expand capabilities and have a more diverse pool of patients.
The Contract Research Organizations Global Market is segmented into Drug Discovery, Preclinical Studies, Phase 1, Phase 2, Phase 3 ,Phase 4 and Others.
Drug DiscoveryThe goal of the drug discovery process is to find a promising molecule or lead compound, from a pool of 10,000-15,000 compounds that has the potential to become a new medicine.
Preclinical StudiesIn this stage, the relevant compounds are tested in-vitro (in tubes) and in-vivo (animals) over a wide range of doses to establish relative toxicity of the compound and detect any potential adverse reactions to the therapeutic.
Phase 1During the earliest phase of clinical (human) trials, testing is focused on basic safety and pharmacology.
Phase 2In this phase, the primary focus is on efficacy evaluation, along with determination of optimal dosage levels, dosage schedule and administration routes
Phase 3In this phase, advanced efficacy and safety testing is completed to provide enough data for valid statistical conclusions required by the regulatory authority.
Phase 4Phase IV research takes place after the regulatory body approves the marketing of a new drug. Through Phase IV clinical studies, new drugs are tested continuously to uncover more information about efficacy, safety and side effects after being approved for marketing.
OthersThe Others segment includes various support activities such as pharmacovigilance, bio-statistics, clinical data management, site management, monitoring, regulatory services, protocol development and medical writing.