The contract research organization services are the organizations that provide support to the biopharmaceutical or biotechnological industries and academic institutes in the form of outsourced pharmaceutical research services. The CROs work for both drugs and medical devices and also range from large, international full service organizations to small niche specialty groups to fulfill the clients’ requirement. Initially, the pharmaceutical companies used to carry their own discovery work, along with every other elements to get the drug or medical device in the market. But nowadays, any research work required by biotechnology or pharmaceutical companies from designing assay to planning and running the clinical trials are outsourced from CROs. Outsourcing or partnering with a CROs by the biotechnological companies provide a strategic benefit to the manufacturers, such as cost and time saving in the development and approval process of new drug or therapeutic device, which is expected to increase the demand for CROs.
Furthermore, increasing demand for effective biotherapies and increasing competition between manufacturers to discover new drugs are expected to foster growth of CROs market. Increasing need for product development is leading to high demand for experience and high skilled professionals to implement and conduct the biotechnological research and clinical trials, which can be provided by CROs.
Contract Research Organization Services Market Dynamics
Increasing number of Food and Drug administration (FDA) approvals are supporting the growth of biopharma industry, which in turn is fuelling growth of the CROs market. According to article published in Nature, the U.S. FDA approved 46 novel drugs for various indication by the agency’s Center for Drug Evaluation and Research (CDER) in 2017 and 22 drugs in 2016. As the drug companies and few research institutes face challenges in marketing their product due to limited resources and huge capital investment, which decreases the affordability of errors in research work. Therefore CROs play an important role in reducing the cost of research and help in successful clinical development program, which is the most important step of drug development process. As developing a safe and efficacious biological product for human is demonstrated through clinical trials.
Furthermore, stringent regulatory policies for drug development make process more complex, as it required more resources to develop new drugs, devices, and biologics. These process requires expertise in broad scientific disciplines of preclinical, clinical, ancillary clinical in chemistry, packaging, manufacturing, project management, and regulatory affairs which are provided by the CRO’s, considered as a major reason for drug companies to outsource clinical trials to CROs. Besides, the pharmaceuticals & biopharmaceutical companies are collaborating to undergo clinical trials with CROs to undergo the drug development process.
For instance, in May 2018, Ritter Pharmaceuticals, Inc. a developer of novel therapeutic products signed an agreement with the clinical research organization (CRO) Medpace to conduct the first of two pivotal Phase 3 clinical trials for RP-G28 in patients with lactose intolerance (LI).
Contract Research Organization Services Market - Regional Insights
North America market accounted for the largest share in the contract research organization services market, followed by Europe in 2016. This is attributed to increasing number of biotechnology-based companies with rising demand for CROs outsourcing services. Furthermore, increasing number of clinical trials and robust pipeline of Novartis, AstraZeneca, Merck and Pfizer, Inc. in the North America region are the factors responsible for growth of market in North America region over the forecast period.
In Asia Pacific region, the countries such as China and India particularly have increasing number of clinical trials for many application areas. Furthermore, due to large patient population, these countries provides a huge opportunity to the manufactures to market their drugs in Asia Pacific region, which is considered as major driver for rapid growth of CRO services. Besides, in some cases, the multinational companies are not allowed to conduct first-in-human Phase I studies in India and China where CROs plays a vital role to conduct such projects under such circumstances.
Furthermore, ongoing adoption of international standards and patent protection laws are been improved over the years particularly in India, China, and Japan. For instance, International Conference on Harmonization (ICH) Guidance document on Good Clinical Practice (GCP) followed by U.S. and Europe is been now adopted in India, Japan, and China. Hence the entrance of CROs in Asia Pacific region helps to provide clinical, regulatory infrastructure and practices in this region.
Contract Research Organization Services Market - Competitive Analysis
The Contract research organization players are involved in acquisition to expand the geographical presence of the CROs. For instance, in April 2018, Frontage Laboratories, Inc. an early-stage contract research organization located in China and the U.S. acquired Concord Biosciences, a preclinical organization based in Cleveland, OH aiming the company’s goal to build a global CRO with integrated services. Furthermore, in May 2018, RxCelerate acquired Total Scientific, a CRO focused in bioanalysis, protein assays and gene-phenotype association.
Key players operating in the global contract research organization services market include IQVIA, LabCorp, PAREXEL, ICON plc, PPD, PRA Health Sciences, Syneos Health, Charles River, Wuxi PharmaTech, Medpace Holdings, SGS, Envigo, and MPI Research.
Contract Research Organization Services Market - Taxonomy:
- Clinical Research Services
- Early Phase Development Services
- Laboratory Services
- Consulting Services
By Therapeutic Application:
- Infectious Diseases
- Central Nervous System (CNS) Disorders
- Immunological Disorders
- Cardiovascular Diseases
- Respiratory Disorders
- Other Therapeutic Areas
By End User:
- Pharmaceuticals & Biopharmaceutical Companies
- Medical Device Companies
- Academic Institutes