Global Healthcare Regulatory Affairs Outsourcing Market is valued approximately USD 6.55 billion in 2019 and is anticipated to grow with a healthy growth rate of more than 12.30% over the forecast period 2020-2027. Healthcare Regulatory Affairs Outsourcing is the regulatory policies that are implemented to ensure that companies comply with certain functioning standards in relation to their business. These policies are aimed at safeguarding the public health and welfare by ensuring the safety of healthcare and pharmaceutical products. The Healthcare regulatory affairs outsourcing includes medical publishing and writing the regulatory documents offered by quality control, experienced medical writers and publishers that play an important role in developing high-quality documents for clinical research projects. Also, the ascertaining the advent of an increasing number of drugs in the clinical development process, regulatory affairs outsourcing is shifting more towards the healthcare sector.
Also, the key players are focusing on strategies such as product launch, innovation and merger & acquisition to sustain themselves amidst fierce competition. The growth of the market is attributed owing to the increasing R&D activities, rising investments in the healthcare sector in developed and developing countries, and increasing collaborations between regulatory outsourcing and drug developers. As per the Government of China in January 2018, China’s 13th five-year plan stipulates that biotechnology sector is expected to exceed around 4% of gross domestic product by 2020. Also, China has more than 100 life science parks and approx. USD 100 billion has already been invested by Chinese government to promote biotechnology.
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Also, the department of biotechnology (DBT) along with other government funded institutions such as National Biotechnology Board (NBTB) and many other autonomous bodies in the biotechnology sector are working together to project India as a global hub for biotechnology research and business excellence. In the Union budget of India 2017-18, the department of biotechnology (DBT) India, received USD 333.31 million to continue the implementing the department’s national biotech strategy to support the Indian government aim of establishing India as biotech hub. However, risk associated with data security, system access, and loss of control and technological advances leading to pricing fluctuations is hampering the growth of the market during the forecast period of 2020-2027.
The regional analysis of global Healthcare Regulatory Affairs Outsourcing market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. North America is the leading/significant region due to the increased focus on reducing investment cost and capitalize on the availability of cheap labor, rising concentration on the optimum utilization of resources, and changing regulatory scenarios. Whereas Asia-Pacific is also anticipated to exhibit highest growth rate / CAGR over the forecast period 2020-2027.
Major market player included in this report are:
Accell Clinical Research
PAREXEL International Corporation