12 August 2020
Visiongain has launched a new pharma report CRO Regulatory Services for Generics and Biosimilars Drugs Market Report 2020-2030: Forecasts by Services (Regulatory Writing and Publishing, Clinical Trial Application and Product Registration, Regulatory Consulting, Legal Representation, and Other Regulatory Services analyses), by Application (Oncology, Cardiology, Infectious Diseases, Metabolic Disorders, Others), by Clinical Phase (Pre-clinical, Phase I, Phase II, Phase III, Phase IV), by End-use (Pharmaceutical Companies, Biotechnology Companies, Government Institutes, Others), by Geography (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa) PLUS COVID-19 Impact Scenarios and Profiles of Leading CRO Regulatory Services Companies.
The global CRO generic and biosimilar drug market regulatory services market was accounted for US$ xx bn in 2019 and is projected to reach US$ xx bn by 2030. Growing demand for contract manufacturing services; concentrating on core competencies of pharmaceutical and biopharmaceutical companies; and increasing demand for biosimilars and generics are key factors driving the global CRO regulatory services for the generic and biosimilar drug market. Nevertheless, many factors, including project delays and cancellations and skilled professional shortages, are hindering the sector.
Emerging markets with less stringent regulatory processes, such as India and China, expected to showcase fast CAGR during 2020-2030. Also, these developing markets in the Asia Pacific and Latin America will increase their market shares throughout the forecast period 2020-2030 as patents expire on the originator products. The growing outsourcing of work from CROs by big pharma companies will boost the industry through increased collaboration and partnership activities.
Some CROs will target specific market regions due to their strategies being best suited to certain regulatory guidelines. Also, the CRO regulatory services for generics and biosimilars drugs market will face challenges posed by competition from biobetters and a lack of confidence of some clinicians in biosimilar interchangeability. Visiongain expects the governmental policy to increase preferences for use of biosimilars and generics over branded ones as healthcare budgets become increasingly strained. CRO regulatory services for generics and biosimilar drugs will, therefore, have an important, rising role to play in healthcare systems from 2020 to 2030.
We conclude the following from this study that:
• The global CRO regulatory services for generics and biosimilars drugs industry will grow at a CAGR of xx% from 2020 to 2025 and xx% from 2025 by 2030.
• In 2019, the regulatory writing and publishing submarket holds the highest proportion with a market share of xx%. This submarket will grow at a CAGR of xx% from 2020-2025 and xx% from 2025-2030.
• The regulatory consulting submarket will be the fastest-growing submarket from 2020-2030 with a CAGR of xx%.
• In 2019, the North America region accounted for the largest share of xx% in the global market. The US held the first position with xx% revenue share in the North American market.
• The other leading national market for CRO regulatory services for generics and biosimilars drugs in Canada, UK, Germany, France, Spain, India, China, South Africa, and Japan.
• Pharmaceutical Product Development (PPD); Covance Inc.; IQVIA; ICON plc.; Genpact Ltd.; Criterium; Charles River Laboratories International; Accell Clinical Research LLC.; Medpace, Inc.; and WuXi AppTec are the key vendors operating in the market.
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