MENA BIOLOGICS & BIOSIMILARS MARKET ANALYSIS

Market Challenges And Opportunities

MENA Biologics & Biosimilars Market– Drivers

• Increasing investments and funding activities to strengthen the business: Increasing investments and funding activities to strengthen business in the region is expected to drive the growth of the market in the near future. For instance, on January 7, 2021, Abu Dhabi Developmental Holding Company, an Investment company has, announced two strategic investments, significantly expanding its healthcare and pharma portfolio. ADQ acquired Pharmax Pharmaceuticals FZ-LLC, a UAE-based pharmaceutical company that manufactures and markets affordable, branded generic medication, and invested minority stake in Biocon Biologics Limited ("Biocon Biologics"), a subsidiary of Biocon Ltd. that specializes in developing, manufacturing, and marketing high-quality, affordable biosimilars across global markets.

Compliance with stringent regulatory guidelines

• Regulations are sets of standards and norms that manufacturers must follow to ensure maximum public protection from developed products. Biological product regulation involves the overall management system to secure high levels of safety and quality for biological products. Stringent regulatory guidelines mandated by different regulatory bodies for biologic products are expected to hamper market growth over the forecast period. The approval of biologics follows a sequential process and involves various authorities such as the Institutional Biosafety Committees, the Institutional Animal Ethics Committee, the Review Committee on Genetic Manipulation (RCGM), the Genetic Engineering Advisory Committee, the Drug Controller General of India Office, and the Food and Drugs Control Administration. These guidelines for similar biologics provide the regulatory requirements regarding manufacturing processes and quality aspects and comparative exercise for preclinical studies, clinical studies, and post-marketing requirements.
• Counterbalance: A unified guideline must be established that is based only on scientific yet logical proposals in order to enable cost-effective development and cost reduction without compromising safety and efficacy.