BIOLOGICS MARKET ANALYSIS

Biologics Market, By Product (Monoclonal Antibodies, Vaccines, Recombinant Hormones/Proteins, Cellular-based Biologics, Gene-based Biologics, and Others), By Drug Classification (Branded Drugs and Generic Drugs), By Route of Administration (Oral, Parenteral, and Other Routes), By Mode of Purchase (Prescription-Based Drugs and Over-The-Counter Drugs), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), By Geography (North America, Latin America, Asia Pacific, Europe, Middle East, and Africa).

Published In : Feb 2025
Code : CMI2663
Pages :210
Formats :
Excel and PDF
Industry : Pharmaceutical

Market Challenge- High costs associated with biologics development and manufacturing

Key challenges faced by global biologics market includes high costs associated with biologics development and manufacturing. Developing a new biologic typically costs over US$ 2.6 billion and takes close to 10-12 years of extensive research and clinical testing. This is significantly more expensive than developing a traditional small molecule drug. Manufacturing of biologics is a complex process that requires sophisticated infrastructure and stringent regulatory standards. Biomanufacturing relies on living systems like cell culture which can be susceptible to contamination.

Market Opportunity - Expansion of biosimilars and their acceptance in various markets

Major opportunity for the global biologics market includes expansion of biosimilars and their acceptance in various markets. Biosimilars are biologic medical products that are similar to an already approved biological reference product. These offer cost savings of up to 30% compared to originator biologics which have lost patent exclusivity. Many developed regions like the European Union, the U.S., and Japan have established biosimilar pathways and regulations in last decade.