BIOPHARMACEUTICAL AND BIOMEDICINE MARKET ANALYSIS

Biopharmaceutical and Biomedicine Market, By Product Type (Biopharmaceuticals (Monoclonal Antibodies, Vaccines, Recombinant Human Insulin, Human Growth Hormone, Erythropoietin, Interferon, Colony Stimulating Factor, Nanomedicine, Cell & Gene Therapy, Bioinformatics, and Molecular Enzymes & Kits), By Application (Therapeutics (Oncology, Cardiovascular Diseases, Neurological Disorders, Infectious Diseases, Immune Disorders), and Diagnostics (In Vitro Diagnostics, Research and Development), By Type (Branded Biopharmaceuticals and Generic Biopharmaceuticals), By Route of Administration (Oral, Intravenous, Subcutaneous, and Intramuscular), By Patient Demographics (Adult, Pediatric, and Geriatric), By Geography (North America, Latin America, Asia Pacific, Europe, Middle East, and Africa)

Published In : Feb 2025
Code : CMI18
Pages :156
Formats :
Excel and PDF
Industry : Biotechnology

Market Challenge - Stringent regulatory requirements and lengthy approval processes

The stringent regulatory environment and lengthy approval processes for new biopharmaceutical drugs pose a major challenge for the growth of the global biopharmaceutical and biomedicine market. Most major regulatory bodies like the U.S. FDA and EMA in the EU have robust and meticulous approval systems to ensure safety and efficacy of new drugs. However, this often results in clinical trial periods lasting 7-10 years on an average before a new drug is approved. The extensive documentation and data requirements at each stage of development and regulatory review prolong the overall R&D cycle significantly. Additionally, failure in any stage leads to starting the process all over again, further draining resources and increasing costs for manufacturers. These regulatory hurdles make the drug development process highly risky, time-consuming and capital intensive, discouraging many companies especially startups. Harmonizing standards across markets and expediting approvals for breakthrough therapies can help address this challenge to some extent.

Biopharmaceutical and Biomedicine Market Opportunity - Growing demand for targeted therapies and biosimilars

The market presents robust opportunities stemming from the rising demand for biosimilars and targeted therapies. As the understanding of disease pathology improves at the molecular level, more targeted biologic drugs are being developed to precisely treat conditions. This shift from conventional drugs to precision medicines is being driven by their higher efficacy and fewer side effects. Additionally, patent expiration of major blockbuster biologics is paving the way for biosimilars which provide comparable quality at significantly lower costs. For instance, Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, received the U.S. FDA approval for HERCESSI (trastuzumab-strf), a biosimilar to Herceptin. HERCESSI is approved for treating HER2-overexpressing breast cancer and gastric or gastroesophageal junction adenocarcinoma, marking Accord BioPharma, Inc’s first USFDA-approved biosimilar.