Biopharmaceuticals Market, By Product Type (Monoclonal Antibodies, Recombinant Growth Factors, Purified Proteins, Recombinant Proteins, Recombinant Hormones, Vaccines, Recombinant Enzymes, Cell and Gene Therapies, Synthetic Immunomodulators, and Other Product Types), By Therapeutic Application (Oncology, Inflammatory and Infectious Diseases, Autoimmune Disorders, Metabolic Disorders, Hormonal Disorders, Cardiovascular Diseases, Neurological Diseases, and Other Diseases), and By Geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

Published In : Jun 2023

Code : CMI5785

Pages :150

Formats :

Excel and PDF

Industry : Biotechnology

Market Challenges And Opportunities

Global Biopharmaceuticals Market Drivers:

Rise in patient pool to people the market growth

One of the key factors expected to augment the growth of the global biopharmaceuticals market during the forecast period is the growing burden of chronic, infectious, and neurological diseases an across the globe. Such a high burden of disease and rise in patient pool increase the demand for safe and effective biopharmaceuticals. According to the Alzheimer's Association, 2021 report, the Food and Drug Administration (FDA) approved five drugs, such as Rivastigmine, Galantamine, Donepezil, Memantine, and Memantine, to treat Alzheimer's. Such a high disease prevalence will increase demand for API over the coming years.

Growing geriatric population to drive market growth

Another factor which is driving the growth of the global biopharmaceuticals market is the growing geriatric population around the world. For instance, the share of older people in the population is gradually increasing. An increase in age means an increase in number and complexity of illnesses. Cardiovascular diseases, cancer, diabetes, dementia, diseases of the respiratory organs and cerebral perfusion are among the many ailments often associated with age. According to the World Health Organization (WHO), by 2030, one in six people in the world will be aged 60 years or over, and by 2050, the world’s population of people aged 60 years and older will double (2.1 billion).

Global Biopharmaceuticals Market Opportunities:

The outbreak of COVID-19 (pandemic) is expected to provide significant growth opportunities for players in the biopharmaceuticals market. For instance, in February 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a monoclonal antibody to treat COVID-19 that retains activity against the omicron variant. Bebtelovimab treats mild to moderate COVID-19 among adults and pediatric patients. It is also for those for whom alternative treatment options approved or authorized by the FDA are not accessible or clinically appropriate. In short, the pandemic had a positive impact on the market growth.

Increase in research and development (R&D) is expected to offer significant growth opportunities for players in the global biopharmaceuticals market. For instance, the ability of biopharmaceutical products to address previously untreatable conditions has paved the way for innovative drugs to be introduced to the market. In June 2022, GSK Plc. announced that the U.S. FDA has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunization for the prevention of measles, mumps and rubella (MMR) in people 12 months of age and older. Priorix is currently licensed in more than 100 countries worldwide.

Global Biopharmaceuticals Market Restraints:

High-end manufacturing requirements to hamper market growth

One of the key factors expected to hamper the growth of the global biopharmaceuticals market is the high-end manufacturing requirements. Biopharmaceuticals are challenging to manufacture and need specialized as well as expensive processing and purification methods. Their sensitivity to the environmental conditions also makes it difficult to develop their biosimilars, as a minor variation in the production process may significantly disrupt the safety and efficacy of the product. Thus, a control switch over every feature of the production process is vital for the manufacturing.

Stringent rules and regulations to hinder market growth

Another factor which is hampering growth of the global biopharmaceuticals market is the stringent rules and regulations and/or complicated and cumbersome regulatory requirements. The uncertain safety concerns involved with biopharmaceuticals triggered regulatory interests of the concerned authorities, after the introduction of biosimilars. Moreover, strict regulatory guidelines for both the clearance and approvals of these products are expected to slow down the process further. This in turn is restraining the growth of the market.