The Future of BioManufacturing

Evolution Global’s ongoing BioManufacturing series will provide an exclusive, in-depth analysis of key trends that will shape the future of biologic drug development in the coming years and decades.

By exploring the history of the BioManufacturing market from conception to present day and by analysing both past and ongoing key trends, we will predict what the future of the industry is likely to hold.

This page serves as an overview for The Future of BioManufacturing, providing historical context and an outline of key trends that Evolution Global will elaborate on throughout the series.

DEVELOPMENT PIPELINE

Since its inception in the 1980s-1990s, the field of biologics has developed from being a relative rarity in the human pharmaceutical market to one that, by the beginning of the next decade, will more than likely equal new molecular entities (NMEs) in terms of generating revenue for the pharmaceutical industry.

MARKET SHARE

IN THE PIPELINE

This change has been driven in part by the fact that the potential for clinical development success for biologics is superior to new NMEs, as highlighted by the table below.

 PRECLINICALPHASE IPHASE IIPHASE IIIREGISTRATION
BIOLOGIC12%17%27%58%82%
NME2%4%9%44%72%

Table 1: Percentage likelihood of successful transition to next phase of development

As Biologics have progressed clinically, the category has broadened to include a number of the therapeutic options such as Cell Therapy, Antibody Drug Conjugates (ADCs) and Cancer Vaccines. The chart below outlines the breakdown of Biologics currently in development.

DEVELOPMENT PIPELINE

Since its inception in the 1980s-1990s, the field of biologics has developed from being a relative rarity in the human pharmaceutical market to one that, by the beginning of the next decade, will more than likely equal new molecular entities (NMEs) in terms of generating revenue for the pharmaceutical industry.

MARKET SHARE

IN THE PIPELINE

This change has been driven in part by the fact that the potential for clinical development success for biologics is superior to new NMEs, as highlighted by the table below.

 BIOLOGICNME
PRECLINICAL12%2%
PHASE I17%4%
PHASE II27%9%
PHASE III58%44%
REGISTRATION82%72%

Table 1: Percentage likelihood of successful transition to next phase of development

As Biologics have progressed clinically, the category has broadened to include a number of the therapeutic options such as Cell Therapy, Antibody Drug Conjugates (ADCs) and Cancer Vaccines. The chart below outlines the breakdown of Biologics currently in development.

the breakdown of Biologics currently in development graph.

KEY PRODUCTION TRENDS

As novel types of Biologics have been developed, changes in BioManufacturing approaches have been running in parallel with the intention of maximising yield and/or lowering production costs. Evolution Global have identified and outlined 8 key production trends below, and Evolution Director Dr. Frank Rinaldi will publish a dedicated analysis of each key production trend as we build towards a detailed vision for the future of biomanufacturing.


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