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The Market for Therapeutic Biologicals is Evolving as Pipeline Candidates Reach Commercialization

The Convergence of New Biologicals and the Growth of Biosimilars Will Require Changes at FDA according to Greystone Research Associates

(Amherst, NH) – Activity in the biological drug sector is set to escalate, as a growing number of drug candidates reach the market and the number of applications requesting marketing authorization for biosimilars increases to a level that will force the FDA to institute new review procedures and expand its resources.

The number of new FDA-approved biologicals has averaged between four and five per year over the past decade. This number will increase with the eventual definition and streamlining of an approval process for evaluating biosimilars for market authorization in the U.S. The FDA expects to receive multiple applications requesting marketing approval for biosimilars for a number of underlying biological drugs previously approved under a BLA.

As the market evolves, the impact across various disease segments will be uneven. Approved biologicals indicated for autoimmunity and immunotherapeutics are primarily mAbs with the remainder fusion proteins. This segment will remain one of the three most active for drug developers.

Oncology remains the largest segment for biologic drugs, accounting for 35% of all biologics. About two-thirds are antibodies or antibody-drug conjugates. Recombinant drugs for cardiovascular conditions are primarily glycoproteins, with the remainder mAbs. The majority of proteins for orphan diseases are enzymes. Other important disease classes for biologicals include antivirals, hematopoietics, and drugs for ophthalmology.

Compliance with drug therapy and disease management protocols has been and is a primary concern within the healthcare and pharmaceutical industries. Efforts to enhance compliance are having a non-negligible effect on drug formulations and delivery decisions, and can be a significant factor in the prescribing decisions of most physicians. Compliance concerns have driven and continue to drive investment in new drug delivery technologies.

A new and comprehensive report on therapeutic biological drugs researched and written by Greystone Research Associates is now available. The report – Therapeutic Biological Drugs to 2020 – analyzes all currently FDA-approved therapeutic biologicals, and provides assessments of biological drug development factors, disease segments, market factors and regulatory issues.

More information is available at

About Greystone

Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.