Although small molecules dominate the global pharmaceutical market, the percentage share of biologic-based drugs is projected
to rise reflecting both the entry of new biologic-based drugs and increased revenues for existing biologics.
Following several years of slowing growth, the global market for medicines is expected to rebound from a projected low of
3–4% growth in 2012 to 5–7% growth in 2016, according to a July 2012 analysis by the IMS Institute for Healthcare Informatics.
Growth will primarily be from emerging markets as growth in established markets in the United States, Western Europe, and
Japan remains weak comparative to historical levels. Overall, annual global spending on medicines will rise from $956 billion
in 2011 to $1 trillion by 2013, to nearly $1.2 trillion in 2016, representing a compound annual growth rate of 3–6%.
Biologics are expected to account for approximately 17% of total global spending on medicines by 2016 and reach an overall
market value of $200 billion to $210 billion in 2016, up from $157 billion in 2011, according to IMS. Seven of the top 10
global medicines by spending will be a biologic within five years, according to IMS. Adoption of biosimilars as low-cost alternatives
to original biologic medicines will remain limited as biologics remain protected by patents or market exclusivity in many
countries. The global market for biosimilars is expected to be between $4 billion and $6 billion in 2016, representing 2%
of biologics spending. In 2011, the global biosimilars market was estimated at $693 million, or only 0.4% of the global biologics
market, according to IMS.
New biologics gain US approval
In 2012, FDA's Center for Drug Research and Evaluation approved several new biologic license applications (BLAs) (see Table I). Roche/Genentech received approval for Perjeta (pertuzumab), a HER2/neu receptor antagonist indicated in combination with
trastuzumab and docetaxel for treating patients with HER2-positive metastatic breast cancer. Sanofi received approval for
Zaltrap (ziv-aflibercept), a recombinant fusion protein, which acts as a soluble receptor that binds to vascular endothelial
growth factor-A (VEGF-A), VEGF-B, and placental growth factor and is used to treat metastatic colorectal cancer. Sanofi partnered
with the biopharmaceutical company Regeneron Pharmaceuticals for Zaltrap. Also, the generic-drug company Teva received approval
for tbo-filgrastim, which was approved as an original BLA and not as a biosimiliar to Amgen's Neupogen (filgrastim), which
is a previously approved biologic. Tbo-filgrastim is a human granulocyte colony-stimulating factor produced by recombinant
DNA technology and is used to reduce neutropenia in patients with non-myeloid malignancies.
Table I: Approvals of new biologic license applications (BLA) in 2012 by FDA’s Center for Drug Evaluation and Research.
Also, GlaxoSmithKline received FDA approval for raxibacumab, a monoclonal antibody to treat inhalational anthrax. Raxibacumab
was developed by Human Genome Sciences (HGS) in conjunction with the Biomedical Advanced Research and Development Authority
of the Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services. HGS was
acquired by GSK in July 2012. ThromboGenics received FDA approval for Jetrea (ocriplasmin) for treating vitreomacular adhesion.
Alcon, a division of Novartis, acquired the rights to commercialize Jetrea outside the United States in March 2012; ThromboGenics
retains US rights.
Patricia Van Arnum is executive editor of Pharmaceutical Technology, firstname.lastname@example.org