Traditional drugs have always been derived from small molecule sources. But the current market is witnessing a large number of biologic drugs hitting the market and also in the pipeline. E.g. Sanofi’s
pipeline in 2011 consisted of 60% biologics, whereas in 2013
the pipeline consisted of 80% biologics. Some part of it also
represents cellular and gene therapeutics. Cell therapy is
another class of drugs which is gaining traction at present. A
large number of development activities are underway and a
good number of them have also attained commercial success.
This article discusses how cell therapy is expected to transform the therapeutic space and how Big pharma companies
and Cell therapy contract manufacturers look at this shift. It
also discusses about the initiatives taken form the manufacturer’s end and how the government supports the industry
as a whole. Therefore the contents of this article will help
understand the current status of cell therapy industry and
also give a futuristic view to the category manager.
Cell therapy is the process of using cellular material to
treat patients. The treatment is carried out by producing
new cells to replace damaged or malfunctioning cells.
The global stem cell therapy products market is expected
to grow at a CAGR of 17.18% from USD 3. 5 billion in 2012 to
USD 6. 6 billion in 2016.
This industry is expected to become one of the pillars of
pharma apart from small molecules, large molecules, and
AUTOLOGOUS AND ALLOGENEIC
Autologous –Stem cells are harvested from the patient,
cultured ex-vivo over many weeks and returned to the patient for treatment.
Allogeneic –Stem cells are collected from a single donor
and the culture expanded stem cells are used to provide
treatment for a large number of patients.
WHY IS CELL THERAPY GROWING?
Cell therapy as an industry is growing due to the demand
for cellular therapeutics which can offer treatment or cure
to some of the conditions which are not easily treated using biopharmaceutical or drug-based approaches. E.g.
Novartis’s cellular therapy, CTL019 helps to address the
unmet needs of patients with refractory acute lymphoblastic leukemia. CLT019 was granted Breakthrough Therapy
Status by the FDA in July 2014. Some of the areas where cell
therapy can play a major role are, in the case of Alzheimer’s
disease, osteoarthritis, immunosencence and some chronic
CELL THERAPY PRODUCTS IN THE
Presently, there are relatively few new
drugs in the market. However, there are
increasing numbers of molecules which are
currently in the pipeline
Currently, there are nearly 17 ap-
proved cell therapy products in the
USA, 12 in Europe and 8 in other
parts of the world like S. Korea,
Japan Canada etc. These include
MACI (Aastrom Biosciences), LAVIV
(Fibrocell Bioscience), Apligraf, Gintuit
(Organogenesis Inc.) etc.
The next "Go" in biologics
n By Vaishnavi Loganathan, Beroe Consulting