Few big pharma companies like Pfizer, Merck,
Novartis, etc. have entered into manufacturing partnerships to manufacture cell therapies. Novartis also plans
to acquire Israel based Stem cell specialist Gamida Cell
and has invested close to USD 35 million as initial exercise.
Hence with growing interest on cell therapy, CMOs are
looking to expand their capabilities so as to meet the
As the cell therapy industry is growing rapidly the
need for large-scale manufacturing facilities is being met
by the investments from the government.
The UK Government in March 2014 has invested
USD 91 million (£ 55 million) in the development of the
UK Cell Therapy manufacturing centre. This centre is
expected to help improve cell therapy manufacturing
activities and the support the UK cell therapy industry.
The manufacturing centre is expected to open in 2016 or
The regulatory frame work for cell therapy products
is quite similar to that of a biologic drug. But in certain
cases the regulations have been modified in order to
meet the growing demand for cell therapy products. E.g.
• Fast track approval for cell therapy products in
Japan. The regulations in Japan for cell therapy prod-
ucts have been revised since November 2013. This new
regenerative medicine law allows the Japanese govern-
ment to give conditional approval to cell therapy prod-
ucts if their safety is confirmed in clinical trials.
Government investments are also focused in lines of
developing advanced therapies for some unmet medical
needs and to stay prepared to meet possible mass cau-
• US government i.e., Biomedical Advanced Research
and Development Authority
(BARDA) has extended its contract
with Cytori Therapeutics to develop
cell therapy for treatment of ther-
mal burns combined with radiation
injury. As a part of the extended
contract BARDA has funded Cytori
up to USD 20. 4 million. The original
deal was said to be worth USD 106
The key highlights of the cell
therapy market are
• Currently market has very
few cell therapy products, mostly
owned by small companies. Most of
these drugs are manufactured in-
• Increased focus on cell therapy
based projects. All the major pharma
companies have in licensed or own
molecules which are in trials.
• Since pharma companies do not have in-house expertise, major companies outsource clinical manufacturing to CMOs.
• As a result major CMOs have expanded their development and manufacturing capabilities.
Presently supplier market is relatively small with specialized players. Depending on the market success, we
would see increased penetration on biologic CMOs into
this focus area. n
ABOUT THE AUTHOR
Vaishnavi Loganathan is a Research Analyst with
Beroe Inc., a global provider of customized procurement
services specializing in sourcing, supply chain visibility, financial risk analysis and environmental impact to
Fortune 500 organizations.
Vaishnavi Loganathan specializes in tracking various
biologics. She has worked on multiple projects for many
Fortune 500 clients involving categories such as upstream and downstream processing in biologics.
Vaishnavi Loganathan earned her degree in
Biotechnology and Environmental Engineering from the
Anna University and Pondicherry University respectively.