discovery of stem cells is one of the biggest achievements in modern
medical history. Stem cell-based researches are conducted almost every
where in the world and has triggered interest in India too. The promise
regenerating anything from head to toe using stem cells is luring
Indian companies. An overview of the stem cell sector in India.
Stem cell are being
called as wonder therapies for their innate quality in regrowing
anything within and
outside the body from head to toe. Currently available therapies are
‘symptomatic’ in nature and do not address the root
cause of the disease. But stem cell therapy aims at addressing the root
cause of the disease by replacing the damaged or diseased cells by
healthy functional cells there by offering possible cure for unmet
Stem cell market scenario
Indian stem cell companies
and research institutes are known for their innovation and R&D
expertise. The successes of these companies
have encouraged start-ups to enter this promising new sector. Toppers
of the prominent stem cell companies share their views on the current
trend and future prospects of stem cell research in India.
Bangalore-headquartered Stempeutics Research, a part of the $3 billion
(Rs 13,889 crore) diversified Manipal Group, is one of the leading stem
cell companies in India. The company is in the process of bringing the
first stem cell therapy product in India. While the initial foray of
Stempeutics is in bone marrow derived mesenchymal stem cells,
Stempeutics is investing heavily on its R&D to bring out some
innovative products such as tailor-made cells based on adult stem
cells. It is working on alternate sources like
Jelly, adipose tissue, and dental ligament for mesenchymal stem cells.
The company is also investing on leveraging human embryonic stem cells
for therapeutics purpose. Stempeutics is also focusing on enhancing the
upscaling process of mesenchymal stem cells using latest technology in
order to bring down the cost of the end product.
According to BN Manohar, president of Stempeutics Research,
“Stem cells would be a major branch of medical treatments and
would be a standard cure and practice in the years to come.
Regenerative medicine is a rapidly emerging area of biomedical research
with enormous therapeutic potential, and this would be an ideal
supplement for existing medical treatments.
“The global market for stem cell therapies is expected to be
$20 billion (Rs 92,593 crore) by 2010. Adult stem cell therapy
currently dominates the global stem cells market with a share of almost
58 percent. There are almost 30 prominent adult stem cell companies in
the world. Majority of these companies are based out of the US,
followed by the European Union, Israel, Thailand, Canada and
Australia,” Manohar says. Prominent stem cell companies
outside India are Osiris, Organogenisis, Genzyme, Cytori, Aastrom and
Mumbai-based Reliance Life Sciences, which is owned by Mukesh Ambani
led Reliance Group, has been a pioneer in stem cell research in India
and the company focuses on developing stem cell therapies, right from
research, cell processing in cGMP facilities, clinical research and
clinical practice. The company is developing a wide range of novel
research-led, autologous and allogenic cell therapies and tissue
engineered products. Cell-based therapies from Reliance Life Sciences
aims to fulfill unmet patient needs in the areas of cardiac disorders,
neural degeneration, spinal cord injury, metabolic disorders like
diabetes, ophthalmic diseases, hematological diseases, oncological
diseases, burns and wound management, diabetic and venous ulcers, and
While commenting on the Indian scenario of stem cell therapy, KV
Subramaniam, president and CEO, Reliance Life Sciences, says,
“India is one of the few countries in the world pursuing stem
cell research. But regenerative medicine, comprising stem cell
therapies and tissue engineered products, is at a nascent stage in
India. According to our estimate, by 2011 about 16.44 crore patients,
suffering from diabetes, cardiovascular disorders, neurological
disorders, burns and wounds, osteoarthritis, osteoporosis, bone,
cartilage (joints & replacements), liver disorders, congenital
abnormalities and neoplasms, would benefit from stem cell therapies in
“Presently, stem cell therapies have good potential in
ocular, cardiovascular, and neurological disorders. There are several
companies and institutions engaged in various clinical trials of stem
cell research. With growing interest of private companies in this
domain and support from government bodies, stem cell therapy holds
great potential to emerge as the therapy for several diseases in
future,” adds KV Subramaniam.
Chennai-based Nichi-In Center for Regenerative Medicine (NCRM) is an
Indo-Japan joint venture institute carrying out research, training and
clinical applications-protocol development in regenerative medicine,
with an emphasis on stem cells, progenitor cells and autologous adult
cells with regenerative capability to take them to clinical
application, while maintaining the highest ethical and scientific
values of international standards. NCRM is the first institute in India
to start providing autologous NK cell based immuno-cell therapy (AIET)
for cancer and has been providing stem cell isolation, enrichment and
expansion services to partner hospitals all over India for various
diseases as per Indian Council of Medical Research (ICMR) guidelines.
“Indian stem cell market is quite big. However, we have to
educate the public about the possibilities and limitations of the
cell-based therapies. With a huge population where lifestyle-related
diseases are increasing and with rapidly increasing death rate due to
cardiac diseases and cancer, more emphasis is needed for all those
diseases that are prevalent in India,” says Dr Samuel JK
Abraham, director, NCRM.
Bangalore-headquartered Cryo–Save India is a part of
Cryo-Save Group, Europe’s largest adult stem cell storage
bank. The company recently achieved a significant milestone with TUV
Rheinland, Germany, conferring the Indian operations an ISO 9001:2008
“India, as a country, is much more developed and advanced in
medical science. It has adapted to the modern medical science than any
other Asian countries. With easy accessibility across the nations,
India has emerged as the ideal hub for the industry to grow.
Considering the growing population in the country, the market is huge
and is expected to grow at a rapid pace,” observes VR
Chandramouli, managing director, Cryo-Save India.
“Stem cell banking in India is yet to come under a regulatory
frame work where government bodies need to spell out the clear-cut
procedures for storing the stem cells. As a first step, senior
officials at the Ministry of Health and Family Welfare need to lay the
process together with the help of an expert committee for stem cell
banks and therapy,” adds Chandramouli.
ICMR and the Department of Biotechnology (DBT) had laid down the
fundamental guidelines for stem cell research and therapy in
2007, but in the absence of laws specific to the issue, the guidelines
were set aside. Apparently in India we are in a stage to formulate the
norms governing stem cell banking and the storage procedures, opines
The guidelines put forth jointly by ICMR and DBT have not become a law
so far. Government needs to create a separate task force on stem cells
research and therapy and see how India can leverage its intellectual
talent and become a global leader in this field. In countries like
Malaysia excellent support is provided by the Malaysian Biotechnology
Corporation. It provides seed funding, R&D funding and export
funding for start-up companies (BioNexus Status Companies).
Also it provides 10-year tax benefits from the year the company starts
profit, duty exemptions and a host of benefits for promoting stem cell
companies. Indian government should provide these benefits to stem cell
companies based on certain evaluation. Also on stem cell clinical
trials front, government needs to think on fast track approval process
considering it as ‘orphan’ drug status –
like what FDA is doing in the US, suggests Manohar of Stempeutics.
India needs to speed up its activities related to human clinical trials
(as per cGCP standards). There are only few dedicated companies
focusing on real research and clinical trials. The current stem cell
therapy market in India is approximately $540 million and it is
expected to grow rapidly. The country is also becoming an attractive
destination for global stem cell companies and research institutes in
the areas of clinical trials/clinical research, stem cell research and
Recent approval of clinical trials of stem cell-based drugs by the Drug
Controller General of India (DCGI) has created immense interest among
global stem cell players to conduct their clinical trials in India.
Well-defined guidelines, efficient and speedy processes for approving
clinical trials by regulatory bodies and availability of vast patient
pool makes India a good destination for conducting clinical trials.
ICMR supported by DCGI has drafted guidelines to conduct clinical
trials in India in an ethical and scientific manner. ICMR has formed an
expert stem cell committee to validate and recommend trials in India.
DCGI recently made registry of all clinical trials mandatory with
Clinical Trials Registry- India (CTRI) registry – so that all
trials can be monitored for proper conduct as per international norms.
Availability of skilled manpower and initiatives taken by the
government in creating good infrastructure for stem cell research are
attracting foreign institutes and private companies for collaborative
research with Indian institutes and private companies. The initiative
taken by the DBT in creating a world-class stem cell research center in
Bangalore is another positive step in nurturing value-added stem cell
research in India.
Another area where India can take a lead in stem cells is the stem
cells production technology i.e. large scale upscaling of stem cells.
It is an area where private players can take a lead in the global
market in the next three to four years. Global stem cell players may
outsource their ‘production’ process to India if
India can show the cost/quality advantage.
India has the opportunity to be a global force in biotechnology and
stem cell research can be an important constituent of this aspect of
global leadership in this frontier technology area.
Pradeep Kumar in Bangalore