The Indian bio-pharmaceutical industry: Making inroads into nanotechnology

(Nanowerk Spotlight) Chronic diseases such as cancer, diabetes mellitus, epilepsy, osteoporosis and cardiovascular among others are not well diagnosed, because symptoms of these diseases are often less apparent (progress slowly) than acute and communicable diseases. With the rapid urbanization and the unhealthy lifestyles, the disease profile in India is gradually shifting towards an ample growth in the chronic diseases segment. According to the World Health Organization (WHO), India has the highest number of patients with diabetes and 60 percent of the world’s cardiac patients belong to India (read more: «Background Paper: Burden of Disease in India»; pdf). It is also estimated that India has the largest number of coronary artery disease related deaths in the world. The bio-pharmaceutical industry expert says that the chronic disease-related therapeutics is the fastest growing segment in the Indian pharmaceutical market

Nanotechnology-enabled bio-pharmaceuticals are the most innovative and highly specialized alternative medicines for curing chronic diseases. For example, nanomaterials such as quantum dots, metallic nanoparticles, polymeric nanoparticles, nanofibers, carbon nanotubes, dendrimers and liposomes are ideal candidates for developing contrast agents for the cancer imaging, nanomedicines and drug delivery systems. These nanomaterials are suitable for molecular imaging and drug delivery systems because of their unique characteristics such as: 1) available large surface areas; which can be functionalized with one or more targeting molecules at a wide range of densities; 2) their plasma circulation time that can be tuned over several orders of magnitude based on their physicochemical properties; and 3) their capability to include contrast agents and drugs at predetermined ratio either in the interior or on the surfaces (see: P. S. Kuyate and V. Patel, Nanotech insights 2 (2011) 39–44). These functionally modified nanomaterials help in early detection of chronic diseases. In addition to this, they also detect the microorganisms and viruses associated with infections. In this article, we have analysed the immense potential of nanotechnology in India’s pharmaceutical and biotechnology industries.

• Nanotechnology-enabled bio-pharmaceutical R&D and products in the Indian industry are still in the early stages of evolution. Only modest amount of investments have been made so far and most of projects are moving through different phases of research/clinical trials (phase I-III), even though a few nano-based drug delivery systems have already reached the market. The Indian bio-pharmaceutical industry is witnessing business opportunity trends such as merger & acquisitions/takeovers/collaborations/in-licensing, increase in R&D investments, innovations in healthcare and drug delivery as well as product penetration into the tier I to tier VI markets to make significant inroads into nanomedicine and nanodiagnostics. CKMNT believes that these trends, along with the favourable macroeconomics and growth drivers, nanotechnology will propel Indian bio-pharmaceutical industry to the next level of growth. It is expected that in the next 10–20 years, market will be flooded with nano-based medicines and drug delivery systems as well as nano-enabled ultrasensitive and rapid detection devices for diagnostics and therapy.

Market Outlook and Products

The scope of nanotechnology in bio-pharmaceutical industry is very wide and it is finding applications in diverse areas such as tissue engineering, nanomedicines, diagnostic tools, image enhancement devices, nanorobots, implant technology, biosensors, biomarkers, bioactive surfaces and as carriers of diagnostic and therapeutic modalities.

• The market size for nanomedicine and nanodevices in India as of today is very small. There is a large number of Indian companies that have developed nanomedicines, which are already in the pipeline stage while some have even reached Phase III clinical trials, and greater focus is on innovative and blockbuster medicines (medicines that can generate annual sales of at least $1 billion for a company at global level). CKMNT estimates that over a period of next 10–15 years, the domestic nanotechnology market in this segment will grow upto US$ 1.6 billion at a Compounded Annual Growth Rate (CAGR) of 47%, with the potential to reach US$ 2.1 billion and India will be the fastest emerging player in the bio-pharmaceutical nanotechnology sector worldwide.

Oncology, diabetes mellitus, arthritis, viral infections etc. are the potential areas where nanotechnology can have significant impact for the Indian bio-pharmaceutical industries in the future. With rising incidence of diabetes mellitus and cancer in India and the emergence of new products on the horizon, nanotechnology is bound to make a significant impact on the Indian bio-pharmaceutical industry. India’s leading public pharmaceutical companies such as Lupin Ltd., Sun Pharma Advance Research Company, Cipla Ltd., Cadila Healthcare Ltd., Biocon Ltd., Fresenius Kabi Oncology Limited (erstwhile Dabur Pharma Ltd.), Panacea Biotec Ltd., Piramal Life Sciences Ltd., Cadila Pharmaceuticals Ltd., Dr. Reddy's Laboratories Ltd., Natco Pharma Ltd., Shasun Pharma Ltd. and Venus Remedies Ltd., among others are working on nanomedicines or launched nanotechnology-enabled therapeutics. Apart from this, private companies such as Lifecare Innovations Pvt. Ltd., Prakruthik Health Care Pvt. Ltd., Imgenex India, etc. are focused on developing nanomedicines.
The growing size of the Indian geriatric population, rising prevalence of chronic diseases, adoption of product patents and aggressive market penetration driven by the relatively small and medium-sized companies will be the driving forces influencing the growth of the Indian nanomedicine market. CKMNT expects that the market for nanomedicines and nanodevices will be focused on five therapeutic areas, vis. oncology, neuropsychiatry, diabetes mellitus, cardiovascular and arthritis. CKMNT expects that by 2030 these five therapies will contribute to 50 to 60 percent of total nanomedicine product launches in the Indian market.

• The most prolific Indian public companies, which are engaged in the nanomedicine product development

Fresenius Kabi Oncology Ltd. (erstwhile Dabur Pharmaceuticals Ltd.) made its foray into the field of oncology with the launch of ‘Nanoxel’, which is a novel nanoparticle-enabled formulation of Paclitaxel in 2007. It was India’s first indigenously developed nanotechnology based chemotherapy agent and a revolutionary drug for various types of cancer treatment. The company has been the front-runner in launching many generics in oncology.

Lupin Ltd., one of the world’s largest producers of tuberculosis drugs, with 12 factories and six research centres in India and Japan, has launched ‘Genexol-PM’ (paclitaxel nanoparticle) nanomedicine for cancer treatment by tie-up with the South Korean company Samyang Corporation. Genexol-PM is a PEG-poly (lactic acid) micelle formulation of paclitaxel with particle size in the range 20 to 50 nm.

It reduces Cremophor EL-related toxicities and increases therapeutic efficacy. Cipla Ltd., one of the world’s largest generic pharmaceutical companies with a presence in over 170 countries, has successfully developed and manufactured Paclitax Nab (nanoparticle albumin bound) product for the treatment of metastatic breast cancer in 2012.

• Sun Pharma Advanced Research Company Ltd. is engaged in creating new drugs and delivery systems such as ‘Paclitaxel Injection Concentrate for Nanodispersion (PICN)’and ‘Docetaxel Injection Concentrate for Nanodispersion (DICN)’. PICN has completed phase II/III study in metastatic breast cancer while DICN has completed Phase I clinical trials in patients with solid tumors.

  In 2012, Venus Remedies Ltd. has launched two nanotechnology-enabled products for arthritis and cancer treatments, respectively.

The brand Taxedol consists of Docetaxel in nanoparticle form and company claims that it gives 11 % higher cancer cell killing potential as compared to existing Docetaxel. It is used mainly for the treatment of breast cancer, prostate cancer, gastric adenocarcinoma, non-small cell lung cancer, head and neck cancer and ovarian cancer. Other product Trois, which is used for the treatment of pain and inflammation associated with rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis, juvenile idiopathic arthritis, backache, sprain psoriatic arthritis, and fibromyalgia, is based on nanoemulsion formulations with all natural ingredients. Cadila Healthcare Ltd. (erstwhile Zydus Cadila) has successfully developed and launched nanotechnology-based ‘Oxalgin Nanogel’ formulation for the pain management therapy (arthritis, backache, joint pain etc.).

• Shasun Pharmaceuticals Ltd., the active pharmaceutical ingredients manufacturer has entered into collaboration (50:50 joint ventures) with Nanoparticle M/s. Biochem, Inc., USA to develop gold nanoparticles-enabled radioactive medicine to treat prostate cancer.

Cadila Pharmaceuticals Ltd. has established a joint venture company, CPL Biologicals Pvt. Ltd., in partnership with M/s. Novavax Inc., USA to develop, manufacture and sell nanotechnology-based novel therapeutic and prophylactic vaccines, biological therapeutics and diagnostics in India. It represents an important strategic alliance for vaccine development and manufacturing in India.

Conclusions
In recent years, many Indian companies such as Piramal Enterprises Ltd., Cadila Healthcare Ltd., Dr. Reddy's Laboratories Ltd., and Ranbaxy Laboratories among others have made new chemical entities research wing, which is an integral part of their growth strategy and have scaled up operations in the nanotechnology segment. Many multinational bio-pharmaceutical companies are planning to launch their nanotechnology-based products or invest in R&D operations in India either by setting up their subsidiaries or through joint research and collaboration and in/out licensing agreements with the Indian companies. With the growing size of the Indian geriatric population and rising prevalence of lifestyle diseases, the demand for nanomedicine is expected to grow significantly. These key factors provide ample opportunities for Indian bio-pharmaceutical players to explore various avenues in the nanotechnology segment.

By Vivek Patel, CKMNT. A comprehensive report on “Indian Nanotechnology Market: Technologies, Applications and Opportunities” is slated to be released by CKMNT in the future. Interested readers may please contact Mr. Vivek Patel at vivek@ckmnt.com or info@ckmnt.com for further details.

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