Monday, November 19, 2018
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Who wants to create a new product pipeline?

-Dr. R B Smarta

Abstract

With the growing uncertainties and changes in the pharmaceutical industry every company wants to be ahead in the race. But how will this be possible unless newer strategies or a unique way is identified to be different? This article chalks out certain possibilities to develop newer product pipelines as per the companies need to stay positioned in the competition.

Introduction

Change in lifestyle has led to the rise of diseases of the heart and increase in the number of people suffering from diabetes, leading to increased number of cases reported for cardiac arrest and patients suffering from diabetes. This corresponds to the rise in sales of pharmaceutical products. The Indian pharmaceutical industry has a hub of activities in process to provide the healthcare system with variations in treatment options, for newer diseases including research and development, manufacturing branded, generics and branded generic drugs, manufacturing APIs etc.

Indian Pharmaceutical Industry is at a mature stage from its nascent stage back in the 1970s and today accounts for 10 percent in terms of volume and 2.4 percent of in terms of value of the world market and is the third largest, in terms of volume and stands at thirteenth position in terms of value and is expected to grow at a compounded annual growth rate of 15.92% between 2015-2020.

The market is also looked upon as a destination of branded, generic as well as branded generic drugs which contribute 70 percent of market share in terms of revenue. The patented drug market contribute 21 percent whereas, over the counter (OTC) drug market contribute 9 percent of total USD 20 billion revenue of the Indian pharmaceutical market.

The industry has tremendous achievement over the years due to the various challenges faced by the industry. To understand the future opportunities that lie at hand we take a look at some of the issues faced by the industry and the coping strategies.

Industry Issues

 As the business environment is continuously changing, the situation in pharmaceuticals is such that it is flooded with generics and it is becoming difficult for pharmaceutical companies to differentiate between products. Even product definition is expanded from merely being a product, to its indications, contra-indications, caution & compatibility with other drugs, food and drug interactions and thereby lot of consulting and FAQs.

Besides these issues in the market, youngsters have also learnt how to identify products available in the market for various indication or disease, and also which product will correspond to a particular indication. Hence, there is a lot of awareness amongst patients for even generic products. Along with the generics load, there is a proliferation of competition and I may not exaggerate even one molecule may have 80-90 competitors in India.

As the sales model has changed from knowledge exchange to transaction, the current industry is finding it difficult to create an edge in the market. This edge can be created by, creating a new product pipeline as well as differentiating existing products through service consulting and other counseling centers. Besides, there are also possibilities of launching new products and creating a product pipeline through biologics, nutraceuticals, ayurvedic products and also newly accepted as drugs- phytopharmaceuticals.

International industry is concentrating on treatment for lifestyle diseases, hence, the major investments of the companies have gone towards lifestyle diseases and patenting products. However, the market today is filled with ayurvedic products, traditional medicines, Chinese herbs, nutraceuticals, dietary supplements etc. to take care of various indications in both geriatric and pediatric patients.  The herbal healthcare industry is estimated to be around $ 47 billion while India’s contribution is $ 1 billion.

Similarly, another positive change in the industry is due to Biosimilars, a biological product made from living organisms- plant or animal cells, which has to be similar to the original biologic drug and the only difference allowed is with the non-active ingredients or components. Biosimilars have a promising future for companies manufacturing biologics, as the products are as efficient, safe and reliable in delivering results as the original biological product but at reduced costs. They are used in treatment for Inflammatory Bowel diseases, Crohn’s disease, Cancer, HIV/ AIDS, Alzheimer’s disease, Multiple Sclerosis and other serious diseases. Biocon, Dr.Reddy’s, Zydus Cadila, Wockhardt, Intas, etc. – are already active in biosimilar markets in India. The global biosimilar industry is growing rapidly with the market estimated to reach $ 20 billion by 2020 and this could emerge as a growth driver for the pharmaceutical industry.

For the companies which cannot afford investing in biologics they have another avenue which I would present is phytopharmaceuticals. Let me provide you a difference between nutraceuticals and phytopharmaceuticals. It is as follows:

Nutraceutical product is a food or fortified food product that not only supplements the diet but also assists in treating or preventing disease, so provides medical benefits. The main differentiating point between a Nutraceutical and Phytopharmaceutical is that nutraceuticals are not tested and regulated to the extent of pharmaceutical drugs. But with the advent of phytopharmaceuticals that gap is addressed.

Whereas, a Phytopharmaceutical can be defined, “As a drug that includes processed or unprocessed standardized materials derived from plants or parts thereof or combination of parts of plants, extracts or fractions thereof in a dosage form for internal or external use of human beings or animals and intended to be used for diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, but does not include administration by parenteral route”.

 

Beneficial effects in diseases

Phytopharmaceuticals are anthocyanidins, carotenoids, lycopenes, flavonoids, glucosinolates, isoflavonoids, polyphenols, omega-3 fatty acids, phytoestrogens, resveratrol, phytosterols, probiotics and terpenoids. These nutrients have specific pharmacological effects in human health and they have anti-inflammatory, anti-allergic, antioxidant, antimicrobial, antispasmodic, anti-ageing, anti-diabetic and many more therapeutic benefits and hence can be effective in diseases such as Cancers, Obesity, Hypertension, Glaucoma, Rheumatism, Diabetes, HIV/AIDS etc.

Positive aspects of Phytopharmaceuticals

These natural ingredients are more easily and more readily metabolized by the body. Therefore they may produce fewer, if any, side effects and may provide increased absorption in the blood stream resulting in more thorough and effective treatments. So, Phytopharmaceuticals will boost the innovations and development of new drugs from plants enhancing the research in drug development for various diseases. It will provide a new direction for treatment of certain diseases thereby helping the pharmaceutical industry to grow.

Indian Regulations

Ayurveda, Unani, Siddha and Homeopathy (AYUSH) are traditional Indian medicines and come under the department of AYUSH of the Indian regulations. Whereas, the phytopharmaceuticals are under the purview of the Central Drugs Standards Control Organization (CDSCO) as per the 2015 regulatory requirements. After NDA approval from CDSCO, the marketing status of the new phytopharmaceutical drug would be like that of a new chemical entity-based drug. The new regulation for phytopharmaceutical is in line with regulations in USA, China, and other countries involving scientific evaluation and data generation.

Conclusion

Phytopharmaceutical is comparatively a new industry. Due to the current turn of events and increasing awareness among consumers, preference for natural products as compared to chemical based products is increasing. The need to find cure for many diseases and increasing research and development in this area creates a growth factor for the new product pipelines. So with such scenario the question pharma companies need to address is will this be a profitable venture to step in and if yes, what are the steps they need to take to make it a successful product pipeline.

References

  • Business Monitor International, FCCI Indian Pharma Summit 2014-15, TechSci Research
  • Equity Master Report
  • http://www.business-standard.com/content/b2b-pharma/indian-companies-gearing-up-to solve-the-biosimilars-puzzle-116071200648_1.html
  • Gazette notification dated 24th October, 2013