Insight: The Biopharmaceuticals ecosystem in India and opportunities for European collaboration

1

India’s population is over one billion at present and projected to rise to 1.6 billion by 2050, web becoming the world’s most populous country. It is estimated that by 2025, illness 189 million Indians will be 60 years old. This projection indicates that the demand of pharmaceutical drugs will rise over the coming years and hence the contribution of the biopharmaceutical sector which is the largest component (about 64%) of the Indian biotechnology industry will have increasing significance towards improving life condition.

The bio-pharmaceutical sector comprises of biologics viz., vaccines, bio-similars, therapeutics, diagnostics, regenerative medicines and medical technology, and is also known for being major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across the globe. Vaccines and bio-similars which constitute the largest component of the Indian bio-pharma segment  has been creating immense opportunities in India that will take India to the next level as a hub for global biologics including their development and manufacturing.

Market Segment

The bio-pharmaceutical segment accounted for the largest share of the biotech industry, with 64 per cent of total revenues in FY13.

ebtc-insight-market-segment-of-indian-biotechnology-fy2013

Fig.1-Market Segment of Indian Biotechnology FY2013

Opportunities across Bio-Pharmaceuticals

India is now the largest producer of vaccines of which the recombinant Hepatitis B vaccine stands first with major players such as the Serum Institute, Bharat Biotech, Shanta Biotech and Panacea Biotec contributing to India’s emergence as a leading hub for vaccine manufacturing and suppliers to global institutions such as WHO and UNICEF.

The drug classes for bio-similars in India comprises of human insulin, human growth hormone, granulocyte colony stimulating factor (G-CSF), Erythropoietin, and Streptokinase. Recent estimates indicate that:

  • 20 companies in India are already developing bio-similars.
  • There are around 25 recombinant therapeutics available in India and 15 of them are manufactured within the country.
  • About 50 brands are commercialized in the country by leading companies such as Biocon, Shantha Biotechnics, Reliance Life Sciences, Wockhardt and Intas Biopharmaceuticals among others.
  • Approximately 72 recombinant drugs are currently undergoing different stages of clinical trials.

The in-vitro diagnostics market has emerged as one of the best segments in the Indian healthcare industry. Various factors such as the rising prevalence of diseases, improving affordability of patients, and increasing the penetration of health insurance has contributed substantially to spur the demand for diagnostic services in India.

Regenerative medicine or stem cell research in India is still at a nascent stage with around 40 organizations, both public and private, involved in various aspects of research and development. Public funded institutions have been supported by the Department of Biotechnology (DBT) and the Council of Scientific & Industrial Research (CSIR).

DBT, in 2009, established The Institute for Stem Cell Biology and Regenerative Medicine (inStem), which is India’s first dedicated institute for research in stem cells. Private firms in India are in the early stages of producing stem cell therapies and products while mostly dealing with umbilical cord blood banking. Home grown companies, such as Reliance Life Sciences, Stempeutics and L.V. Prasad Eye Institute (LVPEI) are at the forefront in the development of stem cell products and therapies in India. Companies such as LifeCell, StemCyte India therapeutics and Cryo Stem Cell are involved with the collection and storage of umbilical cord blood stem cells.

Medical technology primarily encompasses healthcare devices and imaging methods that aid in clinical diagnosis, monitoring and therapy for patients. The medical technology industry in India is currently the fourth largest in Asia and comprises of varied segments such as medical instruments, syringes, X-ray equipment, among many others. The Indian medical devices, diagnostics and equipment sector is growing. However, India imports 70% of all medical technology, which has a downstream affect on affordability of these technologies. Since costs are high, rural healthcare providers are unable to afford buying medical instruments.

Government Support

The Indian pharmaceutical industry is highly regulated wherein the Government controls prices of a large number of bulk drugs and formulations. India manufactures more than 96 generic group drugs, and the Indian government has framed a favorable policy to boost foreign investment in the pharmaceutical sector.

As per the World Trade Organization (WTO), from the year 2005, India granted product patent recognition to all new chemical entities (NCEs) i.e., bulk drugs developed then onwards. This introduction of the product patent regime from January 2005 leads to long-term growth for the future which mandated patent protection on both products and processes for a period of 20 years. With this favorable environment, the industry is being forced to adapt its business model to recent changes in the operating environment. From being a pure reverse engineering industry focused on the domestic market, the industry is moving towards basic research driven, export oriented global presence, providing a wide range of value added quality products and services, innovation, product life cycle management and enlarging their market reach. Old and mature categories like anti-infectives, vitamins, analgesics are slowing while new lifestyle categories such as Cardiovascular, Central Nervous System (CNS), and Anti-Diabetic are expanding at double-digit growth rates. Indian companies are putting their act together to tap the generic drugs markets in the regulated high margin markets of the developed countries.

Outsourcing in the fields of R&D and manufacturing is the next best event in the pharmaceutical industry. Spiraling costs, expiring patents, low R&D cost and market dynamics are driving MNC’s to outsource both manufacturing and research activities. India with its apt chemistry skills and low cost advantages, both in research and manufacturing coupled with skilled manpower will attract a lot of business in the days to come. The Indian Government's decision to allow 100 % FDI into the drugs and pharmaceutical industry is expected to aid the growth of contract research in the country. MNC’s in India are facing the problem of having a very high Drugs Price Control Order (DPCO) coverage, weakening their bottom lines as well as hindering their growth through the launch of new products. DPCO coverage is expected to be diluted further in the near future benefiting the MNCs.


 

Biotechnology Mission 2014 – Virtual & Physical

In this context, the European Business and Technology Centre (EBTC) in colloboration with the Council of EU Chambers of Commerce in India (CEUCCI) and EB Meeting®  will be organising a unique two level biotechnology event on ‘Synergies between India and the EU’ consisting of a virtual meeting (29th-31st October 2014) and a physical delegation (February 2015 9 TBC). The Mission will ensure that participants gain a comprehensive understanding of the Indian biotech market especially with a special focus on biopharmaceuticals opportunities.

Bringing together eminent EU and Indian biotechnology experts, the Mission provides a unique interactive platform to exchange experiences and ideas. Emerging trends, oppurtunties, facilities, policies and regulatory frameworks for smoother biotech colloborations in future will be discussed, and the core focus areas will be:

  • Biopharma special emphasis on biosimilars and generics
  • Bioservices including Contract Research and Manufacturing services (CRAMS)

Both EU and Indian biotech companies will be given a chance to showcase their technologies products and services through virtual meetings and they will be given a chance meet their business prospectives in India through a delegation visit to explore businesses in terms of collaborations, joint ventures, technology development andtransfer, as well as clinical trials covering research organisations, industries and public or private funding organisations. This event is open to any Indian and European organization, cluster, and/or individual interested in exploring the best Indian opportunities on the biotech sector.

Why should you participate in the mission? 

  • Prior to spending time and resources for a physical event, delegates can benefit from virtual meetings on a customized schedule of B2B meetings with pre-screened Indian industrial and research partners.
  • Take potential relationships further by participating in a mission to India program and engaging in face-to-face meetings with relevant Indian partners met through virtual platforms.
  • Explore the market and visit the Mumbai/Pune bio-cluster.
  • Based on your requirements, customize visits to industrial and research institutions can be organised in the region.
  • Display European technologies, products/produces, services and equipments in an exhibition area.

Click here to view the event details


 

References

  1. Contract Manufacturing in India: Is the CMO Model a Viable Business?Indian biologics manufacturers can tap into the global biologics marketby enhancing their quality image and maintaining cost competitiveness. India Today
  2. Biotechnology-Industry Recommendations to Department of Biotechnology (DBT) for the 12th Plan, A report prepared by Association of Biotechnology Led Enterprises (ABLE), July 2011.
  3. http://www.biospectrumasia.com/biospectrum/analysis/2804/biopharma-accounts-62- indian-ifjbt-industry#.UCIk6_YgdXs
  4. ABLE-BioSpectrum Survey, Volume 9, Issue 6, June 2011
  5. Alka Sharma (2006), Stem Cell research in India: Emerging Scenario and Policy Concerns. Asian Biotechnology & Development Review, Vol 8, No. 3, 43-53
  6. Medical Technology Industry in India Riding the growth curve. CII & Deloitte, July 2010 (http://www.deloitte.com/assets/Dcom-India/Local%20Assets/Documents/Medical_technology_Industry_in_India.pdf)
  7. FINPRO: Diagnostic Centre Feasibility Study in India. November 2008.
  8. Biospectrum –ABLE Survey-10 years of Indian Biotech(Top 20 Industry Insights)2012
  9. Annual Report 2013-Department of Biotechnology,Ministry of Science and Technology,Government of India

Contact the author: This email address is being protected from spambots. You need JavaScript enabled to view it. (Biotechnology Sector Specialist, EBTC)


 

Additional information