December 2016

All Set for Great Future

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Dr Suresh Jadhav
utive Director, Serum Institute of India Pvt Ltd

The rising level of public awareness on preventive healthcare, governmental push for maximum vaccination coverage, rise in public and private healthcare expenditures and a strong growth in the market for adult vaccines are expected to propel the Indian vaccine market to grow at a CAGR of over 15 per cent in coming years, says Dr Suresh Jadhav, utive Director, Serum Institute of India Pvt Ltd, in an exclusive interview with Elets News Network (ENN).

How do you see the Indian vaccine market evolving in recent times? Where does the country stand today?

The Indian vaccine industry began as a network of state-owned manufacturers supplying basic childhood vaccines to the national immunisation programme. In recent decades, the number of privately owned firms active in the sector has grown rapidly.

Their success in brining lowcost vaccine solutions to the market is an important driver behind the emergence of the sector. As the industry is becoming more sophisticated, the focus on innovation is increasing. Across the industry, a dozen or so new vaccines are in clinical development. Disease areas covered includes rotavirus, Japanese encephalitis, typhoid, malaria, rabies, pneumonia, HPV and influenza. Many more projects are at early stages of development, including those related to dengue, chikungunya and cholera.

On supply side, presently the Indian vaccine industry has recognised itself as a global health supplier. Majority of manufacturers from India export their vaccines to UN agencies. Most of the manufacturers are WHO prequalified for such supplies.

So far the growth of domestic vaccine market is concerned, the recent governmental push on vaccination and setting up of health goals are the key drivers. The current government has taken good initiativesfor introduction of rotavirus, measles rubella and pneumococcal vaccines in EPI schedules. These vaccines are relatively costly but will boost the domestic market significantly.

Public awareness on vaccination has increased considerably over the years. We also observe the urban population opting for vaccinations for flu, pneumococcal and HPV for their children.

The major factors driving growth of the Indian vaccine market include globally accepted and recognised national regulatory authority, skilled manpower, ease of access by patients, awareness on healthy lifestyle, growing population and new technological advancement in the field of immunology/vaccinology.

Other factors include high prence of diseases, rising government and non-government funding for vaccine development, increasing investments by companies, and increasing focus on immunisation programmes.

Many new vaccines have found their target among adolescents and adults. The pediatrics segment accounts for the largest share of the global vaccines market in 2016. Increasing prence of diseases in adults and increasing costs of health care will promote vaccination in adults and likely to drive growth of future market.

Which policy initiatives you believe are important to boost the vaccine sector?

Despite its recent growth, the Indian vaccine industry still has a number of challenges to address. The market remains small (currently accounts for less than 2 per cent of the global market) and underpenetrated compared to the developed countries. India also lags behind its global peers in terms of vaccine coverage with a significant number vaccine preventable deaths still occurring in the country.

Nevertheless, despite these challenges the situation appears bright for vaccine manufacturers, especially because of the push from Prime Minister Narendra Modi himself. The country sees around 28 million births each year. This coupled with the sustained growth of the Indian economy, a consequent rise in public and private healthcare expenditures and a strong growth in the market for adult vaccines is expected to propel the Indian vaccine market to grow at a CAGR of over 15 per cent in the coming years.

The global vaccines market is expected to reach $48.03 billion by 2021 from $32.24 billion in 2016 at a CAGR of 8.3 per cent from 2016 to 2021.

The key policy initiatives are important in the following areas:

Vaccine regulations and approvals

Clear global policy on vaccine requirement and newer vaccines required for the country

Focus on skilled manpower, designing special courses and training centres for vaccinology

Promote and help development of contract manufacturing and analytical facilities in the country

Develop a robust supply pipeline for delivery of vaccines to remotest areas of the country

Funding for research and development of newer vaccines

Promote ease of doing business and export of vaccines to other world

What are the key innovations happening in the sector? How modern technology is aiding them?

Vaccines have traditionally been used for the prevention of infectious diseases. To date, vaccines have been developed for approximately 20 viral and bacterial diseases. While most of these vaccines are for vaccinepreventable diseases in children, in recent years manufacturershave introduced vaccines targeting age segments such as the elderly (Sanofis high dose influenza vaccine and Mercks shingles vaccine), and adolescents (conjugated meningococcal vaccines).

In addition to infectious diseases, research and development targets for vaccines continue to expand to address unmet needs, with products in early stage development for targets such as HIV and Alzheimers disease, and auto-immune diseases.

Vaccine innovation is particularly active in oncology with promising leads for ovarian, breast, prostate and lung cancers. Merck and GSK have HPV vaccines on the market, and many manufacturers are now focusing on therapeutic vaccines. There are currently over 130 oncology therapeutic vaccines in the pipeline.

Newer technologies and enhanced scientific knowledge are enabling companies to differentiate traditionally commoditised products.

Vaccine manufacturers are exploring a variety of technological advances to make better products, improve the manufacturing process and drive down costs.

Research is being conducted to make vaccines stable at room temperature, which would make products easier to transport and store, especially in developing countries. For example, the NIH is funding research on the development of a silk-based stabiliser to keep vaccines stable at temperatures up to 140°F (60°C).

New vaccine delivery mechanisms are also being explored. For example, nanoparticle delivery technology for infectious diseases such as HIV and malaria. Certain new production and manufacturing processes hope to address patient needs such as egg allergy (Novartiss cell-based influenza vaccine) and needle phobia, as some of the needle-free delivery systems are already licensed in the US and also approved by WHO for mass vaccination.

In addition, numerous opportunities exist in improving the performance of current vaccines considered to have sub-optimal efficacy or safety profiles.

Please tell our readers the key divers of growth for Indian vaccine sector?

Large birth cohort
Relatively low cost of manufacturing
Skilled Manpower
Advancement in Science and Technology
Global Access to Technology
Large population
Prime-Ministers Make in India Initiative.

What are the opportunities and challenges for young entrepreneurs and start-ups in the vaccine industry (Vaccines & Biosimilars)?

The Indian biotech sector may be seen to comprise of five segments biopharma, bioservices, bioagriculture, bioindustrial and bioinformatics. Of these, biopharma continues to be the largest with 60per cent of the total market share. We have seen a significant growth in biopharma sector in the last decade. The biopharma sector is capital intensive and requires large amount of investment for product development. However, sectors like bioservices and bioinformatics are service oriented sectors. These sectors will be important targets for start-ups and promotion of entrepreneurships.

How Indian pharma companies like yours ensure that your products meet the highest global standards to compete in the world market?

The company ensures products of highest quality by following best in class technology and infrastructure, investing in best talent and skilled manpower and continued focus on the training of human resource in manufacturing and testing of vaccines. We are able to implement the latest technologies because our company philosophy from the very beginning is to develop indigenous processes and products, which gave us competitive edge by employingmodern, efficient manufacturing technologies. The companies have also invested heavily on continual improvement of these processes in accordance with current and global trends in good manufacturing practices, by having International collaboration, tech transfers, with reputed research institutes.

Which are the key global markets you see hold potential for the Indian vaccine sector to grow?

Consolidation is one big trend right now. Its being seen across the developed pharma and biopharma industries because of cost pressures and the need to be more efficient. In the vaccines area, weve seen major deals such as GlaxoSmithKlines acquisition of Novartis global vaccines business, which took place earlier this year. Due to this consolidation, in Europe and US markets (so called developed world markets) vaccine supplies are dominated by 2-3 vaccine manufactures. Therefore, these countries are always at risk, if supplies by these lead vaccine manufacturers gets affected. Large vaccine manufacturers based in Europe and North America are also seeing increased competition from developing markets. More and more companies in Asia and Latin America are setting up their own domestic vaccine production as well acquiring newer companies.

Similarly, there is a huge market in those developing countries which do not have vaccine manufacturing capabilities and are serviced by either UNICEF or PAHO. In addition, there is a big cohort of middle income and low-middle income countries with no manufacturing capacity and they probably present new market opportunities for Indian vaccine players. We strongly believe that these markets hold potential for emerging Indian vaccine manufacturers.

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