Life Sciences and Genome Valley – Promising Investment Destination

Introduction to Life Sciences Industry
The life sciences market consists of players offering pharmaceuticals, biotechnology-based food and medicines, medical equipment, biomedical technologies, nutraceuticals, cosmeceuticals, food processing, and other goods that help organisms live longer.

India's life sciences industry has played a crucial role in improving health outcomes in India and globally, supported by the country's inherent strengths in vaccine production, generic medicine development, and, more recently, biopharmaceutical development. India has secured a position among the top 12 biotech destinations in the world, ranking third in the Asia-Pacific region. Recent initiatives implemented by the government, coupled with the technological changes brought about by the private sector, have led to considerable development in the sector. Emerging markets such as India, have also increased the attractiveness of the industry due to the regulated prices of pharmaceuticals, wherein estimates are that about 20-40% of the Indian Pharma Market could potentially fall under price caps by 2024. The Genome Valley has played a critical part in the development of the life sciences industry.

Overview of Genome Valley
Genome Valley is India's first structured hub for life sciences R&D and clean manufacturing operations, with world-class infrastructure including Industrial/Knowledge Parks, Special Economic Zones (SEZs), multi-tenanted dry and wet laboratories, and incubation facilities. Located in Hyderabad, it is home to more than 200 enterprises, including well-known global brands such as Novartis, GlaxoSmithKline, Ferring Pharma, Chemo, DuPont, Ashland, United States Pharmacopeia, and Lonza, with a workforce of around 10,000 qualified people. The R&D hub, spanning an area of 25 square kilometres, provides synergistic potential for a diverse range of firms focusing on agri-biotech, clinical research management (CRM), biopharma, vaccine manufacturing, regulatory and testing, and other areas in the life sciences industry. With the Genome Valley catering to an estimated one-third of the demand for children’s vaccines globally, Hyderabad has emerged as India’s major life sciences cluster, ranking above Chennai and Bengaluru. Furthermore, the Genome Valley houses the nation’s largest animal resource and testing facility; the Life Science Zone houses corporations such as GlaxoSmithKline Pharmaceuticals and Dr. Reddy Labs. 

The Genome Valley is home to numerous firms (from around 18 nations worldwide), including India’s three largest vaccine manufacturers – Bharat Biotech, Biological E, and Indian Immunologicals. It is considered the European hub of India as it houses major European corporations such as Novartis, Sandoz, Londa, Ferring, Chemo, and GSK. The Genome Valley includes more than 2.5 million square feet of multi-tenanted laboratory space. Of this, around 500,000 square foot space was estimated to be ready by March 2021; construction of another 1.5 million square foot site is underway.

Some globally well-known entities are located in the Genome Valley, as mentioned below.

• The Genome Valley is home to the DuPont Knowledge Center, one of DuPont's seven global research facilities. Around 350 scientists work at the institution, focusing on agriculture and industrial biotechnology research.
• AMRI’s research centre is located in the Genome Valley; it is among the company’s few advanced research and development centres outside the US.
• Mylan is one of the world’s largest generics and speciality pharmaceutical firms, catering to customers across more than 140 countries. The company launched its first biologics R&D laboratory in the Genome Valley; subsequently, it expanded operations in the country.
• Ferring Pharma, a Swiss-based firm developing products in areas such as reproductive health and urology, has acquired a site to establish a centre focusing on reproductive healthcare.
• Biological E Limited, India’s first private sector biological products company, has leased pivot plants and other suites to develop pneumococcal conjugation vaccines (PCVs) and typhoid conjugation vaccines (TCVs).

Novartis operations in Genome Valley, which were commenced in 2010, serve as the corporate’s major R&D centre

Genome Valley Initiatives-

Government Initiatives
The government of Telangana in 2018 had initiated a plan that was named ‘Genome Valley 2.0’. The project was intended to be an upgraded version of the erstwhile life sciences and biotechnology cluster. It aims to evolve into an industry-led, knowledge-based ecosystem, catalyzing local economic development. The expansion would serve its purpose of gathering more global enterprises that would establish themselves in the area and thus expand their operations.

The Telangana government aims to double the valuation of the life sciences ecosystem from Rs 3.9 lakh crore (US$ 50 billion) currently to Rs. 7.8 lakh crore (US$ 100 billion), besides creating over four lakh jobs.

The government is developing Sultanpur Medical Devices Park Project with an investment of Rs. 249.9 crores (US$ 32.2 million).

A single-window mechanism has been promised in the new Industrial Policy of 2014. The Telangana State Industrial Project Approval and Self-Certification System (TS-iPASS) Act, 2014 made this possible. The Act requires all approvals and permissions to be granted within 15–30 days. It has been provided for automatic approvals based on self-certifications. The government has also introduced Right to Single Window Services for entrepreneurs.

The government offers additional support, as described below.

• Industrial Category: Life sciences has been categorised as an industrial sector to provide power at industrial tariffs for life sciences units and parks, at par with other industries.
• Industrial Area Local Authority: The major existing clusters, Genome Valley and MedTech Valley, were established as Industrial Area Local Authorities to effectively coordinate activities and address the needs of industrial units.
• Labour Concessions: Keeping in mind the knowledge-intensive industry requires a high level of operational continuity, the government has decided to relax labour restrictions related to working hours and work schedules, among others. All life sciences firms are granted general authority to operate 24 hours a day, seven days a week, in three shifts, subject to approved preventative measures implemented to guarantee the safety of employees.
• Scientific Regulatory Approvals: The State Life Sciences Council will establish a guidance cell to support and advise business units on regulatory compliance and procedures, including any adjustments.
• The government of Telangana has teamed up with Cytiva to set up a 10,000 square foot Biopharma Scale facility in the Genome Valley. The facility will provide consultancy services, professional training, and technology evaluation, infrastructure support for process development as well as support to scale up.

The government, through its various initiatives in the life sciences sector, aims to develop the infrastructure, to attract more companies. Moreover, the government plans to establish various research centres to promote development, with an objective to make the state an attractive destination for companies to invest and set up their business. Moreover, swift permits are an excellent incentive to pose as a suitable area for companies.

Investments
Hyderabad's position as a leader in the life sciences industry is expected to strengthen, and the Genome Valley is expected to remain the most popular investment destination for enterprises around the world. Genome Valley's synergistic benefits and the presence of various firms, research centres, and other entities continue to draw investments from multiple corporations. For instance, numerous investments were announced during the World Economic Forum 2022. Some companies have announced plans to make investments in the Genome Valley, as given below.

• Ferring Pharma plans to invest Rs. 500 crores (US$ 64.4 million) over the next 2–3 years to set up a facility to manufacture its product Pentasa.
• Bharat Serums and Vaccine Limited announced an investment of Rs. 200 crores (US$ 25.7 million) for manufacturing state-of-the-art injectables and vaccines, including women’s health products, rabies vaccines, immunoglobulins, and hormones.
• Chemo Pharma announced a corpus of Rs. 100 crores (US$ 12.9 million) to set up a second line in their Hyderabad facility for the production of pharmaceutical finished dosage forms. Further, the company is planning to open a new active pharmaceutical component, and an R&D centre in Hyderabad, as well as continue new product development activities in solids and injectables in the Genome Valley.
• Switzerland-based EMPE Diagnostics plans to open a global production facility with an investment of Rs. 25 crores (US$ 3.2 million).The facility will focus on the production of tuberculosis diagnostic kits with a monthly target of two million kits.

Promising Prospects for Life Sciences Sector
The Genome Valley has transformed the life sciences sector in Telangana and nationally. The project houses about 800 companies that have catalysed the sector. Developments in the sector have enabled Hyderabad to contribute one-third of the global vaccine output (i.e., 35% of India’s pharmaceutical production). Moreover, Telangana has emerged as the only state in the world to house 200+ USFDA-approved facilities. The government has been taking further steps such as developing Genome Valley 2.0 and securing investments during international meets such as the World Economic Forum. The government is planning to encourage 3-5 of the top 10 MNCs to set up their R&D centres, creating a solid surveillance platform, and developing the public health infrastructure to accelerate clinical research. The sector is expected to attract investments, with the government announcing its Vision 2030 initiative that aims to create 400,000 jobs, double the value of the sector to Rs. 7.8 lakh crore (US$ 100 billion) and provide support to the sector to emerge as the leading life-sciences hub in Asia.