Success story of the pharma industry in India – is it the time to pivot?
The Indian pharmaceutical industry, valued at around $50 billion, is expected to reach $130 billion by 2030, growing at a Compound Annual Growth Rate of 10.7%. Performing as per its tag as the ‘Pharmacy of the World’, India today is the largest producer of vaccines in the world, contributing 60% to the world’s supply of vaccines and the largest exporter of generic medicines, supplying to over 200 countries.
The Indian pharma industry is relatively young and the credit for this success goes to the dedication, vision and foresight of the founders of leading Indian pharma companies, Dilip Shanghvi (Sun Pharma), K Anji Reddy (Dr. Reddy’s Laboratories), Dr. Desh Bandhu Gupta ‘(Lupin), Dr. Y K Hameid (Cipla), Dr. Habil Khorakiwala (Wockhardt), Dr. Shaw (Biocon), Dr. Poonawala (Serum Institute), and Dr. Krishna Ella (Bharat Biotech), to name a few.
The authors of this article consider themselves fortunate for the opportunity to work with such leaders. This experience has provided us valuable insights in their profound understanding of the pharma business, and an appreciation for their commitment to ensure the availability, accessibility and affordability of high-quality medicines to patients across the world.
As per the 2020-21 Annual Report of the Indian Ministry of Health and Family Welfare, the Indian pharmaceutical industry is the world’s 3rd largest by volume and 14th largest in terms of value. This mismatch between volume and value, where the latter being just a small fraction of the global pharma value, is due to the fact that the success of Indian pharma companies is primarily based on the development of generic drugs. The Achilles heel of Indian pharma is a lack of innovative drugs from India.
To the best of our understanding, by Indian pharma companies, only one innovative drug is approved in the USA through 505(b)(1) regulatory path. Nonetheless, few drugs with incremental innovation are approved through 505(b)(2) regulatory pathway in the USA as well as approved and marketed in India.
One of the reasons cited for the lack of breakthrough innovative drugs from India is the extremely high cost of bringing a new drug to the market, $1.3 to $2.5 billion, with clinical development accounting for 50- 58% of the total cost. However, much of big pharma’s R&D is directed at extending the franchises of existing drugs through line extensions and an extensive spend on the launch plan.
Further, it is also notable that sources of innovation are shifting to small size companies with 80% of total pipeline projects from discovery to filing being from Emerging Biopharma (EBP). EBP is defined as companies that spend less than $200 million annually on R&D or have less than $500 million in global revenues, thus emphasizing the importance of pragmatic approaches to increase R&D productivity.
Dr. Sumith Kularatne1, Executive VP, On Target Laboratories (USA) says, “While biotech is experiencing a challenging time during these market fluctuations, innovation keeps us more optimistic about the outlook of the businesses.
Moreover, larger pharmaceutical companies still heavily rely on biotech as a source of innovation. Innovation of a biotech comprises of R&D strategies and management capabilities. Attracting and retaining experienced talent, outsourcing models, co-development, partnering, joint venture, and offshoring can be considered as R&D strategies. On the other hand, R&D managerial capabilities are relied on openness for technological evolution and strategic cognition such as handling complexities (i.e., investors, funding, competitors, etc.)”.
Dr. Amit Biswas2, Pharma R&D Management Advisor says, “Despite having a large pool of scientists and researchers, Indian Pharma is faced with a shortage of cutting edge, skilled professionals in the field of drug discovery and development. India has the potential to create a vibrant Pharma Innovation Ecosystem, wherein the pharma industry, academia and publicly funded research institutes come together to foster innovation, collaboration and creation of skilled manpower.
By working together, they can ensure that the brightest minds are contributing to the global growth and success of the Indian pharma industry, starting from drug discovery and development to advanced drug manufacturing.”
Innovative product development, both breakthrough and incremental innovation will be growth drivers for Indian pharma in coming years. Indian pharma has made significant progress in complex generics and few biosimilars are also approved.
Indian ecosystem offers a unique advantage for conducting clinical trials for complex generics. India and neighboring regions have cost effective and efficient clinical sites with a strong track record of valuable contributions to the clinical trials.
CLINEXEL, a full-service Clinical Research Organization (CRO), was founded with the vision of making the best use of these advantages offered by the local ecosystem to support small and mid-size pharma companies in providing time efficient, high quality and cost-effective clinical development solutions. CLINEXEL is supporting 6 NCE programs in oncology, infections, respiratory and kidney disease indications.
CLINEXEL has deep expertise and good experience in supporting start-ups and small biotech companies in their global clinical development programs. Additionally, CLINEXEL has a strong network across the United States, Europe and emerging economies to support global clinical trials.
Using levers of optimization can significantly reduce the cost of clinical trials, clinical development, hence, overall drug development. There are many real case studies, including some clinical programs supported by CLINEXEL, wherein multiple levers have been successfully used, e.g., clinic regulatory negotiations (Pre-IND, scientific advice), efficient clinical study design, selection of low-cost clinical trial sites providing high quality data and building operational efficiencies.
The value of involving qualified and experienced clinical research professionals, deep diligence and continued conversation with regulatory agencies is immense in achieving efficiency and effectiveness in the early phase and pivotal clinical trials. These principles also apply to post approval studies to maximize the value of the product by using abbreviated pathways for products with incremental innovation.
Therefore, the success of new drug development significantly depends on the successful collaboration of a pharma/ discovery company with an expert CRO with a strong understanding, expertise and experience of conducting clinical trials for innovative therapies.
The Govt. of India also recognizes this need for the development and global approval of innovative drugs by Indian pharma and intends to support Indian pharma industry with focus on “Make in India” and launch of several grants and funding schemes. It appears that the right time for Indian pharma to pivot to innovation and new drug development to fuel an exemplary growth of the industry has finally arrived.
Some of the factors that can contribute to this are the paradigm shift in Pharma R&D, successful regulatory approvals of new drugs with efficient clinical trial strategies at a global level, favorable legislation and regulations in India supporting innovation.
To achieve this, adoption of an optimized clinical development model that leverages the advantages offered by Indian clinical trial ecosystem is needed. This objective can be realized by partnering with an experienced clinical research organization, such as CLINEXEL, which possesses comprehensive understanding of Indian strengths, deep understanding of global drug development with well-established international networks.
About Authors:
- Dr. Kularatne has pioneering experience in drug design and development of small molecules and antibody-drug conjugates. Trained at The Scripps Research Institute and at Purdue University, Dr. Kularatne’s scientific efforts have resulted in 3 FDA-approved drugs, 8 drug candidates in human clinical trials, over 250 US and foreign-issued/pending patents, as well as over 100 scientific publications. (Sumith Kularatne | LinkedIn)
- Dr. Amit Biswas has more than 35 years of diverse and rich global experience, spanning academic and industrial research, product & process development, technical service, leadership coaching and management of research & technology in the areas of pharmaceuticals, engineering polymers and plastics, high performance fibers, coatings, catalysts and chemicals. He held R&D leadership positions in multi-national companies like DuPont, ICI, GE, Reliance Industries and Dr. Reddy’s Laboratories (Amit Biswas | LinkedIn)
- Dr. Desai has over 36 years of Leadership experience in Quality and worked as Head of Corporate Quality Management at Lupin, Dr Reddy’s, Mylan, Alembic, Orchid and Dishman. He worked extensively in Quality Management, Basic Research, Process Development, Analytical development, Project management, Technology Transfers and Automation programs. He has worked in India, Switzerland, and China. Collaborated with companies in several geographies around the world Experience and involvement in Regulatory inspections by USFDA, MHRA, EDQM, WHO, PMDA, ANVISA, COFEPRIS, TGA, Kosher and ISO certifications. He is a member of Indian Pharmacopoeia Expert committee and an advisor at IPA, working on several guideline publications, seminars, and workshops as a key representative of the Pharmaceutical Industry with the regulatory agencies and Govt of India, Science and Technology departments. He is nominated by the Ministry of Chemicals and Fertilizers, Dept. of Pharmaceuticals, Govt of India as member of Board of Governors for the NIPER. (Dr Rajiv Desai | LinkedIn)
- Dr. Deepa is a physician with 20+ years of industry experience in leadership positions with pharma companies in Clinical Research and Pharmacovigilance. Her experience includes development and execution of clinical development strategy and clinical operations for NCEs, biosimilars, vaccines, complex generics and repurposed drugs. Dr Arora has led successful technical discussions with regulatory agencies, USFDA, EMA, MHRA, MEB, Health Canada, WHO, TGA for scientific advice, Pre-IND meetings, end of phase meetings to discuss clinical development path, clinical trial designs and post marketing commitments including PMS/ Phase IV studies and PIPs. Her experience includes early phase development in Oncology, infection, CNS, CVS, Respiratory, Diabetes, infectious diseases, and rare disorders. She is a well-known leader in the field of Clinical Research and Pharmacovigilance and held leadership positions in multinational Pharma companies and International CROs. (Dr Deepa Arora MBBS, MD | LinkedIn)
