5 minute read
PUSHPA VIJAYARAGHAVAN
DIRECTOR, SATHGURU MANAGEMENT CONSULTANTS PVT. LTD. STRONG FOUNDATION
Industry rests on a foundation of sustainable scale and is now embarking on a journey of transformation
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The most poignant “Make in India” success story, the Indian pharma industry has truly embodied the possibility of global impact with Indian manufacturing. The industry rests on a foundation of sustainable scale and has expanded access to quality drugs across the world and is now embarking on a journey of transformation to replicate this success across next-generation drugs and healthcare solutions.
Scale with a foundation of quality and research
With leading Indian research institutions such as IICT Hyderabad, NCL Pune and ICT Mumbai providing early support on process development for high volume production of chemicals with application in global pharma, the industry forged a presence across the value chain. While India is no longer a leading API exporter to the world, route code chemistry and competitive API production still power the large base of backward integrated pharma companies at the forefront of the country’s formidable growth story in generics. Our analysis points to leading Indian pharma companies enjoying backward integration into API for ~ 70 to 80 per cent of their ANDA portfolio compared to an average of ~40 per cent for global counterparts with comparable scale. Of the 616 Drug Master Files filed with USFDA in 2019, Indian companies contributed to more than 50 per cent (~331). The vertically integrated presence has powered not only cost competitiveness in global markets but also the overall engine of product development. Timely access to in-house developed APIs has also implied high participation in first-time generics. Similar to our contribution to total ANDA filings, our overall contribution to first-time generics (FTGs) has also remained at the 30 per cent threshold. This has been a driver of economic value given the relatively lower level of competition in FTGs and participation at the beginning of the price erosion curve. This high contribution to FTGs has also been a strong enabler of access to drugs due to enhanced affordability. Several of these FTGs have included complex chemistry as well as para IV filings with non-infringing claims or patent invalidation. Industry’s capability around both API route code chemistry and complex formulations have progressively expanded to enable India to today stand tall as the largest supplier of pharmaceutical drugs to highly regulated US and EU markets.
Extending global health priorities
India’s impact on expanding access to medicines and delivering on the promise of affordability is apparent in the most regulated markets of the world. It is also apparent at the other end – global public health. Akin to what Indian vaccine companies have achieved on enabling access to routine immunisation for all children in low and middle-income countries (LMIC) with an aggregate capacity of
WHO prequalified manufacturing exceeding a billion doses, Indian pharma companies have played a critical role in the global fight against HIV as well as viral hepatitis. While the global supply footprint of antiretroviral drugs for HIV treatment is relatively more discussed and known globally, the impact on novel anti-viral used for the treatment of Hepatitis B and Hepatitis C infections is often under-appreciated. In 2014, Gilead voluntarily licensed
its novel drug for Hepatitis C, Sovaldi, to seven India based generic drug manufacturers (including Indian companies such as Cipla and multinationals such as Mylan with manufacturing operations in India). With access to 91 LMIC countries, this consortium of generic manufacturers has leveraged India’s cost competitiveness to enable access to the drug for about 150 million people in the world living with viral hepatitis. Erst-
while price benchmark of US $30,000 for the 28 tablet course now pales before the $300 price benchmark set by Indian manufacturers. While the price rationalisation has been far-reaching in impact, access would have still been a mirage if adoption in public markets would have been elusive. In 2018, we witnessed the celebration-worthy milestone of the Indian government launching the National Viral Hepatitis Control program covering 5 crore people living with chronic Hepatitis B and C in India. Without the preceding possibility of price rationalisation of the novel antiviral drugs, this National Control Program would not have been practically possible. Impact in India is most emphatic as it is on its home turf. The same possibility is now created across 91 LMIC countries.
Embracing delivery innovation
On the foundation of formulation and chemistry capability, delivery innovation is now the next layer of expertise that is powering the potential of the Indian pharma industry. From a portfolio comprising largely of vanilla generics a decade ago, the industry has now embraced breadth that spans transdermal formulations, depot formulations of peptides and biologicals delivered through selfadministration pens, inhalation drugs, ophthalmic implants and vaginal rings. While the strength of delivery innovation has not been a historical focus, it is being rapidly pursued through multiple strategic approaches – acquisition of technologies, in-licensing and strategic partnerships and finally organic development of in-house expertise in offshore teams across the US and Europe. With an evolving ecosystem of device developers now actively pursuing the bastion of Indian pharma companies, several codeveloped device innovations are spurring the robust pipeline of drug-device combinations being advanced through the development and approval process. Notable examples include Zydus Cadila leveraging its 2012 acquisition of Hercon Pharmaceuticals to now pursue a globally energized pipeline of transdermal drugs and Glenmark partnering with Texas-based Evestra to develop generic to Nuvaring, Merck’s contraceptive drug formulated as an intra-vaginal ring.
Simultaneously with the breadth of delivery expertise, the industry is also embracing the higher risk expanded engagement across the spectrum of peptides, biologicals and vaccines. With more than ten Indian companies having a peptide pipeline, Indian manufacturers are now emerging as a potential global source of next-generation diabetes drugs such GLP-1 agonists produced through chemical synthesis (SPSS) as well as recombinant routes. Again, the lead pipeline candidates across several companies are generic liraglutide, a product that calls for device innovation for realizing commercial value in global markets.
The current threshold of scale closing in the US $40 billion thresholds is built on chemistry synthesis and formulation strength. While this will remain as a core competitiveness driver, current investment in accretive layers of innovation-driven competitiveness shall propel the industry to the next sphere of growth and global influence.
