Page 8 - Pharma Darpan August 2021 Anniversary Issue

EXPERT REVIEW Volume -II Issue -1 August-2021

NAVITAS 2021: The Annual Festival
Pharma Outlook 2030- Unlocking India’s Potential For Future Innovation

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The Indian pharmaceutical industry is the world’s third largest of drugs by volume . The Industry’s
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journey to annual revenues of about USD 38 billion today can be attributed to world-class
capabilities in formulation development, the entrepreneurial ability of the firms and the vision of
the industry to establish India’s footprint in large international markets such as the United States.
The Indian pharmaceutical industry’s positioning in the world order, define India’s ambition by
2030 and identify a set of imperatives for all stakeholders to realize this ambition. The
pharmaceutical industry, along with the healthcare sector globally, has been impacted in an
unseen way due to the outbreak of the COVID-19 pandemic leading to material impact around
consumer requirements and preferences accompanied by macroeconomic, structural and
microeconomic changes in the end-to-end value chain. Mr. Vikrant V. Chadawar
In the midst of the pandemic and a changed world, the pharmaceutical industry across the world
has responded with agility — from the sequencing of the novel coronavirus in January to vaccines Sr. Technical Account Specialist-
TCS, West Pharmaceutical
being administered to the first recipient in the United Kingdom by December 2020, with efficacy Packaging India Pvt. Ltd.
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levels over 90%, exceeding all expectations of governments and markets across the world .
In the 2020-2030 period, we expect Indian pharma industry to grow at a compounded annual growth rate (CAGR) of ~12% to reach at
US$130 bn by 2030 from US$41.7 bn in 2020. Though the pharmaceutical industry has grown at a CAGR of approx. 13% over the two
decades, in the last decade, the CAGR has been ~ 8.5% and it has currently been ~6.2% over the past five years. In order to attain self-
sufficiency and be the real pharmacy of the world, we need to refocus on the next set of avenues to feed the growth engine of this
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industry, which is of strategic as well as economic significance .
Opportunities for Indian pharmaceutical industry: Indian companies are involved in the following R&D models and have developed
globally competitive expertise in following few areas such as,
Generics: R&D in generics has been a traditional focus area for most India-based pharma companies. India’s dominant share in the
overall ANDA approvals and first-time ANDA approvals by the USFDA is a good reflection of the country’s strength in the global generics
market. Indian companies received over 35% of total ANDA approvals between 2010 to 2019 (2,046 of the total 5,768 ANDA
approvals)4 The generics market remains lucrative globally. It is driven by increased push in the US to prescribe generics to contain
healthcare costs. The share of generic drugs in the US’s total prescription volume has increased from 72% in 2008 to 90% in 2017,
driven by loss of exclusivity of patented products in the past decade. Further looming patent expiries will provide a continuing driver for
market growth. Drugs worth US$83b have lost patent protection between 2013 to 2017, and another US$72b worth of small molecule
drugs will go off-patent from 2018 to 20225. The rise in competition and consolidation among distributors in the US over the last few
years have resulted in price erosion for generic drugs. While Indian companies should continue to maintain their strong position in the
global generics market, they can’t rely on basic generics exclusively to ensure future growth.
Complex generics :Focusing on more complex products represents an emerging model for Indian pharma companies, with the
potential to bring sustained long-term growth for the sector. Complex generics hold great potential to drive future market growth. They
involve more difficult production processes and therefore face less competition, compared to simple generics. Simple generics constitute
only ~20% of the total US generics market by value. Complex generics approvals constituted 12% of total USFDA4 generics in 2018,
and 11% of approvals in 2019. The USFDA has started new initiatives to further facilitate availability of complex generic drug products
and to assist the generic pharmaceutical industry in identifying the most appropriate methodology for developing complex drugs.
Biosimilars: The global biosimilars market size was reported to be US$11.8 billion in 2020 and is estimated to reach US$35.7 billion by
2025 growing at a CAGR of 24.7%7 . The industry has come a long way since the first approval of a biosimilar in Europe in 2006
(Omnitrope from Sandoz/Novartis – a biosimilar version of the human growth hormone somatropin) and in the US in 2015 (Zarxio from
Sandoz/Novartis – a biosimilar version of the granulocyte colony-stimulating factor filgrastim)8. While the initial uptake was slow in both
the geographies, increase in the number of approvals in the last five years indicates a positive trend towards the acceptance of
biosimilars. Indeed, about 65% of all biosimilars approved in the US gained their approval between 2018 to 2019, while 58% of
biosimilars in Europe were approved between 2017 to 20199
According to a recent report from Biotechnology Industry Research Assistance Council (BIRAC), more than 52 Indian companies collectively
now have over 200 biosimilars in pipeline10. Despite the largest number of approved biosimilars in India, very few Indian companies have
been able to penetrate the US and European markets, which is partially because India’s regulatory guidelines are not sufficiently aligned with
the guidelines in these markets.

https://aptimumbai.blogspot.com ASSOCIATION OF PHARMACEUTICAL TEACHERS OF INDIA MUMBAI-REGION 6