CARE Ratings expects India's pharma segment to develop at an annual rate of roughly 11% over the next two years, reaching a value of more than $60 billion. With rising share in the global marketplace, the Indian pharma industry has evolved to become the 3rd largest in the world.
By demonstrating strength and devotion amidst the disruption caused by the pandemic, the pharmaceutical sector not only exhibited its capacity to offer appropriate medications, but also made important contributions to other areas such as sanitation, preventative healthcare, and quarantine facilities. India has been a leading player globally when it comes to generic drugs, but has failed to move up in the value chain of innovative drugs. However, this situation is increasingly changing.
Today, leading Indian pharmaceutical firms are planning to increase their research spending over the next five years, as the country's pharmaceutical sector is expected to grow to $130 billion in 10 years, states Business Standard. In recent years, the pharmaceutical business has shifted from relying on reverse engineering—low-knowledge medications—to R&D-based pharmaceuticals supported by high-knowledge chemicals.
Also, India's Big pharma players have already started working on new drugs in the lab. Dr. Reddy's Laboratories (DRL) chairman Satish Reddy stated that the clinic has 13 products. Reddy felt that new technologies will play a major role in determining the way forward. Having said that, in this article let's understand the key areas Indian pharma are going to focus on for R&D.
Formulation of NCEs & NBEs
Leading international pharmaceutical companies are concentrating their efforts on the NCEs & NBEs. With the goal of introducing new innovative molecules, Indian firms are beginning to strengthen their in-house unique medication research.
The development of NCEs and NBEs pits Indian enterprises against global innovators. Large Indian pharmaceutical corporations including Zydus, Glenmark, and Sun, as well as clinical research organizations (CROs) and contract development and manufacturing organizations (CDMOs), are already working on novel medication development, mentions a report titled Indian Pharmaceutical Industry 2021. In 2013, Zydus became the first Indian business to market Lipaglyn (saroglitazar), the world's first glitazar medication for diabetic dyslipidemia or hypertriglyceridemia in Type 2 diabetes that is ndot managed by statins alone. In the United States, Lipaglyn is in the second phase of development and is scheduled to be approved in 2027.
Biocon was the first business in India to commercialize innovative biologics produced in-house. In 2006, the business released BIOMab EGFR for the treatment of head and neck cancer, and Alzumab (itolizumab) for the treatment of psoriasis in 2013. In conjunction with worldwide corporations, both of these innovative monoclonal antibodies have been commercialized in a number of countries.
Development of APIs
During the pandemic, India's pharma sector nearly collapsed due to its over-reliance on China for API outsourcing.Recognizing the importance of API manufacturing and R&D, the Indian government has also launched two Product Linked Incentive (PLI) schemes – PLI 1.0 (in 2020) and PLI 2.0 (in early 2021) – in the hopes of making the Indian pharmaceutical industry more robust and self-reliant in terms of APIs and other key starting materials (KSMs).
Although, India has earned a name for itself by developing at least 16 new synthetic active medicinal compounds (APIs). However, when compared to the total number of APIs created worldwide, this figure is insignificant. According to a study titled Novel active pharmaceutical ingredients in India, more than 5000 APIs have been developed globally, with roughly 3000 of them being used to treat human illnesses.
Out of which there are around 2200 APIs in use in India. India has made a mark in the supply of branded generic and generic formulations for use in the country and abroad in an environment of cut-throat competition. To maintain and improve the mark, India needs to carry out R&D not only for process innovation but would also have to invest and invent novel APIs.
Leveling up the Complex Generics Segment
According to the Indian Pharmaceutical Industry 2021, Complex generics hold great potential to drive future market growth. The study also stated that as complex generics are difficult to develop, there is limited competition in this space and hence, they offer higher margins.
This in turn will bring new opportunities for the top Indian companies such as Dr. Reddy’s, Zydus, Glenmark, Aurobindo, Torrent, Strides, Lupin, Cipla, Sun, etc. India will give much impetus to developing complex generics. Hence in the coming days, the country’s R&D segment will witness much boost to develop the complex generics indigenously.
The Future Map
The pandemic has taught the pharmaceutical industry how to utilize capabilities in times of need and importantly turned the attention towards the increasing need for R&D efforts and innovation. The pharma industry is already a well-established presence globally and it just needs to increase its efficiency in affordable yet innovative products which cater to the needs of patients worldwide. Apart from R&D, the other key drivers will be innovation funding, continuous regulatory reforms, and infrastructure and industry-academia collaboration.
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