Vildagliptin

New Delhi: From being in the backwaters of the global drug market to surpassing the $50 billion mark, with nearly 50 per cent of that coming from exports , the Indian pharmaceutical industry has truly materialised the outcome foreseen by the leaders in 1991 and now is further aspiring to hit the $130 billion mark by 2030. Though the industry might have the potential to achieve such heightened figures, meeting the self-stipulated deadline can be a daunting task given the context that majority of domestic players operate in generics segment where growth is more steady and remains heavily dependent on chinese API imports whereas, the x factors, particularly novel patented drugs, still lie in the warehouses of MNCs whose availability and affordability is an excruciating struggle for a vast range of Indian consumers. So is the anticipation of $130 just a quixotic pipe dream or is it a concrete reality and is the Indian pharmaceutical industry on the right track to achieve this by 2030? To discuss this pertinent question and obtain a better holistic outlook along with possible challenges ETPharma organised a webinar where Industry stalwarts including Dr SV Veeramani, Chairman, Pharmexcil; Sudarshan Jain, Secretary General, IPA; Sheetal Sapale, Vice President Commercial, Pharmarack; Parag Swadia, Chief Executive Officer, Otsuka Pharmaceutical India and the discussion was co-moderated by Vikas Dandekar, Editor ETPharma and Rashmi Mabiyan Kaur, Principal Correspondent, ETPharma. Reflecting upon some of the key takeaways from 2024, Sheetal Sapale, Vice President Commercial, of market research firm, Pharmarack highlighted that, though the industry has not experienced a double digit grown but it has a growth in the range of 8-10 per cent and the top ten therapy segments which represent 90 per cent of the market have also grown at modest rate during the year.” “The Cosmoderma segment has performed well, and the rising adoption and demand for biosimilars and semaglutide (an anti-obesity drug) further suggest a positive outlook. However, considering the expanding base, the market may not witness double-digit growth figures,” she added. Elaborating on this, IPA Secretary General Sudarshan Jain emphasised that among the key areas the industry needs to focus on are maintaining its commitment to quality, innovation, and global reach. He voiced that the revision of Schedule M guidelines, the outcomes of the PLI scheme, the establishment of a penicillin manufacturing plant, and collaborations with foreign players are promising steps in the right direction. As the PLI scheme approaches its deadline, with discussions ongoing in top policy circles about a possible extension in the upcoming budget, for achieving a better relative outcome, Dr. SV Veeramani, Chairman of Pharmexcil (Pharmaceuticals Export Promotion Council of India), shared that while the PLI (Production Linked Incentive) scheme has largely been welcomed by the industry, the main issue lies in price adjustments in line with China , as this arrangement is not profitable for the bulk drug industry in India. “To overcome this the industry has recommended to levy a minimum import duty on Chinese products. Additionally, there is a need to extend the scope of the scheme to include APIs and key starting materials (KSMs) for which the industry is heavily dependent on Chinese imports. Secondly, government can introduce incentives for formulators for sourcing their APIs from domestic companies in order to balance the pricing advantage of Chinese firms,” Dr Veeramani said. Commenting over the role of MNCs Parag Swadia, Chief Executive Officer, of Otsuka Pharmaceutical India, shared that, “The Indian Pharmaceutical Market (IPM) is miniscule and represents only 3-4 per cent of the $1.5 trillion valued global market. However, in terms of volume, it holds a significant share, ranking third globally and with growing awareness among the consumers (patients) MNCs are increasingly focusing on the Indian market, and they are expected to intensify their manufacturing efforts in the country. Furthermore, over the next two decades, patent cliffs worth around $250 billion are anticipated, which will provide a major boost to MNCs.” For achieving the $130 billion mark, Jain, underlined that currently it is operating at 8-9 per cent (CAGR) growth rate and to achieve that, the market needs to grow at a rate of of 13-14 per cent for which we need to focus on our innovation pipeline, shift from small molecules to large molecules, upgrade our exports and increase the penetration of domestic products in rural markets.” Over the possible changes of reaching these figures, Sapale, echoed that, “over the past few years, instead of doubling, the market has grown by 22X (in certain therapy segments). However, this spike has not solely been driven by an increase in the number of patients, but rather by the growing adoption of medications, including the rising penetration of telemedicine and teleconsultations, particularly in rural areas during the Covid pandemic.” “Additionally, at present 50 per cent of the total population falls in the 20-60 age group, which is highly prone to lifestyle diseases. As a result, we are likely to see positive growth in the near future. While it may not be exponential, the upcoming patent cliffs will lead to the availability of more affordable medications, as seen with innovative molecules like sitagliptin, vildagliptin, and others,” she anticipates. With respect to leveraging global innovations like Cell and Gene Therapies, (CGTs) Jain commented that this is all early science but going forward some of the leading companies will like to upgrade their portfolios by adding biosimilars, CAR-T cell therapies and including specialised products for the US market.” “Innovations like AI and cloud computing are widely used in fast-tracking clinical trials, with one notable example being the Moderna vaccine. However, with respect to IPM a major challenge lies in the compatibility of these technologies with existing data platforms, and it will take some time to address these integration issues,” Swadia added. Replying to a query on whether Indian companies will go for large scale acquisitions in the coming years, Sapale stated, Indian companies have realised that collectively they can make most of the market as we already see a lot of mergers and divestments taking place. Future partnerships are going to pick up really well especially those driven by operational excellence of each interested partner. One of the major roadblocks which still impacts Indian pharmaceutical exports is the quality aspect and for achieving an expansion of around 58 per cent ($55 billion to $130 billion) in the next five years it is likely to play a key role. Simplifying this point, Dr Veeramani stressed that, from the quality aspect there isn’t much to worry on a larger outlook because Indian companies are conscious of the quality aspect as data suggest that 50 per cent of our (Indian Pharma) exports are to the most stringent regulated markets– 30 to the US and 20 to Europe respectively and it is growing further at a rate of 15 per cent (US) and 17 per cent (UK). In addition to this, he added on the part of the regulator, CDSCO has given grace period ( six months till December 2024) to small manufacturers (companies with an annual turnover of ₹250 crore or less) to adhere to the revised Schedule ‘M’ guidelines, and there is a technology upgradation scheme (Pharmaceutical Technology Upgradation Assistance Scheme, PTUAS) to ensure a smooth transition.” “Quality is a fundamental license to operate in the pharma industry , the government is providing the necessary support now it is up to the industry and individual player to highlight, emphasise and implement it in practice,” Jain stated. For addressing other problems like counterfeits, spurious drugs and LASA (look alike and sound alike drugs) which negatively impacts brands sales and reputation among consumers, Jain suggested to create an online portal to store and share the complete information of manufacturers along with increasing the number of raids and severely punishing the violators. In the last decade the biologics and biosimilars segment has witnessed an unprecedented growth, undercovering the outlook of India companies towards this market Sapale shared, “biologics present a positive opportunity and have a promising future in India. To capitalise on this, many biologics players in India have developed their own R&D facilities or formed partnerships with research-based companies. With several biologics set to go off-patent in the coming years, the biosimilars market is also expected to expand significantly.” Sharing some of the potential challenges for expanding into this growing market, Swadia said,” If India wants to leap frog into this segment fundamentally there are two challenge one is of investment because for a new product it will at least five years before that will give returns and second is the harmonisation of regulatory standards across various emerging markets.” Elaborating on the possible implications of Donald Trump presidency on Indian pharma, Dr Veeramani noted that developments in the US are positive for India. Once the 'Biosecure Act' comes into force, it will drive efforts to reduce dependency on China. Additionally, with the preludes of tariffs (up to 35 per cent) on China, will create a big opportunity in the next four-five years and Indian companies can jump onto that bandwagon.” Concluding the discussion, Sapale underlined that, “of late, US investments in R&D have declined, and insurance agencies have imposed caps on drug prices, which is discouraging US-based companies from allocating a substantial portion of their funds to R&D. In contrast, Indian companies, even those with an annual turnover of ₹1000 crores, have established US FDA-approved manufacturing plants and clinical research facilities. So, this shifting trend could provide a significant boost to Indian companies in the coming years.” In conclusion, whilst the certainty of the Indian Pharmaceutical Market reaching the $130 billion mark by 2030 may yet be veiled in uncertainty, but it is abundantly clear that it has a huge opportunity to expand its size and share in a conducive environment offered by stakeholders approach, policy support and evolving geo-political dynamics. By Rashmi Mabiyan & Abhijeet Singh ,

Dipeptidyl peptidase-4 (DPP-4) is an enzyme found in the human body that plays a crucial role in regulating glucose metabolism. It is primarily expressed in the pancreas, intestines, and immune cells. DPP-4 is responsible for breaking down incretin hormones, such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which are released after a meal to stimulate insulin secretion and reduce blood sugar levels. By inhibiting DPP-4 activity, pharmaceutical drugs can prolong the action of these incretin hormones, leading to increased insulin release, improved glycemic control, and potential therapeutic benefits for individuals with type 2 diabetes. Several dozens of DPP-4 inhibitors have been introduced to the market, with sitagliptin, vildagliptin, saxagliptin, alogliptin, and linagliptin being available in domestic markets. DPP-4 inhibitors can be combined with multiple antidiabetic drugs to form fixed-dose combinations, among which, the combinations with metformin are most common. The currently available DPP-4 inhibitor-metformin fixed-dose combinations in the domestic market include sitagliptin/metformin tablets, vildagliptin/metformin tablets, saxagliptin/metformin extended-release tablets, linagliptin/metformin tablets. DPP-4 inhibitors can be used as monotherapy for type 2 diabetes and can also be combined with other antidiabetic drugs for the treatment of type 2 diabetes. The most commonly combined antidiabetic drugs with DPP-4 inhibitors are metformin, followed by sulfonylureas, thiazolidinediones, and insulin. They can also be used in combination with two other antidiabetic drugs, forming a triple therapy commonly including combinations of DPP-4 inhibitors + metformin + sulfonylureas, DPP-4 inhibitors + metformin + thiazolidinediones, and DPP-4 inhibitors + metformin + insulin. The analysis of the target DPP-4 in the pharmaceutical industry reveals a competitive landscape with several companies focusing on the development of DPP-4 inhibitors. Merck & Co., Inc., Takeda Pharmaceutical Co., Ltd., C.H. Boehringer Sohn AG & Co. KG, LG Chem Ltd., and AstraZeneca PLC are among the companies growing fastest under this target. The primary indication for the approved drugs is diabetes mellitus, type 2. Small molecule drugs are progressing most rapidly, indicating intense competition around the innovative drug. The United States, European Union, Japan, and China are the countries/locations developing fastest under this target, with China showing significant progress. Overall, the target DPP-4 presents opportunities for further research and development in the treatment of diabetes and related indications. Unlocking Blood Sugar Control: The Role of DPP-4 Inhibitors in Type 2 Diabetes ManagementDPP-4 inhibitors, also known as dipeptidyl peptidase-4 inhibitors, are a type of medication used in the treatment of type 2 diabetes. From a biomedical perspective, DPP-4 inhibitors work by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which is responsible for breaking down incretin hormones in the body. Incretin hormones play a role in regulating blood sugar levels by stimulating the release of insulin and reducing the production of glucagon. By inhibiting DPP-4, these medications increase the levels of incretin hormones, leading to improved blood sugar control. DPP-4 inhibitors are typically taken orally and are often prescribed as an adjunct to diet and exercise in the management of type 2 diabetes. They can be used as monotherapy or in combination with other antidiabetic medications, such as metformin. Some common examples of DPP-4 inhibitors include sitagliptin, saxagliptin, linagliptin, and alogliptin. These medications have been shown to be effective in lowering blood sugar levels and have a favorable safety profile. It's important to note that DPP-4 inhibitors are not recommended for the treatment of type 1 diabetes or diabetic ketoacidosis. They are primarily used in the management of type 2 diabetes and can help improve glycemic control in individuals with this condition. As with any medication, DPP-4 inhibitors may have potential side effects, and it is essential to consult with a healthcare professional for proper evaluation and monitoring while taking these medications. Catalog of DPP-4 InhibitorsThe currently marketed DPP-4 inhibitors include: Sitagliptin/Metformin HydrochlorideSitagliptinRetagliptin PhosphateGemigliptin/DapagliflozinMetformin Hydrochloride/Sitagliptin HydrochlorideEmpagliflozin/Linagliptin/Metformin HydrochlorideAnagliptin/Metformin HydrochlorideErtugliflozin/Sitagliptin PhosphateGosogliptinEvogliptinFor more information, please click on the image below. What is the purpose of using DPP-4 inhibitors?DPP-4 inhibitors can be used as a mono-drug treatment for type 2 diabetes, or in combination with other glucose-lowering drugs for the treatment of type 2 diabetes. For more information, please click on the image below to log in and search. How can you get the most recent advancements in DPP-4 inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of DPP-4 inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!