15 minute read
Virus Outbreak Impact on pharma industry
Though the viral outbreak is not common but it happens time to time ie. Ebola, Swine Flu, SARS and most recent COVID-19 outbreak. Because of the pandemic outbreak of COVID-19 and global lockdown, the demand and supply of pharma industry has significantly affected due to the shortage of manpower and resources in pharma industry. This kind of viral outbreak negatively regulate the pharma industry which affect the world economy.
Dhruv Kumar, Associate Professor, Amity Institute of Molecular Medicine and Stem Cell Research, Amity University Uttar Pradesh, India
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Viral outbreaks are not new to the world. Before COVID-19, we had other outbreaks such as Ebola in 2014-2016, Swine Flu (H1N1) in 2009, and Severe Acute Respiratory Syndrome (SARS) outbreak in 2009-2010. But the COVID-19 outbreak became a pandemic, and broke the record of all viral outbreak in past 100 years, forcing the World Health Organization (WHO) to declare health emergency globally. Most of the affected countries have declared global lockdown as a consequence of the high rate of transmission of the Novel Coronavirus Disease (COVID19). In recent weeks, 30 per cent to 40 per cent new cases have been reported in European countries and in USA alone. Whereas, some countries like China, Singapore, Israel, and South Korea are effectively managing and the incidence of new cases have sharply declined. Some countries like India, Pakistan, Russia, Turkey are experiencing controlled rise in new cases in last few weeks. Other parts of the world are also experiencing the exponential rise in new cases. Initially the coronavirus affected the Asian markets largely, but now it has become the global issue.
The aggressive virus control strategies of China and low case load in India has somehow stabilised the coronavirus infection as compared to the rest of the world, mainly USA and European countries. This global lockdown has significantly affected key industries such as oil, industry, and pharma. This is not a completely new experience for the pharma industry. In last few weeks, the public-private partnership has promoted pharma industries around the globe to work in association with Government agencies to solve the COVID-19 issues. This public-private partnership to fight against COVID19 is supporting the development of new therapeutic approaches, vaccines development, medical equipment development, and personal protective equipment (PPE) development. As reported by the Association of the British Pharmaceutical Industry, several pharma companies are working on the development of vaccines, therapeutic development, and repurposing of drugs which are already FDA approved for other diseases like Ebola and HIV against SARS-CoV-2.
Some companies have identified potential compounds against SARSCoV-2 and donated compounds with the potential to treat coronavirus patients for emergency use and clinical trials. As per the data available on ClinicalTrials.gov, there are 902 studies found for SARS-CoV-2/COVID-19, which are currently under consideration for the clinical trials. Several antiviral drugs (ritonavir, remdesivir, favipiravir, umifenovir, triazavirin, sofosbuvir etc.,) antimalarial drugs (chloroquine and hydroxychloroquine), immunomodulators (tocilizumab, adalimumab, eculizumab, sarilumab, ixekizumab, fingolimod, meplazumab, camrelizumab etc.), and other cell- (mesenchymal stem cells (MSCs)) and plasma-based therapies are currently under trial. Pharma companies are taking different approaches in vaccine, therapeutics, and diagnostics development for COVID-19. Pharma companies such as Gilead Lifesciences, Cipla, Glenmark, Dr. Reddys etc., are exploring ways to use existing technologies that provide the ability to rapidly upscale production once a potential vaccine candidate and therapeutic drugs are identified against COVID-19.
In the current situation, pharma and healthcare systems are being put under significant pressure to fulfil the demand of medical equipment, PPE, vaccines, generic medicines and other hospital-related supplies in the critical situation of global lockdown. India is the largest producer of generic medicine and vaccines which require raw materials mainly from China. The global lockdown has already affected the demand and supply of the medicine, and related products due to the shortage of manpower and resources in pharma industry. Now, after five months of COVID-19 outbreak and thousands of deaths, most of the pharma companies in India and China resumed their production lines, but the major concern is countries like India have restricted the export of dozens of medicines; and China has restricted export of active
pharmaceutical ingredients (APIs) made from them. APIs are used in antibiotics, vitamins and other essential medicines, and are heavily sourced from China and India. These APIs include mainly aspirin, amoxicillin, paracetamol, azithromycin, ofloxacin, metronidazole, HIV drugs lopinavir and ritonavir, vitamins such as B1, B6, B12 and E, female reproductive hormone progesterone etc.. The main reason of restriction of export of selected medicine was to prevent the domestic shortage of those pharma products in their home country. Most of the big pharma industry are working only from 10 per cent to 30 per cent of their capacity, which has hampered the demand and supply of pharma products globally. The United States is the largest consumer of pharmaceutical product and the restriction in supply of those medicines has hugely impacted the American healthcare systems. In this scarceness, countries like the USA and European countries are planning to bring back the production of hundreds of medicines back to their own house. Though, several countries have resumed their manufacturing of the pharma products, the major concern is interruption in product delivery. The huge restrictions on population movements across the world makes distribution and delivery a huge problem. Even if the manufacturing of an APIs in one country goes well, it has to be moved to another dominion to be processed into a final product. In this incredibly fluid situation, the pharma industry needs to constantly monitor these issues and assess their possible impact for the immediate future as well as long term impact. The industry must think around corners and anticipate problems before they become larger immediate issues. Businesses should revaluate their contracts and plan strategies to minimise the big losses because of this outbreak.
In view of the present situation of COVID-19, the social distancing approach has emerged as one of the best ways to control the spread. But the question is, how long can this go on? In this current scenario, the proper utilisation of the pharma products and health-related medical resources is very important. The very important thing is supply comes after demand.When people stay safely and healthy, there is no need to take extra medicine and extra medical care. So, in this scenario, the load on pharma industries will be minimised. While drug shortages due to COVID-19 are so far limited and expected to remain in the short-term, if the pandemic continues then stockpiles of pharmaceuticals, APIs and other chemicals may decrease, resulting in short-term shortages of several pharma products. Further complications come from distribution, particularly with population movement restrictions around the globe. A number of pharma companies are already in huge loss in last few months because of COVID-19.
AUTHOR BIO
After completion of B.Sc in Chemistry(Hons) from Banaras Hindu University (BHU), India and M.Sc in Bioinformatics from the University of Allahabad, I completed PhD from the School of Biotechnology at University of Bologna (UNIBO), Italy. I have received postdoctoral training from the School of Medicine at University of Kansas Medical Center, USA. Currently, my lab works on Molecular Medicine, Drug Designing, Drug Development, Translational Cancer Research and Bioinformatics.
DELIVERING A COMPLETE SOLUTION TO CUSTOMERS
Lonza is a company that designs, develops and manufactures a wide range of dosage forms for the pharmaceutical, consumer health and nutrition industries. We currently have more than 4,000 customers in over 100 countries. In the APAC region, we operate from eight sites in Sydney, Hong Kong, Mumbai, Bangkok, Jakarta, Suzhou, Delhi and Sagamihara.
Deepak Sood, Head of Sales, APAC
What is your role at Lonza and how long have you worked there? I joined Lonza in January 2018 as the commercial director for the organisation’s Capsule Delivery Solutions team. In July 2019, I became Head of Sales in the Asia Pacific region for our innovative capsules in the Capsule Delivery Solutions portfolio. Then in early April 2020, I assumed responsibility for the APAC business as head of Lonza’s newly formed business unit for Capsules & Health Ingredients. I’m also currently Lonza’s Managing Director for India.
What are the latest trends in the pharmaceutical industry, particularly in the APAC region? A notable trend in the APAC region is that the market for traditional medicines remains as strong as the market for western chemical API driven pharma products. As a result, we’re dealing with significant differences in regulatory and quality demands as well as supporting different approaches to brand marketing – for example, the nutrition market is very focused on green label and animal-free products at the moment, whereas for pharma this is less of a focus.
The region is also very fragmented and while we have strong and growing presence across the entire APAC region, the competitive landscape varies from country-to-country. In addition, there are further nuances in each market where the number of manufacturers, pricing, attitude to quality and the accessibility of various markets by pharma manufacturers all play a part in partner selection. As more western companies look towards the APAC region for services in the coming years, we’re likely to see this fragmentation lessen as the focus on quality increases. This is cyclical as it is not that long since manufacturing moved to the west, however, increasing growth in the APAC region and higher quality products becoming readily available for patients and consumers is making it an attractive prospect for customers once more.
A lot of our focus has been in the US and EU over recent years as these markets have been responsible for most of the innovation in the pharma and biopharma sectors. The APAC region is still very much relied upon to deliver traditional hard gelatin capsules so there are significant opportunities to introduce innovative products that deliver additional value.
Where are you seeing the most demand for products?
Lonza’s Capsugel ® range of capsules is one of the most diverse portfolios ranging from plant based HPMC (Hydroxy Propyl Methyl Cellulose) capsules to hard gelatin capsules.
The Asia Pacific market is still very heavily driven by the hard gelatin capsule market, with over 90% of Lonza’s manufacturing volume within the region remaining in this area currently. This is typically driven by western chemical API-based medicines. If we look at the traditional medicines market in India, the most common products
AUTHOR BIO
Deepak Sood, Head of sales, APAC and Managing Director for Lonza in India. Deepak has over 30 years of industry experience in India & Asia Pacific in the pharma and healthcare space. He has a deep understanding of various business segments and has wide contacts in the Indian healthcare and chemical industries. Deepak has been actively involved in setting up greenfield and brownfield (capacity expansion) projects. His career achievements are a reflection of strong leadership skills and a proven track record in sales, R&D, pilot plant operations, business development, strategic planning and operations including P&L management.
are immunity supplements which are available in a range of dosage forms including powders and syrups, meaning at the moment there is a very limited share for capsules. This may in part be due to the animal derived polymer of traditional gelatin capsules which is problematic in a country where roughly a third of its population are vegetarian.
There are a few trends which may alter this dynamic in coming years. Firstly, the current drug development pipeline is heavily focused on oncology and where the dosage form is a capsule, developers are opting for HPMC products. These are a more robust capsule and are strong delivery vehicle for highly specialised APIs – both of which are vital for highvalue oncological drugs. There will be a challenge when it comes to volume as these products will not be typical blockbuster mass-market therapies but very specific, targeted therapies.
There is scope for hygroscopic APIs currently on the market to move into HPMC capsules and we are working with various customers to show them the advantages of our Vcaps ® Plus products, for example its known pH dissolution performance. In general, we anticipate that there will be a movement to such capsules, but it will be gradual.
On the nutrition and nutraceutical side of the market, there is a huge push towards both sustainability and vegetarian products. Brand owners want to market their products with ‘Green Label’ claims to meet consumer demand and as a result there is a huge movement towards non-animal based capsules where provenance can be proven.
This is a very fast-growing market for us at the moment, particularly in the APAC region. Are there any major challenges?
We have two major challenges at the moment.
First is capacity – such is the demand for Capsugel ® products that we are always working at a very high utilisation rate - that sometimes means our lead times can be longer than some of our competitors. However, we are continuously investing in our facilities to expand and ensure we can continue to cater for customer demand.
Second is cost – Capsugel ® products are quality-centric and we focus on developing and using robust, validated processes to ensure the quality of our capsules is at the highest standard, in addition our processes and vendor qualification criteria is uniform across all our manufacturing sites to ensure consistency. Some of our competitors can undercut our prices by developing ‘minimum viable products’ that only just satisfy regulatory requirements but offer no value to brand owners or patients beyond that. Lonza’s offering is very different in this sense as quality is something that we pride ourselves on and it is the added value of our team’s expertise and ongoing support that really makes the difference for our customers.
How do you see the APAC pharma landscape developing over the next five years? As cost pressures increase in western markets, more and more companies will look to the East to support their manufacturing needs. 15 years ago, there was a very strong resistance to Indian APIs in western markets, now if you look at the United States, Indianmade APIs and generics are growing in
popularity as they are more cost effective than those provided by competitors which manufacture domestically.
In addition, a lot of Lonza’s customers in India are manufacturing finished formulations and supplying them to the developed markets, for example some of the largest suppliers of paracetamol in the UK are manufacturers from India.
This dynamic is showing a steady, sustained move of manufacturing to the APAC region. There is a gap in the excipients supply market which will need to be filled in the coming years to ensure a long-term shift to manufacturing in the region can be sustained – given the scale of the opportunity, I’ve no doubt this will happen.
How can Lonza support companies during this transition? The pharma industry will always be a highly regulated market, and this poses a challenge for customers – switching a capsule over is not just about changing manufacturing processes. To convert a new capsule, or to qualify an alternate supplier for a particular molecule can be a very painfully slow process due to the regulations and it requires changes to be made to the dossier. The timeline can be anywhere from two years to three years. It also demands a lot of investment in terms of internal resources and capex from customers to develop an alternate vendor and ensure proper onboarding.
Adding to this is the increased interest from regulators such as the FDA and the EMA that is peaked when process changes occur.
From our customers’ perspective, if everything is working with their current supplier, why should they change? This works well for when it comes to retention as there are never any problems with our products, but when it comes to securing new business it can be a challenge.
Our approach to knowledge sharing and the support of our regulatory teams are two of the key enablers that help us overcome these challenges. We work hard to become knowledge partners to our customers, not merely a transactional dealer for them and that's how we drive the value. Our efforts around HPMC capsules are indicative of these efforts. We are conducting a significant number of seminars and bridging knowledge gaps for our customers so they can understand the value of HPMC capsules and start considering whether they can convert some of their hard gelatin volumes.
Rather than just support functions, we have regulatory experts in key geographic markets who have experience with local bodies and can provide additional consultancy to the customer. We have an advantage over our competition in terms of geographic flexibility because we have a physical presence in most major markets – especially in the APAC region where we have sites in China, Japan, Indonesia and India. Importantly, we can support our partners when they look to enter new markets – we have access to western markets and knowledge partners around the globe who can provide insight into the regulatory compliance requirements of most countries.
Lastly, Lonza also offers Lonza Engine TM equipment and we have seen high uptake of the filling machine in the APAC region usually combined with our Capsugel ® capsules as well. This means we can deliver a complete solution to our customers.
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