Preparing for 2022: Lessons and Strategies

COVID-19 has made serious dents on global economy

India is an exclusive generic exporter. As of FY21, India’s exports of pharmaceuticals to North America and Europe are a little over 51 per cent. These regions being trend setters are all the more important. Hence, developments and thinking of these two regions would be of interest to India’s pharma exporters. India has 18 per cent of the US FDA-registered facilities, the second largest source outside of the US.

COVID-19 has made serious dents on global economy, and has tested each country’s preparedness to handle emergency and resilience to bounce back. India’s pharma industry responded splendidly in managing its clientele. Most importantly, it could also contribute by crystallising its own version of COVID-19 vaccine which has covered many overseas brethren besides lot many countrymen.

Governments all over are exploring various possibilities, inclusive of extending financial concessions, for minimising import dependence of at least off-patented essential medicines. They are considering local production, or reshoring supply chains to regional peers. The Indonesian government is in talks over the possibility of offering the US-controlled pharma firms that wish to move factories out of China, a new production base, according to Coordinating Maritime Affairs and Investment Minister Luhut Pandjaitan (as reported in Fitch solutions). Besides, in high-value markets like the US, pricing controls being discussed is likely to rollover by mid-2022.

The EU parliament recommendations suggest promoting European-made pharmaceuticals by strengthening manufacturing and supply resilience throughout the EU; developing adequate capacity for sustainable production of active substances, raw materials and medicines to reduce dependence on external sources; and setting up a wider political high-level pharma forum.

Africa, yet another important region for India’s pharma industry, is also gearing up for increased local production and some of the Multi-National Companies (MNCs) are loudly thinking of shifting some R&D facilities to these cost-effective locations.

The situation in LAC Region is getting tougher, and instances of companies pulling out of those countries are on the rise.

In this scenario, Indian pharma may have to adapt to the changing scenario of the industry which is moving towards biosimilars and newer dosage forms like drug delivery devices and injectables.

India’s vaccine exports may bring in substantial revenue at least in three quarters of FY23 but it has to face intense competition from Africa besides the existing, where more than six units are in the making.

While India’s pharma exporters made fairly good in roads in device delivery doses of respiratory therapy and more to catch-up in other therapies, biopharma needs to be addressed more intensely.

Off-patent, highly-potent formulations offer major opportunities, especially in the segments of oncology and respiratory. Nearly half of the bio products are slated in this therapy. In the next five years, $26 billion worth of products may go off-patent in some markets. Barrier to entry is high expenses, which requires specialised technologies and dedicated facilities, besides vast experience in regulations. India possesses workforce comparable to the best in the world. To meet the expenses of such infrastructure, working capital, top Indian pharma companies can pool their resources and, probably with adequate government contribution, can zero in on some select bio products to produce biosimilars and a way to share the gains could be modelled.

Pace of vaccine development holds great potential for future of drug development

For the clinical research industry, the pandemic brought to the fore the need for expedited approvals and how a combination of innovative and tech-enabled solutions could fast track the process without compromising on patient safety and confidentiality.

The pace of vaccine development across the globe is testimony to the possibilities of expedited trials and holds great potential for the future of drug development. For emerging biopharma reliant on quick and nimble processes to progress their drug development aspirations, such developments hold much promise. The approach, however, requires the collaborative efforts of multiple stakeholders, amongst whom regulators play a vital role in creating an enabling environment.

India has been on the path of regulatory changes for the last few years. With the introduction of the New Drugs and Clinical Trial Rules in 2019, several regulatory concerns were addressed, resulting in a more balanced and robust regulatory environment. However, despite the progress made to date, there is a need to take stock, review how much we have gained and what more needs to be done to further strengthen the regulatory environment, particularly as we incorporate learnings and the best practices from the pandemic that can become the norm in the future.

The key enablers that will encourage research and innovation from a regulatory perspective are quicker approval and response time (regulatory approvals in some innovator countries like the US, EU and Israel take 20 to 40 per cent less time than India), simplification in the clinical trial submission and review process, inclusion of more technology/subject matter experts in the review and approval committees, and a more collaborative approach with sponsors. A key opportunity, and much needed by the industry is more digital enablement across various touchpoints in the clinical trial lifecycle and creating a robust technology backbone.

While the pandemic saw the introduction of digital approval processes for clinical trial protocol review by ethics committees, more needs to be done and the regulators need to incorporate more tech-enabled options, such as decentralised trials (DCTs), which are becoming more pervasive world over. These remote-based trials with patients participating from the comfort of their homes would be a significant advantage in a country like India which has such a diverse and geographically spread-out population. Tech innovations in DCTs include telemedicine, electronic clinical outcome assessments, e-consent and integrated digital health platforms such as participant reminders and other engagement tools.

Strengthening India’s research and innovation ecosystem requires consistent and strong collaborative efforts of all stakeholder groups from big and emerging biopharma companies, startups and entrepreneurs, academia and clinical researchers. These stakeholder groups’ efforts further need to be supported by growth enablers like infrastructure, financing, and supporting policies and regulations.

All of these developments hold promise for emerging biopharma companies that are flexible and eager to embrace new and innovative processes, be it for DCTs, remote monitoring, patient enrollment and more. There is no doubt that India is a significant market with untapped potential in the biopharma industry. As we come out of the pandemic, we need to take lessons from the last couple of years and work closely with regulators to build an ecosystem that is predictive and precise, and drives better patient outcomes in a country that has the second-highest patient population and the world’s largest disease burden.

Enhance resilience of industrial networks through longer-term emergency planning and strategic collaborations

Following the outbreak of the COVID-19 pandemic, the pharma industry and the global healthcare sector have been significantly affected in an unseen way, prompting pharma companies to shift their focus to prompt, flexible and transparent operations, as well as helping shape the workforce of the future.

In the path of COVID-19 recovery, focussing on key factors is critical for Indian pharma to emerge in the global pharma hierarchy. This involves creating a favourable climate for local production and exports, as well as fostering innovation through a greater focus on research and development.

While pharma sector companies had previously begun to consider methods to improve their value offer, the COVID-19 outbreak has hastened this process due to the challenges it has brought. Massive joint initiatives involving the government, industry and regulatory bodies are becoming increasingly prominent. Various stakeholders have banded together to facilitate the cross-border delivery of critical medications, manage labour safety and deal with increasing regulatory limitations, all while preparing for new vaccines and therapies. Several businesses have established crisis-response command centres to restore calm and effectively control a rather tense situation.

Companies may begin taking stock of what the future holds now that these efforts have been made. Corporations are also shifting their focus to recovery and the route to the new normal. This will very certainly result in significant changes in pharma operations. While several of these changes will be driven by individual enterprises, others will be industry-wide, along with external factors, such as government engagement, that will also influence the post-COVID-19 recovery.

Commonalities between well-studied diseases and the coronavirus are being assessed by researchers, who are sifting through massive databases and previous findings using AI, with the purpose of reusing drugs that have been already marketed or designing ground-breaking new drugs for corona virus or other diseases. An important step to be taken is to enhance the resilience of industrial networks, for which longer-term emergency planning and strategic collaborations are required. Companies must be able to rely on a large number of partners for this purpose. Following the pandemic, industry leaders are incorporating Artificial Intelligence (AI) in their processes and utilising AI’s benefits. AI can also help pharma businesses manage the massive volumes of data and contracts they deal with on a regular basis. One of the key lessons learnt from the pandemic is that countries prioritising their own interests results in ramifications on the global supply chains which include bans or severe restrictions on the export of raw materials, medical products, personal protective equipment, human resources, as well as manufacturing supplies.

The progress gained in treating and preventing COVID-19 was enormous. When the world begins to recover, pharma should consider what remains to be done to better harness the industry’s collective expertise garnered over this period, and to build on what worked while improving on what did not.

Technological trends are sure to transform pharma industry

In India, the pharma market is projected to reach $65 billion by 2024 and grow to $120-130 billion by 2030. Recent initiatives like the National Digital Health Mission (NDHM) and government attempts to unify the pharma sector are providing opportunities for innovation from within the pharma sector in different forms of technology. This includes AI and Machine Learning (ML) capabilities being used more extensively now than ever before.

The use of AI and ML is propelling the drug discovery and development processes. Startups are employing these technologies to address the numerous challenges in the healthcare industry, including automation of manufacturing processes as well as designing effective post-launch strategies. Eligibility criteria identification is an essential step in the drug discovery and development process, which makes it vital for conducting clinical trials. AI simplifies patients’ identification by making it fast and affordable, thus saving time for this key step. 

The large volume of data available throughout the drug discovery and development process requires high-performance systems to properly analyse data and derive value from it. Therefore, pharma companies are looking to open up their data to third parties who can leverage those numbers for applications like modeling, thus making data management a crucial aspect of the innovation ecosystem. Moreover, the analytical techniques are used on almost all types of medical data from patient records, medical imaging, hospital data, etc.

Blockchain technology is being explored to track the sale of counterfeit drugs and substandard medicine that enter into the pharma supp