US Biosimilar Overhaul: A Breakthrough Moment or a Strategic Test for Indian Pharma

On 31 October 2025, the Economic Times (ET) headline— “US biosimilar norms to keep local drug cos in good health” - quickly became one of the most discussed topics across India’s biopharmaceutical circles.

For India, which is transitioning from a global generics’ powerhouse to an emerging biologics player, this shift is more than regulatory news. It marks a critical moment that could either accelerate India’s biopharma ambitions or expose deep structural gaps.


What Has the US FDA Changed?

The ET report highlights a few key regulatory shifts:

  • Reduced clinical trial requirements where scientifically justified
  • A more predictable and transparent review pathway
  • Lower development costs for manufacturers
  • Quicker regulatory timelines

These changes significantly lower the barriers for biosimilar entry into the US – the world’s most lucrative biologics market.

For Indian companies, this means faster commercialization of assets previously slowed by cost, litigation, and development complexity.


Why These Norms Matter Deeply for India:

1. The Big Leap Beyond Generics

India’s pharmaceutical success has historically been built on small-molecule generics. Biosimilars represent the next step – complex, high-value biologics requiring advanced R&D, analytics, and precision manufacturing.

A friendlier US regulatory landscape can:

  • Boost Indian biologics capabilities
  • Enhance India’s scientific reputation
  • Accelerate the transition from volume-based to value-based pharma exports

This is not incremental – it is transformational.


2. A Chance to Make Biologics Affordable – Globally and at Home

Indian biosimilars entering the US could push global prices downward, increasing patient access everywhere.

But the unanswered question remains:

Will India ensure the same benefits reach its own patients?

Historically, many biologics approved in India remain unaffordable. This opportunity must change that narrative.


3. Catalyst for Investment and Innovation

Success in the US market – considered the gold standard – often brings:

  • Investor confidence
  • International collaborations
  • High-value licensing deals
  • Technology transfer opportunities

If Indian firms reinvest this momentum into R&D, it can accelerate India’s shift toward a future where ‘innovated-in-India’ becomes as common as ‘made-in-India’.


4. Competitive Pressure on Originator Biologics

Lower-cost Indian biosimilars could challenge multinational biologics giants in their strongest market.

This may result in:

  • Reduced prices
  • Greater insurance coverage
  • Wider patient access

It positions India as a meaningful global competitor – not just a contract manufacturer.


But the Red Flags Are Too Important to Ignore:

A) Biosimilars Are Not Generics – Quality Risks Are Heightened

Biologics demand:

  • High-precision fermentation
  • Immunogenicity evaluation
  • Strong data integrity
  • Robust GMP compliance

Any compliance slip-up in the US biosimilar space could severely damage India’s credibility.

This is a risk India cannot afford.


B) Patent Barriers Will Still Be Tough

Even with simplified norms, US biosimilar entry often faces:

  • Patent thickets
  • Secondary patents
  • Litigation from innovator companies
  • Market-access hurdles

Indian companies will need smarter IP and litigation strategies – not just efficient manufacturing.


C) India’s Own Ecosystem Needs Modernization

India must strengthen:

  • Analytical labs for similarity assessments
  • Biologics manufacturing clusters
  • Cold-chain logistics
  • CDSCO guidelines
  • Pharmacovigilance systems

Without this, Indian biosimilars may flourish abroad while India continues lagging in domestic biologics availability and safety monitoring.


D) The Risk of Mission Drift

If export markets become the primary focus:

  • Domestic patients may remain an afterthought
  • Prices of biologics may not reduce meaningfully within India
  • Public health benefits may fall behind corporate goals

Balancing global ambition with national responsibility is crucial.


What India Should Prioritize Now:

For Indian Pharma Companies

  • Invest heavily in biologics R&D, analytics, and quality systems
  • Strengthen data integrity and regulatory compliance
  • Pursue strategic co-development partnerships
  • Ensure domestic market access for biosimilars – not merely exports

For Indian Policymakers and Regulators

  • Align CDSCO norms with US/EU biosimilar standards
  • Build biotech clusters and offer strategic incentives
  • Strengthen post-marketing surveillance
  • Use public procurement to promote affordable biologics for Indian patients
  • Encourage transparent pricing and competition

For Public Health Stakeholders

  • Monitor domestic pricing of biosimilars
  • Demand safety and immunogenicity transparency
  • Advocate access for oncology, autoimmune, and rare disease treatments

A Defining Moment: Opportunity vs. Responsibility

India stands at a strategic crossroads.

If industry, policymakers, and regulators move in alignment, India can become a global biosimilar powerhouse known for quality, affordability, and innovation.

If not, this moment may turn into yet another case where India enables global affordability while failing to deliver it domestically.


“The true test of India’s biosimilar advantage will be measured not in US approvals – but in whether Indian patients finally gain access to affordable biologics.”


Quick Takeaways:

  • New US FDA biosimilar norms promise faster, less burdensome approval pathways.
  • Indian companies like Biocon, Intas, and Dr. Reddy’s stand to gain significantly.
  • But quality risks, patent barriers, and domestic-access concerns remain real.
  • India must upgrade its biologics ecosystem—not just chase US profits.
  • The real test: Will Indian patients benefit from this global opportunity?

Conclusion:

Closing Thought

The US FDA may have opened the door.
The world may be watching.
But only India can decide whether this moment becomes a turning point – or a missed opportunity.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Navigating Potential US Tariffs: Challenges and AI-Driven Opportunities for Indian Pharma

India’s pharmaceutical industry, reportedly supplying 47% of US generic drugs and exporting $27.9 billion in FY24, faces the threat of 10-25% US tariffs under a potential Trump policy. Major players like Sun Pharma, Dr. Reddy’s, Cipla, Lupin, and Aurobindo, reportedly deriving 30-50% of revenues from the US, must prepare despite tariffs not yet being imposed. This article examines the challenges and AI-driven opportunities, emphasizing the need to protect the Indian Patents Act, 2005, during US trade talks, with Indian and global examples.

Challenges of Potential US Tariffs:

  1. Profit Margin Pressures: Generics operate on 10-15% margins. A 10% tariff could cut EBITDA by 1-2%, while 25% could slash profits by 5%, hitting firms like Aurobindo and Zydus Lifesciences. Raising prices risks losing US market share, where generics fill 90% of prescriptions.
  2. Supply Chain Risks: The US lacks immediate alternatives to India’s generics. Building US facilities could take 3-5 years and cost six times more. Tariff uncertainty could worsen the 271 US drug shortages in Q3 2024.
  3. Competitiveness Threats: Tariffs could erode India’s cost edge, especially if competitors face similar tariff. This deters investment in India’s 20% global generic supply share.
  4. Strategic Uncertainty: Tariff uncertainty complicates planning. US facilities need 12-24 months for FDA approvals and $50-100 million, risky without clear policies.

AI-Driven Opportunities:

AI can help Indian pharma navigate tariff threats by boosting efficiency and exploring new markets. Key strategies include:

1. AI-Driven R&D for High-Value Products:

AI accelerates development of high-margin biosimilars and specialty drugs, less tariff-sensitive.

  • Indian Example: Sun Pharma, reportedly used AI in 2024 to optimize ILUMYA (tildrakizumab) trials, cutting costs by 20% and time by six months.
  • Global Example: Pfizer’s 2023 Watson AI partnership reduced rare disease drug development time by 30%, saving $120 million. Indian firms can use similar tools.

2. Supply Chain Optimization:

AI enhances supply chain resilience, cutting costs and preparing for tariffs.

  • Indian Example: Dr. Reddy’s 2024 SAP AI platform, reportedly optimized atorvastatin inventory, reducing logistics costs by 15%.
  • Global Example: Merck’s 2022 Blue Yonder AI system saved $100 million annually, cutting stockouts by 25%. Indian firms can adopt similar tools.

3. Market Diversification:

AI identifies new markets like Africa and ASEAN, reducing US reliance.

  • Indian Example: Cipla’s 2024 Salesforce Einstein Analytics, reportedly boosted East African exports by 25%, adding $50 million in revenue.
  • Global Example: Novartis’ 2023 AWS AI expanded Southeast Asia sales by 18% ($200 million). Indian firms can target similar markets.

4. AI-Enhanced Manufacturing:

AI optimizes production, lowering costs to offset tariffs.

  • Indian Example: Biocon’s 2023 Bangalore AI facility, using Rockwell Automation, reportedly improved insulin production efficiency by 22%, saving $30 million.
  • Global Example: Roche’s 2024 Siemens AI platform in Switzerland cut antibody production costs by 15%. Indian firms can invest similarly.

5. AI in Regulatory Compliance:

AI streamlines FDA compliance, ensuring market access.

  • Indian Example: Aurobindo’s 2024 Deloitte AI tool, reportedly cut FDA audit preparation time by 40% for metformin.
  • Global Example: Amgen’s 2023 Accenture AI system improved biologics approval rates by 25%. Indian firms can adopt similar tools.

Strategic Recommendations:

  1. Invest in AI: Allocate 5-10% of revenues to AI, following Sun Pharma’s, reportedly  $500 million R&D model.
  2. Protect Patents Act: In US trade talks, like the UK FTA, India must uphold the Indian Patents Act, 2005, especially Section 3(d), to preserve affordable generics.
  3. Secure Trade Agreements: Push for a US trade deal targeting $500 billion by 2030 to avoid tariffs.
  4. Diversify Markets/Products: Use AI to prioritize high-margin drugs and new markets.
  5. Partner with AI Leaders: Collaborate with Google, IBM, or SAP for tailored AI solutions.

Conclusion:

Potential US tariffs threaten Indian pharma’s profits, supply chains, and competitiveness, but they also spur innovation. AI can enhance R&D, supply chains, market diversification, manufacturing, and compliance. Examples from Sun Pharma, Dr. Reddy’s, Cipla, Biocon, Aurobindo, Pfizer, Merck, Novartis, Roche, and Amgen show AI’s potential. India must protect the Indian Patents Act, 2005, in US trade talks to maintain its generics edge. By embracing AI and strategic advocacy, India can turn tariff threats into opportunities to lead globally.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Sources:

  • Trump Tariff to Push Indian Pharma Co to Embrace AI, Cost-Efficient R&D | analyticsindiamag.com
  • Donald Trump tariff relief for now: India’s pharma sector navigates an uncertain US trade future – Times of India
  • How Trump tariffs could impact Indian pharma’s $8.7 bn dream run – India Today
  • Trump Tariffs: Impact & Opportunities in Indian Pharma – www.moneymuscle.in
  • The future of India-US pharmaceutical trade – www.pharmaceutical-technology.com
  • Indian Pharma Braces For Trump Tariff Fallout – Forbes India
  • Indian pharma companies escape Trump’s reciprocal tariffs, for now – www.livemint.com
  • 5 Indian Pharma Companies That Could Be Impacted by Trump’s Tariff Move – www.equitymaster.com
  • Indian Pharmaceutical Alliance Annual Report 2024 – www.ipa-india.org
  • US FDA Drug Shortage Database, Q3 2024 – www.fda.gov
  • India-UK FTA: Safeguarding the Indian Patents Act – www.financialexpress.com

 

The Great Indian Pharma Consolidation: A Strategic Imperative for Global Ambition

The Indian pharmaceutical industry, long characterized by its formidable generic manufacturing capabilities, has decisively entered a robust phase of consolidation. In a landmark development, Torrent Pharmaceuticals has announced definitive agreements to acquire a controlling stake in JB Chemicals & Pharmaceuticals for an equity valuation of ₹25,689 crore. This momentous deal, one of the largest in Indian pharma history after Sun Pharma’s acquisition of Ranbaxy, will significantly reshape the domestic landscape and propel the combined entity into the top tier of Indian pharma.

The acquisition, structured in two phases and involving a subsequent merger, underscores the ongoing, aggressive drive within the industry to achieve greater scale, enhance market reach, and diversify product portfolios through strategic mergers and acquisitions (M&A). This move by Torrent not only bolsters its presence in chronic therapy segments and opens up new areas like ophthalmology but also marks its entry into the high-potential Contract Development and Manufacturing Organization (CDMO) space.

Evolution through M&A: A Snapshot:

Historically, the Indian pharma landscape was characterized by a large number of small to medium-sized companies, primarily focused on generic drug manufacturing for the domestic market. The liberalization of the Indian economy in the early 1990s and the adoption of product patents in 2005 spurred a wave of M&A activities.

Key examples of this evolution include:

- Sun Pharma’s acquisition of Ranbaxy (2014): This landmark $4 billion deal was one of the biggest in Indian pharma, creating a powerhouse with a vast product portfolio and global reach. It aimed to expand market penetration and diversify product lines, as both companies had complementary strengths.

- Abbott’s acquisition of Piramal Healthcare’s domestic formulations business (2010): This significant inbound M&A deal showcased the interest of global giants in the lucrative Indian domestic market and its strong generic capabilities.

- Daiichi Sankyo’s acquisition of Ranbaxy (2008) and its subsequent sale to Sun Pharma: This demonstrates both the influx of foreign investment seeking access to low-cost R&D and manufacturing, and the eventual re-consolidation within Indian hands.

- Lupin’s numerous outbound acquisitions: Lupin has actively acquired companies in the US (e.g., GAVIS Pharmaceuticals in 2015) and Russia (ZAO “Biocom”) to expand its international footprint and product offerings, particularly in key markets.

- Mankind Pharma’s acquisition of Bharat Serums & Vaccines (2024): This recent deal highlights the strategic intent of Indian companies to diversify into high-growth segments like biologics and specialty care.

Increasing Dominance of Top Companies:

While precise historical market share data for the top 10 over many decades is complex to aggregate, the trend is clear: consolidation has significantly increased the contribution of the top pharmaceutical companies to the total market.

Today, companies like Sun Pharmaceutical Industries, Divi’s Laboratories, Cipla, Dr. Reddy’s Laboratories, and Torrent Pharmaceuticals are consistently at the top of the market capitalization and revenue charts. For instance, as of June 2025, Sun Pharma alone holds a substantial market share, and the top 10 companies collectively command a significant portion of the overall Indian pharmaceutical market. This is a stark contrast to the highly fragmented landscape of previous decades where market leadership was far less concentrated. The proposed Torrent-JB Chemicals merger is expected to further solidify this trend, potentially placing the combined entity among India’s top five pharma companies by market capitalization.

An Assessment: Benefits and Challenges:

Experts generally agree that this consolidation has benefited the Indian Pharmaceutical industry in several ways:

- Enhanced Scale and Efficiency: Larger entities can achieve economies of scale in manufacturing, R&D, and distribution, leading to cost efficiencies and improved profitability.

- Global Competitiveness: Mergers have enabled Indian companies to expand their geographical reach, acquire advanced technologies, and strengthen their product pipelines, making them more competitive on the global stage. India is now the third largest in production volume and a major supplier of affordable generics and vaccines worldwide.

 - Increased R&D Investment: While concerns about innovation decline post-merger exist, larger companies often have greater financial muscle to invest in research and development, particularly in high-value areas like biologics, biosimilars, and specialty drugs, moving beyond traditional generics.

- Improved Quality and Compliance: Consolidation can lead to better adherence to stringent international quality standards (like USFDA and EU-GMP), as larger companies have the resources and infrastructure to implement robust quality control measures.

- Portfolio Diversification: M&A allows companies to broaden their therapeutic areas and product offerings, reducing reliance on a few key drugs and mitigating risks. The potential acquisition of JB Chemicals would add several established domestic brands to Torrent’s portfolio and also provide an entry into the Contract Development and Manufacturing Organization (CDMO) business.

Challenges and potential downsides also exist:

- Potential for Reduced Competition (in specific segments): While the overall market may not be concentrated, specific therapeutic categories or drug molecules can experience high concentration ratios, raising concerns about potential monopolistic practices and impact on drug affordability.

- Innovation vs. Cost Savings: The focus on integration and cost synergies post-merger can sometimes lead to a reduction in R&D spending or the elimination of overlapping research projects, potentially impacting overall innovation in the short term.

- Impact on Smaller Players: Consolidation can make it harder for smaller, independent players to compete, potentially stifling new entrants and diverse approaches to drug development.

Defining the Strategic Imperatives:

As of today, the Indian pharmaceutical industry is poised for continued growth and evolution, with the following key trends and strategies envisaged:

- Focus on High-Value Products: The industry is actively shifting from a heavy reliance on generic formulations to investing in complex generics, biosimilars, biologics, and specialty drugs, which offer higher margins and greater innovation opportunities.

- Strengthening API and KSM Manufacturing: To reduce import dependence, particularly on China, there’s a strong push for self-reliance in Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) through government initiatives like Production-Linked Incentive (PLI) schemes.

- Digital Integration and Technology Adoption: Leveraging digital technologies, AI, and data analytics in R&D, manufacturing, supply chain management, and patient engagement is crucial for future growth and efficiency.

- Global Collaboration and Partnerships: Strategic alliances, joint ventures, and targeted acquisitions, both inbound and outbound, will continue to be vital for market access, technology transfer, and portfolio expansion.

- Quality and Regulatory Compliance: Continued emphasis on stringent quality control measures and adherence to global regulatory standards is paramount to maintain India’s reputation as a reliable pharmaceutical supplier.

- Talent Development: Addressing skill gaps and fostering a highly skilled workforce, particularly in areas of advanced research and digital technologies, will be critical for sustained growth.

Conclusion: 

The Indian pharmaceutical industry’s journey of consolidation has largely been a positive one, fostering scale, global competitiveness, and increased R&D capabilities. The path ahead involves a strategic shift towards innovation, self-reliance in key materials, and leveraging technology to solidify its position as a global pharmaceutical leader, with ongoing M&A activities like the potential Torrent-JB Chemicals deal serving as key catalysts in this transformative journey.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Closed Doors, Open Channels: India’s Ban on Medical Reps in Govt Hospitals Reshapes Pharma Engagement

The June 3, 2025, directive from the Directorate General of Health Services (DGHS), banning medical representatives (MRs) from meeting doctors in central government hospitals, marks a pivotal policy shift in India’s evolving healthcare ecosystem. It signals a firm step toward delinking clinical decisions from commercial influence—particularly in public institutions where millions of patients depend on subsidized or free medical treatment.

Issued by DGHS Director Sunita Sharma, the directive mandates strict compliance from hospital officials, effectively barring pharmaceutical sales representatives from physically accessing doctors within government hospital premises. Instead, MRs have been advised to share scientific updates, product information, and procedural advancements through digital platforms like email or other non-intrusive channels.

This move aligns with the Indian government’s broader push to promote generic drug prescriptions, minimize undue influence from pharmaceutical marketing, and uphold the ethical integrity of public health systems.


Understanding the Implications: A Two-Sided Coin:

Advantages of the DGHS Ban:

  1. Reduces Conflicts of Interest:
    Government-employed doctors are expected to prioritize cost-effective treatments, especially generics. This restriction curbs the risk of biased prescribing practices that favor brand-name drugs driven by promotional efforts rather than patient outcomes.
  2. Rebuilds Public Trust:
    Patients—especially those from low-income backgrounds—can now feel more assured that medical prescriptions are based purely on clinical judgment, not marketing tactics.
  3. Fosters Evidence-Based Prescribing:
    Doctors may increasingly depend on peer-reviewed research, institutional protocols, and academic updates rather than potentially biased promotional content from MRs.
  4. Supports Smaller and Generic-Only Companies:
    Large pharmaceutical firms with aggressive marketing budgets have long held an advantage. By cutting off direct promotional access in government hospitals, the directive levels the playing field for smaller, innovation-driven or generic-focused companies.

Challenges and Concerns

  1. Information Gaps for Physicians
    MRs are often the primary source of updates on new drug launches, dosage changes, safety alerts, and emerging therapies. Without an effective alternative, doctors could miss crucial therapeutic advancements.
  2. Communication Breakdown
    The absence of a regulated, real-time channel may hinder the timely dissemination of important updates like drug recalls, contraindications, or revised usage guidelines.
  3. Potential Spillover to the Private Sector
    If this approach extends to private hospitals, it could severely disrupt the pharma sales model and widen the communication gap between drug manufacturers and prescribers.
  4. Impact on Employment
    Thousands of MRs, whose roles have traditionally depended on face-to-face detailing, may face job losses or be forced to transition into unfamiliar roles.

How Pharma Can Adapt: Strategic Remedial Measures:

Pharmaceutical companies must act swiftly and smartly to align with the new reality. Below are actionable pathways to ensure continued, ethical engagement with healthcare professionals:

1. Invest in Digital Medical Platforms:

  • Build secure, doctor-only portals offering clinical literature, prescribing information, and continuing medical education (CME) modules.
  • Create apps where physicians can request drug updates or schedule virtual sessions with medical experts.

2. Deploy Medical Science Liaisons (MSLs):

  • Replace promotional visits with interactions led by trained MSLs who provide evidence-based insights, answer complex clinical queries, and maintain strict compliance with non-promotional norms.

3. Collaborate with Medical Institutions:

  • Partner with hospital departments and medical councils to conduct scheduled scientific sessions, like pharmacology briefings or journal clubs, vetted by ethics committees for neutrality.

4. Prioritize Peer-Reviewed Communication:

  • Shift the focus from brand promotion to publishing clinical data in reputable journals and conference proceedings to build scientific credibility organically.

5. Reskill the Field Force:

  • Train MRs for hybrid roles in digital marketing, pharmacovigilance, medical writing, or regulatory affairs.
  • Equip them with skills in non-promotional communication, data analysis, and virtual engagement tools to remain relevant in the new ecosystem.

Conclusion:

Ethical Reform, Strategic Opportunity:

The DGHS directive marks a turning point in India’s pharmaceutical policy landscape—one that reflects global trends toward transparency, ethics, and data-driven healthcare. While it challenges the long-standing model of pharmaceutical detailing, it also opens doors for a new paradigm: ethical, digital, and education-based engagement.

For pharmaceutical companies, this is more than a restriction—it’s an opportunity to reset their value proposition and become trusted scientific partners in the healthcare journey.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Being Eclectic – A Pharma Leadership Quality In The New Normal

It’s no-brainer that since the onset of Covid pandemic, digitalization initiative of many pharma companies in critical facets of business operations, has reached a new high. The process is now fast accelerating with the adoption of avant-garde ideas, and scalable digital tools and platforms. Some of these initiatives may be incremental in nature, but several others possess game changing potential in delivering business outcomes.

This period of transformation is also an opportune time for pharma leadership to be more eclectic, while working out strategies to gain business momentum – outpacing the competition. As is being revealed, strategic inputs from a diverse range of sources – often from totally different areas, to meet fast changing customer needs and expectations, would immensely help in the new normal.

In this article, I shall argue on the need of being eclectic for pharma leadership to gain competitive edge, especially in the trying times. I shall elaborate this point with the example of an eclectic idea – Gamification. If used where it ought to be, eclectic ideas may help organizations to successfully navigate through unprecedented disruptions, especially, caused by Covid pandemic, in various critical areas of pharma business.

Gamification – an eclectic strategic tool for pharma:

Gamification – an eclectic strategic tool, ‘incentivizes people’s engagement and activities to drive results with game-like mechanics.’ Various companies, across the industries, are leveraging this technique for greater effectiveness in different business domains. This includes, driving employee motivation for sustainable performance excellence.

I discussed ‘Gamification in Pharma’ in this blog – about a year before the onset of the pandemic. However, its potential is being increasingly realized with virtual engagement becoming more common during Covid pandemic. Several drug companies are now imbibing Gamification techniques to offer greater value in several areas of business. These include, among others, chronic disease management, adherence to the prescribed dosage regimen, and also for training and development.

The core purpose and value: 

The core purpose of Gamification is to effectively engage with both internal and external customers of an organization, with clearly captured details of their changing needs and expectations in the new normal. Game mechanics are basically the rules and rewards that build the foundation of game play. Game dynamics involve a set of emotions, behaviors and desires found in game mechanics that help foster engagement and motivate participants.

The broad process of Gamification entails integration of game mechanics on various existing platforms. These include, a website, online community, learning tools - providing target audiences with proactive directives and feedback through game mechanics that lead to the accomplishments of business goals and objectives.

According to BI Worldwide - a global engagement agency, ‘Gamification is about driving engagement to influence business results.’ When people participate and engage with gamification initiatives, they learn the best way to interact with the business, its products, services and in thereby in the brand building process.

It further says, the business value of Gamification doesn’t end with the participant. Engagement with game mechanics provides insightful data that can help influence marketing campaigns, platform utilization and performance goals. Every employee or customer interaction gives a better sense of where a participant is spending their time and what activities drive interest.

Application of ‘Gamification’ in pharma is a decade old now:

Gamification isn’t totally a new concept in the pharma industry. It was successfully tried by some pharma majors, at least, about a decade ago. Let me give below just a couple of examples from that period to get a feel of it:

Way back in 2011, Pfizer created the Back in Play game for European patients, to boost knowledge of ankylosing spondylitis, a disease that causes inflammation in the spine and pelvis joints. Interestingly, the game delivered a simple healthcare message to a notoriously difficult to reach audience 38 million times.

In 2012, Boehringer Ingelheim launched its pharma game – ‘Syrum’ on Facebook platform. This particular initiative is considered as an evolution in the pharma industry’s use of the social media platform. It gave the Company a new tool to educate and expand the knowledge of the general public about the challenges of its business. It also helped to improve disease awareness, besides allowing the company to conduct its market research.

Besides these two, other interesting Gamification initiatives taken around that period include, Zec Attack (Novartis), Silence Your Rooster (Sanofi).

Its potential in pharma marketing – and what to avoid:

Applying game mechanics to healthcare marketing could also help ensure that patients are activated, educated, and engaged throughout the duration of their care, driving both – business performance and patient outcomes. This observation was made in an article on ‘Gamification’, published in the Pharmaceutical Executive on February 28, 2019. Another article titled, ‘Gamification is Serious Business’ also reiterates, ‘Research and case studies from both the academic and healthcare space bring forth ample evidence that games can improve patient compliance and healthcare outcomes.’

However, if any pharma marketer enters into the gamification arena with greater focus on the desired outcome than on patient goals, or the games themselves don’t excite, engage, and motivate the users, the efforts may not succeed.

Gamified e-learning helps during Covid pandemic:

An interesting study on ‘The Impact of COVID-19 on Learning,’ conducted by find courses, noted some interesting points. A few of which, are as follows:

  • Covid pandemic is fueling an unprecedented interest and opportunity for many people to acquire more job knowledge and skills, mainly to protect their future in uncertain times.
  • In tandem, people’s priorities when it comes to learning are also changing. Health-safety being at the forefront of many learners’ minds, they prefer mostly online courses, or heavily reduced classroom sizes - to maintain social distancing.

It has also been noted that many such learners often find virtual learning programs uninteresting and lackluster. Sensing this issue, many organizations, which include some pharma companies, are now using Gamification to augment learning effectiveness and build greater team harmony. Let me illustrate this point with an example from the pharma industry during the ongoing pandemic.

It’s more relevant in the new normal:

On June 04, 2021, Fierce Pharma featured an article on Pharma companies’ getting into gaming to boost retention, recall – and fun. There, it quoted a top official of the global pharma major AbbVie, who said: “Gamification has become more important and more impactful in the virtual environment.”  The honcho further said: “The pandemic showed we need this now more than ever. – It’s given an extra push to what has always been core to what we do, which is retention and recall in a fun and engaging manner.”

The report elaborates, AbbVie Canada uses gamification to onboard new reps, district managers and brand managers as well as for national sales meetings. Instead of studying or reading up, AbbVie asks employees to do the advance work through gamification tasks and then follows with more tasks after the meetings to boost retention and recall.

The Global Healthcare Gamification Market Report 2021-2027, also vindicates this point. As it reported, utilization of new healthcare gamification applications based on mobile tablets and laptops, witnessed a good growth during Covid pandemic. It reported, ‘Healthcare Gamification Market’ is expected to reach US$35,982.7 million in 2027 from US$ 3,072.5 million in 2019 with an estimated CAGR of 36.2% from 2020-2027.

Gamification is now being used by pharma in India, as well:

Abbott India is using elements of gamification in its customer services through a: care program. As the company Press Release says: ‘This new healthcare service is designed with games, quizzes and recognition programs to support patients, doctors and pharmacists throughout the entire healthcare journey, from awareness and prevention to motivation to get and stay healthy.’

In India, since quite some time, many well-known non-pharma companies are successfully using gamification for employee engagement and hiring.

Conclusion:

Unprecedented disruptions caused by Covid pandemic have considerably impacted the business operations of virtually every industry in India – just as other nations, across the globe. Since the onset of the pandemic, non-covid related medical centers, fitness institutions or gyms remained shut. Getting F2F – in clinic or hospital care, especially for non-Covid patients were also challenging for several reasons, with virtual care being the only options for many.

Interestingly, with most interactions and engagements – including learning, training and development programs going virtual, ‘Gamification’ initiatives started gathering wind on the sail, in some of those areas. This happened mainly because, organizations, institutions and people were driven to look for digital and app-based solutions for all needs and necessities, for a sustainable progress in an uncertain future.

An article on gamification, published in the PharmaPhorum on March 21, 2021, reiterated the same. It said, “Gamification” – adding game-like elements into non-game or real-world settings – has become a popular concept in the pharmaceutical, healthcare, and event industries, especially as virtual engagement becomes more common during COVID-19.’

With diverse applications and approaches, Gamification is quickly becoming a promising tool in various areas of pharma service and operations. These include, patient adherence, chronic disease management, preventive medicine, rehabilitation, besides better customer engagement, medical education, training, hiring and more.

From this perspective, in my view, pharma leadership now needs to more eclectic, and try using methods and approaches, such as, ‘Gamification’ – drawn from various other disciplines, in pursuit of excellence in the new normal.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Focus On Core Competencies – Regardless of Generic Or Innovative Drug Business

On February 11, 2021, by two different Press Releases, two global pharma majors – GSK and Novartis simultaneously made interesting announcements. Both were related to three generic cephalosporin antibiotics.

GSK revealed, ‘it has reached an agreement with Sandoz – a division of Novartis, to sell its Cephalosporin antibiotics business. Sandoz will pay GSK USD 350 million at closing, plus additional milestone payments up to USD 150 million, subject to the terms of the transaction.’

While articulating the purpose of hiving of its generic cephalosporin brands, the company reasoned: GSK is now dividing itself into two companies – one with core competencies focused on OTC products, and the other – prescription drugs and vaccines. The company emphasized: ‘The transaction aligns with GSK’s strategy to prioritize and simplify its portfolio and invest in the company’s innovative R&D pipeline and new product launches.’ Other brands in GSK’s antibiotics portfolio, are not impacted by this divestment. In other words, this would possibly mean that the generic drug business doesn’t fall within the core competencies of GSK, any longer.

Whereas, Novartis disclosed, the company’s Sandoz division, ‘has signed an agreement to acquire GSK’s cephalosporin antibiotics business, reinforcing its leading global position in antibiotics.’ Its noteworthy that Sandoz’s core competencies lie in the generic drug business.

While explaining the purpose of this acquisition, Novartis explained, cephalosporins being the largest antibiotic segment by global sales, acquiring these 3 leading brands - Zinnat, Zinacef and Fortum,“will further position Sandoz as a global leader in antibiotics – truly essential medicines that are the backbone of modern healthcare systems.”

The above transactions bring to the fore the criticality of focusing on core competencies for business excellence, regardless of innovative drug business and in multiple situations, such as:

  • Bringing organizational focus back on core competencies when these tend to get diluted.
  • Increasing the focus on core competencies as opportunities arise.

In this article, I shall revisit this critical management concept in the current perspective.

A brief recap:

The concept of core competencies of a business organization was introduced by two global pioneers in business management – C.K. Prahalad and Gary Hamel with the article – ‘The Core Competence of the Corporation.’ This was published in the May-June 1990 edition of the Harvard Business Review.

The relevance of focusing on ‘core competencies’:

The quality and quantum of commercial dividend in consistently focusing on ‘core competencies’ in any space, spanning across individual professionals to business organizations, have been profound. This calls for defining these in detail and collectively, at the top rungs of organizational leadership. Then, cultivate, and leverage the core competencies to differentiate an organization from its competition, creating a company’s long-term competitive and sustainable advantage in the marketplace – for business excellence.

What constitutes core competencies to gain strategic strength?

Core competencies – whether for individuals or for businesses, comprise primarily of resources, such as, special skills, capabilities and rewarding experience in those activities as strategic advantages of a business. Garnering financial resources would usually follow, thereafter. Thus, core competencies are always considered as a strategic strength, everywhere. That said, core competencies require continuous monitoring to always be in-sync with changing market dynamics. Otherwise, the strategies are likely to fail.

Broad examples – from pharma perspective:

Broadly speaking, discovering, developing and successfully marketing new drugs, identifying repurposed drugs for new clinical trials, and churning out novel vaccines quickly, may be considered as core competencies for innovative drug makers. They have demonstrated this skill even during Covid-19 pandemic. Similarly, immaculate skills in reverse engineering of existing drug molecules and high efficiency in process research to gain price-competitiveness, may be construed as core competencies of generic drug companies.

Examples of shifting focus on core competencies:

Although, it is desirable that pharma players stick on core competencies for sustainable long-term performance excellence, regardless of being in primarily innovative or generic drug business, we have witnessed this focus shifting on several occasions for both. However, expected success did not generally follow those companies with such tweaking in the strategic business models.

Nevertheless, some drug companies did get tempted to deviate from their core competencies. For example, innovative drug players tried to expand into low-risk generic medicines, which, in the long run, did not deliver expected results for many companies. However, this deviation wasn’t without any compelling reasons.

There were some valid reasons, though:

As is much known, traditionally, global R&D companies prefer to focus only on the business of innovative prescription medicines. Low margin generic business wasn’t their cup of tea. Subsequently, this trend shifted. Especially in those cases, where the pipeline of high potential new drug molecules did not meet the concerned company’s expectations. To stick to the knitting, some companies with deep pockets, explored another model of Mergers and Acquisitions (M&A) of innovative patented products and companies with rich new drug pipelines. Interestingly, in this M&A business model, low risk, low cost and high-volume turnover of generic business also started attracting several R&D based companies, alongside.

Which is why, an increasing number of R&D based companies started planning to expand their business in less risky generic drug business. This appeared to be a quick fix to tide over the crisis, as the generic drug business model won’t require going through lengthy R&D processes. Besides, compliance with ever increasing stringent regulatory approval protocols, particularly in the developed markets of the world.

Examples of why focus on core competencies matter, even in new normal: 

There are several examples of large companies to illustrate this point – both from the old and the new normal. Just to give a flavor of the relevance of focusing on core competencies of organizations, I shall draw upon three interesting examples. Each of these, highlight different organizational visions and perspectives at different times, particularly the relevance of focus on core-competencies for a corporation. These are as follows:

  • The first one is Daiichi Sankyo of Japan’s acquisition of India’s generic drug major of that time – Ranbaxy, in June 2008. The parent company claims: “We provide innovative products and services in more than 20 countries around the world. With more than 100 years of scientific expertise, our company draws upon a rich legacy of innovation and a robust pipeline of promising new medicines to help patients.” It is much known today, what happened to this acquisition, thereafter, for various reasons, including faulty pre-acquisition due diligence. However, later on, the domestic pharma leader – Sun Pharma, acquired Ranbaxy. Nonetheless, at least from Daiichi Sankyo’s narrative, its areas of core competencies, appear closer to any R&D-based drug company.
  • The second example is US-based Abbott Laboratories acquisition of domestic formulations business of Primal Heath care in India in May 2010. Like Daiichi Sankyo, this acquisition was also a part of Abbott’s strategy to enter into ‘generic drug business’ -dominated emerging markets. Abbott, at that time, apparently decided to expand its strategic focus beyond its core competencies in business, primarily of patented products. However, by the end of 2012, the company separated into two leading healthcare companies. Abbott became a diversified medical products company. The other one – a totally separate company was formed, with the name – AbbVie, as a new researched-based global biopharmaceutical organization. AbbVie now operates in India, as well – with erstwhile Abbott’s innovative brands. In this case, by an innovative restructuring of the parent organization, Abbott brought back its sharp focus on core competencies of both the companies with both doing well in India.
  • The third example is a recent move of reverting to the original focus of core competencies, when moving beyond these did not yield results. In that sense, this example is different from the second one. On November 16, 2020, Pfizer also announced the creation of ‘the new Pfizer’, as it reverted to its original core competencies of “developing breakthrough treatments and delivering innovative, life-changing medicines to patients around the world.” On that day, Pfizer completed transaction to spin off its Upjohn generic drug business and combined it with Mylan to create a new entity – Viatris Inc. Earlier, the company had sold its veterinary business, a baby formula unit and its consumer products division as part of a deal with GSK – for similar reasons. Earlier, the company’s moving beyond its core competencies to pluck low hanging fruits of generic drug business, did not yield dividend, as Pfizer’s profit in the generic drug sector, reportedly, had gone South.

Conclusion:

According to Pharma Intelligence, several large players, such as, Novartis, Sanofi, AstraZeneca are now focusing on core competencies, as they start recovering from their unsettling patent cliff and other headwinds. Meanwhile, one may expect to witness more of Spin-offs, Carving-out, Splitting-off or further strengthening of core-competencies of organizations – for a sustainable long-term business excellence in the years ahead.

Spin-off and acquisition of Cephalosporin generic business by GSK and Sandoz Division of Novartis, respectively, is a part of the same ball game. Thus, maintaining or reverting focus on core competencies – regardless of generic or innovative drug business, I reckon, are the new imperatives of commercial success, even in the new normal.

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

2020: Learnings From A Yearlong Catastrophic Disruption And Crystal-Gazing 2021

 Wishing All My Readers A Very Happy, Healthy, Peaceful and Prosperous 2021

Just a few days left for the year 2020 to merge with history. It will be remembered by all – as a year of all-round catastrophic global disruption. With unprecedented impact on human lives, livelihoods, economy, and ways of doing things – sparing virtually nothing. The sole cause of which is an unprecedented single event – Covid-19 pandemic. As of December 27, 2020 morning, India recorded a staggering figure of 10,118,392 new Coronavirus cases with 147,659 deaths. The threat of subsequent waves for further infection of Covid-19 infection continues.

In this article, I shall focus on some critical lessons learnt from the 2020 health crisis, while crystal-gazing 2021. I’ll do this purely from the health care perspective, in general, and the pharmaceutical industry, in particular. Keeping this in view, some of the lessons learnt during the pandemic are as follows:

A. Never allow a sense of hubris setting in:

This is easier said than done. Nonetheless, before the Covid pandemic played havocs with all, many top pharma leaders were, apparently, in a hubris. It was often laced with excessive confidence, if not arrogance. The predominant belief was nothing can go so wrong sans unfavorable policy decisions by the governments. This was against a much-known management dictum for all – always anticipate future probabilities that may impact the business and keep prepared for the worst, while hoping for the best. On a hindsight, this was, obviously jettisoned – lock, stock and barrel. No one was prepared for any biological threats, such as, Covid pandemic, till the deadly virus caught the humanity off-guard around December 2019, as we see below:

The pandemic was expected, but struck unexpectedly:

A pandemic wasn’t totally unexpected either. Therefore, they question that surfaces - Experts warned of a pandemic decades ago. Why weren’t we ready? Just in 2015, even Bill Gates, during a Ted talk titled, “The next outbreak? We’re not ready,” also predicted - based on available facts that an epidemic would kill millions in the future.

He further added: “If anything kills over 10 million people in the next few decades, it’s more likely to be a highly infectious virus rather than a war – not missiles, but microbes.” Gates further emphasized: “We have invested a huge amount in nuclear deterrents, but we’ve actually invested very little in a system to stop an epidemic. We’re not ready for the next epidemic.”

B. Research on anti-infective drugs shouldn’t be pushed to the back burner: 

These warnings were, apparently, ignored by the pharma industry. For example, as reported in the first quarter of 2020, many research-based pharma companies shifted ‘resources away from emerging infectious diseases into more lucrative areas like cancer treatment. Their business decisions risk leaving gaping holes in the fight against epidemics, such as the one caused by the novel Coronavirus.’

Let’s now take a pause for pharma players to ponder. Are they ready, at least now, with a robust plan – based on almost a year’s experience of an unprecedented agony along with its customers, specifically to counter any future biological threat? Be that as it may, there have also been some good outcomes out of the Covid crisis, both for the pharma industry and also for the health care customers.

C. The pandemic hastened pharma’s digital transformation process:

As is known, compared to many other industries, pharma industry was a late learner in the digitalization process of organizations. The new realities of disruptions caused by the pandemic had significantly expedited this process to keep the business going. There were no other effective options available, either, but to move beyond business stabilization and redefine how they do business. The IQVIA article, ‘Digital transformation in a post-Covid-19 world,’ published in the Pharmaceutical Technology, on August 31, 2020, also reiterated this point.

Elaborating the point further, the article pointed out: ‘As a result, acceleration of three key capabilities is occurring to create sustainable competitive advantage,’ as follows:

  • Digital capabilities with modern technology are enabling companies doing the right things during the pandemic and accelerating the process.
  • Providing access to granular data to support the extraction of precise insights into the needs of patients and physicians.
  • Ensuring capabilities for sustaining relationships. While face-to-face interaction has been dramatically reduced, relationships with HCPs and patients are taking new shapes and are of more importance than ever before.

D. Telemedicine came under mainstream care, supported by Government:

Finding no other viable alternatives during the Covid lockdown period and the need to stringently follow prescribed health measures, many patients were pushed to search for a robust digital solution for health care needs. Just as many of them were already using online platforms to meet other regular needs. In that sense, Covid propelled health care into a virtual world, bringing telehealth or telemedicine toward mainstream care, supported by the Government with a policy, for the first time, ever.

E. Quality of pharma response to pandemic enhanced industry image:

As I had discussed before in this blog, Consumer centric communications, driven by the  ‘hope and confidence as companies rushed to come up with COVID-19 vaccines and treatments’ of all, helped to significantly enhance the industry’s image during the year. In my view, pharma shouldn’t let go this opportunity to reposition itself, to reap a rich harvest in the years ahead.

Crystal-gazing 2021: 

A. A lurking fear will keep haunting:

Moving away from the outgoing year – 2020, if one crystal gazes the incoming – yet another brand-new year – 2021, a lurking fear still haunts most peoples’ minds. Will the all-round disruptions of 2020 be the new normal in 2021 – with no further escalation of the current situation?

B. Vaccine rollout will reduce rapid spread, but not eliminate Covid-19:

Gradual rolling out of vaccines may reduce the rapid spread of pandemic, provided Covid-19 doesn’t throw more surprises, such as, complicated mutation, blunting this initiative. However, currently available evidence indicates, the new variant could be more transmissible, yet vaccines may work very well against it.

 C. Masking, physical distancing, hand washing, etc., will continue:

Besides, many yet unknown side effects, the duration of immunity following coronavirus vaccination is still largely unknown due to the simple lack of time we’ve had to study such immune responses. Moreover, the trials do not tell us if the vaccines can block the transmission of the disease from those who are asymptomatic and have been vaccinated. Thus, masking, physical distancing, hand washing, testing, treating and contact tracing, reportedly, will continue to be important in the global campaign against COVID-19, even after vaccine rollout.

D. NDDS for Covid drugs and vaccines may come: 

New formulations, new Covid drug delivery systems, newer methods to bring Covid vaccines, like nasal sprays, in a powder form for easy transportation and to reach more people around the world, are expected to commence in 2021.

E. Waiting for going back to pre-Covid game plan is a losing strategy:

Vaccines are unlikely to take us back to pre-Covid time, any time soon. Even McKinsey & Companypredicted the same in its article: ‘‘How COVID-19 is redefining the next-normal operating model,’ published on December 10, 2020. It emphasized: “With everything disrupted, going back to the same old thing is a losing strategy. The strongest companies are reinventing themselves by embracing pandemic- driven change.”

Many pharma majors are also echoing the same, even as Covid-19 vaccines have started rolling out for public in different parts of the world. After weighing-in the pros and cons of waiting, many of them have articulated: ‘We will not return to the old ways of working.’ They believe, it’s too early to put a specific timeline on turning that page now. Hence, the year 2021, working of the pharma companies is unlikely to be significantly different from the year 2020.

F. Need to capture and respond fast to changing customer behaviors:

Covid-19 pandemic is fast changing many human attitudes and behaviors, forcing organizations to respond. ‘However, the need to respond won’t end when the virus’s immediate threat eventually recedes,’ reaffirmed the Accenture article ‘COVID-19: 5 new human truths that experiences need to address.’ The massive behavior changes of key pharma stakeholders, at a never before scale and speed, will continue to prompt many leading drug companies to respond to them with well thought through digital tools, to gain competitive advantages.

G. Virtual meetings with reps, doctors and others will continue:

As witnessed in 2020, often for the first time – virtual meeting of sales reps, key opinion leaders and others will continue in 2021, even after ‘live’ ones return, but with more innovative structure and content. Pharma marketing’s long awaited and comprehensive digital foray will continue gaining a strong foothold, entering into new areas, without glancing back over the shoulder, in 2021.

H. More new drug launches will move entirely digital:

It began in 2020. For example, dozens of new drug launches moved entirely to digital, for the first time in 2020. As a pharma leader remarked, with the traditional launch framework gone during the pandemic, “we had to throw out the playbook and really embed into people’s heads that playbook is no longer meaningful. It no longer works, and we have to think outside the box.” She further added: “There’s truly no bigger place for a marketer right now. This is the new world.” None can deny this fact as we enter into the new year.

I. Success requirements of pharma professionals will be different:

With significant transformation of pharma’s operational strategies, success requirements of pharma professionals will also be significantly different in the new normal. Quick capturing and fast adaptation to the changing customer behavior for multi-channel engagement digital platforms, will be fundamentally important – not just for business excellence, but for its long-term sustainability, as well. This is a totally new and highly cerebral strategic ballgame, where obsolescence of cutting-edge technology is much faster than anything in the tradition driven old normal.

J. More pharma companies will explore inorganic growth opportunities:

More pharma companies will look for acquisitions to bridge the strategic gaps, as AstraZeneca did in 2020.

Conclusion:

In 2021, Covid Mayhem may possibly be over with a gradual rollout of vaccines. But, the impact of utter disruptions that the pandemic has caused in multiple areas of businesses in 2020, especially within the pharma industry, would continue, as we step into 2021. As the drug industry overwhelmed by Covid-19, reset themselves with the digital transformation in the new normal -for growth beyond Coronavirus, one may also view this much awaited metamorphosis, as a blessing in disguise, as it were.

Overall, as the W.H.O observed very rightly on December 27, 2020: “We throw money at an outbreak, and when it’s over, we forget about it and do nothing to prevent the next one. This is dangerously short-sighted, and frankly difficult to understand.” He further added: “History tells us that this will not be the last pandemic, and epidemics are a fact of life.” I hope, all concerned will realize this point in 2021. Alternatively, we may need to keep ourselves prepared to move, in a similar way, from the current new normal to yet unknown next normal.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 


A Rare Strategic Acrobatic Feat in Covid Time

‘Keep nose to the grindstone while lifting eyes to the hills.’ Quite a while ago, all-time global management guru – Peter Drucker used this essential acrobatic feat as an example, for the business strategists. This illustration signifies the criticality of harmonizing decisions affecting both the short and the long-term goals of an organization, for a sustainable business excellence.

In most recent times, the pharma major AstraZeneca that has virtually become one of the household names, for developing a Covid-19 vaccine candidate with the University of Oxford, has performed the above acrobatic feat – with precision. During the prevailing unprecedented health crisis, the Company has unequivocally proven that it remains on course – in achieving its dual objectives, as Drucker had prescribed in his management classic – ‘The Practice of Management.’

It happened in tandem – without getting overwhelmed by the disruptive forced of Covid pandemic, unlike most others. Immediately, the Company focused on an urgent objective of saving the humanity – by developing, manufacturing and delivering a Covid vaccine to the world, in a record time. This was possibly a relatively short-term goal. And closely followed the other – a critical strategic decision for the organization’s long-term sustainable business excellence.

I have discussed before, the Company’s first initiative – developing a Covid vaccine candidate with the University of Oxford. Hence, in this article, I shall focus on two other related areas:

  • Deadly impact of rare diseases in some Covid infected young patients.
  • Why not some large Indian companies also explore similar strategies as demonstrated by AstraZeneca – and the reasons behind the same?

Before going into those areas up front, let me start with a brief description of AstraZeneca’s intent to expand its footprint in the of area of rare diseases, besides immunology area to help treat rare types of cancer.

The acquisition:

On December 12, 2020 AstraZeneca announced that to accelerate its strategic and financial development, the company will acquire Alexion valuing $39 billion. Subject to all statutory approvals, the deal is expected to close in the third quarter of 2021. Interestingly, Alexion’s top brand – Soliris, is the world’s one of the most expensive drugs in the world. It is prescribed to treat a rare – life-threatening blood disease paroxysmal nocturnal hemoglobinuria (PNH). Incidentally, rare diseases have also some significant relevance for Covid infected patients. Let me now recapitulate, some key aspects of rare diseases.

Some key aspects of rare diseases: 

Rare Diseases (RD) – also referred to as Orphan Disease (OD), are diseases affecting a small percentage of the population, and include genetic diseases, rare cancers, infectious tropical diseases and degenerative diseases. There is no universally accepted definition of a rare disease, yet. Different countries define these differently. However, the common considerations in the definitions are, primarily, disease prevalence and to a varying extent – severity and existence of alternative therapeutic options.

Impact of some rare diseases in Covid infected patients: 

Since the beginning of the Covid pandemic, people with underlying diseases, such as, hypertension, diabetes, cardiovascular and kidney disorders, are considered to fall in the high-risk group. They are more likely to have severe disease and complications and need to be extra cautious of the infection. Importantly, it has been recently reported that some rare diseases also increase risk of dying during Covid-19 pandemic at a younger age.

For example, as reported on December 07, 2020, recent studies indicate, rare autoimmune rheumatic diseases increase risk of dying during Covid-19 pandemic for younger patients. The researchers also found that women with rare autoimmune rheumatological diseases (RAIRD) had a greater increase in all-cause mortality rates during the pandemic when compared to men with RAIRD. However, there seems to be an India specific issue also in this situation, as well.

India specific issue for Covid infected patients with some rare diseases:

Some India specific issues on RD, could have a significant adverse impact on Covid infected patients in the country. One such critical issues is the ‘Baseline Knowledge of Rare Diseases in India.’ This fact was well captured in an important survey that was published with the same name, as an original article, in the ‘International Journal of Rare Diseases & Disorders,’ on November 06, 2019.

The study noted, among others:

  • Although, rare diseases have recently received worldwide attention, the developing countries are seriously behind in regard to awareness, drug development, diagnosis, and social services, in this area. India, which has one-third of the world’s rare disease population, has no accurate assessment of the problem.
  • The drugs for ‘Rare Diseases (RD), also called Orphan Drugs (OD)’, often cost exorbitant with difficulties in diagnosis and treatments.
  • Indian policymakers want to find out the number of RD and the extent of the population suffering from them and help provide treatment for them, which is a challenging task with 1.45% GDP health care budget for 1.3 billion people.
  • The health care professionals appear to have some awareness as compared with non-healthcare professionals, but even among health care professionals, only one third had a rudimentary understanding of RD and OD, whereas three-fourths have virtually no knowledge of RD.
  • Forty-three percent of health professionals had not seen rare disease patients, and a large percent of practicing physicians had not seen even one rare disease patient in their entire professional practice.

Thus, it is clear from this survey that the most important issues are awareness and diagnosis, as many rare diseases are not diagnosed or possibly misdiagnosed. Besides, the survey also observed, since 1983, many global companies started developing orphan drugs after the Orphan Drug Act implementation. There is none at this time in India, although in 2017, the Drugs & Cosmetic Act. 1945 has been amended to include “rare diseases and orphan drugs”.

The National Policy on Rare Diseases flagged some of these facts:

The ‘National Policy on Rare Diseases 2020,’ for India, released by the Union Ministry of Health on February 07, 2020, acknowledged many of these important facts. It also said, ‘Considering the limited data available on rare diseases, and in the light of competing health priorities, the focus of the draft policy is on prevention of rare diseases as a priority as identified by experts.’

Interestingly, the first of such policy was prepared by India in 2017 and a committee was appointed to review it in 2028. However, recently published the National Policy on Rare diseases, has also noted one more important point. It noted: ‘Paradoxically, though rare diseases are of low prevalence and individually rare, collectively they affect a considerable proportion of the population in any country, which according to generally accepted international research is – between 6% and 8%.’ Currently, India, reportedly, doesn’t have any registry of rare disease, which has now been entrusted to the Indian Council of Medical Research (ICMR) in the National policy.

Common symptoms can hide underlying rare diseases, leading to misdiagnosis:

The above policy has also noted, rare diseases are characterized by a wide diversity of signs and symptoms that not only, reportedly, vary from disease to disease, but also from patient-to-patient suffering from the same disease. Importantly, relatively common symptoms can hide underlying rare diseases, leading to misdiagnosis.

During Covid treatment, similar circumstances could lead to a serious life-threatening situation. The 2020 RD Policy also reiterates: “Early diagnosis of rare diseases is a challenge owing to multiple factors that include lack of awareness among primary care physicians, lack of adequate screening and diagnostic facilities etc.” That said, yet another key question arises – will developing and marketing such drugs be profitable for the pharma industry?

Will developing such drugs be profitable for the pharma industry?

It is worth noting that the National Policy on Rare Diseases 2020, aims more at lowering the incidence and prevalence of rare diseases based on an integrated and comprehensive prevention strategy, rather than ensuring patient access to affordable treatments. Nonetheless, it also says, within the constraints on resources and competing health care priorities, India will try to enable access to affordable health care to patients of rare diseases which are amenable to one-time treatment. In general, the policy suggests, ‘voluntary crowdfunding for treatment’ of rare diseases.

With this being the prevailing situation in India, even during Covid pandemic, an interesting article – ‘How Orphan Drugs Became a Highly Profitable Industry,’ published in The Scientist, noted some important facts in this area. It highlighted: ‘Government incentives, advances in technology, and an army of patient advocates have spun a successful market—but abuses of the system and exorbitant prices could cause a backlash.’

It also articulated, despite higher costs and less-certain returns, investments in drug development on the rare diseases side appear to ‘be bucking the trend.’ The result of the global focus on RD nowadays is: ‘Firms with marketing authorization for orphan products, are now more profitable than those without.’

This also partly explains the financial rationale behind AstraZeneca’s recent acquisition of Alexion Pharmaceuticals, valuing $39 billion.

Conclusion: 

As of December 20, 2020 morning, India recorded a staggering figure of 10,031,659 of new Coronavirus cases with 145,513 deaths. The country has already crossed 10 million in Covid cases as the vaccine approval remains pending. The threat of subsequent waves for further spread of Covid infection continues to loom large in many states. Meanwhile, many studies indicate that comorbidity should now include rare diseases, as well, especially to prevent deaths in younger patients. From this perspective effective diagnosis and treatment of RD are also coming under spotlights. Curiously, the National Policy on Rare Diseases 2020 focuses more on awareness and prevention of RD rather than access to affordable treatment, particularly in Covid infected patients to save precious younger lives. As I wrote previously and still believe, the ‘National Policy on Rare Diseases’ becomes more meaningful with ‘Orphan Drugs Act.’

Vaccines to prevent Covid infections are also expected to get emergency approval in India, shortly. At lease, some of these being available at affordable prices, including AstraZeneca-Oxford vaccine, according to reports. As recent reports indicate the same company, is also entering into RD therapy areas, through a key acquisition, yet another hope looms large. A hope for availability of relevant RD drugs at an affordable price for Covid infected patients, despite other apprehension, as I wrote before.

That apart, purely from the business management perspective, as well, this rare strategic acrobatic feat of AstraZeneca - ‘Keep nose to the grindstone while lifting eyes to the hills,’ during the Covid crisis, I reckon, is exemplary for the practicing managers.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.