Mindset Change: Now A Bigger Factor in The Rise And Fall of Pharma Corporations

Currently, in the pharma industry across the world, almost everyone is talking, thinking, and trying to implement several significant changes – just to be in sync with the changing customer needs and market expectations. As Covid vaccination process gathers momentum with markets gradually opening up, many envisage even much bigger changes. Such changes encompass, medium to long-term strategic thinking process, re-engineering business operations, customer-centric new value creation and value delivery mechanism in the new normal.

Several pharma players have also started expressing it explicitly, even on their websites. One such example is a Novartis communique of January 21, 2021. It says: COVID-19 was a catalyst for change in healthcare during 2020 – an accelerator for digital health. As the virus spread exponentially, the world was forced to work virtually, wherever possible. Digital solutions were needed fast – not just to support remote working, but to keep the very fabric of business, healthcare, education, and essential services in operation. The need to cope with multi-faceted pandemic–triggered challenges of change, prompted the rise of digital health as the only viable option of the time, as it were. In the following months thereafter, it has set some emerging trends for digital innovation to meet global healthcare needs, which will continue through 2021.

The communique underscored: “For Novartis and many other pharmaceutical companies, the challenge was not just to enable employees to continue working, but to ensure that medicines reached patients as needed, and that healthcare professionals (HCPs) had the information they required to support their patients’ questions and needs. It was also essential to make sure that clinical trials remained on schedule and the development pipeline continued.”

Similar mindset was exhibited by many other pharma companies when the chips were down, and Covid vaccines were under development or just had hit the markets. Its impact, got reflected in The Harris Poll Survey of February 2021, which reported a peak positive rating of 62% for the image of the pharma industry – an incredible turnaround from 32% of just the previous year.

Therefore, the question, arises – with Covid vaccination initiatives gathering steam what will major pharma players, both local and global, possibly do? Will they use the pandemic period experience as a springboard – for more innovation of all kinds to reap a sustainable harvest – with an ongoing customer-centric mindset? Or they will try to get back to the old normal – with self-serving interests – till it stings – very hard. This article will explore that area.

What prompts the above questions?

The above questions are prompted by the fact that since then, pharma industry’s image slipped from a peak positive rating of 62% in February as the vaccine rolled out and then dipping to 60% in May and now at 56%, according to The Harris Poll Surveys. Thus, many wonders – ‘is it time to ask whether the halo around COVID-19 vaccine and treatment innovation is gone?

Further, some recent instances on pharma’s reverting to self-serving interests, could also play some role in this regard. Interestingly, notwithstanding pharma’s image going south after achieving a peak of 62%, the ghost of unreasonable drug pricing appears to haunt again.

As an illustration, amid Covid pandemic, the public perception that pharma companies’ business practices changed – from mostly self-serving interest orientated – to meeting customer value and expectations, did not last long. Several actions akin to pre-Covid period, went against the above perception. These include, Covid vaccine prices and Biogen’s $56,000 (Rs.40 lakhs/year in India) price tag for its recently approved Alzheimer drug – Aduhelm that requires monthly infusions with no clear limit on treatment duration. No wonder, Alzheimer’s Association, reportedly, finds this price simply unacceptable,’ as it further “complicates and jeopardizes sustainable access to this treatment” and could further deepen health equity issues.

I reckon, how pharma companies conduct their strategic business operations from now on will possibly reveal the nature of Covid-triggered changes, if at all, within the industry. Industry watchers generally believe the majority will follow the digital transformation path with a new organizational culture, and an agile mindset to always be in sync with stakeholder values and expectations. However, there are also some, who want to mostly revert to the pre-pandemic business culture, practices, and mindset. It will be interesting to know what some top ‘Think Tank’ of the pharma industry envisage.

What some top pharma ‘Think Tank’ envisage: 

Notwithstanding some recent developments as mentioned above, which could be outliers, some top pharma think tanks are quite optimistic about the continuity of Covid triggered positive changes in the industry. For example, in an interview with Pharmaceutical Executive, published on May 19, 2021, a current Amgen Board Member and former CEO of several global pharma majors - Fred Hassan, made some profound statements.

He reiterated, ‘COVID-19 has accelerated the ongoing shift to enterprise-level digital transformation across Fortune 500s.’ Fred further emphasized, “the impact of digital in helping transform the customer experience or to improve efficiencies, is now a bigger factor in the rise and fall of corporations. Astute C-suite executives recognize the opportunity to not only enable, but to also empower their teams to quickly embrace digital as a differentiating tool.” 

A journey – not just a destination:

The above interview further underscored – ‘Digital transformation is a journey — not just a destination.’ The speed of transition to digital must be accompanied by sustainability. It should take all stakeholders on board in the journey of change. The key requirement is to ‘actively energizing the entire organization so that people internalize the digital mindset to help empower their customers, their own company and themselves, as individuals.’

More importantly, ‘Dithering around scaling past the initial digital pilots, is rapidly becoming an unacceptable option,’ as Fred Hassan cautioned. Which is why, while the C-suite needs to actively lead during a digital transformation, they must leverage the commitment of their middle management to motivate front line managers to keep following through with passion, courage, and tenacity. This is because: ‘Digital transformation is a journey – not just a destination.’

Indian pharma suddenly had to ride the wave of digital transformation:

The unprecedented pandemic literally compelled most Indian pharma companies of all sizes, to ride the digital wave in business, mostly for survival – to keep the business operations running. However, with the passage of time, Covid related disruptions started accelerating their journey for digital transformation – at a varying pace, though. This was also reported in the KPMG paper – ‘India’s healthcare sector transformation in the post-COVID-19 era,’ published on February 01, 2021.

The paper also articulated that this unprecedented health crisis “have not just laid bare the myriad challenges and gaps in our health system, but also highlighted the importance of investing in ‘well-being’ at both personal and system levels. It has ushered in an era of digital and technological innovations and advancements that is expected to help communities fulfil those requirements at a much faster pace.”

The pandemic has also accelerated the pace of evolution of ‘Smart Healthcare’ in India. This is also not a destination, but a journey with the digital transformation process, where changing or flexible mindset of the leadership, is the catalyst for change.

‘Smart Healthcare’ is also a digital journey:

As more and more health care customers are entering the digital space, triggered mainly by Covid appropriate behavioral norms, Virtual Healthcare initiatives are also increasing manifold, backed by robust supports from the Government. As a result, several integrated ‘Smart Healthcare’ platforms like Telemedicine, are now, reportedly, being, considered as the “Natural evolution of healthcare in the digital world.” Specifically, in the Indian scenario of low doctor to patient ratio, telemedicine has the potential to be one of the frontline health care value delivery systems, in the “new normal.”

Capturing early signals for such changes in the market trends, and leveraging the same to create a win-win situation for both the company and stakeholders, would necessitate a changing or flexible pharma leadership mindset. The reason being the digital transformation of an organization is an ongoing process with increasing rate of obsolescence of digital tools, platforms, and applications. Let me illustrate this point taking ‘Smart Healthcare’ as an example.

‘A bigger factor in the rise and fall of corporations:’

In today’s digital environment any transformation initiative is a continuous journey, and not a one-time exercise. Digital transformation of an organization – if, as and when pursued for business excellence in the new normal, would demand, at least, two big leadership commitments. These constitute – one, to continuously exceed stakeholder expectations in value delivery, and the other – a changing mindset that always puts customer perceived value on a higher pedestal than a company’s self-perceived value, both for product and services.

For example, for telehealth to carve out its niche as a dominant force in health care after the pandemic ends, will depend on how successfully virtual health care is humanized that will allow physicians and patients to build and maintain trusting relationships. These issues were well deliberated in Harvard Business Review article – ‘3 Ways to Humanize the Virtual Health Care Experience,’ published on March 25, 2021.

The paper concluded by emphasizing, the future rate of adoption of telehealth will ‘heavily depend on its ability to support a trusting relationship between patients and physicians. As provider organizations choose telehealth technologies and digital health companies develop new tools, they must keep the core human needs of both patients and physicians front and center.’

Conclusion:

The above examples clearly point out that any digital transformation process, be it of a corporation or of a system, such as telehealth, is a journey and not a destination. To successfully leverage the benefits of moving into a digital frontier would call for a changing or a flexible mindset of the provider or its leader.

This requirement undoubtedly, therefore, is ‘a bigger factor in the rise and fall of corporations,’ or any digital application, platform, or a system. Which is why, as many believe: ‘pharma still needs to be on its front foot and pushing forward,’ in the new normal. Going back to the traditional practices of the old normal is not an option, any longer.

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.

 

 

Global API manufacturers are poised to penetrate the Indian market in a bigger way – will the API ‘marketing warfare’ be even more intense, in future?

India currently plays a relatively dominant role in the Global Active Pharmaceutical Ingredient (API) Market with China being ahead of India. While this is the current scenario, many experts in this field contemplates that important players from the regulated markets will soon start making significant inroads in India.Current API Market situation in India:In 2007 the API output value in India was around US $4.1 billion registering a 5 year CAGR of around 19% and ranking fourth in the world API output. According to the Tata Strategic Management Group, Indian API export value is expected to increase to US $12.75 billion in 2012.

Currently in India about 400 different types of APIs are manufactured in around 3000 plants, Ranbaxy Laboratories, Lupin, Shasun Chemicals, Orchid Chemicals, Aurobindo Pharma, Sun Pharmaceuticals Ipca Laboratories and USV being the top API manufacturers of the country. Indian domestic companies source almost 50 percent of their API requirements from China, because of lower cost in that country.

In terms of global ranking, India is now the third largest API producers of the world just after China and Italy and by 2011 is expected to be the second largest producer after China. However, in Drug Master File (DMF) filings India is currently ahead of China.

In addition, India scores over China in ‘documentation’ and ‘Environment, Health and Safety (EHS)’ compliance. All these have contributed to India having around 100 US FDA approved world class manufacturing facilities, which is considered the largest outside the USA.

Indian API manufacturers are facing a cut throat competition from their Chinese counterparts mainly because of lower costs in China. Considerably higher economies of scale and various types of support that the Chinese API manufacturers receive from their Government are the main reasons for such cost differential.

Growing competiton from the regulated markets:

We now observe a new trend within the API space in India. Many of the global innovators and generic companies are keen to enter into the API space of India.

It is known that API manufacturers from the regulated markets are already selling their products in India. However, at present, the numbers of Indian registrations for API applied by some of the large global companies, as reported by ‘Thomson Reuters Newport Horizon Premium’, are quite significant, which are as follows:

1. Novartis, Switzerland:20
2. Pfizer, USA:16
3. Sanofi-Aventis, France: 26
4. Teva, Israel: 45
5. Schering-Plough, USA:39
6. BASF: 37
7. DSM: 26
8. E.ON AG: 16
9. Kyowa Hakko: 23

All these companies who are entering into the API business space in India, I am sure, have worked out a grand design to compete not only with the the low cost domestic API manufacturers, but also with the cheaper imports, particularly from China.

What will then be the competitive edge of these companies in India?

It appears that each of these companies has weighed very carefully the existing strategic opportunities in the API sectors of India, both in terms up technology and also in terms of domestic demand.

Strategic gap in API manufacturing technology:

India, undeniably, is one of the key global hubs in the API space, with competitive edge mainly in ‘non-fermentation technology’ product areas. This leaves a wide and perceptible technological gap in the areas of products requiring ‘fermentation technology‘.

Significant demand from domestic formulations manufacturing :

India is much ahead of China in pharmaceutical formulations manufacturing, especially in the area of exports to the regulated markets like, the USA and EU. Over 25 domestic Indian companies are currently catering to exports demand of the U.S market. However, it is interesting to note that the global manufacturers like Sandoz, Eisai, Watson, Mylan have already set up their formulations manufacturing facilities in India and some more are expected to follow suit over a period of time. Hence, fast growing domestic demand for APIs, especially for exports, will drive the business plan of the global API players for India.

Is the cost advantage in India sustainable?

Indian API manufacturers although currently have a cost advantage compared to their counterparts in the regulated market, this advantage is not sustainable over a period of time because of various reasons. The key reason being sharp increase in cost related to more stringent environmental and regulatory compliance, besides spiralling manpower and other overhead costs.

Indian regulatory requirements for the global API players:

To sell their APIs into India, global companies are now required to obtain the following regulatory approvals from the Indian authorities:

1. Foreign manufacturing sites for the concerned products
2. APIs which will be imported in the country

The Drug Controller General of India (DCGI) has stipulated a fee of U.S$1,500 to register the manufacturing premises and U.S$1,000 to register each individual API. Since January 2003, around 1,200 registration certificates have been issued in India. Large number of Indian registrations is attributed by many to the strategic technology gap in India, as stated above, demand of high-quality API for finished formulations required by the regulated markets like the U.S and EU, and relatively cheaper product registration process.

As we see above Teva has gone for maximum number of Indian registrations, so far and most probably selling the APIs to their contract formulations manufacturers in India. Similarly, Schering-Plough and Sanofi-Aventis, if not Pfizer are perhaps catering to the API demand of their respective formulations manufacturing plants in the country.

Whatever may be the reasons, these global players are now exporting APIs at a much larger scale to India and in that process have started curving out a niche for themselves in the Indian API market. Impressive growth of the domestic pharmaceutical formulations manufacturing market fueled by increasing domestic consumption and exports to the regulated markets, coupled with gradual improvement in the regulatory environment of the country, is expected to drive the growth of API business of the global players.

However, the moot question is how significant will this competition be?

By Tapan 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.