Is Pharma Industry A Late Learner, Always?

Several upcoming concepts in the pharmaceutical industry are becoming buzzwords today. But, most of these were recommended by stalwarts several decades ago. Interestingly, the prevailing scenario is no different, even related to wide-scale adoption of a number of cutting-edge technologies, to squarely face the ongoing challenge of changing market dynamics. Various studies point out that other industries are making transformative use of these – to be on the same page with their customers, much faster.

Pharma is considered to be a late entrant in the digital space, too. It’s still not quite clear to many, the extent by which ‘Digitalization’ is transforming the way pharma industry functions – aiming at unleashing huge opportunities for value creation – from supply chain to manufacturing – right up to creating a unique customer experience. As this subject was well deliberated in the August 2016 article on McKinsey Digital, I am not going to delve into that area today.

Therefore, the question that comes up: Is pharma industry, in general, a late learner – always, to be in sync with its contemporary customers? For exploring this point, I shall focus mainly on four areas of current hypes in the pharma business, namely - ‘patient empowerment’, ‘patient-centricity’, ‘customer experience’ and ‘E-Patients’.

In this article, I shall dwell on this subject, ferreting out some critical recent findings on the relevance of these not so recent concepts in today’s perspective. Let me start by diving deep into the time capsule.

How old are these concepts?

Industry watchers may know that these are not new concepts, in any way. The relevance of ‘patient empowerment’, ‘patient-centricity’, ‘customer experience’ and ‘E-Patients’ in the drug industry has not unfolded today, neither are these new ideas. The American medical doctor - Thomas William ”Tom” Ferguson (July 8, 1943 – April 14, 2006) was an early advocate for ‘patient empowerment’.

Since 1975: “He urged patients to educate themselves and share knowledge with one another and urged doctors to collaborate with patients rather than command them. Predicting the Internet’s potential for disseminating medical information long before it became a familiar conduit, he was an early proponent of its use, terming laymen who did so – ‘E-Patients‘.”  

Technology follows a concept and not vice versa:

With ‘E-Patient’ terminology, Dr. Thomas Ferguson talked about empowered, engaged, equipped and enabled patients. I reckon, even after close to 45 years, most of the drug industry, is still not quite there – ‘Digitalization’ initiatives notwithstanding. This is because, technology follows a concept and not vice versa.

Why it’s so?

I reckon, this is primarily because, many stakeholders often don’t pay much importance to a critical fact, which is: ‘Patient expectations and needs can differ considerably from the aims and objectives of health care providers, at both the policy and delivery levels,’ and also by many drug companies. Still, most of these entities are yet to lap up this concept.

Is reviving focus on ‘Patient Centricity’ a realistic proposition today?

Several studies in this area have concluded, to be accepted by patients, the patient experience should be the key driver for the development of solutions.’ These include, medicines, devices, information, support programs and even digital apps. Among many others, one such study was published on March 28, 2017, in the SAGE Journals, titled, ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?’

The basic question of its feasibility would prompt: ‘Would this approach help pharma players to make enough profit with the drugs?’ While addressing this query, the researchers put across the following points that need to be seriously reflected on:

  • Profit is necessary. But, how drug companies make and use business ‘profit’ is more important for long-term business sustainability.
  • It requires a clear vision at the top of creating and delivering ‘customer value’ as patients will perceive, followed by a robust assertion of ‘Patient Centricity’ across the business domains.
  • This will help break out of the cycle of “recover costs of R&D – make a profit – invest in new drugs – make more profit.” The new ball game will be – profit through customer satisfaction – invest in new drugs for greater ‘customer value and more customer satisfaction’
  • Such commitments, in turn, will help generate not just reasonable profit, but credibility with external stakeholders – such as, patients, regulators, media, etc. – creating an invaluable reputation for the organization, as a future growth booster.

Since old practices have continued for very long, virtually unchanged, a legacy factor has now crept into the system, mostly as a retarding force.

A legacy issue to overcome:

As the above research article underscores: ‘Historically, the pharmaceutical industry’s role has been to develop the science and medicines for prevention or treatment of disease.’ Whereas, ‘Patient Centricity’ involves patients as stakeholders in this scientific process. It calls for an innovative mindset, whereby ‘the industry is challenged to engage and collaborate with patients when deciding the best course of action.’ This need is now palpable within the industry, at the long last. 

Palpable needs for a new focus on designing ‘healthcare solutions’:

With the shift in the environment around the industry and its stakeholders, including patients, are feeling the need to ferret out some old classic concepts for a new focus in designing various ‘healthcare solutions.’ For this purpose, as the above research article reiterated, a better understanding of ‘patient experience’ at critical points, in the course of the diagnosis and treatment of the disease, would help designing more effective ‘health care solutions’ for better patient outcomes.

The commercial necessity for better patient outcomes, merits ‘Patient Centricity’ at the core of the pharma business model, which, in turn, calls for a shift in the cultural mindset within the pharmaceutical industry. Such a shift would involve, among others:

  • Redefining the core strategy, organizational structure, processes and capabilities to focus on transparency and value creation for the patient.
  • A change from a disease-centered to a patient-centered strategy, and from a product-led to a patient-led development process.
  • Listening to and partnering with patients, and understanding the patient perspective, rather than simply inserting patient views into the established process.

Therefore, ‘patient-centric’ initiatives of any company should begin with the basic question: how can the company make a difference for patients?

The new realization: Compete better to win, neutralizing healthcare consumerism:

To better compete and win even in the midst of evolving healthcare consumerism, instead of adding fuel to it around the world, including India, a new book – ‘Making the Healthcare Shift: The Transformation to Consumer-Centricity,’ brings some contemporary ideas where, again, many old ideas seems to have been tested with a new perspective.

Interestingly, the content of this book is based on over 60 executive interviews with the biggest names in healthcare and a quantitative research study. Some of these names include leading academic institutions, such as, the Mayo Clinic, USCF Medical Center; big drug companies like Pfizer, Lilly and Novartis. The book reveals, while healthcare organizations have recognized the need to change to ‘Patient Centricity, they often don’t know where or how to begin.

To help healthcare organizations reinvent how even traditional pharma players engage with consumers in the new paradigm, the authors identify five shifts that pharma players can make to better compete and win in this evolving landscape of healthcare consumerism. 

Need to ‘reinvent the wheel’, is more than ever before!

To ascertain the above point, I shall paraphrase just a few – ‘Patient-Centric’ and ‘Customer Experience’ related areas of the book along with my own views to help you to come to your own logical conclusion:

  • To provide a holistic disease treatment solution, keeping the patients engaged along the entire journey in the disease treatment process, pharma players should bring ‘consumer experience’ at the core of the business model. As I also deliberated in this blog that: ‘Enhancing End-To-End Customer Experience’ is, therefore, considered by many astute pharma marketers, as a vital ingredient of pharma brand building exercise. In that article, I articulated, such initiatives should cover, all the ‘’touchpoints’ and ‘episodes.’ Where ‘touchpoints’ are spots of contact or interaction and ‘episodes’ focus on end-to-end design of a specific customer-need for an organization. Aligning management and the front line around the customer experience, is critical.
  • As things stand today, the entire journey through the disease diagnosis and treatment process, in the current healthcare ecosystem, remains fragmented. Mostly because, it involves many ‘touchpoints’ and ‘episodes,’ comprising of different health care entities. Providers’ inefficiencies, of various types, encountered by patients at different points of this journey often lead to their frustration, causing an unpleasant ‘customer experience.’ To achieve this objective, by effectively addressing the aforesaid common denominator for all – ‘Patient-Centricity,’ is of paramount importance. This entails, as stated before, integrated measures for listening to and partnering with patients, alongside, placing patients’ well-being at the core of all healthcare business initiatives. From this perspective, ‘patient-centricity’ based on customer insights,represents a holistic approach to provide the disease management solutions.
  • With rapid advancement in medical science, culminating into several breakthrough innovations, the world has stepped into a new era of disease treatment solution. Increasingly, ‘one size fits all’ type of population-centric treatment, is giving away a sizeable space for a new ‘patient-centric’ variety of the same. Moving towards this direction would necessitate pharma players, along with all health care organizations to acquire a deep insight on patients. The acquired insights must be based on in-depth analysis of a robust and contemporary sets of data, including demography, attitude towards health, treatment needs and preferred options available to the targeted audience.

This brings me back to where I started from. Dr. Thomas William ”Tom” Ferguson and maybe several others, as well, had recommended similar approaches over four and a half decade ago. We did not learn it then. But, while fighting against all odds, as the industry has been facing over some time, some companies are feeling the need of learning it now. Better late than never!

Conclusion:

It has been universally accepted that market dynamics keep changing in all industries, may be faster in some than others. Looking back, one can sense similar ongoing changes both within the pharma industry and the business and social and cultural environments outside, especially related to its stakeholders. When faster, proactive changes take place within the industry than outside, it delights the customers. Similarly, faster changes in the outside environment that industry fails to keep pace with – deliberately or otherwise, will invite strong headwind impeding growth of the business and even denting its reputation. Although, the former one is desirable, the latter prevails in most areas of pharma business. A Working Paper of the Harvard Business School wanted to understand ‘How do organizations learn?’ It found, among others:

  • Performance outcomes can be augmented, if one deliberately focuses on learning from experience accumulated in the past.
  • The competitive advantage of firms critically depends on the skills of individual contributors. Hence, the centrality of individual and organizational learning is a critical factor for competitiveness of any organization.

This brings us to the question, what is a learning organization. From many similar definitions of the same, let me quote the following one, as it is apt, simple and old enough for all to have learned: “A Learning Organization is the term given to a company that facilitates the learning of its members and continuously transforms itself.” (M. Pedler, J. Burgoyne and T. Boydell, 1997)

Keeping today’s deliberation in perspective, one may possibly conclude, quick individual learners, including the organizations, can offer better performance outcomes than late learners. As the pharma business is encountering a strong headwind for quite some time, it is up to the readers making out, what type of learner the industry, in general, is, and more importantly, why it is so?

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.

The domestic API players are fast losing their dominance in the Indian API market

There are two broad categories of markets for the Active Pharmaceutical Ingredients (API) across the world namely, highly regulated and semi regulated markets. Countries like, USA, Europe and Japan will fall under highly regulated category with high entry barriers for the global API players like, robust Intellectual Property (IP) regime and stringent regulatory requirements to meet their product quality standards. Such an environment prompts a premium price for the APIs. On the other hand, the semi regulated markets, which offer low entry barriers with not so stringent IP and regulatory requirements, attract more number of API players engaging in cut throat price competition.

The top three markets for Active Pharmaceutical Ingredients (APIs) are the US, Europe and Asia Pacific. According to ‘Business Wire (July 13, 2011), the API market in the Asia-Pacific is expected to grow from 6.7% between 2005 and 2010 to 9.6% between 2010 and 2016.

Currently a perceptible shift in API manufacturing is being noticed from the western markets to the emerging markets like, India and China. In the Asia Pacific region Japan and China enjoy the highest market share for API with 42.8% and 20.8%, respectively. India accounts for 10.3%, while South Korea holds an 8.1% share of the market. To avoid price erosions now seen in the US, Indian manufacturers have started exporting more APIs to Japan.

In 2010, contribution of generic API from the Asia-Pacific market was at 71.5%, with patented APIs contributing for the rest, where Japan enjoys a larger share than India and China. 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 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 Pharmaceuticals, 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 end 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 125 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 competition 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. MSD, USA: 39 6. BASF: 37 7. DSM: 26 8. EON AG: 16 9. Kyowa Hakko: 23

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

China an emerging global force to reckon with in the API market:

An economy of scale leading to cost leadership is fast establishing China in the global API market as a force to reckon with. Dominant presence of China even in the bulk intermediate category with high level of technical expertise, especially in the fermentation technology, strong manufacturing base, supported by increasing standard of regulatory compliance and better IP protection, as perceived by the global pharmaceutical community, are helping the API manufacturers of China to gradually increase their presence even in the highly regulated markets of the world.

In this emerging scenario, when China throws a tough competition to the API producers of India,  developing and manufacturing niche APIs will be the key differentiating factors for the Indian players to maintain their global presence in future, especially with APIs involving non-fermentation technology.

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 of technology as well as 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 arbitrage of 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 spiraling 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, if not Pfizer are perhaps catering to the API demand of their respective formulations manufacturing plants in the country.

Apprehension of counterfeit APIs from the emerging markets:

Growing apprehensions of counterfeit APIs from the emerging markets like, India and China must also be addressed expeditiously by all concerned.

‘The New York Times’ dated August 15, 2011 reported that APIs from India, China and elsewhere now constitute 80% of the active ingredients in US drugs. The US FDA Commissioner Margaret Hamburg was quoted saying, “Supply chains for many generic drugs often contain dozens of middlemen and are highly susceptible to being infiltrated by falsified drugs.”

Conclusion:

Be that as it may, some key global players mainly China, as mentioned above, 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 and some global collaboration for the pharmaceutical formulations sourcing from India, are expected to drive the growth of API business of the global players in India. However, the moot question still remains: will the Indian API players be able to thrive or even survive the tough competition from the global players, especially China?

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.

‘Medical Outsourcing’ – a fast evolving area in the healthcare space with high business potential.

Medical outsourcing is an evolving area in the global healthcare space. It can offer immense opportunity to India, if explored appropriatly with a carefully worked out strategic game plan from the very nascent stage of its evolution process. This sector could indeed be a high potential one in terms of its significant financial attractiveness by 2015.
Key components of medical outsourcing:

The following four basic components constitute the medical outsourcing industry:

• Healthcare providers: Hospitals, mainly corporate hospitals and doctors

• Payer: Medical/ Health insurance companies

• Pharmaceutical Companies

• IT companies operating in the healthcare space

So far as payers are concerned, currently they are primarily involved in the data entry work, the present market of which in India is estimated to be around U.S$ 100 million.

Key drivers and barriers for growth:

The world class cost-effective private sector healthcare services are expected to drive the growth of the medical outsourcing sector in India. However, shortages in the talent pool and inadequate infrastructure like roads, airports and power could pose to be the major barriers to growth.

At present, majority of medical outsourcing is done by the US followed by the UK and the Gulf countries.

How is this market growing?

Medical Tourism, by itself, is not a very recent phenomenon all over the world. Not so long ago for various types of non-essential interventions like, cosmetic surgeries, people from the developed world used to look for cheaper destinations with relatively decent healthcare facilities like, India, Thailand etc.

Now with the spiraling increase in the cost of healthcare, many people from the developed world, besides those who are underinsured or uninsured have started looking for similar destinations for even very essential medical treatments like cardiac bypass surgery, knee replacement, heap bone replacements, liver and kidney transplants, to name just a few.

Significant cost advantage in India with world class care:

It has been reported that for a cardiac bypass surgery, a patient from abroad will require to pay just around U.S$ 10,000 in India, when the same will cost not less than around U.S$ 130,000 in the US. These patients not only get world class healthcare services, but also are offered to stay in high-end ‘luxury’ hospitals fully equipped with the latest television set, refrigerator and even in some cases a personal computer. All these are specially designed to cater to the needs of such groups of patients.

Recently ‘The Washington Post’ reported that the mortality rate after a cardiac bypass surgery is better in Indian private hospitals than their equivalents in the USA.

An irony:

It is indeed an irony that while such private hospitals in India are equipped to provide world class healthcare facilities for their medical outsourcing business and also to the rich and super rich Indians, around 65 percent of Indian population still does not have access to affordable modern medicines in the country.

Is the government indirectly funding the private medical outsourcing services in India?

In India, from around 1990, the government, to a great extent, changed its role from ‘healthcare provider’ to ‘healthcare facilitator’. As a result private healthcare facilities started receiving various types of government support and incentives (Sengupta, Amit and Samiran Nundy, “The Private Health Sector in India,” The British Journal of Medical Ethics 331 (2005): 1157-58).

While availing medical outsourcing services in India, the overseas patients although are paying for the services that they are availing from the private hospitals, such payments, it has been reported, only partially fund the private hospitals. If such is the case, then the question that we need to answer: Are these medical tourists also sharing the resources and benefits earmarked for the Indian nationals?

Conclusion:

Due to global economic meltdown many business houses in the developed world are under a serious cost containment pressure, which includes the medical expenses for their employees. Such cost pressure prompts them to send their employees to low cost destinations for treatment, without compromising on the quality of their healthcare needs.

Other countries in quite close proximity to ours like, Thailand, Singapore and Malaysia are offering tough competition to India in the medical outsourcing space. However, superior healthcare services with a significant cost advantage at world class and internationally accredited facilities, treated by foreign qualified doctors, supported by English speaking support staff and equipped with better healthcare related IT services, will only accelerate this trend in favor of India. In this ball game it surely is, ‘Advantage India’.

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.

Biosimilars –Indian Pharmaceutical Companies are sharpening their focus on fast growing Oncology segment

The global market for Bio-pharmaceuticals is estimated to be around US$ 50 billion by the next year. Currently about 25% of New Molecular Entities (NMEs) under development are of biotech origin. Indian pharmaceutical majors like Dr. Reddy’s Laboratories (DRL), Reliance Life Science, Shantha Biotech, Ranbaxy, Biocon, Wockhardt and Glenmarkhave made good investments in biotech drugs manufacturing facilities keeping an eye on the emerging opportunities with Biosimilar drugs in the developed markets of the world.
Regulatory pathway for Biosimilar drugs:
Already a regulatory pathway for Biosimilar drugs exists in the European Union (EU). In the USA President Barak Obama administration has already expressed its clear intention to have similar pathway established in the country through the US-FDA, which is expected to come by the end of this year.

Steps taken by the Indian pharmaceutical companies towards this direction:

Copycat version of Rituxan (Rituximab) of Roche used in the treatment of Non-Hodgkin’s lymphoma has already been developed by DRL in India. Last year Rituxan clocked a turnover of over US$ 2 billion. DRL also has developed filgastrim of Amgen, which enhances production of white blood-cell by the body, and markets the product as Grafeel in India. Similarly Ranbaxy has collaborated with Zenotech Laboratories to manufacture G-CSF. Meanwhile Biocon of Bangalore has commenced clinical trial of Insugen for the regulated markets like EU. All these initiatives are being taken in India.

On the other hand Glenmark is planning to come out with its first biotech product by 2010 from its biological research establishment located in Switzerland.

Within Biopharmaceuticals the focus is on Oncology:

Within Biopharmaceuticals many of these domestic Indian pharmaceutical companies are targeting Oncology disease area, which is estimated to be the largest segment with a value turnover of over US$ 55 billion by 2010 growing over 17%. As per recent reports about 8 million deaths take place all over the world per year due to cancer. May be for this reason the research pipeline of NMEs is dominated by oncology with global pharmaceutical majors’ sharp R&D focus and research spend on this particular therapy area. Thus about 50 NMEs for the treatment of cancer are expected to be launched in the global markets by 2015.

Indian market for oncology products:

Current size of the Indian oncology market is US$ 18.6 million, which is expected to be over US$ 50 million by the end of 2010; the main reason being all these are and will be very expensive products. Biocon has just launched its monoclonal antibodybased drug BIOMAb-EGFR for treating solid tumours with an eye to introduce this product in the western markets, as soon as they can get regulatory approval from these countries. Similarly, Ranbaxy with its strategic collaboration with Zenotech Laboratories is planning to market oncology products in various markets of the world like Brazil, Mexico, CIS and Russia.

Conclusion:

From the available information it appears that many Indian domestic pharmaceutical companies are now poised to leverage their R&D initiatives on Biosimilars. Oncologies being one of the fastest growing therapy segments, sharp focus on this area is indeed a step in the right direction.

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.