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Pharma’s Oncology Focus: Some Key Drivers With Pros And Cons For Patients

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Just in the first ten days of the brand-new year – 2019, three important oncology focused acquisitions were announced by three top global pharma companies.

On January 03, 2019, Bristol-Myers Squibb announced that it will acquire Celgene for a hefty sum of USD 74 billion to be a leading Biopharma player, focusing on high-value innovative medicines. As reported by BioSpace on January 04, 2019, the BMS CEO said, the combined might of the two pipelines will create “the number one oncology franchise” for both solid and hematologic tumors.

Just four days thereafter, on January 7, 2019, at the J.P. Morgan Healthcare Conference, Eli Lilly announced that it will acquire targeted cancer drug maker Loxo Oncology for USD 8 billion. This deal gives the company TRK inhibitor Vitrakvi – the first drug approved by the FDA to target tumors based on genetic abnormality, rather than the location of the cancer.

On June 08 2019, at the same J.P. Morgan Healthcare Conference, GlaxoSmithKline CEO Emma Walmsley, reportedly said that GSK has agreed to acquire already approved PARP inhibitor Zejula as well as a range of pipeline assets valued USD 5 billion.It’s noteworthy that Walmsley announced the company’s new focus on oncology just the last year and has now almost doubled its immuno-oncology pipeline.

Even in the last year – 2018, a significant number of oncology focused Merger and Acquisitions (M&A) took place. The acquisition values are also interesting – ranging from a few-hundred million to billions of USD. In this article, I shall examine what could be the main drivers of this emerging trend with its pros and cons from the patients’ perspective, in general. As a brief backdrop, let me start with a few examples of such M&As in 2018.

Some oncology focused M&As in 2018:

Following are examples of some oncology focused acquisitions that took place in 2018:

  • In January 2018, Celgene Corporation, which has now been acquired by Bristol-Myers Squibb, announced theacquisition of Juno Therapeutics for about USD 9 billion. This deal came shortly after Celgene’s deal for Impact Biomedicines valuing USD 1.1 billion.
  • In late-January 2018, the biggest deals this year were by Sanofi. It acquired Waltham, Massachusetts-based Bioverativ for about USD 11.6 billion. Bioverativ was a spinoff by Biogen. About a week later, Sanofi bought Ghent, Belgium-based Ablynx for USD 4.8 billion.
  • In April 2018, Roche completed its acquisition of Flatiron Health, an oncology-specific digital health company for about USD 1.9 billion.
  • In the same month of April 2018, Shire sold its oncology business to France’s Servier for USD 2.4 billion.
  • In May 2018,  Janssen Biotech, a subsidiary of Johnson & Johnson’s Janssen Pharmaceuticals, announced that it was buying Rockville, Maryland-based BeneVir Biopharma, in a deal of more than USD 1 billion.

Thus, the question that follows: what could be the primary drivers of this trend?

The primary drivers:

In my view, the primary drivers for focus on the oncology segment by pharma and biotech companies is a combination of the following factors:

  • Leading cause of death: The incidence of cancer is fast increasing across the world, making it the leading cause of death, says 2018 report of the International Agency for Research on Cancer (IARC).
  • High incidence: Cancer burden rose to 18.1 million new cases, with 9.6 million cancer deaths in 2018. IARC report further highlighted, one in 5 men and one in 6 women worldwide develop cancer during their lifetime, and one in 8 men and one in 11 women die from the disease.
  • The need for new treatment approaches is increasing: Various types of cancers are getting more and more complex.Genetic and epigenetic alterations in tumor cell populations are generating heritable variation, requiring new drugs along with novel treatment approaches.
  • High price: According to Journal of Oncology Practice, the average cancer drug price for approximately 1 year of therapy or a total treatment duration was less than USD 10,000 before 2000. This had increased to USD 30,000 to USD 50,000 by 2005. In 2012, twelve of thirteen new drugs approved for cancer indications were priced above USD 100,000 per year of therapy. For example, Keytruda (Merck) was launched in the US in 2014 at a price of reportedly USD 12,500 for each patient monthly or USD 150,000 annually. The drug is expected to be 30 percent cheaper in India than the global prices.
  • Longer product exclusivity period: As is often reported, many of the newer high-priced cancer drugs are for very specific types of cancer, with virtually no real competition. Consequently, they generally enjoy the benefits of a longer price exclusivity period, even after patent expiry. Humira of AbbVie is one such example.

The strategy is paying rich dividend to pharma players:

That this strategy continues paying rich dividend to concerned pharma players, gets reflected on the therapy group-wise performance of the global drug industry. Today, the global cancer therapeutics segment assumed mind-boggling size in value term. It was estimated at USD 121 billion in 2017 and projected to reach USD 172.6 billion by 2022. The top 10 oncology drugs accounted for revenue of USD 54.48 billion in 2017. Celgene, which has just been acquired by Bristol-Myers Squibb, dominates the oncology market, with its best-selling product – Revlimid.

Successive launches of a large number of high-priced novel cancer drugs, has pushed the oncology segment in the top slot in therapy ranking. It is expected to remain this way, at least for some time, as June 2018 report of Evaluate Pharma forecasts that the oncology therapy area will maintain the top ranking in the 2017-2024 period.

IQVIA report on ‘Global Oncology Trends 2018’ ofMay 24, 2018 also reconfirms that the number of approved cancer therapies continues to rise, with 63 cancer drugs launching within the past five years.’ Illustrating the point further, the report highlights that global spending on cancer medicines keeps rising with therapeutic and supportive care use at USD133 billion globally in 2017, up from USD 96 billion in 2013.

Pros and Cons of this trend for patients:

Interestingly, this trend has both pros and cons for patients, almost in equal measure. Some of the important pros are, as follows:

  • Advancement of cancer treatments at an accelerated pace in recent years, is offering notable improvements in clinical benefit to patients, comments the above IQVIA report.
  • Consequently, cancer incidence and mortality have been declining with an increase in the survival rate, especially in the developed countries, such as the United States, in recent times.
  • Nevertheless, decreased incidence and improved survival rate have also been attributed to both – reductions in smoking, as well as advances in early detection and treatments.

Alongside, examples of some of major cons are also bothering many patients, such as:

  • The real benefits of newer and novel high-priced cancer drugs have not been felt by most people in the developing world, which constitutes the majority of the global population.
  • The GLOBOCAN 2018 database, accessible online as part of the IARC Global Cancer Observatory, also highlights that countries with lower Human Development Index (HDI) have a higher frequency of certain cancer types associated with poorer survival. This is mainly because access to timely diagnosis and effective treatment is less common.
  • Although, the new generation of treatment is transforming the field of cancer, yielding more cures and long-term remissions than ever before, the healthcare systems worldwide continue to struggle to deliver the benefits of these drugs to deserving patients.
  • As the above IQVIA report says, the list prices of new cancer drugs at launch have risen steadily over the past decade, and the median annual cost of a new cancer drug launched in 2017 exceeded USD 150,000, compared to USD 79,000 for the new cancer drugs launched in 2013.
  • If the affordability of drugs is not addressed soon, many people with cancer might not be able to reap the rewards of cutting-edge therapies.This concern was also expressed by Nature in an article titled, ‘Bringing down the cost of cancer treatment,’ published on March 07, 2018.

Thus,access to cancer treatment, mostly with modern cancer drugs, is becoming a major challenge in all countries, but much more acute in the developing nations. A special article titled, ‘Facing the Global Challenges of Access to Cancer Medication,’ published in the Journal of Global Oncology on March 28, 2018, also broached the question of affordability of modern anticancer medication and commented, “the financial challenge presented by the rising cost of care will create a barrier to its delivery.”

Conclusion:

On the above perspective, the emerging trend of large pharma and biotech companies’ focus on novel oncology drugs is an interesting one. The key drivers fueling this ascending trend are also understandable. However, a deep-stick analysis of pros and cons of its impact on patients indicate, it has helped patients in the developed world, significantly more than those in the developing world, with affordability being the primary issue.

The article titled, ‘Bringing down the cost of cancer treatment,’ published in Nature on March 07, 2018, also reconfirms the current situation eloquently. It asserted, there isn’t an iota of doubt that new generations of cancer drugs are transforming the field of cancer treatment, yielding long-term remissions and even cure – more than ever before. Nevertheless, while medicine’s ability to tackle tumors increases by manifold, patients and healthcare systems worldwide are struggling to deliver their benefits to most cancer patients.

To address this situation, some drug players did try out ‘tiered pricing’, while a few others announced – ‘patient assistance programs’. Unfortunately, none of these measures seem to have benefitted majority of deserving patients, materially. Thus, echoing the above article from Nature, I would emphasize, if the affordability issue of new cancer drugs is not effectively addressed soon, collectively by all stakeholders, a vast majority of cancer patient won’t be able to reap expected rewards from such cutting-edge therapies.

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.

For Patient-Centricity: Emerging a C-Suite Role

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Regardless of skepticism of many, the formidable power of physicians to take all treatment decisions for patients, is gradually getting moderated, globally. Although, its pace may vary from country to country. An increasing number of more informed patients are carving out a greater role for themselves in this important process.

The central focus for brand demand generation can no longer remain just on the doctors. This is because, as I wrote this in my article, published in this Blog on July 06, 2015: “Slowly but steadily the process of taking treatment decisions for the patients is undergoing a metamorphosis, where well informed patients no longer want to play just a passive role. These patients want the doctors to take a final decision on their treatment only after meaningful interactions with them.” Besides a broad prescription pattern, this includes the medicines that they will consume, including meaningful details on product cost against the benefits to be accrued.

The age-old practice of doing a little bit on patient education or compliance, are grossly inadequate in an evolving new scenario. The good news is, many pharma companies have started realizing that appropriate engagement with patients to deliver what they want and more, can lead to better financial performance.

Consequently, the ball game for prescription demand generation is showing early signs of a change – somewhat radical in nature. To spearhead this unavoidable metamorphosis for the organization, there surfaced a brand-new role of a CxO – The Chief Patient Officers (CPO).

This new senior management position is expected to direct organizational focus on patients. Understand their concerns, needs, wants and goals, particularly in the disease areas where the company represents. And finally, give shape to new multichannel well-coordinated platforms of patient engagement, for better commercial returns. In this article, I shall try to explore how this transformation pans out, if at all.

The direction is right, but patients must feel the change:

As I said before, some pharma players have started accepting the reality. The crucial need for an organization to become ‘Patients-Centric’ can’t be wished away anymore. For example, a 2015 “Industry Healthcheck” survey where 1600 pharma executives participated, found that 85 percent of respondents agreed that ‘Patient-Centricity’ is the best route to improve profitability, in the fast changing business environment.

It is perhaps well understood that the pharma industry has arrived at this point due to increasing access of the general population to easily available, all-kind of information on the cyber space, including health care. The enabling facility has already prompted many patients evaluating various treatment options for a disease, including choice of drugs and their cost.

As a result, pharma companies felt the necessity to have a new leader who will give a new perspective and direction in creating a new value for the organization, for a sustainable progress. This involves charting a comprehensive pathway to gradually shift the entire company focus on ‘patients for products’, and not on ‘products for patients.’

According to reports, a few global pharma majors, such as Merck and Sanofi already have their CPO in place, but patients are yet to feel any difference on the ground even for these companies, as many say.

What exactly is ‘Patient-Centricity?’ – Two perspectives:

It won’t be a bad idea to get to know two different perspectives on what ‘Patient-Centricity’ exactly is – one from a CPO and the other from patient groups, as follows:

A. 3 three pillars of ‘Patient-Centricity’ from the CPO perspective:

To get a ringside perspective to this question from the industry, let me quote from the first CPO - Anne C. Beal appointed in a top-10 pharma – Sanofi, on March 31, 2014, though the CPO position is in existence, since 2012.

On December 2014, at the 11th annual Patient Summit USA conference, Anne Beal, reportedly deliberated on the three pillars of her company’s patient-centric strategy, which I shall describe, as follows:

  • Utilizing patients’ input to get a better sense of their needs in order to design and deliver solutions that help fulfill them.
  • Engaging and supporting patients to ensure the solutions that the company delivers help enhance their lives and improve outcomes.
  • Involving with the company employees and supporting them to create an engaged community and patient-centric culture.

B. 9 attributes of ‘Patient-Centricity’ from the patients’ perspective:

‘Patient View’ – a UK-based research, publishing, and consultancy group, arrived at the ‘9 Key Attributes’ of ‘Patient-Centricity’. This is based on the analysis of feedbacks (2016-17) from 2,000 patient groups worldwide, 50+ different medical specialties in 100+ countries. The critical attributes of the same that patients want to see in a drug company can be summarized, as follows:

  • Demonstrate integrity and authenticity through all company actions.
  • Understand all the issues that patients face ‘beyond the pill’ and help in dealing with them.
  • Transparency in drug pricing policy, research, results, funding relationship.
  • Ensure that all patients are included in access strategies, regardless of the returns to the company.
  • Products to provide quantifiable value to patients.
  • Reliable supply and comprehensive patient safeguard.
  • Provide quality product information – Consistent, current, balanced and usable.
  • Patient group relation – good intention, effective governance, communication and training.
  • Ensure patients are engaged and their opinions are sought at each stage of R&D.

On a broader canvas, the two perspectives on ‘Patient-Centricity’ – one from the CPO and the other from the patients’ groups, do have some important similarities. Nevertheless, I reckon, the CPOs would still need to cover more ground to match patients’ expectations from a ‘Patient-Centric’ pharma company. 

Claimants of ‘patient-centric’ focus are many, but few deliver consistently:

Quite expectedly, there are many claimants for a ‘patient-centric’ organizational focus. Interestingly, few actually deliver consistently. This was vindicated in the article – ‘How patient-centric is the pharma industry’, published by PDD - a design and innovation consultancy firm on June 06, 2016.

The paper indicates both the up and downside of pharma company claims on ‘Patient-Centricity.’ The upside is that the hype has influenced, at least, some drug players to openly talk about the need to shift the company focus more on patients. A few have initiated some tangible action, as well. Whereas, the downside of it is the lack of consistency in the enthusiasm of ‘patient-centric’ actions by these companies. To illustrate the point, let me quote the following two examples from the article:

  • In the 2013 survey on ‘Patient-Centricity’ by the research firm ‘Patient View’, ViiV Healthcare (the GSK & Pfizer joint venture focused on HIV therapies), Gilead, AbbVie, Menarini and Janssen occupied the top 5 spots.
  • However, in the ‘eyeforpharma Barcelona Awards 2016 ’ that too focuses on ‘Patient-Centricity’, none of these companies featured in the “Most Valuable Patient Initiative or Service” category. Whereas, Sanofi took the top spot, and Merck, Roche, Novartis and TEVA were the remaining nominees.

The criteria of the two selection processes, apparently being similar, this is interesting. More so, when the ‘patient-centric’ focus of an organization is an ongoing strategy, with a ‘top priority’ tag attached to it.

Be that as it may, that some serious efforts being made by a few companies in this area, can’t be brushed aside, either, regardless of the fact that the CPO position came into existence, since 2012. It flagged, at that time, the criticality of ‘Patient-Centricity’ in the pharmaceutical business and possibly, sent a signal to pharma players for a course correction, in this direction, soon enough.

Conclusion:

In an interview, published in December 2016 issue of McKinsey Quarterly, LEO Pharma’s president and CEO, Gitte Aabo, aptly summarized the process of ‘Patient-Centricity’, as follows:

“Patient-Centricity means being deeply entrenched in the patient’s needs, not just thinking about how to develop new products and new features. It means reaching out to patients and considering treatments that will help them in whatever situation they find themselves in.”

However, since long, most drug manufacturers are apparently solely driven by commercial considerations, both for new drug discovery and also in generic product development. Subsequent marketing strategies are obviously an integral component of the same organizational thought leadership and value chain. Several examples from the current status of the R&D pipeline for multi-drug resistant antibiotics, or what is happening even with the generic drug pricing in many countries, including the United States, will vindicate this point.

That said, a mild wind of change on the sails of traditional pharma mindset seems to be slowly catching up, as some CPOs position themselves in the saddle. Hopefully, this will  ultimately make patients the centerpiece of pharma business. Can more of this kind of actions be construed as signals for imbibing ‘Patient-Centricity’ by the drug companies? Will its impact be visible and felt by all – in real life, soon?

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 Hype of Digitalization in Pharma Marketing

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Having access to the fountain of knowledge residing in the cyberspace, fueled by word of mouth information and aided by social media, patients’ behavior is fast changing globally. Its degree may vary. But the change is real. The good news is – in a digital world of today, people are talking about ‘digitalization’ to rejuvenate per dollar productivity even in the pharma business, while navigating through a strong environmental headwind.

But, the bad news seems to be, that many pharma players, especially in India, can’t possibly quite fathom, just yet, the profound impact of the changing customer profile. With the hype of ‘digital marketing’ and associated cacophony, most of them seem to be focusing on automation of various processes with digital tools, rather than a customer-centric pan-organization digitalization of business. In this article, I shall dwell on the relevance of such intervention in the pharma marketing model, including the processes, before it’s too late for an organization.

The reality – profile of pharma consumers is changing:

It is well documented today that the profile of pharma consumers is changing. There are several studies in this area. For example, the McKenzie paper of November 2014, titled “A digital prescription for pharma companies,” penned some important observations in this regard, as follows:

  • Consumers in the healthcare sector are becoming more informed, empowered, and demanding.
  • The vast majority of connected patients using an array of digital tools, to take control of their health and the health care services they access and buy.
  • Over 70 percent of patients who are online in the United States use the Internet to find healthcare information, and around 40 percent of people who diagnosed their condition through online research had it confirmed by a physician.
  • Patients equip themselves with information about product safety, efficacy, cost comparison, quality indicators from websites and online communities.
  • The more healthcare data become digitally accessible, the more patients will use it to weigh—and potentially reject—expensive health care treatments, as is particularly true in the United States.
  • These patients are demanding more information, so they can apply the same cost-benefit analysis and research techniques they use to purchase cars or phones when they purchase health care.
  • They are also making more informed, rational choices about where they put their money.
  • If pharma companies do not join the digital dialogue and influence the conversation, they will lose an opportunity to shape it, and they may be put on the defensive trying to refute the statements made by those that do take part.

In this evolving scenario, the expectations of pharma customers even in India, are also changing. It may not be as fast as in the United States, but certainly can’t be ignored in any way, for long term business success. Thus, I reckon, it would be futile to keep the basic process of business as tradition-bound as it has always been, of course, with some interesting tweaking here or there.

When everybody talks about digital intervention, what it is really?

To effect this desired change, all concerned are now talking about ‘digitalization’. It has already become a buzz word and is often considered as a ‘magic wand’ by many enthusiasts. There is nothing wrong in this hype, provided this process is properly understood. I tried to explain it in my article, published in this Blog on January 2018. Are we missing wood for the tree? Let me start with the current ‘digitalization’ focus of pharma marketing in this area, particularly in India – as I see it.

Where’s the current focus on ‘digitalization’ in pharma marketing?

Generally, the pharma marketing focus broadly covers two different categories:

A. Push marketing 

B. Pull marketing

A. Push marketing: 

In my view, ‘push marketing’ involves targeting physicians through Medical Representatives and other means, including several contentious ones. These ensure that the doctors “push” the identified pharma brands of the company while writing prescriptions for patients. Some experts call it an ‘inside out’ and brand focused strategy of the industry players to drive sales.

Many companies are taking major digital steps to introduce automation in this area, which are not transformative, but incremental and aimed at improving productivity. Such drive encompasses many areas of a pharma organization, including the field staff related functions. For example, replacing usage of paper-based items, such as detailing folders or reporting material, with algorithm-based digital tablet devices. These reforms help answer customer questions promptly, besides almost real-time entry of accurate doctors’ call related data into a remote computer server for continuous analysis and feedback.

Automation of such types may free enough time of the field staff for greater customer contacts in different ways, but may not be considered as digitalization of the organization. Moreover, these are not transformative in nature either, as the overall process of doing business remains the same.

Nonetheless, process automation and its re-engineering add significant, but incremental value to the business, as the organization continues to maintain similar ‘inside-out’ focus on brands. The re-engineered processes also become faster and more accurate to help improve productivity. However, patients’ knowledge-base, needs, demands, values and aspiration keep changing fast, which just process automation can’t leverage to excel in business.

B. Pull marketing: 

Unlike ‘push marketing’, ‘pull marketing’ targeting pharma consumers who are increasingly becoming more informed and want to get involved in their treatment decision making process, including selection of a drug. The evolving trend suggests, to succeed in business, pharma players would require focusing more on patients, using various digital tools and platforms of engagement, in different ways.

To make this process meaningful, it is essential for a drug company to venture into mapping the patient’s journey from end-to-end for a specific disease or a set of diseases. This means capturing real-life data right from the time patients feel the need for a medical intervention, through the search for the right treatment, to effective disease management or cure, including follow-up, if any. Thus, mapping this arduous and complex odyssey would demand application of state-of-the-art digital tools.

Thereafter, equally sophisticated measures structured on digital platforms and formulated accordingly, require to be and implemented on the ground. It then becomes the ground-rock to transform the company’s focus – ‘through brands to patients’ to – ‘through patients to brands.’ Dovetailing this new marketing concept to a pan-organization initiative will call for new insight and wherewithal of the right kind.

When implemented by the right kind of people, this approach will encouragepatients to “pull” the demand of the selected brands, as they participate along with doctors in the drug selection part of the entire treatment process. The informed patients won’t hesitate posing questions to doctors – why ‘this’ drug is being prescribed and why not ‘that’ drug?’ The doctor would require responding with convincing answers in that situation. Some experts have termed this process as – an ‘outside in’ strategy.

Difference in impact – one ‘Incremental’, the other ‘transformative’:

It’s important to reiterate that the impact of digitalization for an ‘inside-out push strategy’, is generally incremental. Whereas, the same for ‘outside-in pull strategy’ is expected to be transformative in nature, not just in the business performance, but also the way pharma business is viewed and conducted as on date, especially in India.

Conclusion:

As I understand, process automation may be based on digital platforms and even with the application of Artificial Intelligence (AI) or robotics, the overall business process remains unchanged. It brings greater efficiency in the same business processes, improving employee productivity, and usually adds incremental success to brand performance.

Whereas, digitalization helps create a new way of achieving excellence – gaining a new insight for the business. This happens, first through generation, and then detail analysis of an enormous amount of relevant customer-centric data. Effective interpretation and use of the same, help transform the business – giving shape to new business processes for organizational distinction.

Simply speaking, automation improves the business efficiency with its key focus on ‘pushing brand prescription demand’, as much as possible. Whereas, digitalization aims at business transformation for a long-term organizational effectiveness. It creates a new purpose for business based on changing customer profile, across the organization. A sharp focus on delivering research-based and well-targeted customer values help ‘pulling brand prescription demand’, the decision of which is often jointly taken by the doctors and the patients or will happen that way even in India, sooner than later.

In this perspective, what we see in pharma marketing, generally in India, is automation of various types, of course, by using digital tools, platforms and even AI, in some cases. There isn’t anything wrong in that. But, digitization would call for much more. First, the core organizational focus to shift from being ‘brand-centric’ to ‘customer-centric’ for financial achievements, and then effectively delivering customer values through each ‘company-brand-customer interface’ and beyond that. This is essential for sustainable excellence of pharma players in the digital age.

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.

Sharper Focus On Vaccine: A Huge Scope To Reduce Disease Burden In India

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Several international research studies have conclusively established that the aggressive application of nationally recommended prevention activities could significantly reduce the burden of disease in several areas. Immunization or vaccination program is one such critical areas.

Several ailments, which used to be so common all over the world, can now be effectively prevented through vaccination. The most common and serious vaccine-preventable diseases are: diphtheria, Haemophilus influenzae serotype b (Hib), hepatitis B and C, measles, meningitis, mumps, pertussis, poliomyelitis, rubella, tetanus, tuberculosis, rotavirus, pneumococcal disease and yellow fever.  The list of the World Health Organization (WHO) indicates that vaccines are now available for 25 different diseases.

Thus, vaccination can save millions of lives and morbidity that such diseases still cause to a very large number of global population. Thanks to vaccines, two most scary diseases – small pox (totally) and polio (almost totally), have been eliminated from the world.

No doubt, why vaccination was voted as one of the four most important developments in medicine of the past 150 years, alongside sanitation, antibiotics and anesthesia by readers of the ‘British Medical Journal (BMJ)’ in 2007. It has been decisively proved that vaccines are one of the most successful and cost-effective public health interventions, which help preventing over 3 million deaths every year, throughout the world, topping the list in terms of lives saved.

In tandem, concerted efforts need to be made by both the industry and the Governments to improve affordable access to all these vaccines for a larger section of the population, especially in the developing world.

A crying need still exists:

Nevertheless, there is still a crying need for greater encouragement, more resource deployment and sharper focus towards newer vaccine development for many more dreaded and difficult diseases. One such area is malaria vaccine.

Some areas of new vaccine development:

Following is an example of some newer therapy areas where novel vaccines are now reportedly under development:

  • Malaria vaccine
  • Cancer vaccine
  • AIDS
  • Alzheimer’s disease

Malaria vaccine:

A July 24, 2015 article of the BBC News states, the ‘European Medicines Agency (EMA)’ gave a positive scientific opinion after assessing the safety and effectiveness of the first anti-malarial vaccine of the world – Mosquirix, developed by the British pharma major GlaxoSmithKline.

The vaccine reportedly targets the ‘P. falciparum’, the most prevalent malaria parasite and the deadlier of the two parasites that transmit the disease. At present, in the absence of any licensed vaccines for malaria, the main preventive measures to contain the spread of this parasitic disease are spraying of insecticides, use of other mosquito repellent and mosquito nets.

However, it was observed during its clinical trial that he best protection with this vaccine was achieved among children aged five to 17 months, receiving three doses of the vaccine a month apart, plus a booster dose at 20 months. In this group, cases of severe malaria were cut by a third over a four-year period, the report said.

Some concern was also expressed, as the effectiveness of the vaccine waned over time, making the booster shot essential, without which the vaccine did not cut the rate of severe malaria over the trial period. Moreover, the vaccine did not prove very effective in protecting young babies from severe malaria.

This caused a dilemma for the ‘World Health Organization (WHO)’. On the one hand, the stark reality of malaria killing around 584,000 people a year worldwide, and on the other, lack of conclusiveness in the overall results for this vaccine. Therefore, the world health body decided at that time to further consider about it, soon after the experts’ deliberation on whether to recommend it for children, among whom trials have yielded mixed results, gets completed.

The good news is, on November 18, 2016, Newsweek reported the announcement of the W.H.O, that Mosquirix will be piloted across sub-Saharan Africa in 2018, after a funding approval of US$ 15 million for this purpose.

Cancer vaccines:

According to the National Cancer Institute, which is a part of the National Institutes of Health (NIH) of the United States, cancer vaccines belong to a class of substances known as biological response modifiers. Biological response modifiers work by stimulating or restoring the immune system’s ability to fight infections and disease. There are two broad types of cancer vaccines:

  • Preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people.

-       Persistent infections with high-risk human papillomavirus (HPV) types can cause cervical cancer, anal cancer, oropharyngeal cancer, and vaginal, vulvar, and penile cancers. Three vaccines are approved by the US Food and Drug Administration (FDA) to prevent HPV infection: Gardasil®, Gardasil 9®, and Cervarix®.

-       Chronic Hepatitis B virus (HBV) infection can lead to liver cancer. The FDA has approved multiple vaccines that protect against HBV infection, such as, Engerix-B and Recombivax HB, which protect against HBV infection only.

  • Treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body’s natural immune response against the cancer. Treatment vaccines are a form of immunotherapy.

-       In April 2010, the USFDA approved the first cancer treatment vaccine. This vaccine, sipuleucel-T (Provenge®), is approved for use in some men with metastatic prostate cancer. It is designed to stimulate an immune response to prostatic acid phosphatase (PAP), an antigen that is found on most prostate cancer cells.

Another type of cancer vaccine is currently being developed, known as the Universal Cancer Vaccine.

  • Universal Cancer Vaccine,  June 1, 2016 issue of ‘The Independent’ reported that scientists of Johannes Gutenberg University in Germany have taken a “very positive step” towards creating a universal vaccine against cancer that makes the body’s immune system attack tumors as if they were a virus. The researchers had taken pieces of cancer’s genetic RNA code, put them into tiny nanoparticles of fat and then injected the mixture into the bloodstreams of three patients in the advanced stages of the disease. The patients’ immune systems responded by producing “killer” T-cells designed to attack cancer.

The vaccine was found to be effective in fighting “aggressively growing” tumors in mice. At the same time, such vaccines are fast and inexpensive to produce, and virtually any tumor antigen (a protein attacked by the immune system) can be encoded by RNA, the report said.

The analysts forecast the global cancer vaccines market to grow at a CAGR of 27.24 percent over the period 2014-2019.

HIV/AIDS Vaccine:

The 21st International AIDS Conference (AIDS 2016) held in Durban, South Africa from July 18 to 22, 2016, revealed that a vaccine against HIV will be trialed in South Africa later in 2016, after meeting the criteria needed to prove it, could help fight the epidemic in Africa. A small trial, known as HVTN100, took place in South Africa in 2015 to test the safety and strength of immunity the vaccine could provide, ahead of any large-scale testing in affected populations.

This development reportedly has its origin in a large landmark 2009 trial of RV 144 vaccine in Thailand, demonstrating the proof of concept that a preventive vaccine with a risk reduction of 31 percent could effectively work.  The trial was supported by the World Health Organization (WHO) and UNAIDS. The clinical trial participants who received Vacc-4x, reportedly “experienced a 70 percent viral load decrease relative to their level before starting Anti-Retroviral Therapy (ART), compared with no notable reduction among placebo recipients.”

Alzheimer’s disease vaccine:

A vaccine for Alzheimer’s disease could be trialed in human within the next 3-5 years, after researchers from the United States and Australia have uncovered a formulation that they say successfully targets brain proteins, which play a role in the development and progression of the disease, states a July 18, 2016 report published in the ‘Medical News Today (MNT)’.

This vaccine generates antibodies that target beta-amyloid and tau proteins in the brain – both of which are considered hallmarks of Alzheimer’s disease. In their study, the researchers found that the formulation was effective and well-tolerated in Alzheimer’s mouse models, with no reports of adverse reactions. The vaccine was also able to target the proteins in brain tissue from patients with Alzheimer’s.

Study co-author Prof. Michael Agadjanyan, Institute for Molecular Medicine, California said: “This study suggests that we can immunize patients at the early stages of AD (Alzheimer’s disease), or even healthy people at risk for AD, using our anti-amyloid-beta vaccine, and, if the disease progresses, then vaccinate with another anti-tau vaccine to increase effectiveness.”

If the vaccine continues to show success in these preclinical trials, the researchers envisage that they could be testing the vaccine in individuals at high risk for Alzheimer’s, or those in the early stages of the disease, within the next 3-5 years.

More details on vaccine development:

A 2012 report on vaccines, published by the Pharmaceutical Research and Manufacturers of America (PhRMA) give details of vaccines under development.

Vaccine requirements of the developing world: 

Developing countries of the world are now demanding more of those vaccines, which no longer feature in the immunization schedules of the developed nations. Thus, to supply these vaccines at low cost will be a challenge, especially for the global vaccine manufacturers, unless the low margins get well compensated by high institutional demand.

Issues and challenges:

To produce a safe, effective and marketable vaccine, besides R&D costs, it takes reportedly around 12 to 15 years of painstaking research and development process.

Moreover, one will need to realize that the actual cost of vaccines will always go much beyond their R&D expenses. This is mainly because of dedicated and highly specialized manufacturing facilities required for mass-scale production of vaccines, and then for the distribution of the same mostly using cold-chains.

Around 60 percent of the production costs of vaccines are fixed in nature (National Health Policy Forum. 25. January 2006:14). Thus, such products will need to have a decent market size to be profitable. Unlike many other medications for chronic ailments, which need to be taken for a long duration, vaccines are administered for a limited number of times, restricting their business potential.

Thus, the long lead time required for the ‘mind to market’ process for vaccine development together with high cost involved in their clinical trials/marketing approval process, special bulk/institutional purchase price and limited demand through retail outlets, restrict the research and development initiatives for vaccines, unlike many other pharmaceutical products.

Besides, even the newer vaccines will mostly be required for the diseases of the poor, like Malaria, Tuberculosis, HIV and ‘Non-Communicable Diseases (NCDs)’ in the developing countries, which may not necessarily guarantee a decent return on investments for vaccines, unlike many other newer drugs. Thus, the key issue for developing a right type of newer vaccine will continue to be a matter of pure economics.

India needs a vibrant vaccine business sector:

For a greater focus on all important disease prevention initiatives, there is a need to build a vibrant vaccine business sector in India. To achieve this objective the government should create an enabling ecosystem for the vaccine manufacturers and the academics to work in unison. At the same time, the state funded vaccine R&D centers should be encouraged to concentrate more on the relevant vaccine development projects, ensuring a decent return on their investments for long-term economic sustainability.

Often, these stakeholders find it difficult to deploy sufficient fund to take their vaccine projects successfully through various stages of clinical development to obtain marketing approval from the drug regulator, while earning a decent return on investments. This critical issue needs to be urgently addressed by the Government to make the disease prevention initiatives in the country sustainable.

A possible threat to overcome: 

As per reports, most Indian vaccine manufacturers get a major chunk of their sales revenue from exports to UN agencies, charitable organizations like, the Bill & Melinda Gates Foundation, GAVI, and other country-specific immunization programs.

The report predicts, the virtual monopoly that Indian vaccine manufacturers have enjoyed in these areas, will now be challenged by China, as for the first time in 2012, the Chinese national regulatory authority received ‘pre-qualification’ certification of WHO that allows it to approve locally manufactured vaccines to compete for UN tenders.

Conclusion:

Keeping this in perspective, vaccine related pragmatic policy measures need to be taken in the country for effective disease prevention, covering all recommended age groups, of course, with an equal focus on their effective implementation, without delay. Consequently, this will not only help reduce the disease burden in the country, but also provide the much-awaited growth momentum to the vaccine market in India.

Alongside, increasing number of modern imported vaccines coming in, would help India address one of its key healthcare concerns effectively, and in a holistic way.

It is about time to aggressively garner adequate resources to develop more modern vaccines in the country. In tandem, a rejuvenated thrust to effectively promote and implement vaccine awareness campaigns, would help immensely in the nation’s endeavor for disease prevention with vaccines, that offers a huge scope to reduce disease burden, for a healthier India.

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.

Are Preventive Medicines always cost effective to be an area of focus in healthcare management?

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American Board of Preventive Medicine defines ‘Preventive Medicine’ as follows:

“Preventive Medicine is the specialty of medical practice that focuses on the health of individuals, communities, and defined populations. Its goal is to protect, promote, and maintain health and well-being and to prevent disease, disability and death.”

The most basic examples of preventive medicines are known to be hand washing, breast feeding and immunization.

Simple preventive measures, such as, increasing awareness against tobacco smoking, misuse of alcohol or unprotected sex, especially in an emerging economy like India, will go a long way to prevent and control such habit related diseases, help saving significant expenditure of the nation towards healthcare.

The purpose:

The primary purpose of preventive medicines could well have dual objectives as follows:

  • Disease prevention of a large section of the population
  • Reduce the healthcare expenses

Primary, secondary and tertiary prevention:

As stated above, primary disease prevention usually would include vaccination against specific disease types, whereas secondary and tertiary prevention are usually done through early detection process and screening of the target population.

Relevance to chronic diseases:

A World Health Organization (WHO) report, titled, “Preventing Chronic diseases – a vital investment” argues that globally of the 58 million deaths in 2005, approximately 35 million were due to chronic diseases, which were expected to increase by 17% in the next 10 years thereafter.

It points out that 80% of all premature heart disease, stroke and diabetes are preventable. This assumes greater significance as 80% deaths due to chronic disease occur in low and middle income nations where most of the world population lives, against only 20% of the same in the high income countries.

The report, therefore, articulates that it is absolutely necessary for the countries to review and implement a comprehensive and integrated preventive public health strategy.

Regular preventive measures:

Experts recommend following regular preventive measures, which are very relevant to India:

  • Counseling on hygienic life style
  • Routine primary vaccinations
  • Counseling on quitting smoking, alcohol misuse, protected sex, losing weight, eating healthy food, treating depression etc.
  • Regular general health check-up
  • Cancer screenings like mammograms and colonoscopies

Immense potential in India:

In a country like India, with high prevalence of many preventable diseases involving a large section of the nation’s population, preventive medicine promises immense potential to reduce the healthcare expenditure of the country significantly and at the same time would promise a much better quality of life to its population.

A counter point:

Another school of thought, primarily US based, advocates that preventive medicines, on the contrary, would raise the healthcare expenditure.

  • Preventive Medicine increases healthcare cost:

In support of this contrarian view, a paper published in ‘The New England Journal of Medicine (NEJM)’ on February 14, 2008 based on 599 studies between 2000 and 2005 infers that though disease prevention in some cases may reduce the cost of healthcare, more preventive medicines in many cases could, in fact, increase  the overall healthcare expenditure.

  • Screening cost is more than savings:

It says that screening cost of a disease for a large section of the population may far exceed the savings from treatment avoidance in those cases where only a small part of the population would have become ill in the absence of preventive measures.

  • Treatment with medicine offers greater value:

The article also points out that:

“The drugs used to treat high cholesterol yield much greater value for the money, if the targeted population is at high risk for coronary heart disease, and the efficiency of cancer screening can depend heavily on both the frequency of the screening and the level of cancer risk in the screened population.”

  • Preventive medicine more expensive:

The authors argue that preventive medicine will be more expensive where to make a small populations free from a particular disease, preventive measures are taken involving a large population, most of whom even otherwise would not have suffered from that illness.

Conclusion:

Coming back to the WHO report which categorically says, contrary to the belief of some section of the society, especially in the USA that measures for control and prevention of chronic diseases are really not too expensive for any nation, not even for the low and middle income countries.

In reality, even chronic diseases can be prevented and effectively controlled to reduce the disease burden of any country very significantly. The WHO article also says that expensive patented medicines are no longer required for prevention of, for example, even cardiac ailments. The cheaper generic drugs, if used along with counseling on life style changes, will be quite affordable to a vast majority of population even in the middle and low income countries.

Weighing all pros and cons, WHO aims to reduce the death rates from all chronic diseases by 2% per year through preventive medicines, which would mean prevention of 36 million deaths due to chronic disease by 2015, mostly in the low and middle income countries.

These statistics will more than vindicate the argument that preventive measures and medicines are cost effective, in the long run for any nation, particularly for a country like India.

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.

Why does the Government divert focus on to fringe issues to address critical healthcare concerns of the nation?

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The Department of Industrial Policy and Promotion (DIPP) of the Ministry of Commerce and Industry of the Government of India has recently initiated a public debate through a ‘Discussion Paper on Compulsory Licensing (CL) of Patented Pharmaceutical Products’.

The key intent of the discussion is presumably to improve access to quality medicines at an affordable price to the people of the country.

Could such debate serve any meaningful purpose?

Since the issue of CL involves only patented products, I wonder, whether this debate would in any way help sorting out the issue of poor access to modern medicines in our country or this is just another ‘hog wash’ or ‘diversion ploy’ of the decision makers to divert the attention of the stakeholders from the core issues of poor access to healthcare for the common man of India.

Will CL be able to address abysmally poor access to medicines issues in India?

A quick analysis of the prevailing situation related to access to modern medicines in India suggests that the usage of patented pharmaceutical products account for much less than 1% of the sum total of all medicines consumed in India in value terms. In volume terms it will be even more miniscule in terms of percentage.

As per IMS (MAT July, 2010) Indian Pharmaceutical Market size is Rs. 44,476 Crore, even 1% market share of the patented pharmaceutical products will mean Rs. 445 Crore, which is quite far from reality.

Thus, CL of patented medicines would have no sustainable and meaningful impact on improving access to modern medicines for the common man of the country. Moreover, around 40% of the population of India live below the poverty line (BPL). These ‘Children of a lesser God‘ very unfortunately, will not be able to afford any price of medicine, however cheap these could be. Vast majority of the such population who lack the financial capability to pay for even the cheapest off-patent generic medicines, which comprise more than 99% of the total medicines consumed within the country, will continue to be left in the lurch.

65% of Indians do not have access to WHO list of essential medicines, which surpasses even the African countries:

Our government also admits that 65% of Indians do not have access to even WHO list of essential medicines, none of which holds a valid patent in the country. This should be the key concern in the country. Moreover, the World Health Organization (WHO) reported that during 2000-2007, India had poorer access to essential medicines than even many African countries. It is worth noting that many of these African countries has a patent life for pharmaceuticals for around 30 years, against of 20 years in India. What are we then talking about?

Provisions of CL in the Indian Patents Acts are robust enough:

In any case, the provisions of CL in the Indian Patents Acts are not only quite clear and well articulated, but also at the same time offer flexibility in the decision making process to the Indian Patent Offices (IPOs) to invoke CL in a justifiable situation. Thus proposed guidelines related to CL would possibly invite more questions than answers. Consequently, it will be an extremely complicated process for the IPOs to categorize all the situations related to CL. Therefore, in my view, such initiatives, as initiated by the DIPP to frame guidelines for CL could prove to be totally counterproductive, as such guidelines, as stated above, would seriously limit the flexibility of the IPOs to take appropriate action, even when it would require to do so.

Moreover, it is absolutely imperative for the Government to ensure that the primacy of the patent statutes is not disturbed in any way, as such guidelines related to CL would only be consistent with the appropriate provisions within the statute and cannot be used beyond the Patent Law of the land. It goes without saying that any dispute between the parties related to the interpretation of the provisions within the statute related to CL, should only be resolved by the judiciary.

Conclusion:

How could then CL possibly offer answers to the vexing healthcare access issues of the nation? Is the Government not wasting its precious little time, instead of trying to ‘take the bull by the horns’ and resolve the critical ‘access to affordable quality medicines’ issue of India through Public Private Partnership (PPP) initiatives?

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.

‘Prevention is better than cure’: Such a healthcare policy focus could effectively reduce the disease burden in India

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First National Health Policy was passed by the Parliament of India in 1983 and was last updated in 2002. How much of the policy intent has seen the light of the day is anybody’s guess.
Healthcare issues are not being effectively addressed:
Even after six decades of independence only one in three Indians has access to basic sanitation facility like toilets, exposing a large number of population to various types of ailments. World Health Organization (WHO) reports that around 9 lakh Indians die every year breathing polluted air and drinking contaminated water. Maternal mortality rate is the highest in India. Almost half of the children in our country are grossly underweight and this phenomenon is growing at a rate which is nearly double the rate of even Sub-Saharan Africa. One third of the world’s tuberculosis patients live in India. It is indeed an irony that even today India belongs to one of those four countries of the world where polio has not been successfully eradicated, as yet.

Increasing incidences of chronic ailments are exerting further pressure on the disease burden:

Along with diseases originating due to poor hygienic conditions and life style, new challenges are coming up with rapid emergence of non-infectious chronic diseases like, diabetic, cardiovascular and psychosomatic disorders.

Chronic diseases could soon become the most critical issue in the Indian healthcare system, if these are not prevented and successfully managed. It has been reported that population suffering from, for example, diabetes could generate health care costs which are almost double of those without this ailment.

All these factors together are leading to an abnormally high disease burden in the country where very unfortunately over 65% of the population are not having access to modern medicines, either due to lack of infrastructural facilities or the people just cannot afford the basic costs of healthcare.

Most of the diseases are preventable:

Many of these chronic ailments ascribe to common preventable risk factors. Poor hygienic conditions, unhealthy nutrition, lack of proper physical activity, alcohol and tobacco abuse are the major risk factors for these diseases. An integrated approach towards disease prevention, though challenging for the nation, is the need of the hour. It is a pity that our healthcare systems do not support this process. India as a whole carries an abysmally poor track record for a well thought out and structured healthcare promotion and disease prevention policies and strategies.

Indian healthcare system is highly skewed towards disease treatment rather than disease prevention:

Current healthcare systems of India, which offer access to modern medicines just to 35% of the population, are aimed mostly towards responding to urgent needs of patients.

Relieving symptoms of the disease with an expectation of curing the ailment are the basic pattern of healthcare in our country, wherever it is available and in whatever scales and proportion. Preventive health care is quite different from the above approach.

Australia has shown a way:

Australian National Health and Hospitals Reforms Commission report titled, “A healthier future for all Australians”, published in July 2009 recommends the establishment of an independent National Health Promotion and Prevention Agency, with a significant budget for creating a robust evidence base to find out what exactly works in prevention of a disease. Like for example , the report highlights “comparison of the relative efficacy of a medical intervention (gastric bypass), a pharmaceutical intervention (an anti-obesity drug), an allied health intervention (an exercise and diet program) and a population health intervention ( a community walking program) in reducing obesity.”

The report clearly articulates that just collecting evidence on prevention will not be enough; disease prevention should be put on the same footing as the treatment of the disease.

Are we listening?

The way forward in India:

As many diseases are preventable, every interaction with a healthcare professional should include advice and follow-up on the preventive measures. When with an integrated and systematic approach, patients will be provided with information and practices to reduce health risks, it is quite likely that they will then try to maintain a healthy and hygienic life style with regular exercise, drinking safe water, eating healthy food which they can afford, practicing safe sex, avoiding tobacco and alcohol abuse.

Such integrated and systematic preventive healthcare measures can significantly help reducing the disease burden of individuals and families, besides improving vastly the quality of life. To promote prevention in healthcare, the very basic requirement is the change in mindset of both the policy makers and the civil society. A collaborative or partnership approach involving all concerned to create mass awareness is absolutely essential to ensure commitment of the common man towards such an important healthcare initiative.

Important areas for action:

• Effective use of persuasive communication tools to establish that preventive health care can help avoiding expensive disease burden and improve quality of life

• Mass awareness and demonstration program to help creating a positive attitude and required skill sets in disease prevention activities within the community

• Motivate healthcare professionals to make prevention an integral part of every interaction with the patients

• Medical insurance and healthcare policies to offer adequate incentives for preventive healthcare through innovative means

What the government of India is doing towards preventive healthcare:

The Planning Commission of India reports as follows:

• Health education for primary and secondary prevention of Non Communicable Diseases (NCDs) through mobilization of community action

• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs

• Research support for: Multi-sectoral population-based interventions to reduce risk factors

• Explanation of the role of nutrition and lifestyle-related factors

• The development of cost effective interventions at each level of care.

All these are very appreciable statements of intent. However, how much of these intents are getting translated into reality will be very difficult fathom by the common mortals.

Conclusions:

Most of the serious types of ailments of a vast majority of the population of India can be prevented and the disease related complications can be effectively avoided, if we all have a will to do that. Can we take a leaf out of the formation of “National Health Promotion and Prevention Agency” in Australia?

Healthcare costs of the nation and utilization of its scarce resource can be successfully optimized by properly focusing on disease prevention related activities. In my view, effective measures towards preventive healthcare can quite efficiently address many pressing healthcare issues of the nation.

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

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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.