Would ‘Complex Generics’ Attract More ‘Authorized Generics’?

Would ‘Complex Generics’ Attract More ‘Authorized Generics’?

Despite increasing numbers of alleged scams involving generic drugs, both in the United States and also in India, even involving many large generic drug manufacturers, the traditional generic drug market, keeps growing globally. Although, the current growth is in mid-single digit, the market can’t be ignored, either.

That apart, enormous pricing pressure, squeezing bottom line and cutthroat competition, are prompting many companies, including Big Pharma, to craft different strategies to excel in this market. One such involves a shift in business focus from relatively low priced traditional generic drugs to comparatively higher priced complex or specialty generic medicines with a few competitors.

In this emerging situation, a lurking apprehension does surface for many. If the margin is good and the prices of these complex or specialty generics, are much higher than traditional ones, won’t it prompt more ‘Authorized Generics’ coming into the market? Won’t that jeopardize the interest of other generic drug makers? In this article, I shall explore this area, along with its possible consequences. Before doing that, it will be worthwhile to give an overview of the generic market, before recapitulating what are ‘Authorized’ and ‘Complex’ generics.

How lucrative is the generic drugs market now?

According to the latest report by IMARC Group, the global generic drug market size reached US$ 340 Billion in 2018 and is expected to be at US$ 475 Billion by 2024, growing at a CAGR of 5.3 percent during 2019-2024 period.

The key market growth drivers remain, increasing number of product patent expiration, higher prevalence of chronic diseases and different government initiatives to encourage faster generic launch, including the United States. The pace of increase is faster in the emerging markets, like India. However, unlike India, non-branded generic drugs, rather than branded generics, are dominating most the markets.

Although, Central Nervous System (CNS), cardiovascular, dermatology, oncology and respiratory are among the dominant segments in the market, CNS and Cardiovascular segments are the two largest ones in this market. North America holds the largest market share, with more than 88 percent of total prescriptions being written for generic drugs in the U.S., as the report highlights. Despite this scenario, to mitigate huge pricing pressure, cutthroat competition and low margin, many drug players are preparing to move into specialty or complex generics.

The size and growth of complex or specialty generics market: 

The April 2019 report by Research and Markets- “Specialty Generics Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024″ states, the global specialty generics market reached a value of US$ 44.8 Billion in 2018. By 2014, its value is expected to reach US$ 88.9 Billion with a much higher CAGR of 11.9 percent, in 2019-2024 period.

Which drugs would belong to this market?

According to the ‘White Paper’ titled, ‘Complex Generics: Maximizing FDA Approval Prospects’ of Parexel, the following are …continue reading… 

Reaping Rich Harvest With Orphan Drugs

Reaping Rich Harvest With Orphan Drugs

A set of perplexing questions on the drug industry has been haunting many, since long. One such area is intimately associated with the core purpose of this business, as enunciated by each company, often publicly. Just to give a feel of it, let me quote what one of the largest global pharma players – Pfizer articulated in this regard, on April 5, 2019: “Health for All is at the core of our company’s purpose. We advance breakthroughs that change patients’ lives by ensuring they have access to quality health care services and Pfizer’s medicines and vaccines.”

Publicly expressed core purpose of any pharma business being generally similar, it may be construed as the same of the industry, at large. Hence, some baffling questions – not ethical, but purely commercial in nature, float at the top of mind, such as:

• How the core purpose of business – “Health for All”, gets served when companies bring to the market mostly exorbitantly high-priced drugs, having access only to a minuscule patient population?

• How are these companies growing at a faster pace and doing better commercially, by focusing more on orphan drugs approved for the treatment of rare diseases, affecting a very small patient population.

At this point, it will be worthwhile to have a quick recap on ‘orphan drug’ and ‘rare disease’. According to MedicineNet, orphan drugs are those which are developed to specifically treat rare medical condition. This rare medical condition is also referred to as an orphan disease. With that preamble, I shall now focus on this knotty area in search of evidence-based answers to – Is it possible to reap a rich harvest in business with orphan drugs for rare disease? And, if so, how?

Is the focus on high priced orphan a strategic business move?

Regardless of an affirmative or negative answer to the above questions, many people are head scratching with anguish while observing this trend in the drug industry. Mainly because, it is possibly the most important industry for most patients, not only while suffering from an ailment, but also before and after it happens, for various reasons.…continue reading…

Dynamics of Cancer Therapy Segment Remain Enigmatic

Dynamics of Cancer Therapy Segment Remain Enigmatic

Currently, cancer is likely to occupy the center stage on any discussion related to the fastest growing therapy segments in the pharma or biotech industries. There are several reasons behind such probability, some of which include:

• Cancer is not only the second leading cause of death globally, but also offer outstanding new drug treatment options, though, mostly to those who can afford.

• Consequently, these drugs are in high demand for saving lives, but not accessible to a vast majority of those who need them the most.

• Alongside, oncology is one of the fastest growing therapy segments in sales in many countries, including the largest and most attractive global pharma market - the United States.

• New cancer drugs being complex, involves highly sophisticated cutting-edge technology – creating an entry barrier for many, and are generally high priced, fetching a lucrative profit margin.

These are only a few basic dynamics of the segment. Nevertheless, understanding these dynamics, in a holistic way, is indeed an enigma – caused mostly by directly conflicting arguments on many related issues, within the key stakeholders. Thus, I reckon, this issue will be an interesting area to explore in this article. Later in this discussion, I shall try to substantiate all the points raised, backed by credible data. Let me start with some causative factors, that may make comprehensive understanding of the dynamics of this segment enigmatic.

Some causative factors for triggering the enigma:

Close overlap of several contentious factors is associated with this head-scratcher. These come in a package of reasoning and counter reasoning, a few examples of which may be seen below:

• When increasing incidence of cancer related deaths are a global problem, fast growing oncology segment, regularly adding novel drugs in its portfolio, ideally should be a signal for containing this problem. Whereas, the World Health Organization (W.H.O) reports, cancer drugs are beyond reach to millions, for high cost. Nonetheless, the cancer drug sales keep shooting north.

• Nearer home, while Indian anti-cancer drug market growth has, reportedly, ‘outstripped that of all other leading countries in recent years and is set to go on doing so,’ another study report underscores, ‘Indians have poor access to essential anti-cancer drugs.’

• Although, a 2019 report of W.H.O highlights: Expensive cancer drugs ‘impairing’ access to cure, innovator companies also have their counter argument ready. They claim, higher prices ‘are necessary to fund expensive research projects to generate new drugs.’

• When innovator companies keep touting that many new…continue reading…
   

Pharma: ‘Digitalization’ Not A Panacea – A Basic Step For Giant Leaps

Pharma: ‘Digitalization’ Not A Panacea – A Basic Step For Giant Leaps

The hype of ‘Digitalization’ in the pharma industry, virtually as a panacea, is palpable all around. It gives many a feel, directly or indirectly, that this one-time, resource-intensive, disruptive transformation would reap a rich harvest for a long time. In some way, good or bad, the sense of urgency underlying the hype, could possibly be akin to Y2K, that one witnessed before the turn of the new millennium.

Notwithstanding the current ballyhoo, the process of digitization in several Indian pharma companies began since quite some time and is now gathering wind in its wings. Several studies vindicating this point, were reported by the Indian media, as well. One such report of October 31, 2016 highlighted – even around 2013, a number of Indian drug players commenced adopting digitization. They mostly began with the use of modern technology for scientific detailing to doctors, often using algorithms for better insights into issues, like patient compliance. A similar trend was seen also in China, the report added.

Be that as it may, this article will explore whether or not ‘Digitalization’ is a panacea for all pharma business hurdles. Or, it is the backbone to build and maintain a patient-centric organization, with need-based subsequent giant technological leaps, for game changing sustainable outcomes. For better clarity of all, I shall dwell on this concept with AI as the next disruptive step, as it would play an increasingly critical role to be in sync with the customers of the fast-growing digital world.

Digitization is the bedrock to move forward with newer technologies:

That digitization is the backbone of AI adoption was brought out in the May 2019 paper by McKinsey Global Institute - titled, ‘Twenty-five years of digitization: Ten insights into how to play it right.’ It articulated, leveraging, and transitioning from, digital to new frontier technologies is an imperative, as several new frontier technologies are opening up, such as AI.  It also spotlighted that early digitization is the foundation of AI deployment.

Elaborating the point further, the article wrote: ‘70 percent of companies that generate 50 percent of their sales through digitization are already investing in one AI domain. The evidence suggests that incumbents that have adopted AI early and are savvy about deploying these technologies have experienced strong profit growth. In effect AI is a new, higher- performance type of digital technology that may boost the ability of firms to accelerate their digital performance.’

No doubt, several hundred AI use cases would provide evidence of widespread benefits to operations and profitability for AI adoption. However, from the drug industry perspective, the possible dilemmas that will be important to understand, what factors are prompting faster adoption of AI in pharma. Besides, how to make out – what type of use of AI is likely to be most effective for an organization.

Regardless of the dilemma, the AI buzz is gaining momentum:

The fervor around AI is now peaking up, more than ever before. Regardless of the general dilemma – ‘what type of use of AI is likely to be most effective for an organization.,’ several companies are working on AI application in various areas. In sales and marketing domain, these include, improving customer interactions, maximizing product launches, understanding patient insights. This was also corroborated…continue reading…