Category Archives: Global Pharmaceutical Industry

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The ‘Make in India’ campaign by Prime Minister Narendra Modi has 25 sectors in focus including Pharmaceuticals and Chemical sector. This may proven to be a booster dose to the Pharmaceutical Manufacturing Industry.

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The Make India campaign will result in attracting investment from foreign markets. The government has already created a dedicated online cell to answer queries from all over the globe. Primarily, the ‘Make In India’ focuses on zero defect and zero effect. In which zero defect means products which are manufactured in India should not be rejected in the overseas market. Zero effect means that the manufacturing should not have any negative impact on the environment. Continue reading

‘Make In India’ is focusing on Pharmaceutical sector this week. Considering India as one of the major markets for Pharmaceuticals in the world this is a great move. Right from the beginning there has been much hype about Indian Prime Minister Mr. Narendra Modi’s dream project ‘Make In India’. According to experts the program is promising and will have great and enduring effect on Indian economy through manufacturing industry.

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Reduced production

In the recent economic slowdown where the industrial sector in India has been grossly affected, the Pharmaceutical Industry is no exception. The Pharmaceutical Industry has been facing pressure on the export front because of the ups and downs in the dollar, stricter laws from the US FDA, increase in the generic drug fee of the ANDA dossier, rising manufacturing costs, rising cost of the raw material, pricing pressures (DPCO) and the Pharma MNC’s trying to buy out existing units in Indian and trying to increase their geographic presence.

Even semi regulated markets are in the process of enforcing stricter regulations for exports of medicines from India. Continue reading

The conventional use of social media is to connect with friends, near and dear ones. This concept exists worldwide. However the western world has been the first to tap the social media to its right use and that is why many good businesses thrive because of the social media. The pharmaceutical industry is no exception to the above rule.

Pharmaceutical industry in the west has picked up the social media for educating its customers i.e. patients and doctors Continue reading

Disease Spends, Medicines and Healthcare budgets – Latest Trends

Since 1950, life expectancy for men and women in the U.S. has increased by a full decade, from 68.2 to 78.2. Breakthroughs in scientific research are driving advances in treatment and prevention strategies, resulting in life expectancy gains and improvements in patient outcomes across disease areas. The chances that a cancer patient will live at least 5 years has increased from 50% (1975-1979) to 68.5% (2002). Heart failure and heart attack death rates fell by nearly half from 1999 to 2005.[iv] Though HIV/AIDS was once a uniformly fatal disease, patients diagnosed today have a range of treatment options that are improving survival and helping to keep them symptom-free for years.

In the last ten years over 300 new medicines have been approved by the U.S. Food and Drug Administration (FDA).  These medicines are helping patients to live longer, healthier lives.  They are transforming many cancers into treatable conditions, reducing the impact of cardiovascular disease, and offering new options for patients with chronic diseases like diabetes and rheumatoid arthritis.

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According to IMS, global spending on medicines may touch $1.1 trillion by 2015. This is based on a slowing annual growth rate of 3-6 per cent over the next five years. The growth rate in global spending on medicines used to be 6.2 per cent in the past five years. According to IMS, there are a few key reasons for the slowdown in growth rate. These are lower levels of spending for medicines in the US, ongoing impact of patent expiries in developed markets and continuing strong demand in emerging markets.

The changing trend is the rapid shifts in the mix of spending by players between branded products and generics amongst the developed and emerging markets. While aging populations in developed markets may continue to drive incremental spending on brands, which could be more than offset by the impact of patent expiries in the years to come. As a result, spending for branded products in developed markets will remain at the same level in 2015 as in 2010. Globally, market share for branded medicines, which fell from 70 per cent in 2005 to 64 per cent in 2010, is expected to decline further through 2015, to 53 per cent.

IMS projection indicates that expiring patents for branded products will yield as much as $98 billion in net savings to patients in developed countries through 2015, as compared to $54 billion in savings realized in five years upto 2010. And patent expiries will help to save a total of $120 billion to whole world by 2015. Among developed markets, the US will experience the largest expansion of generic spending while Japan will continue to have the lowest share despite serious policy initiatives to increase generic prescribing and dispensing. Two key trends in global consumption of pharmaceuticals are emerging from these set of figures. One is the unprecedented rise in the consumption of generics in the US market, a traditional bastion of branded pharmaceuticals. This is mainly attributed to the drying up of newly patented products in most therapeutic categories in the market. Certainly this growing shift to generic buying has brought a sharp cut in medical expenditure to growing number of patients.

Sources:

  1. http://uk.reuters.com/article/2011/04/12/uk-india-pharma-idUKLNE73B00O20110412

The pharmaceutical industry is passing through a very challenging period since the last 2-3 Years particularly in the area of new drug development and its outsourcing of clinical trials (Clinical Research) to external providers.

The rising rate of failures of new compounds in the post Phase I stages has added to the woes of the Global Pharmaceutical companies. Big Pharma is facing challenges ranging from the loss of patent protection on blockbuster drugs to declining R&D productivity. There are unprecedented pressures that drug makers face and what the industry needs to do restore itself to past glory. There are many different things that drug developers can do or need to do because of which they can efficiently spend their R&D dollars and avoid late-stage blow-ups. This would be a key factor in driving the market growth of the CRO’s i.e. in the outsourcing of clinical trials/ research to clinical research organizations particularly in emerging nations like India.

The forecasted/projected growth of the Global CRO market according to Business Insights is shown below:

More drug makers are seeing potential in the business of producing copycat versions of expensive biotechnology drugs as U.S. guidelines take shape.
Merck & Co said it has struck an alliance with contract researcher Parexel International Corp to develop copies of biotech medicines, deepening the U.S. drug maker’s investment in so-called bio similar medicines.

Because of the complexity of biotech drugs, which are produced through biological processes that generally involve recombinant DNA technologies, they are often called “bio similars” rather than generic copies.

Merck is not alone in its biosimilar intentions. In October 2010, Pfizer formed a strategic global agreement for the worldwide commercialization with the Indian biotechnology company Biocon for biosimilar versions of insulin and insulin analog products (e.g., recombinant human insulin, glargine, aspart, and lispro).

Sandoz, the generics arm of Novartis, which has three approved biosimilar products, announced that it has begun a Phase II clinical trial for a biosimilar version of rituximab, the active ingredient in Rituxan/Mabthera, a monoclonal antibody to treat non-Hodgkin’s lymphoma and rheumatoid arthritis, which is marketed by Roche/Genentech and Biogen Idec.

So what is next? We continue to look for positioning of both innovator companies (large and small) as well as generic-drug companies in the bio similars market and foremost, watch for the crucial developments in FDA’s and EMA’s regulatory positions for biosimilars.

The global drug market will grow to 5 to 7 percent in 2011, to $880 billion, as higher spending in nations like China, Brazil and India makes up for slow growth and patent losses in the United States, according to a forecast released Wednesday by IMS Health, an industry data company. Prescription drug sales in 17 countries are growing at a 15 to 17 percent clip, led by China. It alone is expected to have sales growing at a rate of 25 to 27 percent to $50 billion next year, IMS Health said. Next year, patents expire on the two top-selling drugs in the world: Lipitor, the cholesterol drug from Pfizer, which had $13.2 billion in sales last year, and Plavix, the blood thinner from Bristol-Myers Squibb and Sanofi-Aventis, which had $9.1 billion in sales. Mr. Aitken said the full effect of lower-priced generic competition would be felt in 2012.

Collaborations as a home grown business model
This is one of the models which many global Pharma companies are eyeing in the current competitive scenario. One of the major countries eyeing the Indian geography today is Japan. Top Japanese drug makers are planning big presence and investments in India, within two years of India’s largest manufacturer, Ranbaxy Laboratories, being taken over by Daiichi Sankyo, the third largest Japanese one. Last week, the $40-billion Mitsui & Co Ltd announced it would acquire a five per cent stake in pharmaceuticals ingredient manufacturer Arch Pharmalabs for `65 crore. The move is to strengthen its contract manufacturing business in the pharmaceutical sector. Mitsui has had a business relationship with Arch for the past four years. The strategic stake sale will help the 1,200-crore Arch to foray into supply of active ingredients and intermediates in the tough Japanese market, as Mitsui will exclusively market Arch’s products in Japan.”