Companies & Sectors
Pharma companies eye bigger share in expanding diabetes therapeutics market

Competition is stiff between domestic and international companies to gain a large share for the diabetes market that is growing at a phenomenal rate

With the number of patients spiralling up, India is becoming the ‘diabetes capital’ of the world. This growth will propel pharma companies’ future as well. According to research reports, total anti-diabetic market in India will grow at a compound annual growth rate (CAGR) of 13% over 2009-2019 to Rs7,348.9 crore from Rs2,127.3 crore.

 
 “Poor affordability, bio-similars of insulin analogues and lack of data protection restricts growth of the anti-diabetics market in India. Relative positions of top companies in Indian diabetes market are likely to remain unchanged. However, Indian companies could lose a marginal market share on account of new patented product launches lined up by multi-national pharma companies (MNCs),” said BRICS Securities in a research note.

The total diabetes therapeutics market in India has grown at a CAGR of 21% to Rs3,307.20 crore in 2011 from Rs1,852.4 crore in 2008 while the oral anti-diabetics accounts for 71% of the diabetes treatment market in 2011. According to some reports, the prevalence of diabetes in the country has reached at around 3.7% of the total population.
 
During 2011, insulin sales were Rs950.3 crore comprising over 27% of the anti-diabetes market. The insulin market recorded 20% CAGR over 2006-09 and is expected to grow to Rs2816.4 crore by 2019 of which pre-mixed insulin is the major revenue contributor.

In the insulin market, the pre-mixed class has high acceptance with human Mixtard 30/70 from Abbott (Novo Nordisk) is the leader in this segment, followed by Humulin Mix from Eli Lilly. According to market research firm IMARC Group the size of India’s insulin market is expected to grow three-fold by 2015 from $147 million in 2010.

“Indian regulators have banned rosiglitazone due to possible risks of myocardial infarction. This has left a void in thiazolidinediones-often called TZDs or glitazones market of which majority of patients will move to other TZD class drug like pioglitazone and its combinations,” the brokerage said.

In India, Abbott, with a large insulin portfolio, is the leader in anti-diabetic market with 22% share while USV with 11% market share is the leader in oral anti-diabetic segment. Although generics still dominate the Indian diabetes therapeutics market, a number of new launches like Januvia have witnessed strong uptake on stronger IPR regime and greater affordability by patients.

Bio-similar incursion will eat into the market share of insulin analogues of MNCs. Leading domestic companies like Biocon, Shreya Lifesciences, USV and Wockhardt are developing bio-similars for recombinant human insulin and insulin analogues. Biocon has successfully created bio-similars for insulin analogues like lispro, aspart and glargine. “However, despite having capability to manufacture bio-similars for insulin aspart and lispro, Biocon does not market these in India. Wockhardt has also developed bio-similars for insulin glargine,” said BRICS Securities.

Affordability of healthcare is a serious challenge in India because more than 75% of expenses on healthcare are through out-of-pocket while per capita personal disposable income is low. Many MNCs have adopted differential pricing strategy for new drugs to enable more patients’ access these drugs. However, these drugs with reduced prices remain out of reach and unaffordable for a large section on the population.
 
International Diabetes Federation, in a release said data from global studies demonstrates that the number of people with diabetes in 2011 has reached a staggering 366 million, 46 lakh deaths are due to diabetes and health care spending on diabetes has reached $465 billion. In 2011, one person is dying from diabetes every seven seconds, the release said.
 

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New drug pricing policy may increase prices of essential medicines

The government plans to bring 348 essential drugs, accounting for 60% of the entire domestic pharma market, under price control. The fine print in the policy may result in increasing the prices rather than decreasing!

The Supreme Court recently asked the union government to ensure that drug prices go down, not up, if and when a new pharmaceutical pricing policy comes into force. Government is patting itself on the back for having expanded the scope of the self-styled "price control" from current 74 to 348 drugs listed under the National List of Essential Medicines. Pharmaceutical companies are opposing the move with the biggest drug maker Pfizer going to the extent of propagating that it will push the sector into a semi-recession. Ironically, the medical prices may increase due to the proposed unfounded Market Based Pricing (MBP). MBP is a misnomer. It is not market based pricing, but top-brands-based pricing, where it is not the cheapest brands which will determine, but the top brands will determine the prices of all other drugs.

Dr Chandra M Gulhati, editor, Monthly Index of Medical Specialities (MIMS) says, "Government's new drug pricing policy has come out with a new, never-heard-of-before methodology called MBP. Under this strange system, the weighted average price of three top selling branded medicines will be the benchmark for price fixation. Why top three brands only? Why not top 10 to get a more reasonable figure? Why not take into account the price of drugs sold under their generic names also? Why not the average price of three or more least expensive brands?"

He adds, "The total number of molecules being used in India exceeds 1,000. Thus even the expanded list leaves out a huge number of drugs from any price control. Unlike other consumer items, in the case of medicines the decision maker is the doctor who selects the drugs and the brands. With manufacturers giving huge incentives to prescribers to push their products, the top selling brands are generally the ones which are also more expensive. Thus under MBP the maximum permissible prices of most drugs will fall in the higher band. Once this happens, the manufacturers of cheaper equivalent products will push up the prices to take advantage of government-sanctioned levels." Currently, the drugs that are not in the price control were allowed to raise prices by 10% annually.

Dr Anant Phadke is leader of the People's Health Movement in Maharashtra; he is also active with the Shramik Mukti Dal movement. He says, "The biggest flaw is drug category will not be in price control and hence pharma companies can promote medicines from the same category which are not in price control and doctors will start prescribing them. E.g. Among anti-hypertensives while enalapril will have a price cap, prices of all other widely used ACE inhibitors such as captopril, fosinopril, imidapril, lisinopril, perindopril, quinapril, ramipril and trandolapril will be free from any regulation. Doctors will be discouraged to prescribe enalapril and promote other prils even though there is no therapeutic advantage."
 
Edelweiss research report calls the government proposed draft policy as pro industry. It says that MBP and annual price hike based on WPI (Wholesale Price Index) is likely to limit losses for the pharma industry. It says that the pharma industry will heave a sigh of relief as the proposed policy is not as harsh as anticipated and overall impact could be less than 2% on the domestic market.
 
If so, why is OPPI (Organization of Pharmaceutical Producers of India) vehemently opposing the drug pricing control? It could be because OPPI is multinational-led industry body. Nomura research report says MNCs will be impacted the most. PINC research expects GSK (GlaxoSmithKline) to be most negatively impacted.

The government, under the proposed policy, would also remove bulk drugs from the list of medicines whose prices need to be controlled. This would lead to a rise in prices of all formulations based on the bulk drugs.
 
According to S Srinivasan, managing trustee, LOCOST (Low Cost Standard Therapeutics), "Bulk drug prices left to the market can lead to cartelization on vital drugs. In some vital drugs (like anti-TB Rifampicin) only 2-3 major manufacturers are present. Government has no recourse if bulk drug prices shoot up without reason (or with reason). Smaller manufacturers for all drugs will have to rely on higher priced local manufacturers of bulk drugs. This will render smaller manufacturers of formulations uncompetitive. Eventual shakeout of the market will leave only bigger players. Control of Formulations prices only is not a good idea as it delinks from prices of bulk drugs. It may lead to shortages. It gives no idea of how much profits are being made as MRP to raw material ratio is about 2000 % to 3000 % for many formulations."

Dr Phadke says, "The proposed MBP pricing is deceptive and will only rationalise and legitimise higher pricing. Cost based pricing is not difficult to arrive. The reason of the fight was huge difference between cost and market price. It was expected to come down with drug price control, but it will not happen. All India Drug Action Network (AIDAN) is given permission to file affidavit in response to new policy. They will file their argument to go with cost based pricing."
 
AIDAN had filed public interest litigation (PIL) with the supports of several NGOs. Hearing on this PIL on November 17, the apex court had expressed their concern over government's policy and has given three months duration to the government to take appropriate action to fulfil its promise. The next hearing will be in January 2012.

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COMMENTS

naren

5 years ago

many pharma companies owe lot of penalties due to price violation, but do not pay. abt 2000 crores. they can get away with it due to lobby, litigation

captainjohann

5 years ago

The WHO essential drug list is one of those lists prepared by Drug MNCs who are based in Geneva and control the WHO.Most of them are not in use now are banned in western countries.The list does not contain clozapine an Essential anti Psychotic drug(which is out of patent due to 20 year limit already over) but drugs which have most side effects.and so not used by patients.the list does not contain anti/Galucoma drugs nor eye drops required after Cataract surgery.I can go on about the list about diabetic,blood pressure etc etc but as generic names alone to be used the Government must ensure Quality control of the drugs

Govt seeks Parliament nod for Rs56,848.46 crore net spend

The approval for second supplementary grants for 2011-12 amounting to Rs56,848.46 crore was sought by finance minister Pranab Mukherjee in the Lok Sabha. A statement in this regard was laid in the Upper House

New Delhi: Faced with a resource crunch, the government today sought Parliamentary approval for additional net expenditure of Rs56,848.46 crore for the current fiscal, with under-recoveries of oil marketing companies accounting for Rs30,000 crore, reports PTI.

The approval for second supplementary grants for 2011-12 was sought by finance minister Pranab Mukherjee in the Lok Sabha. A statement in this regard was laid in the Upper House.

“Approval of Parliament is sought to authorise gross additional expenditure of Rs63,180.24 crore. Of this, the proposals involving net cash outgo aggregate to Rs56,848.46 crore and gross additional expenditure, matched by the savings of the ministries/departments aggregates to Rs6,330.80 crore,” the introductory note for demand said.

A maximum of Rs30,000 crore grant has been sought for ministry of petroleum and natural gas.

The statement for supplementary demands said the grants for ministry of petroleum is sought for “providing compensation towards estimated under-recoveries to oil marketing companies on account of sale of petroleum products (Rs30,000 crore)....”

Besides ministry of petroleum, Rs13,778.93 crore grants has been sought for Department of Fertilisers to meet Rs2,200 crore expenditure on subsidy on imported fertilisers and Rs3,000 crore on imported decontrolled fertilisers.

Of the additional expenditure sought Rs3,800 crore has been sought for the ministry of defence, Rs2,297.52 crore for ministry of consumer affairs, food and public distribution, Rs1,500 crore for police and Rs1,030 crore for pensions.

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