With an alarming increase in the incidence of Parkinson’s, curbing and controlling the disease has become of paramount importance, globally. This, in turn, has led to the growth of the Parkinson’s drugs manufacturing market. Usha Sharma examines this phenomenon and its implications
Named after the English physician James Parkinson, who first described the illness in 1817, PD is also referred to as paralysis agitans, which is simply the Latin translation of “shaking palsy.” The names PD, shaking palsy and paralysis agitans all refer to the same illness.
Patients of PD suffer impaired motor skills and this impacts their ability to walk, talk and perform simple tasks. The motor symptoms of PD result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in the course of the disease, the most obvious symptoms are movement-related and these include shaking, rigidity, slowness of movement and difficulty with walking and gait. Later, cognitive and behavioural problems may arise, with dementia commonly occurring in the advanced stages of the disease.
PD afflicts people across the globe and is not confined to any certain race, however, it is reportedly more prevalent in Caucasians.
Facts and figures
Hitesh Gajaria, Partner, KPMG India |
According to Hitesh Gajaria, Partner, KPMG India, PD has affected over two million people across the US, Japan, France, Germany, Italy, Spain and the UK. The PD therapeutic market was estimated to be worth $2.99 billion in 2011. In the said year, US was at the forefront with an estimated value of $1.04 billion which contributes to 35 per cent of the total market share. Japan was at the second position with an estimated value of $542 million and 18.1 per cent of the total market share followed by Germany with a market share of 15.6 per cent. Together, these three countries contributed around 70 per cent of the market share. The global PD therapeutics market showed a cumulative annual growth rate (CAGR) of 5.8 per cent between 2002 and 2009. PD have been reported from countries like Brazil, Russia, India and China, where India’s therapeutic market share is about Rs 75 crore.
According to records available from Sun Pharma, in 2011 the Indian PD therapeutic market grew by 23 per cent and even during the previous years, the numbers were not dramatically different. Boehringer Ingelheim has a strong presence in the PD market as do Merck Serono, Novartis, Pfizer, GSK and UCB Pharma. Sun Pharma, Wyeth, Intas, Cipla, Serdia, Micro Labs, Orchid, Torrent Pharma, Shine Pharma, Abbott Healthcare, Mankind, Lupin are some of the key players in the Indian market for PD therapeutic market. There was a decline in the global market valuations from $3.49 billion in 2010 to $2.99 billion in 2011, possibly due to the entry of generic substitutes for innovator products going off patent.
As per a study conducted by Viartis, a London-based independent and self funded medical researcher specialising organisation in PD, the Parsi community in Mumbai, India have a prevalence of PD of 328.3 per 100,000 population, which is almost in excess of that found in Nebraska. This is despite India, as a whole, having a low prevalence of PD. This has been linked to a ritual practiced by the Parsis as part of Zoroastrianism, where aspand seed, the richest natural source of two alkaloids, harmine and harmaline, is burnt and even inhaled to ward off the evil eye from children. The two alkaloids are known as MAO inhibitors and are also used in curing PD. However, their long-term use of MAO inhibitors, eventually, has the opposite effect, which may be one of the causes for high prevalence of PD among the Parsi population.
Gajaria further says, “Studies have shown that there is evidence to prove that the genetic make-up of an individual may predispose one to the disease. People with family members afflicted with PD are reportedly at a higher risk of contracting the disease. Other theories that explain the causes of the disease are exposure to toxins/minerals. Areas with high concentration of minerals such as zinc and manganese have a higher population of PD affected patients. Studies have also shown that populations residing in rural areas/low income strata reportedly exhibit higher occurrence of PD.”
Different line for PD treatment
Today in India, medicines used to treat symptoms of Parkinson’s disease are: Levodopa (L-dopa), Sinemet, Levodopa and carbidopa (Atamet) Pramipexole (Mirapex), Ropinirole (Requip), Bromocriptine (Parlodel) Selegiline (Eldepryl, Deprenyl), Rasagiline (Azilect) Amantadine or anticholinergic medications are available to reduce early or mild tremors. Also Entacapone, helps to prevent the breakdown of Levodopa.
Sun Pharma’s spokesperson mentioned that since India is a generic market, products are generally available at a fraction of the international price.
Gajaria suggests opting for lifestyle changes that may help prevent PD. He advocates good general nutrition and health, exercising, but adjusting the activity level to meet changing energy levels, regular rest periods and avoiding stress, physical therapy, speech therapy, and occupational therapy, railings or banisters placed in commonly used areas of the house and special eating utensils.
Apart from undertaking allopathic treatment, patients in India can also opt for alternative methods of therapy. Several herbs like turmeric and brahmi have been explored for the treatment of PD. Giving details Gajaria says, “As PD is neurologically characterised by the deficiency of dopamine, most drugs are targeted to substitute its action on the dopamine receptors in the brain. Deep brain stimulation is one of the non conventional treatment methods currently being explored. In this method, electrodes are used to stimulate the brain.” However he cautions that the challenges associated with these kind of therapies are numerous.
Dr R B Smarta, Mng. Director, Interlink Consultancy |
Dr RB Smarta, Managing Director, Interlink Consultancy says, “Deep brain stimulation is the most common surgical procedure to treat PD. It involves implanting an electrode deep within the parts of your brain that control movement. The amount of stimulation delivered by the electrode is controlled by a pacemaker-like device which is placed under the skin on the upper chest.”
Stem cell therapy is another alternate option for PD medication. Explaining the rationale, Gajaria says, “PD is caused by loss of cells in the brain and an attractive treatment strategy would be to replace the lost cells. The goal of stem-cell research is to create or find a renewable resource of cells for transplantation. The potential sources are embryonic stem cells, tissue-specific stem cells, genetically-modified cells from other species and stimulation of stem cells in the brain to repair themselves. Each of these potential sources come with its own technical challenges.”
Both Alzheimer’s and Parkinson’s are neuro-degenerative disorders and differ widely in terms of aetiology (causes, origins, evolution, and implications of disease and other phenomena). While Alzheimer’s affects memories and personality and eventually leads to lowered motor function, PD impairs the person’s rudimentary motor function resulting in a trembling or palsy to dominate the body. PD focuses more on physical impairment whereas Alzheimer’s disease appears to afflict the mental abilities.
Smarta points out that PD is a syndrome of tremor, rigidity and akinesis. In Alzheimer’s disease, the key features are worsening of memory and general deterioration in intellect without any impairment of consciousness. Alzheimer’s is still not readily treatable whereas in the case of PD, it can be treated if it is diagnosed in the early stages.
Under development stage
In 2010, there were around 180 drugs for treating PD in different stages of development. Most of the drugs that are being researched are aimed at symptomatic treatment of the disease. Balancing the pipeline with the disease burden and high patient expectations is a prevalent challenge.
“If a company wants to enter/capture a position in this segment, it will need to work on circumventing the challenges posed by the current therapy. Adverse effects such as dyskinesia, psychiatric side effects and obsessive-compulsive disorder are associated with most drugs that are prescribed for Parkinson’s,” adds Gajaria.
The developed markets offer better access to healthcare to their citizens, and since awareness levels are high, the possibility of diagnosis of conditions like PD is timely. Here, there is an opportunity to introduce generic versions of off patent drugs.
The situation is different in developing countries. Speakers at a conference organised on World Health Day made the point that while 7.4 per cent of India’s total population was aged 60 years in 2001, this will rise to 17 per cent by 2050. The challenge will be to create markets by creating awareness of old-age related diseases, Over time, as healthcare access and awareness level increases in India, patients with currently under-diagnosed ailments such as PD, etc. would seek medical intervention.
With better awareness and access, and with the availability of some of cheapest branded generics, this market is sure to continue to grow at a decent pace.