Evaluation of Rapidly Evolving Parkinson’s Disease Therapeutic Market

Parkinson’s disease is a neurodegenerative disorder that affects predominately dopamine-producing (“dopaminergic”) neurons in a specific area of the brain called substantia nigra. Parkinson’s disease has four main symptoms such as tremor (trembling) in hands, arms, legs, jaw, or head, stiffness of the limbs and trunk, slowness of movement, impaired balance, and coordination, sometimes leading to falls. Other symptoms may include depression and other emotional changes; difficulty swallowing, chewing, and speaking; urinary problems or constipation; skin problems; and sleep disruptions. Parkinson’s disease symptoms and the rate of progression differ among individuals. Sometimes people dismiss early Parkinson’s symptoms as the effects of normal aging. In most cases, there are no medical tests to definitively detect the disease, so it can be difficult to diagnose Parkinson’s disease accurately.

Scientists believe a combination of genetic and environmental factors is the cause of Parkinson’s disease. Parkinson’s disease is an extremely diverse disorder. While no two people experience Parkinson’s the same way, there are some commonalities. It affects about one million people in the United States and ten million worldwide. The main finding in the brains of people with Parkinson’s disease is loss of dopaminergic neurons in the area of the brain known as the substantia nigra.

There is no “one way” of Parkinson’s disease diagnosis. However, there are various symptoms and diagnostic tests used in combination. Making an accurate diagnosis of Parkinson’s — particularly in its early stages — is difficult, but a skilled practitioner can come to a reasoned conclusion that it is Parkinson’s disease. People with Parkinson’s-like symptoms that result from other causes are sometimes said to have parkinsonism. While these disorders initially may be misdiagnosed as Parkinson’s, certain medical tests, as well as response to drug treatment, may help to distinguish them from Parkinson’s.

Current Parkinson’s Disease Treatment Market

There is no permanent cure for Parkinson’s disease, unfortunately. But there is availability of several medicines, surgical treatment, and other therapies can often relieve some symptoms. There are several FDA approved therapies for Parkinson’s disease which are categorized into seven groups that include levodopa, carbidopa-levodopa infusion (Duodopa), dopamine agonists (Mirapex, Requip, Neupro), MAO B inhibitors (Zelapar, Azilect, Xadago), catechol o-methyltransferase (COMT) inhibitors (Tasmar, Comtan), anticholinergics (Cogentin, Artane), adenosine A2a antagonists (Istradefylline) and amantadine (Gocovri, OSMOLEX ER). The treatment is given based on the stages of the disease, symptoms shown, and those who are already receiving some medication. 

The main therapy for Parkinson’s is levodopa, also called L-dopa. Nerve cells use levodopa to make dopamine to replenish the brain’s dwindling supply. Usually, people take levodopa along with another medication called carbidopa. Carbidopa prevents or reduces some of the side effects of levodopa therapy—such as nausea, vomiting, low blood pressure, and restlessness—and reduces the amount of levodopa needed to improve symptoms. In April 2020, the US FDA has approved Ongentys (Opicapone) (Neurocrine Biosciences), as an oral, add-on daily treatment for Parkinson’s disease patients experiencing off periods while on a levodopa/carbidopa regime. Then in May 2020, the US FDA approved KYNMOBI (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease.

Other than levodopa, dopamine agonists followed by amantadine, MAO-B inhibitors, and others (COM-T inhibitors, anticholinergic inhibitors etc.) accounted for the major market share in the US. The current Parkinson’s Disease therapeutic landscape in the US is driven by several approved therapies being produced by major pharmaceutical companies such as AstraZeneca, Seattle Genetics, Incyte Corp., Neurocrine Biosciences, and many others. 

As per DelveInsight estimates, Parkinson’s Disease market size in the United States was USD 1390.1 million in 2020.

Parkinson’s Disease market size is expected to increase in the coming years, the major reason behind market upsurge is the launch of the most anticipated launch of potential therapies and several other gene therapy for Parkinson’s Disease.

As per DelveInsight analysis, the total prevalent population of Parkinson’s Disease in the United States was estimated to be 1,073,894 cases in 2020. These cases are also anticipated to rise in the coming years which will directly increase the Parkinson’s Disease market size. An emerging pipeline of Parkinson’s Disease, better understanding of disease, and development of gene and stem therapies is projected to boost the growth of the Parkinson’s Disease treatment market.

Emerging Therapies in the Parkinson’s Disease Treatment Market

Some pharmaceutical and biotech companies like Prevail Therapeutics, Axovant Gene Therapies, Neurocrine Biosciences/Voyager Therapeutics, Denali Therapeutics, International Stem Cell Corporation, Living Cell Technologies, Addex Pharma, Annovis Bio Inc, Pharma Two B Ltd, AbbVie, Prevail Therapeutics, Axovant Gene Therapies, Denali Therapeutics, Neurocrine Biosciences, and others are researching new therapies that target other aspects of Parkinson’s disease pathology, namely genetic mutations, and Lewy bodies (a hallmark feature of Parkinson’s disease).

The expected launch of novel and emerging therapies will impact the market size of Parkinson’s Disease in the upcoming years, few of them are mentioned below-

Atuzaginstat/ COR388 is an investigational therapy by Cortexyme. It is a Lysine gingipain inhibitor which is being evaluated for degenerative diseases including Alzheimer’s and Parkinson’s Disease. It was announced that Atuzaginstat would to be studied in the PEAK trial, a new Phase II study for PD. It has begun study start-up activities. Cortexyme is targeting a specific, infectious pathogen found in the brain and other organs and tied to degeneration and inflammation in humans and animal models.

Tavapadon is being developed by Cerevel Therapeutics which is an orally-bioavailable, once-daily partial agonist that selectively targets dopamine D1/D5 receptor subtypes to balance meaningful motor activity with a favorable tolerability profile. It is being developed to treat both early and late-stage PD. The drug is presently being evaluated in four Phase III studies ( TEMPO 1,2,3,4) in Parkinson’s Disease subjects.

IPX203 is an investigational extended-release oral capsule being developed by Amneal Pharmaceuticals. It is a formulation of carbidopa and levodopa, being studied as a potential treatment for the advanced Parkinson’s Disease symptoms. The drug is presently being evaluated in two Phase III studies in Parkinson’s Disease patients.

P2B001 is an investigational drug produced by Pharma Two B which comprises of low doses of two drugs, pramipexole, and rasagiline. The development of P2B001 is intended to provide a combination of low doses of these two drugs in an improved formulation that is hoped to be more effective in controlling Parkinson’s Disease symptoms and with fewer side effects than each of the drugs taken alone or the currently available commercial drugs taken together. The drug is currently being evaluated in a Phase III clinical study to assess the safety and efficacy of P2B001 in the subjects with early Parkinson’s Disease.

Prasinezumab is a humanized monoclonal antibody developed by Roche that targets alpha-synuclein, a protein found in neurons that can aggregate and spread from cell to cell, resulting in the neuronal dysfunction and loss that causes Parkinson’s disease. Prasinezumab is designed to block the cell-to-cell transmission of the aggregated, pathogenic forms of alpha-synuclein in Parkinson’s disease, thereby slowing clinical decline.

KDT-3594  is a novel orally administrable non-ergot dopamine agonist is being produced by Kissei Pharmaceutical. It acts by stimulating dopamine receptors in the basal ganglia, thereby ameliorating the symptoms of Parkinson’s disease caused by insufficient action of dopamine. It is also confirmed as a new therapeutic agent for Parkinson’s disease that KDT-3594 reduces the risk of the characteristic side effects of existing ergot and non-ergot dopamine agonists. KDT-3594 is currently under Phase 2 clinical trials in Japan.

CVN424 is an orally bioavailable, brain penetrant small molecule being developed by Cerevance Beta.It acts as a potent inverse agonist of a novel target that is highly selectively expressed in striatal neurons of the dopamine D2 receptor-dependent pathway (the “indirect” pathway) compared to the D1 receptor-dependent (“direct”) pathway. The drug is intended to generate the positive effects of L-dopa and deep brain stimulation, the current standard of care for Parkinson’s disease. The drug is currently being evaluated in a Phase II clinical study to treat Parkinson’s Disease.

There are several other drugs in the Parkinson’s Disease pipeline which includes therapies such as ABBV-951 by AbbVie, THN102 by Theranexus, and many others that will fuel the Parkinson’s Disease market in the coming years.

Parkinson’s Disease Treatment Market: Progress and Setbacks

The current therapeutic landscape of Parkinson’s Disease currently is driven by several approved therapies. Also, the Parkinson’s Disease market is expected to surge due to factors such as the increasing prevalence of Parkinson’s Disease, entry of novel and emerging therapies with better clinical profile and increased market penetration of targeted/ advanced therapies, new biomarkers for diagnosis of Parkinson’s Disease and also the involvement of digital technology for diagnosis and treatment. In addition to that focus on development of adherence-friendly drug formulations, development of drug for better treatment of motor symptoms as well as gene therapy and stem cell therapy for Parkinson’s Disease treatment can move the market much forward.

On the other hand, inadequate knowledge of pathophysiology of Parkinson’s Disease, undiagnosed and unreported cases, lack of diagnostic measures and methods and lack of efficacy of existing therapies  are considered as some of the potential drawbacks for Parkinson’s Disease treatment market.

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