PUBLISHER: DelveInsight | PRODUCT CODE: 1415487
PUBLISHER: DelveInsight | PRODUCT CODE: 1415487
DelveInsight's "Parkinson's Disease - Market Insights, Epidemiology, and Market Forecast - 2032" report delivers an in-depth understanding of the Parkinson's disease historical and forecasted epidemiology as well as the market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The Parkinson's disease market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Parkinson's disease market size from 2019 to 2032. The report also covers current Parkinson's disease treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2019-2032.
Parkinson's disease is a progressive disorder that is caused by the degeneration of nerve cells in the part of the brain called the substantia nigra and primarily affects movement.
The motor symptoms of Parkinson's disease include tremors, bradykinesia (slowness of movement), rigidity, and postural instability, while the non-motor symptoms may include cognitive impairment, mood disorders, sleep disturbances, and autonomic dysfunction. These symptoms can severely affect a patient's quality of life if uncontrolled. Additionally, caregiver burden is significant due to the progressive nature of the disease.
The cause of Parkinson's disease remains unknown, but it has long been hypothesized that exposure to environmental risk factors may be one cause, along with an inherited susceptibility. While men are slightly more susceptible than women are, it typically affects individuals over the age of 60, but early-onset cases also occur.
Diagnosing Parkinson's disease can be challenging, as there is no definitive test for the condition. 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 conclude it is Parkinson's disease. To avoid misdiagnosis, consultation with a movement disorder specialist (MDS) is recommended.
Further details related to country-based variations are provided in the report…
The medications used to treat Parkinson's disease include levodopa, dopamine agonists, MAO-B inhibitors (MAO-B), catechol-O-methyl transferase (COMT) inhibitors, amantadine, and anticholinergics. The main goal of these medications is to lessen motor symptoms or the symptoms that affect movement in people with Parkinson's disease. Several US FDA-approved medications such as XADAGO, DUOPA/DUODOPA, INBRIJA, ONGENTYS, and others are also being used to treat motor and non-motor symptoms associated with Parkinson's disease. In addition, several other approaches are also recommended including deep brain stimulations, physical and occupational therapies, speech therapy, and exercise programs.
Levodopa is the gold standard for the treatment of motor symptoms, but it is common for people with Parkinson's to take a combination of medications. Dopamine agonists are recommended as monotherapies in the early stages of the disease but in later stages as a combination or adjunct therapy with carbidopa/levodopa. They function like dopamine in the brain and improve the motor symptoms of individuals with Parkinson's, but they are less effective than levodopa. They have longer half-lives than levodopa and help reduce "off" time or enhance the benefits of levodopa. Many dopamine agonists were approved by the US FDA, like REQUIP, REQUIP XL (ropinirole), MIRAPEX, MIRAPEX ER (pramipexole), NEUPRO skin patch (rotigotine), and (APOKYN) apomorphine subcutaneous injection; however, they now have their generics in the market.
As the market is derived using a patient-based model, the Parkinson's disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of Parkinson's disease, gender-specific diagnosed prevalent cases of Parkinson's disease, age-specific diagnosed prevalent cases of Parkinson's disease, and stage-specific diagnosed prevalent cases of Parkinson's disease in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.
Among gender-specific cases of Parkinson's disease, in the US, males accounted for 660,458 cases, while females accounted for approximately 491,736 cases in 2022. These cases are expected to change during the forecast period.
According to estimates based on DelveInsight's epidemiology model for Parkinson's disease, in Japan, in 2022, the highest cases of Parkinson's disease were found in Stage III, i.e., approximately 83,477 cases, followed by 55,450 cases in Stage IV, 31,253 cases in Stage II, and others. These cases are expected to increase during the study period
The drug chapter segment of the Parkinson's disease report encloses a detailed analysis of Parkinson's disease - currently used drugs and mid-stage (Phase II and Phase I) pipeline drugs. It also helps understand the Parkinson's disease clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
XADAGO/EQUFINA (safinamide): Newron Pharmaceuticals/Zambon/Supernus Pharmaceuticals/Eisai
XADAGO tablets contain safinamide as the mesylate salt. The precise mechanism by which XADAGO exerts its effect on Parkinson's disease is unknown. XADAGO is an inhibitor of monoamine oxidase B (MAO-B). Inhibition of MAO-B activity by blocking the catabolism of dopamine is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain.
In September 2019, EQUFINA tablets 50 mg received approval in Japan for the improvement of the wearing-off phenomenon in patients with Parkinson's disease under the treatment with levodopa-containing preparations.
In March 2017, the US FDA approved XADAGO as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.
In February 2015, XADAGO received marketing authorization in the European Union for treating adult patients with idiopathic Parkinson's disease as an add-on therapy to a stable dose of levodopa, alone or in combination with other Parkinson's medications, in mid-to late-stage Parkinson disease patients with motor fluctuations.
Note: Detailed marketed drugs assessment will be provided in the final report.
SPN-830 (apomorphine infusion device) is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease patients that are not adequately controlled with oral levodopa and one or more adjunct Parkinson's disease medications. SPN-830 is an SC formulation of apomorphine delivered continuously through a portable electronic infusion pump under the skin for 14-18 h. Recently, the US FDA accepted the NDA filed by Supernus Pharmaceuticals for SPN-830, with the scheduled PDUFA date in 2024. In 2022, the US FDA issued a CRL to Supernus Pharmaceutical for the SPN-830 NDA, filled in September 2020. Prior to this, it had filed an NDA for which it received a refusal to file (RTF) letter. The drug completed a Phase III trial, and the company is anticipated to launch the SPN-830 in 2024.
Note: Detailed emerging therapies assessment will be provided in the final report.
Although the current treatment landscape lacks curative therapy, many pharmacological and nonpharmacological options are tailored together to alleviate the symptoms of Parkinson's disease. Physical, occupational, and speech therapy can be critical to the treatment plan. Surgical options also have an important role for a subset of patients with Parkinson's disease, and complementary therapies can be used to treat some Parkinson's disease symptoms. Several classes of medications are available; however, carbidopa/levodopa remains the most effective symptomatic therapy and is available in many strengths and formulations.
Levodopa, developed around 30 years back, is often regarded as the gold standard of Parkinson's therapy. Levodopa works by crossing the blood-brain barrier, the elaborate meshwork of fine blood vessels and cells that filter blood reaching the brain, where it is converted into dopamine. Levodopa is extremely beneficial to people with Parkinson's disease and can dramatically improve their quality of life. However, the common side effects may include nausea, vomiting, dry mouth, and dizziness. Dyskinesias (abnormal movements) may occur as the dose is increased. In some patients, levodopa may cause confusion, hallucinations, or psychosis. INBRIJA is a widely used levodopa formulation.
Although the current treatment landscape lacks curative therapy, many pharmacological and nonpharmacological options are tailored together to alleviate the symptoms of Parkinson's disease. Physical, occupational, and speech therapy can be critical to the treatment plan. Surgical options also have an important role for a subset of patients with Parkinson's disease, and complementary therapies can be used to treat some Parkinson's disease symptoms. Several classes of medications are available; however, carbidopa/levodopa remains the most effective symptomatic therapy and is available in many strengths and formulations.
Bromocriptine, pergolide, pramipexole, and ropinirole are dopamine agonists that mimic the role of chemical messengers in the brain, causing the neurons to react as they would to dopamine. They are prescribed alone or with levodopa and may be used in the early stages of the disease or administered to lengthen the duration of the effectiveness of levodopa. These medications generally have more side effects than levodopa, so that is taken into consideration before doctors prescribe dopamine agonists to patients. HARUROPI TAPE (ropinirole HCL), a systemic transdermal Parkinson's disease treatment patch developed by Hisamitsu Pharmaceutical, utilizing its TDDS technologies, is only authorized in Japan. KYNMOBI, a sublingual film containing apomorphine hydrochloride and a nonergoline dopamine agonist, was approved in the US in 2020; however, the company has discontinued the drug.
While there have been few major developments in Parkinson's disease treatment since the introduction of levodopa, several unmet need prevails. The current market of Parkinson's disease lacks curative and disease-modifying therapy, leaving symptomatic treatments with a multidisciplinary approach as the only option. Despite several decades of advances in medications and neurosurgical approaches, there remains an unmet need for symptomatic motor control. Better control of tremors, gait and balance, posture, dexterity, and communication skills are major challenges for better therapeutics of Parkinson's disease movement disorder. Further, treatment of psychosis is another unmet need of Parkinson's disease patients.
The current market has been covered by the symptomatic treatment that includes different pharmacological agents used across the 7MM, which presents minor variations in the overall prescription pattern. XADAGO/EQUFINA (safinamide), NOURIANZ/NOURIAST (istradefylline), DUOPA/DUODOPA (carbidopa and levodopa-ES), INBRIJA (levodopa), HARUROPI TAPE (ropinirole HCL), GOCOVRI (amantadine), and ONGENTYS (opicapone) are among the major drugs considered for in the Parkinson's disease forecast model.
Key players Supernus Pharmaceutical, Britannia Pharmaceutical, Cerevel Therapeutics, Pfizer, AbbVie, Pharma Two B, Annovis Bio, and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of Parkinson's Disease and fulfill unmet needs.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, Pharma Two B's P2B001 (extended-release pramipexole and rasagiline), a once-daily combination of extended-release pramipexole, a low-dose dopamine agonist, and rasagiline, a low-dose MAO-B inhibitor, with an anticipated entry by 2025 in the US, is predicted to have a slow-medium uptake during the forecast period.
The report provides insights into therapeutic candidates in late-stage development (Phase III). It also analyzes key players involved in developing targeted therapeutics in different Phases of clinical trials.
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Parkinson's disease.
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the Parkinson's disease evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like Johns Hopkins University School of Medicine, the University of California Davis School of Medicine, Universite Bordeaux, IRCCS-Mario Negri Institute for Pharmacological Research, Hiroshima University, and the University of Cambridge were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Parkinson's disease market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
According to the primary research analysis, levodopa was the most common first-line Parkinson's disease treatment. Other commonly prescribed Parkinson's disease medications were pramipexole, entacapone combined with levodopa, ropinirole, and pergolide. Further, commonly prescribed adjunct therapies were monoamine oxidase type B inhibitors, non-ergot dopamine agonists, and zonisamide, regardless of age. Droxidopa and amantadine were prescribed as adjunct levodopa therapy slightly more frequently among elderly patients; levodopa adjunct therapy was prescribed when the levodopa dose was 300 mg, regardless of age.
The approval of emerging therapies and drugs that specifically target a-synuclein pathology, providing disease-modifying therapies for Parkinson's disease, will change the treatment regime and market dynamics for Parkinson's. Several regenerative approaches, including stem cells and gene therapies, and therapeutics for Parkinson's disease are likely to see significant advances over the coming years, with several novel, effective options likely to become available in the foreseeable future.
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based upon change from baseline in the total "on" time and "off" time and change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The therapies' safety is evaluated wherein treatment-related and serious adverse events were majorly observed. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
In the case of Parkinson's disease, CMS covers a range of different treatments, medications, and services; Part A covers deep brain stimulation surgery, Part B: speech therapy and physical therapy, and Part C covers everything in the original Medicare (Part A and Part B); Part C: includes the additional drug coverage, and Part D: dopaminergic medications.
GOCOVRI is supported by GOCOVRI Onboard, a program designed to support patient access through one direct line of contact, copay assistance, and timely fulfillment. Further, to be eligible for the GOCOVRI Copay program, the patient must be a United States or Puerto Rico resident and have a valid GOCOVRI prescription for an indication included in the FDA-approved product labeling.
AccessOsmolex is a patient support services center focused on helping eligible patients obtain financial assistance for their OSMOLEX ER treatment plan. If the physician prescribes OSMOLEX ER for a patient, one must send the prescription to AccessOsmolex. Thus, AccessOsmolex will work with the office on coverage of OSMOLEX ER and with the patients to explain their coverage and affordability options.
INBRACE support program: The INBRACE Support Program is designed to help patients who are prescribed capsules, from prescription fulfillment to navigating coverage requirements and providing financial assistance information to support patients along their treatment journey.
ONGENTYS savings program for commercially insured patients: Eligible patients may qualify for a USD 0 copay on their prescription for ONGENTYS capsules. This offer is valid only for patients with commercial (nongovernment-funded) insurance. Additional terms and conditions apply.
ONGENTYS patient assistance program: Patients with no prescription drug coverage may be eligible to receive their prescriptions at no cost through the ONGENTYS Patient Assistance Program. Eligible patients who do not have prescription drug coverage for ONGENTYS and do not have the financial resources to pay for their medicine may receive their prescriptions at no cost through the ONGENTYS Patient Assistance Program.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.