Last Updated 29 September 2014
Parkinson’s disease (PD) is one of the most common chronic neurodegenerative diseases in the elderly, and its prevalence is expected to grow 2% annually as the general population ages. The PD therapy market features a high rate of polypharmacy that is unique among neurological disorders, driven by the need to simultaneously manage the primary motor symptoms and associated nonmotor symptoms of the disease, as well as the common complications associated with chronic treatment with levodopa (Merck/Bristol-Myers Squibb/DuPont Pharma’s Sinemet, Sinemet CR, other brands, generics), the long-standing foundation of PD treatment. A growing population, high drug-treatment rates, a high rate of polypharmacy, and several key areas of unmet need combine to make the PD therapy market one of significant commercial opportunity. Based on the active and diverse late-stage pipeline—which includes innovative reformulations, novel adjuncts to levodopa, agents for key nonmotor symptoms, and new and improved rescue therapies—we forecast continued growth of the PD therapy market over the next decade.
Questions Answered in This Report:
- Impax Laboratories’ long-acting levodopa reformulation IPX-066 (Rytary) has shown notable efficacy in reducing levodopa complications, but the product’s launch has been significantly delayed owing to regulatory concerns and manufacturing challenges. How do experts interviewed anticipate incorporating IPX-066 into the PD treatment algorithm, and how will the drug fare against other novel and long-generic levodopa formulations?
- Acadia Pharmaceuticals’ pimavanserin (Nuplazid), a first-in-class inverse agonist of 5-HT2A receptors, showed positive results in a late-stage trial in PD-associated psychosis and could become the first agent specifically approved to treat psychotic symptoms in PD patients. What are thought leaders’ reactions to pimavanserin, and what level of uptake will the drug garner in the PD market? How will the drug’s availability affect the treatment algorithm in PD patients experiencing psychotic symptoms, which are currently managed by off-label use of mostly generic atypical antipsychotics?
- Thought leaders cite a lingering need for improved rescue therapies to treat PD patients’ “wearing off”; injectable rescue options (e.g., U.S. World Meds/Britannia/Kyowa Hakko Kirin’s Apokyn, other brands, generics) are effective but costly and burdensome. What are physicians’ opinions of several patient-friendly rescue alternatives currently in the pipeline? What clinical and commercial impact will Civitas Therapeutics’ promising inhaled reformulation of levodopa, CVT-301, have on the underserved market for rescue interventions and on the market as a whole?
- A range of newly launched and late-stage levodopa adjuncts are designed to reduce motor fluctuations and troublesome dyskinesias for patients taking levodopa, including first-in-class adenosine A2A receptor antagonist istradefylline (Kyowa Hakko Kirin’s Nouriast), an amantadine reformulation (Adamas Pharmaceuticals’ ADS-5102 [Nurelin]), and the novel COMT inhibitor opicapone (Bial/Ono Pharmaceutical). What are the clinical advantages and disadvantages of these products, and what role can they establish in PD treatment amid strong competition from a range of currently available competitors in this space, many of which are already generic?
- Rasagiline (Teva/Lundbeck’s Azilect), one of the few remaining branded agents in the PD therapy market, remained the market leader in 2013 thanks to its established clinical profile and strong marketing support. What do experts interviewed now say about previous studies suggesting a disease-modifying effect? How will rasagiline’s uptake change over the forecast period as a new competitor, Newron Pharmaceuticals/Zambon Pharma/Meiji Seika Pharma’s MAO-B inhibitor safinamide, reaches the market in the first half of our forecast period?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 32 country-specific interviews with neurologists.
Epidemiology: Prevalence of PD by country, diagnosed prevalence by disease stage (Hoehn & Yahr); diagnosed prevalence of dementia, psychosis, “wearing off,” dyskinesia, and mild parkinsonian signs.
Emerging therapies: Phase II: 25 drugs; Phase III: 3 drugs; preregistration: 2 drugs; registered: 0 drugs. Coverage of 37 select preclinical and Phase I products.
Market forecast features: Using market research, primary research with key opinion leaders, and our proprietary forecasting model, we forecast population sizes and sales of PD therapies through 2023.
Michael Hughes, M.Sc., Ph.D.