Last Updated 16 December 2015
Parkinson’s disease (PD) is one of the most common chronic neurodegenerative diseases in the elderly; its prevalence is expected to grow 2% annually in the major pharmaceutical markets. The market for PD pharmacotherapies 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, a complex symptomology, and several key areas of unmet need combine to make the PD market one of significant commercial opportunity for therapeutic advances. Based on the active and diverse late-stage pipeline—which includes innovative reformulations, novel adjuncts to levodopa, agents for key nonmotor symptoms (e.g., psychosis), and new and improved rescue therapies—we forecast continued growth of the PD pharmaceutical market over the next decade.
Questions Answered in This Report:
- Impax Laboratories’ long-acting levodopa reformulation Rytary/Numient has launched in the United States and shown notable efficacy in reducing levodopa complications. How are U.S. neurologists incorporating Rytary 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, is under FDA review for the treatment of PD-associated psychosis and could become the first agent specifically approved for this important aspect of treatment. 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 for PD-related psychosis, which is often managed through off-label use of mostly generic atypical antipsychotics?
- Thought leaders cite a lingering need for improved rescue therapies to treat “wearing off”; injectable rescue options (e.g., U.S. World Med/Britannia/Kyowa Hakko Kirin’s Apokyn, other brands, generics) are effective but costly and burdensome. What are physicians’ opinions of new, patient-friendly rescue alternatives currently in the pipeline? What clinical and commercial impact will Acorda Therapeutics’ CVT-301, a promising inhaled reformulation of levodopa, and Cynapsus Therapeutics’? APL-130277, a sublingual reformulation of apomorphine, 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 the troublesome dyskinesias associated with levodopa. These agents include adenosine A2A receptor antagonists istradefylline (Kyowa Hakko Kirin’s Nouriast) and tozadenant (Biotie Therapies), two amantadine reformulations (Adamas Pharmaceuticals’ ADS-5102 [Nurelin] and Osmotica Pharmaceutical’s OS-320 [Osmolex ER]), 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 variety of currently available drugs, many of which are already generic?
- Newron Pharmaceuticals/Zambon Pharma/Meiji Seika Pharma’s novel MAO-B inhibitor safinamide (Xadago) launched in Germany and is forecast to launch in the rest of Europe and the United States during our study period. What impact will safinamide have on the dynamics of the MAO-B inhibitor class, which has historically been dominated by soon-to-be generic rasagiline (Teva/Lundbeck’s Azilect)?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 37 country-specific interviews with neurologists.
Epidemiology: Total, diagnosed, and drug-treated 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: 15 drugs; Phase III: 6 drugs; preregistration: 2 drugs. Coverage of 38 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 sales and use of current and emerging PD therapies through 2024.
Tamara Blutstein, Ph.D.
Michael Hughes, M.Sc., Ph.D.