US CNS Disorders Drug Pipeline Insight 2014
The Central Nervous System (CNS) disorders market in US is one of the largest segments of pharmaceuticals industry. The numbers of CNS disorders have increased at an alarming rate, while the available therapies were unable to meet the market requirements. There has been steady to rapid growth in the market for CNS disorder, especially over the past two decades. The market for CNS therapies is one of the largest therapeutic categories and also one of the fastest growing. US account for more than 55% of the global CNS Disorders drugs market.
Within the CNS market, the biggest therapeutic area is the market for anti-psychotics, followed by anti-depressive and mood stab markets. Anti-epileptic and anti-Alzheimer’s markets come next while other classes of drugs have a marginal share. Antipsychotics have a market share of nearly 30% while antidepressants corner about 25% of the market. Anti convulsants have about 17% of the market share while drugs used in Alzheimer's Disease form about 9% of the market, with ADHD and narcolepsy drugs medications have about 7% market share. The other classes of drugs have market shares of less than 5% each.
New technology including advancements in stem cell therapy and of nanotechnology is expected to drive the growth of the CNS market. Nanotechnology in the form of the nanomaterials for wound care, drug delivery and immunomodulation is specifically seen as a positive influence on CNS therapy that is expected to open growth opportunities. While each of these therapeutic subcategories are served by established treatments there are certain markets segments with significant unmet medical needs still remain, indicating potential in these areas. There are newer treatment methodologies under development such as that using stem cell therapy and of nanotechnology that seek to address these opportunities.
The rapid advances in the R&D segment, many novel drugs are currently available for the treatment of CNS disorders. Industry related to CNS drug delivery system has also got a boost due to rapid advancement of CNS disorders market. Given the magnitude of number of patients and demand for better drugs is going to push pharmaceutical companies for significant investments. Changing life-style is one the main contributor of CNS disorders in US. Increased longevity and ageing population along with launch of novel drugs will drive the growth of CNS disease market in future.
“US CNS Disorders Drug Pipeline Insight 2014” Report Highlight:
- Market Overview & Incidence by Disease
- CNS Disorder Market Dynamics
- CNS Disorder Pipeline by disease, Phase & Company
- CNS Disorder Pipeline: 1083 Drugs in Pipeline
- Majority CNS Drugs in Preclinical Phase: 396 Drugs
- Majority CNS Drugs for Neurodegenerative Disorders: 228 Drugs in Pipeline
- CNS Disorder Market Drugs: 109 Drugs
- Majority CNS Drugs Marketed for Epilepsy: 24 Drugs
2. US CENTRAL NERVOUS SYSTEM (CNS) DISORDER MARKET OVERVIEW
2.1 Market Overview
2.2 Clinical Pipeline Insight
3. US CENTRAL NERVOUS SYSTEM (CNS) DISORDER INCIDENCE BY DISEASE
3.1 Alzheimer's Disease
3.2 Multiple Sclerosis
3.3 Epilepsy
3.4 Parkinson Disease
3.5 Migraine
3.6 Huntington's disease
3.7 Schizophrenia
3.8 Anxiety
3.9 Insomnia
3.10 Bipolar Disorder
3.11 ADHD
4. US CENTRAL NERVOUS SYSTEM (CNS) DISORDER MARKET DYNAMICS
4.1 Favorable Market Parameters
4.2 Market Challenges
4.3 Future Growth Opportunity
5. US MULTIPLE CNS DISORDER DRUG PIPELINE BY PHASE & COMPANY
5.1 Clinical Pipeline Insight by Phase & Company
5.2 Marketed Drugs Clinical Profile
6. US ALZHEIMER'S DISEASE DRUG PIPELINE BY PHASE & COMPANY
6.1 Clinical Pipeline Insight by Phase & Company
6.2 Marketed Drug Clinical Profile
7. US MULTIPLE SCLEROSIS DRUG PIPELINE BY PHASE & COMPANY
7.1 Clinical Pipeline Insight by Phase & Company
7.2 Marketed Drug Clinical Profile
8. US PARKINSON'S DISEASE DRUG PIPELINE BY PHASE & COMPANY
8.1 Clinical Pipeline Insight by Phase & Company
8.2 Marketed Drug Clinical Profile
9. US CNS DISORDER/NEURODEGENERATIVE DISORDERS DRUG PIPELINE BY PHASE & COMPANY
9.1 Clinical Pipeline Insight by Phase & Company
9.2 Marketed Drug Clinical Profile
10. US EPILEPSY DRUG PIPELINE BY PHASE & COMPANY
10.1 Clinical Pipeline Insight by Phase & Company
10.2 Marketed Drug Clinical Profile
11. US MIGRAINE DRUG PIPELINE BY PHASE & COMPANY
11.1 Clinical Pipeline Insight by Phase & Company
11.2 Marketed Drug Clinical Profile
12. US HUNTINGTON'S DISEASE DRUG PIPELINE BY PHASE & COMPANY
12.1 Clinical Pipeline Insight by Phase & Company
12.2 Marketed Drug Clinical Profile
13. US NEUROPATHIC PAIN CLINICAL PIPELINE BY PHASE & COMPANY
13.1 Clinical Pipeline Insight by Phase & Company
13.2 Marketed Drug Clinical Profile
14. US SCHIZOPHRENIA CLINICAL TRIAL INSIGHT BY PHASE & COMPANY
14.1 Clinical Pipeline Insight by Phase & Company
14.2 Marketed Drug Clinical Profile
15. US SLEEP DISORDERS DRUG PIPELINE BY PHASE & COMPANY
15.1 Clinical Pipeline Insight by Phase & Company
15.2 Marketed Drug Clinical Profile
16. COMPETITIVE LANDSCAPE
16.1 Alkermes
16.2 Allergan
16.3 AstraZeneca
16.4 Biogen Idec
16.5 Bristol-Myers Squibb
16.6 Eli Lilly
16.7 GlaxoSmithKline
16.8 Merck
16.9 Novartis
16.10 Pfizer
16.11 Roche
16.12 Sanofi
16.13 Sunovion Pharmaceuticals
16.14 Teva Pharmaceutical
Figure 2-1: US – CNS Disorders Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-2: US – CNS Disorders Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-3: US – CNS Disorder Drugs Clinical Pipeline by Disease (%), 2014
Figure 2-4: US – CNS Disorder Drugs Clinical Pipeline by Disease (Number), 2014
Figure 2-5: US – CNS Disorder Drugs in Research Phase by Disease (%), 2014
Figure 2-6: US – CNS Disorder Drugs in Research Phase by Disease (Number), 2014
Figure 2-7: US – CNS Disorder Drugs in Preclinical Phase by Disease (%), 2014
Figure 2-8: US – CNS Disorder Drugs in Preclinical Phase by Disease (Number), 2014
Figure 2-9: US – CNS Disorder Drugs in Clinical Phase by Disease (%), 2014
Figure 2-10: US – CNS Disorder Drugs in Clinical Phase by Disease (Number), 2014
Figure 2-11: US – CNS Disorder Drugs in Phase-0 by Disease (%), 2014
Figure 2-12: US – CNS Disorder Drugs in Phase-0 by Disease (Number), 2014
Figure 2-13: US – CNS Disorder Drugs in Phase-I by Disease (%), 2014
Figure 2-14: US – CNS Disorder Drugs in Phase-I by Disease (Number), 2014
Figure 2-15: US – CNS Disorder Drugs in Phase-I/II by Disease (%), 2014
Figure 2-16: US – CNS Disorder Drugs in Phase-I/II by Disease (Number), 2014
Figure 2-17: US – CNS Disorder Drugs in Phase-II by Disease (%), 2014
Figure 2-18: US – CNS Disorder Drugs in Phase-II by Disease (Number), 2014
Figure 2-19: US – CNS Disorder Drugs in Phase-II/III by Disease (%), 2014
Figure 2-20: US – CNS Disorder Drugs in Phase-II/III by Disease (Number), 2014
Figure 2-21: US – CNS Disorder Drugs in Phase-III by Disease (%), 2014
Figure 2-22: US – CNS Disorder Drugs in Phase-III by Disease (Number), 2014
Figure 2-23: US – CNS Disorder Drugs in Preregistration Phase by Disease (%), 2014
Figure 2-24: US – CNS Disorder Drugs in Preregistration Phase by Disease (Number), 2014
Figure 2-25: US – CNS Disorder Drugs in Registration Phase by Disease (%), 2014
Figure 2-26: US – CNS Disorder Drugs in Registration Phase by Disease (Number), 2014
Figure 2-27: US – Marketed CNS Disorder Drugs by Disease (%), 2014
Figure 2-28: US – Marketed CNS Disorder Drugs by Disease (Number), 2014
Figure 2-29: US – Alzheimer's Disease Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-30: US – Alzheimer's Disease Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-31: US – Multiple Sclerosis Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-32: US – Multiple Sclerosis Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-33: US – Parkinson's Disease Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-34: US – Parkinson's Disease Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-35: US – Neurodegenerative Disorders Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-36: US – Neurodegenerative Disorders Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-37: US – Epilepsy Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-38: US – Epilepsy Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-39: US – Migraine Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-40: US – Migraine Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-41: US – Huntington's Disease Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-42: US – Huntington's Disease Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-43: US – Neuropathic Pain Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-44: US – Neuropathic Pain Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-45: US – Schizophrenia Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-46: US – Schizophrenia Drugs Clinical Pipeline by Phase (Number), 2014
Figure 2-47: US – Sleep Disorders Drugs Clinical Pipeline by Phase (%), 2014
Figure 2-48: US – Sleep Disorders Drugs Clinical Pipeline by Phase (Number), 2014
Figure 3-1: US - Alzheimer’s Disease Incidence (Million), 2013-2020
Figure 3-2: US - Multiple Sclerosis Incidence (‘000), 2013-2020
Figure 3-3: US - Epilepsy Incidence (Million), 2013-2020
Figure 3-4: US - Parkinson’s Disease Incidence (Million), 2013-2020
Figure 3-5: US - Migraine Incidence (Million), 2013-2020
Figure 3-6: US - Huntington’s Disease Incidence (‘000), 2013-2020
Figure 3-7: US - Schizophrenia Disease Incidence (Million), 2013-2020
Figure 3-8: US - Anxiety Disorder Incidence (Million), 2013-2020
Figure 3-9: US - Insomnia Incidence (Million), 2013-2020
Figure 3-10: US - Bipolar Disorder Incidence (Million), 2013-2020
Figure 3-11: US - ADHD Incidence (Million), 2013-2020
The market for CNS disorders can be segmented as:
- Psychiatry drugs market comprising those related to anxiety, depression, bipolar disorders, schizophrenia and ADHD (attention deficit hyperactivity disorder)
- Neurology drugs market for those related to migraine, epilepsy, Parkinson’s disease, multiple sclerosis, narcolepsy and Alzheimer’s disease
- Pain management drugs market segment including drugs used to treat pain associated with CNS disorders.
The psychiatry segment accounts for the major share with more than 40% of the market, followed by neurology and pain segment.
At the granular level the CNS disorders market includes diseases such as major depressive disorder (MDD), epilepsy, schizophrenia, Alzheimer’s disease (AD), Parkinson’s disease (PD), migraine, insomnia, attention-deficit hyperactivity disorder (ADHD), bipolar disorder among others.
There has been steady-to-rapid growth in the market for Central Nervous System disorder, especially over the past two decades. The overall market is expected to continue with the pace of growth. The market for Central Nervous System (CNS) therapies is the second largest therapeutic category and is one of the fastest growing. The US accounts for more than 60% of the sales although sales growth was stronger in other regions and countries also. In terms of cost of the disease, CNS disorders account for more than 15% of the global cost of disease.
Apart from the value growth in the US market there have been noticeable trends in the market that hold interest. These trends include:
- The use of combination drugs such as treximet for the treatment of several CNS disorders using a synergistic action and patient acceptance. This marks a direction of therapy whereby multiple classes of drugs are used and the presence of these drugs in a single combination or dose.
- Pricing of major drugs were an issue until some drugs started moving off the patent, opening up the market to lower prices. Interestingly, price rise was steady in the United States but remained stable or declined in other major markets. For some class of drugs such as neurology and psychiatry the price rise was about 30-40%.
- While R&D is the cornerstone of the CNS drug market, it is a matter of concern that only about 8.2% of CNS drug candidates ever move to the clinical use stage as against 15% seen in other drugs. Likewise, the time to get regulatory approval is also a concern. It takes about 1.9 years for CNS drugs, while non-CNS drugs take only about 1.2 years. Similarly an average of 8.1 years is required for Phase II and III development for CNS drugs which is more than two years longer for other drugs.
Within the CNS market, the biggest therapeutic area in the CNS market is the market for anti-psychotics, followed by anti-depressive and mood stab markets. Anti-epileptic and anti-Alzheimer’s markets come next while other classes of drugs have a marginal share. The share level has been maintained between 2009 and 2013. Antipshychotics have a market share of nearly xx% while antidepressants corner about xx4% of the market. Anti convulsants have about xx% of the market share while drugs used in AD form about 9% of the market, with ADHD and narcolepsy drugs medications have about xx% market share.
The other classes of drugs have market shares of less than 5% each. While each of these therapeutic subcategories are served by established treatments there are certain markets segments with significant unmet medical needs still remain, indicating potential in these areas. There are newer treatment methodologies under development such as that using stem cell therapy and of nanotechnology that seek to address these opportunities.
The market outlook remains positive given that there are over 800 clinical candidates in development for a wide range of CNS indications, with 89 under Phase III clinical testing. Specifically AD is one of the major areas of R&D effort for pharmaceutical companies and there are more than 200 compounds in various stages of development. However, only few of these products are distinctly novel or offer any differentiated mechanism of action. At the same time, a large number of established CNS players are aggressively engaged in acquiring novel, clinically differentiated CNS products. The CNS therapeutic area is a good reflection of the challenges that confront the big pharma currently. With many key brands on the verge of losing patent exclusivity, companies are working to extend their market presence with newer follow on products. This means that the market is likely to be genericized but there are many original brands in the CNS disorders market that dominate the sales.
