The growth is powered by the factors such as extended market exclusivity and government incentives for orphan medicine. In USA, 7 Years of marketing exclusivity from approval and 10 Years in Europe is granted to orphan drugs developing companies. In the recent past many companies have been entering in this promising segment as there happens to be provision of government incentives.
However, High initial investment, regulatory obstacles and clinical studies hurdles happens to be major constraining factors in the run of orphan drugs market. The regulatory framework and standards vary from country to country making it difficult for companies to operate on global level. It asks for high initial investment in developing orphan drug, hence only the companies with high operating profits consider entering in this business segment.
The global Orphan Drugs market is composed of segments like type, therapeutic and geographical terrain. The type segment is further divided into biological and non-biological orphan drugs; Therapeutic into oncology, hematology, neurology and other and Geography into regions of North America, Europe, Asia pacific and Rest of the world.
The report covers the regional orphan drugs market landscape specifically highlighting the regulatory framework in each region; orphan drugs pipeline insights like clinical trials status, number of drugs registered and waiting for approval etc.
Bristol Myers Squibb, Novartis, Celgene, Roche, Pfizer, Alexion, Sanofi, Vertex, GlaxoSmithKline, Merck are the top players fetching profits from wealthy orphan drug market. This report offers comprehensive profiles of these companies composed of their business strategy for orphan drugs, financials, SWOT analysis, products and services and the insightful company analysis by our analyst.
What this Report Offers:
Market Definition for the specified topic along with identification of key drivers and restraints for the market.
Market analysis for the global orphan drugs Market, with region specific assessments and competition analysis on a global and regional scale.
Identification of factors instrumental in changing the market scenarios, rising prospective opportunities and identification of key companies which can influence the market on a global and regional scale.
Extensively researched competitive landscape section with profiles of major companies along with their strategic initiatives and market shares.
Identification and analysis of the Macro and Micro factors that affect the global orphan drugs market on both global and regional scale
A comprehensive list of key market players along with the analysis of their current strategic interests and key financial information.
1.1.DEFINATION- ORPHAN DRUGS
1.2.ORPHAN DRUG CLASSIFICATION CRITERIA
2.1. RARE DISEASES PREVALENCE
2.2. RARE DISEASES - RARE STATISITCS
2.2.1. ORIGIN OF RARE DISEASES
2.2.3. FDA APPROVALS
2.2.4. AGE WISE PREVALENCE
3.1. MARKET DRIVERS
3.1.1. VIGOROUS PATIENT ADVOCACY
3.1.2. VENTURE CAPITALIST INVESTMENTS
3.1.4. LEGISLATIVE INCENTIVES
3.1.5. MARKET EXCLUSIVITY
3.2. MARKET CONSTRAINTS
3.2.1. HIGH INITIAL INVESTMENT
3.2.2. REGULATORY OBSTACLES
3.2.3. DIFFERENT REIMBRUSMENT POLICIES
3.2.4. CLINICAL STUDY HURDLES
4.1. BY TYPE
4.1.2 NON BIOLOGICAL
4.3.1 North America
126.96.36.199 The UK
5.US ORPHAN DRUGS MARKET OUTLOOK
5.1. ORPHAN DRUG DESIGNATION CRITERIA
5.2. MARKET OVERVIEW
5.3. REIMBURSEMENT POLICY
5.4. REGULATORY FRAMEWORK
6.EUROPE ORPHAN DRUGS MARKET OUTLOOK
6.1. ORPHAN DRUG DESIGNATION CRITERIA
6.2. MARKET OVERVIEW
6.3. REIMBURSEMENT POLICY
6.4. REGULATORY FRAMEWORK
7.ASIA ORPHAN DRUGS MARKET OUTLOOK
7.1. ORPHAN DRUGS DESIGNATION CRITERIA
7.2. MARKET OVERVIEW
7.3. REIMBURSEMENT POLICY
7.4. REGULATORY FRAMEWORK
8.GLOBAL ORPHAN DRUGS PIPELINE INSIGHTS BY PHASE, ORPHAN DESIGNATED DISEASES , COUNTRY
8.1. CLINICAL PHASE
8.2. PHASE 1
8.3. PHASE 2
8.4. PHASE 3
8.5. DRUGS REGISTERED FOR DESIGNATION APPROVALS
8.6. APPROVED DRUGS
9.1. COMPETITIVE ANALYSIS- PORTER'S FIVE FORCES
9.2. MERGERS AND ACQUISITIONS
9.3. NEW PRODUCT LAUNCHES
9.4. RECOMMENDATIONS TO NEW ENTRANTS
10.1. BRISTOL MYERS SQUIBB
10.2. NOVARTIS PHARMACEUTICALS