WiseGuyReports.Com Publish a New Market Research Report On - “Next Decade Generic String Of Pearls Market Research Report 2017 Global Analysis and Forecast to 2022”.

New York, NY -- (SBWire) -- 12/14/2017 --The rapid growth of the generic industry has come with a number of challenges, such as heavy competition, including from authorized generics and government-mandated price cuts. All contribute to diminishing prices and ever decreasing margins. In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Diversification of product portfolios, vertical integration across the manufacturing process, and expanding their geographic presence, especially into emerging markets are some of the key strategies which can be implemented by the generic companies to overcome the existing challenges.

One of the most initial and important step for the development of a prospective generic drug product comprises of product (Active Pharmaceutical Ingredient-API) selection and identification. API is the primary constituent of a pharmaceutical drug product that governs the final cost of the drug product as well as the commercial profit earned by the company. Early access to high-quality active pharmaceutical ingredients (API) that are not infringing patents is critical to success in regulated finished-dose markets as a significant part of generics' profits is made during the early days of their availability.

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Factors which have to be taken into consideration during the generic product evaluation process include:
- The total geographical and target disease market size.

- Therapeutic areas of the product-whether the drug in question is approved for a niche condition or is trying to make a space for itself in the already crowded therapy class.

- Competitor intelligence.
- Current market sales of the innovator product.
- Patent/exclusivity time frame.
- Complexity in the development and time frames.
- Availability of API, equipment and expertise.
- Budget required and return on investment.

Keeping in mind the above mentioned elements we have scrutinized and selected 10 drug molecules. This information in the report can aid a prospective generic developer to review and evaluate products which can be incorporated in the company's developmental pipeline.

The therapy classes covered in this report are:
- Oncology
- Cardiovascular
- Respiratory
- Gastroenterology
- Psychiatry
- Infectious disease

The following points were considered while selecting the products:
- Blockbuster drugs with a likelihood of lucrative future sales.
- Drugs with novel therapeutic approach for rare disease.
- Specialized products in niche therapeutic markets with no existing competitors.
- Products with robust ongoing clinical trials which will lead to future label expansions and ultimately act as sales booster.
- First in class drug products with novel targeting mechanism.

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Table Of Contents – Major Key Points

FACTORS TO BE CONSIDERED DURING THE PRODUCT EVALUATION PROCESS 16
STAGES IN THE DEVELOPMENT OF A GENERIC DRUG PRODUCT 16
POTENTIAL CHALLENGES IN THE VARIOUS DEVELOPMENT STAGES 17
OPPORTUNITY AREAS FOR GENERIC PRODUCT DEVELOPMENT 17
JAKAFI 21
MECHANISM OF ACTION 21
JAKAFI IN MYELOFIBROSIS (MF) 21
JAKAFI IN POLYCYTHEMIA VERA (PCV) 22
JAKAFI IN GRAFT-VERSUS-HOST DISEASE (GVHD) 23
CLINICAL STUDY DATA 24
The COMFORT-I and –II study 24
COMFORT-I: 24
The primary end point: 24
Secondary end points: 25
COMFORT –II: 27
RESPONSE trial: 28
The primary end point: 28
The secondary end points: 29
ONGOING RESEARCH PROGRAM: 32
ORKAMBI 34
CLINICAL STUDY DATA: 36
TRAFFIC and TRANSPORT 36
PROGRESS STUDY 38
LABEL EXPANSION TO TREAT 6- TO 11-YEAR-OLD: 38
MARKET PERFORMANCE AND COMPETITION: 38
IMBRUVICA 42
AN OVERVIEW OF THE FDA APPROVAL HISTORY OF IMBRUVICA 43
IMBRUVICA IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) 44
IMBRUVICA IN WALDENSTRÖM'S MACROGLOBULINEMIA(WM) 45
IMBRUVICA IN MANTLE CELL LYMPHOMA (MCL) 45
IMBRUVICA IN MARGINAL ZONE LYMPHOMA (MZL): 46
IMBRUVICA IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVHD) 46
CLINICAL STUDY DATA 47
MANTLE-CELL LYMPHOMA 47
The PCYC-1104 47
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): 49
RESONATE TRIAL: Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia 49
Long-term follow-up results from the pivotal Phase 3 RESONATE trial: 51
RESONATE-2: Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia 51
Updated results from the pivotal Phase 3 RESONATE-2 trial: 54
Imbruvica in Waldenstrom's macroglobulinemia: 54
Imbruvica for Relapsed/Refractory Marginal Zone Lymphoma (MZL): 54
Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease: 55
IMBRUVICA- ON THE VERGE OF BECOMING A MEGA-BLOCKBUSTER DRUG 55
MARKET PERFORMANCE AND COMPETITION: 55
ENTRESTO 59
CLINICAL STUDY DATA 60
PARADIGM-HF 60
MARKET PERFORMANCE AND COMPETITION 62
IBRANCE 66
CLINICAL STUDY DATA 66
PALOMA-1: 67
PALOMA-2: 67
PALOMA-3: 68
ONGOING RESEARCH 72
1. The PATINA trial- 72
2. The PALLAS Trial 72
3. NCT02499120: 72
EPCLUSA 75
CLINICAL STUDY DATA 77
ASTRAL-1: 77
ASTRAL-2 and ASTRAL-3: 77
ASTRAL-4 78
ASTRAL-5 80
MARKET PERFORMANCE AND COMPETITORS 80
LYNPARZA 85
HARNESSING THE POTENTIAL OF PARP INHIBITORS IN OVARIAN CANCER 86
CLINICAL STUDY DATA 87
SOLO-2: 87
Study 19 88
MARKET PERFORMANCE AND COMPETITION: 91
ONGOING RESEARCH 93
Lynparza: Paving its way towards BRCA-Mutated Breast Cancer- the OlympiAD trial 93
PAOLA trial 94
POLO trial 94
PROfound trial 94

Continue…….

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