The rising of the generic string has come with variety of challenges, like significant competition, including approved generics and government-mandated worth cuts. All contribute to decreasing costs and ever decreasing margins. During this era of raised pharmaceutical trade competition, success for drug corporations relies on their ability to manufacture therapeutic-equivalent drug merchandise in a cost-effective and timely manner, whereas conjointly being cognizant of violation and alternative legal and restrictive considerations. Diversification of product portfolios, vertical combination across the producing method, and increasing their geographic presence, particularly into rising markets are a number of the key ways which might be enforced by the generic corporations to beat the present challenges.
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 medicine companies is dependent on their ability to manufacture therapeutic-equivalent medicine 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 medicine product comprises of product (Active Pharmaceutical Ingredient-API) selection and identification. API is the primary constituent of a pharmaceutical medicine product that governs the final cost of the medicine 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 medicine 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 medicine 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:
- Infectious disease
The following points were considered while selecting the products:
- Blockbuster medicines with a likelihood of lucrative future sales.
- medicines 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 medicine products with novel targeting mechanism.
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