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    These factors, when studied together, shape up an overall context for an organization in
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    an industry. To determine strategy for existence and profitability of an organization,
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    the management should analyze the industry and its structure and how they change with th
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    e changing environment.

    Michael E. Porter, 1980, wrote a book named “Competitive Strate
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    gy: Techniques for Analyzing Industries and Competitors”. In this book he developed a mo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    del that is famous with the name of “Porter’s Five Forces Model” to analyze the industry
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    structure. With the help of five forces model, Porter suggested that an industry struct
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    ure can be analyzed with the help of five factors. Or, in other words, the profitability
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    of any industry can be determined by a careful examination of five forces that exist wi
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    thin and or for an industry. “The five forces are competitive factors which include: sup
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    pliers, rivalry within an industry, substitute products, customers or buyers, and new en
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    trants.

    After a detailed analysis of all the five competitive forces of an industry, th
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e development of the corporate strategy can be done in accordance to exploit the structu
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    re and variables of an industry so as to decide about the entry an exit to any market, c
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    hoose between products and services to offer, maximization of profitability, growth and
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    market share.

    The porter’s five forces model is a very useful tool to provide a first h
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    and knowledge to management about an industry and its variables which forms the basis fo
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r further analysis. But at the same time, management also needs to consider the dynamics
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    of environment, effects of globalization and legislations and regulations imposed by go
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    vernment to the industrial sector while using the information gained by using the model.


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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