5 critical risks facing the Pharmaceutical Industry

1
Critical Risks Facing the Pharmaceutical Industry
2

• There is no industry in which risk management has
  risen to the forefront of executives' and boards
  of directors' concerns to the same degree as the
  pharmaceutical industry. Pharmaceutical companies
  operate in an environment that is both
  politically and monetarily unstable. As a result,
  the consequences they face, in particular those
  associated with the design and execution of
  clinical trials, drug approval, quality of the
  product, and worldwide commercial procedures, are
  increasing in both frequency and magnitude.
• The sharp decrease in the valuation of specialty
  organizations (a reduction of 35), nonexclusive
  medication producers (a diminishing of 25), and
  biotech organizations (a lessening of 30)
  throughout the course of recent years is an
  undeniable indication of the difficult gamble
  climate at work. Numerous drug firms have said
  that they don't completely accept that they are
  enough prepared to explore these violent oceans.
  This is because of the way that their medicine
  investigation and the board isn't as far
  reaching, information driven, activity arranged,
  or broad as they would maintain that it should
  be.

3

• 1. Increased Competition from Generic Drugs
• Once a new medicine with a brand name has been
  authorized, it is given an exclusivity period of
  180 days. During this time, generic copies of the
  drug are not allowed to go on the market.
  However, because of a backlog of generic
  applications, that period of 180 days has been
  significantly extended. The Food and Drug
  Administration (FDA) is making a renewed effort
  to clear that backlog and expedite the clearance
  process for generic applications, which will
  result in an influx of lower-priced alternatives
  to more expensive medications into the market.
• 2. Responsibility under the Law for Drug
  Dependence
• Manufacturers of opioids are coming under
  pressure for their role in contributing to the
  pandemic that is sweeping the country. Alleging
  that pharmaceutical companies misled consumers
  about the addictive potential of opioid
  medications, hundreds of lawsuits have been
  brought against the industry at all levels, from
  the state to the federal. In addition, the
  lawsuits allege that pharmaceutical companies was
  not true about the efficacy of their products and
  encouraged medical professionals to write
  excessive prescriptions so that they could
  increase their profits.

4

• 3. Responsibility for Products
• The Food and Drug Administration (FDA) is doing
  more than just encouraging competition from
  generic drugs they are also encouraging
  pharmaceutical companies to reduce the cost of
  new drugs by streamlining and speeding up the
  research and development process. This should
  help eliminate some unnecessary costs.
• While this does make pharma franchise company
  India more inexpensive for end users, it also
  means that medicines spend less time in the
  testing phase, which increases the danger to
  patient safety as well as the risk to the
  regulatory system.
• 4. Cliffs of Patents
• The rapid decrease in sales of items that had
  previously made up a significant portion of the
  market may be referred to as a "patent cliff."
  This phenomenon occurs when drug patents run out
  and are allowed to expire. Patent cliffs, in
  their most basic form, provide rivals the
  opportunity to manufacture and patent an
  identical brand name medication, so making these
  monies up for grabs.
• According to market research conducted by
  Statista, the pharmaceutical sector might face
  the loss in sales of prescription drugs
  throughout the globe in the year 2022 as a direct
  result of patents expiring.

5

• 5. Fake medications for quality control
• Even if many American manufacturers have moved
  their operations abroad, there is still an issue
  with the importation of fake medications from
  other countries into the American market.
• In addition to being responsible for preventing
  the illegal trafficking of counterfeit
  medications, multinational pharmaceutical
  companies are obligated to ensure that their
  products meet quality standards while also
  adhering to all of the regulations that are in
  place in the countries in which they operate.
  Because of this, all of the suppliers and third
  parties that are engaged in the processes of
  manufacturing and shipping must adhere to high
  criteria.

6
(No Transcript)