Off-label is also called non-approved or unapproved use of a drug.
There are three conditions under which a drug can be considered as off-label:
(i) As no steps have been taken to extend the approval although efficacy evidence is available.
(ii) As these drugs come under the ‘grey zone’ category of evidence- based medicine, within which it is difficult to reach high-level evidence even for likely effective treatments especially in rare disease cases.
(iii) As these drugs are ineffective or it is irrational to believe it as effective.
The issue of off label drugs market is more prominent in the field of oncology than in other areas. One of the major reasons is the types of cancer. An anticancer drug assigned for a particular type of cancer can also be used for other cancer types. In actuality, many anticancer drugs that are widespread don’t get the label for all the symptoms for which they can be used effectively for treatment.
Persistent demand of anti-neoplastic drugs in better management of cancer fuelled the demand of off-label drugs. It is most common among cancer therapies due to limited availability of approved drugs for treatment. They are proven effective for many indications and in combination therapies when compared to monotherapy. Further, rising cancer prevalence among general population fueled the growth of the market. Along with this, changing regulatory conditions to support manufacturers in the rapid advancement of technologies led to robust growth. It is legal in the US for off-label drug use and offers reimbursements for cancer treatment. Additionally, growing research activities to expand the disease indication fueled the investments. All these factors led to the robust growth of the market during the forecast period.
Global market is dominated by North America due to supportive regulatory policies and high adoption among the physicians. North America is dominated by the US and it is expected to remain dominant same throughout the forecast period. It is followed by the European region and it is dominated by the UK, Germany, and France. European regulatory bodies restrict the off-label drug use but there is high adoption among the general physicians. It is followed by the Asia Pacific and Latin America regions are fast growing regions due to increasing adoption. They are expected accounts for 25% share of the global market. Rest of World accounts the small fraction of the global market and expected to remain the same throughout the forecast period.