Drug development is both a prohibitively costly and spectacularly lucrative enterprise
Prohibitively Costly
It’s estimated that the total cost of getting a drug through various stages of development from target discovery, to lead identification and optimization, to clinical trials, and to market approval is anywhere between $1 billion to $2.5 billion depending on how you calculate the expenses and the lost opportunity cost. In addition to the prohibitively high cost, it takes 10 to 15 years to see it through.
Spectacularly Lucrative
A single drug Humira brings an annual sales of $16 billion in 2017, and is projected to approach $21 billion in 2020. The cumulative sales of Humira since its market introduction has exceeded $100 billion.
Drug development is the ultimate high risk, high reward business
Drug development process is a cold-hearted elimination process that starts with hundreds of thousands of lead compounds in discovery phase, proceeding to clinical trials of 3 increasingly elaborated testing phases, to regulatory review for approval. From hundreds of thousands of initial contenders would emerge just one victor at the end. This is the reason why it costs so much and takes so long to get one drug to the market. The failure rate is just unbearable too high.
Target selection is key to avoid failure
While there’s a plethora of reasons and factors a drug fails in the development, among them, drug target identification and validation stands out as the most fundamental and essential.