')">

Market access update

The rise of precision medicine

Precision medicine is rapidly evolving, and manufacturers are considering more factors than ever before to achieve market access success. This update, available to read in full in the free report “Precision medicine: positioning for market access success”, summarizes the rise of precision medicine.

 

Precision medicine: year on year growth  

The number of drugs with companion diagnostics for solid and heme malignancies has grown dramatically year on year, increasing five-fold over the last 10 years to around 50 at the end of 2022. 

The table below shows FDA approvals for the last 5 years. It is split by new molecular entities, in blue, and additional indications for previously approved drugs in orange. It clearly shows the number of indication extensions has outnumbered first approvals of new drugs every year. 

 Source: “Precision medicine: positioning for market access success”. 

These are drugs which have been developed to target an aberration in a gene product in a specific tumor type. Herceptin for HER2 positive breast cancer is the obvious example; first approved by the FDA in 1998 with additional breast cancer indications added from 2006, it only moved in 2010 into a different tumor histology (gastric cancer – HER2 positive gastric cancer). 

This can be contrasted with Enhertu. It was first approved for unresectable or metastatic breast cancer after a prior anti-HER2-based regimen in 2019, approved in gastric cancer in January 2021, and another two breast cancer indications plus nonsmall cell lung cancer (NSCLC) last year. That is three different tumor locations in 4 years. 

 
Precision medicine: the growing complexity of decision-making  

However, until recently, development of these products was histology dependent – i.e., tumor type by tumor type. As these drugs have launched, we have seen the division of tumor types into subtypes defined by biomarker status (e.g., NSCLC may be divided by EGFR, ALK, ROS or KRAS status with multiple different therapies approved for each). 

The consequences of this include the increasing fragmentation of indications in clinical practice and the growing complexity of decision-making – as described in our free report “Precision medicine: positioning for market access success”. 

 

FREE Ebook

Precision medicine: positioning for market access success

Latest insights

Driving BioPharma Access in Europe: Insights for ...

Welcoming Lewis Ruff, Senior Director, Global HEOR, ...

Adapting to Change: Strategies for Pharma Service ...

Webinars

Driving BioPharma Access in Europe: Insights ...

Read more >

EBOOK

Value, Evidence, and Access: insights for ...

Read more >

EBOOK

Digital therapeutics: policy, access, value, and ...

Read more >

Blog

Evidence generation and launch strategies in ...

Read more >

Articles

Value, Evidence, and Access: insights for ...

Read more >

Blog

Digital therapeutics: value, evidence, and access ...

Read more >

EBOOK

Precision medicine: positioning for market access ...

Read more >

Blog

Welcoming Philip Drew, Head of Global ...

Read more >

Blog

Evidence supporting reimbursement of digital therapeutics

Read more >

Blog

Reducing the care gap in cancer ...

Read more >

Blog

ISPOR 2023: insight from Avalere’s expert ...

Read more >

Webinars

Positioning for market access success in ...

Read more >

Blog

AMCP 2023: key trends and highlights

Read more >

Blog

Why a market access career in ...

Read more >

Blog

E-learning for market access professionals

Read more >

Blog

Showcasing Robust Policy, Access, Value, and ...

Read more >

Blog

Principles of HTA Early Scientific Advice ...

Read more >

Blog

Driving BioPharma value, evidence, and access ...

Read more >

Articles

Market access success in the evolving ...

Read more >

Blog

5 benefits of e-learning for your market ...

Read more >

Articles

Cell and gene therapy: navigating the ...

Read more >

Blog

Market access careers in the Asia-Pacific ...

Read more >

Blog

Driving BioPharma value, evidence, and access ...

Read more >

Blog

The benefits of utilizing Early Scientific ...

Read more >

Blog

Driving BioPharma value, evidence, and access ...

Read more >

Blog

Cell and gene therapies: common challenges ...

Read more >

Blog

Avalere’s Healthcare Industry Outlook Report 2023

Read more >

Blog

Driving BioPharma value, evidence, and access ...

Read more >