Highlights:
- Since its launch, the immune checkpoint inhibitors market, led by PD-1/PD-L1 inhibitors has reached ~$40 Bn in revenue. The growth is led primarily by Merck’s Keytruda, followed by BMS’ Opdivo, and Roche’s Tecentriq
- The immune checkpoint inhibitors space is now maturing. The current market spectrum is highly consolidated with top three assets commanding ~90% of the market share
- To counter the dominance of early movers, new entrants now need to highly strategize their positioning, including combination strategies and targeting of specific patient segments
- Other innovative approaches in oncology market being pursued includes therapeutic cancer vaccines, CAR-T therapeutics, and CRISPR based gene editing
The PD-1/PD-L1 Journey:
The arrival of PD-1/PD-L1 inhibitors as one of the first immune checkpoint inhibitors in the mix of oncology therapies has been one of the most profound step-ahead in the way oncologists treat cancer worldwide.
The concept of blocking PD-1 and PD-L1 as an effective way of managing cancer was first discussed in the year 2000. Nivolumab (the monoclonal immunoglobulin G4 antibody to PD-1) entered scrutiny of clinical trial by 2006. Industry analysts were very excited once promising clinical data started making rounds in 2012, and finally FDA approved the first immune checkpoint inhibitors in the year 2014.
Since then, multiple approvals across different indications have been sought and the checkpoint inhibitors segment has outpaced the overall growth of oncology market. PD-1/PD-L1 inhibitors market has already reached ~$40 Bn, and is expected to cross the $50 Bn threshold by 2024.
PD-1/PD-L1 Current Market Challenges:
Currently, the immune checkpoint inhibitors have been collectively approved for 15+ indications. The market itself is very concentrated. Keytruda is dominating the market with ~50% market share and FDA approvals in 19 indications and sub-segments. FDA also recognizes Keytruda as the SOC benchmark.
Apart from Keytruda, Opdivo and Tecentriq command a ~30% and ~10% share of the market. Which leaves limited share for other therapies to compete.
For new entrants, regulatory checks are also now more stringent. In March, 2022, FDA had rejected Eli Lilly’s China-developed cancer immunotherapy, sintilimab. Directive was to conduct a SOC comparative trial in the U.S.
In March 2021, FDA Oncologic Drug Advisory Committee had also decided to review the status of therapies granted accelerated approval for specific indications. Following the review, BMS, AstraZeneca, Merck and Roche voluntarily withdrew indications for their cancer drugs.
Opportunities ahead:
To counter the dominance of Keytruda, the newer market entrants need to highly strategize their developmental plans. This includes picking the right combination strategy and targeting of a niche but correct patient segment.
Identifying and focusing on the key differentiators are the most important factors currently for new entrants.
In the immune checkpoint inhibitor story, the biomarkers have always been of value. New players need to incorporate biomarkers into their therapies’ developmental plan. An early partnership with diagnostic players is a necessity for grabbing a foothold among current market dynamics.
New Horizons:
With all the success achieved by immune checkpoint inhibitors market, the key question stands – is there an alternative opportunity that can lead to yet another seismic shift in the way tumors are being treated?
Interestingly, the oncology pipeline is brewing with interesting concepts that may arise in similar market tail-winds as seen with the PD-1/PD-L1 story.
Various forms of targeted oncology therapies are being pursued currently, that includes:
- Cancer vaccines – A personalized tailor made approach to develop therapeutic vaccines for specific tumor types for each individual
- CAR-T therapies – Another personalized approach where patient’s immune T-cell is genetically engineered to target the cancer antigens
- CRISPR/Cas9 based approach – Makes gene editing precise. Application of CRISPR gene editing can be to improve other therapeutic approaches like the CAR-T therapies. Current CAR-T generation can further be improved upon to be more precise with CRISPR enabled precision DNA editing
All these approaches have their own challenges and roadblocks in terms of development and market adoption. However, increasing innovations with each passing day is making the management of cancer better. Longer Overall Survival (OS) rates, Progression Free Survival (PFS) improvements, extended Duration of Response (DoR) and Objective response rates (ORR) are collectively hinting at further expansion of the oncology market and improvement of patient’s lives.