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Harnessing the body's immune system to fight cancer is one of the most remarkable achievements in the medical field of
the past decade.
As the first cancer immunotherapy approved for marketing, PD-1/PD-L1 checkpoint inhibitors have led the transformation of cancer treatment, and a series of blockbuster products have been born one after another, becoming a new choice and new hope
for patients with refractory tumors.
However, the immune checkpoint inhibitor market is facing significant challenges
.
The booming business prospects have attracted many companies to participate, the market competition has become more fierce, and R&D has become increasingly concentrated
.
According to statistics, the number of clinical trials of PD-1/PD-L1 inhibitors has exceeded 5600 worldwide, and the prospects of immunotherapy are complex, which worries regulators and payers
.
At the same time, many innovative companies are trying to disrupt the market
through aggressive price competition.
PD-1/PD-L1 inhibitors are one of
the most dynamic segments.
IQVIA statistics show that in the past 5 years, the PD-1/PD-L1 inhibitor market has significantly outperformed other anti-tumor drugs in the world, with a five-year compound growth rate of 45%, which is 3 times
the overall growth rate of anti-tumor drugs.
Based on factory prices, the global market size of PD-1/PD-L1 inhibitors reached $36 billion
in 2021.
As the market matures, future growth will slow to 15% (5-year CAGR), and global sales in this segment are expected to reach $58 billion
by 2025.
Sales by Region IQVIA statistics show that in 2021, sales of PD-1/PD-L1 inhibitors in the United States accounted for 47%
of the global market.
As the European market catches up, the market share of the United States gradually declines
.
At present, the four EU countries and the United Kingdom together account for a quarter
of the global market for PD-1/PD-L1 inhibitor sales.
These six developed markets, together with Japan, account for 79%
of global sales of PD-1/PD-L1 inhibitors.
However, the other six markets lag behind the U.
S.
in terms of checkpoint inhibitor use per capita, and there is still potential unmet demand
.
It is worth noting that imported PD-1/PD-L1 inhibitors are not included in China's national medical insurance directory
.
At the same time, the price of domestic PD-1/PD-L1 inhibitors can be reduced by up to 80%
after entering the national medical insurance catalog.
Sales by Brand In the current competitive landscape, the position of the world's leading brands is still largely influenced
by the order of market entry.
Among the 7 highly competitive PD-1/PD-L1 inhibitors Keytruda, Opdivo, Tecentriq, Imfinzi, Bavencio, Libtayo, and Jemperli, early entrants Opdivo and Keytruda still accounted for 80%
of the global market share in 2021.
Notably, Keytruda's market share has increased
over the past 5 years.
Tecentriq has an 11% market share
.
Other products have a very limited market share, accounting for only 9%
of the total market share.
Sales by Tumor Type The above 7 PD-1/PD-L1 inhibitors that have been approved for marketing worldwide are used
in 17 different tumor types.
Among them, PD-1/PD-L1 inhibitors for non-small cell lung cancer (NSCLC) account for the largest market share, about 40%.
Different indications are dominated by different products, such as Keytruda for the treatment of NSCLC, Opdivo for the treatment of melanoma and kidney cancer, and Tecentriq for the treatment of small cell lung cancer
.
PD-1/PD-L1 detection levels Diagnostic and predictive biomarkers are essential
to outperform competitors and demonstrate differentiated value (e.
g.
, targeting subpopulations with less easily met needs, more aggressive outcomes).
For example, tumor mutation burden (TMB) and microsatellite high instability (MSI-H) are important biomarkers for understanding patient response to PD-1/PD-L1 inhibitors
.
However, detection levels vary widely across biomarkers, tumor types, and countries and regions, which is a challenge
for PD-1/PD-L1 inhibitor therapy in practice.
Therefore, in addition to the co-development and commercial strategy of incorporating biomarkers into checkpoint inhibitors, the readiness of the healthcare system for the use of biomarkers is a key factor
that must be considered.
For example, to address the widespread inclusion of new biomarkers in routine clinical practice, testing infrastructure and capabilities, consideration of impact on workflows, establishment of testing standards, or training of key personnel are required
.
Emerging Innovation Prospects Although PD-1/PD-L1 inhibitors have extraordinary impact in altering the therapeutic landscape and improving the outcomes of patients with different types of malignancies, there is still an unmet need
in this field.
For example, the patient's response to treatment is uncertain
in both intensity and duration.
Only a relatively small proportion of patients develop a lasting sensitivity to PD-1/PD-L1 inhibitors, and many patients do not respond to PD-1/PD-L1 inhibitor therapy at all; A small number of people eventually develop resistance through a range of mechanisms
.
PD-1/PD-L1 inhibitor therapy is also associated with immune-related toxicity, which can affect organ systems and tissues and, depending on its severity, may require discontinuation of treatment
.
In addition, such immune-related adverse events may occur
months or even years after completion of treatment.
These unmet needs, combined with the potential of PD-1/PD-L1 inhibitor therapies in early treatment, including neoadjuvant therapies, and the opportunity to expand into new indications, have stimulated active clinical R&D activities
in this area.
IQVIA statistics show that in 2021, there were more than 5,600 clinical trials related to PD-1/PD-L1 inhibitors worldwide, of which more than 4,800 were active
.
The vast majority of these clinical trials are investigating the combination
of PD-1/PD-L1 inhibitors with other immunotherapies, targeted therapies, chemotherapy and radiotherapy.
Combination therapies promise to overcome drug resistance and deliver long-lasting and tolerable efficacy
.
For example, stimulating a stronger T cell response by blocking other inhibitory checkpoints; Direct alteration of tumor immunogenicity by chemotherapy, radiotherapy or oncolytic viruses; or multipathal attack
by using other targeted therapies (VEGF or PARP inhibitors).
Fierce competition and wave of innovation have brought great challenges to the PD-1/PD-L1 inhibitor market, and innovators can break through the unmet clinical needs and new combination therapies and other needs and seize valuable opportunities
.
(Contributed by IQVIA)
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