PD-1/PD-L1 Inhibitors Market

PD-1/PD-L1 Inhibitors Market Outlook (2023 to 2033)

The PD-1/PD-L1 Inhibitors Market size is projected to be valued at USD 49.5 billion in 2023 and is expected to reach a valuation of USD 123.3 billion by 2033. The market is also expected to record a significant CAGR of 9.6% during the forecast period.

Significant Aspects Influencing the Market

• Cancer immunotherapy has advanced significantly in recent years, with PD-1/PD-L1 immunotherapy emerging as one of the most prominent therapies.
• Many clinical trials have demonstrated their significance, and many more are still being conducted to identify other cancers that can be treated with this therapy.
• Innovative insights into how the human immune system responds to and is formed by diverse tumor types are likely to be produced through dynamic immunologic investigations, which are also anticipated to direct the development of combination medicines. These investigations are likely to contribute to the understanding of genetics and epigenetics in the microenvironment of human cancer.
• In comparison to their counterparts, immune checkpoint inhibitor drugs have a high target affinity and specificity. Rising approval ratings for these drugs and lower costs are likely to drive product demand.
• Immune checkpoint inhibitor drugs were discovered to be a better alternative to most approved therapies, which have severe side effects during cancer treatments. As a result, the market for immune checkpoint inhibitors has grown tremendously among healthcare professionals in recent years.
• Immune checkpoint inhibitors are highly specific, making them far more effective than conventional treatments.

Limiting Aspects of the Market

Regardless of the various factors influencing the growth of this market, several key issues must be addressed to facilitate future growth. The relatively high total costs of developing and using PD-1/PD-L1 inhibitors, as well as reimbursement policies, are limiting the market's growth.

Attributes	Details
PD-1/PD-L1 Inhibitors Market CAGR	9.6 %
PD-1/PD-L1 Inhibitors Market Valuation (2023)	USD 49.5 billion
PD-1/PD-L1 Inhibitors Market Valuation (2033)	USD 123.3 billion

How The Market Progressed till June 2022?

Market Statistics	Details
H1,2021 (A)	13.19%
H1,2022 Projected (P)	10.71%
H1,2022 Outlook (O)	9.61%
BPS Change: H1,2022 (O) - H1,2022 (P)	(-) 110 ↓
BPS Change: H1,2022 (O) - H1,2021 (A)	(-) 349 ↓

According to Future Market Insights' analysis, the global PD-1/PD-L1 inhibitors market dropped by 349 Basis Point Share (BPS) in H1-2022 as compared to H1- 2021. Whereas in comparison to H1-2022 projected value, the market during the H1-2022 outlook period showed a dip of 110 BPS.

The drop in the BPS values is associated with the reported resistance to PD-1/PD-L1 therapy among patients, with only a few estimated to present a positive outlook of treatment.

Due to the need for developing predictive biomarkers, the industry noticed a decline in the linked BPS values with low frequencies of positive clinical outcomes. The FDA has approved 10 immune checkpoint inhibitors for the PD-1/PD-L1 pathway till 2018. The growth in FDA approvals for clinical therapy with PD1/PDL1 inhibitors is expected to provide the market landscape with a positive growth outlook for the forecast years.

For instance, six anti-PD-1/PD-L1 mAbs (monoclonal antibodies) have received approval as of December 2020, with indications covering 19 different cancer types and two tissue-agnostic diseases.

Key developments in the market include the development of monoclonal antibodies for targeted therapeutic approaches. The market is subject to changes as per drug trial assessment and regulatory impositions, in accordance with the macro and industry standards.

2018 to 2022 PD-1/PD-L1 Inhibitors Market Outlook in Comparison to 2023 to 2033 Growth Forecast

Leading industry players are concentrating on the development and commercialization of novel PD-1/PD-L1 inhibitors to treat a variety of cancers. The expansion in the market availability of PD-1/PD-L1 immunotherapeutic is expected to drive the growth of the PD-1/PD-L1 inhibitors market.

The global PD-1/PD-L1 Inhibitors market is expected to expand due to an increase in cancer incidence. PD-1/PD-L1 inhibitors, for example, are important Immune Checkpoint Inhibitors (ICIs) used as first-line treatments for a variety of cancers.

Cancer was one of the leading causes of death worldwide in 2020, accounting for around ten million deaths, or nearly one in every six deaths, according to the World Health Organization (WHO). Breast, lung, colon, rectum, and prostate are the most common cancers. As a result, there is a global increase in demand for PD-1 and PD-L1 inhibitors.

The Union for International Cancer Control (UICC) estimates that older individuals (those 65 and older) have an 11-fold increased risk of cancer compared to younger individuals.

According to the United Nations, there are over 703 million people aged 65 and up, with that number expected to rise to 1.5 billion by 2050. According to the most recent United Nations DESA population division estimates and projections, one in every six people in the world is likely to be over the age of 65 by 2050, up from one in every eleven in 2019.

Considering this, FMI expects the global PD-1/PD-L1 inhibitors market to record a CAGR of 9.6% through 2033.

What Factors are Restraining Demand for PD-1/PD-L1 Inhibitors?

The high cost of cancer immunotherapy and stringent regulatory scenario are the primary factors hampering the PD-1/PD-L1 inhibitors market over the forecast period.

Cancer treatment costs generate substantial economic issues for healthcare providers and patients because of the impact they have on patient safety, quality of care, and overall healthcare.

The high cost of cancer therapy is anticipated to slow down the rate of treatment uptake, particularly in emerging nations. The regulatory requirements are expected to be strengthened as biologics move through clinical studies and into commercial production.

Biologics must be rigorously verified and monitored against critical quality attributes (CQAs) throughout the manufacturing process, not just at the end like chemistry-based medications, due to the nature of biologics, which are created by live cells. This makes it more difficult for biologics to obtain regulatory approval, which restricts market expansion.

Country-wise Analysis

In 2023, the United States is expected to account for around 98.9% of the North American PD-1/PD-L1 inhibitors market

The dominance of the United States can be attributed primarily to the rising prevalence of several chronic diseases such as lung cancers, urothelial carcinomas, skin cancer, and diabetes in the United States, which necessitated efficient treatment.

According to the American Cancer Society's 2020 report, lung cancer is the second leading cause of death for both men and women, accounting for 135,720 deaths. According to the statistics, nearly 84% of all lung cancers in the United States are NSCLC (non-small cell lung cancer) and 13% are SCLC (small cell lung cancer), which is expected to continue in the coming years, resulting in an increasing demand for PD-1/PD-L1 Inhibitors in the country.

Attributes	Details
United States Market Size (USD million/billion) by End of Forecast Period (2033)	USD 23.4 billion
United States Market Absolute Dollar Growth (USD million/billion)	USD 2.9 billion
CAGR % 2018 to 2022	31.0%
CAGR % 2023 to End of Forecast (2033)	8.4%

In 2023, Germany is expected to account for 26.7% of the PD-1/PD-L1 inhibitors market in Europe

Germany is expected to expand more rapidly than the rest of Europe, owing to several clinical trials being conducted in the industry.

Organizations such as the European Medicines Agency have increased their focus on PD-1/PD-L1 inhibitors for combination therapy and monotherapy use, intending to treat diseases in adults as well as in pediatric trials. The growing awareness of the low toxicity levels and compliance between PD-1/PD-L1 inhibitors and regional healthcare safety regulations can be attributed to the market's growth in Germany.

Attributes	Details
Germany Market Size (USD million/billion) by End of Forecast Period (2033)	USD 3.8 billion
Germany Market Absolute Dollar Growth (USD million/billion)	USD 508.6 million
CAGR % 2018 to 2022	43.6%
CAGR % 2023 to End of Forecast (2033)	10.4%

In the global market, the PD-1/PD-L1 inhibitors market in China is expected to be worth USD 1.8 billion by 2033

Given its significant population base and significant private and public sector investment in healthcare infrastructure development, China is expected to expand at a relatively rapid rate during the forecast period.

Also, the surge in cancer cases, combined with the growing interest in immune checkpoint inhibitors, is expected to drive market growth over the forecast period.

Besides, an increase in product launches and product innovations in oncology immunotherapy is expected to drive growth in China.

Attributes	Details
China Market Size (USD million/billion) by End of Forecast Period (2033)	USD 1.8 billion
China Market Absolute Dollar Growth (USD million/billion)	USD 305.6 million
CAGR % 2018 to 2022	44.8%
CAGR % 2023 to End of Forecast (2033)	14.0%

In India, demand for PD-1/PD-L1 inhibitors is expected to record a CAGR of 15.4% over the forecast period.

The rising cancer incidence, increased government involvement in cancer diagnosis, the introduction of new immunotherapies with fewer side effects, and the increasing adoption of inorganic growth strategies such as collaborations, acquisitions, and mergers by key players in the market are the primary factors expected to drive the growth of the PD-1/PD-L1 inhibitors market in India during the forecast period.

Category-wise Insights

Pembrolizumab is expected to have a Sizeable Market Share of 49.5% in 2023, Growing at a rate of nearly 8.7% over the Forecast Period

Pembrolizumab, out of all the products in the PD-1/PD-L1 inhibitors market, is expected to expand significantly due to increased adoption of the product over the other products.

Pembrolizumab's increased use is due to its proven efficacy in treating various FDA-approved indications such as head and neck squamous cell cancer (HNSCC), non-small cell lung cancer (NSCLC), melanoma, and others since its approval in 2014.

This is boosting the segment's growth over the forecast period. Significant investments in the development of this product by key players are driving segment sales over the forecast period.

Hospital Pharmacies are expected to have a significant share of 48.3% in 2022, Expanding at a Rapid Rate of 9.9% CAGR during the Forecast Period

The growth of the hospital pharmacy segment is due to massive orders, robust supply chains, and hospital facilities' efforts to maintain large-scale inventories for cancer therapy applications.

Also, the presence of advanced equipment and the availability of well-developed infrastructure contribute to the segment's growth. Besides, as more patients are admitted to hospitals for cancer treatment, the use of PD-1/PD-L1 inhibitors in hospitals is increasing, thus boosting sales in hospital pharmacies.

The Non-small Cell Lung Cancer (NSCLC) Segment is Likely to Lead the Market, accounting for 37.0% of the total Market Revenue Share in 2023

NSCLC (non-small cell lung cancer) accounts for around 80% to 85% of all cases of lung cancer worldwide, and this significant share has encouraged several key players to focus on continuous innovation of advanced therapeutics and improving the efficacy of existing therapeutics.

Growing NSCLC (non-small cell lung cancer) diagnoses and rising awareness in developing and developed markets are driving the growth of the non-small cell lung cancer segment.

Competitive Background

The global adoption of PD-1/PD-L1 inhibitors has prompted companies to invest in the development of products in the PD-1/PD-L1 immunotherapy segment for cancer treatment. Merck & Co., Inc. has been a pioneer in this field and a significant competitor in this market due to its diverse product portfolio and intense market penetration.

Recent Developments

• Bristol Myers Squibb received a favorable opinion from the committee for medicinal products for human use (CHMP) in July 2022, recommending approval of the LAG-3-blocking antibody combination Opdualag (nivolumab and relatlimab) for the treatment of patients with unresectable or metastatic melanoma.
• Merck received the United States FDA approval for KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1, as determined by an FDA-approved test, in October 2021.

Leading Companies Operating in the PD-1/PD-L1 Inhibitors Market are

• Akeso Inc.
• Alphamab Oncology
• Amgen Inc.
• AstraZeneca Plc
• BeiGene Ltd.
• Bristol Myers Squibb Co.
• Chia Tai Tianqing Pharmaceutical Group Co. Ltd.
• Eli Lilly and Co.
• F. Hoffmann La Roche Ltd.
• Gilead Sciences Inc.
• GlaxoSmithKline Plc
• Innovent Biologics Inc.
• Jiangsu Hengrui Pharmaceuticals Co. Ltd.
• Merck and Co. Inc.

Scope of Report

Attribute	Details
Forecast Period	2023 to 2033
Historical Data Available for	2018 to 2022
Market Analysis	USD million for Value
Key Countries Covered	United States, Canada, Germany, United Kingdom, France, Italy, Spain, Russia, China, Japan, South Korea, India, Thailand, Malaysia, Indonesia, Australia, New Zealand, GCC Countries, Türkiye, Northern Africa, and South Africa
Key Segments Covered	Product, Indication, Distribution Channel, Region
Key Companies Profiled	Akeso Inc.; Alphamab Oncology; Amgen Inc.; AstraZeneca Plc; BeiGene Ltd.; Bristol Myers Squibb Co.; Chia Tai Tianqing Pharmaceutical Group Co. Ltd.; Eli Lilly and Co.; F. Hoffmann La Roche Ltd.; Gilead Sciences Inc.; GlaxoSmithKline Plc; Innovent Biologics Inc.; Jiangsu Hengrui Pharmaceuticals Co. Ltd.; o Merck and Co. Inc.
Report Coverage	Market Forecast, Company Share Analysis, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, and Strategic Growth Initiatives
Customization & Pricing	Available upon Request

PD-1/PD-L1 Inhibitors Market by Category

By Product:

• Nivolumab
• Pembrolizumab
• Atezolizumab
• Avelumab
• Durvalumab

By Indication:

• Melanoma
• Non-Small Cell Lung Cancer (NSCLC)
• Renal Cell Carcinoma (RCC)
• Head and Neck Squamous Cell Cancer (HNSCC)
• Bladder Cancer
• Merkel Cell Carcinoma (MCC)
• Others

By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region:

• North America
• Latin America
• Europe
• South Asia & Pacific
• East Asia
• The Middle East & Africa (MEA)

Frequently Asked Questions

How Big is the PD-1/PD-L1 Inhibitors Market?

The market is valued at USD 49.5 billion in 2023.

What is the Projected Market CAGR from 2023 to 2033?

The market is anticipated to record a CAGR of 9.6%.

What is the Market Share of Germany in 2023?

Germany is expected to account for 26.7% of the market in 2023.

How Big will the PD-1/PD-L1 Inhibitors Market in 2033?

The market is estimated to reach USD 123.3 billion.

What is United States Market CAGR over the Forecast Period?

The United States is projected to expand at a CAGR of 8.4% over the forecast period.