Capecitabine Market Size - By Indication (Breast, Colorectal, Gastric, Pancreatic), By Synthesis Type (Chemical Based API, Biological API, Highly Potent API, Mode, Global Forecast 2023- 2032

Capecitabine Market Size

Capecitabine Market size was valued to be USD 408.2 million in 2022 and is expected to reach USD 652.9 million in 2032 with a CAGR of 4.9% from 2023 to 2032 driven by a number of important factors, such as capecitabine has demonstrated significant clinical effectiveness in treating different cancer types over the years. It is particularly valued for its role in adjuvant therapy (post-surgery) and as a component of combination regimens for metastatic disease and hence its proven efficacy drives its use in cancer treatment.

Furthermore, the increasing global population susceptible to various cancer types such as colorectal cancer, breast cancer, and gastric cancer, serves as a significant driver of the capecitabine industry expansion. According to the report published by World Cancer Research Fund International, 2020 saw an estimated 18.1 million cancer cases worldwide, with breast cancers emerging as the most prevalent, contributing 12.5% to the total number of new diagnoses that year.

Capecitabine is a chemical compound used as the active pharmaceutical ingredients in formulations, particularly in the manufacturing of medications for cancer treatment. As an API, capecitabine is synthesized and formulated as tablets to be administered orally as part of cancer treatment regimens.

COVID-19 Impact

The COVID-19 pandemic had a notable effect on the overall economy, with its most significant impact occurring in the early months of 2020. During this period, the closure of numerous API manufacturing facilities due to the pandemic led to various challenges for the API industry. Some of these challenges included reduced operational capacity due to labor shortages, disruptions in the supply chain, and difficulties in sourcing raw materials and packaging materials. However, as the COVID-19 crisis continued to unfold, especially in the latter half of 2020, there was a surge in demand for specific pharmaceuticals, driving increased demand for APIs used in the production. the market experienced significant growth due to the heightened demand for medications during the COVID-19 pandemic.

Capecitabine Market Driving Factors

The increasing incidence of cancer is among a significant driver influencing the industry gains. Cancer has emerged as a global health challenge, with a steadily increasing burden of new cancer cases reported each year. This surge in cancer incidences is driven by factors such as aging populations, lifestyle changes, environmental factors, and increased cancer screening and detection efforts. Further, the most straightforward impact of rising cancer incidence and prevalence is the larger pool of patients who require cancer treatment. With more individuals diagnosed with cancer, the demand for cancer drugs, including capecitabine, also increases. For instance, according to the American Cancer Society, Inc., around 1.9 million new cancer cases are expected to be diagnosed in the U.S. in 2023, and approximately 609,820 cancer-related fatalities in the U.S. in 2023, which is about 1,670 deaths per day.

Capecitabine Restraint

The high manufacturing costs in the capecitabine market is a complex issue with several detailed factors contributing to this challenge. Capecitabine API originates using a multistep process. Each stage necessitates careful monitoring of reaction conditions as well as the use of specialized equipment, reagents, and solvents. Due to the requirement for experienced workers and expensive infrastructure, the complex nature of the synthesis process can push up production prices. In addition, to ensure its safety and efficacy in cancer therapy, capecitabine API must comply with stringent quality and purity criteria. Manufacturers must spend in quality control procedures, analytical testing, and regulatory compliance, all of which can raise manufacturing costs.

Capecitabine Market Analysis

Based on the indication, the capecitabine market is segmented into breast cancer, colorectal cancer, gastric cancer, pancreatic cancer and other indications. The breast cancer segment is expected to reach USD 265.8 million by end of 2032. This leading market share is owing to the rising prescriptions of capecitabine for the treatment of metastatic breast cancer due to its proven efficacy. Capecitabine is an approved prodrug used for the treatment of metastatic breast cancer. It can be used as a single-agent chemotherapy or in combination with other chemotherapy drugs, such as docetaxel, Lapatinib, Oxaliplatin, Bevacizumab, etc.

Based on the synthesis type, the capecitabine market is classified into chemical-based API, biological API, and highly potent API (HPAPI). The chemical-based API segment dominated the market with 58.1% revenue share in 2022 and is projected to expand at 4.7% CAGR from 2023-2032. There is a growing focus on sustainability in pharmaceutical manufacturing, including the production of chemical-based APIs. Companies are adopting green chemistry practices, reducing waste, and optimizing processes to minimize environmental impact. In addition, to meet the increasing demand for capecitabine and other cancer therapies, pharmaceutical companies are expanding their production capacities. This involves investing in new manufacturing facilities and equipment. Furthermore, innovations in chemical synthesis techniques are enhancing the efficiency and yield of capecitabine production.

Based on the mode, the global capecitabine market is fragmented into in-house manufacturing and contract manufacturing. The potential for progression in this sector is substantial, driven by the prominent trend of continuous process optimization. This trend focuses on enhancing efficiency, cutting down manufacturing expenses, and minimizing environmental footprints. To optimize capecitabine API production, manufacturers are applying efficient production techniques, automation, and enhanced process monitoring. Along with this, as demand for capecitabine and cancer medicines increases, pharmaceutical companies are increasing their in-house production capacity. This may entail building new facilities or improving current ones to meet rising production demands.

In 2022, the North American region capecitabine market anticipated to witness significant progression to reach USD 252.5 million by end of 2032. In North America, the market for Capecitabine API is characterized by a well-established network of pharmaceutical manufacturers, both domestic and international. These manufacturers adhere to rigorous regulatory standards set forth by authorities such as the U.S. Food and Drug Administration (FDA) and Health Canada to ensure product safety, quality, and efficacy. The stringent regulatory oversight is essential in maintaining the high standards required for pharmaceutical ingredients. Moreover, North America remains a global hub for cancer research, with leading academic institutions, research centers, and pharmaceutical companies conducting extensive studies.

Capecitabine Market Share

Major players operating in the capecitabine is as mentioned below:

• Sun Pharmaceutical Industries Ltd
• Shilpa Medicare limited
• Atom Pharma
• Global Calcium
• LGM Pharma
• Dr. Reddy’s Laboratories Ltd
• Cipla Ltd
• Zeon Pharma
• Avanscure Lifesciences Pvt Ltd
• Hepartex

Capecitabine Company Market Share Analysis

Industry share within this capecitabine market is influenced by various factors, including product quality, regulatory compliance, pricing strategies, and the ability to effectively manage demand fluctuations. Sun Pharmaceutical Industries Ltd, Dr. Reddy’s Laboratories Ltd and Shilpa Medicare limited accounts for largest market share in the overall industry. Further, adherence to regulatory requirements, such as good manufacturing practices (GMP), is crucial for building and retaining customer trust.
 

Capecitabine Market Industry News:

• In December 2022, Shilpa Medicare announced that it has introduced Capecitabine (Capebel) dispersible tablet (DT) with technology of faster dispersion within 90 seconds to treat colorectal and metastatic breast cancer. This product launch may help the company to enhance their product portfolio and enhance business revenue.
   
• In February 2021, Dr Reddy’s Laboratories announced the launch of Capecitabine Tablets, USP, in the U.S. market. The product is a therapeutic equivalent generic version of Xeloda (capecitabine) tablets approved by the US Food and Drug Administration (USFDA). This product launch helped the company to enhance their product portfolio and enhance their business revenue.
   

The capecitabine market report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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By Indication

• Breast cancer
• Colorectal cancer
• Gastric cancer
• Pancreatic cancer
• Other indications

By Synthesis Type

• Chemical based API
• Biological API
• Highly potent API (HPAPI)

By Mode

• In-house manufacturing
• Contract manufacturing

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Russia
  • Rest of Europe
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Malaysia
  • Rest of Asia Pacific
• Latin America 
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa 
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East & Africa