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Last Updated: December 22, 2024

Drugs Containing Excipient (Inactive Ingredient) POLY(DL-LACTIC-CO-GLYCOLIC ACID)


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Branded drugs containing POLY(DL-LACTIC-CO-GLYCOLIC ACID) excipient, and estimated key patent expiration / generic entry dates

Generic drugs containing POLY(DL-LACTIC-CO-GLYCOLIC ACID) excipient

POLY(DL-LACTIC-CO-GLYCOLIC ACID) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Poly(DL-Lactic-Co-Glycolic Acid) (PLGA)

Introduction

Poly(DL-Lactic-Co-Glycolic Acid) (PLGA) is a biodegradable and biocompatible copolymer that has garnered significant attention in the pharmaceutical and biomedical industries. Its versatility and tailored properties make it an ideal material for various applications, including drug delivery systems, tissue engineering, and personal care products.

Market Size and Growth

The global PLGA market is experiencing robust growth, driven by increasing demand from the pharmaceutical and biotech sectors. As of 2023, the PLGA market size was valued at USD 0.825 billion and is projected to reach USD 2.4 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 13.2% during the forecast period of 2024-2030[5].

Key Drivers of Market Growth

Several factors are driving the growth of the PLGA market:

Growing Demand for Drug Delivery Applications

The primary driver is the increasing demand for drug delivery applications. PLGA's biodegradability and ability to control the release of drugs over a prolonged period make it an attractive material for long-acting injectable and implantable drug products[2][4].

Increasing Number of Surgical Interventions

The rise in surgical interventions and traumatic injuries, particularly due to road accidents, is also boosting the demand for PLGA. Its use in surgical implants, wound dressings, and other medical devices is on the rise[2].

Expanding Personal Care and Dermatology Segment

PLGA is gaining traction in the personal care and dermatology segment due to its biodegradability and suitability for facial fillers, body contouring devices, and skin substitutes. This segment is expected to contribute significantly to the market growth during the forecast period[2].

Geographical Overview

The PLGA market is segmented geographically into North America, Europe, Asia Pacific (APAC), South America, and the Middle East and Africa.

North America

North America is expected to contribute substantially to the market growth, with the US being a major consumer. The region's favorable research and development (R&D) landscape and increasing demand from the pharmaceutical sector are key factors driving this growth[2].

Asia Pacific

The Asia Pacific region is anticipated to experience the fastest growth, driven by the rising demand for advanced healthcare technologies in countries like China and India. This region is expected to be a significant contributor to the global PLGA market in the coming years[5].

Challenges and Complications

Despite the growth, the PLGA market faces several challenges:

Complexity in Developing Generic PLGA-Based Products

Developing generic PLGA-based long-acting injectable/implantable drug products is complex due to the lack of a standard compendial in vitro method for measuring drug release profiles. This complexity can lead to differences in in vitro and in vivo pharmacokinetic profiles between generic and reference products[3].

Physicochemical Properties

The physicochemical properties of PLGA, such as molecular weight and the ratio of lactic acid to glycolic acid, significantly affect its drug release mechanism. These properties need to be carefully controlled to ensure effective drug encapsulation and release[3][4].

Manufacturing Process

The manufacturing process of PLGA-based products is intricate, and variations in the process can lead to differences in product performance. Special attention is required for pH-sensitive protein or peptide drugs to avoid oxidation and acylation during encapsulation[3].

Strategies to Improve Encapsulation Efficiency and Drug Release

To overcome these challenges, several strategies are being employed:

Tailoring PLGA Properties

By adjusting the ratio of lactic acid to glycolic acid and controlling the molecular weight, PLGA's hydrophobicity, crystallinity, mechanical properties, and biodegradation rate can be tailored. This allows for the development of diverse forms of PLGA suitable for various applications[4].

Advanced Drug Delivery Systems

The use of computational drug delivery platforms and flow-through cell-based in vitro release methods can help in developing more efficient and predictable drug release profiles. These methods can simulate and predict the in vivo performance of PLGA-based drug products[3][4].

Financial Trajectory

The financial trajectory of the PLGA market is promising, with significant growth projected over the next few years.

Market Size Forecast

The market is expected to grow from USD 0.825 billion in 2023 to USD 2.4 billion by 2030, at a CAGR of 13.2%[5].

Investment in R&D

The growth is also fueled by increasing investment in research and development. Companies are focusing on developing new products, forming strategic alliances, and collaborating with other businesses to enhance their market share[5].

Regulatory and Market Challenges

Despite the positive outlook, the PLGA market faces some challenges:

High Cost of PLGA-Based Products

The high cost of PLGA-based products is a significant barrier to market expansion. This cost is partly due to the complexity of the manufacturing process and the need for high-quality raw materials[5].

Raw Material Scarcity

The scarcity of raw materials can also impact the production and availability of PLGA, affecting market growth[5].

Regulatory Requirements

Severe regulatory requirements pose another challenge. Ensuring compliance with these regulations can be time-consuming and costly, but it is essential for maintaining the quality and safety of PLGA-based products[5].

Key Takeaways

  • The global PLGA market is growing rapidly, driven by demand from pharmaceutical and biotech sectors.
  • The market is expected to reach USD 2.4 billion by 2030, growing at a CAGR of 13.2%.
  • North America and the Asia Pacific region are key contributors to market growth.
  • Tailoring PLGA properties and using advanced drug delivery systems can improve encapsulation efficiency and drug release.
  • High costs, raw material scarcity, and regulatory requirements are significant challenges.

FAQs

What are the primary applications of PLGA in the pharmaceutical industry?

PLGA is primarily used in drug delivery systems, including long-acting injectable and implantable products, due to its biodegradability and ability to control drug release over time[2][4].

How does the ratio of lactic acid to glycolic acid affect PLGA properties?

The ratio of lactic acid to glycolic acid in PLGA affects its hydrophobicity, crystallinity, mechanical properties, and biodegradation rate. Adjusting this ratio allows for the creation of diverse forms of PLGA suitable for various applications[4].

What are the challenges in developing generic PLGA-based drug products?

Developing generic PLGA-based products is challenging due to the lack of a standard compendial in vitro method for measuring drug release profiles, which can lead to differences in in vitro and in vivo pharmacokinetic profiles[3].

Which regions are expected to drive the growth of the PLGA market?

North America and the Asia Pacific region are expected to be significant contributors to the growth of the PLGA market, driven by increasing demand from the pharmaceutical sector and the need for advanced healthcare technologies[2][5].

What are the major challenges facing the PLGA market?

The major challenges include the high cost of PLGA-based products, scarcity of raw materials, and severe regulatory requirements[5].

Sources:

  1. Mechanism of Alternating Poly(lactic-co-glycolic acid) Formation - ACS Publications
  2. Poly (Lactic-Co-Glycolic Acid) (PLGA) Market size to grow by USD 106.84 million from 2022 to 2027 - PR Newswire
  3. Challenges and Complications of Poly(lactic-co-glycolic acid)-Based Long-Acting Drug Product Development - MDPI
  4. Recent Progress in Poly (Lactic-co-Glycolic Acid)-Based Biodegradable Drug Delivery Carriers for Pain Management - MDPI
  5. Poly (Lactic-Co-Glycolic Acid) (PLGA) Market Size & Forecast - Verified Market Research

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