Prolastin-C Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

This Prolastin-C market report delivers an in-depth analysis of the market’s key characteristics, including size, growth potential, and segmentation. It provides a detailed breakdown of the market across major regions and leading countries, highlighting historical data and future growth projections. The report also examines the competitive landscape, market share insights, emerging trends, and strategic developments shaping the market.

Market growth during the historic period can be attributed to several factors, including increased healthcare funding for rare disease therapies, a rise in the number of clinical trials, expanded insurance coverage, a higher volume of diagnostic tests, and the ongoing improvement of healthcare infrastructure.

Growth during the market's forecast period is driven by the increasing prevalence of alpha-1 antitrypsin deficiency, a rising demand for personalized medicine, growing need for lung disease treatments, the expansion of diagnostic tools, and increasing government initiatives. Key trends expected to shape the forecast period include technological advancements, the rise of personalized medicine, developments in gene therapy, the adoption of digital health technologies, and the growth of non-invasive diagnostic tests.

The rising incidence of respiratory infections is anticipated to drive the growth of the prolastin-C market. Respiratory infections, which affect the respiratory system - including the nose, throat, airways, and lungs - are caused by a variety of pathogens, including viruses, bacteria, fungi, and other microorganisms. Contributing factors such as the emergence of new viral strains, seasonal fluctuations, compromised immune systems, environmental pollution, and increased human mobility are fueling this rise. Prolastin-C, an alpha-1 antitrypsin (AAT) replacement therapy, is crucial for managing respiratory diseases, particularly chronic obstructive pulmonary disease (COPD) linked to alpha-1 antitrypsin deficiency. By replenishing the deficient AAT protein, Prolastin-C helps reduce lung inflammation, prevent tissue damage from protease activity, and enhance lung function, thereby improving the overall respiratory health of patients with this genetic disorder. According to the Bureau of Labor Statistics, a U.S. government agency, in November 2023, the illness rate among private industry employers increased to 45.2 cases per 10,000 full-time equivalent (FTE) workers in 2022, up from 37.7 cases in 2021. This increase was largely attributed to a rise in respiratory illnesses, which jumped from 27.8 to 35.8 cases per 10,000 FTE workers during the same period.

The growth of the prolastin-C market is being fueled by the rising expenditure in research and development (R&D). R&D refers to systematic activities aimed at discovering new knowledge, developing innovative products, or improving existing services and processes. The surge in R&D spending is driven by growing demand for innovation, technological advancements, and the need to develop new therapies in competitive markets. This heightened investment supports the Prolastin-C market by funding advanced clinical trials, enhancing treatment efficacy, and enabling the development of better formulations and dosage regimens for improved patient outcomes. For example, in July 2024, the Department of Health and Social Care reported that UK businesses invested $10.98 billion (£9 billion) in pharmaceutical research and development in 2022, representing 0.36% of the country’s GDP. This investment accounted for 18% of the total R&D expenditure by businesses in the UK, making it the largest share among all product sectors.

A significant trend shaping the prolastin-C market involves clinical trials assessing the safety and effectiveness of the drug. Clinical trials are essential for evaluating the safety, efficacy, and potential side effects of new treatments, drugs, or medical devices in human participants. For example, in July 2023, Grifols SA, a Spain-based pharmaceutical company, announced the successful enrollment of 339 patients in the SPARTA (Study of Prolastin-C Randomized Therapy with Alpha-1 Augmentation) Phase 3 clinical trial. The trial aims to determine if Prolastin-C can slow the rate of lung tissue loss in patients with emphysema and alpha-1 antitrypsin (AAT) deficiency (alpha-1) when administered weekly at two different dose regimens. The study will compare the effects of 60 mg/kg and 120 mg/kg doses against a placebo to assess Prolastin-C’s effectiveness in reducing emphysema progression in AAT deficiency patients by increasing AAT protein levels.

The key players operating in the prolastin-c market is Grifols S.A.

North America was the largest region in the prolastin-C market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in prolastin-C report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the Prolastin-C market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Prolastin-C is a purified alpha-1 proteinase inhibitor (also known as alpha-1 antitrypsin or AAT) sourced from human plasma. It is primarily indicated for augmentation therapy in individuals with alpha-1 antitrypsin deficiency (AATD), a genetic condition associated with a heightened risk of severe lung diseases such as emphysema. Prolastin-C functions by elevating alpha-1 antitrypsin levels in the blood and lungs, thereby protecting lung tissue from damage caused by neutrophil elastase - an enzyme that, when unregulated, compromises lung elasticity.

The primary types of prolastin-C include 20 mL and 40 mL formulations. The 20 mL version is a sterile, ready-to-use liquid alpha-1 proteinase inhibitor designed for intravenous infusion in individuals with alpha-1 antitrypsin deficiency. It is indicated for multiple conditions, including chronic obstructive pulmonary disease (COPD), liver disease, and pulmonary disorders, and is used in both hospital and pharmacy settings.

The prolastin C market research report is one of a series of new reports that provides prolastin C market statistics, including prolastin C industry global market size, regional shares, competitors with a prolastin C market share, detailed prolastin C market segments, market trends and opportunities, and any further data you may need to thrive in the prolastin C industry. This prolastin C market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The prolastin-C market consists of sales of inhalable pulmonary medications, nutritional supplements and other related products. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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