Prolastin, Prolastin-C Market Report 2026

Prolastin, Prolastin-C Market Overview

• The Prolastin, Prolastin-C market growth in the historic period has been driven by approval for alpha-1 antitrypsin deficiency, clinical efficacy in lung protection • Market expansion is supported by improved genetic screening rates, rising awareness of aat deficiency • Growth Driver: Rising Respiratory Infections Drive Growth In The Prolastin, Prolastin-C Market • Market Trend: Phase 3 Clinical Trial For Prolastin-C To Assess Efficacy In Slowing Emphysema Progression In AAT Deficiency Patients • North America was the largest region in 2025 and Asia Pacific is the fastest growing region.

What Is Covered Under Prolastin, Prolastin-C Market?

Prolastin is a purified human alpha-1 antitrypsin protein replacement therapy designed to manage alpha-1 antitrypsin deficiency. Prolastin-C is a formulation of alpha-1 antitrypsin used to help prevent lung disease progression in patients with alpha-1 antitrypsin deficiency. Both products are used to reduce the risk of lung damage and associated complications in individuals with alpha-1 antitrypsin deficiency. The main types of prolastin, prolastin-C, are 20 mL and 40 mL, catering to different patient needs. The primary indications for these products include Alpha-1 antitrypsin deficiency, respiratory health, chronic lung disease, and genetic disorders, addressing essential areas of patient care. These are applied in various settings, such as hospitals and pharmacies, ensuring accessibility and appropriate treatment administration.

What Is The Prolastin, Prolastin-C Market Growth Forecast?

The growth in the forecast period can be attributed to improved genetic screening rates, rising awareness of aat deficiency, expansion of specialty care centers, growth in respiratory disease burden, long term therapy adherence. Major trends in the forecast period include growing use of alpha-1 replacement therapy, expansion of long term lung protection treatment, rising diagnosis of aat deficiency, hospital based augmentation therapy adoption, focus on preventing disease progression.

Global Prolastin, Prolastin-C Market Segmentation

1) By Type: 20ml, 40ml 2) By Indication: Alpha-1 Antitrypsin Deficiency, Respiratory Health, Chronic Lung Disease, Genetic Disorders 3) By Application: Hospital, Pharmacy

What Are The Drivers Of The Prolastin, Prolastin-C Market?

The increase in incidence of respiratory infections is expected to propel the growth of the prolastin, prolastin-C market going forward. Respiratory infections refer to infections that affect the respiratory system, which includes the nose, throat, airways, and lungs. These infections are caused by various pathogens, such as viruses, bacteria, fungi, or other microorganisms. The rise in respiratory infections is driven by factors such as emerging viral strains, seasonal changes, and weakened immune systems, exacerbated by environmental pollution and increased human mobility. Prolastin and Prolastin-C, both forms of alpha-1 antitrypsin (AAT) replacement therapy, help manage respiratory diseases, particularly alpha-1 antitrypsin deficiency-related chronic obstructive pulmonary disease (COPD), by replenishing the deficient AAT protein, thereby reducing lung inflammation, protecting against tissue damage caused by protease activity, and improving lung function and overall respiratory health for patients affected by this genetic disorder. For instance, in October 2024, according to the National Asthma Council, an Australia-based non-profit organization, in 2023, Australia recorded a total of 474 asthma-related deaths, comprising 325 females and 149 males. This figure is almost identical to the 473 asthma-related deaths reported in 2022, highlighting a consistent trend in asthma mortality over the two years. Therefore, the increase in incidence of respiratory infections is driving the growth of the prolastin, prolastin-C industry. The increasing research and development expenditure is expected to propel the growth of the prolastin and prolastin-C market going forward. Research and development (R&D) refers to the systematic and organized activities conducted by companies, organizations, or individuals to discover new knowledge, create innovative products, or improve existing processes and services. Research and development expenditure is rising due to increasing demand for innovation, technological advancements, and the need to develop new products and therapies in competitive markets. Increased research and development expenditure positively impacts Prolastin and prolastin-C by enabling advanced clinical trials, enhancing its efficacy, and accelerating the development of improved formulations or dosage regimens for better patient outcomes. For instance, in February 2025, according to the National Center for Science and Engineering Statistics (NCSES), a US-based government statistical agency, U.S. research and development expenditures rose from $892 billion in 2022 to $940 billion in 2023, reflecting an increase of $48 billion. Therefore, the increasing research and development expenditure is driving the growth of the prolastin and prolastin-C market.

Key Players In The Global Prolastin, Prolastin-C Market

Major companies operating in the prolastin, prolastin-c market are Grifols SA

Global Prolastin, Prolastin-C Market Trends and Insights

Major companies operating in the peolastin and prolastin-C market are focusing on clinical trials to assess the safety and effectiveness of pharmaceuticals. Clinical trials are research studies conducted to evaluate the safety, efficacy, and potential side effects of new treatments, drugs, or medical devices on human participants. For instance, in July 2023, Grifols SA, a Spain-based pharmaceutical company, announced that it had reached the target of enrolling 339 patients in the SPARTA (Study of ProlAstin-c Randomized Therapy with Alpha-1 Augmentation) phase 3 clinical trial. The purpose of this trial is to find out if patients with emphysema who have alpha-1-antitrypsin (AAT) deficiency (alpha-1) have a slower rate of lung tissue loss when they receive weekly treatment with two different dose regimens of Grifols Prolastin-C. This aims to assess the effectiveness of Prolastin-C in reducing emphysema progression in alpha-1 antitrypsin deficiency (AATD) patients by increasing AAT protein levels through weekly administration of two active doses (60 and 120 mg/kg) compared to a placebo.

Regional Insights

North America was the largest region in the prolastin or prolastin-C market in 2025. Asia Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in this market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, India, China, South Korea, Japan, UK, France, Germany, USA, Canada.

What Defines the Prolastin, Prolastin-C Market?

The prolastin, prolastin-C market consists of sales of pre-filled syringes, customized dosing kits, and lyophilized powder formulations. 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.

How is Market Value Defined and Measured?

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.

What Key Data and Analysis Are Included in the Prolastin, Prolastin-C Market Report 2026?

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