Prolastin, Prolastin-C Market Report 2026: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

The growth in the historic period can be attributed to approval for alpha-1 antitrypsin deficiency, clinical efficacy in lung protection, specialist pulmonology adoption, limited treatment alternatives, plasma derived protein availability.

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.

The rising incidence of respiratory infections is expected to drive the growth of the Prolastin and Prolastin-C market in the coming years. Respiratory infections affect the respiratory system, including the nose, throat, airways, and lungs, and are caused by pathogens such as viruses, bacteria, fungi, or other microorganisms. The increase in respiratory infections is driven by factors such as emerging viral strains, seasonal variations, weakened immune systems, 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. This reduces lung inflammation, protects against tissue damage caused by protease activity, and improves lung function and overall respiratory health for affected patients. For example, in October 2024, the National Asthma Council, an Australia-based non-profit organization, reported that in 2023, Australia recorded 474 asthma-related deaths - 325 females and 149 males - almost identical to the 473 deaths reported in 2022, reflecting a consistent trend in asthma mortality. Therefore, the rising incidence of respiratory infections is driving the Prolastin and Prolastin-C market.

Increasing research and development expenditure is also expected to support the growth of the Prolastin and Prolastin-C market. Research and development (R&D) includes systematic activities undertaken by organizations or individuals to generate new knowledge, develop innovative products, or improve existing therapies and processes. Rising R&D expenditure is driven by technological advancements, growing demand for innovation, and the need to develop new therapies in competitive markets. Higher R&D spending benefits Prolastin and Prolastin-C by enabling advanced clinical trials, improving efficacy, and accelerating the development of optimized formulations or dosage regimens to enhance patient outcomes. For instance, in February 2025, the National Center for Science and Engineering Statistics (NCSES), a US-based government agency, reported that U.S. R&D expenditures increased from $892 billion in 2022 to $940 billion in 2023, reflecting a $48 billion increase. Therefore, increasing research and development expenditure is driving the Prolastin and Prolastin-C market.

Key companies in the Prolastin and Prolastin-C market are focusing on clinical trials to evaluate the safety and effectiveness of these therapies. Clinical trials are research studies conducted to assess the safety, efficacy, and potential side effects of new drugs, treatments, or medical devices on human participants. For example, in July 2023, Grifols SA, a Spain-based pharmaceutical company, announced that it had reached the enrollment target 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 whether patients with emphysema due to alpha-1 antitrypsin (AAT) deficiency experience a slower rate of lung tissue loss when treated weekly with two different dose regimens of Grifols Prolastin-C. The study evaluates the effectiveness of Prolastin-C in reducing emphysema progression by increasing AAT protein levels through weekly administration of two active doses (60 and 120 mg/kg) compared to a placebo.

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

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 the prolastin, prolastin-c market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the prolastin, prolastin-c market report are Australia, India, China, South Korea, Japan, UK, France, Germany, USA, Canada.

Tariffs have impacted the prolastin and prolastin-c market by increasing costs related to plasma collection, fractionation technologies, and specialized cold chain transportation. These effects are most pronounced in North America and Europe where alpha-1 therapies are widely used. Hospitals and specialty pharmacies face higher acquisition costs due to import duties on plasma derived biologics. Supply chain planning has become more complex because of regulatory and customs requirements. However, tariffs are supporting domestic plasma processing capabilities and improving long term supply security.

The prolastin, prolastin-c market research report is one of a series of new reports that provides prolastin, prolastin-c market statistics, including prolastin, prolastin-c industry global market size, regional shares, competitors with a prolastin, prolastin-c market share, detailed prolastin, prolastin-c market segments, market trends and opportunities, and any further data you may need to thrive in the prolastin, prolastin-c industry. This prolastin, 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.

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 that helps prevent the progression of lung disease in patients with this deficiency. Both therapies aim to reduce the risk of lung damage and related complications in individuals with alpha-1 antitrypsin deficiency.

The main forms of Prolastin and Prolastin-C are 20 mL and 40 mL, accommodating different patient needs. Their primary indications include alpha-1 antitrypsin deficiency, respiratory health, chronic lung disease, and genetic disorders, addressing key areas of patient care. These products are used in settings such as hospitals and pharmacies, ensuring proper accessibility and administration.

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.

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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