Europe Prothrombin Complex Concentrate (PCC) Market Size, Share & Covid-19 Impact Analysis, By Product (4-factor PCC and 3-factor PCC), By Application (Acquired Coagulation Deficiency and Congenital Coagulation Deficiency and By End User (Hospitals & Ambulatory Surgical Centers, Specialty Clinics, and Others), 2020-2027

The Europe prothrombin complex concentrate (PCC) market size was valued at USD 174.6 million in 2019 and is projected to reach USD 398.9 million by 2027, exhibiting a CAGR of 10.9% during the forecast period.

Prothrombin complex concentrates (PCCs) are emergency products designed for the treatment of bleeding events associated with hemophilia B, congenital deficiencies of other vitamin K-dependent clotting disorders, or severe liver disease. The growing prevalence of coagulation factor deficiencies, cases of warfarin-associated bleeding disorders, and increasing spending capacity of individuals are some of the major reasons for the growth of the market during the forecast period.

COVID-19 Pandemic to Have a Minimal Impact on the Market

The outbreak of COVID-19 has had no significant impact on the prothrombin complex concentrate market growth. For instance, according to the quarterly report 2020 of CSL Limited, one of the dominating players in the PCC market, no material revenue impact was witnessed by the company resulting from the COVID-19 pandemic. In fact, the company’s specialty product sales grew normally by 10%. Perioperative bleeding sales were also up 10%, primarily driven by the strong demand for Beriplex and the company’s fibrinogen concentrate products used for the treatment of acute bleeding. However, the demand for blood and blood products decreased during the pandemic due to the postponement of elective surgeries. Nonetheless, even though measures such as physical distancing and a complete or partial lockdown of cities, provinces, or countries were followed, the demand for PCCs has remained stable due to their use in emergency warfarin-reversal situations.

LATEST TRENDS

Emergence of Anticoagulation Clinics to Drive Market Growth

With a rapid rise in the uptake of oral anticoagulants and warfarin, the emergence of anticoagulation care clinics has established a new era of bleeding disorders management. Due to considerable variations in intrapatient & interpatient responses during warfarin administration, the concept of warfarin clinics is being widely accepted in the developed nations of Europe. This is attributable to the availability of well-qualified healthcare professionals and well-equipped infrastructure. This is likely to drive the Europe prothrombin complex concentrate market growth during the forecast period.

DRIVING FACTORS

Benefits of PCC over Other Anticoagulation-Reversal Therapies to Boost the Market

PCC has several more advantages as compared to  other alternative anticoagulation-reversal therapies, such as FFP (Fresh Frozen Plasma), Vitamin  K1, and others, which are responsible for its widespread use in urgent warfarin-reversals. The biggest advantage of PCC is that it eliminates the requirement of blood type matching and thawing, which is mandatory in the case of FFP, hence reducing the total time of administration.

Also, PCC products have shorter penetration time and greater efficiency due to the presence of numerous clotting factors and thus, they are required in relatively fewer volumes when compared to other anticoagulation-reversal therapies. Owing to these advantages, a few government authorities, such as The American College of Chest Physicians (ACCP), the Italian Federation of Anticoagulation Clinics, and others, recommend the use of PCC over FFP in life-threatening bleeding. As a result, PCC is preferred by healthcare professionals for Vitamin K antagonist reversal, which is a key factor for the estimated expansion of the PCC market.

RESTRAINING FACTORS

High Treatment Costs Associated with PCC to Impede Market Growth

Despite the multiple advantages of prothrombin complex concentrate, there are certain factors that are hindering its market growth. One such factor is its high cost. According to the World Federation of Haemophilia, therapies, such as factor concentrates, that are used for the treatment of hemophilia are among the top 10 most expensive therapeutics to be purchased. For instance, the 4-factor PCC, Octaplex (500 iu/vial), costs around US$ 300.7 per vial, while Beriplex costs over US$ 155-626.0 in the U.K. In contrast, the cost of the alternative therapy of freshly frozen plasma is around US$ 34.2 per dose.

SEGMENTATION

By Product Analysis

4-factor PCC to Dominate throughout the Forecast Period

In terms of product type, the market segments include 4-factor PCC and 3-factor PCC. In the Europe PCC market, the 4-factor PCC segment was leading in terms of revenue in 2019. The increasing off-label use of 4-factor PCC, such as Cofact & Octaplex in Europe, and the introduction of activated PCC products by key manufacturers were the prominent factors for the dominance of this segment in 2019. For instance, according to an article published by Springer, currently, 1–2% of Europe’s population is receiving oral vitamin K antagonists, such as warfarin, which places them at an estimated increased risk of hemorrhage of 1.0% to 15.0%.

On the other hand, the preference for 3-factor PCC in the price-sensitive countries of Europe due to their low cost as compared to 4-factor PCC is projected to boost the segment’s growth during 2020-2027.

By Application Analysis

Acquired Coagulation Factor Deficiency Segment to Account for Lion’s Share in the Market

In terms of application, the acquired coagulation factor deficiency segment is expected to grow with the highest CAGR and dominate the market. The increasing prescription rate for warfarin in the U.K, coupled with the established guidelines for the dosing schedule of PCC in case of warfarin-related bleeding episodes, is likely to augment the growth of this segment during the forecast period. For instance, according to research reports published by the National Center of Biotechnology Information (NCBI), in the UK, it has been estimated that at least 1% of the whole population and 8% of those aged over 80 years are taking warfarin.

By End-User Analysis

Hospitals and Ambulatory Surgical Centers Segment to Retain Its Leading Position

Hospitals & ambulatory surgical centers accounted for a dominating revenue share in 2019, and this segment expected to continue its dominance over the forecast period. Favorable reimbursement policies for therapies for life-threatening rare congenital bleeding disorders and improved distribution of PCC products in hospital pharmacies are the key factors associated with the leading position of the hospitals & ambulatory surgical centers segment during the forecast period. 

The others segment consists of emergency care centers, urgent care centers, clinics, physicians offices, etc. The increasing number of trauma cases, a rise in the incidence of road accidents, and the growing use of urgent care centers due to improved facilities are likely to drive the segment’s growth by 2027.

REGIONAL INSIGHTS

The Europe market value stood at USD 174.6 million in 2019. Germany and France are anticipated to be the prominent countries in the Europe PCC market, due to a substantially large patient pool suffering from congenital factor IX deficiency. The U.K., on the other hand, is expected to grow at the highest rate during the forecast period owing to the rising prevalence of hemophilia B. According to the World Federation of Hemophilia, the prevalence of Hemophilia B in the U.K. in 2018 was 1,518. This is projected to increase the uptake of PCC in the country. The established operations of CSL Behring for its PCC brand Confidex in Scandinavia, and its usage for managing acquired as well as congenital coagulation factor deficiency, are driving the growth of the PCC market in Scandinavia.

France & Italy are likely to expand at a sustainable growth rate, which is attributed to the significant demand for the Uman Complex D.I., a 3-factor PCC by Kendrion in Italy, the rising prevalence of bleeding disorders, and a strong foothold of major PCC manufacturers in France.

KEY INDUSTRY PLAYERS

CSL Limited and Takeda to Focus on the Introduction of Novel Products to Gain Strategic Position in the Market

CSL Limited and Takeda accounted for the highest share of the market in 2019. CSL Limited is reinforcing its strategic position in the PCC market by implementing its diversification approach.

Other players, such as Sanquin, CBPL, Kendrion, etc., are also contributing to the expansion of the PCC market. The rising uptake of PCC over FFP owing to its cost-effectiveness and improved penetration of PCC products in emerging economies are expected to boost the market share of other players by 2027.

LIST OF KEY MARKET PLAYERS PROFILED IN THIS REPORT::

• CSL Limited (Melbourne, Australia)


• Grifols, S.A. (Barcelona, Spain)  


• Octapharma AG (Lachen, Switzerland)


• Kedrion S.p.A (Lucca, Italy)


• Sanquin (Amsterdam, The Netherlands)


• Takeda Pharmaceutical Company Limited (Tokyo, Japan)


• Other Prominent Players

KEY INDUSTRY DEVELOPMENTS:

• July 2019 – Octapharma AG collaborated with Pfizer with an aim to gain the global commercialization rights of the company’s PCC products, except in the U.S. This is projected to efficiently enhance the core capabilities of both the companies as well as add value to the PCC portfolio of Octapharma.


• August 2018 – Grifols S.A. acquired Biotest Pharmaceuticals Corporation. Post this acquisition, Grifols is likely to gain access to Biotest’s plasma collection centers, in order to increase the supply of plasma proteins to be used for therapeutic purposes.

REPORT COVERAGE

The Europe prothrombin complex concentrate market report offers qualitative and quantitative insights on PCC products and a detailed analysis of the size & growth rate for all possible segments in the market. Along with this, the report provides an elaborative market study of the dynamics, emerging trends, and competitive landscape. Key insights offered in the report are the prevalence of coagulation factor deficiency cases for key countries, key industry developments, reimbursement policies, regulatory scenario, and key industry trends.

Report Scope & Segmentation