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

The Australia and New Zealand prothrombin complex concentrate market size was USD 17.8 million in 2019 and is projected to reach USD 40.4 million by 2027, exhibiting a CAGR of 10.9% during the forecast period.

Prothrombin complex concentrates (PCC) are used for the rapid reversal of Vitamin K antagonist (VKA) induced severe bleeding and congenital bleeding disorders. PCC is applicable in situations that require rapid reversal of anticoagulation by non-vitamin k antagonists. This enables PCC to be a general antidote for oral anticoagulation. The increasing usage of warfarin and other anticoagulants and the rising prevalence of bleeding disorders are likely to augment the market growth during the forecast period. Moreover, positive government support and high investment by the key players in novel product launches are anticipated to drive the market growth in the forthcoming years.

Stable Revenue Growth of PCC Products amid COVID-19 to Lead to Minimal Impact on Market

The COVID-19 pandemic has had a minimal impact on the market for Australia and New Zealand prothrombin complex concentrate. The key manufacturers involved in this field have reported stable growth with no remarkable impact on the sales of the products due to the pandemic. For instance, according to the quarterly report 2020 by CSL Limited, one of the dominating players in the market, no material revenue impact with a 10% of the growth of their specialty products segment was witnessed due to the novel coronavirus.

The majority of the patients with mild coronavirus infection do not require blood transfusions. A group of critically ill patients with severe coronavirus infection in the ICU, especially those with overt gastrointestinal bleeding, requires mostly packed red blood cell transfusion, with lesser requirements for prothrombin complex concentrate (PCC) fresh frozen plasma (FFP) products. Several patients who suffered from the novel coronavirus have experienced a pronounced hypercoagulability state characterized by decreased fibrinolysis and impaired endogenous anticoagulation. Thus, the usage of PCC on COVID-19 diagnosed patients is prohibited, which may otherwise result in an adverse effect.

LATEST TRENDS

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Recommendations for Adoption of PCC over FFP to Boost Market Growth

The time-saving management of life-threatening warfarin-induced bleeding events is a priority of public authorities. The government of various countries is recommending the use of PCC. The government guideline regarding the use of emergency products for warfarin-reversal states that fresh frozen plasma (FFP) has only a partial effect and should never be used to the reversal of Warfarin in the absence of severe bleeding events. Thus, many international guidelines and various research reports recommend PCC over FFP due to their rapid onset of action and fewer side-effects. This is likely to spur the Australia and New Zealand prothrombin complex concentrate market growth during the forecast period.

DRIVING FACTORS

Increasing Adoption of Vitamin K Antagonists to Promote Growth

The introduction of various Vitamin K antagonist products, especially warfarin, has led to an upsurge in the use of prothrombin complex concentrate. Despite the availability of novel oral anticoagulants, warfarin's uptake is relatively high globally due to its low cost. The increasing number of prescriptions for it is estimated to fuel PCC's demand, as anticoagulants may result in life-threatening bleeding conditions. For instance, according to an article published by The National Center for Biotechnology Information (NCBI), in Australia, it has been estimated that at least 1%-2% of the whole population is taking warfarin therapy.

RESTRAINING FACTORS

Thrombotic Complications associated with Adoption of PCC to Restrain Market Growth

Though prothrombin complex concentrate (PCC) has achieved worldwide acceptance for use in warfarin-associated bleeding in life-threatening conditions, the thrombotic complications associated with PCC use are likely to hinder the Australia and New Zealand prothrombin complex concentrate market growth. The blood clots may result in thrombotic complications such as venous thromboembolism, microvascular thrombosis, disseminated intravascular coagulation (DIC), and myocardial infarction. Apart from these, few minor side effects include allergic reactions, vomiting, headache, sleepiness, and others. These thrombotic complications associated with PCC use raise a concern of patient safety, limiting its usage.

According to a study on Thromboembolic Events After Vitamin K Antagonist Reversal with 4-Factor Prothrombin Complex Concentrate, the percentage of patients with post thromboembolic events post 4 factor PCC administration was 7.3%.

SEGMENTATION

By Product Analysis

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Higher Adoption of 4-factor PCC Enabled to Lead to its Dominance

Based on the product type, 4-factor PCC is expected to be a leading segment in Australia and New Zealand prothrombin complex concentrate during the forecast period. This is attributed to the better clinical efficacy of 4-factor PCC than the 3-factor PCC, the increasing number of patients taking warfarin, and the growing prevalence of thromboembolic events. There is an increased risk of bleeding due to the use of blood thinners leading to organ failure and stroke. The 4 factor PCC products are proven to be effective in the management of these symptoms. This is projected to drive the demand and growth for 4-factor PCC during the forecast period.

The rising uptake of 3-factor PCC due to their low price compared to 4-factor PCC is driving this segment's growth. Prothrombinex-VF, a three-factor PCC, is the only product currently in routine use in Australia and New Zealand for warfarin reversal.

By Application Analysis

Acquired Coagulation Factor Deficiency Segment to Dominate Market with Highest Share

In terms of application, the acquired coagulation factor deficiency segment is expected to dominate the Australia and New Zealand prothrombin complex concentrate market with the highest growth rate. One of the most commonly encountered anticoagulants in Australia remains warfarin, despite its unpredictable pharmacological nature. And due to the increasing problems associated with the use of warfarin, there is increased demand for the PCC. This is expected to drive the segmental growth during the forecast period.

On the other hand, the improved healthcare facilities and increasing government initiatives to treat congenital coagulation factor deficiency contribute to the segment’s growth during the forecast period.

By End User Analysis

Hospitals and Ambulatory Surgical Centers to Lead

In terms of end-user, hospitals and ambulatory surgical centers segment is estimated to dominate the Australia and New Zealand prothrombin complex concentrate market during the forecast period. The growing number of hospitals and ambulatory surgical centers with the increasing number of invasive surgeries are responsible for the segment’s growth. Moreover, proper facilities and easy availability of prothrombin complex concentrate in hospitals contribute to the segment’s growth during the forecast period.

The rising number of specialty clinics in Australia and New Zealand, the aging population, and the growing volume of invasive surgical procedures are primary drivers for expanding the specialty clinics segment during the forecast period.

The others segment consists of emergency care centers, urgent care centers, clinics, physician offices, etc.

KEY INDUSTRY PLAYERS

CSL Limited and Takeda Pharmaceutical Company Limited to Dominate due to Strong Presence Globally

In terms of revenue, CSL Limited and Takeda dominated the market in 2019. CSL Limited is maintaining its strategic position in the PCC market by launching novel products and expanding its distribution network. Shire (Takeda Pharmaceutical Company Limited) is considered the second most prominent player in the global PCC market in terms of revenue due to its remarkable contribution in rare hematology and diversified operations of the company sale of its 4-factor PCC.

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 (Mumbai, India)


• Other Prominent Players

KEY INDUSTRY DEVELOPMENTS:

• July 2019- Portola Pharmaceuticals introduced new in vitro data demonstrating the four-factor prothrombin complex concentrates (4F-PCCS) having no direct effect on inhibition of thrombin generation by factor XA inhibitors. This demonstration was held during a poster session at the International Society's Annual Congress on Thrombosis and Haemostasis (ISTH 2019) in Melbourne, Australia.


• August 2018 - Grifols received FDA approval for its new consolidated manufacturing facility (CMF) to develop recombinant proteins. This will further ensure the steady supply of plasma to produce immunoglobulins and other plasma-derived products.

REPORT COVERAGE

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The market for Australia and New Zealand prothrombin complex concentrate report offers qualitative and quantitative insights on the products and the detailed analysis of market 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. The report's key insights 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