IV and Oral Iron Drugs Market

Market Overview

The global IV and oral iron drugs market size was valued at USD 6.25 billion in 2022. It is estimated to reach USD 16.51 billion by 2031, growing at a CAGR of 11.43% during the forecast period (2023–2031). The major players in the oral and intravenous (IV) iron supplements place a high value on strategic alliances with their international competitors to expand globally.

Iron plays a significant role in multiple metabolic pathways, including energy production, respiration, DNA synthesis, and cell proliferation. The clinical consequences of untreated iron deficiency (ID) are diverse and include fatigue, neurobehavioral disorders such as restless leg syndrome, exacerbations of certain diseases such as angina, and cognitive impairment in children. ID is the most prevalent single deficiency affecting children, men, and women worldwide. Untreated ID can create serious consequences, but people tend to ignore or downplay them because ID is usually a side effect of other diseases or ailments rather than the primary cause. In addition to increasing risk factors, iron deficiency anemia (IDA) can develop in people whose ID goes untreated.

Several research and clinical studies confirm that early diagnosis and prompt treatment enhance IDA patients' quality of life and physical condition and alleviate fatigue and cognitive deficits. Iron drugs are iron preparations administered orally or injected to treat iron deficiency. Iron replacement therapy involves the administration of intravenous (IV) iron or oral iron medications to treat iron deficiency (ID) and iron deficiency anemia (IDA). Oral iron therapy is widely regarded as the primary treatment for iron deficiency (ID) and iron deficiency anemia (IDA). However, the adoption of IV iron drugs is increasing as they are proven safe and effective compared to oral iron.

Market Dynamics

Market Drivers

Strategic Collaboration and Licensing Opportunities

The prominent market players for intravenous (IV) and oral iron medications strongly emphasize strategic collaborations with their counterparts in different countries to enhance their global presence. Most market players collaborate to develop and commercialize IV and oral iron drugs. The originator companies are partnering with large and mid-sized, regional and local, and biotechnology companies to boost the penetration of IV and oral iron drugs worldwide.

In addition, key player Vifor Pharma entered a strategic partnership with Fresenius Kabi in February 2020. In this agreement, Fresenius Kabi will be fully responsible for marketing Vifor Pharma's IV iron portfolio in China. Vifor Pharma also formed a strategic collaboration with American Regent (a Subsidiary of Daiichi Sankyo Group), which gave an exclusive sales license of Venofer to American Regent in the US and Canada.

Similarly, Shield Therapeutics is establishing strategic commercialization agreements and has already signed three European agreements. These partnerships provide the company with early validation of Feraccru and its potential. In September 2018, the company granted Norgine an exclusive commercial license in Europe (excluding territories not covered by the company's existing partners, AOP Pharmaceuticals and Ewopharma), Australia, and New Zealand. Therefore, companies seek to improve iron drug market penetration through strategic collaborations and partnerships.

Investigational Iron Drugs

The global IV and oral iron market is characterized by many generic and few branded drugs for treating ID and IDA. Although the market potential of IV and oral drugs is huge due to a large patient pool, the lack of branded iron drugs affects the overall market growth. For instance, the oral iron drugs segment is expected to witness a significant decrease in revenue by 2024 due to the unavailability of popular branded drugs. Few branded oral drugs such as Auryxia, Maltofer, and Feraccru are available.

Regarding the number of branded drugs available, the IV iron drugs segment is faring relatively better than the oral iron drugs segment. The global IV and oral iron market's overall growth is driven by the increased uptake of branded IV iron drugs, especially in the US and European markets. However, the scenario will likely change in the upcoming years as the market has several promising iron therapeutics under different stages of development worldwide.

Several companies are concentrating on creating new iron treatments for ID and IDA because of the promising growth prospects in the industry. Market players are conducting clinical trials to obtain regulatory approval in different countries. In particular, vendors that launched their iron drugs in Europe are actively conducting clinical studies in the US to gain regulatory approval and enter the major market for IV and oral iron drugs worldwide. Vifor Pharma, a significant player in the industry, introduced its flagship product, Ferinject, to the Chinese market in 2021. Therefore, such a product pipeline is anticipated to boost the growth of the global IV and oral iron drugs market in the upcoming years.

Market Restraint

Availability of Alternative Options for Treating ID and IDA

Treatment of IDA can include dietary changes, iron supplements, dietary supplements, medications, blood transfusions, and surgery. Although clinically proven iron therapeutic drugs are available for treating ID, the growing prevalence of ID and its associated chronic conditions worldwide and the lack of exclusive and popular prescription drugs encourage patients to opt for alternative treatment methods. Currently, the available prescription and generic drugs do not treat ID permanently. Regularly giving iron replacement medications to raise iron levels is advised to treat ID since normal iron levels must be preserved in the body for the entirety of a person's life.

Long-term treatment of ID and IDA with iron drugs is associated with various adverse effects such as constipation, nausea, heartburn, gastric discomfort, and diarrhea. Moreover, once the medication is stopped, ID can recur in individuals, increasing the need for an external source of elemental iron in the form of drugs, dietary intake, and other alternative products. Although oral iron drug formulations are considered the gold standard option for treating ID, they are associated with various adverse effects. Therefore, patients opt for many non-pharmacological treatment methods for ID, which hampers market growth.

Market Opportunities

Growing Availability of Branded Iron Therapeutics and Expanded Indication Approvals

Companies competing worldwide for intravenous and oral iron niacin therapies are concentrating on creating and releasing iron treatments to treat iron deficiency anemia (ID and IDA). Market players can grow their presence, boost market growth, and maintain their market position through research and development (R&D) and new product approvals/launches. For instance, players such as Vifor Pharma, Daiichi Sankyo Company, AMAG Pharmaceuticals, PHARMACOSMOS, Akebia Therapeutics, and Shield Therapeutics are dominating the market owing to their continuous involvement in product innovations and launches.

Moreover, new product approvals and launches from 2016−2020 positively influenced the market and contributed majorly toward the growth of IV and oral iron drugs worldwide. For instance, Rockwell Medical received FDA approval for its Triferic in May 2019. The market saw increased indication approvals for iron therapies already licensed by multiple regulatory bodies globally, in addition to the approval of new products. This, in turn, positively influences the market as drug usage increases by adding a new patient group to the existing patient pool.

Regional Analysis

Based on region, the global IV and oral iron drugs market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and. the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global IV and oral iron drugs market shareholder and is estimated to exhibit a CAGR of 12.56% during the forecast period. The high consumption of branded iron drugs is among the major reasons for such strong growth. For instance, the uptake of branded iron drugs is higher in the US than in other countries. Vendors offering branded iron drugs are generating more revenue from the US than the other markets. Moreover, the increased healthcare spending by the population in countries, including the US and Canada, is further leading to the growth of the region's IV and oral iron drugs market. The region is also the single largest IV and oral iron drug market, thus becoming strategically important to several market players.

Furthermore, key players are launching new IV and oral iron drugs by forming strategic alliances to meet end-user requirements. For instance, owing to the significant opportunity for IV and oral iron drugs in 2019, American Regent and Daiichi Sankyo Company expanded their promotional strategy among gynecologists to increase awareness of the unmet need to treat anemia among the female population. Such initiatives by major players are anticipated to fuel market growth in the upcoming years. Therefore, with favorable patient demography, the region offers tremendous growth opportunities for the market to grow continuously.

Europe is anticipated to exhibit a CAGR of 12.48% over the forecast period. The region, particularly Western Europe, has a sophisticated and established healthcare infrastructure, and people have access to advanced healthcare services, including advanced treatment for ID and IDA. IV and oral iron drugs are Europe's most widely used products due to their easier accessibility, reversibility, and lower-cost usage for ID patients. The high disposable income is one of the primary reasons for the high adoption of IV and oral iron drugs among European households. Moreover, IV and oral iron drugs are becoming mainstream for treating ID and IDA. This has resulted in a rising adoption rate among the region's end consumers.

The Asia-Pacific IV and oral iron drugs market is expected to experience a surge in demand during the forecast period. The government in several Asia Pacific countries also prioritizes increasing access to various popular therapeutics, increasing the demand for iron replacement therapies in the region. Higher healthcare expenditures give end-users access to various treatment options for various conditions, thereby boosting the consumption of IV and oral iron drugs. Therefore, the increase in healthcare spending, coupled with favorable government support to provide better healthcare assistance, enhances end-users accessibility to a wide range of treatment options for ID and IDA, thereby driving the demand for IV oral iron drugs in the Asia-Pacific region.

Segmental Analysis

The global IV and oral iron drugs market is bifurcated into the route of administration, application, patient group, and distribution type.

By route of administration, the global market is segmented into IV and oral segments. 

The IV segment owns the highest market share and is predicted to exhibit a CAGR of 16.03% over the forecast period. The growth is mainly owing to the expected launch of branded IV iron drugs in the rising incidence of chronic conditions associated with ID as a comorbid factor, increasing the demand for the treatment of ID among chronic disease patients and patients with a high rate of unresponsive oral therapy. One of the major reasons for this significant growth rate is the increased uptake of branded IV drugs in the US and European markets.

Furthermore, Straits Research estimates that the number of patients diagnosed with ID, regardless of the underlying cause for administering IV iron drugs, is increasing at a healthy rate. Moreover, the rising global medicine and healthcare expenditure and high sensitivity, accuracy, and easy and convenient access to intravenous iron dosages are expected to drive the demand for the IV iron drug market in the upcoming years.

Based on application, the global IV and oral iron drugs market is segmented into nephrology, OBGYN, surgery, gastroenterology, oncology, and heart failure segments. 

The nephrology segment owns the highest market share and is projected to grow at a CAGR of 14.17% over the forecast period. The market for iron drugs in nephrology is increasing faster due to the rising prevalence of CKD worldwide. Chronic kidney disease (CKD) is a frequently occurring condition in adults, and its occurrence increases as individuals get older. Rising adoption of iron medications for the treatment of chronic kidney disease (CKD). CKD affects around 10-15% of the global population, and millions of people die each year due to a lack of inexpensive treatment options.

Furthermore, it is predicted that the number of renal failure patients will increase in developing nations like China and India, where the population of older persons is growing. According to estimates, one in four women and one in five men over 65 worldwide have CKD. Patients with CKD frequently have iron-restricted erythropoiesis as a clinical condition. In individuals with CKD, iron insufficiency is present in about 70% of cases. Iron therapy, which includes IV and oral iron medications, is a crucial treatment choice for CKD patients and promotes segmental growth.

Based on patient groups, the global market is segmented into adult and pediatric segments. 

The adult segment is the most significant contributor to the market share and is anticipated to exhibit a CAGR of 12.81% throughout the forecast period. The segment dominates the market due to the higher incidence/ prevalence of ID and IDA among older adults worldwide. With a prevalence of up to 13%, CKD is a rather prevalent condition among adults, and it continues to climb as the population gets older. The primary causes of chronic kidney disease, including diabetes and hypertension, are more common in older persons, increasing their risk of anemia. A large portion of the global population is also getting older. One example is the projected increase in the global population aged 60 and above, from 12% in 2015 to 22% in 2050. Therefore, the rising aging population is a key factor driving the growth of the adult segment of the global market.

Based on distribution type, the global IV and oral iron drugs market is segmented into hospital pharmacies, offline retail pharmacies, and online channel segments. 

The hospital pharmacies segment accounts for the largest market share and is anticipated to exhibit a CAGR of 14.22% throughout the forecast period. Hospital pharmacies are specialist areas of pharmacy that work in tandem with medical facilities to provide integrated patient care. These pharmacies offer iron drugs with adequate discounts and rebates. Consequently, it provides an affordable means of reducing the strain on patients and healthcare systems. Moreover, in several countries, hospital pharmacists appeared to be fully aware of the impact of highly discounted medicines on outpatient care. This is one of the primary factors driving the growth of the segment.

Recent Developments

• June 2023- Key findings from the Phase 3 XTEND-Kids study evaluating ALTUVIIIOTM [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis, a first-in-class, high-sustained factor VIII replacement therapy, were presented at the International Society on Thrombosis and Haemostasis (ISTH) Annual Meeting in Montreal, Canada.
• June 2023- A new Open Innovation Portal was made available by Sanofi's Consumer Healthcare Business Unit, enabling the larger supply chain community to contribute innovative, game-changing solutions to the problems posed by the consumer healthcare industry's constant change.