North America Human Growth Hormone Market – Segmented By Product (Long Acting, Others), By Application (Growth Hormone (GH) Deficiency, Turner Syndrome, Idiopathic Short Stature, Prader-Willi Syndrome, Small for Gestational Age, Other), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy, Specialty Pharmacy), By Region, Competition, Forecast, Opportunities, 2018-2028

Market Overview

North America Human Growth Hormone Market has valued at USD 1.99 billion in 2022 and is anticipated to project robust growth in the forecast period with a CAGR of 12.29% through 2028. The Human Growth Hormone Market has witnessed steady growth over the years. Factors contributing to this growth include the increasing awareness of the importance of early diagnosis and treatment of growth hormone deficiencies, biopharmaceutical innovation, and the expansion of treatment options for rare conditions. The market is expected to continue growing, driven by innovations in biotechnology, increasing prevalence of hormone deficiencies, and advances in personalized medicine.

Key Market Drivers

Increased Awareness and Diagnosis

Increased awareness and diagnosis play a critical role as a market driver for the growth of the North America Human Growth Hormone Market the fundamental component of this driver is the heightened awareness among patients and healthcare providers regarding the importance of early diagnosis and treatment of growth hormone deficiencies. This awareness has been facilitated through various channels, including healthcare campaigns, educational initiatives, and information dissemination through medical professionals. Patients and their caregivers are increasingly recognizing the signs and symptoms of growth hormone deficiencies, leading to more individuals seeking medical evaluation and diagnosis. In the case of children, early diagnosis and intervention are crucial in addressing pediatric growth disorders. These disorders encompass conditions such as idiopathic short stature, growth hormone deficiency, and Turner syndrome. Parents and caregivers are now better informed about these conditions, which has led to more children being screened and diagnosed. As a result, there is an increased demand for growth hormone therapies tailored to children with growth disorders.

The awareness of growth hormone deficiencies is not limited to children. There is a growing recognition of hormone deficiencies in adults as well. Adult growth hormone deficiency can be linked to various health issues, and with increased awareness, more adults are seeking medical evaluation and treatment. This expansion of the patient base into the adult population further drives market growth. Many government and non-governmental health organizations have launched awareness campaigns and health initiatives that focus on growth hormone deficiencies. These initiatives include the dissemination of educational materials, the organization of health camps, and partnerships with healthcare providers to promote early diagnosis and treatment. These efforts have a profound impact on raising awareness and encouraging individuals to seek medical attention. The involvement of the medical community is crucial in driving awareness and diagnosis. Healthcare professionals, including pediatricians, endocrinologists, and primary care physicians, play a pivotal role in recognizing symptoms, referring patients for diagnostic testing, and initiating treatment. The medical community's increased awareness and commitment to early diagnosis enhance the effectiveness of this driver.

Biopharmaceutical Innovation

Biopharmaceutical innovation is a significant market driver for the growth of the North America Human Growth Hormone Market. Biopharmaceutical companies invest heavily in research and development to create innovative growth hormone therapies. These efforts involve the discovery and development of new treatment modalities, formulations, and delivery methods, aimed at improving the effectiveness and safety of growth hormone products. Ongoing R&D activities are at the core of biopharmaceutical innovation in this market. Biopharmaceutical innovation has led to the development of recombinant and synthetic growth hormones, which have become standard treatment options. These engineered hormones closely mimic the body's natural growth hormone, resulting in safer and more efficacious treatments. The availability of these advanced hormone formulations has significantly improved patient outcomes and contributed to market growth.

Biopharmaceutical companies continually introduce new and improved growth hormone therapies to the market. These innovations offer healthcare providers and patients a broader range of therapeutic options to choose from, tailored to specific needs and preferences. Such enhancements expand the market's product portfolio and cater to diverse patient populations. Innovations in drug delivery systems have enhanced patient convenience and compliance. For instance, long-acting growth hormone formulations have been developed, reducing the frequency of administration, which is particularly beneficial for patients. These systems increase patient adherence to treatment plans, further fueling market growth. Ongoing biopharmaceutical innovation focuses on enhancing the safety and efficacy of growth hormone therapies. New formulations are designed to minimize side effects and reduce the potential for adverse reactions. Improved safety profiles are attractive to healthcare providers and patients alike, increasing the adoption of these therapies.

Regulatory Approvals

Regulatory approvals play a pivotal role as a market driver for the growth of the North America Human Growth Hormone Market. Regulatory approvals by government health agencies and relevant authorities instill credibility and trust in the products and therapies within the Human Growth Hormone Market. When a growth hormone product receives regulatory approval, it signifies that it has met stringent safety and efficacy standards, providing assurance to healthcare providers and patients. This credibility encourages healthcare professionals to prescribe approved treatments, and patients to trust and choose them. Regulatory approvals are prerequisites for market entry and commercialization. Products that have received the green light from regulatory authorities can be legally marketed and distributed for medical use. This paves the way for pharmaceutical companies to introduce their products to a wider patient base, ensuring broader market access.

Regulatory approvals lead to increased adoption of approved growth hormone therapies. Healthcare providers are more likely to recommend treatments that have undergone thorough evaluation and received official endorsements. Patients are also more inclined to accept these therapies, as they believe in the safety and efficacy of approved products. Regulatory approvals often expand the target patient population for a particular growth hormone therapy. For example, an approval for a pediatric growth hormone therapy may later be extended to include adults with hormone deficiencies, broadening the market's reach and revenue potential. Products that receive regulatory approval gain a competitive advantage in the market. They stand out as trusted and legitimate treatments, positioning themselves ahead of non-approved or generic alternatives. This competitive edge can drive market share and growth.

Research in Rare Conditions

Research in rare conditions is a significant market driver for the growth of the North America Human Growth Hormone Market. Ongoing research efforts have deepened our understanding of rare conditions related to growth hormone deficiencies. This includes conditions such as Turner syndrome, Prader-Willi syndrome, and other pediatric growth disorders. As research advances, the medical community gains valuable insights into the causes, symptoms, and treatments of these conditions. The research conducted in rare conditions has led to the development of tailored treatment approaches. Growth hormone therapies designed specifically for these rare conditions consider the unique needs and challenges that patients with such conditions face. These tailored therapies aim to optimize treatment outcomes, improving the quality of life for affected individuals.

Research in rare conditions expands the potential patient population for growth hormone therapies. While these conditions individually affect a relatively small number of people, the cumulative impact is substantial. As tailored therapies are developed and researched, they become available to patients who may have previously had limited or no treatment options. Many growth hormone therapies developed for rare conditions receive orphan drug designations from regulatory authorities. These designations provide certain incentives to pharmaceutical companies, such as extended market exclusivity and financial incentives, to develop treatments for rare diseases. This encourages research and innovation in this area. Pharmaceutical companies increasingly recognize the market growth opportunities in rare conditions. While each rare condition may have a small patient population, the combined market potential across various rare conditions is substantial. Companies invest in research and development to tap into these underserved markets and offer specialized treatments.

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Key Market Challenges

High Treatment Costs

Growth hormone therapies are often costly, and the expenses can be a significant burden on patients and healthcare systems. The high cost of therapy can limit accessibility for many patients, particularly those without adequate insurance coverage.

Healthcare Budget Constraints: In many countries, healthcare budgets are limited, and the cost-effectiveness of growth hormone therapies is a consideration for policymakers and healthcare providers. Cost constraints may lead to restricted access to these therapies, potentially slowing down market growth.

Challenges in Emerging Markets: In emerging economies, affordability is a considerable concern. The cost of growth hormone therapies can be prohibitively high for a large portion of the population, limiting market expansion in these regions.

Regulatory Hurdles

The process of obtaining regulatory approvals for new growth hormone therapies can be lengthy and costly. Stringent requirements by regulatory authorities demand extensive clinical data, leading to prolonged development timelines.

While orphan drug designation can provide incentives for developing therapies for rare conditions, it also poses challenges. Meeting orphan drug designation criteria may limit the patient population that can benefit from the therapy, affecting market potential. Variations in regulatory processes and requirements across countries can create barriers for market entry and expansion, particularly for smaller biopharmaceutical companies.

Limited Awareness and Diagnosis

Underdiagnosis of Growth Hormone Deficiencies: Despite awareness efforts, there are still challenges in diagnosing growth hormone deficiencies. This underdiagnosis can lead to missed treatment opportunities, limiting the patient pool and market growth. The effectiveness of awareness programs can vary by region. In some areas, there may be limited access to educational initiatives, resulting in lower awareness levels and, subsequently, delayed diagnosis and treatment.

Stigma and misconceptions surrounding growth hormone therapies can impede patient willingness to seek treatment. Concerns about side effects or perceived health risks may deter some individuals from pursuing therapy, affecting market growth.

Key Market Trends

Biotechnology Advancements

One significant trend in the market is the continued advancement of recombinant technologies. Recombinant DNA techniques enable the production of synthetic growth hormones that closely mimic the body's natural growth hormone. These biotechnological advances have led to safer and more effective treatments, improving patient outcomes.

Biotechnology has enabled the development of targeted growth hormone therapies for specific patient populations. This trend includes the creation of treatments tailored for conditions like Turner syndrome, Prader-Willi syndrome, and pediatric growth disorders. Targeted therapies enhance the precision and effectiveness of treatments, meeting the unique needs of these populations.

Telemedicine and Remote Monitoring

The COVID-19 pandemic accelerated the adoption of telemedicine in healthcare, including the management of growth hormone deficiencies. Patients can now consult with healthcare providers remotely, which enhances access to specialized care, particularly in regions with limited healthcare infrastructure. Telemedicine offers convenience and the potential for increased diagnosis and treatment rates.

Remote monitoring technology, such as wearable devices, is increasingly used to track patient response to growth hormone therapies. These devices allow healthcare providers to remotely assess treatment compliance and effectiveness. This trend aids in personalized treatment adjustments and data-driven decision-making.

Orphan Drug Development

Pharmaceutical companies are increasingly focusing on orphan drug development for rare genetic conditions associated with growth hormone deficiencies. These conditions, such as Turner syndrome and Prader-Willi syndrome, may individually have a small patient population, but collectively represent a substantial market. The development of specialized treatments for these rare conditions is a growing trend in the market.

Regulatory authorities grant orphan drug designation to therapies developed for rare diseases. This designation provides certain incentives to pharmaceutical companies, such as extended market exclusivity and financial support, encouraging the development of treatments for rare conditions. This trend promotes innovation in addressing unmet medical needs.

Segmental Insights

Product Insights

Based on the category of Product, the Others segment emerged as the dominant player in the North America market for Human Growth Hormone in 2022. This particular segment is anticipated to maintain a steady growth rate throughout the forecast period. Other segments within the market encompass short-acting and intermediate-acting growth hormones. The short-acting and intermediate-acting segment is poised for significant traction in the coming years due to the rising incidence of insufficiency and the availability of diverse products such as Genotropin (Pfizer Inc.), Humatrope (Eli Lilly & Co.), Saizen (Merck & Co. Inc.), and Norditropin (Novo Nordisk A/S), among others.

Recent product launches and the increased adoption of short-acting preparations, which tend to have fewer side effects, are additional factors contributing to the expansion of this segment. On the other hand, the long-acting segment is expected to register the fastest growth rate during the forecast period. This growth is driven by advantages like reduced administration frequency, enhanced patient compliance, and convenience.

The robust investigational pipeline and recent product launches are fueling the growth of this segment. For instance, in January 2022, Ascendis Pharma A/S announced European Commission approval for the marketing authorization of SKYTROFA, aimed at treating growth failure in children and adolescents aged 3 to 18. These factors are expected to drive the growth of this segment.

Application Insight

Based on the category of Application, the growth hormone deficiency segment emerged as the dominant player in the North America market for Human Growth Hormone in 2022. The increasing emphasis on the early detection and treatment of hormone deficiencies, coupled with the efforts of biopharmaceutical companies to introduce innovative therapies, is spurring the adoption of this segment. As an illustration, in May 2023, Novo Nordisk announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a favorable statement endorsing the use of their once-weekly Sogroya (somapacitan). This endorsement pertains to the treatment of growth hormone deficiency in children aged three years and older, as well as in adolescents with growth development issues.

Distribution Channel Insights

The hospital pharmacy segment is projected to experience rapid growth during the forecast period. The growing incidence of the ailment, more frequent hospital visits, and advantageous reimbursement policies are fueling the utilization of this sector. Additionally, patients are increasingly favoring recombinant and synthetic HGH, which is easily accessible in hospital pharmacies. These elements are contributing to the expansion and utilization of this field. The online pharmacy category is poised for swift growth in the forthcoming years. These factors collectively contribute to the growth of this segment.

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Regional Insights

United States emerged as the dominant player in the North America Human Growth Hormone market in 2022, holding the largest market share in terms of value. The growth of the regional market is expected to be driven by heightened healthcare awareness among the population, significant government initiatives, and favorable reimbursement policies. Additionally, increasing research and development activities, ample research funding, and the presence of organizations dedicated to raising awareness and improving treatment rates are anticipated to contribute to the region's market expansion. Furthermore, the strong presence of key industry players, such as Pfizer Inc. and Lilly, is projected to bolster the region's growth. In Europe, the second-largest market share is attributed to factors such as the rising prevalence of growth hormone deficiencies, the availability of synthetic growth hormones, and extensive research and development efforts in the region.

The Canada market is poised to be the fastest-growing market, offering lucrative growth opportunities for Human Growth Hormone players during the forecast period. Factors such as stress, insufficient sleep, and low glucose levels affect individuals. For instance, in 2021, the European Medicines Agency reported that growth hormone deficiency affected approximately 4.7 out of 10,000 individuals in the Canadian Population. Among European countries, Germany leads the market, while France is expected to achieve the highest compound annual growth rate (CAGR) from 2023 to 2030.

Recent Developments

• In October 2023 - Novo Nordisk to acquire ocedurenone for uncontrolled hypertension from KBP Biosciences.
• In September 2023, Eli Lilly and Company announces that the FDA has approved Tyvyt® (sintilimab injection) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior lines of systemic therapy, including an anthracycline-containing chemotherapy regimen and rituximab.   
• In September 2023, European Commission approves Pfizer's LITFULO™ for adolescents and adults with severe alopecia areata.

Key Market Players

• Novo Nordisk A/S
• Eli Lilly and Company
• Pfizer, Inc.
• Sandoz International GmbH (Novartis AG)
• Genentech, Inc. (Roche)
• Merck KGaA
• Ferring Pharmaceuticals
• Ipsen
• Teva Pharmaceutical Industries, Ltd.

Report Scope:

In this report, the North America Human Growth Hormone Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• North America Human Growth Hormone Market, By Product:

o   Long Acting

o   Others

• North America Human Growth Hormone Market, By Application:

o   Growth Hormone (GH) Deficiency

o   Turner Syndrome

o   Idiopathic Short Stature

o   Prader-Willi Syndrome

o   Small for Gestational Age

o   Other

• North America Human Growth Hormone Market, By Distribution Channel:

o   Hospital Pharmacy

o   Retail Pharmacy

o   Online Pharmacy

o   Specialty Pharmacy

• North America Human Growth Hormone Market, By Region:

o   United States

o   Canada

o   Mexico

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the North America Human Growth Hormone Market.

Available Customizations:

North America Human Growth Hormone market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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