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Global Human Growth Hormone Market

---------------------------------------------2012


View Report Details Executive Summary Pituitary - the master gland of human body is responsible for controlling crucial hormonal secretion, which, in turn, regulates other key aspects of the body such as temperature, growth, thyroid functioning, urination, and production of other hormones. It is a pea sized gland situated at the base of brain and is a major component of human body as it expedites the response towards the surrounding environment and settings.

Any deformity or damage to the pituitary gland can adversely impact the production and activity level of the above mentioned hormones, thereby affecting the body work process and stunting the outcomes especially in the case of growth hormone. Marred pituitary function leads to either over or under secretion of the somatropin that is the growth hormone. Its over secretion causes disfiguration in the body parts like hands, face, feet, etc. whereas, its deficiency impedes the growth of body parts/whole body, thus leading to disease states like dwarfism or gigantism. It is observed that the growth hormone related problems usually affect children and teenagers, but it is seen to grip adults as well though to a lesser extent. The major factors which vitiate the pituitary operations thus impairing the GH role include kidney malfunction, tumors/cancer especially associated with brain. There are some other unknown causes as well which are termed as idiopathic. Earlier, to deal with these predicaments, growth hormone (GH) used to be extracted from the human cadavers but, as time passed and evolution of technology/tools/techniques/R&D took place, the extraction of GH also got altered and many novel innovations and discoveries were made in the respective field. Nowadays, many leading companies are heavily involved in the R&D process for devising longer acting and sustained release versions of the somatropin which are produced using the recombinant technology. The competition prevalent in the respective industry is heating up day by day. The human growth hormone market (HGH) is monopolized by a few players viz. Pfizer, NovoNordisk, Eli Lilly and Roche.

The global HGH report also discusses the key ongoing trends like licensing agreement, development of needle free injectors and comparison between generic and biosimilar drug versions. On the industry development front, the current inclination is towards creating innovative therapeutic products with novel properties. Furthermore, the major factors driving the HGH market include rising cancer and CKD/ESRD cases and increasing GNI and healthcare expenditure on worldwide basis. In addition, a few factors posing challenges in front of the HGH industry are the off-label HGH use, associated risks and side effects and the escalating price pressure which, to an extent, are hindering the growth and development of the same. By combining SPSS Inc.’s data integration and analysis capabilities with our relevant findings, we have predicted the future growth of the industry. We employed various significant variables that have an impact on this industry and created regression models with SPSS Base to determine the future direction of the industry. Before deploying the regression model, the relationship between several independent or predictor variables and the dependent variable was analyzed using standard SPSS output, including charts, tables and tests.


Growth hormone (GH) is a type of peptide hormone produced by the body, responsible for stimulating cell reproduction, growth and regeneration amongst humans and animals Global HGH Market Share (2010)

GHD (Growth Hormone Deficiency), occurs when the GH production is hampered. Any disruption in GH’s endogenous production causes adverse impact on the body processes, like muscle protein production, lipid catabolism, and other direct/indirect functions performed by the hormonal cascade.

As of 2010, HGH market included NovoNordisk’s Norditropin, which constituted for around …….% of the global market share, Pfizer’s Genotropin with approximately ……%, followed by Roche’s Nutropin, and Eli Lilly’s Humatrope with ………% and ……..% shares, respectively. The global market for human growth hormone reached approximately US$.........billion based on key drug sales in 2010. Within the defined period of 6 years, this market registered a CAGR of ………% from US$...........billion in 2004 to reach US$........billion in 2010. Global Human Growth Hormone Market (2004-2010)

According to IMS Health, in the US, the total sales of Saizen for 2010 and 2011 were approximately US$..... million and US$……….million, respectively. Another rHGH available in the market is manufactured by Pfizer, which it markets as Genotropin. The US sales of Genotropin for 2010 and 2011 were US$........million and US$...........million, respectively.


HGH is a protein hormone, naturally occurring, and is synthesized by the pituitary gland, responsible for normal human growth and development especially among the teenagers and children Global hGH-CTP Market Opportunity (2014E-2020E)

With the advent of novel technology in the field of medical sciences, it is now possible to develop rHGH in wet-labs by precisely combining the 191 amino acids which compose the peptide chain of the HGH.

The global opportunity for Prolor’s hGH-CTP is projected to be US$......million for the year 2014, which is estimated to be worth US$.........million by 2020, rising at an impressive CAGR of ……….%.

Growth Hormone Volume Market share (February 2007-February 2012)

The GH market share in volume terms has been continuously ………. in case of Pfizer, Eli Lilly and Roche thereby registering a modest …….. in all the cases over a ………. year period. •Key Trends in the hGH market include: -Strategic Agreements -Inclination towards Needle-Free Injectors -Generic Vs Biosimilar Version of the drugs

On the Industry development front, a lot many improved and long acting GH products are being developed and are undergoing clinical trials.


Disorders associated with GH depict the underlying lesions of pituitary, hypothalamus or in the target cells Global HGH Market Forecast (2009-2015E)

The global HGH market is forecasted to be US$.......billion in 2012 as compared to US$.......... billion estimated for the year 2011, registering a modest increase of roughly ………%. The same is expected to record a CAGR of about …….% for the period spanning 2010 to 2014 on the back of rising global cancer cases, global ESRD cases and GNI.

The market for GH products is most evolved in the regions like Europe, the US and Japan wherein the GH products for use among infants constitute approximately …………% of the total GH demand.

The challenges encountered by the industry include unapproved off-label uses of HGH, possible side effects and other associated risks and escalating price pressure.

Note: Market attractiveness is inverse of penetration. Low penetration means high attractiveness and vice-versa


Table of Contents

1. Human Growth Hormone 1.1 Physiological Effects of Growth Hormone 1.2 GH Secretion Control 1.3 GH Deficiency (GHD)

1.3.1 Disease States 1.4 Therapeutic and Other Uses of GH/HGH 1.5 Recombinant Human Growth Hormone (rHGH) 2. Global HGH Market Size

Market Value Market Share 2.1 HGH-CTP Market Opportunity Model 2.2 SRhGH Market Opportunity Model 3. Market Dynamics 3.1 Key Trends

3.1.1 Strategic Agreements 3.1.2 Inclination towards Needle-Free Injectors 3.1.3 Generic Vs Biosimilar Version of the drugs 3.2 Industry Developments

3.2.1 New Products under Development 3.3 Growth Drivers

3.3.1 Increasing Prevalence of Cancer 3.3.2 Increasing Cases Chronic Kidney Disease (CKD) 3.3.3 Rising Healthcare Expenditure 3.3.4 Increasing Global GNI (Gross National Income)

Tables and Charts

List of Charts GH’s Physiological Effect GH Secretion Control Global HGH Market Share (2010) Global Human Growth Hormone Market (2004-2010) Global hGH-CTP Market Opportunity (2014E-2020E) Market Share of Chemical Drugs and Biologics as per Drug Versions Number of Cancer Cases Worldwide (2007-2011) Worldwide Patients with End Stage Renal Disease (2005-2011) Global Healthcare Spending (2005-2015E) World Gross National Income (2005-2010) Growth Hormone Volume Market share (February 2007-February 2012) Roche’s Revenues by Business Segments (2011) Roche’s Revenues and Net Income, 2007-2011 Novo Nordisk Revenue Share by Business Segments (2011) Novo Nordisk Revenues & Net Income (2008-2011) Pfizer’s Revenue Share by Business Segments (2011) Pfizer’s Revenues & Net Income (2008-2011) Eli Lilly’s Revenues by Segment (2011) Eli Lilly’s Revenue and Net Income (2008-2011) Global HGH Market Forecast (2009-2014E)


3.4 Challenges Tables and Charts

3.4.1 Unapproved/off-label Uses of HGH 3.4.2 Possible Side Effects and other Associated Risks 3.4.3 Escalating Price Pressure 4. Competitive Landscape

Competitive Overview Market Share 5. Company Profiles 5.1 Roche Holdings AG

Business Overview Financial Overview Business Strategies Focus On Innovative Pharmaceuticals Leverage Expertise in Molecular Biology 5.2 Novo Nordisk Business Overview Financial Overview Business Strategies Focus on Hormone Therapy Leadership in Hemophilia Treatment 5.3 Pfizer, Inc.

Business Overview Financial Overview Business Strategies Focus on Growth Strategic Acquisitions

List of Tables Worldwide Revenues of Marketed hGH Products (2011) hGH-CTP US Market Opportunity Model (2014E-2020E) hGH-CTP European Market Opportunity Model (2014E-2020E) SRhGH Market Opportunity Model (2013E-2020E) Annual US Sales of rHGH and Injectors LG Life Sciences Product under Development Sustained-release HGH under Development Worldwide Prolor’s Product under Development GH Products Devised by NovoNordisk Growth Hormone Volume Market share (February 2007-February 2012) Dependent & Independent Variables (2006-2011) Correlation Matrix Model Summary – Coefficient of Determination Regression Coefficients Output


5.4 Eli Lilly and Company Business Overview Financial Overview Business Strategies Focus on Novel Therapeutic Molecules Capacity Expansion 6. Market Outlook 6.1 Market Forecast 6.2 Forecast Methodology

6.2.1 Dependent and Independent Variables 6.2.2 Correlation Analysis 6.2.3 Regression Analysis


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Koncept Analytics

Vikas Gupta BD Manager

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Global Human Growth Hormone Market Report 2012 Edition - Koncept Analytics