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The Specialty Pharmaceutical Market Outlook: Key players, opportunities and future trends

The Specialty Pharmaceuticals Market Outlook reveals market dynamics, leading players and key therapy areas of opportunity for specialty pharma companies. Market drivers include increasing reimbursement from national health bodies and governments, industry consolidation, big pharma divestments and biotech growth. Resistors including increased competition, big pharma entry to specialty markets and the financial crisis are also examined in the context of industry strategies of licensing deals, product acquisitions and orphan drug development. Ten leading players are profiled including an analysis of current products, drug pipelines and threats from patent expiries.

The effects of industry trends such as rising costs, and generic erosion are analyzed and developed into an outlook for the future of the specialty sector, including strategies for future success.

Key features of this report

• Sizes the specialty pharmaceutical market and makes quantitative forecasts to 2014
• Details market drivers and resistors against the background of pharmaceutical market dynamics.
• Profiles the ten largest specialty pharma companies, including recent deals, product pipelines and key patent expiries.
• Analyzes the effects of wider pharmaceutical industry trends on specialty players.
• Details strategies for success in the future specialty pharma market.

Scope of this report

• Assess leading players in the specialty sector.
• Understand the drivers and resistors of the specialty pharmaceutical market.
• Understand key market strategies such as in-licensing, acquisitions and orphan drug development.
• Determine therapy areas of rich opportunity which are well suited to the specialty pharma business model.
• Develop strategies for success in the future specialty pharma market.

Key Market Issues

• Which therapy areas and indications have suitable dynamics for the specialty pharmaceutical business model?
• How is the financial crisis affecting the specialty pharma industry?
• Competition for licensing deals is increasing as big pharma companies rush to fill their pipelines.
• Healthcare reform is set to have wide ranging effects on the largest pharmaceutical market in the world.
• A further round of pharma industry consolidation will impact the specialty pharmaceutical industry.

Key findings from this report

• The specialty pharmaceutical market is estimated at 6bn in 2010 and is forecast to grow to 1bn by 2014.
• In 2008, specialty pharma companies accounted for 15% of global pharmaceutical sales, and 40% of sales not accounted for by big pharma companies.
• Central nervous system, anti-infectives, cardiovascular and ophthalmology were the largest specialty pharma therapy areas in 2008.
• Industry pressures on large diversified pharma companies are having a knock-on effect on the specialty sector in the form of increased competition for licensing deals.

Key questions answered

• What is outlook for specialty pharma companies and therapeutic markets to 2014?
• What are the drivers and resistors of the specialty pharma market?
• What are the leading players in the specialty pharmaceutical sector?

Job in Pharmaceutical Industry

Health has taken a new dimension in everyone’s life. Every individual is getting more health conscious compare to earlier time. In an era where diseases are spreading day by day, the Pharmaceutical Jobs are increasing at a rapid pace. To keep the demand in check the Pharmaceutical companies are focusing more on expansion plans. Pharmaceutical Industry in recent time has shown tremendous growth. There has been a sudden rise in demand and supply. Even the mergers and acquisitions have been seen in recent period. Without a doubt the pharmaceutical industry is one the fastest growing industry which ensures job opportunities for job seekers.

Pharmaceutical careers have attracted many enthusiastic young people with job security and growth. More job opportunities compared to last year has been seen in the sector. The youth is now giving more preference to Pharmaceutical Careers. Pharmaceutical companies has started hiring freshers and experienced staff with lucrative packages and incentives. Job opportunities are seen not only in manufacturing and research side but are also visible in sales and marketing of medicines. Pharmaceutical industry has added to its growth by organizing informative pharmaceutical events globally. There are large numbers of Pharmaceutical consultants that are covering all kinds of diseases and providing right kinds of medical products to pharmacy stores and hospitals.

Pharmaceutical industry thus plays an important role in providing pharmaceutical jobs to science graduate as well as to non science graduate in the field of marketing and sales. The growth of the industry has given good competition to other sectors like IT and Manufacturing, which are prone to fluctuate with market condition. These industries have seen many layoffs and cutoffs during global crises. Thus Pharmaceutical Careers are preferably more secure and safe in time of crises.

Investment Opportunities in Pharmaceutical Industry of India

Amongst all the countries that fall under the category of developing countries, Indian pharmaceutical industry is one of the biggest and the most advanced. This industry has been a boon to the Indian economy. It provides employment to a huge number of people and ensures that vital drugs are made available to the huge population of India at affordable rates.

The drugs and pharmaceutical industry plays a pivotal role in the economic development of India. Being a very intense knowledge-based industry, it offers innumerable business opportunities for investors worldwide. Indian pharmaceutical exports accounts for export to more than 200 countries around the world. The annual turnover of pharmaceutical products contributes to about US$ 17 billion. In recent times, the Indian pharmaceutical industry has shown tremendous growth in terms of infrastructure development, product usage, and technology.

The pharmaceutical industry in India provides several opportunities for investments and trade due to the following factors:

With respect to India’s huge population it is an excellent center for clinical trials.
India has efficient and cost-effective sources for getting a hold of generic drugs, especially the drugs that are going off their patents in the coming years.
India has abundant manpower with strong scientific, technical knowledge.
The cost involved for research and development is very low.
The production cost of quality drugs in bulk quantities is very low.
India houses excellent laboratories with world-class facilities. It has laboratories that specialize in process development and the development of cost-efficient drug manufacturing technology.
India is self-reliant in terms of the production of bulk drugs. Almost 70% of the requirements for the formulation of drugs is available within the country itself.
Another important factor that is responsible for attracting foreign investments in the Indian pharmaceutical sector is the increasing balance of trade in the pharma sector.
India’s fast growing biotech industry, which offers great potential in the international market, also has contributed in making the pharma sector in India an attractive industry to make investments.
Besides the presence of different systems of medicines, such as Siddha, Naturopahy, Ayurveda, Homeopathy apart from its strengths in manufacturing makes the Indian pharmaceutical industry an attractive industry to invest in.

Due to all these advantageous factors, India is recognized as one of the leading players in pharmaceuticals in the global market.

The Indian pharmaceutical industry got a major boost with the signing of the General Agreement on Tariffs and Trade in 2005. This agreement helped India to recognize global patents. After recognizing global patents, the Indian pharmaceutical market has become a sought-out destination for foreign players to invest in the sector. Also, investment in pharmaceutical industry has vastly increased over the years since the industrial licensing for a huge number of drugs and pharmaceutical products has been abolished.

The Department of Chemicals and Petrochemicals, which falls under the Ministry of Chemicals and Fertilizers, overlooks all the planning, developing, and regulating of the pharmaceutical industry in India. The ministry permits up to 100% foreign investment provided that the investor adheres to certain stipulations laid down by the government. The ministry allows for exemption from price control for a period of 15 years if the product is patented under the Indian Patent Act and is developed through indigenous R&D in the country.

Thus, with such remarkable initiative of the Indian government, the Indian prospective pharmaceutical industry looks extremely positive for attracting more foreign investments.

The Top 10 Pharmaceutical Companies in Latin America: Growth performance, strategies and SWOT analysis

The leading pharmaceutical companies in Latin America comprise multinational companies and domestic players. Brazil, Mexico, Venezuela and Argentina remained the major markets in Latin America with a market share of around 90%. This report provides an insight into the current state of the Latin American pharmaceutical industry, market structure, pricing, regulation, as well as evolving trends. This report profiles the top ten pharmaceutical companies in Latin America and provides a brief summary of the 11 to 20 players. The report also gives a strategic insight into the companies , brands, therapeutic classes and geographic breakdown of the revenue generated by these companies in Latin America. The top 10 companies were assessed on following parameters: each company’s market share in the Latin American pharmaceutical market; key marketed products, geographic and therapeutic focus; growth strategies; key mergers and acquisitions; business-related strengths and weaknesses of these companies; and insights into the opportunities and threats facing them.

Key features of this report

• Market dynamics of the Latin American pharmaceutical market during the period 2004–08.
• Key market drivers and resistors in the Latin American market.
• Trends of the Latin American pharmaceutical market.
• Profile of top 10 players in the Latin American pharmaceutical market.
• Company analysis and market share of the top 10 players in the Latin American pharmaceutical market.

Scope of this report

• Develop insights for the Latin American pharmaceutical market, pricing and regulation, intellectual property rights and trends in these countries.

• Quickly understand how recent events are affecting the performance of major company’s products and how their marketers are confronting competitive challenges in the Latin American market.

• Gain up-to-date competitive intelligence across a wide-range of marketed products, R&D pipeline, market share data, sales forecast and competitive landscape for the major players in the Latin American pharmaceutical market.

• Save time, money and resources on analyzing the performance of the key Latin American pharmaceutical companies using this report.

Key Market Issues

• Regulatory environment in Latin America: The regulatory frameworks in Latin American countries have improved rapidly after they became signatories to TRIPS and various other international trade treaties. Overall, the aim of regional regulatory protocols to reduce pharmaceutical costs have indirectly promoted the generic industry.

• Rising trial registrations: Global drug giants have all entered Latin America for conducting clinical trials in recent years. An increase in research investments is result of the fast-paced regional socioeconomic transformation. Apart from the rising economic status, which has ensured better return on investments, improvement in healthcare infrastructure played an important role in attracting clinical trial projects from multinational pharmaceutical companies to the region.

• Regulatory harmonization and tie-ups: In the last few years, there has been increased activity in regulatory interaction between the Latin American countries. These countries are also involved in collaborations with regulators of EU nations. The intention is to harmonize the regulatory framework in the region.

• Compulsory licensing trends in Latin America: The compulsory licensing policy of Latin American countries is modeled on those used in most developed countries. Such an action is taken only when certain life sustaining drugs are in short supply.

Key findings from this report

• Latin American economies have been relatively less affected by the global economic meltdown compared to their developed counterparts.

• In 2008 the top 10 companies managed to capture around 40% of the Latin American market. Brazil followed by Mexico remained the leading markets in the Latin American region.

• The regulatory scenario in the Latin American region is continuously evolving, despite the fact that improvements in patent legislation protection of intellectual property are uncertain.

• According to Pharmaceutical Research and Manufacturers of America (PhRMA, US), lack of implementation of data exclusivities, non-approval of second use patent, drug counterfeiting and the regulatory backlogs are the major concerns in Latin American market.

Key questions answered

• What was the market size of the Latin American pharmaceutical market in 2008?
• What are the important trends in the Latin American market?
• Who were the top 10 players in the Latin American market in 2008?
• How are the companies positioned in the Latin American market in terms of geographic focus?
• Which are the key therapeutic areas in Brazil, Mexico, Venezuela, Argentina, Colombia, Chile & Peru?

FDA Audit- A Necessary Evil of Pharmaceutical Manufacturing Company

The Pharmaceutical manufacturing industry is governed by regulations which are different in different countries. A regulatory pharmaceutical FDA audit is an imperative and apparently feared event. The fortune of a pharmaceutical manufacturing marketing license depends on its final result. According to the diverse market’s demand, many regulatory agencies periodically have to adhere the standard and regulations of the company. The pre-determined regulatory standards are a part of series of activities and procedures reviewed by FDA audit. In general, FDA audit in pharmaceutical industry is distinctly positioned to determine the existing capability of manufacturing processes to affirm safety and standardization. The whole process is outlines by an audit report and provides an abstract of the audit findings.

It is desirable in every progressive pharmaceutical manufacturing company that the audited report be induced to grow a positive and professional attitude. In this process of audit, the skills of each participant should be upgraded and enhanced. The goal for highest possible standards cannot be considered as being too ambitious. Constant and fierce competition demands the “Right First Time” approach. Safety and promise quality can be ensured only by accurate assessment and thus help to evolve best practices. FDA audit is acknowledged as a necessary evil by innumerable professional involved in pharmaceutical manufacturing units. It has to be faced with preparation and one has to adapt accordingly.

It has been highlighted that focused training in this field is a neglected area. Many individuals have been self-trained in this procedure only because they have been subjected to several audits in the past. The success rate is dependent on the experience they have gained gradually.

With the emerging and evolving market, quality and regulatory affairs professional should be trained and retrained for audits. The basic aim of audits in pharmaceutical manufacturing companies is to evolve and collectively prescribe an acceptable level of safety. The acceptance of the audits is subjected to procedures set by the foremost Regulatory Agencies, USFDA, MHRA and other European agencies.

Gradually the pharmaceutical industry has learnt the importance of FDA audits. The industry has accepted that an audit helps in standardizing practices and procedures of the company. It is further recommended that one should attend a workshop and participate in discussion of FDA audit.