Small Molecule Drug Discovery Market Overview
As per National Cancer Institute “a substance which is able to enter cells easily due to its low molecular weight and after entering inside the cells, it affects other molecules such as proteins and may cause cancer cells to die. These small molecule drugs are different from other drugs which have a large molecular weight. So, these targeted therapies are small-molecule drugs or small molecule inhibitors. The increasing applications of small molecule drugs for the treatment of chronic diseases are leading to the increased demand for these drugs in the market. Moreover, due to the aforementioned factors, small molecule drugs dominate the biologics in the current healthcare market. The preference of small molecules, along with the increasing disease complications and technological advancements, has lead major players to increase their R&D expenditure, which is further acting as a major growth driver for the global small molecule drug discovery market.
The rise in Demand for Small Molecule Drugs Boost the growth of Small Molecule Drug Discovery Market
Small molecules continue to maintain increasing applications in drug discovery and development of biopharmaceutical companies. Some of the primary reasons for their demand are their ability to be formulated in several dosage forms, such as pills and tablets, increasing patient preference for oral dosing, lower manufacturing costs, with ease of transportation. In 2017, the Center for Drug Evaluation and Research (CDER), division of US Food and Drug Administration (FDA) approved 46 new drug approvals of 33, with an average of 31 each year. There is a significant increase in the growth of priority drugs having significant improvement than those in the market and orphan drugs, particularly for both new molecular entity (NME) and biologic license applications (BLAs). There is a rise in new drug classes, such as protein kinase inhibitors, which has significantly revitalized the existence of the small molecules industry in the modern day medicine consumption. The trend toward shifting focus on orphan diseases has increased the volumes in small molecule active pharmaceutical ingredients (APIs). In addition, the pharmaceutical industry is constantly evolving. Small molecules still contribute to about 85% of the therapeutics in the pharmaceuticals. Other factors. Such as ease to make, largely scalable, and with high profitability, are often tailored-made for the smaller sub-section of patients suffering from genetic diseases, for example, Ivacaftor for cystic fibrosis patients. The diverse chemical compounds, which share nothing common except that their size is below 900 Dalton, are made from synthetic chemical reactions, and they have enormous potential to treat complex diseases. Roche in recent years has restructured its small molecule manufacturing plant, which shows the growing significance of small molecules in spite of the advent of biologic therapies.
High Drug Development Cost Hinders the Growth of Small Molecule Drug Discovery Market
The cost of developing a drug depends on multiple factors that can put the range the cost of a drug between USD 10 million to around USD 2 billion. According to a study conducted in 2014 by the Tufts Center for the Study of Drug Development (TCSDD), the cost of the drug from R&D to marketing approval was about USD 2.9 billion. Some of the major factors for high cost include the cost of failures of drug candidates in trial stages. A high percentage of drugs that were tested on patients do not reach the market since were unsafe or ineffective. Apart from that, the return on investment (ROI) is declining significantly, which keeps the pharmaceutical companies under pressure for increasing their success rate in limited resources to reduce the cost of failure. Companies try to adopt several strategies, such as forming public and private collaborations and increase the success rate. Several pharmaceutical companies are reducing their drug development costs by finding and eliminating in R&D and data management process. In 2017, the US FDA chief commissioner Scott Gottlieb discussed the increasing cost of drug development and released Strategic Policy Roadmap, as steps to better evaluate and cultivate new approaches as part of ongoing efforts to modernize drug development approaches. Furthermore, it was mentioned that instead of conducting the usual three phases of the study, one adaptive study where phases are separated by interim monitoring could be essential. Behind the success of one drug targeting complex and poorly understood conditions, drug failures are of high percentage, sometimes crossing 90%, where the failures become a certainty rather than risk. Here, high cost becomes one of the primary barriers for the growth of the small molecule drug discovery market. Several big pharmaceutical companies go through that phase, such as failure of Phase III EPOCH trial by Merck against Alzheimer’s. The big companies sustain losses for some period. However, small- and medium-sized companies are significantly affected by losses, such as in 2016, NewLink Genetics laid off 87 employees following the failure of one of their major drug candidate. Recently in 2018, the shares of NewLink dropped by 43%, due to the failure of Phase III drug cancer-fighting IDO (Indoleamine 2,3-dioxygenase) inhibitor epacadostat. Thus, the high cost of drug development remains a major barrier in this industry.
Market Segmentation Insights for the Small Molecule Drug Discovery Market
Oncology has the largest share about 35% in the small molecule drug discovery market in 2017 as the prevalence of various cancers, such as breast, lung, cervical, prostate, and other cancers are growing rapidly. Also, multiple biologic drugs targeting the immune checkpoint proteins PD(L)1 or CTLA4 have been approved and/or are in advanced stages of clinical development for many cancers. As per the data published by the Quintiles-IMS, between the years 2011-2015, 42 new cancer medicines were launched globally. The effectiveness of cancer immunotherapy with biologics is spurring research in alternate approaches including the small-molecule-mediated targeting of intracellular pathways modulating the innate and adaptive immune response and is also growing with the highest CAGR in the market.
By Process/phase segment lead optimization has the largest share in the market in 2017 as lead identification/optimization is one of the most important steps in drug development. In order to increase potency, selectivity, or pharmacokinetic parameters, the chemical structure of the lead compound is used as an initial point for chemical modifications. Also, a rise in cancer and other neglected diseases is encouraging investments in lead optimization for enhanced therapeutic value, in order to provide patients with efficient and targeted therapies. However, Target Identification/Validation is growing rapidly registering a CAGR of 9.5% in the future forecast.
North America is dominating the Small Molecule Drug Discovery market
The North America market occupies the largest share of the global market owing to its high investments in drug discovery activities. Some estimates indicate that 64% of all research on new drugs approved in the last ten years was done in the United States. This shows that the United States is focusing on R&D activities to meet the increasing demands of its citizens, ultimately leading the market of North America. Also, there is an increasing number of contract organizations for research and development, increasing the use of small molecules in the treatment of chronic diseases, and high research and development expenditure in small molecule drugs. Hence, the market for small molecule drug discovery is expected to grow during the forecast period in North America.
Key Developments in the Small Molecule Drug Discovery Market
- Dec 2017: Pfizer entered into an agreement to Develop and Commercialize CRESEMBA® (isavuconazole) in China and Asia-Pacific Region.
- Dec 2017: Teva Pharmaceutical launched a generic version of Viread that is used for the treatment of HIV-1 infection in adults and pediatric patients
The major companies include Pfizer Inc., Bristol- Myers Squibb, Merck & Co., Boehringer Ingelheim Gmbh, GlaxoSmithKline, AstraZeneca, Johnson & Johnson, Gilead Sciences Inc., and Teva Pharmaceuticals among others.
Small Molecule Drug Discovery Market Segmentation
- Therapeutic Area
- Central Nervous System
- By Process Phase
- Target Id/Validation
- Hit Generation and Selection
- Lead Identification
- Lead Optimization By Geography
- North America
- Asia Pacific
- South Korea
- The Middle East and Africa
- South Africa
- South America
- North America
Country-Level Data Points Coverage and Deliverables for Small Molecule Drug Discovery Market
Small Molecule Drug Discovery Market Report Summary
Small Molecule Drug Discovery Market
(2015 – 2023)
By Therapeutic area, the market studied has been further segmented into oncology, central nervous system, cardiovascular, respiratory, metabolic disorders, gastrointestinal, orthopedics, anti-infective, dermatology, immunology, and other therapeutic areas. By process/phase, the market studied has been segmented into target id/validation, hit generation and selection, lead identification, and lead optimization.
North America (US, Canada, Mexico), Europe (UK, Germany, France, Italy Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Australia, South Korea and Rest of Asia Pacific), Middle East & Africa (GCC, South Africa and Rest of MEA) and South America (Brazil, Argentina and Rest of South America)
Dec 2017: Pfizer entered into an agreement to Develop and Commercialize CRESEMBA® (isavuconazole) in China and Asia-Pacific Region.
Pfizer Inc., Bristol- Myers Squibb, Merck & Co., Boehringer Ingelheim Gmbh, GlaxoSmithKline, AstraZeneca, Johnson & Johnson, Gilead Sciences Inc., and Teva Pharmaceuticals among others.
Small Molecule Drug Discovery Market offers latest trends, growth prospects, industry competitiveness, major players, regional share of market and forecast to 2023.
Reasons to Purchase the Small Molecule Drug Discovery Market Report
- Current and future of small molecule drug discovery market outlook in the developed and emerging markets
- Analysis of various perspectives of the market with the help of Porter’s five forces analysis
- The segment that is expected to dominate the market
- Regions that are expected to witness the fastest growth during the forecast period
- Identify the latest developments, market shares, and strategies employed by the major market players
- 3-month analyst support, along with the market estimate sheet (in Excel)
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1.1 Market Definition
2. Research Methodology
3. Executive Summary
4. Key Inferences
5. Market Overview
5.1 Current Market Scenario
5.2 Porters Five Forces
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threats of New Entrants
5.2.4 Threat of Substitute Product and Services
5.2.5 Competitive Rivalry Within the Industry
6. Drivers, Restraints, Opportunities And Challenges Analysis (DROC)
6.1 Market Driver
6.1.1 Rise in Demand for Small Molecule Drugs
6.1.2 Dominance of Small Molecules in the Market
6.1.3 Increasing Number of Contract Organizations for R&D
6.1.4 Small Molecules in Treatment of Chronic Diseases
6.1.5 High R&D Expenditure in Small Molecule Drugs
6.2 Market Restraints
6.2.1 High Drug Development Cost
6.2.2 Strict Regulations
6.4 Key Challenges
7. Market Segmentation
7.1 By Therapeutic Area
7.1.2 Central Nervous System
7.2 By Process Phase
7.2.1 Target Id/Validation
7.2.2 Hit Generation and Selection
7.2.3 Lead Identification
7.2.4 Lead Optimization
7.3 By Geography
7.3.1 North America
22.214.171.124 United States
126.96.36.199 United Kingdom
188.8.131.52 Rest of Europe
184.108.40.206 Australia & New Zealand
220.127.116.11 South Korea
18.104.22.168 Rest of Asia-Pacific
7.3.4 Middle East & Africa
22.214.171.124 South Africa
126.96.36.199 Rest of Middle East & Africa
7.3.5 South America
188.8.131.52 Rest of South America
8. Competitive Landscape
8.1 Mergers and Acquisition Analysis
8.2 Agreements, Collaborations & Partnerships
8.3 New Products Launches
9. Company Profiles
9.1 Pfizer Inc
9.2 Bristol- Myers Squibb
9.3 Merck & Co.
9.4 Boehringer Ingelheim Gmbh
9.7 Johnson & Johnson
9.8 Gilead Sciences, Inc.
9.9 Teva Pharmaceuticals
10. Future Outlook of the Market